Kaminaka, Akihiro; Nakano, Tamaki; Ono, Shinji; Kato, Tokinori; Yatani, Hirofumi
2015-10-01
This study evaluated changes in the horizontal and vertical dimensions of the buccal alveolar bone and soft tissue over a 1-year period following implant prosthesis. Thirty-three participants with no history of guided bone regeneration or soft tissue augmentation underwent dental implant placement with different types of connections. The dimensions of the buccal alveolar bone and soft tissue were evaluated immediately and at 1 year after prosthesis from reconstructions of cross-sectional cone-beam computed tomography images. The vertical and horizontal loss of buccal bone and soft tissue around implants with conical connections were lower than around those with external or internal connections. Statistically significant negative correlations were observed between initial horizontal bone thickness and changes in vertical bone and soft tissue height (p < .05), and between initial horizontal soft tissue thickness and the change in vertical soft tissue height (p < .05). Implants with a conical connection preserve peri-implant alveolar bone and soft tissue more effectively than other connection types. Furthermore, the initial buccal alveolar bone and soft tissue thickness around the implant platform may influence their vertical dimensional changes at 1 year after implant prosthesis. © 2014 Wiley Periodicals, Inc.
Toward Balance Recovery With Leg Prostheses Using Neuromuscular Model Control
Geyer, Hartmut
2016-01-01
Objective Lower limb amputees are at high risk of falling as current prosthetic legs provide only limited functionality for recovering balance after unexpected disturbances. For instance, the most established control method used on powered leg prostheses tracks local joint impedance functions without taking the global function of the leg in balance recovery into account. Here we explore an alternative control policy for powered transfemoral prostheses that considers the global leg function and is based on a neuromuscular model of human locomotion. Methods We adapt this model to describe and simulate an amputee walking with a powered prosthesis using the proposed control, and evaluate the gait robustness when confronted with rough ground and swing leg disturbances. We then implement and partially evaluate the resulting controller on a leg prosthesis prototype worn by a non-amputee user. Results In simulation, the proposed prosthesis control leads to gaits that are more robust than those obtained by the impedance control method. The initial hardware experiments with the prosthesis prototype show that the proposed control reproduces normal walking patterns qualitatively and effectively responds to disturbances in early and late swing. However, the response to mid-swing disturbances neither replicates human responses nor averts falls. Conclusions The neuromuscular model control is a promising alternative to existing prosthesis controls, although further research will need to improve on the initial implementation and determine how well these results transfer to amputee gait. Significance This work provides a potential avenue for future development of control policies that help improve amputee balance recovery. PMID:26315935
Categorization of compensatory motions in transradial myoelectric prosthesis users.
Hussaini, Ali; Zinck, Arthur; Kyberd, Peter
2017-06-01
Prosthesis users perform various compensatory motions to accommodate for the loss of the hand and wrist as well as the reduced functionality of a prosthetic hand. Investigate different compensation strategies that are performed by prosthesis users. Comparative analysis. A total of 20 able-bodied subjects and 4 prosthesis users performed a set of bimanual activities. Movements of the trunk and head were recorded using a motion capture system and a digital video recorder. Clinical motion angles were calculated to assess the compensatory motions made by the prosthesis users. The video recording also assisted in visually identifying the compensations. Compensatory motions by the prosthesis users were evident in the tasks performed (slicing and stirring activities) as compared to the benchmark of able-bodied subjects. Compensations took the form of a measured increase in range of motion, an observed adoption of a new posture during task execution, and prepositioning of items in the workspace prior to initiating a given task. Compensatory motions were performed by prosthesis users during the selected tasks. These can be categorized into three different types of compensations. Clinical relevance Proper identification and classification of compensatory motions performed by prosthesis users into three distinct forms allows clinicians and researchers to accurately identify and quantify movement. It will assist in evaluating new prosthetic interventions by providing distinct terminology that is easily understood and can be shared between research institutions.
Rosenberg, Nahum; Neumann, Lars; Modi, Amit; Mersich, Istvan J; Wallace, Angus W
2007-01-01
Background The uncemented Nottingham Total Shoulder Replacement prosthesis system (Nottingham TSR) was developed from the previous BioModular® shoulder prosthesis taking into consideration the causes of the initial implant's failure. We investigated the impact of changes in the design of Nottingham TSR prosthesis on its survivorship rate. Methods Survivorship analyses of three types of uncemented total shoulder arthroplasty prostheses (BioModular®, initial Nottingham TSR and current Nottingham TSR systems with 11, 8 and 4 year survivorship data respectively) were compared. All these prostheses were implanted for the treatment of disabling pain in the shoulder due to primary and secondary osteoarthritis or rheumatoid arthritis. Each type of the prosthesis studied was implanted in consecutive group of patients – 90 patients with BioModular® system, 103 with the initial Nottingham TSR and 34 patients with the current Nottingham TSR system. The comparison of the annual cumulative survivorship values in the compatible time range between the three groups was done according to the paired t test. Results The 8-year and 11-year survivorship rates for the initially used modified BioModular® uncemented prosthesis were relatively low (75.6% and 71.7% respectively) comparing to the reported survivorship of the conventional cemented implants. The 8-year survivorship for the uncemented Nottingham TSR prosthesis was significantly higher (81.8%), but still not in the desired range of above 90%, that is found in other cemented designs. Glenoid component loosening was the main factor of prosthesis failure in both prostheses and mainly occurred in the first 4 postoperative years. The 4-year survivorship of the currently re-designed Nottingham TSR prosthesis, with hydroxylapatite coating of the glenoid baseplate, was significantly higher, 93.1% as compared to 85.1% of the previous Nottingham TSR. Conclusion The initial Nottingham shoulder prosthesis showed significantly higher survivorship than the BioModular® uncemented prosthesis, but lower than expected. Subsequently re-designed Nottingham TSR system presented a high short term survivorship rate that encourages its ongoing use PMID:17683577
Yamanaka, Hajime; Goto, Ken-ichiro; Suzuki, Munetaka
2012-02-22
Total knee arthroplasty (TKA) is a common form of treatment to relieve pain and improve function in cases of rheumatoid arthritis (RA). Good clinical outcomes have been reported with a variety of TKA prostheses. The cementless Hi-Tech Knee II cruciate-retaining (CR)-type prosthesis, which has 6 fins at the anterior of the femoral component, posterior cruciate ligament (PCL) retention, flat-on-flat surface component geometry, all-polyethylene patella, strong initial fixation by the center screw of the tibial base plate, 10 layers of titanium alloy fiber mesh, and direct compression molded ultra high molecular weight polyethylene (UHMWPE), is appropriate for TKA in the Japanese knee.The present study was performed to evaluate the clinical results of primary TKA in RA using the cementless Hi-Tech Knee II CR-type prosthesis. We performed 32 consecutive primary TKAs using cementless Hi-Tech Knee II CR-type prosthesis in 31 RA patients. The average follow-up period was 8 years 3 months. Clinical evaluations were performed according to the American Knee Society (KS) system, knee score, function score, radiographic evaluation, and complications. The mean postoperative maximum flexion angle was 115.6°, and the KS knee score and function score improved to 88 and 70 after surgery, respectively. Complications, such as infection, occurred in 1 patient and revision surgery was performed. There were no cases of loosening in this cohort, and prosthesis survival rate was 96.9% at 12 years postoperatively. These results suggest that TKA using the cementless Hi-Tech Knee II CR-type prosthesis is a very effective form of treatment in RA patients at 5 to 12 years postoperatively. Further long-term follow-up studies are required to determine the ultimate utility of this type of prosthesis.
Treatment based on the type of infected TKA improves infection control.
Kim, Young-Hoo; Choi, Yoowang; Kim, Jun-Shik
2011-04-01
A classification system with four types of infected TKAs has been commonly used to determine treatment, especially with regard to whether the prosthesis should be removed or retained. We asked whether (1) the classification-dictated treatment of the four types of infection after TKA would control infection and maintain functional TKA; (2) repeated débridement and two-stage TKA would further improve the infection control rate after initial treatment; and (3) fixation of TKA prosthesis to the host bone was achieved. We retrospectively reviewed 114 patients with 116 infected TKAs. We determined the infection control rate after initial treatment, repeated débridement and two-stage TKA. We evaluated the functional and radiographic results using the Knee Society and Hospital for Special Surgery knee scoring systems. The minimum followup was 2 years (mean, 5.6 years; range, 2-8 years). The overall infection control rate was 100% in all patients. All patients with early superficial postoperative infection, 94% of patients with early deep postoperative infection, 96% of patients with late chronic infection, and 86% of patients with acute hematogenous infection maintained functioning knee prosthesis at the final followup. One hundred nine of the 114 patients could walk with no or only slight pain and maintained functioning knee prostheses. These 109 patients had stable fixation of the TKA prosthesis to host bone. The techniques proposed by the classification effectively controlled infection and maintained functional TKA with firm fixation of the TKA prosthesis in most patients. Repeated débridement and two-stage TKA further improved the control of infection and functional TKA after initial treatment. Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
Effects of alignment on the roll-over shapes of prosthetic feet.
Hansen, Andrew
2008-12-01
Recent work suggests that a prosthetic ankle-foot component's roll-over shape - the effective rocker it conforms to between initial contact and opposite initial contact (the 'roll-over' interval of walking) - is closely linked to its final alignment in the prosthesis (as determined by a skilled prosthetist using heuristic techniques). If true, this information may help to determine the appropriate alignment for a lower limb prosthesis before it is built, or a priori. Knowledge is needed for future models that will incorporate the roll-over shape including the relative effect of alignment on the roll-over shape's radius of curvature and arc length. The purpose of this study was to evaluate the hypotheses that: (i) Changes in prosthesis alignment alter the position and orientation of a foot's roll-over shape in prosthesis-based coordinates, and (ii) these changes occur without changing the radius of curvature or arc length of the roll-over shape. To examine the hypotheses, this study examined the effects of nine alignment settings on the roll-over shapes of two prosthetic feet. The idea that alignment changes move and rotate roll-over shapes of prosthetic feet in prosthesis coordinates is supported by this work, but the hypothesis that the radius of curvature and arc length do not change for different alignments is not strongly supported by the data. A revised approach is presented that explains some of the changes to the roll-over shape parameters due to changes in rotational alignment.
Intention detection of gait initiation using EMG and kinematic data.
Wentink, E C; Beijen, S I; Hermens, H J; Rietman, J S; Veltink, P H
2013-02-01
Gait initiation in transfemoral amputees (TFA) is different from non-amputees. This is mainly caused by the lack of stability and push-off from the prosthetic leg. Adding control and artificial push-off to the prosthesis may therefore be beneficial to TFA. In this study the feasibility of real-time intention detection of gait initiation was determined by mimicking the TFA situation in non-amputees. EMG and inertial sensor data was measured in 10 non-amputees. Only data available in TFA was used to determine if gait initiation can be predicted in time to control a transfemoral prosthesis to generate push-off and stability. Toe-off and heel-strike of the leading limb are important parameters to be detected, to control a prosthesis and to time push-off. The results show that toe-off and heel-strike of the leading limb can be detected using EMG and kinematic data in non-amputees 130-260 ms in advance. This leaves enough time to control a prosthesis. Based on these results we hypothesize that similar results can be found in TFA, allowing for adequate control of a prosthesis during gait initiation. Copyright © 2012 Elsevier B.V. All rights reserved.
Wijdenes, Paula; Brouwers, Michael; van der Sluis, Corry K
2018-02-01
In order to create more uniformity in the prescription of upper limb prostheses by Dutch rehabilitation teams, the development and implementation of a Prosthesis Prescription Protocol of the upper limb (PPP-Arm) was initiated. The aim was to create a national digital protocol to structure, underpin, and evaluate the prescription of upper limb prostheses for clients with acquired or congenital arm defects. Prosthesis Prescription Protocol of the Arm (PPP-Arm) was developed on the basis of the International Classification of Functioning and consisted of several layers. All stakeholders (rehabilitation teams, orthopedic workshops, patients, and insurance companies) were involved in development and implementation. A national project coordinator and knowledge brokers in each team were essential for the project. PPP-Arm was successfully developed and implemented in nine Dutch rehabilitation teams. The protocol improved team collaboration, structure, and completeness of prosthesis prescriptions and treatment uniformity and might be interesting for other countries as well. Clinical relevance A national protocol to prescribe upper limb prostheses can be helpful to create uniformity in treatment of patients with upper limb defects. Such a protocol improves quality of care for all patients in the country.
2012-01-01
Background Total knee arthroplasty (TKA) is a common form of treatment to relieve pain and improve function in cases of rheumatoid arthritis (RA). Good clinical outcomes have been reported with a variety of TKA prostheses. The cementless Hi-Tech Knee II cruciate-retaining (CR)-type prosthesis, which has 6 fins at the anterior of the femoral component, posterior cruciate ligament (PCL) retention, flat-on-flat surface component geometry, all-polyethylene patella, strong initial fixation by the center screw of the tibial base plate, 10 layers of titanium alloy fiber mesh, and direct compression molded ultra high molecular weight polyethylene (UHMWPE), is appropriate for TKA in the Japanese knee. The present study was performed to evaluate the clinical results of primary TKA in RA using the cementless Hi-Tech Knee II CR-type prosthesis. Materials and methods We performed 32 consecutive primary TKAs using cementless Hi-Tech Knee II CR-type prosthesis in 31 RA patients. The average follow-up period was 8 years 3 months. Clinical evaluations were performed according to the American Knee Society (KS) system, knee score, function score, radiographic evaluation, and complications. Results The mean postoperative maximum flexion angle was 115.6°, and the KS knee score and function score improved to 88 and 70 after surgery, respectively. Complications, such as infection, occurred in 1 patient and revision surgery was performed. There were no cases of loosening in this cohort, and prosthesis survival rate was 96.9% at 12 years postoperatively. Conclusion These results suggest that TKA using the cementless Hi-Tech Knee II CR-type prosthesis is a very effective form of treatment in RA patients at 5 to 12 years postoperatively. Further long-term follow-up studies are required to determine the ultimate utility of this type of prosthesis. PMID:22356935
Burma, O; Ustunsoy, H; Davutoglu, V; Celkan, M A; Kazaz, H; Pektok, E
2007-08-01
Tricuspid annuloplasty procedures have been widely performed in clinics for many years. The Kalangos Biodegradable Tricuspid Ring (Kalangos Biodegradable Tricuspid Ring, Bioring SA, Lonay, Switzerland) is a novel prosthesis for the treatment of tricuspid insufficiency. The aim of this study was to evaluate the clinical and echocardiographic results of this novel prosthesis for functional tricuspid insufficiency. Between October 2005 and May 2006, 15 patients with the diagnosis of moderate or severe functional tricuspid insufficiency were treated by implantation of a Kalangos Biodegradable Tricuspid Ring. All patients were evaluated clinically and by echocardiography preoperatively, and control tests were performed at the end of the 1st and 6th month following surgery. Moderate and severe insufficiency was documented in 11 and 4 patients, respectively, in the preoperative tests. 1 and 6 months after surgery, 4 patients had trace and 1 patient had mild tricuspid insufficiency, while 10 patients had none. At the 1st and 6th month follow-up, systolic pulmonary arterial pressure, right atrial dimension and right ventricular diastolic diameter were found to be significantly lower than the preoperative values ( P < 0.0001). The right atrial diameter and tricuspid valve area had decreased significantly at the end of the 1st month; however, no significant difference was found between the 1st and 6th month tests ( P > 0.05). Three-quarters of the annuloplasty ring had degraded at 6 months. No complications related to the prosthesis or the procedure occurred within this period. Kalangos Biodegradable Ring is a promising prosthesis in patients with functional tricuspid insufficiency, with encouraging initial results.
A second prosthesis as a procedural rescue option in trans-apical aortic valve implantation.
Kempfert, Jörg; Rastan, Ardawan J; Schuler, Gerhard; Linke, Axel; Holzhey, David; van Linden, Arnaud; Mohr, Friedrich-W; Walther, Thomas
2011-07-01
Trans-apical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved to a routine procedure for selected high-risk elderly patients. In rare cases, misplacement of the SAPIEN™ valve (too low a position), dysfunction of the leaflets or perforation of the interventricular septum (ventricular septal defect, VSD) occurs and requires immediate implantation of a second prosthesis within the first one. Results of this 'bailout' maneuver have not been reported yet. Of 305 TA-AVI procedures, 15 patients required a second prosthesis due to dysfunctional leaflets (n = 6), low position (n = 7), or VSD (n = 2). Mean age was 82.5 ± 1.3 years, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 45.5 ± 5.4, and Society of Thoracic Surgeons (STS) Score was 13.5 ± 1.5. All second SAPIEN™ valves could be implanted successfully within the first one. The second prosthesis solved leaflet dysfunction, sealed the VSD (lower position of the second prosthesis), or corrected the initial misplacement (higher position of the second prosthesis) in all patients. Within 30 days, four patients died (low cardiac output n = 3, all with preoperative ejection fraction (EF) <35%; intestinal ischemia n = 1). Intra-operative echocardiogram and angiogram revealed mild paravalvular leak in three and none/trace in 12 patients. Transvalvular gradients were low despite the implantation of the second valve (P(max)/mean 13.7 ± 4.3/6.4 ± 2.0). Placement of a second SAPIEN™ valve is a valuable 'bailout' technique in case of VSD, dysfunctional leaflets, or too low placement of the first prosthesis. The technique leads to an excellent functional result with low transvalvular gradients. The simple, straight, tubular stent design of the SAPIEN™ prosthesis may be the ideal design for such valve-in-valve procedures. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.
Matter-Parrat, V; Ronde-Oustau, C; Boéri, C; Gaudias, J; Jenny, J-Y
2017-04-01
Whether pre-operative microbiological sampling contributes to the management of chronic peri-prosthetic infection remains controversial. We assessed agreement between the results of pre-operative and intra-operative samples in patients undergoing single-stage prosthesis exchange to treat chronic peri-prosthetic infection. Agreement between pre-operative and intra-operative samples exceeds 75% in patients undergoing single-stage exchange of a hip or knee prosthesis to treat chronic peri-prosthetic infection. This single-centre retrospective study included 85 single-stage prosthesis exchange procedures in 82 patients with chronic peri-prosthetic infection at the hip or knee. Agreement between pre-operative and intra-operative sample results was evaluated. Changes to the initial antibiotic regimen made based on the intra-operative sample results were recorded. Of 149 pre-operative samples, 109 yielded positive cultures, in 75/85 cases. Of 452 intra-operative samples, 354 yielded positive cultures, in 85/85 cases. Agreement was complete in 54 (63%) cases and partial in 9 (11%) cases; there was no agreement in the remaining 22 (26%) cases. The complete agreement rate was significantly lower than 75% (P=0.01). The initial antibiotic regimen was inadequate in a single case. Pre-operative sampling may contribute to the diagnosis of peri-prosthetic infection but is neither necessary nor sufficient to confirm the diagnosis and identify the causative agent. The spectrum of the initial antibiotic regimen cannot be safely narrowed based on the pre-operative sample results. We suggest the routine prescription of a probabilistic broad-spectrum antibiotic regimen immediately after the prosthesis exchange, even when a pathogen was identified before surgery. IV, retrospective study. Copyright © 2017 Elsevier Masson SAS. All rights reserved.
Farrell, Brad J; Prilutsky, Boris I; Kistenberg, Robert S; Dalton, John F; Pitkin, Mark
2014-01-01
Background Despite the number of advantages of bone-anchored prostheses, their use in patients is limited due to the lack of complete skin-implant integration. The objective of the present study was to develop an animal model that would permit both detailed investigations of gait with a bone-anchored limb prosthesis and histological analysis of the skin-implant-bone interface after physiological loading of the implant during standing and walking. Methods Full-body mechanics of walking in two cats was recorded and analyzed before and after implantation of a percutaneous porous titanium pylon into the right tibia and attachment of a prosthesis. The rehabilitation procedures included initial limb casting, progressively increasing loading of implant, and standing and locomotor training. Detailed histological analysis of bone and skin ingrowth into implant was performed at the end of the study. Findings The two animals adopted the bone-anchored prosthesis for standing and locomotion, although loads on the prosthetic limb during walking decreased by 22% and 62%, respectively, 4 months after implantation. The animals shifted body weight to the contralateral side and increased propulsion forces by the contralateral hindlimb. Histological analysis of the limb implants demonstrated bone and skin ingrowth. Interpretation The developed animal model to study prosthetic gait and tissue integration with the implant demonstrated that porous titanium implants may permit bone and skin integration and prosthetic gait with a prosthesis. Future studies with this model will help optimize the implant and prosthesis properties. PMID:24405567
Hughey, Laura; Wheaton, Lewis A
2016-01-01
Loss of an upper extremity and the resulting rehabilitation often requires individuals to learn how to use a prosthetic device for activities of daily living. It remains unclear how prostheses affect motor learning outcomes. The authors' aim was to evaluate whether incidental motor learning and explicit recall is affected in intact persons either using prostheses (n = 10) or the sound limb (n = 10), and a chronic amputee on a modified serial reaction time task. Latency and accuracy of task completion were recorded over six blocks, with a distractor task between blocks 5 and 6. Participants were also asked to recall the sequence immediately following the study and at a 24-hr follow-up. Prosthesis users demonstrate patterns consistent with implicit learning, with sustained error patterns with the distal terminal device. More intact individuals were able to explicitly recall the sequence initially, however there was no significant difference 24 hr following the study. Acute incidental motor learning does not appear to diminish task related error patterns or accompany with explicit recall in prosthesis users, which could present limitations for acute training of prosthesis use in amputees. This suggests differing mechanisms of visuospatial sequential learning and motor control with prostheses.
Goulart, Douglas Rangel; Queiroz, Elizabeth; Fernandes, Aline Úrsula Rocha; Oliveira, Luciana Martins de
2011-01-01
Facial integrity is a condition which interferes in the daily life of the individual. The loss of an eyeball has psychological impact, requiring adaptation. Interventions such as prosthetic repair seem to lead to emotional and behavioral change. The objective of this study was to identify the psychosocial aspects related to unilateral anophthalmic socket and evaluate patient adaptation to prosthesis. All participants responded to a semi-structured interview. This was composed of two parts, the first regarding the general data of patient identification and socioeconomic aspects. The second part included information about eye loss and rehabilitation, with 31 questions. Twenty-eight volunteers were interviewed. Most were male (53.57%). Ages ranged between 11 and 67. Trauma was the prevalent etiological factor (60.71%). A significant statistical difference (p<0.05) was found between the scores of the feelings of loss before and after prosthesis (z Wilcoxon=-4.41; p<0.001). The data showed emotional difficulties in the initial contact with the loss of an eye and the role of the prosthesis as an element of social inclusion, stressing the importance of teamwork and access to fitting services in adapting these patients.
Evaluation of direct and indirect additive manufacture of maxillofacial prostheses.
Eggbeer, Dominic; Bibb, Richard; Evans, Peter; Ji, Lu
2012-09-01
The efficacy of computer-aided technologies in the design and manufacture of maxillofacial prostheses has not been fully proven. This paper presents research into the evaluation of direct and indirect additive manufacture of a maxillofacial prosthesis against conventional laboratory-based techniques. An implant/magnet-retained nasal prosthesis case from a UK maxillofacial unit was selected as a case study. A benchmark prosthesis was fabricated using conventional laboratory-based techniques for comparison against additive manufactured prostheses. For the computer-aided workflow, photogrammetry, computer-aided design and additive manufacture (AM) methods were evaluated in direct prosthesis body fabrication and indirect production using an additively manufactured mould. Qualitative analysis of position, shape, colour and edge quality was undertaken. Mechanical testing to ISO standards was also used to compare the silicone rubber used in the conventional prosthesis with the AM material. Critical evaluation has shown that utilising a computer-aided work-flow can produce a prosthesis body that is comparable to that produced using existing best practice. Technical limitations currently prevent the direct fabrication method demonstrated in this paper from being clinically viable. This research helps prosthesis providers understand the application of a computer-aided approach and guides technology developers and researchers to address the limitations identified.
Martinez, Daniel R; Terlecki, Ryan; Brant, William O
2015-11-01
Erectile dysfunction has plagued humanity for millennia. For years, treatment had been in the hands of mental health professionals. It was not until the 1970s that urologists created a modality that was marketable, reproducible, and consistently successful at treating impotence, the Small-Carrion Penile Prosthesis. We present the evolution of the malleable/semi-rigid penile prosthesis, concentrating our efforts reviewing and critiquing the pivotal article published by Drs. Michael P. Small, Hernan M. Carrion, and Julian A. Gordon. We then discuss its continued advancement, current-day utilization, and the future of the malleable prosthesis. From the early 1900s, surgeons have been toying with the idea of creating a penile implant. These initial attempts utilized rib cartilage, and eventually synthetic materials, including acrylic, silicone, and polyethylene. In 1975, Drs. Carrion and Small presented their initial experience of 31 patients utilizing their silicone implant. In their manuscript titled, "The Small-Carrion Penile Prosthesis: New Implant for the Management of Impotence," they discuss their technique, perioperative management of complications, and results. The malleable penile prosthesis continued to evolve throughout the years to the current day Genesis and Spectra. Although the current market is dominated by the inflatable penile prosthesis, there are specific situations where the malleable is ideally utilized. The pivotal article by Drs. Carrion and Small helped pave the way for the "New Era" of penile prosthetics and still remains one of the most impactful contributions to the management of erectile dysfunction. © 2015 International Society for Sexual Medicine.
2011-05-01
leg prosthesis for above-the-knee amputees currently commercialized by Ossur hf and developed by Victhom Human Bionics Inc., a medical device...did not feel they worked as hard when wearing the K-SRDTM version POC during the loaded conditions. However, based on our heart rate measured, there
Walking on uneven terrain with a powered ankle prosthesis: A preliminary assessment.
Shultz, Amanda H; Lawson, Brian E; Goldfarb, Michael
2015-01-01
A successful walking gait with a powered prosthesis depends heavily on proper timing of power delivery, or push-off. This paper describes a control approach which provides improved walking on uneven terrain relative to previous work intended for use on even (level) terrain. This approach is motivated by an initial healthy subject study which demonstrated less variation in sagittal plane shank angle than sagittal plane ankle angle when walking on uneven terrain relative to even terrain. The latter therefore replaces the former as the control signal used to initiate push-off in the powered prosthesis described herein. The authors demonstrate improvement in consistency for several gait characteristics, relative to healthy, as well as controller characteristics with the new control approach, including a 50% improvement in the consistency of the percentage of stride at which push-off is initiated.
Jiang, Fei-Fei; Hou, Yan; Lu, Li; Ding, Xiao-Xu; Li, Wei; Yan, Ai-Hui
2015-01-01
To evaluate the facial profiles and functional recovery of 18 patients treated by a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis) after total maxillectomy for malignant maxillary sinus tumor. A retrospective observational study was performed to evaluate the facial profiles and functional recovery of 18 patients with T3-4a N0 M0 maxillary sinus cancer, who were treated by total maxillectomy and simultaneous implantation of a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis). Follow-ups were performed 1, 3, 6, and 12 months after surgery. Facial measurements, speech intelligibility, and chewing and swallowing functions were examined. Thirteen patients converted to a permanent prosthesis 6 months after surgery. Comparisons were made between patients with and without the CAD/CAM or permanent prosthesis at various times using SPSS13.0 statistical software (SPSS Inc., Chicago, IL, USA). Speech intelligibility, facial depression, and eyeball prolapse results showed improvements with prosthesis use at 1, 3, and 6 months after surgery (p < 0.05). Swallowing function improved from level V to level II-IV with prosthesis use at 1, 3, and 6 months, and reached level I or II with permanent prosthesis use at 12 months after surgery. Simultaneous CAD/CAM prosthesis implantation recovered the facial profile, enhanced the speaking, swallowing, and chewing functions, and improved the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. Therefore, this operation is recommended for simultaneous excision repair and functional reconstruction after total maxillectomy. This surgical treatment of maxillary sinus cancer is applied rarely in China, but it has a good effect based on our observation. Simultaneous CAD/CAM prosthesis implantation after total maxillectomy can recover the facial profile, enhance the speaking, swallowing, and chewing functions, and improve the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. This technique avoids the need for dental implants because the bottom part of the prosthesis contains a palatal plate with dentures. © 2014 Wiley Periodicals, Inc.
Transcatheter heart valves for the treatment of aortic stenosis: state-of-the-art.
Del Valle-Fernández, R; Ruiz, C E
2008-10-01
Degenerative aortic stenosis is the most frequent heart valve disease. As an alternative to surgical aortic valve replacement, several companies are working on the development of new prosthesis designed to be deployed by transcatheter approaches. Both transfemoral and transapical techniques are feasible, and initial trials in high-risk patients show good procedural outcomes and mid-term (up to 2 years) functionality. Two first-generation prosthesis (Edwards-SAPIEN and CoreValve Revalving System) are commercially available in Europe, and a number of other second-generation valves (with the capabilities of repositioning and retrievability) are under evaluation. Among them, the Sadra-Lotus Valve, The Direct Flow Medical valve and the Paniagua Heart Valve have published first-in-man results; the JenaValve and AorTx devices have also been temporarily implanted in humans. The development of repositionable and retrievable prosthesis with improved profile is mandatory, and it is the main focus of current projects. Not only technical improvements but also operators specialization and an optimal patient selection are essential to improve these initial Some procedural challenges need to be overcome prior to the expansion of these techniques to lower risk groups, and time is needed for detailed long-term outcomes and risk estimations. Only with a close collaboration among different specialists, basic researchers and the industry will the future development of transcatheter aortic implantation techniques be ensured.
Benavent, Jose Vicente; Igual, Celedonia; Mora, Enrique; Antonio, Rosa; Tenias, Jose Maria
2016-12-01
The lack of specific prosthetic-related outcome instruments for Spanish amputees must be addressed. To elaborate a culturally equivalent version of the Prosthesis Evaluation Questionnaire in the Spanish language. Cross-cultural questionnaire validation. Two-step process for cultural adaptation: forward and backward translations of English original and Spanish translated versions; assessment of both construct and criterion validity and reliability in a group of vascular amputees. A total of 61 patients were recruited, 44 men (72.1%) and 17 women (27.9%), with a median age of 71.1 years (standard deviation: 7.7 years; range: 51-87 years). In the Prosthesis Evaluation Questionnaire-Spanish, the lowest scores were for gait and frustration, and the highest scores were for noise and stump health. Internal consistency of the questionnaire was acceptable (>0.70) for four of the scales used in the Prosthesis Evaluation Questionnaire but poor (<0.50) for the scales relating to appearance and stump health. Correlations with the quality-of-life levels as measured by the Short Form-36 were positive and mostly significant. Prosthesis Evaluation Questionnaire-Spanish could assess the quality of life in patients who have undergone vascular amputations and then been fitted with a prosthetic limb. The questionnaire shows adequate criteria validity when compared with other instruments for measuring quality of life. The Prosthesis Evaluation Questionnaire-Spanish could be a valid and reliable instrument for assessing adaptation to prostheses in vascular amputees. The questionnaire adds information relevant to the patient and the physician and may identify cases with poor expected adaptation to the prosthesis. © The International Society for Prosthetics and Orthotics 2015.
Hsi, David H; Ryan, Gerald F; Taft, Janice; Arnone, Thomas J
2003-01-01
An 81-year-old woman was evaluated for prosthetic mitral valve function. She had received a Harken disk mitral valve 29 years earlier due to severe mitral valve disease. This particular valve prosthesis is known for premature disk edge wear and erosion. The patients 2-dimensional Doppler echocardiogram showed the distinctive appearance of a disk mitral valve prosthesis. Color Doppler in diastole showed a unique crown appearance, with initial flow acceleration around the disk followed by convergence to laminar flow in the left ventricle. Cineradiographic imaging revealed normal valve function and minimal disk erosion. We believe this to be the longest reported follow-up of a surviving patient with a rare Harken disk valve. We present images with unique echocardiographic and cineangiographic features.
A 29-Year-Old Harken Disk Mitral Valve
Hsi, David H.; Ryan, Gerald F.; Taft, Janice; Arnone, Thomas J.
2003-01-01
An 81-year-old woman was evaluated for prosthetic mitral valve function. She had received a Harken disk mitral valve 29 years earlier due to severe mitral valve disease. This particular valve prosthesis is known for premature disk edge wear and erosion. The patient's 2-dimensional Doppler echocardiogram showed the distinctive appearance of a disk mitral valve prosthesis. Color Doppler in diastole showed a unique crown appearance, with initial flow acceleration around the disk followed by convergence to laminar flow in the left ventricle. Cineradiographic imaging revealed normal valve function and minimal disk erosion. We believe this to be the longest reported follow-up of a surviving patient with a rare Harken disk valve. We present images with unique echocardiographic and cineangiographic features. (Tex Heart Inst J 2003;30:319–21) PMID:14677746
Boston type 1 keratoprosthesis for failed keratoplasty.
Hager, Jonathan L; Phillips, David L; Goins, Kenneth M; Kitzmann, Anna S; Greiner, Mark A; Cohen, Alex W; Welder, Jeffrey D; Wagoner, Michael D
2016-02-01
The purpose of this study was to evaluate the outcomes of the Boston type 1 keratoprosthesis (Kpro-1) in eyes with failed keratoplasty. A retrospective review was performed of every patient treated with a Kpro-1 at a tertiary eye care center between January 1, 2008 and July 1, 2013. Eyes with a failed keratoplasty originally performed for corneal edema, trauma, or keratoconus were included in the statistical analysis. The main outcome measures were visual outcome, prosthesis retention, and postoperative complications. Twenty-four eyes met the inclusion criteria, including 13 eyes with corneal edema, 8 eyes with trauma, and 3 eyes with keratoconus. After a mean follow-up period of 28.9 months (range 7-63 months), the median best corrected visual acuity (BCVA) was 20/125. The BCVA was ≥ 20/40 in 4 (16.7 %) eyes, ≥ 20/70 in 9 (37.5 %) eyes, and ≥ 20/200 in 14 (58.3 %) eyes. Overall, the postoperative BCVA improved in 17 (70.9 %) eyes, was unchanged in 3 (12.5 %) eyes, and was worse in 4 (16.7 %) eyes. The initial Kpro-1 was retained in 22 (91.7 %) eyes, and was successfully repeated in the other 2 eyes. One or more serious prosthesis- or sight-threatening complications occurred in 8 (33.3 %) eyes. These included 1 case of wound dehiscence leading to prosthesis extrusion, 1 case of fungal keratitis leading to prosthesis extrusion, 4 cases of endophthalmitis, and 5 retinal detachments. The Boston Kpro-1 is associated with an excellent prognosis for prosthesis retention and satisfactory visual improvement in eyes with previous failed keratoplasty.
Paulu, D; Alaei, P
2012-06-01
To evaluate the ability of treatment planning algorithm to accurately predict dose delivered at the interface of high density implanted devices. A high density (7.6 g/cc) Cobalt-Chromium-Molybdenum hip prosthesis was molded into an epoxy-based cylindrical leg phantom. The phantom was designed to be separated in half to access the prosthesis and to place the TLDs. Using MVCT to image the apparatus, a simple treatment plan was developed using the Philips Pinnacle treatment planning system. Wires were placed in the molded epoxy to allow for accurate definition of measurement sites (TLD positions) along the surface of the prosthesis. Micro-cube TLDs (1 mm 3 ) were placed at six measurement locations for which the dose had been calculated by the treatment planning system. An Elekta Synergy linear accelerator was used to deliver a 400 cGy plan to the phantom with 6 MV photons in a single fraction. A total of four 10 cm × 21 cm fields were used at 0, 90, 180, and 270 degree gantry rotations. Initial results indicate that the measured dose is 7-17% lower than the dose calculated by the treatment planning system. Further study using high energy beams are also in progress. Initial results indicate that the treatment planning system does predict the dose near a high density prosthetic device within 10-15% but underestimates the dose. The results of this study could help in designing treatment plans which would reduce the uncertainty of the dose delivered in the vicinity of prosthetic hip implants and similar devices. © 2012 American Association of Physicists in Medicine.
Roubelakis, Apostolos; Karangelis, Dimos; Sadeque, Syed; Yanagawa, Bobby; Modi, Amit; Barlow, Clifford W; Livesey, Steven A; Ohri, Sunil K
2017-07-01
The treatment of complex prosthetic valve endocarditis (PVE) with aortic root abscess remains a surgical challenge. Several studies support the use of biological tissues to minimize the risk of recurrent infection. We present our initial surgical experience with the use of an aortic xenograft conduit for aortic valve and root replacement. Between October 2013 and August 2015, 15 xenograft bioconduits were implanted for complex PVE with abscess (13.3% female). In 6 patients, concomitant procedures were performed: coronary bypass (n=1), mitral valve replacement (n=5) and tricuspid annuloplasty (n=1). The mean age at operation was 60.3±15.5 years. The mean Logistic European system for cardiac operating risk evaluation (EuroSCORE) was 46.6±23.6. The median follow-up time was 607±328 days (range: 172-1074 days). There were two in-hospital deaths (14.3% mortality), two strokes (14.3%) and seven patients required permanent pacemaker insertion for conduction abnormalities (46.7%). The mean length of hospital stay was 26 days. At pre-discharge echocardiography, the conduit mean gradient was 9.3±3.3mmHg and there was either none (n=6), trace (n=6) or mild aortic insufficiency (n=1). There was no incidence of mid-term death, prosthesis-related complications or recurrent endocarditis. Xenograft bioconduits may be safe and effective for aortic valve and root replacement for complex PVE with aortic root abscess. Although excess early mortality reflects the complexity of the patient population, there was good valve hemodynamics, with no incidence of recurrent endocarditis or prosthesis failure in the mid-term. Our data support the continued use and evaluation of this biological prosthesis in this high-risk patient cohort.
2011-01-01
Background Testicular prosthesis has been applied clinically for decades, and implantation of testis prosthesis under the tunica albuginea has been considered to be the standard method in the most of the reports. However, postoperative scrotal appearance, the mobilization and the palpitation of the prosthesis are not always satisfactory to all the patients. Modifications in surgical techniques might be necessary to bring improvements to the clinical outcomes in testicular prosthesis implantation. Findings In a group of 9 beagle dogs in this study, an orchiectomy succeeded with a testicular prosthesis implantation under the tunica vaginalis, and a complete mechanical denudation of the testicular parenchyma succeeded with an implantation under the tunica albuginea were performed, respectively. Histopathological evaluations of the scrotal tissues and the implants, which were made at the end of the follow-up, showed that all the tested animals lived uneventful lives during the follow-up period, and no rejections or infections were found. Prostheses implanted under the tunica vaginalis showed a more satisfying mobilization and palpation than those implanted under the tunica albuginea. Chronic inflammation in the para-prosthesis tissues with vascular proliferation and fibrinogenesis were more common in the "under tunica albuginea" group than that in the "under tunica vaginalis" group, although differences in fibrinogenesis between the two groups were found to be statistically insignificant. Conclusions In this comparative study, we have re-evaluated the two most popular implantation methods of testicular prosthesis, the "under the tunica albuginea" and the "under the tunica vaginalis" pathways, in animal models. We found that the testicular prosthesis were all well tolerated, but the prosthesis implanted under the tunica vaginalis showed a more satisfying result concerning appearance, palpability, and histopathological findings than that of the "under the tunica albuginea" group. The "under the tunica vaginalis" method might become a more practical method for future testicular prosthesis implantation. PMID:21457571
Shi, Youxing; Tang, Kanglai; Yuan, Chengsong; Tao, Xu; Wang, Huaqing; Chen, Bo; Guo, Yupeng
2015-03-24
Modern shoulder prosthesis has evolved through four generations. And the fourth generation technology has a core three-dimensional design of restoring 3D reconstruction of proximal humeral anatomy. Thus a new shoulder prosthesis is developed on the basis of the technology of 3D prosthesis. Assessment of whether shoulder prosthesis can restore individualized reconstruction of proximal humeral anatomy is based on the adaptability of proximal humeral anatomy. To evaluate the adaptability of proximal humeral anatomy through measuring the parameters of proximal humeral anatomy after shoulder replacement with individualized shoulder prosthesis and compare with normal data. The parameters of proximal humeral anatomy were analyzed and evaluated for a total of 12 cases undergoing shoulder replacement with individualized shoulder prosthesis. The relevant anatomical parameters included neck-shaft angle (NSA), retroversion angle (RA), humeral head height (HH) and humeral head diameter (HD). And the anatomical parameters were compared with the data from normal side. All underwent shoulder replacement with individualized shoulder prosthesis. The postoperative parameters of proximal humeral anatomy were compared with those of normal side. And the difference of NSA was < 3°, RA < 3°, HH < 3 mm and HD < 2 mm. And paired-sample t test was used to study the parameters of proximal humeral anatomy between postoperative and normal side. The normal and postoperative NSA was (140.2 ± 6.8)° and (139.5 ± 6.6)° respectively, RA (34.4 ± 3.3)° and (33.8-3.1)°, HH (15.3 ± 2.1) mm and (14.6+0.9) mm, HW (42.2 ± 2.82) mm and (41.8 ± 2.33) mm respectively. No significant difference existed between two groups (P > 0.05). Individualized shoulder prosthesis has excellent adaptability to shoulder. All core parameters are freely adjustable and specification models may be optimized. With matching tools, individualized shoulder prosthesis improves the accuracy and reliability in shoulder replacement.
Berookhim, Boback M; Karpman, Edward; Carrion, Rafael
2015-11-01
The surgical treatment of comorbid erectile dysfunction and Peyronie's disease has long included the implantation of an inflatable penile prosthesis as well as a number of adjuvant maneuvers to address residual curvature after prosthesis placement. To review the various surgical options for addressing curvature after prosthesis placement, with specific attention paid to an original article by Wilson et al. reporting on modeling over a penile prosthesis for the management of Peyronie's disease. A literature review was performed analyzing articles reporting the management of penile curvature in patients undergoing implantation of an inflatable penile prosthesis. Reported improvement in Peyronie's deformity as well as the complication rate associated with the various surgical techniques described. Modeling is a well-established treatment modality among patients with Peyronie's disease undergoing penile prosthesis implantation. A variety of other adjuvant maneuvers to address residual curvature when modeling alone is insufficient has been presented in the literature. Over 20 years of experience with modeling over a penile prosthesis have proven the efficacy and safety of this treatment option, providing the surgeon a simple initial step for the management of residual curvature after penile implantation which allows for the use of additional adjuvant maneuvers in those with significant deformities. © 2015 International Society for Sexual Medicine.
[Tests of hand functionality in upper limb amputation with prosthesis].
Bazzini, G; Orlandini, D; Moscato, T A; Nicita, D; Panigazzi, M
2007-01-01
The need for standardized instruments for clinical measurements has become pressing in the fields of occupational rehabilitation and ergonomics. This is particularly the case for instruments that allow a quantitative evaluation of upper limb function, and especially hand function in patients who have undergone an amputation and then application of an upper limb prosthesis. This study presents a review of the main tests used to evaluate hand function, with a critical analysis of their use in subjects with an upper limb prosthesis. The tests are divided into: tests to evaluate strength, tests to evaluate co-ordination and dexterity, tests of global or overall function, and tests proposed specifically for subjects with an upper limb prosthesis. Of the various tests presented, the authors give their preference to the Bimanual Functional Assessment, Abilhand and/or the ADL Questionnaire, because of the practical usefulness, clinimetric features, simplicity and ease of administration of these tests.
Chowdhury, Nafees Uddin; Otomaru, Takafumi; Murase, Mai; Inohara, Ken; Hattori, Mariko; Sumita, Yuka I; Taniguchi, Hisashi
2011-01-01
An objective assessment of speech would benefit the prosthetic rehabilitation of maxillectomy patients. This study aimed to establish a simple, objective evaluation of monosyllable /sa/ utterances in maxillectomy patients by using a psychoacoustic system typically used in industry. This study comprised two experiments. Experiment 1 involved analysis of the psychoacoustic parameters (loudness, sharpness and roughness) in monosyllable /sa/ utterances by 18 healthy subjects (9 males, 9 females). The utterances were recorded in a sound-treated room. The coefficient of variation (CV) for each parameter was compared to identify the most suitable parameter for objective evaluation of speech. Experiment 2 involved analysis of /sa/ utterances by 18 maxillectomy patients (9 males, 9 females) with and without prosthesis, and comparisons of the psychoacoustic data between the healthy subjects and maxillectomy patients without prosthesis, between the maxillectomy patients with and without prosthesis, and between the healthy subjects and maxillectomy patients with prosthesis. The CV for sharpness was the lowest among the three psychoacoustic parameters in both the healthy males and females. There were significant differences in the sharpness of /sa/ between the healthy subjects and the maxillectomy patients without prosthesis (but not with prosthesis), and between the maxillectomy patients with and without prosthesis. We found that the psychoacoustic parameters typically adopted in industrial research could also be applied to evaluate the psychoacoustics of the monosyllable /sa/ utterance, and distinguished the monosyllable /sa/ in maxillectomy patients with an obturator from that without an obturator using the system. Copyright © 2010 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.
Evaluation of a new composite prosthesis for the repair of abdominal wall defects.
Losi, Paola; Munaò, Antonella; Spiller, Dario; Briganti, Enrica; Martinelli, Ilaria; Scoccianti, Marco; Soldani, Giorgio
2007-10-01
The degree of integration of biomaterials used in the repair of abdominal wall defects seems to depend upon the structure of the prosthesis. The present investigation evaluates the behaviour in terms of adhesion formation and integration of a new composite prosthesis that could be employed in this clinical application. Full-thickness abdominal wall defects (7 x 5 cm) were created in 16 anaesthetized New Zealand white rabbits and the prosthesis were placed in direct contact with the visceral peritoneum during the experiment. The defects were repaired with a composite prosthesis or pure polypropylene mesh to establish two study groups (n = 8 each). The composite device was constituted by a polypropylene mesh physically attached to a poly(ether)urethane-polydimethylsiloxane laminar sheet. Animals were sacrificed 7, 14, 21 and 30 days after implant and prosthesis/surrounding tissue specimens subjected to light and electron microscopy. Firm adhesions were detected in the polypropylene implants, while they were not present in the composite implants. The excellent behaviour of the composite prosthesis shown in this study warrants further investigation on its use for the repair of abdominal wall defects when a prosthetic device needs to be placed in contact with the intestinal loops.
Kaneko, Takahiro; Yamagishi, Kiyoshi; Horie, Norio; Shimoyama, Tetsuo
2013-01-01
To evaluate the clinical outcome of a novel open-tray impression technique for fabrication of a provisional prosthesis supported by immediately loaded implants in a completely edentulous arch. An open-tray impression technique was evaluated in this retrospective study that included patients treated between March 2006 and October 2009. Preoperatively, a diagnostic prosthesis was delivered, and a novel open tray was fabricated based on this prosthesis. After implant placement, the impression and interocclusal record were taken simultaneously using the novel open tray. Laboratory-fabricated, screw-retained, all-acrylic resin provisional restorations were delivered on the same day of surgery. The prosthesis was assessed from the day of surgery until replacement with a definitive prosthesis. The study included 21 patients (mean age, 64.5 years) and a total of 125 implants. Of these, 104 implants were immediately loaded. In all patients, well-fitting provisional restorations supported by a minimum of four implants were delivered. Fracture of the first molar cusp was observed in one case after 30 days. However, there was no extensive fracture in the framework or functional disorder of the prosthesis. No implant failed during the follow-up after implant surgery. This protocol enabled fabrication of a well-fitting acrylic resin provisional prosthesis supported by immediately loaded implants because the impression was taken while in centric occlusion and an occlusion identical to the diagnostic prosthesis could be reconstructed.
Elective removal of convexo-concave Björk-Shiley valves.
Rajesh, P B; Smith, G H; Lawford, P V; Black, M M
1994-08-01
Replacement has been an accepted method for treating advanced cardiac valvular disease for more than 25 years. However, the perfect prosthesis has yet to be developed, judging by the number of devices available. A prosthesis that initially appears promising may cause problems in due course, and indeed some devices have been modified or withdrawn from clinical use. A notable example of a prosthetic valve that has give problems is the Björk-Shiley convexo-concave prosthesis, some models of which have undergone mechanical failure due to strut fracture. We report the elective removal of such a valve and the subsequent examination of the prosthesis. The results of this examination suggest that a policy of elective removal is justified.
Skull defect reconstruction based on a new hybrid level set.
Zhang, Ziqun; Zhang, Ran; Song, Zhijian
2014-01-01
Skull defect reconstruction is an important aspect of surgical repair. Historically, a skull defect prosthesis was created by the mirroring technique, surface fitting, or formed templates. These methods are not based on the anatomy of the individual patient's skull, and therefore, the prosthesis cannot precisely correct the defect. This study presented a new hybrid level set model, taking into account both the global optimization region information and the local accuracy edge information, while avoiding re-initialization during the evolution of the level set function. Based on the new method, a skull defect was reconstructed, and the skull prosthesis was produced by rapid prototyping technology. This resulted in a skull defect prosthesis that well matched the skull defect with excellent individual adaptation.
2016-10-01
satisfaction with device’’ (i.e. prosthesis) than the IC Socket. During year 1, we received all required IRB approvals, registered the clinical... satisfaction with device” (i.e. prosthesis) than the IC Socket. 2. KEYWORDS: Prosthetic Socket, Artificial Limbs, Prosthesis, Transfemoral Amputee, Gait...FlexSIV Socket will result in better quality of life and “ satisfaction with device” (i.e. prosthesis) than the IC socket. Accomplishments under
Central Visual Prosthesis With Interface at the Lateral Geniculate Nucleus
2017-07-01
burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching...currently used in the field to implant Deep Brain Stimulation electrodes. Page 4 We thus limited ourselves to using a ‘4 French’ size split sheath...this program. At this time , several approaches for realizing the complete system have been evaluated. Initially, a very simple mechanical mockup
2013-05-15
many consecutive hours can you walk in your prosthesis before you feel you need to stop and rest? (hr) 6.9 ± 6.15 8.5 ± 7.1 0.34 0.73 NA *Values are...Walter Reed Army Medical Center and National Naval Medical Center, have since been consolidated. Short Form-36, Prosthesis Evaluation Questionnaire...0.005). There were no significant differences between groups with regard to any of the Short Form-36 domains or Prosthesis Evaluation Questionnaire
Zhang, Fan; Liu, Ming; Harper, Stephen; Lee, Michael; Huang, He
2014-07-22
To enable intuitive operation of powered artificial legs, an interface between user and prosthesis that can recognize the user's movement intent is desired. A novel neural-machine interface (NMI) based on neuromuscular-mechanical fusion developed in our previous study has demonstrated a great potential to accurately identify the intended movement of transfemoral amputees. However, this interface has not yet been integrated with a powered prosthetic leg for true neural control. This study aimed to report (1) a flexible platform to implement and optimize neural control of powered lower limb prosthesis and (2) an experimental setup and protocol to evaluate neural prosthesis control on patients with lower limb amputations. First a platform based on a PC and a visual programming environment were developed to implement the prosthesis control algorithms, including NMI training algorithm, NMI online testing algorithm, and intrinsic control algorithm. To demonstrate the function of this platform, in this study the NMI based on neuromuscular-mechanical fusion was hierarchically integrated with intrinsic control of a prototypical transfemoral prosthesis. One patient with a unilateral transfemoral amputation was recruited to evaluate our implemented neural controller when performing activities, such as standing, level-ground walking, ramp ascent, and ramp descent continuously in the laboratory. A novel experimental setup and protocol were developed in order to test the new prosthesis control safely and efficiently. The presented proof-of-concept platform and experimental setup and protocol could aid the future development and application of neurally-controlled powered artificial legs.
FRIDMAN, GENE Y.; DELLA SANTINA, CHARLES C.
2014-01-01
This article reviews vestibular pathology and the requirements and progress made in the design and construction of a vestibular prosthesis. Bilateral loss of vestibular sensation is disabling. When vestibular hair cells are injured by ototoxic medications or other insults to the labyrinth, the resulting loss of sensory input disrupts vestibulo-ocular reflexes (VORs) and vestibulo-spinal reflexes that normally stabilize the eyes and body. Affected individuals suffer poor vision during head movement, postural instability, chronic disequilibrium, and cognitive distraction. Although most individuals with residual sensation compensate for their loss over time, others fail to do so and have no adequate treatment options. A vestibular prosthesis analogous to cochlear implants but designed to modulate vestibular nerve activity during head movement should improve quality of life for these chronically dizzy individuals. We describe the impact of bilateral loss of vestibular sensation, animal studies supporting feasibility of prosthetic vestibular stimulation, the current status of multichannel vestibular sensory replacement prosthesis development, and challenges to successfully realizing this approach in clinical practice. In bilaterally vestibular-deficient rodents and rhesus monkeys, the Johns Hopkins multichannel vestibular prosthesis (MVP) partially restores the three-dimensional (3D) VOR for head rotations about any axis. Attempts at prosthetic vestibular stimulation of humans have not yet included the 3D eye movement assays necessary to accurately evaluate VOR alignment, but these initial forays have revealed responses that are otherwise comparable to observations in animals. Current efforts now focus on refining electrode design and surgical technique to enhance stimulus selectivity and preserve cochlear function, optimizing stimulus protocols to improve dynamic range and reduce excitation–inhibition asymmetry, and adapting laboratory MVP prototypes into devices appropriate for use in clinical trials. PMID:23044664
Disintegration of porous polyethylene prostheses.
Kerr, A G; Riley, D N
1999-06-01
A Plastipore (porous polyethylene) Total Ossicular Replacement Prosthesis gave an excellent initial hearing result which was maintained for 14 years. Hearing then began to deteriorate and revision surgery showed disintegration of the prosthesis and a defect in the stapes footplate. Histological examination confirmed previous findings in porous polyethylene with multinucleated foreign body giant cells and breakdown of the material.
Gely, P; Drouin, G; Thiry, P S; Tremblay, G R
1984-11-01
A new composite prosthesis was recently proposed for the anterior cruciate ligament. It is implanted in the femur and the tibia through two anchoring channels. Its intra-articular portion, composed of a fiber mesh sheath wrapped around a silicone rubber cylindrical core, reproduces satisfactorily the ligament response in tension. However, the prosthesis does not only undergo elongation. In addition, it is submitted to torsion in its intra-articular portion and bending at its ends. This paper presents a new method to evaluate these two types of deformations throughout a knee flexion by means of a geometric model of the implanted prosthesis. Input data originate from two sources: (i) a three-dimensional anatomic topology of the knee joint in full extension, providing the localization of the prosthesis anchoring channels, and ii) a kinematic model of the knee describing the motion of these anchoring channels during a physiological flexion of the knee joint. The evaluation method is independent of the way input data are obtained. This method, applied to a right cadaveric knee, shows that the orientation of the anchoring channels has a large effect on the extent of torsion and bending applied to the implanted prosthesis throughout a knee flexion, especially on the femoral side. The study suggests also the best choice for the anchoring channel axes orientation.
Ramu, D; Ramesh, Rakesh S; Manjunath, Suraj; Shivakumar; Goel, Vipin; Hemnath, G N; Alexander, Annie
2015-12-01
In India, Breast cancer is now the most common cancer in urban and 2nd most common in rural areas [1]. The incidence is rising, more younger women are getting affected and due to increase in survival rates there is an increase in the total number of women suffering from breast Cancer. So far there are no studies evaluating the pattern of breast prosthesis use in Indian scenario. The aim of this study is to address the patterns of external breast prosthesis used in India and view of Indian women on such prosthesis after mastectomy for breast cancer. This was a descriptive longitudinal study. In this study we interviewed (telephonic) 63 people, after three years of completing treatment under The Department of Surgical Oncology, St. Johns medical college, Bangalore. Among the study group, 27 members (40 %) were using various prosthesis, rest 36 women were not using any type of prosthesis. Among the users of prosthesis, silicon prosthesis was used by 6 women, padded cups by 8 women, cloth or cotton by 12 women and 1 woman used other type of prosthesis. Most women use simple items like cloth and cotton (44 %). Next most commonly used prosthesis are padded cups(). Only 22 % of women were found using silicon prosthesis in this study. Most of the well educated patients used external prosthesis either in the form of silicon prosthesis or padded cups. Most of women below age of 50 used external breast prosthesis. Use of prosthesis was more in urban compared to rural population (48 % vs 25 %). Prosthesis users worried more about the body image than women not using prosthesis. 25 % of women using prosthesis had body image issues where as only 5 % of non prosthesis users had such problems. Prosthesis users need improvement in terms of comfort, size, shape and affordability. Most common reasons for not using prosthesis are age, lack of motivation and awareness. Less than half of the women included in this study used external prosthesis after mastectomy for breast cancer. Most of the women are used home made prosthesis like cloth and cotton (44.4 %). Education, age and urban status are the strong factors which influences use of prosthesis. Prosthesis users are those who are more concerned about their body image. There is a palpable need to develop better prosthesis at affordable price.
A Novel Thermal-activated Shape Memory Penile Prosthesis: Comparative Mechanical Testing.
Le, Brian; McVary, Kevin; McKenna, Kevin; Colombo, Alberto
2017-01-01
To compare a novel nickel-titanium (Ni-Ti) shape memory alloy (SMA) penile prosthesis of our own design with commercially available prostheses using a format similar to mechanical testing done at major penile prosthesis manufacturers. We evaluated the mechanical parameters of commercially available penile prostheses and used this information to guide the development of the Ni-Ti-based physiological penile prosthesis that expands and becomes erect with a small amount of heat applied. A penile prosthesis consisting of an exoskeleton of temperature-tuned Nitinol was designed and prototyped. Mechanical testing was performed in a model of penile buckling, penile lateral deviation, and original penile shape recovery commonly used by penile prosthesis manufacturers for testing. Our SMA penile prosthesis demonstrated useful mechanical characteristics, including rigidity to buckling when activated similar to an inflatable penile prosthesis (2.62 kgf SMA vs 1.42 kgf inflatable penile prosthesis vs 6.45 kgf for a malleable prosthesis). The Ni-Ti also became more pliable when deactivated within acceptable mechanical ranges of existing devices. It could be repeatedly cycled and generate a restorative force to become erect. An SMA-based penile prosthesis represents a promising new technology in the treatment of erectile dysfunction. We demonstrated that an Ni-Ti-based prosthesis can produce the mechanical forces necessary for producing a simulated erection without the need for a pump or reservoir, comparable with existing prostheses. Copyright © 2016 Elsevier Inc. All rights reserved.
Penile Prosthesis Implantation in Patients with a History of Total Phallic Construction.
Zuckerman, Jack M; Smentkowski, Katherine; Gilbert, David; Storme, Oscar; Jordan, Gerald; Virasoro, Ramon; Tonkin, Jeremy; McCammon, Kurt
2015-12-01
Outcomes following penile prosthesis implantation in patients with a history of total phallic construction are not well described. The aim of this study was to evaluate outcomes following neophallus penile prosthesis placement. Retrospective review penile prosthesis placement in patients with prior total phallic construction. GORE-TEX® (Gore Medical, Flagstaff, AZ) sleeve neotunica construction was utilized in all patients. Success defined as patient sexual activity with a functioning prosthesis. Thirty-one patients underwent neophallic prosthesis implantation at a mean 35.6 years of age. Prosthesis placement occurred at an average 56.3 months following phallic construction and follow-up was a mean of 59.7 months. Malleable prostheses were placed in 21 patients and inflatable in 10; implants were bilateral in 94%. Six percent experienced operative complications including a bladder injury (1) and phallic flap arterial injury (1). Postoperative complications occurred in 23% at a median 5.5 months following placement. Five prostheses were explanted secondary to infection or erosion and two additional required revisions. Of the explanted prosthesis two were later replaced without further complication. Eighty-one percent of patients were sexually active following prosthesis placement. Penile prosthesis placement is possible in patients with prior penile reconstruction/phallic construction. Although complications rates appear to be elevated in this population compared with historic controls of normal anatomic men, the majority of patients in this series were sexually active following prosthesis placement. This demonstrates the utility of prosthesis implantation in these difficult patients. © 2015 International Society for Sexual Medicine.
Comparison of mechanical energy profiles of passive and active below-knee prostheses: a case study.
Takahashi, Kota Z; Horne, John R; Stanhope, Steven J
2015-04-01
With the recent technological advancements of prosthetic lower limbs, there is currently a great desire to objectively evaluate existing prostheses. Using a novel biomechanical analysis, the purpose of this case study was to compare the mechanical energy profiles of anatomical and two disparate prostheses: a passive prosthesis and an active prosthesis. An individual with a transtibial amputation who customarily wears a passive prosthesis (Elation, Össur) and an active prosthesis (BiOM, iWalk, Inc.) and 11 healthy subjects participated in an instrumented gait analysis. The total mechanical power and work of below-knee structures during stance were quantified using a unified deformable segment power analysis. Active prosthesis generated greater peak power and total positive work than passive prosthesis and healthy anatomical limbs. The case study will enhance future efforts to objectively evaluate prosthetic functions during gait in individuals with transtibial amputations. A prosthetic limb should closely replicate the mechanical energy profiles of anatomical limbs. The unified deformable (UD) analysis may be valuable to facilitate future clinical prescription and guide fine adjustments of prosthetic componentry to optimize gait outcomes. © The International Society for Prosthetics and Orthotics 2014.
Function of obturator prosthesis after maxillectomy and prosthetic obturator rehabilitation.
Chen, Cheng; Ren, Wenhao; Gao, Ling; Cheng, Zheng; Zhang, Linmei; Li, Shaoming; Zhi, Pro Ke-qian
2016-01-01
Maxillary defects are usually rehabilitated by a prosthetic obturator. This study aimed to evaluate the functioning of obturators prosthesis in patients with unilateral defects after maxillectomy. Of 49 patients, 28 underwent to maxillectomy as a result of tumor ablative surgery, and acquired unilateral maxillary defects. Evaluation of the function was performed by applying the Obturator Functional Scale (OFS). From a total of 49 patients, 28 were treated as follows: 9 with a conventional retained obturator prosthesis (COP), 11 (39%) with an enhanced retentive obturator prosthesis with stud attachment (POP) and 8 (28%) with an enhanced retentive obturator prosthesis with magnetic attachment (POM). The mean OFS score was 80. Scores on functions of speech, swallowing and chewing reached statistical significances (p<0.05) among these three subgroups. Comparing COP and MOP groups, the scores of OFS in the domains of "Speech-ability to speak in public" and "Swallowing-leakage with liquids" were significantly higher in AOP group. Comparing COP group, the scores of OFS in "Swallowing-leakage with solid" and "Chewing/eating" domains were increased significantly (p<0.05) both in MOP and AOP groups. Obturator prosthesis improves oral function of patients after maxillary defects; the retention of the obturator prosthesis enhanced by the addition of attachments showed more benefits in oral function. Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.
Esposito, Marco; Cardaropoli, Daniele; Gobbato, Luca; Scutellà, Fabio; Fabianelli, Andrea; Mascellani, Saverio; Delli Ficorelli, Gianluca; Mazzocco, Fabio; Sbricoli, Luca; Trullenque-Eriksson, Anna
To evaluate whether there are aesthetic and clinical benefits to using a newly designed abutment (Curvomax), over a conventional control abutment (GingiHue). A total of 49 patients, who required at least two implants, had two sites randomised according to a split-mouth design to receive one abutment of each type at seven different centres. The time of loading (immediate, early or delayed) and of prosthesis (provisional crowns of fixed prosthesis) was decided by the clinicians, but they had to restore both implants in a similar way. Provisional prostheses were replaced by definitive ones 3 months after initial loading, when the follow-up for the initial part of this study was completed. Outcome measures were: prosthesis failures, implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, and patient preference. In total, 49 Curvomax and 49 GingiHue abutments were delivered. Two patients dropped out. No implant failure, prosthesis failure or complication was reported. There were no differences at 3 months post-loading for PES (difference = -0.15, 95% CI -0.55 to 0.25; P (paired t test) = 0.443) and marginal bone level changes (difference = -0.02 mm, 95% CI -0.20 to 0.16; P (paired t test) = 0.817). The majority of the patients (30) had no preference regarding the two abutment designs; 11 patients preferred the Curvomax, while five patients preferred the GingiHue abutments (P (McNemar test) = 0.210). The preliminary results of the comparison between two different abutment designs did not disclose any statistically significant differences between the evaluated abutments. However the large number of missing radiographs and clinical pictures casts doubt on the reliability of the results. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two abutment designs. Conflict of interest statement: This research project was originally partially funded by Biomax (Andover, MA, USA), the manufacturer of the Curvomax abutments evaluated in this investigation. Biomax, under pressure from some investigators, asked to modify the original agreed protocol. In a following phase, Zimmer-Biomet (Palm Beach Gardens, Florida, USA), the manufacturer of the implants and the GingiHue abutments, took over the funding of this project. Data belonged to the authors and the sponsors did not interfere with the publication of results.
Finite element analysis of maxillary bone stress caused by Aramany Class IV obturator prostheses.
Miyashita, Elcio Ricardo; Mattos, Beatriz Silva Câmara; Noritomi, Pedro Yoshito; Navarro, Hamilton
2012-05-01
The retention of an Aramany Class IV removable partial dental prosthesis can be compromised by a lack of support. The biomechanics of this obturator prosthesis result in an unusual stress distribution on the residual maxillary bone. This study evaluated the biomechanics of an Aramany Class IV obturator prosthesis with finite element analysis and a digital 3-dimensional (3-D) model developed from a computed tomography scan; bone stress was evaluated according to the load placed on the prosthesis. A 3-D model of an Aramany Class IV maxillary resection and prosthesis was constructed. This model was used to develop a finite element mesh. A 120 N load was applied to the occlusal and incisal platforms corresponding to the prosthetic teeth. Qualitative analysis was based on the scale of maximum principal stress; values obtained through quantitative analysis were expressed in MPa. Under posterior load, tensile and compressive stresses were observed; the tensile stress was greater than the compressive stress, regardless of the bone region, and the greatest compressive stress was observed on the anterior palate near the midline. Under an anterior load, tensile stress was observed in all of the evaluated bone regions; the tensile stress was greater than the compressive stress, regardless of the bone region. The Aramany Class IV obturator prosthesis tended to rotate toward the surgical resection when subjected to posterior or anterior loads. The amount of tensile and compressive stress caused by the Aramany Class IV obturator prosthesis did not exceed the physiological limits of the maxillary bone tissue. (J Prosthet Dent 2012;107:336-342). Copyright © 2012 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.
Measurement of voice onset time in maxillectomy patients.
Hattori, Mariko; Sumita, Yuka I; Taniguchi, Hisashi
2014-01-01
Objective speech evaluation using acoustic measurement is needed for the proper rehabilitation of maxillectomy patients. For digital evaluation of consonants, measurement of voice onset time is one option. However, voice onset time has not been measured in maxillectomy patients as their consonant sound spectra exhibit unique characteristics that make the measurement of voice onset time challenging. In this study, we established criteria for measuring voice onset time in maxillectomy patients for objective speech evaluation. We examined voice onset time for /ka/ and /ta/ in 13 maxillectomy patients by calculating the number of valid measurements of voice onset time out of three trials for each syllable. Wilcoxon's signed rank test showed that voice onset time measurements were more successful for /ka/ and /ta/ when a prosthesis was used (Z = -2.232, P = 0.026 and Z = -2.401, P = 0.016, resp.) than when a prosthesis was not used. These results indicate a prosthesis affected voice onset measurement in these patients. Although more research in this area is needed, measurement of voice onset time has the potential to be used to evaluate consonant production in maxillectomy patients wearing a prosthesis.
Fitting a hand-glove prosthesis to enhance the reconstructed mutilated hand.
Leow, M E; Kour, A K; Pereira, B P; Pho, R W
1998-03-01
Microsurgical reconstruction of the severely mutilated hand aimed at improving prehensile functions often does not address the esthetic aspects of the hand. The poor appearance of the reconstructed hand affects its active display and use. A hand-glove prosthesis may be prescribed in this instance to enhance the overall form and function of the mutilated hand. We reviewed 16 cases of mutilating hand injuries in which surgical reconstructions were performed and the patients were subsequently fitted with a hand-glove prosthesis to augment the outcome. An improved appearance was achieved in all patients fitted with the prosthesis. The patients' sense of confidence was also enhanced, which in turn promoted the active and open use of the reconstructed hands. While prescribed primarily to improve the appearance of the reconstructed hands, these prostheses were documented to enhance the physical hand functions in 11 cases by increasing the span of the hand and providing an opposable post and a palmar base for holding and for anchorage. The prosthesis enhanced assistive functions of the reconstructed hands and freed the contralateral normal hand for use in bimanual activities, such as holding a wallet and taking out money, supporting a note pad for writing, and holding a plate at buffet receptions. At the 18-month follow-up visit, 13 (87%) of the patients continued to use their prosthesis. Wear and tear were problems associated with the frequent use of the prosthesis. The expected life span of the prosthesis with daily use ranged from 2 to 3 years. All the patients acknowledged that the prosthesis played a role in their rehabilitation and that it helped them to overcome the initial psychological trauma and to come to terms with their physical loss.
Metabolics of stair ascent with a powered transfemoral prosthesis.
Ledoux, E D; Lawson, B E; Shultz, A H; Bartlett, H L; Goldfarb, M
2015-01-01
This paper evaluates the effectiveness of a powered knee and ankle prosthesis for stair ascent through a metabolic assessment comparing energy expenditure of a single transfemoral amputee subject while ascending stairs with the powered prosthesis relative to his passive daily use device, as well as comparing the kinematics and kinetics obtained with the passive prosthesis to healthy biomechanics. The subject wore a portable system that measured pulmonary gaseous exchange rates of oxygen and carbon dioxide while he ascended stairs with each of the prostheses in alternating tests. The results indicated that the amputee's energy expenditure decreased by 32 percent while climbing with the powered prosthesis as compared to his passive one, and the kinematics and kinetics achieved were representative of healthy biomechanics.
Control and Evaluation of a Powered Transfemoral Prosthesis for Stair Ascent.
Ledoux, Elissa D; Goldfarb, Michael
2017-07-01
This paper assesses the metabolic effort exerted by three transfemoral amputees, when using a powered knee and ankle prosthesis for stair ascent, relative to ascending stairs with passive knee and ankle prostheses. The paper describes a controller that provides step-over stair ascent behavior reflective of healthy stair ascent biomechanics, and describes its implementation in a powered prosthesis prototype. Stair ascent experiments were performed with three unilateral transfemoral amputee subjects, comparing the oxygen consumption required to ascend stairs using the powered prosthesis (with a step-over gait), relative to using their daily-use energetically passive prostheses (with a step-to gait). Results indicate on average a 24% reduction in oxygen consumption and a 30% reduction in stair ascent timewhen using the powered prosthesis, relative to when using the passive prostheses. All subjects expressed a strong preference for ascending stairs using the powered prosthesis.
MPR-CT Imaging for Stapes Prosthesis: Accuracy and Clinical Significance.
Fang, Yanqing; Wang, Bing; Galvin, John J; Tao, Duoduo; Deng, Rui; Ou, Xiong; Liu, Yangwenyi; Dai, Peidong; Sha, Yan; Zhang, Tianyu; Chen, Bing
2016-04-01
The aims of this article are: 1) to re-evaluate the accuracy of multiple planar reconstruction computed tomography (MPR-CT) imaging on stapes-prosthesis parameters, and 2) to clarify possible relationships between prosthesis intravestibular depth and postoperative hearing outcomes. Seventy patients (46 women and 24 men; 32 right and 38 left sides) with the mean age of 40 years (range, 19-62 yr) with clinical otosclerosis. All patients underwent stapedotomy and were implanted with the same type of titanium piston prosthesis by the same surgeon. Postoperative MPR-CTs were obtained at patients' follow-up visits. The length and intravestibular depth of the stapes prosthesis (including absolute and relative depth) were calculated from the MPR-CT imaging. Relationships between the intravestibular depth of the prosthesis and hearing outcomes (pre- and postoperative audiograms) were analyzed using Spearman correlation analyses. The length of the prosthesis was overestimated by 1.8% (0.1 mm) by the MPR-CT imaging. Axial and coronal measurements were significantly correlated (p < 0.05). There was great intersubject variability in hearing outcomes differed insignificantly, regardless of intravestibular depth within the security range. No relationships were found between the intravestibular depth of the stapes prosthesis, as measured with MPR-CT, and postoperative hearing results. MPR-CT can provide an accurate estimation of stapes prosthesis parameters. However, the prosthesis intravestibular depth did not seem to affect postoperative hearing outcomes.
Powered ankle-foot prosthesis to assist level-ground and stair-descent gaits.
Au, Samuel; Berniker, Max; Herr, Hugh
2008-05-01
The human ankle varies impedance and delivers net positive work during the stance period of walking. In contrast, commercially available ankle-foot prostheses are passive during stance, causing many clinical problems for transtibial amputees, including non-symmetric gait patterns, higher gait metabolism, and poorer shock absorption. In this investigation, we develop and evaluate a myoelectric-driven, finite state controller for a powered ankle-foot prosthesis that modulates both impedance and power output during stance. The system employs both sensory inputs measured local to the external prosthesis, and myoelectric inputs measured from residual limb muscles. Using local prosthetic sensing, we first develop two finite state controllers to produce biomimetic movement patterns for level-ground and stair-descent gaits. We then employ myoelectric signals as control commands to manage the transition between these finite state controllers. To transition from level-ground to stairs, the amputee flexes the gastrocnemius muscle, triggering the prosthetic ankle to plantar flex at terminal swing, and initiating the stair-descent state machine algorithm. To transition back to level-ground walking, the amputee flexes the tibialis anterior muscle, triggering the ankle to remain dorsiflexed at terminal swing, and initiating the level-ground state machine algorithm. As a preliminary evaluation of clinical efficacy, we test the device on a transtibial amputee with both the proposed controller and a conventional passive-elastic control. We find that the amputee can robustly transition between the finite state controllers through direct muscle activation, allowing rapid transitioning from level-ground to stair walking patterns. Additionally, we find that the proposed finite state controllers result in a more biomimetic ankle response, producing net propulsive work during level-ground walking and greater shock absorption during stair descent. The results of this study highlight the potential of prosthetic leg controllers that exploit neural signals to trigger terrain-appropriate, local prosthetic leg behaviors.
Design and Control of a New Biomimetic Transfemoral Knee Prosthesis Using an Echo-Control Scheme
2018-01-01
Passive knee prostheses require a significant amount of additional metabolic energy to carry out a gait cycle, therefore affecting the natural human walk performance. Current active knee prostheses are still limited because they do not reply with accuracy of the natural human knee movement, and the time response is relatively large. This paper presents the design and control of a new biomimetic-controlled transfemoral knee prosthesis based on a polycentric-type mechanism. The aim was to develop a knee prosthesis able to provide additional power and to mimic with accuracy of the natural human knee movement using a stable control strategy. The design of the knee mechanism was obtained from the body-guidance kinematics synthesis based on real human walking patterns obtained from computer vision and 3D reconstruction. A biomechanical evaluation of the synthesized prosthesis was then carried out. For the activation and control of the prosthesis, an echo-control strategy was proposed and developed. In this echo-control strategy, the sound side leg is sensed and synchronized with the activation of the knee prosthesis. An experimental prototype was built and evaluated in a test rig. The results revealed that the prosthetic knee is able to mimic the biomechanics of the human knee. PMID:29854368
[Tracheobronchial prosthesis in Mounier-Kuhn syndrome: New perspectives].
Sauvage, M; Tiffet, O; Vergnon, J-M
2015-05-01
Mounier-Kuhn syndrome or tracheobronchomegaly is a rare congenital condition, the management of which is complex. We report the case of a patient who was treated with interventional endoscopy. We describe the case of a 74-year-old man with a diagnosis of tracheobronchomegaly who was admitted in 2003 with a background of deteriorating respiratory status and the occurrence of postural syncope. He initially received a tracheobronchial silicone Y prosthesis, extended with metal prostheses at the tracheal and bronchial level. This arrangement remained stable until 2011. He then began to develop episodes of asphyxia related to posterior dislocation of the tracheobronchial prosthesis, after breakage of the metallic mesh tracheal prosthesis. A new tracheobronchial prosthesis Y was then placed, custom-made from a 3D model of the airways. This was clinically and functionally effective. This case describes the management of a patient with Mounier-Kuhn syndrome by interventional bronchoscopy, with the adaptation of prosthetic materials, on an individual basis, to the anatomy of the patient's airway. Copyright © 2015 SPLF. Published by Elsevier Masson SAS. All rights reserved.
Kaliki, Rahul R; Davoodi, Rahman; Loeb, Gerald E
2013-03-01
C5/C6 tetraplegic patients and transhumeral amputees may be able to use voluntary shoulder motion as command signals for a functional electrical stimulation system or transhumeral prosthesis. Stereotyped relationships, termed "postural synergies," among the shoulder, forearm, and wrist joints emerge during goal-oriented reaching and transport movements as performed by able-bodied subjects. Thus, the posture of the shoulder can potentially be used to infer the desired posture of the elbow and forearm joints during reaching and transporting movements. We investigated how well able-bodied subjects could learn to use a noninvasive command scheme based on inferences from these postural synergies to control a simulated transhumeral prosthesis in a virtual reality task. We compared the performance of subjects using the inferential command scheme (ICS) with subjects operating the simulated prosthesis in virtual reality according to complete motion tracking of their actual arm and hand movements. Initially, subjects performed poorly with the ICS but improved rapidly with modest amounts of practice, eventually achieving performance only slightly less than subjects using complete motion tracking. Thus, inferring the desired movement of distal joints from voluntary shoulder movements appears to be an intuitive and noninvasive approach for obtaining command signals for prostheses to restore reaching and grasping functions.
Nomura, Tomohiro; Watanabe, Kota; Nosaka, Toshiya; Matsubara, Hiroyuki; Akiyama, Masaharu; Inui, Kimiharu
2016-01-01
[Purpose] It is difficult to identify by visual observation whether alignment abnormalities in trans-femoral prostheses in the frontal plane are attributable to the adduction angle or the abnormal alignment of the positions of the medial and lateral sides of the socket in relation to the foot. Therefore, we focused on the trajectory of the center of plantar pressure during walking, and we proposed a method for differentiating these two alignment abnormalities. [Subjects and Methods] We recruited 4 trans-femoral unilateral amputees. Bench alignment was achieved initially. We compared the amplitude of the trajectory of the center of plantar pressure when walking under 2 conditions: 1) when changing the adduction angle and 2) when changing the positional relationship between the socket and the foot. [Results] It was not possible to distinguish between the 2 types of malalignment on the prosthesis side. There was a significant difference when changing the positional relationship on the contralateral side. Thereby, the plantar pressure of the contralateral side could be used to distinguish between the 2 types of malalignment. [Conclusion] The results of this study suggested that trans-femoral prosthesis malalignment could be evaluated through the plantar pressure of the contralateral side in amputees. PMID:27065546
Levine, Laurence A; Becher, Edgardo; Bella, Anthony; Brant, William; Kohler, Tobias; Martinez-Salamanca, Juan Ignacio; Trost, Landon; Morey, Allen
2016-04-01
Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements in the design of inflatable devices have been made since they first became available more than four decades ago. To review the history of the penile prosthesis, the indications, preoperative evaluation, and patient and partner satisfaction. The current approaches to addressing intra- and postoperative complications, provide an understanding of prosthesis infection, and placement of these devices will be reviewed. A committee of worldwide experts in this field was assembled during the 2015 International Consultation on Sexual Medicine (ICSM) and performed a systematic review of the peer-reviewed published medical literature pertaining to penile prosthesis. Particular attention was given to higher level trials when available. Recommendations are based upon the Oxford Criteria. Unfortunately there is limited level 1 and 2 evidence, and where expert opinion was utilized, the decision was unanimous within the committee with a goal of presenting a clinically relevant guideline pertaining to penile prostheses. Penile prosthesis has undergone an evolution over the past 40 years resulting in a more effective and reliable treatment for advanced erectile dysfunction not responding to less invasive methods including oral treatment with PDE5 inhibitors, vacuum erection device, and intracorporal injection therapy. It should be considered an appropriate treatment option for the man who wishes to restore erectile function and who understands the potential risk of mechanical failure and infection, both of which are less common now as a result of improvements made in device design as well as surgical protocols adhered to in the operating room. Patients must be clearly informed of the risks associated with penile prosthesis including mechanical failure, infection, shortening of the penis, change in sensation and configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis. Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Long-term role of external breast prostheses after total mastectomy.
Glaus, Simone W; Carlson, Grant W
2009-01-01
After total mastectomy, many women choose to wear external breast prosthesis rather than undergo breast reconstruction. The purpose of this study was to evaluate long-term satisfaction among external breast prosthesis wearers and the impact of satisfaction on prosthesis use. A questionnaire was designed to assess demographic information, prosthesis information provision, prosthesis use, and satisfaction with prosthesis. Fifty-nine women who had undergone total mastectomy without breast reconstruction completed the questionnaire. The majority of women (68%) were at least 5 years out from mastectomy. Approximately half (49%) of the women had received information about breast prostheses prior to mastectomy; 29% received information from the surgeon performing the operation. Frequent and prolonged prosthesis use was prevalent with 64% of participants reporting prosthesis use all the time, 6-7 days/week. Participants showed high rates (83%) of overall satisfaction. However, women who wore their prosthesis out in public only were less satisfied than more frequent wearers (50% versus 89%, chi(2) = 8.83, d.f. = 1, alpha = 0.05). Satisfaction increased over time, as women who were greater than 5 years out from mastectomy were more satisfied than women less that 5 years post-mastectomy (90% versus 67%, chi(2) = 4.43, d.f. = 1, alpha = 0.05). The vast majority of women are satisfied with their external breast prosthesis several years after mastectomy. Most women used their prosthesis all the time and overall satisfaction contributed to higher levels of prosthesis use. Given the long-term importance of external breast prostheses for women who have undergone mastectomy, a greater effort to inform patients about external breast prostheses prior to surgery is needed.
Horehledova, Barbora; Mihl, Casper; Hendriks, Babs M F; Eijsvoogel, Nienke G; Vainer, Jindrich; Veenstra, Leo F; Wildberger, Joachim E; Das, Marco
2018-06-16
Incorrect prosthesis size has direct impact on patient outcome after transcatheter aortic valve implantation (TAVI) procedure. Currently, annular diameter, area or perimeter may be used for prosthesis size selection. The aim was to evaluate whether the use different annular dimensions would result in the selection of different prosthesis sizes, when assessed in the same TAVI-candidate during the same phase of a cardiac cycle. Fifty consecutive TAVI-candidates underwent retrospectively ECG-gated computed tomography angiography (CTA). Aortic root dimensions were assessed in the 20% phase of the R-R interval. Annular short diameter, perimeter and area were used to select the prosthesis size, based on the industry recommendations for a self-expandable (Medtronic CoreValve; MCV) and balloon-expandable (Edwards Sapien XT Valve; ESV) valve. Complete agreement on selected prosthesis size amongst all three annular dimensions was observed in 62% (31/50; ESV) and 30% (15/50; MCV). Short aortic annulus measurement resulted in a smaller prosthesis size in 20% (10/50; ESV) and in 60% of cases (30/50; MCV) compared to the size suggested by both annular perimeter and area. In 18% (9/50; ESV) and 10% of cases (5/50; MCV) a larger prosthesis would have been selected based on annular perimeter compared to annular diameter and area. Prosthesis size derived from area was always in agreement with at least one other parameter in all cases. Aortic annulus area appears to be the most robust parameter for TAVI-prosthesis size selection, regardless of the specific prosthesis size. Short aortic annulus diameter may underestimate the prosthesis size, while use of annular perimeter may lead to size overestimation in some cases.
Polat, Beldan; Orhan, Kadir Serkan; Kesimli, Mustafa Caner; Gorgulu, Yasemin; Ulusan, Murat; Deger, Kemal
2015-11-01
This study aims to evaluate the effects of voice rehabilitation with indwelling voice prosthesis on quality of life, depression, anxiety, self-esteem, and sexual functions in laryngectomy patients. Provox-1 was applied to 30 patients who underwent total laryngectomy by opening a tracheoesophageal fistula. WHO Quality of Life-BREF, Beck Depression Inventory, Beck Anxiety Inventory, Rosenberg Self-Esteem Scale, Arizona Sexual Experience Scale forms were asked to be filled out by the patients before voice prosthesis application. These tests were asked to be filled out again 3 months later after the voice prosthesis application. Paired samples and Wilcoxon tests were used to compare before and after operation values. Indwelling voice prosthesis was found to improve quality of life, self-esteem, and sexual function (p < 0.05). Additionally, symptoms of depression and anxiety were regressed (p < 0.05). Indwelling voice prosthesis was found to especially increase the quality of life and decrease depression (p < 0.05). This study is an uncontrolled single-arm study comparing patients' psychosocial statuses pre- and post-voice prosthesis.
Measurement of Forces and Moments Transmitted to the Residual Limb
2010-10-01
forces, moments, and alignments. 15. SUBJECT TERMS Amputees, prosthesis alignment, socket pressure, gait, force and moment sensors 16. SECURITY...evaluate the feasibility of using a tri-axial transducer mounted to the pylon of a lower limb prosthesis directly below the socket to a.) Characterize...weighing up to nearly 500lbs, or activities which involve deceleration or acceleration forces of up to 500 lbs along the pylon of a prosthesis . Diameter
Fottner, Andreas; Schmid, Markus; Birkenmaier, Christof; Mazoochian, Farhad; Plitz, Wolfgang; Volkmar, Jansson
2009-06-01
Stemless and short-stemmed hip prostheses have been developed to preserve femoral bone stock. While all these prostheses claim a more or less physiological load transfer, clinical long-term results are only available for the stemless thrust plate prosthesis. In this study, the in vitro primary stability of the thrust plate prosthesis was compared to two types of short-stemmed prostheses. In addition to the well-established Mayo prosthesis, the modular Metha prosthesis was tested using cone adapters with 130 degrees and 140 degrees neck-shaft-angles. The prostheses were implanted in composite femurs and loaded dynamically (300-1700 N). Three-dimensional micromotions at the bone-prosthesis interface were measured. In addition, the three-dimensional deformations at the surface of the composite femur were measured to gain data on the strain distribution. For all tested prostheses, the micromotions did not exceed 150 microm, the critical value for osteointegration. The thrust plate prosthesis revealed similar motions as the short-stemmed prostheses. The short-stemmed prosthesis with the 130 degrees cone tended to have the highest micromotions of all tested short-stemmed prostheses. The thrust plate prosthesis revealed the lowest alteration of bone surface deformation after implantation. The comparably low micromotions of the thrust plate prosthesis and the short-stemmed prostheses should be conducive to osseous integration. The higher alteration of load transmission after implantation reveals a higher risk of stress shielding for the short-stemmed prostheses.
Use of prostheses in lower limb amputee patients due to peripheral arterial disease
Chamlian, Therezinha Rosane
2014-01-01
Objective To evaluate the indication of prosthesis during rehabilitation and the maintenance of their use or abandonment rate after discharge, as well as mortality of lower limb amputees due to peripheral arterial disease. Methods A retrospective and cross-sectional study carried out with lower limb amputee patients, at transfemoral and transtibial levels, due to vascular conditions. The sample was composed of 310 patients (205 men, 105 women, mean age 61.8 years), transfemoral (142) and transtibial (150) levels, unilateral or bilateral (18). A total of 217 were fitted with prosthesis and 93 did not. Nonparametric statistical tests with equality of two proportions, 95% confidence interval and p value <0,05 were used. Results Out of 195 patients we contacted, 151 were fitted with prosthesis and 44 not. Of those that were fitted with prosthesis, 54 still use it, 80 abandoned and 17 died. In the group without prosthesis, 27 were on wheelchair and 17 died. Mortality is statistically higher among patients who were not fitted with prosthesis and 34 death occur, on average, 3.91 years after amputation. Survival time of patients who were not fitted with prosthesis was smaller than those were fitted. Conclusion The use of prosthesis in lower limb amputees, due to vascular conditions, during rehabilitation is high. However, maintenance of prosthesis is not frequent after discharge. Early and high mortality is observed mainly among diabetic patients. PMID:25628194
Measurement of Voice Onset Time in Maxillectomy Patients
Hattori, Mariko; Sumita, Yuka I.; Taniguchi, Hisashi
2014-01-01
Objective speech evaluation using acoustic measurement is needed for the proper rehabilitation of maxillectomy patients. For digital evaluation of consonants, measurement of voice onset time is one option. However, voice onset time has not been measured in maxillectomy patients as their consonant sound spectra exhibit unique characteristics that make the measurement of voice onset time challenging. In this study, we established criteria for measuring voice onset time in maxillectomy patients for objective speech evaluation. We examined voice onset time for /ka/ and /ta/ in 13 maxillectomy patients by calculating the number of valid measurements of voice onset time out of three trials for each syllable. Wilcoxon's signed rank test showed that voice onset time measurements were more successful for /ka/ and /ta/ when a prosthesis was used (Z = −2.232, P = 0.026 and Z = −2.401, P = 0.016, resp.) than when a prosthesis was not used. These results indicate a prosthesis affected voice onset measurement in these patients. Although more research in this area is needed, measurement of voice onset time has the potential to be used to evaluate consonant production in maxillectomy patients wearing a prosthesis. PMID:24574934
Markovic, Marko; Schweisfurth, Meike A; Engels, Leonard F; Bentz, Tashina; Wüstefeld, Daniela; Farina, Dario; Dosen, Strahinja
2018-03-27
To effectively replace the human hand, a prosthesis should seamlessly respond to user intentions but also convey sensory information back to the user. Restoration of sensory feedback is rated highly by the prosthesis users, and feedback is critical for grasping in able-bodied subjects. Nonetheless, the benefits of feedback in prosthetics are still debated. The lack of consensus is likely due to the complex nature of sensory feedback during prosthesis control, so that its effectiveness depends on multiple factors (e.g., task complexity, user learning). We evaluated the impact of these factors with a longitudinal assessment in six amputee subjects, using a clinical setup (socket, embedded control) and a range of tasks (box and blocks, block turn, clothespin and cups relocation). To provide feedback, we have proposed a novel vibrotactile stimulation scheme capable of transmitting multiple variables from a multifunction prosthesis. The subjects wore a bracelet with four by two uniformly placed vibro-tactors providing information on contact, prosthesis state (active function), and grasping force. The subjects also completed a questionnaire for the subjective evaluation of the feedback. The tests demonstrated that feedback was beneficial only in the complex tasks (block turn, clothespin and cups relocation), and that the training had an important, task-dependent impact. In the clothespin relocation and block turn tasks, training allowed the subjects to establish successful feedforward control, and therefore, the feedback became redundant. In the cups relocation task, however, the subjects needed some training to learn how to properly exploit the feedback. The subjective evaluation of the feedback was consistently positive, regardless of the objective benefits. These results underline the multifaceted nature of closed-loop prosthesis control as, depending on the context, the same feedback interface can have different impact on performance. Finally, even if the closed-loop control does not improve the performance, it could be beneficial as it seems to improve the subjective experience. Therefore, in this study we demonstrate, for the first time, the relevance of an advanced, multi-variable feedback interface for dexterous, multi-functional prosthesis control in a clinically relevant setting.
Variable Cadence Walking and Ground Adaptive Standing with a Powered Ankle Prosthesis
Shultz, Amanda H.; Lawson, Brian E.; Goldfarb, Michael
2015-01-01
Abstract This paper describes a control approach that provides walking and standing functionality for a powered ankle prosthesis, and demonstrates the efficacy of the approach in experiments in which a unilateral transtibial amputee subject walks with the prosthesis at variable cadences, and stands on various slopes. Both controllers incorporate a finite-state structure that emulates healthy ankle joint behavior via a series of piecewise passive impedance functions. The walking controller incorporates an algorithm to modify impedance parameters based on estimated cadence, while the standing controller incorporates an algorithm to modulate the ankle equilibrium angle in order to adapt to the ground slope and user posture, and the supervisory controller selects between the walking and standing controllers. The system is shown to reproduce several essential biomechanical features of the healthy joint during walking, particularly relative to a passive prosthesis, and is shown to adapt to variable cadences. The system is also shown to adapt to slopes over a range of ± 15 deg and to provide support to the user in a manner that is biomimetic, as validated by quasi-static stiffness measurements recorded by the prosthesis. Data from standing trials indicate that the user places more weight on the powered prosthesis than on his passive prosthesis when standing on sloped surfaces, particularly at angles of 10 deg or greater. The authors also demonstrated that the prosthesis typically began providing support within 1 s of initial contact with the ground. Further, the supervisory controller was shown to be effective in switching between walking and standing, as well as in determining ground slope just prior to the transition from the standing controller to the walking controller, where the estimated ground slope was within 1.25 deg of the actual ground slope for all trials. PMID:25955789
[The length of the piston in otosclerosis surgery].
Portmann, D; Alcantara, M; Vianna, M
2007-01-01
The measurement of the piston is always described as a significant stage of the surgery but its length is never clearly defined. The goal of this work is to determine the length of the prosthesis. From May 2003 to May 2005, 128 patients with otosclerosis, diagnosed on the basis of their clinical history and their audiogram, were included in this prospective study. Some of them were revision surgeries. The prosthesis generally used was the Portmann piston clip (Medtronic Xomed Inc Portmann Piston Clip Stainless Steel/Fluoroplastic). In stapedectomies, a Teflon piston of 0.6 mm of diameter was used (Pouret Company Fluoroplastic Stapes Prosthesis). These prostheses must be trimmed before their installation. The measurement technique is described. The length of the prosthesis was increased by 0.5 mm to include the thickness of the footplate. The Portmann piston clip was used 116 times (100 initial surgeries and 16 revisions surgeries) and the Teflon prosthesis of 0.6 mm of diameter only 13 times (6 primary stapedectomies and 7 revisions stapedectomies). The length of the prosthesis was between 3,5 mm and 5 mm. In the majority of cases, the length of the prosthesis was 4.75 mm (62 patients, 48.1%), followed by 4.5 mm (29 patients, 22.5%) and 5 mm (27 patients, 20.9%). In eleven cases (8.5%) the prosthesis measured less than 4,5 mm. None of the patients in this study experienced a postoperative sensorineural hearing loss. The measurement of the length of the piston is very significant, and in our study the majority of the pistons were cut at 4.75 mm which indicates an incus-footplate measurement of 4.25 mm.
Biomechanical Evaluation of a Prototype Foot/Ankle Prosthesis
Quesada, P. M.; Pitkin, M.; Colvin, J.
2016-01-01
In this paper, we report on our pilot evaluation of a prototype foot/ankle prosthesis. This prototype has been designed and fabricated with the intention of providing decreased ankle joint stiffness during the middle portion of the stance phase of gait, and increased (i.e., more normal) knee range of motion during stance. Our evaluation involved fitting the existing prototype foot/ankle prosthesis, as well as a traditional solid ankle cushioned heel (SACH) foot, to an otherwise healthy volunteer with a below-knee (BK) amputation. We measured this individual’s lower extremity joint kinematics and kinetics during walking using a video motion analysis system and force platform. These measurements permitted direct comparison of prosthetic ankle joint stiffness and involved side knee joint motion, as well as prosthetic ankle joint moment and power. PMID:10779119
Kim, Seok-Gyu; Son, Mee-Kyoung
2015-01-01
PURPOSE The purpose of this study was to examine the abutment screw stability of screw- and cement-retained implant-supported dental prosthesis (SCP) after simulated cement washout as well as the stability of SCP cements after complete loosening of abutment screws. MATERIALS AND METHODS Thirty-six titanium CAD/CAM-made implant prostheses were fabricated on two implants placed in the resin models. Each prosthesis is a two-unit SCP: one screw-retained and the other cemented. After evaluating the passive fit of each prosthesis, all implant prostheses were randomly divided into 3 groups: screwed and cemented SCP (Control), screwed and noncemented SCP (Group 1), unscrewed and cemented SCP (Group 2). Each prosthesis in Control and Group 1 was screwed and/or cemented, and the preloading reverse torque value (RTV) was evaluated. SCP in Group 2 was screwed and cemented, and then unscrewed (RTV=0) after the cement was set. After cyclic loading was applied, the postloading RTV was measured. RTV loss and decementation ratios were calculated for statistical analysis. RESULTS There was no significant difference in RTV loss ratio between Control and Group 1 (P=.16). No decemented prosthesis was found among Control and Group 2. CONCLUSION Within the limits of this in vitro study, the stabilities of SCP abutment screws and cement were not significantly changed after simulated cement washout or screw loosening. PMID:26140172
Rehabilitation with dental prosthesis can increase cerebral regional blood volume.
Miyamoto, Ikuya; Yoshida, Kazuya; Tsuboi, Yoichi; Iizuka, Tadahiko
2005-12-01
Treatment with denture for edentulous people is highly important for maintaining quality of life. However, its effect on the brain is unknown. In this experimental study, we hypothesized that dental prosthesis can recover not only the physical condition of mastication system but also the regional brain activity. We evaluated functional brain imaging of edentulous subjects fixed by dental implant prosthesis with clenching tasks by multi-channel near-infrared optical topography. Results revealed a significantly (P<0.001; paired t-test) increased cerebral regional blood volume during maximum voluntary clenching task by implant-retained prosthesis. There were no statistically significant differences between patients with and without prosthesis in the latency to the maximum regional blood volume after the task. Conclusively, clenching can be effective for increasing cerebral blood volume; accordingly maintenance of normal chewing might prevent the brain from degenerating.
Loza-Herrero, María A; Rivas-Tumanyan, Sona; Morou-Bermudez, Evangelia
2015-11-01
The success rate of implant-retained prostheses in a postdoctoral prosthodontics program was unknown and could not be related to any set of potential clinical issues or patient characteristics. The purpose of this study was to determine the success rate of implant-retained prostheses placed by prosthodontic residents between 1997 and 2012 and to evaluate the associations between patient classifications and specific restoration characteristics as related to prosthesis success or failure. A total of 272 prostheses in 119 patients were clinically evaluated. Success was defined as the absence of prosthetic complications or any implant-related complication that affected prosthesis survival. Logistic regression was used to evaluate associations between prosthesis success/failure and a wide array of study variables, adjusting for patient age, sex, and prosthesis longevity. The overall success rate was 71%, with a mean prosthesis age of 4.5 years (range: 4 months to 16.8 years). Implant single crowns were the most successful prosthesis type (81% success). The most common complications observed were porcelain fractures in fixed dental prostheses (15%) and lack of stability (31%) and retention (29%) in removable dental prostheses. Having a removable prosthesis (versus natural dentition) in the opposing occlusion significantly decreased the odds of success (OR=0.26, 95% CI: 0.11-0.64). Definitively cemented fixed prostheses were more successful than those cemented with an interim cement (OR=4.56, 95% CI: 1.37-15.22). The overall success rate of the implant-retained prostheses placed in the program was low compared with previously published studies. This study revealed the need for an efficient, comprehensive recall system for patients receiving implant-retained prostheses, either fixed or removable. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Design and preliminary biomechanical analysis of artificial cervical joint complex.
Jian, Yu; Lan-Tao, Liu; Zhao, Jian-ning; Jian-ning, Zhao
2013-06-01
To design an artificial cervical joint complex (ACJC) prosthesis for non-fusion reconstruction after cervical subtotal corpectomy, and to evaluate the biomechanical stability, preservation of segment movements and influence on adjacent inter-vertebral movements of this prosthesis. The prosthesis was composed of three parts: the upper/lower joint head and the middle artificial vertebrae made of Cobalt-Chromium-Molybdenum (Co-Cr-Mo) alloy and polyethylene with a ball-and-socket joint design resembling the multi-axial movement in normal inter-vertebral spaces. Biomechanical tests of intact spine (control), Orion locking plate system and ACJC prosthesis were performed on formalin-fixed cervical spine specimens from 21 healthy cadavers to compare stability, range of motion (ROM) of the surgical segment and ROM of adjacent inter-vertebral spaces. As for stability of the whole lower cervical spine, there was no significant difference of flexion, extension, lateral bending and torsion between intact spine group and ACJC prosthesis group. As for segment movements, difference in flexion, lateral bending or torsion between ACJC prosthesis group and control group was not statistically significant, while ACJC prosthesis group showed an increase in extension (P < 0.05) compared to that of the control group. In addition, ACJC prosthesis group demonstrated better flexion, extension and lateral bending compared to those of Orion plating system group (P < 0.05). Difference in adjacent inter-vertebral ROM of the ACJC prosthesis group was not statistically significant compared to that of the control group. After cervical subtotal corpectomy, reconstruction with ACJC prosthesis not only obtained instant stability, but also reserved segment motions effectively, without abnormal gain of mobility at adjacent inter-vertebral spaces.
A Canadian Electric-Arm Prosthesis for Children
Nicholls, Peter B.; Stevenson, David A.; Sherman, E. David; Lippay, Andrew L.; Gingras, Gustave
1967-01-01
The thalidomide tragedy in Canada initiated new efforts to produce functional prosthetic appliances for very young amputees. In 1962, the Rehabilitation Institute of Montreal began to fit 36 babies with adapted conventional and gas-operated devices. Practical experience with the Soviet prosthesis proved the feasibility of myoelectric control, and indicated the possibility of using skin electrodes over an active muscle for control purposes in children. We obtained assistance from the Northern Electric Company, whose research laboratories produced the prototype arms described in this report. An all-electric prosthetic system was developed which carries out four different movements driven by a single motor. Function is effected by switches, but a myoelectric control system could be readily adapted without major changes. In the description of our needs for the proposed arm, we asked for modular construction and a minimum service life of one year between major repairs. Details of design and performance are outlined in this report. Initial clinical experience indicates that the prosthesis is completely accepted by the young patient, in spite of its excessive weight and inconvenient control. Four powered joints give the child greater functional freedom. In future we plan to fit an older child and will study more bilateral installations in the next 14 months. After further use, study and improvement, this device will become a useful prosthesis. ImagesFig. 1Fig. 2Fig. 3Fig. 4Fig. 5 PMID:6021562
Liptak, Julius M; Thatcher, Graham P; Bray, Jonathan P
2017-04-15
CASE DESCRIPTION A 12-year-old neutered male domestic shorthair cat had been treated for a mass arising from the lingual aspect of the caudal right mandibular body. Cytoreductive surgery of the mass had been performed twice over a 2-year period, but the mass recurred following both surgeries. The mass was diagnosed as an osteosarcoma, and the cat was referred for further evaluation and treatment. CLINICAL FINDINGS Clinical findings were unremarkable, except for a 2-cm-diameter mass arising from the lingual aspect of the right mandible and mild anemia and lymphopenia. Pre- and postcontrast CT scans of the head, neck, and thorax were performed, revealing that the osteosarcoma was confined to the caudal right mandibular body, with no evidence of lymph node or pulmonary metastasis. TREATMENT AND OUTCOME The stereolithographic files of the CT scan of the head were sent for computer-aided design and manufacture of a customized 3-D-printed titanium prosthesis. Segmental mandibulectomy was performed, and the mandibular defect was reconstructed in a single stage with the 3-D-printed titanium prosthesis. The cat had 1 minor postoperative complication but had no signs of eating difficulties at any point after surgery. The cat was alive and disease free 14 months postoperatively. CLINICAL RELEVANCE Reconstruction of the mandible of a cat following mandibulectomy was possible with computer-aided design and manufacture of a customized 3-D-printed titanium prosthesis. Cats have a high rate of complications following mandibulectomy, and these initial findings suggested that mandibular reconstruction may reduce the risk of these complications and result in a better functional outcome.
Microsystems Technology for Retinal Implants
NASA Astrophysics Data System (ADS)
Weiland, James
2005-03-01
The retinal prosthesis is targeted to treat age-related macular degeneration, retinitis pigmentosa, and other outer retinal degenerations. Simulations of artificial vision have predicted that 600-1000 individual pixels will be needed if a retinal prosthesis is to restore function such as reading large print and face recognition. An implantable device with this many electrode contacts will require microsystems technology as part of its design. An implantable retinal prosthesis will consist of several subsystems including an electrode array and hermetic packaging. Microsystems and microtechnology approaches are being investigated as possible solutions for these design problems. Flexible polydimethylsiloxane (PDMS) substrate electrode arrays and silicon micromachined electrode arrays are under development. Inactive PDMS electrodes have been implanted in 3 dogs to assess mechanical biocompatibility. 3 dogs were followed for 6 months. The implanted was securely fastened to the retina with a single retinal tack. No post-operative complications were evident. The array remained within 100 microns of the retinal surface. Histological evaluation showed a well preserved retina underneath the electrode array. A silicon device with electrodes suspended on micromachined springs has been implanted in 4 dogs (2 acute implants, 2 chronic implants). The device, though large, could be inserted into the eye and positioned on the retina. Histological analysis of the retina from the spring electrode implants showed that spring mounted posts penetrated the retina, thus the device will be redesigned to reduce the strength of the springs. These initial implants will provide information for the designers to make the next generation silicon device. We conclude that microsystems technology has the potential to make possible a retinal prosthesis with 1000 individual contacts in close proximity to the retina.
[Ceramic-ceramic articulation in uncemented total hip arthroplasty].
Synder, Marek; Drobniewski, Marek; Kozłowski, Piotr; Grzegorzewski, Andrzej
2005-01-01
The main problem in total hip arthroplasty (THA) surgery is aseptic loosening of prosthesis components. In most cases the phagocytes reaction against the wear particle during the hip movement is responsible for aseptic prosthesis loosening. To prevent this reaction different hip articulation are invented to reduce this reaction. One of these solutions is ceramic-ceramic hip prosthesis articulation. The aim of this study was to evaluate the long-term results in patients who were treated because of coxarthrosis by means of ceramic-ceramic hip prosthesis. We analyzed 258 primary THA (222 patients, 116 women and 106 men) who were treated because of advanced coxarthrosis by Mittelmeier type hip endoprosthesis (ceramic-ceramic articulation). The mean age of patients at the surgery was 45.6 years and a mean follow-up 10.2 years. In most of our cases the idiopathic, traumatic and dysplastic coxarthrosis was noted. For clinical evaluation the classification system proposed by Merle d'Aubigne and Postel with Charnley modification was used. For radiological evaluation of the steam implantation the classification system proposed by De Lee and Charnley was used and for the cup implantation the system by Gruen and Moreland. In 87 patients (33.7%) the final results was graded as very good, in 96 (37.2%) as good, in 47 (18.2%) as satisfactory and in 28 patients (10.9%) the final results was poor. In analyzed group in 13 patients (5.0%) the revision surgery was necessary. The long-term results of THA with the use of Mittelmeier type of hip prosthesis presented a very low percentage of aseptic loosening. This type of prosthesis gives very high patients satisfaction.
Sekiguchi, Yusuke; Honda, Keita; Ishiguro, Akio
2016-01-01
Sensory impairments caused by neurological or physical disorders hamper kinesthesia, making rehabilitation difficult. In order to overcome this problem, we proposed and developed a novel biofeedback prosthesis called Auditory Foot for transforming sensory modalities, in which the sensor prosthesis transforms plantar sensations to auditory feedback signals. This study investigated the short-term effect of the auditory feedback prosthesis on walking in stroke patients with hemiparesis. To evaluate the effect, we compared four conditions of auditory feedback from plantar sensors at the heel and fifth metatarsal. We found significant differences in the maximum hip extension angle and ankle plantar flexor moment on the affected side during the stance phase, between conditions with and without auditory feedback signals. These results indicate that our sensory prosthesis could enhance walking performance in stroke patients with hemiparesis, resulting in effective short-term rehabilitation. PMID:27547456
Engineering long term clinical success of advanced ceramic prostheses.
Rekow, Dianne; Thompson, Van P
2007-01-01
Biocompatability and, in some applications, esthetics make all-ceramic prostheses compelling choices but despite significant improvements in materials properties and toughening mechanisms, these still have significant failure rates. Factors that contribute to the degradation in strength and survival include material selection and prosthesis design which set the upper limit for performance. However, fabrication operations introduce damage that can be exacerbated by environmental conditions and clinical function. Using all-ceramic dental crowns as an example, experimentally derived models provide insight into the relationships between materials properties and initial critical loads to failure. Analysis of fabrication operations suggests strategies to minimize damage. Environmental conditions can create viscoplastic flow of supporting components which can contribute additional stress within the prosthesis. Fatigue is a particularly challenging problem, not only providing the energy to propagate existing damage but, when combined with the wet environment, can create new damage modes. While much is known, the influence of these new damage modes has not been completely elucidated. The role of complex prosthesis geometry and its interaction with other factors on damage initiation and propagation has yet to be well characterized.
Ficanha, Evandro Maicon; Ribeiro, Guilherme Aramizo; Dallali, Houman; Rastgaar, Mohammad
2016-01-01
This paper describes the design of an ankle–foot robotic prosthesis controllable in the sagittal and frontal planes. The prosthesis was designed to meet the mechanical characteristics of the human ankle including power, range of motion, and weight. To transfer the power from the motors and gearboxes to the ankle–foot mechanism, a Bowden cable system was used. The Bowden cable allows for optimal placement of the motors and gearboxes in order to improve gait biomechanics such as the metabolic energy cost and gait asymmetry during locomotion. Additionally, it allows flexibility in the customization of the device to amputees with different residual limb sizes. To control the prosthesis, impedance controllers in both sagittal and frontal planes were developed. The impedance controllers used torque feedback from strain gages installed on the foot. Preliminary evaluation was performed to verify the capability of the prosthesis to track the kinematics of the human ankle in two degrees of freedom (DOFs), the mechanical efficiency of the Bowden cable transmission, and the ability of the prosthesis to modulate the impedance of the ankle. Moreover, the system was characterized by describing the relationship between the stiffness of the impedance controllers to the actual stiffness of the ankle. Efficiency estimation showed 85.4% efficiency in the Bowden cable transmission. The prosthesis was capable of properly mimicking human ankle kinematics and changing its mechanical impedance in two DOFs in real time with a range of stiffness sufficient for normal human walking. In dorsiflexion–plantarflexion (DP), the stiffness ranged from 0 to 236 Nm/rad and in inversion–eversion (IE), the stiffness ranged from 1 to 33 Nm/rad. PMID:27200342
A new concept in the surgical treatment of gastroesophageal reflux.
Samelson, S L; Weiser, H F; Bombeck, C T; Siewert, J R; Ludtke, F E; Hoelscher, A H; Abuabara, S F; Nyhus, L M
1983-01-01
Surgical treatment of gastroesophageal reflux has been thought to depend on the construction of a valve mechanism at the gastroesophageal junction (GEJ). Recently, a silicone prosthesis that does not construct a valve has been introduced, and in preliminary studies in the human, shown to be effective in the treatment of reflux. A precise mode of action has not been demonstrated for the prosthesis. This study was undertaken to investigate the mechanics of the prosthesis and determine its effectiveness in an animal model. Six canine gastroesophageal specimens were excised and the lower esophageal sphincter (LES) simulated by a rubber band placed around the GEJ at a tension calibrated to give 25 mmHg "sphincter" pressure. Circumferential silk ligatures of varying length were then placed on the stomach 3.0 cm distal to the GEJ. With no ligature, the LES opening pressure (LESOP) was 8.0 mmHg, varying to 17.0 mmHg with an 8.0 cm ligature. Further, 24 adult mongrel dogs were randomly divided into four equal groups: controls, circular myomectomy of the LES alone, myomectomy combined with fundoplication, and myomectomy combined with implantation of the silicone antireflux prosthesis. Evaluation included manometry, endoscopy, and histology. Although only the normal sphincter and fundoplication responded physiologically, the prosthesis was just as effective in preventing reflux, as evidenced by reducing acid exposure time of myomectomized dogs from 35.4% to 1.8%, and by preventing endoscopic esophagitis. It was concluded that the silicone antireflux prosthesis acts in the same fashion as the ligature in the model, by interrupting distraction of the LES by gastric wall tension. This concept is an effective method for raising LESOP, treating experimental gastroesophageal reflux, and eliminating the sequelae of reflux. Long-term evaluations of the prosthesis are required. PMID:6830333
A new concept in the surgical treatment of gastroesophageal reflux.
Samelson, S L; Weiser, H F; Bombeck, C T; Siewert, J R; Ludtke, F E; Hoelscher, A H; Abuabara, S F; Nyhus, L M
1983-03-01
Surgical treatment of gastroesophageal reflux has been thought to depend on the construction of a valve mechanism at the gastroesophageal junction (GEJ). Recently, a silicone prosthesis that does not construct a valve has been introduced, and in preliminary studies in the human, shown to be effective in the treatment of reflux. A precise mode of action has not been demonstrated for the prosthesis. This study was undertaken to investigate the mechanics of the prosthesis and determine its effectiveness in an animal model. Six canine gastroesophageal specimens were excised and the lower esophageal sphincter (LES) simulated by a rubber band placed around the GEJ at a tension calibrated to give 25 mmHg "sphincter" pressure. Circumferential silk ligatures of varying length were then placed on the stomach 3.0 cm distal to the GEJ. With no ligature, the LES opening pressure (LESOP) was 8.0 mmHg, varying to 17.0 mmHg with an 8.0 cm ligature. Further, 24 adult mongrel dogs were randomly divided into four equal groups: controls, circular myomectomy of the LES alone, myomectomy combined with fundoplication, and myomectomy combined with implantation of the silicone antireflux prosthesis. Evaluation included manometry, endoscopy, and histology. Although only the normal sphincter and fundoplication responded physiologically, the prosthesis was just as effective in preventing reflux, as evidenced by reducing acid exposure time of myomectomized dogs from 35.4% to 1.8%, and by preventing endoscopic esophagitis. It was concluded that the silicone antireflux prosthesis acts in the same fashion as the ligature in the model, by interrupting distraction of the LES by gastric wall tension. This concept is an effective method for raising LESOP, treating experimental gastroesophageal reflux, and eliminating the sequelae of reflux. Long-term evaluations of the prosthesis are required.
Hu, Jia; Qian, Hong; Li, Ya-jiao; Gu, Jun; Zhao, Jing Janice; Zhang, Er-yong
2014-01-17
The study was designed to evaluate the effects of moderate prosthesis-patient mismatch (defined as 0.65 cm(2)/m(2)
Yu, Xiu-chun; Xu, Ming; Song, Ruo-xian; Fu, Zhi-hou; Liu, Xiao-ping
2010-08-01
To study the long-term outcomes and complications of giant cell tumors around the knee treated with en bloc resection and reconstruction with prosthesis. From January 1991 to March 2005, 19 patients (11 men, 8 women, average age 35.4 years) were treated in our hospital with en bloc resection and reconstruction with domestic prosthesis (15 hinge knee and 4 rotating-hinge knee). The distal femur was involved in 12 and the proximal tibia in 7 cases. Nine tumors were primary and 10 recurrent. All cases were Campanacci grade III. The affected limb functions were evaluated by the Musculoskeletal Tumor Society scoring system. All patients underwent operation successfully with no complications. The mean follow-up time was 128.9 months (60 to 216 months). Apart from one patient who underwent amputation because of wound infection two years after reoperation, the range of knee motion of 18 patients was 30°-110°. The mean functional score of the affected limb was 22.7 (15 to 27 points). The length of the lower extremities was equal in nine cases; the affected limb was 2-9 cm shorter in the other ten cases. Prosthesis fracture and loosening developed in one, prosthesis aseptic loosening in three, and delayed deep infection and prosthesis loosening in two cases. The prosthesis loosening rate was 31.6%. One patient developed a proximal femur fracture. En bloc resection and reconstruction with prosthesis is a feasible method for treating giant cell tumor of bone around the knee. Complications related to the prosthesis, mainly prosthesis loosening and limb shortening, increase gradually with longer survival time. © 2010 Tianjin Hospital and Blackwell Publishing Asia Pty Ltd.
Ciocca, Leonardo; Fantini, Massimiliano; De Crescenzio, Francesca; Persiani, Franco; Scotti, Roberto
2010-01-01
A new protocol for making an immediate provisional eyeglasses-supported nasal prosthesis is presented that uses laser scanning, computer-aided design/computer-aided manufacturing procedures, and rapid prototyping techniques, reducing time and costs while increasing the quality of the final product. With this protocol, the eyeglasses were digitized, and the relative position of the nasal prosthesis was planned and evaluated in a virtual environment without any try-in appointment. This innovative method saves time, reduces costs, and restores the patient's aesthetic appearance after a disfiguration caused by ablation of the nasal pyramid better than conventional restoration methods. Moreover, the digital model of the designed nasal epithesis can be used to develop a definitive prosthesis anchored to osseointegrated craniofacial implants.
Research and development of a versatile portable speech prosthesis
NASA Technical Reports Server (NTRS)
1981-01-01
The Versatile Portable Speech Prosthesis (VPSP), a synthetic speech output communication aid for non-speaking people is described. It was intended initially for severely physically limited people with cerebral palsy who are in electric wheelchairs. Hence, it was designed to be placed on a wheelchair and powered from a wheelchair battery. It can easily be separated from the wheelchair. The VPSP is versatile because it is designed to accept any means of single switch, multiple switch, or keyboard control which physically limited people have the ability to use. It is portable because it is mounted on and can go with the electric wheelchair. It is a speech prosthesis, obviously, because it speaks with a synthetic voice for people unable to speak with their own voices. Both hardware and software are described.
2014-01-01
Background The design and performance of a new development prosthesis system known as biomechatronics wrist prosthesis is presented in this paper. The prosthesis system was implemented by replacing the Bowden tension cable of body powered prosthesis system using two ultrasonic sensors, two servo motors and microcontroller inside the prosthesis hand for transradial user. Methods The system components and hand prototypes involve the anthropometry, CAD design and prototyping, biomechatronics engineering together with the prosthetics. The modeler construction of the system develop allows the ultrasonic sensors that are placed on the shoulder to generate the wrist movement of the prosthesis. The kinematics of wrist movement, which are the pronation/supination and flexion/extension were tested using the motion analysis and general motion of human hand were compared. The study also evaluated the require degree of detection for the input of the ultrasonic sensor to generate the wrist movements. Results The values collected by the vicon motion analysis for biomechatronics prosthesis system were reliable to do the common tasks in daily life. The degree of the head needed to bend to give the full input wave was about 45° - 55° of rotation or about 14 cm – 16 cm. The biomechatronics wrist prosthesis gave higher degree of rotation to do the daily tasks but did not achieve the maximum degree of rotation. Conclusion The new development of using sensor and actuator in generating the wrist movements will be interesting for used list in medicine, robotics technology, rehabilitations, prosthetics and orthotics. PMID:24755242
Feng, Zhi-hong; Dong, Yan; Bai, Shi-zhu; Wu, Guo-feng; Bi, Yun-peng; Wang, Bo; Zhao, Yi-min
2010-01-01
The aim of this article was to demonstrate a novel approach to designing facial prostheses using the transplantation concept and computer-assisted technology for extensive, large, maxillofacial defects that cross the facial midline. The three-dimensional (3D) facial surface images of a patient and his relative were reconstructed using data obtained through optical scanning. Based on these images, the corresponding portion of the relative's face was transplanted to the patient's where the defect was located, which could not be rehabilitated using mirror projection, to design the virtual facial prosthesis without the eye. A 3D model of an artificial eye that mimicked the patient's remaining one was developed, transplanted, and fit onto the virtual prosthesis. A personalized retention structure for the artificial eye was designed on the virtual facial prosthesis. The wax prosthesis was manufactured through rapid prototyping, and the definitive silicone prosthesis was completed. The size, shape, and cosmetic appearance of the prosthesis were satisfactory and matched the defect area well. The patient's facial appearance was recovered perfectly with the prosthesis, as determined through clinical evaluation. The optical 3D imaging and computer-aided design/computer-assisted manufacturing system used in this study can design and fabricate facial prostheses more precisely than conventional manual sculpturing techniques. The discomfort generally associated with such conventional methods was decreased greatly. The virtual transplantation used to design the facial prosthesis for the maxillofacial defect, which crossed the facial midline, and the development of the retention structure for the eye were both feasible.
Tracheal replacement in rabbits with a new composite silicone-metallic prosthesis.
Dodge-Khatami, Ali; Niessen, Hans W M; Koole, Leo H; Klein, Marloes G; van Gulik, Thomas M; de Mol, Bas A J M
2003-09-01
A new composite silicone-metallic prosthesis was tested, studying the potential for respiratory epithelial covering over the biocompatible inner lining, in a rabbit survival model. Seven New Zealand White rabbits underwent near-total excision of their trachea and implantation of a sterile prosthesis. After 2 months, they were sacrificed and the prostheses were retrieved. Specimens were fixed and histologically examined for tissue reaction around the prosthesis, at the anastomotic lines, and particularly for the presence or absence of epithelialization of the inner lumen over the biocompatible surface. All rabbits survived the operation. At 2 months, the outer layer of the prosthesis was consistently covered with fibrosis and neutrophils. The inner layer showed necrotic cells and scant re-epithelialization over the biocompatible lining, up to 5 mm beyond the anastomosis, with no evidence of organized respiratory epithelium in the middle sections. The new prosthesis is a viable temporary solution for airway replacement in rabbits. Granulation tissue was not observed at the anastomosis, and re-epithelialization did occur, but failed to achieve full-length luminal covering. The potential for granulation tissue does not yet make this an ideal long-term solution. Improvements in prosthesis design or biocompatibility are required, and need to be re-evaluated before applicability for chronic use.
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3660... device are: (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical... metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a...
21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3650... are: (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices... metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a...
Bacterial colonization of penile prosthesis after its withdrawal due to mechanical failure.
Etcheverry-Giadrosich, B; Torremadé-Barreda, J; Pujol-Galarza, L; Vigués-Julià, F
2017-12-01
Prosthetic surgery to treat erectile dysfunction has a risk of infection of up to 3%, but this risk can increase to 18% when the surgery involves replacement. This increased risk of infection is attributed to the bacterial colonization of the prosthesis during the initial surgery. To analyse the presence of germs in the prosthesis that is withdrawn due to mechanical failure (not infection), as well as the surgical results and its progression. A retrospective study was conducted of all replacements performed between 2013 and 2016 at a single centre. We analysed demographic data, prior type of prosthesis, surgical procedure, microbiological study and follow-up. Of the 12 replacement procedures, a microbiological study of the extracted prosthesis was performed in a total of 10 cases. Of the 10 replacements, the cultures were positive in 5 cases (50%). Staphylococcus epidermidis was the most prevalent germ. All patients underwent a flushing procedure, and an antibiotic-coated prosthesis was implanted. We recorded no infections with the new implanted device after a mean follow-up of 27.33 months (SD 4.13; 95% CI 18.22-36.43). In our study population, we observed a high rate of bacterial colonization of the prostheses that were replaced due to mechanical failure. When a flushing procedure was performed during the replacement surgery, there were no more infections than those reported in treatment-naive cases. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.
Paranhos, Regina Márcia Zuccolotto Felippe; Batalhão, Carlos Henrique; Semprini, Marisa; Regalo, Simone Cecílio Hallak; Ito, Izabel Yoko; de Mattos, Maria da Glória Chiarello
2007-01-01
In addition to an initial socket discomfort, ocular prosthesis (OP) installation may allow the adherence of fungi and/or bacteria due to the superficial characteristics of the prosthesis’ material, use of inadequate cleansing solutions and methods, or because the void located between the internal portion of the prosthesis and the anophthalmic cavity (AC) mucosa. Objective: The aim of this study was to evaluate OP biofilm formation and the level of contamination of the internal portion of the OP and the AC in 24 patients. Material and Methods: Material was collected from the AC at the beginning of the study and 15 days after cleansing of the OP with 3 cleansing solutions: a neutral liquid soap, a multiuse solution for contact lens (Complete) and 0.12% chlorhexidine (Periogard). The collected materials were sowed in Petri dishes containing selective media for aerobic and facultative microorganisms, specifically staphylococci (Hipersalt agar with egg yolk), aerobic microorganisms (Brain Heart Infusion Blood Agar), streptococci (Mitis salivarius Agar), gram-negative bacilli (MacConkey Agar) and yeasts (Chromagar CandidaTM), incubated at 35°C or 37°C and the number of colony forming units were counted. Data were analyzed statistically by ANOVA, Friedman’s test and Spearman’s correlation. Results: Aerobic microorganisms, gram-negative bacilli and S. aureus were found in the OP biofilm and in the AC. There was statistically significant difference (p<0.05) between the number of microorganisms before and after the use of the cleansing solutions. Conclusion: There was positive correlation with respect to the microorganisms present in the OP biofilm and AC for the 4 proposed treatments, indicating that the decrease of OP contamination leads to AC contamination as well. PMID:19089097
The "caviar" madreporic knee prosthesis.
Kenesi, C
1979-01-01
The madreporic ("caviar") prosthesis is a hinged knee prosthesis that can be inserted without the use of cement. The surfaces of the intramedullary stems are constructed with contiguous spheres one mm in diameter. These spaces are filled by bone trabeculae and haversian bone, providing permanent biologic fixation. Experimental madreporic knee arthroplasties in dogs show that bone probes these surfaces and produces solid attachments. Histologically, the trabeculae remain separated from the metal by a fine layer of fibrous tissue. The method of insertion of the prosthesis is simple. Preparing the epiphyses before any bone resection avoids the possibility of rotational positioning errors. The form of the intramedullary stems offers good positioning in the frontal plane. The analysis of an initial series of 15 cases shows results that are far from outstanding. The 2 deaths, the 2 cases of sepsis, and the recuperation of only mediocre motion can be explained, at least in part, by the advanced age of the patients and the poor bone quality of the rheumatoid patients. Nevertheless, this type of prosthesis has 2 important advantages. It avoids the complications from the use of acrylic cement and allows for a revision operation for cases of failed surface replacement designs. Obviously further experimentation with noncemented designs will continue and definitive studies will be reported later.
Li, Chaodi; Kotha, Shiva; Mason, James
2003-01-01
The exothermic polymerization of bone cement may induce thermal necrosis of bone in cemented hip arthroplasty. A finite element formulation was developed to predict the evolution of the temperature with time in the cemented hip replacement system. The developed method is capable of taking into account both the chemical reaction that generates heat during bone cement polymerization (through a kinetic model) and the physical process of heat conduction (with an energy balance equation). The possibility of thermal necrosis of bone was then evaluated based on the temperature history in the bone and an appropriate damage criterion. Specifically, we evaluate the role of implant materials and designs on the thermal response of the system. Results indicated that the peak temperature at the bone/cement interface with a metal prosthesis was lower than that with a polymer or a composite prosthesis in hip replacement systems. Necrosis of bone was predicted to occur with a polymer or a composite prosthesis while no necrosis was predicted with a metal prosthesis in the simulated conditions. When reinforcing osteoporotic hips with injected bone cement in the cancellous core of the femur, the volume of bone cement implanted is increased which may increase the risk of thermal necrosis of bone. We evaluate whether this risk can be decreased through the use of an insulator to contain the bone cement. No thermal necrosis of bone was predicted with a 3 mm thick polyurethane insulator while more damage is predicted for the use of bone cement without the insulator. This method provides a numerical tool for the quantitative simulation of the thermal behavior of bone-cement-prosthesis designs and for examining and refining new designs computationally.
Harris, Jeffrey P; Gong, Shusheng
2007-08-01
Recently, a new stapedotomy piston prosthesis, which is a composite metal alloy of nickel and titanium known as nitinol, has been introduced into medical use. This biocompatible alloy has the unique property of shape-memory, which permits tight self-crimping when heat is applied to the wire. To substantiate the favorable initial observations with the SMART piston, this study was undertaken to compare these results (n=26) with those obtained using conventional stainless steel or platinum ribbon prostheses (n=28). Prospective consecutive case review: consecutive cases performed by the same surgeon were analyzed. Tertiary referral center. Fifty-four healthy patients with otosclerosis. Stapedotomy using either SMART prosthesis or conventional prosthesis. Hearing outcomes by audiological assessment. The postoperative hearing mean pure-tone average was 24.81+/-16.20 dBHL for Group 1 (SMART prosthesis) and 27.46+/-15.57 dBHL for Group 2 (conventional prosthesis). Postoperative mean air-bone gap was 7.07+/-8.14 dBHL for Group 1 and 6.38+/-7.54 dBHL for Group 2 using 0.5-, 1-, 2-, and 4-kHz frequencies. When analyzed according to the American Academy of Otolaryngology-Head & Neck Surgery reporting criteria using an estimate of 3 kHz as a mean of the 2-and 4-kHz values, the postoperative mean air-bone gap was 5.42+/-5.4 dBHL for Group 1 SMART and 5.98+/-5.47 dBHL for Group 2 conventional prostheses. Postoperative speech discrimination scores were 96%+/-8.64% and 97%+/-5.9%, respectively. These differences were not shown to be statistically different. Results demonstrate that experienced surgeons may achieve comparable results with both prostheses; however, the ease of self-crimping and the tightness of the crimp may provide advantages that may have long-term benefits. The potential issue of nickel allergy is important when considering patients for this prosthesis.
Justicz, Natalie; Strickland, Kaitlyn F; Motamedi, Kevin K; Mattox, Douglas E
2017-04-01
Stapes surgery with a nickel titanium prosthesis is a safe and well-tolerated procedure that leads to a significant improvement in hearing outcomes. To identify the efficacy and safety of stapedotomy procedures performed with a nickel titanium prosthesis for patients with otosclerosis. A review of 431 unique stapedotomies performed over 14 years by a single surgeon at an academic tertiary care center yielded 312 cases with nickel titanium prosthesis that met inclusion criteria of otosclerosis diagnosis, initial surgery in operative ear, and presence of pre-operative and post-operative audiograms. Pure-tone averages (PTA) at baseline and 8 weeks after surgery were calculated over four frequencies; 0.5, 1, 2, and 4 kHz. Average air-bone gaps (ABG) were calculated from pre-operative and post-operative audiograms. Average pre-operative baseline PTA was 56.7 dB in the affected ear. Post-operative PTA was 30.1 dB, a 26.6 dB improvement. Initial average ABG was 29.7 dB, while post-operative ABG averaged 5.4 dB, a 24.2 dB improvement. Surgical success (closure of ABG within 10 dB) was achieved in 263 (84%) patients. Rate of surgical success was not correlated with age, gender, race, or affected ear. Complications included recurrent conductive hearing loss (14), progressive SNHL (4), and post-operative BPPV (3).
Prabhu, Radhakrishnan; Prabhu, Geetha; Baskaran, Eswaran; Arumugam, Eswaran M
2016-01-01
In recent years, direct metal laser sintered (DMLS) metal-ceramic-based fixed partial denture prostheses have been used as an alternative to conventional metal-ceramic fixed partial denture prostheses. However, clinical studies for evaluating their long-term clinical survivability and acceptability are limited. The aim of this study was to assess the efficacy of metal-ceramic fixed dental prosthesis fabricated with DMLS technique, and its clinical acceptance on long-term clinical use. The study group consisted of 45 patients who were restored with posterior three-unit fixed partial denture prosthesis made using direct laser sintered metal-ceramic restorations. Patient recall and clinical examination of the restorations were done after 6months and every 12 months thereafter for the period of 60 months. Clinical examination for evaluation of longevity of restorations was done using modified Ryge criteria which included chipping of the veneered ceramic, connector failure occurring in the fixed partial denture prosthesis, discoloration at the marginal areas of the veneered ceramic, and marginal adaptation of the metal and ceramic of the fixed denture prosthesis. Periapical status was assessed using periodical radiographs during the study period. Survival analysis was made using the Kaplan-Meier method. None of the patients had failure of the connector of the fixed partial denture prostheses during the study period. Two exhibited biological changes which included periapical changes and proximal caries adjacent to the abutments. DMLS metal-ceramic fixed partial denture prosthesis had a survival rate of 95.5% and yielded promising results during the 5-year clinical study.
MR safety and compatibility of a noninvasively expandable total-joint endoprosthesis.
Ogg, Robert J; McDaniel, C Brian; Wallace, Donald; Pitot, Pierre; Neel, Michael D; Kaste, Sue C
2005-09-01
A noninvasively expandable total-joint endoprosthesis is now available for pediatric patients; the prosthesis can be lengthened by external application of a magnetic field. We investigated the risks of unintentional heating or lengthening of the prosthesis during MR imaging and evaluated the effect of the device on the diagnostic efficacy of MR imaging of surrounding tissues. We performed MR imaging at 1.5 T by using standard pulse sequences and pulse sequences with high-gradient and high-radiofrequency duty cycle. MR imaging caused no measurable change in prosthesis length, and the temperature of the prosthesis increased by less than 1 degrees C during repeated 14-min exposures. Despite significant signal loss and image distortion around the prosthetic joint, clinically useful images were obtained as close as 12 cm from the ends of the prosthetic stems, measured toward the body of the device. Thus, the prosthesis can be safely exposed to MR imaging pulse sequences at 1.5 T, and the visualization of some tissue surrounding the device is clinically useful.
Transition from a failing dentition to a removable implant-supported prosthesis: a staged approach.
Cordaro, Luca; Torsello, Ferruccio; Ribeiro, Carlos Accorsi
2010-05-01
Patients with hopeless dentition often present difficulties in the management of the transitional phase to the final restoration. This article describes a staged approach to achieve a full-arch, implant-supported, removable prosthesis in patients with a hopeless dentition. The approach described allows the clinician to proceed in a staged manner and facilitate prosthetic steps by keeping fixed references for vertical dimension. This technique includes initial conservative periodontal care and, afterward, extraction of some strategic teeth, while others are temporarily maintained. At this point, the implants are positioned, and during the healing period, the remaining natural abutments are used for occlusal reference and to stabilize the removable provisional prosthesis. After osseointegration of the implants, the residual teeth are extracted and the final prosthesis is delivered. The main advantages of the technique include maintenance of function during treatment, stabilization of the removable provisional (especially in the mandibular arch), prosthetic-guided insertion of implants, and easier retrieval of prosthetic references. The main drawbacks are longer treatment time and the need for two surgical steps.
A laparoscopic intraperitoneal onlay mesh technique for the repair of an indirect inguinal hernia.
Fitzgibbons, R J; Salerno, G M; Filipi, C J; Hunter, W J; Watson, P
1994-01-01
OBJECTIVE: This study was done (1) to determine whether congenital indirect inguinal hernias in male pigs could be repaired by placing a polypropylene mesh prosthesis over the defect intra-abdominally, (2) to measure the incidence of adhesions between intra-abdominal viscera and the prosthesis with and without the adhesion barrier oxidized regenerated cellulose, (3) to determine the incidence of other complications, and (4) to assess the effect on fertility. SUMMARY BACKGROUND DATA: Several techniques for laparoscopic inguinal herniorrhaphy are currently being evaluated to determine whether there are advantages over conventional inguinal herniorrhaphy. Perhaps the most controversial is the intraperitoneal onlay mesh procedure (IPOM). Its advantage is its simplicity (in that the repair is accomplished by placing a prosthesis over the hernia defect intra-abdominally, avoiding a groin dissection). Its disadvantage is the potential for complications because the prosthesis is in contact with the intra-abdominal viscera. METHODS: In male pigs, polypropylene mesh alone or polypropylene mesh plus the adhesion barrier oxidized regenerated cellulose (composite prosthesis) was fixed to the peritoneum surrounding the hernia defect. In phase 1 (6-week follow-up), two groups of 13 pigs each underwent herniorrhaphy at laparotomy or laparoscopy. In phase 2 (7.1-month follow-up), 21 pigs underwent laparoscopic herniorrhaphy. RESULTS: All IPOM herniorrhaphies were successful. The prostheses adhered most frequently to the bladder, followed by small bowel, peritoneum, and cord structures. Prosthetic erosion into these organs was not observed. Laparoscopically placed prostheses in phases 1 and 2 had significantly less surface covered by adhesions (13% +/- 13% and 19% +/- 27%, respectively) and a lower adhesion tenacity grade (1.5 +/- 0.9 and 1.3 +/- 1.1, respectively) than those placed at laparotomy (44% +/- 27% and 2.5 +/- 0.7, respectively; p < 0.01). In phase 1, a histologic evaluation of laparoscopically placed specimens demonstrated significantly thinner above-mesh fibrotic tissue compared with the prostheses implanted at laparotomy (p < 0.04). In either phase, the use of the adhesion barrier did not produce any histologic difference between the polypropylene alone and the composite prosthesis. Fertility studies were performed in phase 2 and showed no adverse effects caused by either prosthesis. CONCLUSIONS: This study demonstrated that the intraperitoneal placement of a polypropylene prosthesis was an effective technique for indirect inguinal herniorrhaphy in a pig. Furthermore, with laparotomy, the addition of oxidized regenerated cellulose significantly decreased the rate of adhesion formation to the prosthesis. However, oxidized regenerated cellulose would appear to have no value when used with a prosthesis placed laparoscopically. Images Figure 1. Figure 2. Figure 5. Figure 5. PMID:8129485
Birk, Stephanie; Brase, Christoph; Hornung, Joachim
2014-08-01
In the further development of alloplastic prostheses for use in middle ear surgery, the Dresden and Cologne University Hospitals, working together with a company, introduced a new partial ossicular replacement prosthesis in 2011. The ball-and-socket joint between the prosthesis and the shaft mimics the natural articulations between the malleus and incus and between the incus and stapes, allowing reaction to movements of the tympanic membrane graft, particularly during the healing process. Retrospective evaluation To reconstruct sound conduction as part of a type III tympanoplasty, partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft was implanted in 60 patients, with other standard partial ossicular replacement prosthesis implanted in 40 patients and 64 patients. Pure-tone audiometry was carried out, on average, 19 and 213 days after surgery. Results of the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft were compared with those of the standard prostheses. Early measurements showed a mean improvement of 3.3 dB in the air-bone gap (ABG) with the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft, giving similar results than the standard implants (6.6 and 6.0 dB, respectively), but the differences were not statistically significant. Later measurements showed a statistically significant improvement in the mean ABG, 11.5 dB, compared with 4.4 dB for one of the standard partial ossicular replacement prosthesis and a tendency of better results to 6.9 dB of the other standard prosthesis. In our patients, we achieved similarly good audiometric results to those already published for the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft. Intraoperative fixation posed no problems, and the postoperative complication rate was low.
NASA Astrophysics Data System (ADS)
Purcell, E. K.; Seymour, J. P.; Yandamuri, S.; Kipke, D. R.
2009-08-01
In the published article, an error was made in figure 5. Specifically, the three-month, NSC-seeded image is a duplicate of the six-week image, and the one-day, probe alone image is a duplicate of the three-month image. The corrected figure is reproduced below. Figure 5 Figure 5. Glial encapsulation of each probe condition over the 3 month time course. Ox-42 labeled microglia and GFAP labeled astrocytes are shown. Images are taken from probes implanted in the same animal at each time point. NSC seeding was associated with reduced non-neuronal density at 1 day post-implantation in comparison to alginate coated probes and at the 1 week time point in comparison to untreated probes (P < 0.001). Glial activation is at its overall peak 1 week after insertion. A thin encapsulation layer surrounds probes at the 6 week and 3 month time points, with NSC-seeded probes having the greatest surrounding non-neuronal density P < 0.001). Interestingly, microglia appeared to have a ramified, or `surveilling', morphology surrounding a neural stem cell-alginate probe initially, whereas activated cells with an amoeboid structure were found near an alginate probe in the same hemisphere of one animal (left panels).
Chen, Meng-Chum; Lee, Su-Shin; Hsieh, Ya-Lun; Wu, Shu-Jung; Lai, Chung-Sheng; Lin, Sin-Daw
2008-09-01
The crude major lower limb amputation procedure rate is 8.8 per 100,000 of the population per year in Taiwan. From January 2002 to October 2006, patients that received major lower limb amputation in our department were enrolled in this study. Retrospective chart reviews concerning different factors that can affect the eventual postoperative functional status were investigated. Factors that affected the length of hospital stay included duration before amputation (P < 0.001) and renal function (P = 0.045). Phantom limb pain was affected by wound healing time (P = 0.006). Factors that affected the daily prosthesis usage time were initial infection status (P = 0.021), renal function (P = 0.01), patient educational level (P = 0.016), and pretraining waiting time (P = 0.003). The duration of prosthetic training was affected by patient educational level (P = 0.004) and marital status (P = 0.024). In addition, subjective satisfaction about the usage of prosthesis was affected by pretraining waiting time (P = 0.001) and daily prosthesis usage time (P < 0.001). The daily prosthesis usage time was closely related to life quality improvement (P < 0.001) and subjective satisfaction of prosthesis usage (P < 0.001). Despite reported unchangeable factors like age, end-stage renal disease, dementia, coronary artery disease, and level of amputation, preprosthesis training waiting time significantly affected the satisfaction and daily usage time of the prosthesis. Surgeons can make some contribution to accelerate amputation wound healing and stump maturation by choosing the correct operating procedure, delicately managing the soft tissue, and ascertaining proper wound care to improve the outcome.
Singh, Ipsha; Nair, K Chandrasekharan; Shetty, Jayakar
2017-01-01
The aim of this study is to evaluate the strain developed in simulated mandibular model before and after the joining of an implant-supported screw-retained prosthesis by different joining techniques, namely, arc welding, laser welding, and soldering. A specimen simulating a mandibular edentulous ridge was fabricated in heat-cured acrylic resin. 4-mm holes were drilled in the following tooth positions; 36, 33, 43, 46. Implant analogs were placed in the holes. University of California, Los Angeles, abutment was attached to the implant fixture. Eight strain gauges were attached to the acrylic resin model. Six similar models were made. Implant-supported screw-retained fixed prosthesis was fabricated in nickel-chromium alloy. A load of 400 N was applied on the prosthesis using universal testing machine. Resultant strain was measured in each strain gauge. All the prostheses were sectioned at the area between 36 and 33, 33 and 43, and 43 and 46 using 35 micrometer carborundum disc, and strain was measured in each strain gauge after applying a load of 400 N on the prosthesis. Specimens were joined by arc welding, soldering, and laser welding. After joining, a load of 400 N was applied on each prosthesis and the resultant strain was measured in each strain gauge. Highest mean strain values were recorded before sectioning of the prostheses (889.9 microstrains). Lowest mean strain values were recorded after sectioning the prosthesis and before reuniting it (225.0 microstrains). Sectioning and reuniting the long-span implant prosthesis was found to be a significant factor in influencing the peri-implant strain.
Romkema, Sietske; Bongers, Raoul M; van der Sluis, Corry K
2013-01-01
Intermanual transfer may improve prosthetic handling and acceptance if used in training soon after an amputation. The purpose of this study was to determine whether intermanual transfer effects can be detected after training with a myoelectric upper-limb prosthesis simulator. A mechanistic, randomized, pretest-posttest design was used. A total of 48 right-handed participants (25 women, 23 men) who were able-bodied were randomly assigned to an experimental group or a control group. The experimental group performed a training program of 5 days' duration using the prosthesis simulator. To determine the improvement in skill, a test was administered before, immediately after, and 6 days after training. The control group only performed the tests. Training was performed with the unaffected arm, and tests were performed with the affected arm (the affected arm simulating an amputated limb). Half of the participants were tested with the dominant arm and half with the nondominant arm. Initiation time was defined as the time from starting signal until start of the movement, movement time was defined as the time from the beginning of the movement until completion of the task, and force control was defined as the maximal applied force on a deformable object. The movement time decreased significantly more in the experimental group (F₂,₉₂=7.42, P=.001, η²(G)=.028) when compared with the control group. This finding is indicative of faster handling of the prosthesis. No statistically significant differences were found between groups with regard to initiation time and force control. We did not find a difference in intermanual transfer between the dominant and nondominant arms. The training utilized participants who were able-bodied in a laboratory setting and focused only on transradial amputations. Intermanual transfer was present in the affected arm after training the unaffected arm with a myoelectric prosthesis simulator, and this effect did not depend on laterality. This effect may improve rehabilitation of patients with an upper-limb amputation.
Endoscopic palliation of esophageal and cardial cancer: Nd:YAG laser and prosthesis
NASA Astrophysics Data System (ADS)
Norberto, Lorenzo; Ranzato, Riccardo; Marino, Saverio; Angriman, Imerio; Vella, Vincenzo; Donadi, Michele; D'Amico, D. F.
1997-12-01
From November 1, 1992 to January 31, 1997, 227 patients with inoperable esophageal and cardial carcinomas were treated with Nd:YAG laser therapy and prosthesis intubation. The retrograde technique was used in most cases. The tumor involved in 75 pts the Cardia, in 65 the middle thoracic esophagus, in 47 pts the lower thoracic esophagus, in 23 in the upper thoracic esophagus and in 17 in the cervical esophagus. The indications for palliative Nd:YAG laser and prosthesis intubation were a locally advanced or metastatic tumor in 146 pts (64.4%) and poor surgical risk in 81 pts (35.6%). The quality of palliation was evaluated according to the ability to swallow. The mean survival rate of the patients during the follow up was 22 weeks for the laser therapy and 16 weeks for the prosthesis intubation.
LeBlanc, M
1990-01-01
Present body-powered upper-limb prostheses use a cable control system employing World War II aircraft technology to transmit force from the body to the prosthesis for operation. The cable and associated hardware are located outside the prosthesis. Because individuals with arm amputations want prostheses that are natural looking with a smooth, soft outer surface, a design and development project was undertaken to replace the cable system with hydraulics located inside the prosthesis. Three different hydraulic transmission systems were built for evaluation, and other possibilities were explored. Results indicate that a hydraulic force transmission system remains an unmet challenge as a practical replacement for the cable system. The author was unable to develop a hydraulic system that meets the necessary dynamic requirements and is acceptable in size and appearance.
Just-in-time Design and Additive Manufacture of Patient-specific Medical Implants
NASA Astrophysics Data System (ADS)
Shidid, Darpan; Leary, Martin; Choong, Peter; Brandt, Milan
Recent advances in medical imaging and manufacturing science have enabled the design and production of complex, patient-specific orthopaedic implants. Additive Manufacture (AM) generates three-dimensional structures layer by layer, and is not subject to the constraints associated with traditional manufacturing methods. AM provides significant opportunities for the design of novel geometries and complex lattice structures with enhanced functional performance. However, the design and manufacture of patient-specific AM implant structures requires unique expertise in handling various optimization platforms. Furthermore, the design process for complex structures is computationally intensive. The primary aim of this research is to enable the just-in-time customisation of AM prosthesis; whereby AM implant design and manufacture be completed within the time constraints of a single surgical procedure, while minimising prosthesis mass and optimising the lattice structure to match the stiffness of the surrounding bone tissue. In this research, a design approach using raw CT scan data is applied to the AM manufacture of femoral prosthesis. Using the proposed just-in-time concept, the mass of the prosthesis was rapidly designed and manufactured while satisfying the associated structural requirements. Compressive testing of lattice structures manufactured using proposed method shows that the load carrying capacity of the resected composite bone can be recovered by up to 85% and the compressive stiffness of the AM prosthesis is statistically indistinguishable from the stiffness of the initial bone.
Ackland, David; Robinson, Dale; Lee, Peter Vee Sin; Dimitroulis, George
2018-05-11
Stock prosthetic temporomandibular joint replacements come in limited sizes, and do not always encompass the joint anatomy that presents clinically. The aims of this study were twofold. Firstly, to design a personalized prosthetic total joint replacement for the treatment of a patient's end-stage temporomandibular joint osteoarthritis, to implant the prosthesis into the patient, and assess clinical outcome 12-months post-operatively; and secondly, to evaluate the influence of changes in prosthetic condyle geometry on implant load response during mastication. A 48-year-old female patient with Grade-5 osteoarthritis to the left temporomandibular joint was recruited, and a prosthesis developed to match the native temporomandibular joint anatomy. The prosthesis was 3D printed, sterilized and implanted into the patient, and pain and function measured 12-months post-operatively. The prosthesis load response during a chewing-bite and maximum-force bite was evaluated using a personalized multi-body musculoskeletal model. Simulations were performed after perturbing condyle thickness, neck length and head sphericity. Increases in prosthetic condyle neck length malaligned the mandible and perturbed temporomandibular joint force. Changes in condylar component thickness greatly influenced fixation screw stress response, while a more eccentric condylar head increased prosthetic joint-contact loading. Post-operatively, the prosthetic temporomandibular joint surgery reduced patient pain from 7/10 to 1/10 on a visual analog scale, and increased intercisal opening distance from 22 mm to 38 mm. This study demonstrates effectiveness of a personalized prosthesis that may ultimately be adapted to treat a wide-range of end-stage temporomandibular joint conditions, and highlights sensitivity of prosthesis load response to changes in condylar geometry. Copyright © 2018 Elsevier Ltd. All rights reserved.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Dewanjee, M.K.; Fuster, V.; Rao, S.A.
1983-05-01
A noninvasive technique has been developed in the dog model for imaging, with a gamma camera, the platelet deposition on Bjoerk-Shiley mitral valve prostheses early postoperatively. At 25 hours after implantation of the prosthesis and 24 hours after intravenous administration of 400 to 500 microCi of platelets labeled with indium-111, the platelet deposition in the sewing ring and perivalvular cardiac tissue can be clearly delineated in a scintiphotograph. An in vitro technique was also developed for quantitation of visceral microemboli in brain, lungs, kidneys, and other tissues. Biodistribution of the labeled platelets was quantitated, and the tissue/blood radioactivity ratio wasmore » determined in 22 dogs in four groups: unoperated normal dogs, sham-operated dogs, prosthesis-implanted dogs, and prosthesis-implanted dogs treated with dipyridamole before and aspirin and dipyridamole immediately after operation. Fifteen to 20% of total platelets were consumed as a consequence of the surgical procedure. On quantitation, we found that platelet deposition on the components of the prostheses was significantly reduced in prosthesis-implanted animals treated with dipyridamole and aspirin when compared with prosthesis-implanted, untreated dogs. All prosthesis-implanted animals considered together had a twofold to fourfold increase in tissue/blood radioactivity ratio in comparison with unoperated and sham-operated animals, an indication that the viscera work as filters and trap platelet microemboli that are presumably produced in the region of the mitral valve prostheses. In the dog model, indium-111-labeled platelets thus provide a sensitive marker for noninvasive imaging of platelet deposition on mechanical mitral valve prostheses, in vitro evaluation of platelet microembolism in viscera, in vitro quantitation of surgical consumption of platelets, and evaluation of platelet-inhibitor drugs.« less
Prabhu, Radhakrishnan; Prabhu, Geetha; Baskaran, Eswaran; Arumugam, Eswaran M.
2016-01-01
Statement of Problem: In recent years, direct metal laser sintered (DMLS) metal-ceramic-based fixed partial denture prostheses have been used as an alternative to conventional metal-ceramic fixed partial denture prostheses. However, clinical studies for evaluating their long-term clinical survivability and acceptability are limited. Aims and Objective: The aim of this study was to assess the efficacy of metal-ceramic fixed dental prosthesis fabricated with DMLS technique, and its clinical acceptance on long-term clinical use. Materials and Methods: The study group consisted of 45 patients who were restored with posterior three-unit fixed partial denture prosthesis made using direct laser sintered metal-ceramic restorations. Patient recall and clinical examination of the restorations were done after 6months and every 12 months thereafter for the period of 60 months. Clinical examination for evaluation of longevity of restorations was done using modified Ryge criteria which included chipping of the veneered ceramic, connector failure occurring in the fixed partial denture prosthesis, discoloration at the marginal areas of the veneered ceramic, and marginal adaptation of the metal and ceramic of the fixed denture prosthesis. Periapical status was assessed using periodical radiographs during the study period. Survival analysis was made using the Kaplan–Meier method. Results: None of the patients had failure of the connector of the fixed partial denture prostheses during the study period. Two exhibited biological changes which included periapical changes and proximal caries adjacent to the abutments. Conclusion: DMLS metal-ceramic fixed partial denture prosthesis had a survival rate of 95.5% and yielded promising results during the 5-year clinical study. PMID:27141171
Wang, Shangzeng; Cheng, Shao; Wang, Yisheng
2016-01-01
To evaluate the effectiveness of Oxford mobile-bearing bipolar prosthesis unicompartmental knee arthroplasty (UKA) in the treatment of single compartmental knee osteoarthritis. Between June 2011 and July 2013, 22 cases of single compartmental knee osteoarthritis were treated by Oxford mobile-bearing bipolar prosthesis UKA. Of 22 cases, 8 were male and 14 were female with an average age of 65 years (range, 45-80 years); the left knee was involved in 12 cases, and the right knee in 10 cases, with a mean disease duration of 32.5 months (range, 8-90 months). The mean weight was 55.2 kg (range, 50-65 kg), and the mean body mass index was 20.8 kg/m2 (range, 17-25 kg/m2). Osteoarthritis involved in the single knee medial compartment in all patients. Knee society score (KSS) and range of motion (ROM) were measured to evaluate the knee joint function. Primary healing of incision was obtained in all patients, and there was no complication of infection, bedsore, or deep venous thrombosis. Postoperative follow-up was 2-4 years (mean, 3.2 years). The X-ray films showed good position of prosthesis, no prosthesis dislocation, or periprosthetic infection during follow-up. Knee ROM, KSS function score, and KSS clinical score were significantly improved at 1 week after operation and at last follow-up when compared with preoperative ones (P < 0.05), but no significant difference was shown between at 1 week and at last follow-up (P > 0.05). Oxford mobile-bearing bipolar prosthesis UKA is an effective method to treat single compartmental knee osteoarthritis, with the advantages of less trauma, earlier rehabilitation exercise, near physiological state in joint function, and less risk of complications.
Joshi, Niranjan; Shetty, Sridhar N; Prasad, Krishna D
2013-01-01
The use of different materials and techniques has been studied to decide the safest quantum of reduction of the occlusal surfaces. However, these methods provide limited information as to the actual amount of reduction with limitations in accuracy, accessibility and complexity. The objective of this study was to compare and evaluate the reliability of the most commonly used occlusal registration wax that with polyether bite registration material as a guide for occlusal reduction required during tooth preparations. For the purpose of this study, 25 abutment teeth requiring tooth preparation for fixed prosthesis were selected and tooth preparations carried out. Modeling wax strips of specific dimensions were placed onto the cast of prepared tooth, which was mounted on maximum intercuspation on the articulator and the articulator was closed. The thickness of the wax registration was measured at three zones namely two functional cusps and central fossa. Similar measurements were made using the polyether bite registration material and prosthesis at the same zones. The data was tabulated and was subjected to statistical analysis using anova test and Tukey honestly significant difference test. The differences in thickness between wax record and prosthesis by 0.1346 mm, whereas the difference between polyether and prosthesis was 0.02 mm with a P value of 0.042, which is statistically significant. This means that the wax record was 8.25% larger than the prosthesis while polyether was just 1.27% larger than the prosthesis. The clinical significance of the above analysis is that Ramitec polyether bite registration material is most suitable material when compared with commonly used modeling wax during the tooth preparation.
Reynolds, Matthew R.; Lei, Yang; Wang, Kaijun; Chinnakondepalli, Khaja; Vilain, Katherine A.; Magnuson, Elizabeth A.; Galper, Benjamin Z.; Meduri, Christopher U.; Arnold, Suzanne V.; Baron, Suzanne J.; Reardon, Michael J.; Adams, David H.; Popma, Jeffrey J.; Cohen, David J.
2016-01-01
Background Prior studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. Objectives The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. Methods We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk pivotal trial. Empirical data regarding survival and quality of life (QOL) over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. perspective. Results Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month QOL. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years (QALYs; 0.41 life-years [LYs]) with 3% discounting. Lifetime incremental cost-effectiveness ratios (ICERs) were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ~$1,650 would lead to an ICER <$50,000/QALY gained. Conclusions In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. standards. With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. PMID:26764063
Jugård, Ylva; Odersjö, Marie; Topa, Alexandra; Lindgren, Gun; Andersson Grönlund, Marita
2015-07-13
Anophthalmia/microphthalmia (A/M) are rare congenital eye malformations. Early intervention with ocular prosthesis can stimulate orbital growth and prevent facial asymmetry. We reviewed medical records from 18 individuals with A/M (0.8-31 years) treated with ocular prosthesis at Sahlgrenska University Hospital between 2000 and 2012. A majority had other ocular findings. Seven had subnormal visual acuity in the fellow eye, one third were in contact with vision support services and half of the group wore glasses. Eleven individuals had extra-ocular findings such as cardiac defect, hearing impairment and neuropsychiatric disorders, possibly indicating syndromic conditions. We suggest that investigation of A/M children should include ultrasound of the eye, optionally visual evoked potential and magnetic resonance imaging of the CNS. The ophthalmologist should initiate treatment with prosthesis, pediatric assessment, hearing tests and genetic counseling, but should also monitor visual development of the fellow eye.
Sawers, Andrew; Hafner, Brian J
2018-05-08
Challenging clinical balance tests are needed to expose balance deficits in lower-limb prost-hesis users. This study examined whether narrowing beam-walking could overcome conceptual and practical limitations identified in fixed-width beam-walking. Cross-sectional. Unilateral lower-limb prosthesis users. Participants walked 10 times along a low, narrowing beam. Performance was quantified using the normalized distance walked. Heuristic rules were applied to determine whether the narrowing beam task was "too easy," "too hard," or "appropriately challenging" for each participant. Linear regression and Bland-Altman plots were used to determine whether combinations of the first 5 trials could predict participants' stable beam-walking performance. Forty unilateral lower-limb prosthesis users participated. Narrowing beam-walking was appropriately challenging for 98% of participants. Performance stabilized for 93% of participants within 5 trials, while 62% were stable across all trials. The mean of trials 3-5 accurately predicted stable performance. A clinical narrowing beam-walking test is likely to challenge a range of lower-limb prosthesis users, have minimal administrative burden, and exhibit no floor or ceiling effects. Narrowing beam-walking is therefore a clinically viable method to evaluate lower-limb prosthesis users' balance ability, but requires psychometric testing before it is used to assess fall risk.
Kraeima, J; Merema, B J; Witjes, M J H; Spijkervet, F K L
2018-05-01
Patients suffering from osteoarthritis, ankylosis (e.g. post-trauma or tumour) in the temporomandibular joint (TMJ) can present with symptoms such as severely restricted mouth opening, pain or other dynamic restrictions of the mandible. To alleviate the symptoms, a total joint prosthesis can be indicated, such as the Groningen TMJ prosthesis. This was developed as a stock device with a lowered centre of rotation for improved translational and opening capacity. This study aimed to improve the design of the prosthesis, and produce a workflow for a customized Groningen TMJ prosthesis, in order to make it more accurate and predictable. The fossa and mandibular components of the Groningen TMJ prosthesis were customized. A series of five human cadavers was operated and bilateral TMJ prostheses were placed using custom cutting and drilling guides. Placement accuracy was evaluated based on post-operative CT data. A total of N = 10 prostheses were placed and analysed. The average Euclidean distance deviation from planned to actual position was 0.81 mm (SD 0.21). All prostheses were placed according to the routine surgical approaches and had an excellent alignment with the bony structures. The newly developed custom Groningen TMJ prosthesis can be placed with great accuracy and is the first step for improving TMJ total joint replacement surgery. Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.
Applications of rapid prototyping technology in maxillofacial prosthetics.
Sykes, Leanne M; Parrott, Andrew M; Owen, C Peter; Snaddon, Donald R
2004-01-01
The purpose of this study was to compare the accuracy, required time, and potential advantages of rapid prototyping technology with traditional methods in the manufacture of wax patterns for two facial prostheses. Two clinical situations were investigated: the production of an auricular prosthesis and the duplication of an existing maxillary prosthesis, using a conventional and a rapid prototyping method for each. Conventional wax patterns were created from impressions taken of a patient's remaining ear and an oral prosthesis. For the rapid prototyping method, a cast of the ear and the original maxillary prosthesis were scanned, and rapid prototyping was used to construct the wax patterns. For the auricular prosthesis, both patterns were refined clinically and then flasked and processed in silicone using routine procedures. Twenty-six independent observers evaluated these patterns by comparing them to the cast of the patient's remaining ear. For the duplication procedure, both wax patterns were scanned and compared to scans of the original prosthesis by generating color error maps to highlight volumetric changes. There was a significant difference in opinions for the two auricular prostheses with regard to shape and esthetic appeal, where the hand-carved prosthesis was found to be of poorer quality. The color error maps showed higher errors with the conventional duplication process compared with the rapid prototyping method. The main advantage of rapid prototyping is the ability to produce physical models using digital methods instead of traditional impression techniques. The disadvantage of equipment costs could be overcome by establishing a centralized service.
Yang, Li-qing; Li, Xi; Fu, Qin; Wang, Cheng
2013-07-01
To retrospectively study early therapeutic effects of the ceramics to ceramics prosthesis design in treating hip disease. From October 2007 to September 2010, 42 patients (44 hips) with hip disease underwent replacement of total hip. Hip prosthesis designs included the Pinnacle ceramics to ceramics and the Duraloc metal to polyethylene,produced by DePuy Company, all were non-bone cement type of artificial hip joint. Twenty patients (22 hips) were performed with ceramics to ceramics total hip prosthesis (CoC group, there were 12 males and 8 females, aged from 21 to 49 years) and 22 patients (22 hips) were performed with metal to polyethylene total hip prosthesis (MoP group, there were 13 males and 9 females, aged from 42 to 55 years). All the surgical approachs were posterolateral, and the routine anticoagulation and the corresponding functional exercise were performed after operation. The follow-up time was 6 months at least including clinical and radiographic observation. Measured the motion of joint and evaluated the function of hip joint according to Harris classification. All clinical effects were satisfactory and no dislocation ,loosening,infection, deep venous thrombosis and other complications occurred. There was no statistical significance in Harris scoring and the motion of joint between two groups before and after operation (P>0.05). The clinical effect of ceramics to ceramics prosthesis design in improving clinical symptoms and the motion of joint is coordinate with metal to polyethylene total hip prosthesis, however, its advantages and long-term efficacy need further observing. The ceramics to ceramics prosthesis design may be a good choice for the young patients with hip disease because of its good wear resistance.
Automated estimation of hip prosthesis migration: a feasibility study
NASA Astrophysics Data System (ADS)
Vandemeulebroucke, Jef; Deklerck, Rudi; Temmermans, Frederik; Van Gompel, Gert; Buls, Nico; Scheerlinck, Thierry; de Mey, Johan
2013-09-01
A common complication associated with hip arthoplasty is prosthesis migration, and for most cemented components a migration greater than 0.85 mm within the first six months after surgery, are an indicator for prosthesis failure. Currently, prosthesis migration is evaluated using X-ray images, which can only reliably estimate migrations larger than 5 mm. We propose an automated method for estimating prosthesis migration more accurately, using CT images and image registration techniques. We report on the results obtained using an experimental set-up, in which a metal prosthesis can be translated and rotated with respect to a cadaver femur, over distances and angles applied using a combination of positioning stages. Images are first preprocessed to reduce artefacts. Bone and prosthesis are extracted using consecutive thresholding and morphological operations. Two registrations are performed, one aligning the bones and the other aligning the prostheses. The migration is estimated as the difference between the found transformations. We use a robust, multi-resolution, stochastic optimization approach, and compare the mean squared intensity differences (MS) to mutual information (MI). 30 high-resolution helical CT scans were acquired for prosthesis translations ranging from 0.05 mm to 4 mm, and rotations ranging from 0.3° to 3° . For the translations, the mean 3D registration error was found to be 0.22 mm for MS, and 0.15 mm for MI. For the rotations, the standard deviation of the estimation error was 0.18° for MS, and 0.08° for MI. The results show that the proposed approach is feasible and that clinically acceptable accuracies can be obtained. Clinical validation studies on patient images will now be undertaken.
Nakamura, Yoshinori; Kanbara, Ryo; Ochiai, Kent T; Tanaka, Yoshinobu
2014-10-01
The mechanical evaluation of the function of partial removable dental prostheses with 3-dimensional finite element modeling requires the accurate assessment and incorporation of soft tissue behavior. The differential behaviors of the residual ridge mucosa and periodontal ligament tissues have been shown to exhibit nonlinear displacement. The mathematic incorporation of known values simulating nonlinear soft tissue behavior has not been investigated previously via 3-dimensional finite element modeling evaluation to demonstrate the effect of prosthesis design on the supporting tissues. The purpose of this comparative study was to evaluate the functional differences of 3 different partial removable dental prosthesis designs with 3-dimensional finite element analysis modeling and a simulated patient model incorporating known viscoelastic, nonlinear soft tissue properties. Three different designs of distal extension removable partial dental prostheses were analyzed. The stress distributions to the supporting abutments and soft tissue displacements of the designs tested were calculated and mechanically compared. Among the 3 dental designs evaluated, the RPI prosthesis demonstrated the lowest stress concentrations on the tissue supporting the tooth abutment and also provided wide mucosa-borne areas of support, thereby demonstrating a mechanical advantage and efficacy over the other designs evaluated. The data and results obtained from this study confirmed that the functional behavior of partial dental prostheses with supporting abutments and soft tissues are consistent with the conventional theories of design and clinical experience. The validity and usefulness of this testing method for future applications and testing protocols are shown. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Machhindra, Morey Vivek; Kang, Jong Yeal; Kang, Yeon Gwi; Chowdhry, Madhav; Kim, Tae Kyun
2015-12-01
We determined whether a new mobile-bearing ultra-congruent (UC) TKA system provides better functional outcomes than an established posterior-stabilized (PS) prosthesis. The functional outcomes (motion arc, AKS scores, WOMAC Index, and SForm-36 scores evaluated at 1 and 2 years postoperatively), satisfaction and incidences of adverse events were compared between the knees implanted with mobile-bearing UC prosthesis (n=103) and the mobile-bearing PS prosthesis (n=99). At 2 years, mobile-bearing UC TKAs showed similar functional outcomes and satisfaction, but smaller motion arc compared to mobile-bearing PS TKAs (126° vs. 131°). There were no differences in the incidence of adverse events. Mobile-bearing UC prosthesis can be considered a safe and viable alternative to the PS design, with an expectation of smaller postoperative maximum flexion. Copyright © 2015 Elsevier Inc. All rights reserved.
Zou, Yun; Han, Qing; Weng, Xisheng; Zou, Yongwei; Yang, Yingying; Zhang, Kesong; Yang, Kerong; Xu, Xiaolin; Wang, Chenyu; Qin, Yanguo; Wang, Jincheng
2018-01-01
Abstract Recently, clinical application of 3D printed model was increasing. However, there was no systemic study for confirming the precision and reliability of 3D printed model. Some senior clinical doctors mistrusted its reliability in clinical application. The purpose of this study was to evaluate the precision and reliability of stereolithography appearance (SLA) 3D printed model. Some related parameters were selected to research the reliability of SLA 3D printed model. The computed tomography (CT) data of bone/prosthesis and model were collected and 3D reconstructed. Some anatomical parameters were measured and statistical analysis was performed; the intraclass correlation coefficient (ICC) was used to was used to evaluate the similarity between the model and real bone/prosthesis. the absolute difference (mm) and relative difference (%) were conducted. For prosthesis model, the 3-dimensional error was measured. There was no significant difference in the anatomical parameters except max height (MH) of long bone. All the ICCs were greater than 0.990. The maximum absolute and relative difference were 0.45 mm and 1.10%; The 3-dimensional error analysis showed that positive/minus distance were 0.273 mm/0.237 mm. The application of SLA 3D printed model in diagnosis and treatment process of complex orthopedic disease was reliable and precise. PMID:29419675
Zou, Yun; Han, Qing; Weng, Xisheng; Zou, Yongwei; Yang, Yingying; Zhang, Kesong; Yang, Kerong; Xu, Xiaolin; Wang, Chenyu; Qin, Yanguo; Wang, Jincheng
2018-02-01
Recently, clinical application of 3D printed model was increasing. However, there was no systemic study for confirming the precision and reliability of 3D printed model. Some senior clinical doctors mistrusted its reliability in clinical application. The purpose of this study was to evaluate the precision and reliability of stereolithography appearance (SLA) 3D printed model.Some related parameters were selected to research the reliability of SLA 3D printed model. The computed tomography (CT) data of bone/prosthesis and model were collected and 3D reconstructed. Some anatomical parameters were measured and statistical analysis was performed; the intraclass correlation coefficient (ICC) was used to was used to evaluate the similarity between the model and real bone/prosthesis. the absolute difference (mm) and relative difference (%) were conducted. For prosthesis model, the 3-dimensional error was measured.There was no significant difference in the anatomical parameters except max height (MH) of long bone. All the ICCs were greater than 0.990. The maximum absolute and relative difference were 0.45 mm and 1.10%; The 3-dimensional error analysis showed that positive/minus distance were 0.273 mm/0.237 mm.The application of SLA 3D printed model in diagnosis and treatment process of complex orthopedic disease was reliable and precise.
A pneumatic Bionic Voice prosthesis-Pre-clinical trials of controlling the voice onset and offset.
Ahmadi, Farzaneh; Noorian, Farzad; Novakovic, Daniel; van Schaik, André
2018-01-01
Despite emergent progress in many fields of bionics, a functional Bionic Voice prosthesis for laryngectomy patients (larynx amputees) has not yet been achieved, leading to a lifetime of vocal disability for these patients. This study introduces a novel framework of Pneumatic Bionic Voice Prostheses as an electronic adaptation of the Pneumatic Artificial Larynx (PAL) device. The PAL is a non-invasive mechanical voice source, driven exclusively by respiration with an exceptionally high voice quality, comparable to the existing gold standard of Tracheoesophageal (TE) voice prosthesis. Following PAL design closely as the reference, Pneumatic Bionic Voice Prostheses seem to have a strong potential to substitute the existing gold standard by generating a similar voice quality while remaining non-invasive and non-surgical. This paper designs the first Pneumatic Bionic Voice prosthesis and evaluates its onset and offset control against the PAL device through pre-clinical trials on one laryngectomy patient. The evaluation on a database of more than five hours of continuous/isolated speech recordings shows a close match between the onset/offset control of the Pneumatic Bionic Voice and the PAL with an accuracy of 98.45 ±0.54%. When implemented in real-time, the Pneumatic Bionic Voice prosthesis controller has an average onset/offset delay of 10 milliseconds compared to the PAL. Hence it addresses a major disadvantage of previous electronic voice prostheses, including myoelectric Bionic Voice, in meeting the short time-frames of controlling the onset/offset of the voice in continuous speech.
de la Garza-Castro, Santiago; González-Rivera, Carlos E; Vílchez-Cavazos, Félix; Morales-Avalos, Rodolfo; Barrera-Flores, Francisco J; Elizondo-Omaña, Rodrigo E; Soto-Dominguez, Adolfo; Acosta-Olivo, Carlos; Mendoza-Lemus, Oscar F
2017-07-27
The aim of this study was to evaluate the clinical, biomechanical and morphological characteristics of a Kevlar®-based prosthetic ligament as a synthetic graft of the anterior cruciate ligament (ACL) in an experimental animal model in rabbits. A total of 27 knees of rabbits randomly divided into 3 groups (control, ACL excision and ACL replacement with a Kevlar® prosthesis) were analyzed using clinical, biomechanical and morphological tests at 6, 12 and 18 weeks postprocedure. The mean displacement in mechanical testing was 0.73 ± 0.06 mm, 1.58 ± 0.19 mm and 0.94 ± 0.20 mm for the control, ACL excision and ACL replacement with synthetic prosthesis groups, respectively. The results showed an improvement in the stability of the knee with the use of the Kevlar® synthetic prosthesis in the biomechanical testing (p<0.05) compared with rabbits that underwent ACL excision, in addition to displacements that were larger but comparable to that in the control group (p>0.05), between the replacement group and the control group. The histological study revealed a good morphological adaptation of the synthetic material to the knee. This study proposes a new animal model for the placement and evaluation of Kevlar®-based synthetic ACL implants. The studied prosthesis showed promising behavior in the clinical and biomechanical tests and in the histological analysis. This study lays the foundation for further basic and clinical studies of artificial ACL prostheses using this material.
Ueberrueck, T; Meyer, L; Zippel, R; Nestler, G; Wahlers, T; Gastinger, I
2005-02-01
To investigate the intraluminal and extraluminal healing behaviour of a new metallic silver coated, gelatine impregnated vascular graft. Comparative animal experimental investigation with randomisation of the animals to control and experimental groups. 24 pigs were assigned to two control and two experimental groups. The prostheses were interposed in the pigs' infrarenal aorta. For the evaluation, macroscopic, histological and immunohistochemical criteria were applied. The macroscopic evaluation after explantation of the prosthesis revealed similar healing characteristics in the control and experimental groups. The microscopic determination of neo-intimal thickness showed no significant differences between the groups; nor did the immunohistochemical investigations show any significant difference between the control group and the silver-coated prosthesis group. No disadvantage of the silver coating in terms of healing and graft patency was found. A possible advantage in terms of the antibacterial effect of the silver coating must be investigated in the clinical setting.
Kasparek, Maximilian F; Töpker, Michael; Lazar, Mathias; Weber, Michael; Kasparek, Michael; Mang, Thomas; Apfaltrer, Paul; Kubista, Bernd; Windhager, Reinhard; Ringl, Helmut
2018-06-07
To evaluate the influence of different scan parameters for single-energy CT and dual-energy CT, as well as the impact of different material used in a TKA prosthesis on image quality and the extent of metal artifacts. Eight pairs of TKA prostheses from different vendors were examined in a phantom set-up. Each pair consisted of a conventional CoCr prosthesis and the corresponding anti-allergic prosthesis (full titanium, ceramic, or ceramic-coated) from the same vendor. Nine different (seven dual-energy CT and two single-energy CT) scan protocols with different characteristics were used to determine the most suitable CT protocol for TKA imaging. Quantitative image analysis included assessment of blooming artifacts (metal implants appear thicker on CT than they are, given as virtual growth in mm in this paper) and streak artifacts (thick dark lines around metal). Qualitative image analysis was used to investigate the bone-prosthesis interface. The full titanium prosthesis and full ceramic knee showed significantly fewer blooming artifacts compared to the standard CoCr prosthesis (mean virtual growth 0.6-2.2 mm compared to 2.9-4.6 mm, p < 0.001). Dual-energy CT protocols showed less blooming (range 3.3-3.8 mm) compared to single-energy protocols (4.6-5.5 mm). The full titanium and full ceramic prostheses showed significantly fewer streak artifacts (mean standard deviation 77-86 Hounsfield unit (HU)) compared to the standard CoCr prosthesis (277-334 HU, p < 0.001). All dual-energy CT protocols had fewer metal streak artifacts (215-296 HU compared to single-energy CT protocols (392-497 HU)). Full titanium and ceramic prostheses were ranked superior with regard to the image quality at the bone/prosthesis interface compared to a standard CoCr prosthesis, and all dual-energy CT protocols were ranked better than single-energy protocols. Dual-energy CT and ceramic or titanium prostheses reduce CT artifacts and provide superior image quality of total knee arthroplasty at the bone/prosthesis interface. These findings support the use of dual-energy CT as a solid imaging base for clinical decision-making and the use of full-titanium or ceramic prostheses to allow for better CT visualization of the bone-prosthesis interface.
Gibson, M A; Carell, E S
1997-11-01
The advent of transvenous right heart catheterization has relegated direct transthoracic right ventricular puncture largely to the role of "interesting historical footnote." However, in the case of a right ventricle that is "protected" by a mechanical tricuspid valve prosthesis, direct right ventricular puncture represents a reasonable alternative for obtaining accurate hemodynamic information.
Yamaki, F; Nakano, K; Endo, M; Hashimoto, A; Koyanagi, H
1994-02-01
Although a high incidence of strut fracture of the Björk-Shiley convexo-concave (C-C) valve prosthesis has been reported, it is still controversial whether the prosthesis functioning normally should be replaced electively. To clarify our policy for this issue, we reviewed 28 patients who had undergone mitral valve replacement with a C-C valve prosthesis, and evaluated long-term results according to STS guidelines. The incidence of valve-related complications expressed as % patient-year were; structural deterioration 0.30, nonstructural dysfunction 0.30, thromboembolism 1.20. There were no thrombosed valves, anticoagulant-related hemorrhage or prosthetic valve endocarditis. The actuarial free rate after valve replacement with the C-C at 10 years, constructed by the Kaplan-Meier method, were compared with those with St. Jude Medical (SJM) valve prosthesis. (1) Actuarial survival: 77.9 vs 87.3 (NS), (2) Reoperation-free: 91.6 vs 98.0 (p < 0.05), (3) thromboembolism-free: 83.7 vs 83.9 (NS), (4) Event-free (hospital death+reoperation+valve-related complications: 71.2 vs 77.7 (NS). The long-term results with the C-C were compatible to those with a SJM valve prosthesis. However, if a strut fracture occurs, it is very difficult to save the patient's life. The hospital mortality of re-replacement of valve prosthesis during the last 10 years, at our institute, was 2.6%, which is almost equal to the cumulative risk of strut fracture of the C-C valve after 10 years (3.0%).(ABSTRACT TRUNCATED AT 250 WORDS)
Hayashi, A
1991-02-01
The present experimental study was undertaken to evaluate the efficacy of combined latissimus dorsi muscle flap and soft Marlex mesh in the reconstruction of the trachea. Thirty-one mongrel dogs underwent a two-stage operation. In the first stage operation, they were divided into four groups for implanting a different prosthesis. A silicone rod was used as the core and this was rolled with soft Marlex mesh to make a prosthesis (Group A and B: without reinforce, Group C: reinforced by wrapping stainless steel mesh, Group D: reinforced with helical stain steel wire). The latissimus dorsi muscle flap was rolled circumferentially around the prosthesis and it was left in place for a period of 4 to 6 weeks. In the second stage operation, the long pedicled muscle flap with the biologically organized prosthesis was mobilized to be guided into the cervix, and the tracheal reconstruction was done with them following circumferential tracheal resection. In result, five of six dogs of group D survived more than 6 months after the replacement without anastomotic leakage or stenosis causing inflammatory granulation. Organization with neo-vascularity of the prosthesis at the time of the tracheal reconstruction was important firstly to avoid incurring complications concerning anastomosis and secondly for long-term stability of the healing and epithelialization of the prosthesis.
Evaluation of metal-polymeric fixed partial prosthesis using optical coherence tomography
NASA Astrophysics Data System (ADS)
Sinescu, C.; Negrutiu, M. L.; Duma, V. F.; Marcauteanu, C.; Topala, F. I.; Rominu, M.; Bradu, A.; Podoleanu, A. Gh.
2013-11-01
Metal-Polymeric fixed partial prosthesis is the usual prosthetic treatment for many dental patients. However, during the mastication the polymeric component of the prosthesis is fractured and will be lost. This fracture is caused by the material defects or by the fracture lines trapped inside the esthetic components of the prosthesis. This will finally lead to the failure of the prosthetic treatment. Nowadays, there is no method of identification and forecast for the materials defects of the polymeric materials. The aim of this paper is to demonstrate the capability of Optical Coherence Tomography (OCT) as a non-invasive clinical method that can be used for the evaluation of metal-polymeric fixed partial prostheses. Twenty metal-polymeric fixed partial prostheses were used for this study. The esthetic component of the prostheses has been Adoro (Ivoclar). Optical investigations of the metal prostheses have revealed no material defects or fracture lines. All the prostheses were temporary cemented in the oral cavities of the patients for six month. The non-invasive method used for the investigations was OCT working in Time Domain mode at 1300 nm. The evaluations of the prostheses were performed before and after their cementation in the patient mouths. All the imagistic results were performed in 2D and than in 3D, after the reconstruction. The results obtained after the OCT evaluation allowed for the identification of 4 metal-polymeric fixed partial prostheses with material defects immediately after finishing the technological procedures. After 6 month in the oral environment other 3 fixed partial prostheses revealed fracture lines. In conclusion, OCT proved to be a valuable tool for the noninvasive evaluation of the metal-polymeric fixed partial prostheses.
Major, Matthew J.; Caldwell, Ryan; Fatone, Stefania
2015-01-01
Vacuum-assisted suspension (VAS) of prosthetic sockets utilizes a pump to evacuate air from between the prosthetic liner and socket, and are available as mechanical or electric systems. This technical note describes a hybrid pump that benefits from the advantages of mechanical and electric systems, and evaluates a prototype as proof-of-concept. Cyclical bench testing of the hybrid pump mechanical system was performed using a materials testing system to assess the relationship between compression cycles and vacuum pressure. Phase 1 in vivo testing of the hybrid pump was performed by an able-bodied individual using prosthesis simulator boots walking on a treadmill, and phase 2 involved an above-knee prosthesis user walking with the hybrid pump and a commercial electric pump for comparison. Bench testing of 300 compression cycles produced a maximum vacuum of 24 in-Hg. In vivo testing demonstrated that the hybrid pump continued to pull vacuum during walking, and as opposed to the commercial electric pump, did not require reactivation of the electric system during phase 2 testing. The novelty of the hybrid pump is that while the electric system provides rapid, initial vacuum suspension, the mechanical system provides continuous air evacuation while walking to maintain suspension without reactivation of the electric system, thereby allowing battery power to be reserved for monitoring vacuum levels. PMID:27462383
Technology efficacy in active prosthetic knees for transfemoral amputees: a quantitative evaluation.
El-Sayed, Amr M; Hamzaid, Nur Azah; Abu Osman, Noor Azuan
2014-01-01
Several studies have presented technological ensembles of active knee systems for transfemoral prosthesis. Other studies have examined the amputees' gait performance while wearing a specific active prosthesis. This paper combined both insights, that is, a technical examination of the components used, with an evaluation of how these improved the gait of respective users. This study aims to offer a quantitative understanding of the potential enhancement derived from strategic integration of core elements in developing an effective device. The study systematically discussed the current technology in active transfemoral prosthesis with respect to its functional walking performance amongst above-knee amputee users, to evaluate the system's efficacy in producing close-to-normal user performance. The performances of its actuator, sensory system, and control technique that are incorporated in each reported system were evaluated separately and numerical comparisons were conducted based on the percentage of amputees' gait deviation from normal gait profile points. The results identified particular components that contributed closest to normal gait parameters. However, the conclusion is limitedly extendable due to the small number of studies. Thus, more clinical validation of the active prosthetic knee technology is needed to better understand the extent of contribution of each component to the most functional development.
Zhu, Da; Chen, Yucheng; Guo, Yingqiang; Hu, Jia; Zhang, Ji; Wei, Xin; Tang, Hong; Shi, Yingkang
2015-11-15
To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis (AS) or pure/dominant aortic regurgitation (AR) using the J-Valve™ system. Twenty patients with isolated aortic valve disease (11 with pure/dominant AR and 9 with AS) at high risk for open-heart surgery were enrolled in this study. The mean Logistic Euro-SCORE I was 27.2±8.2% (mean age 74.5±4.7years). Four sizes of prosthesis were used for annular size up to 21 mm (n=1), 23mm (n=2), 25mm (n=10) and 27mm (n=7). Clinical and echocardiographic evaluations were performed at baseline, post-procedure and follow-up. The primary endpoint was all-cause mortality. Secondary endpoints were procedural success, major adverse events as well as echocardiographic performance. TAVI with the J-Valve™ device was successfully performed in 19 patients (95%). Conversion to surgical valve replacement was necessary in one patient due to prosthesis embolization. No mortality occurred during 90 days follow-up. Pacemaker implantation for new onset conduction disorders was necessary in one patient (5%). For patient with severe AS, post-procedure TAVI resulted in favorable reduction of mean transvalvular gradients (55.3±8.5 vs. 16.4±13.3 mmHg, P<0.01). Mean transvalvular gradient was also favorable in AR patients after valve implantation (6.9±1mmHg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation. Trans-apical TAVI using the J-Valve™ prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Buttermann, Glenn R; Mendenhall, H Vincent
2012-04-01
The optimal lumbar spinal disc prosthesis has yet to be developed. Failures of clinical device studies may be minimized by appropriate large animal preclinical studies. The lumbar spine of the mature "runt" cow, Corrientes breed, has been shown to have a number of desirable characteristics to the human. This study assessed the feasibility of the "runt" cow for in vivo testing of human-sized lumbar interbody implants and the ability to perform common analyses of explants. Eight cows (four experimental and four controls) were compared. The experimental animals had transosseous implantation of the disc prosthesis at L4-L5, and their spines were harvested at four or six months. They were evaluated for the ease of surgical access and healing, motion segment mobility, ability to remove the implant nondestructively, and microradiography and histomorphology. All animals had successful implantation. All explantations were performed without alteration to the devices. All animals had surgical healing and intended device motion, and histology found device stability by demonstrating bone ingrowth into the device's porous plates. There was a significant 46% increase in the amount of trabecular bone adjacent to the implants. The mature runt cow allows for implantation of human-sized interbody and intrabody spinal prostheses. This animal model allowed for macro- and histological analysis of the implant and surrounding tissues. In vivo stability was demonstrated for the disc prosthesis while also allowing for evaluation of intended mobility. Additionally, this is the first study to suggest increased bone density supporting an interbody prosthesis.
Speech evaluation after palatal augmentation in patients undergoing glossectomy.
de Carvalho-Teles, Viviane; Sennes, Luiz Ubirajara; Gielow, Ingrid
2008-10-01
To assess, in patients undergoing glossectomy, the influence of the palatal augmentation prosthesis on the speech intelligibility and acoustic spectrographic characteristics of the formants of oral vowels in Brazilian Portuguese, specifically the first 3 formants (F1 [/a,e,u/], F2 [/o,ó,u/], and F3 [/a,ó/]). Speech evaluation with and without a palatal augmentation prosthesis using blinded randomized listener judgments. Tertiary referral center. Thirty-six patients (33 men and 3 women) aged 30 to 80 (mean [SD], 53.9 [10.5]) years underwent glossectomy (14, total glossectomy; 12, total glossectomy and partial mandibulectomy; 6, hemiglossectomy; and 4, subtotal glossectomy) with use of the augmentation prosthesis for at least 3 months before inclusion in the study. Spontaneous speech intelligibility (assessed by expert listeners using a 4-category scale) and spectrographic formants assessment. We found a statistically significant improvement of spontaneous speech intelligibility and the average number of correctly identified syllables with the use of the prosthesis (P < .05). Statistically significant differences occurred for the F1 values of the vowels /a,e,u/; for F2 values, there was a significant difference of the vowels /o,ó,u/; and for F3 values, there was a significant difference of the vowels /a,ó/ (P < .001). The palatal augmentation prosthesis improved the intelligibility of spontaneous speech and syllables for patients who underwent glossectomy. It also increased the F2 and F3 values for all vowels and the F1 values for the vowels /o,ó,u/. This effect brought the values of many vowel formants closer to normal.
Axial displacements in external and internal implant-abutment connection.
Lee, Ji-Hye; Kim, Dae-Gon; Park, Chan-Jin; Cho, Lee-Ra
2014-02-01
The purpose of this study was to evaluate the axial displacement of the abutments during clinical procedures by the tightening torque and cyclic loading. Two different implant-abutment connection systems were used (external butt joint connection [EXT]; internal tapered conical connection [INT]). The master casts with two implant replicas, angulated 10° from each other, were fabricated for each implant connection system. Four types of impression copings were assembled and tightened with the corresponding implants (hex transfer impression coping, non-hex transfer impression coping, hex pick-up impression coping, non-hex pick-up impression coping). Resin splinted abutments and final prosthesis were assembled. The axial displacement was measured from the length of each assembly, which was evaluated repeatedly, after 30 Ncm torque tightening. After 250 N cyclic loading of final prosthesis for 1,000,000 cycles, additional axial displacement was recorded. The mean axial displacement was statistically analyzed (repeated measured ANOVA). There was more axial displacement in the INT group than that of the EXT group in impression copings, resin splinted abutments, and final prosthesis. Less axial displacement was found at 1-piece non-hex transfer type impression coping than other type of impression copings in the INT group. There was more axial displacement at the final prosthesis than resin splinted abutments in the INT and the EXT groups. After 250 N cyclic loading of final prosthesis, the INT group showed more axial displacement than that of the EXT group. Internal tapered conical connection demonstrated a varying amount of axial displacement with tightening torque and cyclic loading. © 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.
Acocella, Alessandro; Ercoli, Carlo; Geminiani, Alessandro; Feng, Changyong; Billi, Mauro; Acocella, Gabriele; Giannini, Domenico; Sacco, Roberto
2012-05-01
Immediate occlusal loading of dental implants in the edentulous mandible has proven to be an effective, reliable, and predictable treatment protocol. However, there is limited long-term data available in the literature, when an electroeroded definitive cast-titanium fixed prosthesis is used for this treatment protocol. The aim of this study was to evaluate the clinical effectiveness of dental implants (Astra Tech Dental, Mölndal, Sweden) in the edentulous mandible immediately loaded with an electroeroded cast-titanium screw-retained fixed prosthesis. Forty-five patients received five implants each in the interforaminal area. All the implants were inserted with torque up to 40 Ncm and the distal implants were distally tilted approximately 20 to 30 degrees to minimize the length of posterior cantilevers. Implants were loaded within 48 hours of placement with an acrylic resin-titanium screw-retained prosthesis fabricated by electroerosion. Two of the 225 inserted implants failed after 3 and 16 months of healing, respectively, with a cumulative survival rate of 99.1% and a prosthetic survival rate of 97.8%. Immediate loading of tilted dental implants inserted in the edentulous mandible with a screw-retained titanium definitive prosthesis fabricated with electrical discharge machining provide reliable and predictable results. © 2011 Wiley Periodicals, Inc.
Kinumatsu, Takashi; Umehara, Kazuhiro; Nagano, Kyosuke; Saito, Atsushi
2014-01-01
We report a patient with severe chronic periodontitis requiring regenerative periodontal surgery and different types of prosthesis in the maxillary and mandibular regions. The patient was a 57-year-old woman who presented with the chief complaint of occlusal pain. An initial clinical examination revealed that 73% of sites had a probing depth of ≥4 mm, and 60% of sites exhibiting bleeding on probing. Radiographic examination revealed vertical bone defects in the molar region and widening of the periodontal ligament space around teeth #17 and 24. Initial periodontal therapy was implemented based on a clinical diagnosis of severe chronic periodontitis. Surgical periodontal therapy was subsequently performed at selected sites. Periodontal regenerative therapy using enamel matrix derivative was performed on #14, 15, and 35-37. Tunnel preparation was performed on #46 as it had a 2-wall vertical bony defect and Degree 3 furcation involvement. Other sites with residual periodontal pockets were treated by modified Widman flap surgery. After a re-evaluation, functional rehabilitation was implemented with a removable maxillary partial denture and a fixed mandibular bridge. No further deterioration was observed in the periodontal condition of most of the teeth during a 2-year period of supportive periodontal therapy (SPT). The patient is currently still undergoing SPT and some minor problems remain. However, the results suggest that treatment and subsequent maintenance for severe periodontitis with traumatic occlusion can be successful as long as the appropriate periodontal and prosthodontic treatment is planned and careful SPT carried out.
Golf hand prosthesis performance of transradial amputees.
Carey, Stephanie L; Wernke, Matthew M; Lura, Derek J; Kahle, Jason T; Dubey, Rajiv V; Highsmith, M Jason
2015-06-01
Typical upper limb prostheses may limit sports participation; therefore, specialized terminal devices are often needed. The purpose of this study was to evaluate the ability of transradial amputees to play golf using a specialized terminal device. Club head speed, X-factor, and elbow motion of two individuals with transradial amputations using an Eagle Golf terminal device were compared to a non-amputee during a golf swing. Measurements were collected pre/post training with various stances and grips. Both prosthesis users preferred a right-handed stance initially; however, after training, one preferred a left-handed stance. The amputees had slower club head speeds and a lower X-factor compared to the non-amputee golfer, but increased their individual elbow motion on the prosthetic side after training. Amputees enjoyed using the device, and it may provide kinematic benefits indicated by the increase in elbow flexion on the prosthetic side. The transradial amputees were able to swing a golf club with sufficient repetition, form, and velocity to play golf recreationally. Increased elbow flexion on the prosthetic side suggests a potential benefit from using the Eagle Golf terminal device. Participating in recreational sports can increase amputees' health and quality of life. © The International Society for Prosthetics and Orthotics 2014.
Use of digital technologies for nasal prosthesis manufacturing.
Palousek, David; Rosicky, Jiri; Koutny, Daniel
2014-04-01
Digital technology is becoming more accessible for common use in medical applications; however, their expansion in prosthetic and orthotic laboratories is not large because of the persistent image of difficult applicability to real patients. This article aims to offer real example in the area of human facial prostheses. This article describes the utilization of optical digitization, computational modelling, rapid prototyping, mould fabrication and manufacturing of a nasal silicone prosthesis. This technical note defines the key points of the methodology and aspires to contribute to the introduction of a certified manufacturing procedure. The results show that the used technologies reduce the manufacturing time, reflect patient's requirements and allow the manufacture of high-quality prostheses for missing facial asymmetric parts. The methodology provides a good position for further development issues and is usable for clinical practice. Clinical relevance Utilization of digital technologies in facial prosthesis manufacturing process can be a good contribution for higher patient comfort and higher production efficiency but with higher initial investment and demands for experience with software tools.
Prosthetic ankle push-off work reduces metabolic rate but not collision work in non-amputee walking.
Caputo, Joshua M; Collins, Steven H
2014-12-03
Individuals with unilateral below-knee amputation expend more energy than non-amputees during walking and exhibit reduced push-off work and increased hip work in the affected limb. Simple dynamic models of walking suggest a possible solution, predicting that increasing prosthetic ankle push-off should decrease leading limb collision, thereby reducing overall energy requirements. We conducted a rigorous experimental test of this idea wherein ankle-foot prosthesis push-off work was incrementally varied in isolation from one-half to two-times normal levels while subjects with simulated amputation walked on a treadmill at 1.25 m · s(-1). Increased prosthesis push-off significantly reduced metabolic energy expenditure, with a 14% reduction at maximum prosthesis work. In contrast to model predictions, however, collision losses were unchanged, while hip work during swing initiation was decreased. This suggests that powered ankle push-off reduces walking effort primarily through other mechanisms, such as assisting leg swing, which would be better understood using more complete neuromuscular models.
Prosthetic ankle push-off work reduces metabolic rate but not collision work in non-amputee walking
NASA Astrophysics Data System (ADS)
Caputo, Joshua M.; Collins, Steven H.
2014-12-01
Individuals with unilateral below-knee amputation expend more energy than non-amputees during walking and exhibit reduced push-off work and increased hip work in the affected limb. Simple dynamic models of walking suggest a possible solution, predicting that increasing prosthetic ankle push-off should decrease leading limb collision, thereby reducing overall energy requirements. We conducted a rigorous experimental test of this idea wherein ankle-foot prosthesis push-off work was incrementally varied in isolation from one-half to two-times normal levels while subjects with simulated amputation walked on a treadmill at 1.25 m.s-1. Increased prosthesis push-off significantly reduced metabolic energy expenditure, with a 14% reduction at maximum prosthesis work. In contrast to model predictions, however, collision losses were unchanged, while hip work during swing initiation was decreased. This suggests that powered ankle push-off reduces walking effort primarily through other mechanisms, such as assisting leg swing, which would be better understood using more complete neuromuscular models.
Prosthetic ankle push-off work reduces metabolic rate but not collision work in non-amputee walking
Caputo, Joshua M.; Collins, Steven H.
2014-01-01
Individuals with unilateral below-knee amputation expend more energy than non-amputees during walking and exhibit reduced push-off work and increased hip work in the affected limb. Simple dynamic models of walking suggest a possible solution, predicting that increasing prosthetic ankle push-off should decrease leading limb collision, thereby reducing overall energy requirements. We conducted a rigorous experimental test of this idea wherein ankle-foot prosthesis push-off work was incrementally varied in isolation from one-half to two-times normal levels while subjects with simulated amputation walked on a treadmill at 1.25 m·s−1. Increased prosthesis push-off significantly reduced metabolic energy expenditure, with a 14% reduction at maximum prosthesis work. In contrast to model predictions, however, collision losses were unchanged, while hip work during swing initiation was decreased. This suggests that powered ankle push-off reduces walking effort primarily through other mechanisms, such as assisting leg swing, which would be better understood using more complete neuromuscular models. PMID:25467389
Tavarez, Rudys Rodolfo de Jesus; Goncalves, Leticia Machado; Dias, Ana Paula; Dias, Anna Claudia Pereira; Malheiros, Adriana Santos; Silva, Alice Carvalho; Bandeca, Matheus Coelho
2014-06-01
The rehabilitation of patients requiring an esthetic smile demands a multidisciplinary approach. This clinical report describes a treatment plan for recovery aesthetics' smile of anterior teeth using ceramic prosthesis with zirconia structure. Initially, a review of aesthetic parameters, diagnostic waxing, mock-up and provisional restorations was performed. A contextual assessment of aesthetic, proportion and shape of teeth was done to recreate a natural looking for teeth in consonance with the smile line. Subsequently, based on these parameters, fixed prostheses of the upper anterior teeth using ceramic restorations with zirconia infrastructures were performed. The use of ceramic restorations with zirconia structures associated with a careful treatment plan allows the professional to integrate esthetic and function for satisfactory clinical results. How to cite the article: Tavarez RR, Gonçalves LM, Dias AP, Dias AC, Malheiros AS, Silva AC, Bandeca MC. An harmonic smile resulted from the use of ceramic prosthesis with zirconia structure: A case report. J Int Oral Health 2014;6(3):90-2.
Zepeda-López, Emilia Guadalupe; Bello-Mora, Antonio; Félix-Trujillo, Manuel Martín
2005-11-01
We conducted a retrospective study to compare poststapedectomy hearing gain in study-eligible patients who had received a Teflon (fluoroplastic ASTM F 754) prosthesis (study group; n = 76) with hearing gain achieved in a matched group (by age, sex, and degree of hypoacusis) of patients who had received a Schuknecht-type wire/Teflon prosthesis (control group; n = 70). All procedures had been performed by the authors at our institution between Jan. 2, 1994, and Dec. 31, 1997. Airway averages at low, medium, and high frequencies were estimated on the basis ofpre- and postoperative audiologic evaluations, as were total air-bone gaps at 7 frequencies between 125 and 8, 000 Hz. We found that the study group achieved a significantly greater degree of hearing gain at 125 and 250 Hz and significantly better closure of the air-bone gap at 250, 500, 1,000, 2,000, and 4,000 Hz. The hearing outcomes among patients in the study group were excellent.
Gonzalez, Jorge; Triplett, Robert G
To evaluate the performance of the implant-retained zirconia complete-arch prosthesis with various opposing dentitions. The 40 patients included in this retrospective case series study were treated with one or two implant-retained zirconia complete-arch prostheses (ZIRCAP) using the Zirkonzahn protocol. Prettau zirconia frames were created with strategic cutbacks in the structure to extend zirconia incisal coverage of the esthetic anterior sextants and complete monolithic zirconia in the molar areas; subsequent layers of porcelain were applied to nonfunctional and esthetic areas. Patients had three possible occlusal scenarios: (1) maxillary ZIRCAP and mandibular ZIRCAP, (2) maxillary ZIRCAP and mandibular natural dentition, and (3) maxillary ZIRCAP and mandibular conventional hybrid prosthesis. Complications were recorded during follow-up appointments 3, 6, and 12 months after definitive prosthesis delivery. The mean treatment observation period was 33 months. Eight prosthetic complications were noted for the 40 implant-retained zirconia complete-arch prostheses (18.18%), including six cases of minor porcelain chipping and two cases of debonding of the metal insert from the zirconia framework. Maxillary ZIRCAP opposing mandibular ZIRCAP and maxillary ZIRCAP opposing mandibular natural dentition occlusal scenarios presented the same complication ratio of 4. No complications were seen in the maxillary ZIRCAP opposing mandibular conventional hybrid prosthesis group, yet 16 complications were found as denture tooth fractures in 12 mandibular conventional hybrid prostheses (ratio of 0.75). The results indicate that the implant-retained zirconia complete-arch prosthesis offers acceptable performance for use as an alternative to the conventional titanium framework acrylic veneer prosthesis for complete edentulism with a lower incidence of prosthetic complications and fewer maintenance appointments. Chipping of veneering porcelain was the most common complication, but a low incidence was observed in this study. Acrylic denture teeth may represent the weakest link when restoring complete edentulism with a maxillary ZIRCAP and mandibular conventional hybrid prosthesis.
Implant and prosthesis movement after enucleation: a randomized controlled trial.
Shome, Debraj; Honavar, Santosh G; Raizada, Kuldeep; Raizada, Deepa
2010-08-01
To evaluate implant and prosthesis movement after myoconjunctival enucleation and subsequent polymethyl methacrylate (PMMA) implantation, compared with the traditional enucleation with muscle imbrication using a PMMA implant and with enucleation accompanied by porous polyethylene implantation. Randomized, controlled, observer-masked, interventional study. One hundred fifty patients, equally and randomly allocated to the 3 groups. Group 1 consisted of patients in whom a PMMA implant was used after enucleation with muscle imbrication (traditional PMMA group). Group 2 consisted of patients in whom a PMMA implant was used after enucleation with a myoconjunctival technique (myoconjunctival PMMA group). Group 3 consisted of patients in whom a porous polyethylene implant was used after enucleation by the scleral cap technique (porous polyethylene group). Fifty patients were included in each group. Patients were allocated to 1 of the 3 groups using stratified randomization. Informed consent was obtained. Acrylic prostheses custom made by a trained ocularist were fitted 6 weeks after surgery in all patients. A masked observer measured implant and prosthesis movement 6 weeks after surgery using a slit-lamp device with real-time video and still photographic documentation. Analysis of implant and prosthesis movement was carried out using the Mann-Whitney U test, and a P value of < or =0.03 was considered significant. Complications including implant displacement and exposure also were noted. Implant and prosthesis movement. Myoconjunctival PMMA implant movement was better than the traditional PMMA implant (P = 0.001), but was similar to that of the porous polyethylene implant. Prosthesis movement with the myoconjunctival PMMA implant was better than that of either the traditional PMMA (P = 0.001) or porous polyethylene (P = 0.002) implants. Myoconjunctival enucleation technique with a PMMA implant provides statistically and clinically significantly better implant and prosthesis movement than the traditional PMMA implant and better prosthesis movement than the porous polyethylene implant. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
Xu, Guisheng; Gao, Liang; Tao, Ke; Wan, Shengxiang; Lin, Yuning; Xiong, Ao; Kang, Bin; Zeng, Hui
2017-12-01
For traumatic upper limb amputees, the prohibitive cost of a custom-made prosthesis brings an insufferable financial burden for their families in developing countries. Three-dimensional (3D) printing allows for creating affordable, lightweight, customized, and well-fitting prosthesis, especially for the growing children. We presented a case of an 8-year-old boy, who suffered a traumatic right wrist amputation as result of a mincing machine accident. The patient was immediately sent to the emergency orthopedics department after the accident. He was diagnosed as severed mangled limb crash injury at the level of the right wrist with a Mangled Extremity Severity Score of 8. A wrist disarticulation was performed and a 3D-printed prosthetic hand was designed and manufactured for this child. A personalized prosthetic rehabilitation training was applied after the prosthesis installation at 6 months postoperatively. The function of the prosthesis was evaluated at 1-month and 3-month follow-up using the Children Amputee Prosthetics Projects (CAPP) score and the University Of New Brunswick Test Of Prosthetic Function for Unilateral Amputees (UNB test). The materials cost <20 dollars. The printing took <8 hours and the component assembling was completed within 20 minutes. During the 3-month follow-up, the child's parents were satisfied with the prosthesis and the UNB test showed the significantly improved function of the prosthesis. This novel 3D-printed upper limb prosthesis in a child with the traumatic wrist amputation might serve as a practical and affordable alternative for children in developing countries and those lacking access to health care providers. A personalized prosthetic rehabilitation needs to be undertaken and more clinical studies are warranted to validate the potential superiority of similar 3D-printed prostheses. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.
Bhattacharjee, Kasturi; Bhattacharjee, Harsha; Kuri, Ganesh; Das, Jayanta Kr; Dey, Debleena
2014-01-01
Purpose: The purpose of our study is to present a surgical technique of primary porous orbital ball implantation with overlying mucus membrane graft (MMG) for reconstruction of severely contracted socket and to evaluate prosthesis retention and motility in comparison to dermis fat graft (DFG). Study Design: Prospective comparative study. Materials and Methods: A total of 24 patients of severe socket contracture (Grade 2-4 Krishna's classification) were subdivided into two groups, 12 patients in each group. In Group I, DFG have been used for reconstruction. In Group II, porous polyethylene implant with MMG has been used as a primary procedure for socket reconstruction. In Group I DFG was carried out in usual procedure. In case of Group II, vascularized scar tissues were separated 360° and were fashioned into four strips. A scleral capped porous polyethylene implant was placed in the intraconal space and four strips of scar tissue were secured to the scleral cap and extended part overlapped the implant to make a twofold barrier between the implant and MMG. Patients were followed-up as per prefixed proforma. Prosthesis motility and retention between the two groups were measured. Results: In Group I, four patients had recurrence of contracture with fall out of prosthesis. In Group II stable reconstruction was achieved in all the patients. In terms of prosthesis motility, maximum in Group I was 39.2% and Group II, was 59.3%. The difference in prosthesis retention (P = 0.001) and motility (P = 0.004) between the two groups was significant. Conclusion: Primary socket reconstruction with porous orbital implant and MMG for severe socket contracture is an effective method in terms of prosthesis motility and prosthesis retention. PMID:24618485
Lu, Minxun; Min, Li; Xiao, Cong; Li, Yongjiang; Luo, Yi; Zhou, Yong; Zhang, Wenli; Tu, Chongqi
2018-01-01
Currently, it is challenging to treat giant cell tumor (GCT) of distal radius. For Campanacci grade III or recurrent GCTs, en bloc resection has been accepted as a better treatment option. Although numerous methods are available for reconstruction, all of them have some limitations in joint function and complications. In this study, our aims were to treat the GCT of distal radius with uncemented three-dimensional (3D)-printed prosthesis and to present and evaluate the surgical techniques and short-term outcomes. Between September 2015 and March 2017, 11 patients with distal radius GCTs were treated with personalized uncemented 3D-printed prosthesis. The preoperative/postoperative pain, range of motion, and grip strengths of all patients were evaluated. Oncological results, complications, and degenerative changes in the wrist joint were evaluated. Functional outcomes were assessed according to the disabilities of the arm, shoulder, and hand (DASH) questionnaire and Mayo wrist scoring systems. The average follow-up was 14.45 months (range, 8-18 months). There was a significant decrease in the mean postoperative visual analog scale score (2.33) compared with the preoperative score (5.22; p <0.001). The mean DASH score and Mayo wrist score of the wrist joint function were 18.7 and 72, respectively. There was no local recurrence or lung metastasis. No complication associated with prosthesis was observed, including aseptic loosening, subluxation, and breakage. Joint space narrowing, or disuse osteoporosis, was also not found in all cases. En bloc resection and reconstruction with a personalized uncemented 3D-printed prosthesis can be alternative options to treat Campanacci grade III or recurrent GCTs of distal radius and can result in short-term oncologic salvage, good postoperative function, and low complication rate. However, a long-term follow-up is required to determine the outcome.
Jiang, Ling; Liu, Yan-Qing; Cui, Li-Gang; Meng, Ying; Tian, Hua; Zhang, Ke; Wang, Jin-Rui
2016-10-10
Objective To explore the feasibility and clinical value of ultrasonography in evaluating the morphology and function of medial collateral ligaments (MCL) after total knee arthroplasty (TKA). Methods Totally 38 patients undergoing routine KTA (group A) and 22 patients undergoing constrained condylar knee arthroplasty KTA with MCL injury (group B) were included. Long axis views of MCL were taken and the MCL thickness was measured on femur side and tibial side 1 cm away from the joint line, respectively. The thicknesses were compared between the two groups. Subsequently, the gap between the metal part of the femoral prosthesis and the spacer after dynamic valgus stress was measured. The distribution and composition of the gap between the two groups were compared. Results High-frequency ultrasound clearly showed the prosthesis and MCL after TKA. MCL fiber structures of both groups were intact. The MCL thickness on the tibial side in group B was (0.25±0.06)cm, which was significantly thinner than group A [(0.32±0.14)cm] (t=2.12, P=0.040).For the femur side, there was no significant difference (t=1.65, P=0.110) between these two groups [(0.37±0.09) cm in group B versus (0.42±0.12)cm in group A]. Under the condition of valgus stress, the gaps between the metal part of the femoral prosthesis and the spacer could be found in 11 cases in group B but only in 1 case in group A. The proportion of gaps in group B was significantly higher than that in group A (Fisher's exact test, P=0.000). Conclusions High-frequency ultrasound can clearly show the prosthesis and MCL after TKA. The injured MCL can be well joined but the thickness is thinner. Under the condition of valgus stress of the knee, the stability of the TKA can be evaluated according to the gap between the prosthesis and the spacer.
Malmstrom, H; Dellanzo-Savu, A; Xiao, J; Feng, C; Jabeen, A; Romero, M; Huang, J; Ren, Y; Yunker, M A
2015-12-01
To evaluate the success, clinical performance and patient satisfaction of directly placed fibre-reinforced composite (FRC) fixed partial dentures (FPDs) in 2 years. One hundred sixty-seven FRC FPDs (120 subjects) were directly fabricated to restore a single missing tooth by six Advanced Education in General Dentistry (AEGD) residents. The FRC FPDs recipients were randomised into two groups according to the fibre materials (pre-impregnated glass or polyethylene). Clinical performance was evaluated at baseline (2 weeks), 6, 12 and 24 months by two calibrated evaluators for prosthesis adaptation, colour match, marginal discoloration, surface roughness, caries and post-operative sensitivity using modified United State Public Health Service (USPHS) criteria. Prosthesis appearance, colour, chewing ability and overall satisfaction were evaluated by patients using a visual analogue scale (VAS). Kaplan-Meier estimation was used to estimate the prosthesis success. Ninety-four patients with 137 FRC FPDs returned (21·67% attrition rate for study subjects, 17·94% for FRC FPDs). Seventeen FRC FPDs failed, due to one-end (n = 4) or two-ends (n = 4) debonding or pontic fracture (n = 9). The cumulative 2-year success rate was 84·32% and survival rate was 92·7%; there were no statistically significant differences between the groups according to different missing tooth location, retention type or fibre materials (P > 0·05). Patient satisfaction regarding prosthesis appearance, col-our, chewing ability and overall satisfaction was rated high on the VAS (mean >80 mm) for all criteria at all time points. The FRC FPDs (restoring single tooth) fabricated by AEGD residents achieved acceptable success and survival rates in a 2-year follow-up. © 2015 John Wiley & Sons Ltd.
Game-Based Rehabilitation for Myoelectric Prosthesis Control
Vujaklija, Ivan; Kayali, Fares; Purgathofer, Peter; Aszmann, Oskar C
2017-01-01
Background A high number of upper extremity myoelectric prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train in absence of a physiotherapist. Virtual training systems, in the form of video games, provide patients with an entertaining and intuitive method for improved muscle coordination and improved overall control. Complementary to established rehabilitation protocols, it is highly beneficial for this virtual training process to start even before receiving the final prosthesis, and to be continued at home for as long as needed. Objective The aim of this study is to evaluate (1) the short-term effects of a commercially available electromyographic (EMG) system on controllability after a simple video game-based rehabilitation protocol, and (2) different input methods, control mechanisms, and games. Methods Eleven able-bodied participants with no prior experience in EMG control took part in this study. Participants were asked to perform a surface EMG test evaluating their provisional maximum muscle contraction, fine accuracy and isolation of electrode activation, and endurance control over at least 300 seconds. These assessments were carried out (1) in a Pregaming session before interacting with three EMG-controlled computer games, (2) in a Postgaming session after playing the games, and (3) in a Follow-Up session two days after the gaming protocol to evaluate short-term retention rate. After each game, participants were given a user evaluation survey for the assessment of the games and their input mechanisms. Participants also received a questionnaire regarding their intrinsic motivation (Intrinsic Motivation Inventory) at the end of the last game. Results Results showed a significant improvement in fine accuracy electrode activation (P<.01), electrode separation (P=.02), and endurance control (P<.01) from Pregaming EMG assessments to the Follow-Up measurement. The deviation around the EMG goal value diminished and the opposing electrode was activated less frequently. Participants had the most fun playing the games when collecting items and facing challenging game play. Conclusions Most upper limb amputees use a 2-channel myoelectric prosthesis control. This study demonstrates that this control can be effectively trained by employing a video game-based rehabilitation protocol. PMID:28183689
Talib, Raidh A; Canguven, Onder; Al Ansari, Abdulla
2014-09-06
To examine the benefits of sexual activity on glycated hemoglobin (HbA1c)in penile prosthesis implanted patients with type 2 diabetes mellitus (DM). Sixty-seven male subjects who had HbA1c levels of ≥ 6.5% before and could perform regular sexual activity after the implantations were enrolled. The contribution of sexual activity on glycemic control assessed by HbA1c level as well as age, duration of DM and frequency of sexual activity were evaluated. Mean age and mean time from the surgery of the study patients was 59.9 years (range,30-82) and 22.6 months (range, 10-63), respectively. The average of penile prosthesis usage for sexual activity was 9.9 times per month (range, 2-28). Compared with the preimplantation, the absolute mean change in HbA1c after penile prosthesis implantation was found as - 0.2% (P > .05). This study also revealed that more sexual activity was associated with more reduction in HbA1c. The present study demonstrated that sexual activity is associated with HbA1c reduction, which is clinically important in patients with type 2 DM after penile prosthesis implantation.
Sawers, Andrew; Hafner, Brian J
2018-04-01
To evaluate the feasibility of fixed-width beam walking for assessing balance in lower limb prosthesis users. Cross-sectional. Laboratory. Lower limb prosthesis users. Participants attempted 10 walking trials on three fixed-width beams (18.6, 8.60, and 4.01 wide; 5.5 m long; 3.8 cm high). Beam-walking performance was quantified using the distance walked to balance failure. Heuristic rules applied to each participant's beam-walking distance to classify each beam as "too easy," "too hard," or "appropriately challenging" and determine whether any single beam provided an appropriate challenge to all participants. The number of trials needed to achieve stable beam-walking performance was quantified for appropriately challenging beams by identifying the last inflection point in the slope of each participant's trial-by-trial cumulative performance record. In all, 30 unilateral lower limb prosthesis users participated in the study. Each of the fixed-width beams was either too easy or too hard for at least 33% of the sample. Thus, no single beam was appropriately challenging for all participants. Beam-walking performance was stable by trial 8 for all participants and by trial 6 for 90% of participants. There was no significant difference in the number of trials needed to achieve stable performance among beams ( P = 0.74). Results suggest that a clinical beam-walking test would require multiple beams to evaluate balance across a range of lower limb prosthesis users, emphasizing the need for adaptive or progressively challenging balance tests. While the administrative burden of a multiple-beam balance test may limit clinical feasibility, alternatives to ease this administrative burden are proposed.
Validation of the Narrowing Beam Walking Test in Lower Limb Prosthesis Users.
Sawers, Andrew; Hafner, Brian
2018-04-11
To evaluate the content, construct, and discriminant validity of the Narrowing Beam Walking Test (NBWT), a performance-based balance test for lower limb prosthesis users. Cross-sectional study. Research laboratory and prosthetics clinic. Unilateral transtibial and transfemoral prosthesis users (N=40). Not applicable. Content validity was examined by quantifying the percentage of participants receiving maximum or minimum scores (ie, ceiling and floor effects). Convergent construct validity was examined using correlations between participants' NBWT scores and scores or times on existing clinical balance tests regularly administered to lower limb prosthesis users. Known-groups construct validity was examined by comparing NBWT scores between groups of participants with different fall histories, amputation levels, amputation etiologies, and functional levels. Discriminant validity was evaluated by analyzing the area under each test's receiver operating characteristic (ROC) curve. No minimum or maximum scores were recorded on the NBWT. NBWT scores demonstrated strong correlations (ρ=.70‒.85) with scores/times on performance-based balance tests (timed Up and Go test, Four Square Step Test, and Berg Balance Scale) and a moderate correlation (ρ=.49) with the self-report Activities-specific Balance Confidence scale. NBWT performance was significantly lower among participants with a history of falls (P=.003), transfemoral amputation (P=.011), and a lower mobility level (P<.001). The NBWT also had the largest area under the ROC curve (.81) and was the only test to exhibit an area that was statistically significantly >.50 (ie, chance). The results provide strong evidence of content, construct, and discriminant validity for the NBWT as a performance-based test of balance ability. The evidence supports its use to assess balance impairments and fall risk in unilateral transtibial and transfemoral prosthesis users. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
Candida periprosthetic joint infection: A rare and difficult-to-treat infection.
Escolà-Vergé, Laura; Rodríguez-Pardo, Dolors; Lora-Tamayo, Jaime; Morata, Laura; Murillo, Oscar; Vilchez, Helem; Sorli, Luisa; Carrión, Laura Guío; Barbero, José Mª; Palomino-Nicás, Julián; Bahamonde, Alberto; Jover-Sáenz, Alfredo; Benito, Natividad; Escudero, Rosa; Sampedro, Marta Fernandez; Vidal, Rafael Pérez; Gómez, Lucía; Corona, Pablo S; Almirante, Benito; Ariza, Javier; Pigrau, Carles
2018-05-08
Candida periprosthetic joint infection (CPJI) is a rare, difficult-to-treat disease. The purpose of this study was to evaluate the clinical characteristics and outcomes of CPJI treated with various surgical and antifungal strategies. We conducted a multicenter retrospective study of all CPJI diagnosed between 2003 and 2015 in 16 Spanish hospitals. Forty-three patients included: median age, 75 years, and median Charlson Comorbidity Index score, 4. Thirty-four (79.1%) patients had ≥1 risk factor for Candida infection. Most common causative species were C. albicans and C. parapsilosis. Thirty-five patients were evaluable for outcome: overall, treatment succeeded in 17 (48.6%) and failed in 18 (51.4%). Success was 13/20 (67%) in patients with prosthesis removal and 4/15 (27%) with debridement and prosthesis retention (p = 0.041). All 3 patients who received an amphotericin B-impregnated cement spacer cured. In the prosthesis removal group, success was 5/6 (83%) with an antibiofilm regimen and 8/13 (62%) with azoles (p = 0.605). In the debridement and prosthesis retention group, success was 3/10 (30%) with azoles and 1/5 (20%) with antibiofilm agents. Therapeutic failure was due to relapse in 9 patients, need for suppressive treatment in 5, persistent infection in 2, and CPJI-related death in 2; overall attributable mortality was 6%. CPJI is usually a chronic disease in patients with comorbidities and risk factors for Candida infection. Treatment success is low, and prosthesis removal improves outcome. Although there is insufficient evidence that use of antifungals with antibiofilm activity has additional benefits, our experience indicates it may be recommendable. Copyright © 2018 Elsevier Ltd. All rights reserved.
van der Laan, Tallie M J; Postema, Sietke G; Reneman, Michiel F; Bongers, Raoul M; van der Sluis, Corry K
2018-02-10
Reliability study. Quantifying compensatory movements during work-related tasks may help to prevent musculoskeletal complaints in individuals with upper limb absence. (1) To develop a qualitative scoring system for rating compensatory shoulder and trunk movements in upper limb prosthesis wearers during the performance of functional capacity evaluation tests adjusted for use by 1-handed individuals (functional capacity evaluation-one handed [FCE-OH]); (2) to examine the interrater and intrarater reliability of the scoring system; and (3) to assess its feasibility. Movement patterns of 12 videotaped upper limb prosthesis wearers and 20 controls were analyzed. Compensatory movements were defined for each FCE-OH test, and a scoring system was developed, pilot tested, and adjusted. During reliability testing, 18 raters (12 FCE experts and 6 physiotherapists/gait analysts) scored videotapes of upper limb prosthesis wearers performing 4 FCE-OH tests 2 times (2 weeks apart). Agreement was expressed in % and kappa value. Feasibility (focus area's "acceptability", "demand," and "implementation") was determined by using a questionnaire. After 2 rounds of pilot testing and adjusting, reliability of a third version was tested. The interrater reliability for the first and second rating sessions were к = 0.54 (confidence interval [CI]: 0.52-0.57) and к = 0.64 (CI: 0.61-0.66), respectively. The intrarater reliability was к = 0.77 (CI: 0.72-0.82). The feasibility was good but could be improved by a training program. It seems possible to identify compensatory movements in upper limb prosthesis wearers during the performance of FCE-OH tests reliably by observation using the developed observational scoring system. Interrater reliability was satisfactory in most instances; intrarater reliability was good. Feasibility was established. Copyright © 2018 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.
Granados, U; Fuster, D; Soriano, A; García, S; Bori, G; Martínez, J C; Mayoral, M; Perlaza, P; Tomás, X; Pons, F
2015-01-01
To evaluate the impact of the angioscintigrapy of the three phase bone scan as screening method to rule out infection of the hip and knee prosthesis prior to performing the (99m)Tc-HMPAO leukocyte scintigraphy. A total of 120 (70 women, 50 men; mean age 71±11years) with clinical suspicion of hip (n=63) or knee (n=57) infection of the prosthesis and clinical suspicion of infection were evaluated prospectively. All patients underwent three-phase bone scan (angioscintigraphy, vascular and bone phase) and (99m)Tc-HMPAO-labelled white blood cell scintigraphy. Final diagnosis of infection was made by microbiological documentation or clinical follow-up for at least 12months. Eighteen out of 120 patients were diagnosed of infection of hip prosthesis (n=10) or knee prosthesis (n=8). The angioscintigraphy was positive in 15/18 infected cases and in 21/102 of the non-infected cases with a sensitivity of 83%, specificity of 79% and negative predictive value of 97%. Sensitivity and specificity of (99m)Tc-HMPAO leukocyte scintigraphy were 72% and 95%, respectively. If the leukocyte labeled scintigraphies had been used exclusively for patients with positive angioscintigraphy, this would have saved up to 70% of the (99m)Tc-HMPAO leukocyte scintigraphies performed. There were no cases of infection with positive labeled leukocyte scintigraphy and negative angioscintigraphy. Angioscintigraphy (blood flow phase of bone scan) is a useful technique for screening for hip and knee joint prosthesis infection, significantly reducing the need for (99m)Tc-HMPAO leukocyte scintigraphy without affecting the sensitivity of the technique. Copyright © 2014 Elsevier España, S.L.U. and SEMNIM. All rights reserved.
Beaupre, Lauren A; Stampe, Kyle; Masson, Edward; O'Connor, Gregory; Clark, Marcia; Joffe, A Mark; Boychuk, Lesia R; Lavoie, Guy
2017-01-01
The study purpose was to (1) evaluate health-related quality of life (HRQL) with the PROSthesis of Antibiotic Loaded Acrylic Cement (PROSTALAC) in situ for infected total hip arthroplasty (THA), (2) determine infection resolution, and (3) compare subjects who underwent second stage surgery with those who retained the PROSTALAC on a longer term basis. Demographics, physical demand level, and comorbidities were recorded prospectively in 29 subjects followed to at least 24 months after initial PROSTALAC insertion. HRQL was evaluated using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and RAND 36-Item Health Survey. Infection resolution was determined using a pre-specified clinical definition. Twenty-five of 29 (86%) subjects' infections resolved. Three subjects died, of whom two had resolved infections. For survivors, 22/26 (85%) completed HRQL evaluations. After PROSTALAC insertion, pain and function improved within 3-6 months and was retained at 24 months. Of those followed to 24 months, 7/22 (32%) subjects underwent second stage surgery. They were higher physical demand subjects ( p = 0.03) than those not undergoing second stage surgery. We found no difference in WOMAC scores at 24 months between those who underwent second stage surgery and those who retained the PROSTALAC ( p > 0.32). The PROSTALAC system for THA appears to allow acceptable HRQL while in situ for at least 2 years in low physical demand patients. Subjects with higher physical demand levels are more likely to undergo second stage surgery. Further evaluation is required to determine whether longer term PROSTALAC retention may be appropriate for specific patient groups.
Samuelsson, Kersti A M; Töytäri, Outi; Salminen, Anna-Liisa; Brandt, Ase
2012-06-01
Effects presented on the use of assistive devices such as prosthesis are often based on laboratory findings (i.e. efficacy). To summarise and evaluate findings from studies on effectiveness of lower limb prostheses for adults in real life contexts, primarily in terms of activity, participation, and quality of life (QoL) and secondarily in terms of user satisfaction, use/non-use, and/or cost-effectiveness. Systematic review. We included controlled studies and non-controlled follow-up studies including both baseline and follow-up data. Using 14 different databases supplemented with manual searches, we searched for studies published from 1998 until June 2009. Out of an initial 818 identified publications, eight met the inclusion criteria. Four studies reported on the effectiveness of a microprocessor-controlled knee (MP-knee) compared to a non-microprocessor-controlled knee (NMP-knee). Results were inconsistent except for quality of life and use/non-use, where the authors reported an improvement with the MP-knee compared to the NMP-knee. The remaining four studies included a diversity of prosthetic intervention measures and types of endpoints. Overall, there was an inconsistency in results and study quality. This review highlights the need for high-quality research studies that reflect the effectiveness of different prosthesis interventions in terms of users' daily living and QoL. Clinical guidelines are important to every practitioner. Information on expected effectiveness from assistive devices should be well founded and contain both facts about the device quality and its contribution to users' daily lives. Thus, studies based on users' experiences from prosthetic use in everyday life activities are of great importance.
Post-marketing surveillance of CustomBone Service implanted in children under 7 years old.
Frassanito, Paolo; Tamburrini, Gianpiero; Massimi, Luca; Di Rocco, Concezio; Nataloni, Angelo; Fabbri, Greta; Caldarelli, Massimo
2015-01-01
The CustomBone Service is a bioceramic implant suitable for cranial repair in both adults and children, although there are no clinical data about its use in children under 7 years of age. This surveillance study investigates the outcome in this age group. Twenty-eight children under 7 years old (range, 2.5-6 years) received CustomBone Service from July 2006 to May 2013 in 16 international hospitals. Data of 23 children (12 males and 11 females), harboring 24 prosthesis, were available with a minimum follow-up of 1 year. Sites of the cranial defect were frontal or parietal (20.8 % each), parieto-temporal (16.7 %), fronto-parietal or occipital (12.5 % each), fronto-parieto-temporal or fronto-temporal (8.3 % each). Initial diseases were trauma (54.2 %), malformation (37.5 %), or tumor of the bone/skin (8.3 %). Rupture of the implant occurred in a single case during the implant (1/26 surgeries, 3.8 %) and the cranial repair was achieved by means of the back-up prosthesis. Five adverse events were registered during the follow-up period consisting of three cases of fracture and two of exposure/infection of the prosthesis. All cases required the removal of the device (20.8 %). The failure rate of CustomBone Service under 7 years of age was higher than reported in adults and children over 7 years old (20.8 vs. 3.8 %), However, CustomBone Service may be considered a valid option under 7 years old since other materials are burdened by more significant rates of complications in the long-term period. Due to specific properties of this material, indication to CustomBone Service in toddlers should be carefully evaluated by the surgeon on a case-by-case basis.
Schofer, Joachim; Nietlispach, Fabian; Bijuklic, Klaudija; Colombo, Antonio; Gatto, Fernando; De Marco, Federico; Mangieri, Antonio; Hansen, Lorenz; Bruschi, Giuseppe; Ruparelia, Neil; Rieß, Friedrich-Christian; Maisano, Franscesco; Latib, Azeem
2015-12-21
This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Chiriac, S; Dissaux, C; Bruant-Rodier, C; Djerada, Z; Bodin, F; François, C
2017-06-01
The position of the skin paddle on the breast area is a fundamental element for the breast reconstructions by latissimus dorsi flap and prosthesis implantation. Should, as Millard advocated, to recreate the initial defect and include it in the mastectomy scar or is it better in an additional incision as have others authors. This study compares the long-term morphological results of these two attitudes, with or without additional incision. Eighty-two breast reconstructions by latissimus dorsi flap and prosthesis implantation, with a mean follow-up of 9.5 years were scored from 1 to 5 by a panel of expert and non-expert. The patients scored also their own reconstruction. Various parameters of the reconstructed breast were thus evaluated. We compared the results, according to the positioning of the skin paddle: with additional incision (50 cases); without additional incision (32 cases). The characteristics of the mastectomy scar on the breast area, high or low, horizontal or oblique, defined 6 groups where the results of the 2 surgical options were compared. Only the reconstructions with additional incision get significantly higher results than those without additional incision (P<0.05). This involves the two panels, in the case of high mastectomy scars. In the others cases the additional incision is not essential. If the realization of an additional incision can be perceived like misfit on an area already "mutilated", we plead for this solution in selected cases. This provides a benefit stable in time, in terms of overall results, shape and even rendering scar. Copyright © 2016 Elsevier Masson SAS. All rights reserved.
Ghoseiri, Kamiar; Zheng, Yong Ping; Leung, Aaron K L; Rahgozar, Mehdi; Aminian, Gholamreza; Masoumi, Mehdi; Safari, Mohammad Reza
2018-01-01
The snug fit of a prosthetic socket over the residual limb can disturb thermal balance and put skin integrity in jeopardy by providing an unpleasant and infectious environment. The prototype of a temperature measurement and control (TM&C) system was previously introduced to resolve thermal problems related to prostheses. This study evaluates its clinical application in a setting with reversal, single subject design. The TM&C system was installed on a fabricated prosthetic socket of a man with unilateral transtibial amputation. Skin temperature of the residual limb without prosthesis at baseline and with prosthesis during rest and walking was evaluated. The thermal sense and thermal comfort of the participant were also evaluated. The results showed different skin temperature around the residual limb with a temperature decrease tendency from proximal to distal. The TM&C system decreased skin temperature rise after prosthesis wearing. The same situation occurred during walking, but the thermal power of the TM&C system was insufficient to overcome heat build-up in some regions of the residual limb. The participant reported no significant change of thermal sense and thermal comfort. Further investigations are warranted to examine thermography pattern of the residual limb, thermal sense, and thermal comfort in people with amputation.
Technology Efficacy in Active Prosthetic Knees for Transfemoral Amputees: A Quantitative Evaluation
El-Sayed, Amr M.; Abu Osman, Noor Azuan
2014-01-01
Several studies have presented technological ensembles of active knee systems for transfemoral prosthesis. Other studies have examined the amputees' gait performance while wearing a specific active prosthesis. This paper combined both insights, that is, a technical examination of the components used, with an evaluation of how these improved the gait of respective users. This study aims to offer a quantitative understanding of the potential enhancement derived from strategic integration of core elements in developing an effective device. The study systematically discussed the current technology in active transfemoral prosthesis with respect to its functional walking performance amongst above-knee amputee users, to evaluate the system's efficacy in producing close-to-normal user performance. The performances of its actuator, sensory system, and control technique that are incorporated in each reported system were evaluated separately and numerical comparisons were conducted based on the percentage of amputees' gait deviation from normal gait profile points. The results identified particular components that contributed closest to normal gait parameters. However, the conclusion is limitedly extendable due to the small number of studies. Thus, more clinical validation of the active prosthetic knee technology is needed to better understand the extent of contribution of each component to the most functional development. PMID:25110727
Hellmeier, Florian; Nordmeyer, Sarah; Yevtushenko, Pavlo; Bruening, Jan; Berger, Felix; Kuehne, Titus; Goubergrits, Leonid; Kelm, Marcus
2018-01-01
Modeling different treatment options before a procedure is performed is a promising approach for surgical decision making and patient care in heart valve disease. This study investigated the hemodynamic impact of different prostheses through patient-specific MRI-based CFD simulations. Ten time-resolved MRI data sets with and without velocity encoding were obtained to reconstruct the aorta and set hemodynamic boundary conditions for simulations. Aortic hemodynamics after virtual valve replacement with a biological and mechanical valve prosthesis were investigated. Wall shear stress (WSS), secondary flow degree (SFD), transvalvular pressure drop (TPD), turbulent kinetic energy (TKE), and normalized flow displacement (NFD) were evaluated to characterize valve-induced hemodynamics. The biological prostheses induced significantly higher WSS (medians: 9.3 vs. 8.6 Pa, P = 0.027) and SFD (means: 0.78 vs. 0.49, P = 0.002) in the ascending aorta, TPD (medians: 11.4 vs. 2.7 mm Hg, P = 0.002), TKE (means: 400 vs. 283 cm 2 /s 2 , P = 0.037), and NFD (means: 0.0994 vs. 0.0607, P = 0.020) than the mechanical prostheses. The differences between the prosthesis types showed great inter-patient variability, however. Given this variability, a patient-specific evaluation is warranted. In conclusion, MRI-based CFD offers an opportunity to assess the interactions between prosthesis and patient-specific boundary conditions, which may help in optimizing surgical decision making and providing additional guidance to clinicians. © 2017 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.
Bacchi, Ataís; Consani, Rafael Leonardo Xediek; Mesquita, Marcelo Ferraz; Dos Santos, Mateus Bertolini Fernandes
2013-09-01
This study evaluated the influence of framework material and vertical misfit on stress created in an implant-supported partial prosthesis under load application. The posterior part of a severely reabsorbed jaw with a fixed partial prosthesis above two osseointegrated titanium implants at the place of the second premolar and second molar was modeled using SolidWorks 2010 software. Finite element models were obtained by importing the solid model into an ANSYS Workbench 11 simulation. The models were divided into 15 groups according to their prosthetic framework material (type IV gold alloy, silver-palladium alloy, commercially pure titanium, cobalt-chromium alloy or zirconia) and vertical misfit level (10 µm, 50 µm and 100 µm). After settlement of the prosthesis with the closure of the misfit, simultaneous loads of 110 N vertical and 15 N horizontal were applied on the occlusal and lingual faces of each tooth, respectively. The data was evaluated using Maximum Principal Stress (framework, porcelain veneer and bone tissue) and a von Mises Stress (retention screw) provided by the software. As a result, stiffer frameworks presented higher stress concentrations; however, these frameworks led to lower stresses in the porcelain veneer, the retention screw (faced to 10 µm and 50 µm of the misfit) and the peri-implant bone tissues. The increase in the vertical misfit resulted in stress values increasing in all of the prosthetic structures and peri-implant bone tissues. The framework material and vertical misfit level presented a relevant influence on the stresses for all of the structures evaluated.
Evaluating Internal Model Strength and Performance of Myoelectric Prosthesis Control Strategies.
Shehata, Ahmed W; Scheme, Erik J; Sensinger, Jonathon W
2018-05-01
On-going developments in myoelectric prosthesis control have provided prosthesis users with an assortment of control strategies that vary in reliability and performance. Many studies have focused on improving performance by providing feedback to the user but have overlooked the effect of this feedback on internal model development, which is key to improve long-term performance. In this paper, the strength of internal models developed for two commonly used myoelectric control strategies: raw control with raw feedback (using a regression-based approach) and filtered control with filtered feedback (using a classifier-based approach), were evaluated using two psychometric measures: trial-by-trial adaptation and just-noticeable difference. The performance of both strategies was also evaluated using Schmidt's style target acquisition task. Results obtained from 24 able-bodied subjects showed that although filtered control with filtered feedback had better short-term performance in path efficiency ( ), raw control with raw feedback resulted in stronger internal model development ( ), which may lead to better long-term performance. Despite inherent noise in the control signals of the regression controller, these findings suggest that rich feedback associated with regression control may be used to improve human understanding of the myoelectric control system.
Goiato, Marcelo Coelho; Fernandes, Aline Úrsula Rocha; dos Santos, Daniela Micheline; Hadadd, Marcela Filié; Moreno, Amália; Pesqueira, Aldiéris Alves
2011-02-01
The artificial iris is the structure responsible for the dissimulation and aesthetics of ocular prosthesis. The objective of the present study was to evaluate the color stability of artificial iris of microwaveable polymerized ocular prosthesis, as a function of paint type, drying method and accelerated aging. A total of 40 discs of microwaveable polymerized acrylic resin were fabricated, and divided according to the blue paint type (n = 5): hydrosoluble acrylic, nitrocellulose automotive, hydrosoluble gouache and oil paints. Paints where dried either at natural or at infrared light bulb method. Each specimen was constituted of one disc in colorless acrylic resin and another colored with a basic sclera pigment. Painting was performed in one surface of one of the discs. The specimens were submitted to an artificial aging chamber under ultraviolet light, during 1008 h. A reflective spectrophotometer was used to evaluate color changes. Data were evaluated by 3-way repeated-measures ANOVA and the Tukey HSD test (α = 0.05). All paints suffered color alteration. The oil paint presented the highest color resistance to artificial aging regardless of drying method. Copyright © 2010 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.
Preclinical evaluation of hydrogel sealed fluropassivated indigenous vascular prosthesis.
Unnikrishnan, Madathipat; Umashankar, P R; Viswanathan, Sidharth; Savlania, Ajay; Joseph, Roy; Muraleedharan, C V; Agrawal, Vivek; Shenoy, Sachin J; Krishnan, Lissy K; Mohanan, P V; Sabareeswaran, A
2017-11-01
Polyethylene terephthalate (PET) graft, designed and developed at our institute for vascular reconstruction, is porous to promote optimal incorporation and neointima formation, requiring pre-clotting or biomodification by sealing the pores before implantation. The objective of this study was to characterize, test and perform preclinical evaluation of hydrogel (alginate dialdehyde cross-linked gelatin) sealed fluoropassivated PET vascular prosthesis in pig model, so as to avoid pre-clotting, for its safety and efficacy before employing the indigenous and less expensive graft for clinical use. Hydrogel sealed, fluoropassivated PET vascular prosthesis were tested for haemocompatibility and toxicity followed by small animal toxicology tests and in vivo experiments in pigs receiving implantation at thoracic aorta. All 33 animals received test as well as control grafts with a plan for phased explantation at 2, 12 and 26 weeks. All animals underwent completion angiogram at the end of procedure as well as before graft explantation. Haemocompatibility tests for haemolysis and toxicity tests showed no adverse events in tested mice and rabbits. Completion angiogram showed intact anastamosis and patent graft in each animal in post-operative period and at explantation. Gross and histopathological examination showed well-encapsulated grafts, clean glistening neointima and no evidence of thrombus in both test and control grafts. Hydrogel sealed, fluoropassivated PET vascular prosthesis was found non-toxic, haemocompatible and remained patent in in vivo studies at planned intervals.
Preclinical evaluation of hydrogel sealed fluropassivated indigenous vascular prosthesis
Unnikrishnan, Madathipat; Umashankar, P.R.; Viswanathan, Sidharth; Savlania, Ajay; Joseph, Roy; Muraleedharan, C.V.; Agrawal, Vivek; Shenoy, Sachin J.; Krishnan, Lissy K.; Mohanan, P.V.; Sabareeswaran, A.
2017-01-01
Background & objectives: Polyethylene terephthalate (PET) graft, designed and developed at our institute for vascular reconstruction, is porous to promote optimal incorporation and neointima formation, requiring pre-clotting or biomodification by sealing the pores before implantation. The objective of this study was to characterize, test and perform preclinical evaluation of hydrogel (alginate dialdehyde cross-linked gelatin) sealed fluoropassivated PET vascular prosthesis in pig model, so as to avoid pre-clotting, for its safety and efficacy before employing the indigenous and less expensive graft for clinical use. Methods: Hydrogel sealed, fluoropassivated PET vascular prosthesis were tested for haemocompatibility and toxicity followed by small animal toxicology tests and in vivo experiments in pigs receiving implantation at thoracic aorta. All 33 animals received test as well as control grafts with a plan for phased explantation at 2, 12 and 26 weeks. All animals underwent completion angiogram at the end of procedure as well as before graft explantation. Results: Haemocompatibility tests for haemolysis and toxicity tests showed no adverse events in tested mice and rabbits. Completion angiogram showed intact anastamosis and patent graft in each animal in post-operative period and at explantation. Gross and histopathological examination showed well-encapsulated grafts, clean glistening neointima and no evidence of thrombus in both test and control grafts. Interpretation & conclusions: Hydrogel sealed, fluoropassivated PET vascular prosthesis was found non-toxic, haemocompatible and remained patent in in vivo studies at planned intervals. PMID:29512608
Ostman, Pär-Olov; Hellman, Mats; Sennerby, Lars; Wennerberg, Ann
2008-05-01
During the last years, focus has been paid to implant treatment using immediate function protocols, and different approaches to provide patients with temporary constructions have been presented. Most of these techniques involve dental technicians producing the temporary construction, for example, rebuilding existing dentures, acrylic bridges, etc. The purpose of this prospective clinical study was to evaluate the clinical outcome of a chair-side technique of a cost-effective temporary prosthesis. Fixture survival rate and risk of temporary bridge failure were analyzed. Thirty-seven partially or totally edentate patients (18 female and 19 male; mean age: 66.7 years) treated with chair-side manufactured temporary restorations (QuickBridge, BIOMET 3i, Palm Beach, Fl, USA) for immediate loading have been evaluated. The prostheses extended from two unit bridges supported by two implants to full-arch construction supported by six implants. The temporary prostheses were monitored from the day of surgery and delivery to the time of replacement with a permanent prosthetic construction 3 to 6 months later. No implants were lost during the observation time. One (3%) temporary prosthesis fractured and additional two (6%) loosened during the follow-up time. The study indicated that the tested chair-side concept for manufacturing of temporary prosthesis for immediate loading of dental implants is a viable approach.
Di Mauro, Michele; Dato, Guglielmo Mario Actis; Barili, Fabio; Gelsomino, Sandro; Santè, Pasquale; Corte, Alessandro Della; Carrozza, Antonio; Ratta, Ester Della; Cugola, Diego; Galletti, Lorenzo; Devotini, Roger; Casabona, Riccardo; Santini, Francesco; Salsano, Antonio; Scrofani, Roberto; Antona, Carlo; Botta, Luca; Russo, Claudio; Mancuso, Samuel; Rinaldi, Mauro; De Vincentiis, Carlo; Biondi, Andrea; Beghi, Cesare; Cappabianca, Giangiuseppe; Tarzia, Vincenzo; Gerosa, Gino; De Bonis, Michele; Pozzoli, Alberto; Nicolini, Francesco; Benassi, Filippo; Rosato, Francesco; Grasso, Elena; Livi, Ugolino; Sponga, Sandro; Pacini, Davide; Di Bartolomeo, Roberto; De Martino, Andrea; Bortolotti, Uberto; Onorati, Francesco; Faggian, Giuseppe; Lorusso, Roberto; Vizzardi, Enrico; Di Giammarco, Gabriele; Marinelli, Daniele; Villa, Emmanuel; Troise, Giovanni; Picichè, Marco; Musumeci, Francesco; Paparella, Domenico; Margari, Vito; Tritto, Francesco; Damiani, Girolamo; Scrascia, Giuseppe; Zaccaria, Salvatore; Renzulli, Attilio; Serraino, Giuseppe; Mariscalco, Giovanni; Maselli, Daniele; Foschi, Massimiliano; Parolari, Alessandro; Nappi, Giannantonio
2017-08-15
The aim of this large retrospective study was to provide a logistic risk model along an additive score to predict early mortality after surgical treatment of patients with heart valve or prosthesis infective endocarditis (IE). From 2000 to 2015, 2715 patients with native valve endocarditis (NVE) or prosthesis valve endocarditis (PVE) were operated on in 26 Italian Cardiac Surgery Centers. The relationship between early mortality and covariates was evaluated with logistic mixed effect models. Fixed effects are parameters associated with the entire population or with certain repeatable levels of experimental factors, while random effects are associated with individual experimental units (centers). Early mortality was 11.0% (298/2715); At mixed effect logistic regression the following variables were found associated with early mortality: age class, female gender, LVEF, preoperative shock, COPD, creatinine value above 2mg/dl, presence of abscess, number of treated valve/prosthesis (with respect to one treated valve/prosthesis) and the isolation of Staphylococcus aureus, Fungus spp., Pseudomonas Aeruginosa and other micro-organisms, while Streptococcus spp., Enterococcus spp. and other Staphylococci did not affect early mortality, as well as no micro-organisms isolation. LVEF was found linearly associated with outcomes while non-linear association between mortality and age was tested and the best model was found with a categorization into four classes (AUC=0.851). The following study provides a logistic risk model to predict early mortality in patients with heart valve or prosthesis infective endocarditis undergoing surgical treatment, called "The EndoSCORE". Copyright © 2017. Published by Elsevier B.V.
Choudhury, Dipankar; Rebenda, David; Sasaki, Shinya; Hekrle, Pavel; Vrbka, Martin; Zou, Min
2018-05-01
This study evaluates the impact of dimple shapes on lubricant film formation in artificial hip joints. Micro-dimples with 20-50 µm lateral size and 1 ± 0.2 µm depths were fabricated on CrCoMo hip joint femoral heads using a picosecond laser. Tribological studies were performed using a pendulum hip joint simulator to apply continuous swing flexion-extension motions. The results revealed a significantly enhanced lubricant film thickness (≥ 500 nm) with micro-dimpled prosthesis heads at equilibrium position after the lubricant film has fully developed. The average lubricant film thickness of dimpled prostheses with square- and triangular-shaped dimple arrays over time is about 3.5 that of the non-dimpled prosthesis (204 nm). Remarkably, the prosthesis with square-shaped dimple arrays showed a very fast lubricant film formation reaching their peak values within 0.5 s of pendulum movement, followed by prosthesis with triangular-shaped dimple arrays with a transition period of 42.4 s. The fully developed lubricant film thicknesses (≥ 700 nm) are significantly higher than the surface roughness (≈ 25 nm) demonstrating a hydrodynamic lubrication. Hardly any scratches appeared on the post-experimental prosthesis with square-shaped dimple array and only a few scratches were found on the post-experimental prosthesis with triangular-shaped dimple arrays. Thus, prostheses with square-shaped dimple arrays could be a potential solution for durable artificial hip joints. Copyright © 2018 Elsevier Ltd. All rights reserved.
Key Parameters Evaluation for Hip Prosthesis with Finite Element Analysis
NASA Astrophysics Data System (ADS)
Guo, Hongqiang; Li, Dichen; Lian, Qin; Li, Xiang; Jin, Zhongmin
2007-09-01
Stem length and cross section are two key parameters that influence the stability and longevity of metallic hip prosthesis in the total hip arthroplasty (THA). In order to assess their influence to the stress and fatigue behavior of hip prosthesis, a series model of hip prosthesis with round-shaped or drum-shaped cross section, and with different stem lengths were created. These models were analyzed under both static and dynamic loading conditions with finite element analysis, and dynamic loading represents normal walking was used in the dynamic analysis. The stress on the metallic stem, cement, and adjacent bone were got, micromotion on the cement-metal interface were got too. Safety factors for fatigue life of the hip prothesis were calculated based on data obtained from dynamic analysis. Static analysis shows that drum-shaped cross section can decrease the displacement of the stem, that stress on drum-shaped stem focus on the corner of the femoral neck and the distal part of hip prosthesis, whereas the stress on the round-shaped stem distributes evenly over most part of the stem, and maximum stress on stem prosthesis fluctuates with stem length bottoming out at stem length range from 80 mm to 110 mm, that drum-shaped stems with drum height 8 mm generate more stress at the distal part of stem than drum-shaped stems with drum height 10 mm and round stems do. Dynamic and fatigue analysis shows that drum-shaped stem with drum height 10 mm and stem length 90 mm has the greatest safety factor therefore long fatigue life.
Tarlochan, Faris; Mehboob, Hassan; Mehboob, Ali; Chang, Seung-Hwan
2018-06-01
Cementless hip prostheses with porous outer coating are commonly used to repair the proximally damaged femurs. It has been demonstrated that stability of prosthesis is also highly dependent on the bone ingrowth into the porous texture. Bone ingrowth is influenced by the mechanical environment produced in the callus. In this study, bone ingrowth into the porous structure was predicted by using a mechano-regulatory model. Homogenously distributed pores (200 and 800 [Formula: see text]m in diameter) and functionally graded pores along the length of the prosthesis were introduced as a porous coating. Bone ingrowth was simulated using 25 and 12 [Formula: see text]m micromovements. Load control simulations were carried out instead of traditionally used displacement control. Spatial and temporal distributions of tissues were predicted in all cases. Functionally graded pore decreasing models gave the most homogenous bone distribution, the highest bone ingrowth (98%) with highest average Young's modulus of all tissue phenotypes approximately 4.1 GPa. Besides this, the volume of the initial callus increased to 8.33% in functionally graded pores as compared to the 200 [Formula: see text]m pore size models which increased the bone volume. These findings indicate that functionally graded porous surface promote bone ingrowth efficiently which can be considered to design of surface texture of hip prosthesis.
Using "Rebar" to Stabilize Rigid Chest Wall Reconstruction.
Robinson, Lary A; Grubbs, Deanna M
2016-04-01
After major chest wall resection, reconstruction of the bony defect with a rigid prosthesis is mandatory to protect the underlying thoracic organs, and to prevent flail chest physiology. Although many methods have been described for chest wall reconstruction, a commonly used technique employs a composite Marlex (polypropylene) mesh with methyl-methacrylate cement sandwiched between two layers of mesh (MMS), which is tailored to the defect size and shape. In building construction, steel "rebar" is used to strengthen and reinforce masonry structures. To avoid the initial residual motion of the rigid prosthesis used to reconstruct very large defects, particularly the sternum, we devised a simple technique of adding one or more Steinmann steel pins as "rebar" to strengthen and immediately stabilize the prosthesis to the surrounding ribs and sternum. For the very large defects, particularly over the heart and great vessels, titanium mesh may also be readily added into the sandwich construction for increased strength and to prevent late prosthetic fractures. Short- and long-term results of this inexpensive modification of the MMS reconstruction technique are excellent. This modified MMS tailor-made prosthesis is only one-third the cost of the recently popular prosthetic titanium systems, takes much less operative time to create and implant, and avoids the well-described complications of late titanium bar fracture and erosion/infection as well as loosening of screws and/or titanium bars. Georg Thieme Verlag KG Stuttgart · New York.
Nasofacial defect following fibrosarcoma excision and radiotherapy.
Burget, G L; Panje, W R; Krause, C J
1988-01-01
For initial reconstruction, Dr. Burget suggests that he would have advanced the cheek flap medially toward the nasal septum and, subsequently, reconstructed the missing right half of the nose with a forehead flap and cartilage grafts. Dr. Panje suggested early prosthetic rehabilitation, while Dr. Krause's concepts were similar to Dr. Burget's, with forehead flap nasal reconstruction, after cheek reconstruction to the nasofacial and nasolabial lines with a medially advanced cheek flap. Dr. Panje recommended an immediate maxillary denture prosthesis, as did Dr. Krause (who supplemented this with foam rubber). Dr. Burget placed the prosthesis 3 weeks after tumor ablation. For skin grafts, Drs. Panje and Burget suggested split thickness grafts to all new surfaces to decrease wound contracture, while Dr. Krause used dermis grafts for the same purpose. Other reconstructive methods mentioned were the (1) cervical tubed flap, (2) free scapular flap, (3) Washio flap, (4) tissue expansion, and (5) nasolabial flap. Suggestions for isolated defects included: Lower eyelid--increase internal support by building up the prosthesis; release lower lid from deltopectoral flap and V-Y advancement; support graft or irradiated cartilage (1-2 mm sheet) under orbicularis oculi. Nasal ala--bring present ala down and insert cartilage graft; turn internal skin down and fill the resulting defect with a composite graft. Upper lip--multiple Z-plasty. Retrodisplacement of cheek due to maxillectomy--release buccal scar; skin graft the raw internal surface and build up prosthesis.
Inflammatory fibrous hyperplasia treated with a modified vestibuloplasty: a case report.
Jaimes, Miguel; Muñante, Jose; Olate, Sergio; Rodriguez-Chessa, Jaime Giuseppe; de Albergaria-Barbosa, Jose Ricardo; Mazzonetto, Renato; Klüppel, Leandro Eduardo
2008-03-01
The purpose of this report is to present a case of surgical and prosthetic treatment of a woman with inflammatory fibrous hyperplasia (IFH) and her evaluation during a six month period. IFH is a benign pathology, prevalent in female patients, and principally associated with ill-fitting prosthetic devices in need of adjustment. It is common for patients to require surgical removal of the hyperplastic tissue and fabrication of a new prosthesis. A 55-year-old female with a history of smoking presented with a chief complaint of missing the scheduled adjustment of her maxillary complete denture and the presence of moveable tissue under the denture. Surgical excision of the hyperplastic tissue followed with fixation of the prosthesis for six months to guide the healing of the soft tissue and to reshape the contours of the maxillary supporting tissues. Surgical removal of hyperplasic soft tissue is a routine procedure, and the fixation of the prosthesis for the support of tissue during healing improves intraoral conditions for the fabrication of a new prosthesis in the future.
Beebe, Kathleen; Benevenia, Joseph; Kaushal, Neil; Uglialoro, Anthony; Patel, Neeraj; Patterson, Francis
2010-06-09
The noninvasive expandable prosthesis is used for limb-salvage surgery following tumor resection in skeletally immature patients. The purpose of this retrospective study is to report our experience with the Repiphysis (Wright Medical Technology, Inc; Arlington, Tennessee) noninvasive expandable prosthesis for both the lower extremity and compassionate use in the upper extremity in 12 patients between 2003 and 2008. Twelve prostheses were implanted in 12 patients with an average follow-up of 38 months (range, 12-78 months). Nine patients underwent a total of 38 expansion procedures. Mean total expansion was 4.5 cm (range, 0.8-9.9 cm). No complications of lengthening occurred. Seven nononcologic complications were noted. One infection was reported in 12 patients. The mean MSTS score after rehabilitation was 24.5 (range, 13-30). The Repiphysis noninvasive prosthesis provides acceptable functional outcomes for both upper and lower extremity implantation and appears to have an advantage as compared to conventional expandable prosthetics, which require open procedures that can potentially increase the risk of infection from repeated hardware exposure. Copyright 2010, SLACK Incorporated.
[The endo-exo prosthesis treatment concept : Improvement in quality of life after limb amputation].
Hoffmeister, T; Schwarze, F; Aschoff, H H
2017-05-01
Osseointegrated, percutaneous implants as the force bearer for exoprosthetics after limb amputation have been used in individual cases for clinical rehabilitation of amputees during the past years. Most experience in this field in Germany has been accumulated at the Sana Klinik in Lübeck with the so-called endo-exo prosthesis (EEP) system. The two-step implantation procedure can now be considered as reliable. Following a well-documented learning curve initial soft tissue problems concerning the cutaneous stoma can now be regarded as exceptions. The retrospective examination of the results concerning by now more than 100 patients provided with an endo-exo femoral prosthesis (EEFP) showed a very satisfying outcome concerning objective as well as subjective values, such as duration of daily use and wearing comfort of the exoprosthesis. Regaining the ability of osseoperception due to the intraosseous fixation is described by the patients as a great advantage. The step from a socket prosthesis to an EEP is felt to be a big increase in quality of life by nearly all patients included into the follow-up. Nearly all of the patients questioned would choose an endo-exo prosthesis again. Meanwhile, the success of the EEP resulted in the broadening of indications from above-knee amputations to transtibial as well as transhumeral amputations. The results are likewise encouraging. The use of EEP for the upper limbs leads to substantial improvement in the range of motion of the shoulder joint with the intramedullary anchored percutaneous implant. Furthermore, new pathbreaking possibilities in the fixation of myoelectrically controlled arm prostheses may arise from the EEP technique.
Pillai, Rajath Sasidharan; Mathur, Vijay Prakash; Jain, Veena; Shah, Naseem; Kalra, Sandeep; Kumar, Pravesh; Dey, A B
2015-12-01
To determine the effect of prosthesis need on nutritional status and oral health-related quality of life (OHrQoL) in elderly and to check the disparity between prosthesis need and prosthesis want in the Indian elderly. A total of 946 geriatric participants reporting to a geriatric medicine clinic were recruited in the study. Mini-nutritional assessment (MNA), geriatric oral health assessment (GOHAI) indices, prosthesis need according to WHO criteria, and prosthesis want was recorded along with age, gender, socioeconomic status and posterior occluding pair. Significant associations exist between prosthesis need and age (p = 0.005), MNA (p = 0.006) and GOHAI (p = 0.000). Prosthesis demand too was influenced by age (p = 0.004), posterior occluding pairs (p = 0.000), MNA (p = 0.012) and GOHAI (p = 0.000). GOHAI was negatively correlated with upper (r = -0.445) and lower prosthesis need (r = -0.460). Participants with some prosthesis need had significantly lower MNA and GOHAI scores as compared to those with no prosthesis need. Though prosthesis need was high (79.7 %), demand was low (39.3 %). Prosthesis need affects nutritional status and OHrQoL in elderly, and a wide gap exists between need and want of prosthesis.
De Nunzio, Alessandro Marco; Dosen, Strahinja; Lemling, Sabrina; Markovic, Marko; Schweisfurth, Meike Annika; Ge, Nan; Graimann, Bernhard; Falla, Deborah; Farina, Dario
2017-08-01
Grasping is a complex task routinely performed in an anticipatory (feedforward) manner, where sensory feedback is responsible for learning and updating the internal model of grasp dynamics. This study aims at evaluating whether providing a proportional tactile force feedback during the myoelectric control of a prosthesis facilitates learning a stable internal model of the prosthesis force control. Ten able-bodied subjects controlled a sensorized myoelectric prosthesis performing four blocks of consecutive grasps at three levels of target force (30, 50, and 70%), repeatedly closing the fully opened hand. In the first and third block, the subjects received tactile and visual feedback, respectively, while during the second and fourth block, the feedback was removed. The subjects also performed an additional block with no feedback 1 day after the training (Retest). The median and interquartile range of the generated forces was computed to assess the accuracy and precision of force control. The results demonstrated that the feedback was indeed an effective instrument for the training of prosthesis control. After the training, the subjects were still able to accurately generate the desired force for the low and medium target (30 and 50% of maximum force available in a prosthesis), despite the feedback being removed within the session and during the retest (low target force). However, the training was substantially less successful for high forces (70% of prosthesis maximum force), where subjects exhibited a substantial loss of accuracy as soon as the feedback was removed. The precision of control decreased with higher forces and it was consistent across conditions, determined by an intrinsic variability of repeated myoelectric grasping. This study demonstrated that the subject could rely on the tactile feedback to adjust the motor command to the prosthesis across trials. The subjects adjusted the mean level of muscle activation (accuracy), whereas the precision could not be modulated as it depends on the intrinsic myoelectric variability. They were also able to maintain the feedforward command even after the feedback was removed, demonstrating thereby a stable learning, but the retention depended on the level of the target force. This is an important insight into the role of feedback as an instrument for learning of anticipatory prosthesis force control.
Lee, Ki-Sun; Shin, Sang-Wan; Lee, Sang-Pyo; Kim, Jong-Eun; Kim, Jee-Hwan; Lee, Jeong-Yol
The purpose of this pilot study was to evaluate and compare polyetherketoneketone (PEKK) with different framework materials for implant-supported prostheses by means of a three-dimensional finite element analysis (3D-FEA) based on cone beam computed tomography (CBCT) and computer-aided design (CAD) data. A geometric model that consisted of four maxillary implants supporting a prosthesis framework was constructed from CBCT and CAD data of a treated patient. Three different materials (zirconia, titanium, and PEKK) were selected, and their material properties were simulated using FEA software in the generated geometric model. In the PEKK framework (ie, low elastic modulus) group, the stress transferred to the implant and simulated adjacent tissue was reduced when compressive stress was dominant, but increased when tensile stress was dominant. This study suggests that the shock-absorbing effects of a resilient implant-supported framework are limited in some areas and that rigid framework material shows a favorable stress distribution and safety of overall components of the prosthesis.
Oosterhof, Janine J H; van der Mei, Henny C; Busscher, Henk J; Free, Rolien H; Kaper, Hans J; van Weissenbruch, Ranny; Albers, Frans W J
2005-04-01
Although leakage through a tracheoesophageal shunt prosthesis is the main cause of prosthesis failure in a laryngectomy patient, this has never been the subject of in vitro evaluation. The aim of this study was to compare three commercially available voice prostheses by comparison of their in vitro leakage patterns, in absence or presence of a biofilm. To compare in vitro leakage patterns, a model comprised of an artificial throat equipped with a single prosthesis coupled to a water reservoir was developed. By varying the height of the water reservoir, different pressures on the voice prosthesis can be obtained. Both in absence and presence of a biofilm, the Blom Singer voice prosthesis demonstrated the lowest leakage, followed by Groningen Low Resistance. The Provox2 showed significantly the most leakage, however, in presence of a biofilm the leakage of the Provox2 significantly decreased. Regular airflow during biofilm formation significantly increased leakage through the Provox2. Out of 746 clinical replacements, Provox2 showed 76% and Groningen Low Resistance 57% replacements due to leakage. The model used in this study showed significant differences in leakage of the three types of voice prostheses used. Leakage occurred more readily through Provox2 than through Groningen Low Resistance and Blom Singer prostheses, which is in line with clinical observations and enforces the model. (c) 2005 Wiley Periodicals, Inc.
Luenam, Suriya; Chalongviriyalert, Piti; Kosiyatrakul, Arkaphat; Thanawattano, Chusak
2012-01-01
Many studies comparing the morphology of native radial head with the prosthesis have been published. However, there is limited information regarding the postoperative alignment of the articular surface following the radial head replacement. The purpose of this study is to evaluate the alteration of the end-plane angle in the modular radial head prosthesis with a press-fit cementless cylindrical stem. The study used 36 cadaveric radii. The press-fit size prosthesis with cylindrical stem was inserted into each specimen. The end-plane angles of the radial head before and after prosthetic replacement, were measured in coronal and sagittal planes with a digital inclinometer. The data were analyzed by paired t-test. From paired t-test, there were statistically symmetrical end-plane angles before and after radial head replacement in both coronal and sagittal planes (p-value < 0.01). The mean of radial head end-plane angle alteration in the coronal plane was 3.62° (SD, 2.76°) (range, 0.3°-8.9°). In the sagittal plane, the mean of alteration was 5.85° (SD, 3.56°) degrees (range, 0.3° - 14.2°). The modular radial head prosthesis with cylindrical stem is in vitro able to restore the native end-plane angles of radial heads statistically when used in a press-fit fashion.
Online adaptive neural control of a robotic lower limb prosthesis
NASA Astrophysics Data System (ADS)
Spanias, J. A.; Simon, A. M.; Finucane, S. B.; Perreault, E. J.; Hargrove, L. J.
2018-02-01
Objective. The purpose of this study was to develop and evaluate an adaptive intent recognition algorithm that continuously learns to incorporate a lower limb amputee’s neural information (acquired via electromyography (EMG)) as they ambulate with a robotic leg prosthesis. Approach. We present a powered lower limb prosthesis that was configured to acquire the user’s neural information and kinetic/kinematic information from embedded mechanical sensors, and identify and respond to the user’s intent. We conducted an experiment with eight transfemoral amputees over multiple days. EMG and mechanical sensor data were collected while subjects using a powered knee/ankle prosthesis completed various ambulation activities such as walking on level ground, stairs, and ramps. Our adaptive intent recognition algorithm automatically transitioned the prosthesis into the different locomotion modes and continuously updated the user’s model of neural data during ambulation. Main results. Our proposed algorithm accurately and consistently identified the user’s intent over multiple days, despite changing neural signals. The algorithm incorporated 96.31% [0.91%] (mean, [standard error]) of neural information across multiple experimental sessions, and outperformed non-adaptive versions of our algorithm—with a 6.66% [3.16%] relative decrease in error rate. Significance. This study demonstrates that our adaptive intent recognition algorithm enables incorporation of neural information over long periods of use, allowing assistive robotic devices to accurately respond to the user’s intent with low error rates.
Monte Carlo calculations of the impact of a hip prosthesis on the dose distribution
NASA Astrophysics Data System (ADS)
Buffard, Edwige; Gschwind, Régine; Makovicka, Libor; David, Céline
2006-09-01
Because of the ageing of the population, an increasing number of patients with hip prostheses are undergoing pelvic irradiation. Treatment planning systems (TPS) currently available are not always able to accurately predict the dose distribution around such implants. In fact, only Monte Carlo simulation has the ability to precisely calculate the impact of a hip prosthesis during radiotherapeutic treatment. Monte Carlo phantoms were developed to evaluate the dose perturbations during pelvic irradiation. A first model, constructed with the DOSXYZnrc usercode, was elaborated to determine the dose increase at the tissue-metal interface as well as the impact of the material coating the prosthesis. Next, CT-based phantoms were prepared, using the usercode CTCreate, to estimate the influence of the geometry and the composition of such implants on the beam attenuation. Thanks to a program that we developed, the study was carried out with CT-based phantoms containing a hip prosthesis without metal artefacts. Therefore, anthropomorphic phantoms allowed better definition of both patient anatomy and the hip prosthesis in order to better reproduce the clinical conditions of pelvic irradiation. The Monte Carlo results revealed the impact of certain coatings such as PMMA on dose enhancement at the tissue-metal interface. Monte Carlo calculations in CT-based phantoms highlighted the marked influence of the implant's composition, its geometry as well as its position within the beam on dose distribution.
Assessment of dental prosthetic status and needs among prisoners of haryana, India.
Bansal, Vikram; Veeresha, K L; Sogi, G M; Kumar, Adarsh; Bansal, Shelly
2013-09-01
This cross-sectional study was planned to evaluate the prosthetic status and treatment needs using WHO (1997) format among prisoners of Haryana state, India. 1,393 subjects with age range of 35.26 ± 12.29 years were examined. Of the study subjects, 11 (0.8 %) were completely while 606 (43.5 %) were partially edentulous. Of these 617 subjects, 305 (49.4 %) were edentulous only in posterior region. Dental caries accounted for loss of teeth in 325 (52.7 %) subjects. 44 (7.1 %) subjects were wearing some prosthesis. Regarding dental arch wise prosthetic need, 335 (54.3 %) subjects needed prosthesis in maxillary arch while 482 (78.1 %) needed prosthesis in mandibular arch. With advancing age there was an increase in the number of complete dental prosthesis required. There was no statistically significant difference between length of imprisonment and prosthetic need, except for need of a combination of prosthesis. Only one-fourth of the prisons had a dentist. The prisoners were taken to a hospital outside the prison in case of health needs. Prosthetic needs of prisoners were high. The lack of dental infrastructure in prisons makes the provision for multi-visit conservative dental treatments very difficult leading to higher tooth mortality. People who migrate back and forth across the prisons and communities represent a public health opportunity that should be addressed.
Identification of overlengthening after replacement of the radial head with a bipolar prosthesis.
Wegmann, K; Lamsfuss, J; Ries, C; Neiss, W F; Franklin, J; Müller, L P; Burkhart, K J
2015-12-01
Overlengthening of the radial column leads to insufficient functionality and increased capitellar wear. Methods to detect or prevent overlengthening have been described for monopolar prostheses. The aim of this study was to evaluate whether one such method described by Athwal et al. is also applicable for a bipolar prosthesis. The radial heads of six fresh frozen upper extremities were resected. A bipolar radial head prosthesis was implanted in each, and the effects of sequential overlengthening on the alignment of the radiocapitellar and ulnohumeral joint line were recorded by fluoroscopic images. Digital image analysis and estimation of overlengthening followed according to the method described by Athwal et al. Statistical analysis of the estimated and actual differences between the native state and bipolar replacement of the radial head with stepwise overlengthening of 1.5, 3, 4.5, and 6 mm showed a specificity of 86 % but consistently underestimated the amount of overlengthening with a sensitivity of only 61 %. The method described by Athwal et al. for the identification of overlengthening by a monopolar prosthesis was not found to be reliable for ruling out or quantifying overlengthening of the tested bipolar prosthesis. However, the use of the method to detect (rule in) overlengthening may be acceptable in certain circumstances. A reliable method for postoperative quantification of overlengthening by bipolar prostheses has still to be found.
New synthetic prosthesis for peripheral nerve injuries: an experimental pilot study.
Uranüs, Selman; Bretthauer, Georg; Nagele-Moser, Doris; Saliba, Sarah; Tomasch, Gordana; Rafolt, Dietmar; Justich, Ivo; Waldert, Jörg; Berghold, Andrea; Kleinert, Reinhold; Becker, Heinz; Voges, Udo; Wiederstein-Grasser, Iris; Koch, Horst
2013-04-01
Even the most modern technology has failed to induce satisfactory functional regeneration of traumatically severed peripheral nerves. Delayed neural regeneration and in consequence, slower neural conduction seriously limit muscle function in the area supplied by the injured nerve. This study aimed to compare a new nerve coaptation system involving an innovative prosthesis with the classical clinical method of sutured nerve coaptation. Besides the time and degree of nerve regeneration, the influence of electrostimulation was also tested. The sciatic nerve was severed in 14 female Göttingen minipigs with an average weight of 40.4 kg. The animals were randomized into 2 groups: One group received the new prosthesis and the other underwent microsurgical coaptation. In each group, according to the randomization a part of the animals received postoperative electrostimulation. Postoperative monitoring and the stimulation schedule covered a period of 9 months, during which axonal budding was evaluated monthly. The data from the pilot study indicate that results with the nerve prosthesis were comparable with those of conventional coaptation. The results indicate that implantation of the nerve prosthesis allows for good and effective neural regeneration. This new and simple treatment option for peripheral nerve injuries can be performed in any hospital with surgical facilities as it does not involve the demanding microsurgical suture technique that can only be performed in specialized centers.
Mundim, Fabrício M; Antunes, Pedro L; Sousa, Ana Beatriz S; Garcia, Lucas F R; Pires-de-Souza, Fernanda C P
2012-06-01
To evaluate the colour stability of paints used for ocular prosthesis iris painting submitted for accelerated artificial ageing (AAA). Forty specimens of acrylic resin for sclera (16 × 2 mm) were made and separated into eight groups (n = 10) according to the type of paint (gouache, GP; oil, OP; acrylic AP; and composite resin for characterisation, CR) and the colours used (blue/brown). After drying (72 h), a new layer of colourless acrylic resin was applied and the initial colour readout was performed (Spectrophotometer PCB 6807). New colour readouts were performed after AAA, and ΔE was calculated. Statistical analysis (two-way anova-Bonferroni, p < 0.05) demonstrated that the brown colour showed lower ΔE means in comparison with the blue colour, with statistically significant difference for AP only. Blue colour showed no statistically significant difference with regard to the type of paint used. Brown AP showed lower ΔE than the other groups, with significant difference for OP and GP. GP showed greater alteration in ΔE for the brown colour, being statistically similar only to OP. Only the AP group for brown pigment shows clinically acceptable values for colour stability after AAA. © 2011 The Gerodontology Society and John Wiley & Sons A/S.
Mondani intraoral welding: historical process and main practical applications.
Dal Carlo, L; Pasqualini, M E; Mondani, P M; Rossi, F; Moglioni, E; Shulman, M
2017-01-01
The intraoral welder was invented by Dr. Pierluigi Mondani during the early 70s to weld titanium needle implants to a titanium bar in patients mouth and to load them immediately by means of resin prosthesis. The clinical use documented dates back to 1972. Over the years, many practical applications have been added to the initial one, which have expanded the use of this device. In this scientific work, main applications are described. The aim of the work was to trace the historical process of intra-oral welding according to Mondani and describe the main practical applications. Intra-oral welding is a process introduced by dr. Pier Luigi Mondani of Genova (Italy) which allows to firmly conjoin titanium implants of any shape by means of a titanium bar or also directly between them in the mouth during surgery. The immediate stabilization achieved by intraoral welding increases implants success rate, allows immediate loading even in situations of bone atrophy, saves implants that are running into failure, re-evaluates fractured implants, allows to stabilize submerged implants postponing prosthesis management, allows to achieve efficient rehabilitation protocols to deal with difficult cases. The 40-years experience with intra-oral welding described in this article, confirms the ease of use and efficiency in providing immediate stabilization of titanium implants of all types.
Influence of type of aortic valve prosthesis on coronary blood flow velocity.
Jelenc, Matija; Juvan, Katja Ažman; Medvešček, Nadja Tatjana Ružič; Geršak, Borut
2013-02-01
Severe aortic valve stenosis is associated with high resting and reduced hyperemic coronary blood flow. Coronary blood flow increases after aortic valve replacement (AVR); however, the increase depends on the type of prosthesis used. The present study investigates the influence of type of aortic valve prosthesis on coronary blood flow velocity. The blood flow velocity in the left anterior descending coronary artery (LAD) and the right coronary artery (RCA) was measured intraoperatively before and after AVR with a stentless bioprosthesis (Sorin Freedom Solo; n = 11) or a bileaflet mechanical prosthesis (St. Jude Medical Regent; n = 11). Measurements were made with an X-Plore epicardial Doppler probe (Medistim, Oslo, Norway) following induction of hyperemia with an adenosine infusion. Preoperative and postoperative echocardiography evaluations were used to assess valvular and ventricular function. Velocity time integrals (VTI) were measured from the Doppler signals and used to calculate the proportion of systolic VTI (SF), diastolic VTI (DF), and normalized systolic coronary blood flow velocities (NSF) and normalized diastolic coronary blood flow velocities (NDF). The systolic proportion of the LAD VTI increased after AVR with the St. Jude Medical Regent prosthesis, which produced higher LAD SF and NSF values than the Sorin Freedom Solo prosthesis (SF, 0.41 ± 0.09 versus 0.29 ± 0.13 [P = .04]; NSF, 0.88 ± 0.24 versus 0.55 ± 0.17 [P = .01]). No significant changes in the LAD velocity profile were noted after valve replacement with the Sorin Freedom Solo, despite a significant reduction in transvalvular gradient and an increase in the effective orifice area. AVR had no effect on the RCA flow velocity profile. The coronary flow velocity profile in the LAD was significantly influenced by the type of aortic valve prosthesis used. The differences in the LAD velocity profile probably reflect differences in valve design and the systolic transvalvular flow pattern.
Chidagam, Prudhvi Raj Lakshmi Venkata; Gande, Vijaya Chandra; Yadlapalli, Sravanthi; Venkata, Ramani Yarlagadda; Kondaka, Sudheer; Chedalawada, Sravya
2017-04-01
Emergence of dental implants made the replacement of missing tooth easy. During the early days of introduction, implants were loaded three to six months after implant insertion, but understanding of healing cascade and improved production technology has changed the phase of restoration from delayed to immediate loading. To evaluate and compare the clinical outcome of immediate and delayed loaded implant supported prosthesis for missing mandibular first molar. The objectives were bleeding on probing, probing depth, implant mobility, marginal bone level and peri-implant radiolucency were evaluated during follow up period. Twenty patients were included in this study who were in the need of fixed implant supported prosthesis for missing mandibular first molar. Single tooth implant with immediate loading done within two days of implant insertion in one group and another group were loaded after three months of implant insertion. These groups were evaluated clinically and radiographically over a period of 72 months after loading using Wilcoxon matched pairs test and Mann-Whitney U test. The study consists of 14 male and six female patients with the age range of 19 to 31 years. There was no bleeding on probing and probing depth remained well within the normal range even after 72 months of loading among both the groups. Minimal marginal bone loss observed with no mobility and peri-implant radiolucency. Implant supported prosthesis for missing mandibular first molar with immediate loading can be used as a successful treatment modality. It reduces treatment time, provides early function and prevents undue migration of adjacent tooth. Immediate loading showed similar clinical and radiographic results as that of delayed loading, indicating it as an equally efficient technique for implant supported prosthesis.
Online Phase Detection Using Wearable Sensors for Walking with a Robotic Prosthesis
Goršič, Maja; Kamnik, Roman; Ambrožič, Luka; Vitiello, Nicola; Lefeber, Dirk; Pasquini, Guido; Munih, Marko
2014-01-01
This paper presents a gait phase detection algorithm for providing feedback in walking with a robotic prosthesis. The algorithm utilizes the output signals of a wearable wireless sensory system incorporating sensorized shoe insoles and inertial measurement units attached to body segments. The principle of detecting transitions between gait phases is based on heuristic threshold rules, dividing a steady-state walking stride into four phases. For the evaluation of the algorithm, experiments with three amputees, walking with the robotic prosthesis and wearable sensors, were performed. Results show a high rate of successful detection for all four phases (the average success rate across all subjects >90%). A comparison of the proposed method to an off-line trained algorithm using hidden Markov models reveals a similar performance achieved without the need for learning dataset acquisition and previous model training. PMID:24521944
A pneumatic Bionic Voice prosthesis—Pre-clinical trials of controlling the voice onset and offset
Noorian, Farzad; Novakovic, Daniel; van Schaik, André
2018-01-01
Despite emergent progress in many fields of bionics, a functional Bionic Voice prosthesis for laryngectomy patients (larynx amputees) has not yet been achieved, leading to a lifetime of vocal disability for these patients. This study introduces a novel framework of Pneumatic Bionic Voice Prostheses as an electronic adaptation of the Pneumatic Artificial Larynx (PAL) device. The PAL is a non-invasive mechanical voice source, driven exclusively by respiration with an exceptionally high voice quality, comparable to the existing gold standard of Tracheoesophageal (TE) voice prosthesis. Following PAL design closely as the reference, Pneumatic Bionic Voice Prostheses seem to have a strong potential to substitute the existing gold standard by generating a similar voice quality while remaining non-invasive and non-surgical. This paper designs the first Pneumatic Bionic Voice prosthesis and evaluates its onset and offset control against the PAL device through pre-clinical trials on one laryngectomy patient. The evaluation on a database of more than five hours of continuous/isolated speech recordings shows a close match between the onset/offset control of the Pneumatic Bionic Voice and the PAL with an accuracy of 98.45 ±0.54%. When implemented in real-time, the Pneumatic Bionic Voice prosthesis controller has an average onset/offset delay of 10 milliseconds compared to the PAL. Hence it addresses a major disadvantage of previous electronic voice prostheses, including myoelectric Bionic Voice, in meeting the short time-frames of controlling the onset/offset of the voice in continuous speech. PMID:29466455
Montreal's experience with Cyranose heat and moisture exchanger use in 15 laryngectomized patients.
Dupuis, Paule; Guertin, Louis; Rainville, Marie-Stéphane; Prud'homme, Dominique-Louise; Lavigne, François
2007-08-01
Evaluate the effects of the improvement of filtration, heating and humidification of inspired air with Cyranose heat and moisture exchanger (HME) on voice quality, breathing, and secretion handling in laryngectomized patients. Prospective study. Fifteen laryngectomized patients, mean age 68, ages ranging from 50 to 91 years. Information was given to patients through video and brochures. Patients were selected if they had minimal understanding, permanent decanulization, no tumour progression or bronchopulmonary infections, and received no recent radiation therapy treatment. They were given the prosthesis and a starter kit. They were then evaluated by a speech pathologist with a structured questionnaire after one week, one month, and three months. The outcomes measured were comfort, breathing, secretions, and ease of use of the prosthesis as well as its effect on voice. Impressions of patients on humidification, filtration, and heating of inspired air were also recorded. At conclusion of trial, 75% of patients wore the prosthesis on a daily basis and they all found it easy to use. All patients who completed the trial found breathing and handling of secretions easier as they thought humidification and filtration of air had improved. Quality of voice improved for 50% while remaining unchanged for 37%. The positive effect of the prosthesis progressed throughout the trial. Seven patients dropped out of the trial, mainly because of adhesive-related issues. Laryngectomized patients from the Montreal area could benefit from Cyranose artificial nose following an adaptation period during our cold winter.
TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS.
Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan
2010-01-01
Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years.
Game-Based Rehabilitation for Myoelectric Prosthesis Control.
Prahm, Cosima; Vujaklija, Ivan; Kayali, Fares; Purgathofer, Peter; Aszmann, Oskar C
2017-02-09
A high number of upper extremity myoelectric prosthesis users abandon their devices due to difficulties in prosthesis control and lack of motivation to train in absence of a physiotherapist. Virtual training systems, in the form of video games, provide patients with an entertaining and intuitive method for improved muscle coordination and improved overall control. Complementary to established rehabilitation protocols, it is highly beneficial for this virtual training process to start even before receiving the final prosthesis, and to be continued at home for as long as needed. The aim of this study is to evaluate (1) the short-term effects of a commercially available electromyographic (EMG) system on controllability after a simple video game-based rehabilitation protocol, and (2) different input methods, control mechanisms, and games. Eleven able-bodied participants with no prior experience in EMG control took part in this study. Participants were asked to perform a surface EMG test evaluating their provisional maximum muscle contraction, fine accuracy and isolation of electrode activation, and endurance control over at least 300 seconds. These assessments were carried out (1) in a Pregaming session before interacting with three EMG-controlled computer games, (2) in a Postgaming session after playing the games, and (3) in a Follow-Up session two days after the gaming protocol to evaluate short-term retention rate. After each game, participants were given a user evaluation survey for the assessment of the games and their input mechanisms. Participants also received a questionnaire regarding their intrinsic motivation (Intrinsic Motivation Inventory) at the end of the last game. Results showed a significant improvement in fine accuracy electrode activation (P<.01), electrode separation (P=.02), and endurance control (P<.01) from Pregaming EMG assessments to the Follow-Up measurement. The deviation around the EMG goal value diminished and the opposing electrode was activated less frequently. Participants had the most fun playing the games when collecting items and facing challenging game play. Most upper limb amputees use a 2-channel myoelectric prosthesis control. This study demonstrates that this control can be effectively trained by employing a video game-based rehabilitation protocol. ©Cosima Prahm, Ivan Vujaklija, Fares Kayali, Peter Purgathofer, Oskar C Aszmann. Originally published in JMIR Serious Games (http://games.jmir.org), 09.02.2017.
Custom-made ocular prosthesis.
Gunaseelaraj, Rajkumar; Karthikeyan, Suma; Kumar, Mohan N; Balamurugan, T; Jagadeeshwaran, A R
2012-08-01
An ocular defect may affect a patient psychologically. An ocular prosthesis is given to uplift the patient psychologically and improve the confidence. Ocular prosthesis can be custom made or a stock shell. To improve the comfort and matching of the prosthesis with that of the adjacent natural eye an custom made ocular prosthesis is preferred. Different techniques are available to fabricate a custom ocular prosthesis, here we have used paper iris disk technique.
Gallagher, P; Buckmaster, A; O'Carroll, S; Kiernan, G; Geraghty, J
2009-11-01
A good-quality external breast prosthesis and prosthesis-fitting service is integral to recovery post-mastectomy. However, this area of care has minimal information or research available. The aim of this study was to investigate women's experience of the provision, fitting, supply and use of breast prostheses in Ireland. Three national surveys were undertaken with women (n = 527), breast care nurses (BCNs) (n = 32) and retail prosthesis fitters (n = 12). The findings identified the importance of the prosthesis for shape, appearance to self, appearance to others, sense of well-being, self-confidence and femininity. Dissatisfaction with weight, comfort and movement of the prosthesis was identified. Cost and travel distance were found to influence the replacement of the prosthesis. Dissatisfaction emerged with the display and choice of products, and brochure availability at the prosthesis fitting. Women preferred to be fitted for the first silicone prosthesis by a BCN in a hospital setting whereas for the replacement prosthesis they preferred a trained fitter at a specialized prosthesis supplier. BCNs and retail fitters identified the need for service guidelines and increased availability of professional development opportunities in prosthesis-fitting. These findings contributed to the development of standards of care for breast prosthesis-fitting services to benefit women and to provide guidelines for those providing the service.
Howard, Charla L; Perry, Bonnie; Chow, John W; Wallace, Chris; Stokic, Dobrivoje S
2017-11-01
Sensorimotor impairments after limb amputation impose a threat to stability. Commonly described strategies for maintaining stability are the posture first strategy (prioritization of balance) and posture second strategy (prioritization of concurrent tasks). The existence of these strategies was examined in 13 below-knee prosthesis users and 15 controls during dual-task standing under increasing postural and cognitive challenge by evaluating path length, 95% sway area, and anterior-posterior and medial-lateral amplitudes of the center of pressure. The subjects stood on two force platforms under usual (hard surface/eyes open) and difficult (soft surface/eyes closed) conditions, first alone and while performing a cognitive task without and then with instruction on cognitive prioritization. During standing alone, sway was not significantly different between groups. After adding the cognitive task without prioritization instruction, prosthesis users increased sway more under the dual-task than single-task standing (p ≤ 0.028) during both usual and difficult conditions, favoring the posture second strategy. Controls, however, reduced dual-task sway under a greater postural challenge (p ≤ 0.017), suggesting the posture first strategy. With prioritization of the cognitive task, sway was unchanged or reduced in prosthesis users, suggesting departure from the posture second strategy, whereas controls maintained the posture first strategy. Individual analysis of dual tasking revealed that greater postural demand in controls and greater cognitive challenge in prosthesis users led to both reduced sway and improved cognitive performance, suggesting cognitive-motor facilitation. Thus, activation of additional resources through increased alertness, rather than posture prioritization, may explain dual-task performance in both prosthesis users and controls under increasing postural and cognitive challenge.
[Phonomechanocardiography in the evaluation of the functional status of valvular prosthesis].
Esquivel Avila, J; Molina Zapata, B; Martínez Ríos, M A; Flamand, E
1975-01-01
The FMCG in 22 patients with valvular prosthesis is analyzed and its clinical, hemodynamic and surgical correlation are established (11 from the I.N.C. and 11 from the Hospital Infantil I.M.A.N.). The average age of the patients was 15 years old, 18 had a mitral and six aortic valvulopathy, and they all required a valvular replacement. Of the mitral prosthesis, 14 were Starr-Edwards (13 of ball valve and one of disc), three Lillehei-Kaster and one Börck-Shiley. In 5 patients, the FMCG suspected disfunction that was later corroborated by catheterism in three patients and by surgery in all of them. The important differences of the FMCG between the group with good and the one with bad function were: the aparition of a rumble, a decrease in the amplitud of the closing snap, index of closing snap opering snap of less than one, lenghtening of fases PFVP and IVCP, and shortening of IVDRP. In the patients with auricular fibrilation, after long dyastoles; that would represent an adequate atrial emptying; the closing snap was more intense, the PFVP was lennthened the IVDRP was shortened when the prosthesis was not properly functioning. All the aortic prosthesis were ball valve Starr-Edwards type; in one the FMCG suspected disfunction and the patient had a sudden death outside of the Hospital. The significant differences of the FMCG were the decrease in the intensity of the opening snap, with a Hylen index of less than one, lengthening of the PFVP, IVCP and of the expulsive period (EP). The authors conclude that the FMCG is a good method for an early detection of the disfunctions of valvular prosthesis.
Howard, Charla L; Wallace, Chris; Abbas, James; Stokic, Dobrivoje S
2017-01-01
We developed and evaluated properties of a new measure of variability in stride length and cadence, termed residual standard deviation (RSD). To calculate RSD, stride length and cadence are regressed against velocity to derive the best fit line from which the variability (SD) of the distance between the actual and predicted data points is calculated. We examined construct, concurrent, and discriminative validity of RSD using dual-task paradigm in 14 below-knee prosthesis users and 13 age- and education-matched controls. Subjects walked first over an electronic walkway while performing separately a serial subtraction and backwards spelling task, and then at self-selected slow, normal, and fast speeds used to derive the best fit line for stride length and cadence against velocity. Construct validity was demonstrated by significantly greater increase in RSD during dual-task gait in prosthesis users than controls (group-by-condition interaction, stride length p=0.0006, cadence p=0.009). Concurrent validity was established against coefficient of variation (CV) by moderate-to-high correlations (r=0.50-0.87) between dual-task cost RSD and dual-task cost CV for both stride length and cadence in prosthesis users and controls. Discriminative validity was documented by the ability of dual-task cost calculated from RSD to effectively differentiate prosthesis users from controls (area under the receiver operating characteristic curve, stride length 0.863, p=0.001, cadence 0.808, p=0.007), which was better than the ability of dual-task cost CV (0.692, 0.648, respectively, not significant). These results validate RSD as a new measure of variability in below-knee prosthesis users. Future studies should include larger cohorts and other populations to ascertain its generalizability. Copyright © 2016 Elsevier B.V. All rights reserved.
Scala, Rudy; Cucchi, Alessandro; Ghensi, Paolo; Vartolo, Francesco
2012-01-01
The purpose of this controlled prospective study was to compare the satisfaction of patients rehabilitated with an immediately loaded implant-supported prosthesis and patients rehabilitated with a conventional denture in the mandible. Selected mandibular partially or totally edentulous patients were included in this prospective study. Patients' mandibles were completely rehabilitated with immediately loaded implants supporting a screw-retained full-arch prosthesis (test group) or with a conventional denture (control group). The Satisfaction Profile (SAT-P), which investigates a number of psychologic aspects related to the function and esthetics of the stomatognathic apparatus, was administered to each patient 1 month before and 3 months after provisional prosthetic rehabilitation. The questionnaire comprised four different SAT-P items: quality of eating, eating behavior, mood, and self-confidence. A visual analog scale was used to elicit patient responses. SAT-P item scores were analyzed statistically by means of the Student t test and the chi-square test (or the Mann-Whitney nonparametric test), with P < .05 considered significant. Forty-one patients were consecutively treated with 205 immediately loaded implants supporting a screw-retained full-arch prosthesis (test group); 38 patients were consecutively treated with a conventional denture (control group). Statistically significant differences were observed between the test and control groups for all four SAT-P items. The test group reported greater satisfaction for all items versus the control group. In both groups, the differences between pre- and postrehabilitation values were statistically significant. Each patient was satisfied with their treatment outcomes, but patients who received an implant-supported prosthesis were more satisfied than the patients who received a conventional denture. The results suggest that a screw-retained full-arch prosthesis on immediately loaded implants is a predictable means of enhancing patient satisfaction.
Outcome Assessment after Aptis Distal Radioulnar Joint (DRUJ) Implant Arthroplasty
Kachooei, Amir Reza; Chase, Samantha M; Jupiter, Jesse B
2014-01-01
Background: Conventional treatments after complicated injuries of the distal radioulnar joint (DRUJ) such as Darrach and Kapandji-Sauvé procedures have many drawbacks, which may eventually lead to a painful unstable distal ulna. The development of DRUJ prosthesis has significantly evolved over the past years. In this study, we assessed the outcome results of patients after DRUJ implant arthroplasty using the Aptis (Scheker) prosthesis. Methods: We identified 13 patients with 14 prosthesis during the past 10 years. Patients underwent DRUJ arthroplasty due to persistent symptoms of instability, chronic pain, and stiffness. Records and follow-up visits were reviewed to find the final post-operative symptoms, pain, range of motion, and grip strength with a mean follow-up of 12 months (range: 2-25 months). Also, patients were contacted prospectively by phone in order to administer the disabilities of the arm shoulder and hand (DASH), patient rated wrist evaluation (PRWE), and visual analogue scale (VAS), and to interview regarding satisfaction and progress in daily activities. Eleven patients out of 13 could be reached with a median follow-up time of 60 months (range: 2 to 102 months). Results: No patient required removal of the prosthesis. Only two patients underwent secondary surgeries in which both required debridement of the screw tip over the radius. The median DASH score, PRWE score, VAS, and satisfaction were 1.3, 2.5, 0, and 10, respectively. The mean range of flexion, extension, supination, and pronation was 62, 54, 51, and 64, respectively. Conclusions: Distal radioulnar joint injuries are disabling and patients usually undergo one or more salvage surgeries prior to receiving an arthroplasty. The Scheker prosthesis has shown satisfactory results with 100% survival rate in all reports. The constrained design of this prosthesis gives enough stability to prevent painful subluxation. PMID:25386579
[Mid-term effectiveness of rotating hinge knee prosthesis for severe knee deformity].
Zeng, Min; Hu, Yihe; Xie, Jie; Li, Mingqing; Lin, Shaoru
2014-01-01
To evaluate the mid-term effectiveness of rotating hinge knee prosthesis for severe knee deformity. A retrospective analysis was made on the clinical data of 24 patients (24 knees) who received rotating hinge knee prosthesis for total knee arthroplasty between January 2003 and June 2011. There were 14 males and 10 females, aged from 60 to 81 years (mean, 70 years). The disease causes included osteoarthritis in 5 cases, rheumatoid arthritis in 7 cases, traumatic arthritis in 9 cases, and Charcot's arthropathy in 3 cases. The disease duration ranged from 5 to 25 years (mean, 14.5 years). Of them, 13 cases had flexion deformity, 7 cases had valgus deformity, and 16 cases had varus deformity. The operation time, the amount of bleeding between operation and drainage-tubes removal, hospitalization time, incision healing, and complications were recorded. The results were evaluated according to Knee Society Score (KSS), visual analogue scale (VAS), and the range of motion (ROM) of knee. Short-form 36 health survey scale (SF-36) was used to evaluate the life quality of patients. The position of prosthesis was observed through X-ray examination. The operation time ranged from 70 to 90 minutes (mean, 78 minutes). The amount of bleeding between operation and drainage-tubes removal ranged from 400 to 1 000 mL (mean, 650 mL). The hospitalization time ranged from 14 to 18 days (mean, 15.2 days). Patellar fracture occurred in 1 case (4.17%) during operation, swelling and effusion of incision in 1 case (4.17%), and periprosthetic infections in 2 cases (8.33%) after operation. All patients were followed up 2-10 years (mean, 5.5 years). The X-ray films showed no evidence of obvious radiolucent line, osteolysis, prosthesis subsidence, and limb alignment change. The results of KSS, VAS socres, and ROM of knee at 1 year postoperatively and last follow-up were significantly better than preoperative ones (P < 0.05), but no significant difference was found between at 1 year postoperatively and last follow-up (P > 0.05). The physiological function and body pain scores were significantly lower than the reference value of urban men over 60 years old from Sichuan province (t = 2.42, P = 0.02; t = 5.26, P = 0.00), but no significant difference was found in the other scores of the SF-36 when compared with the reference value (P > 0.05). The mid-term effectiveness of total knee arthroplasty using rotating hinge knee for severe knee prosthesis deformity is satisfactory. But complications of postoperative infection should be emphasized.
Jeong, Jewon; Kim, Hyun-Joo; Oh, Eunsun; Cha, Jang Gyu; Hwang, Jiyoung; Hong, Seong Sook; Chang, Yun Woo
2018-05-23
The development of dual-energy CT and metal artefact reduction software provides a further chance of reducing metal-related artefacts. However, there have been only a few studies regarding whether MARs practically affect visibility of structures around a metallic hip prosthesis on post-operative CT evaluation. Twenty-seven patients with 42 metallic hip prostheses underwent DECT. The datasets were reconstructed with 70, 90 and 110 keV with and without MARs. The areas were classified into 10 zones according to the reference zone. All the images were reviewed in terms of the severity of the beam-hardening artefacts, differentiation of the bony cortex and trabeculae and visualization of trabecular patterns with a three-point scale. The metallic screw diameter was measured in the acetabulum with 110 keV images. The scores were the worst on 70 keV images without MARs [mean scores:1.84-4.22 (p < 0.001-1.000)]. The structures in zone II were best visualized on 110 keV (p < 0.001-0.011, mean scores: 2.86-5.22). In other zones, there is general similarity in mean scores whether applying MARs or not (p < 0.001-0.920). The mean diameter of the screw was 5.85 mm without MARs and 3.44 mm with MARs (mean reference diameter: 6.48 mm). The 110 keV images without MARs are best for evaluating acetabular zone II. The visibility of the bony structures around the hip prosthesis is similar in the other zones with or without MARs regardless of keV. MARS may not be needed for the evaluation of the metallic hip prosthesis itself at sufficient high-energy levels; however, MARS still has a role in the evaluation of other soft tissues around the prosthesis. © 2018 The Royal Australian and New Zealand College of Radiologists.
Guery, Jacques; Favard, Luc; Sirveaux, François; Oudet, Didier; Mole, Daniel; Walch, Gilles
2006-08-01
Reverse total shoulder arthroplasty is currently being used to treat selected patients with disabling shoulder arthropathy. The purposes of this study were to investigate the medium-term results of reverse total shoulder arthroplasty and to analyze the influence of etiology on the result. We carried out a multicenter study with a minimum follow-up of five years and determined the survival rate of the prosthesis according to the initial etiology of the shoulder arthropathy. Eighty prostheses were implanted in seventy-seven patients between 1992 and 1998. Sixty-six shoulders had an arthropathy with a massive rotator cuff tear, and fourteen shoulders had a disorder with another etiology (rheumatoid arthritis, trauma, or revision arthropathy). At the time of review, eighteen patients had died and two were lost to follow-up. The remaining fifty-seven patients (sixty shoulders) were examined or interviewed by telephone at a mean follow-up of 69.6 months. Cumulative survival curves were generated with replacement of the prosthesis, glenoid loosening, and a functional Constant score of <30 as the end points. The survival rate with replacement of the prosthesis and glenoid loosening as the end points were 91% and 84%, respectively, at 120 months, with shoulders that had arthropathy with a massive rotator cuff tear demonstrating a significantly better result than those that had a disorder with another etiology (p < 0.05). On the other hand, the survival rate with an absolute Constant score of <30 as an end point was 58% at 120 months, with no significant difference with respect to etiology. Two breaks were observed in the survival curves. The first concerned survival until replacement of the prosthesis and occurred at around three years, reflecting early loosening of the prosthesis. The curve then became stable. A second break started at around six years and reflected progressive deterioration of the functional result. Our findings indicate that the reverse total prosthesis should be reserved for the treatment of very disabling shoulder arthropathy with a massive rotator cuff rupture, and it should be used exclusively in patients over seventy years old with low functional demands.
Karakoç, Mehmet; Batmaz, İbrahim; Sariyildiz, Mustafa Akif; Yazmalar, Levent; Aydin, Abdülkadir; Em, Serda
2017-08-01
Patients with amputation need prosthesis to comfortably move around. One of the most important parts of a good prosthesis is the socket. Currently, the most commonly used method is the traditional socket manufacturing method, which involves manual work; however, computer-aided design/computer-aided manufacturing (CAD/CAM) is also being used in the recent years. The present study aimed to investigate the effects of sockets manufactured by traditional and CAD/CAM method on clinical characteristics and quality of life of patients with transtibial amputation. The study included 72 patients with transtibial amputation using prosthesis, 36 of whom had CAD/CAM prosthetic sockets (group 1) and 36 had traditional prosthetic sockets (group 2). Amputation reason, prosthesis lifetime, walking time and distance with prosthesis, pain-free walking time with prosthesis, production time of the prosthesis, and adaptation time to the prosthesis were questioned. Quality of life was assessed using the 36-item Short Form Health Survey questionnaire and the Trinity Amputation and Prosthesis Experience Scales. Walking time and distance and pain-free walking time with prosthesis were significantly better in group 1 than those in group 2. Furthermore, the prosthesis was applied in a significantly shorter time, and socket adaptation time was significantly shorter in group 1. Except emotional role limitation, all 36-item Short Form Healthy Survey questionnaire parameters were significantly better in group 1 than in group 2. Trinity Amputation and Prosthesis Experience Scales activity limitation scores of group 1 were lower, and Trinity Amputation and Prosthesis Experience Scales satisfaction with the prosthesis scores were higher than those in group 2. Our study demonstrated that the sockets manufactured by CAD/CAM methods yield better outcomes in quality of life of patients with transtibial amputation than the sockets manufactured by the traditional method.
Chen, B-L; Xie, D-H; Zheng, Z-M; Lu, W; Ning, C-Y; Li, Y-Q; Li, F-B; Liao, W-M
2011-01-01
Alendronate (ALO) and calcitonin (CT), as commonly used antiosteoporosis drugs in current clinical practice, have been experimentally confirmed to produce the effectiveness of promoting osseointegration at the interface between prosthesis and host bone and enhancing the long-term stability of the prosthesis. Our current study compared these two drugs' effects on the osseointegration of prosthesis and found that both of them could promote bone attachment between prosthesis and host bone; moreover, ALO produced more pronounced effectiveness. A series of findings confirmed that ALO and CT improved bone attachment of implant in animals. However, which one shows stronger effectiveness has not yet been reported by previous researches. Our study compared the effects of the two commonly used antiosteoporosis drugs on the bone-prosthesis osseointegration so as to provide valuable reference for current clinical options of medication. Forty female SD rats aged 5 months were randomly set into A, B, C, and D groups. Except for group A, the others were ovariectomized to establish osteoporosis model (lumbar bone mineral density (BMD) decreased by 20% 4 weeks after ovariectomy). All the rats received prosthesis implantation at their tibial plateau. Then, the rats in groups C and D were given ALO (7 mg/kg/w) orally and CT (5 IU/kg/day) subcutaneously for 12 weeks, respectively. Prior to the execution, application of tetracycline hydrochloride for staining in vivo was done. After harvesting and embedding, the tibia with implants were cut into thin slides, then the bone histomorphometry was measured to observe the new bone around prosthesis and to calculate the osseointegration rate of the implants. By comparison, the effect of the two drugs on osseointegration was evaluated. (1) Both ALO and CT can effectively enhance the volume of bone mass surrounding the hydroxyapatite (HA) prosthesis and also significantly lever up osseointegration rate to 63.7% and 45.7%, respectively (p < 0.05). However, ALO produced more periprosthesis osseointegration rate than CT, with difference of 18% (p < 0.05). (2) The rats' lumber BMD increased in both ALO and CT groups, from 0.081 ± 0.009 and 0.078 ± 0.009 to 0.116 ± 0.008 and 0.109 ± 0.010 g/cm(2), respectively. Moreover, the effect of ALO was observed more pronounced than that of CT. In osteoporotic conditions, both administration of ALO orally and CT subcutaneously can enhance periprosthesis bone mass and the effects on osseointegration between host bone and prosthesis. Compared with CT, the effect of ALO is more pronounced.
Women's Satisfaction with Their Breast Prosthesis: What Determines a Quality Prosthesis?
ERIC Educational Resources Information Center
Livingston, Patricia M.; White, Victoria M.; Roberts, Susan B.; Pritchard, Emma; Hayman, Jane; Gibbs, Anne; Hill, David J.
2005-01-01
The aim of this study is to determine what factors constitute a quality prosthesis and ascertain which factors affect prosthesis satisfaction. Sixty-four women who received full funding for their prosthesis and 38 women who received their hospital's usual funding were recruited. Women rated the information provided about breast prostheses very…
Megas, Georgios; Papadopoulos, Georgios; Stathouros, Georgios; Moschonas, Dimitrios; Gkialas, Ioannis; Ntoumas, Konstantinos
2013-07-01
WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Erectile dysfunction after nerve-sparing radical retropubic prostatectomy constitutes a challenge to the urologist. The mainstay of medical treatment after radical prostatectomy to restore spontaneous erectile function remains phosphodiesterase (PDE5) inhibitors, despite the fact that data from animal studies suggesting that PDE5 inhibitors can prevent smooth muscle apoptosis and fibrosis have not yet been extrapolated to humans because of a lack of standardized protocols. If the above treatment fails, second-line therapies such as intraurethral prostaglandins, penile injection therapy and vacuum devices are offered. When less invasive therapies are ineffective, interventions that preserve sexual function such as penile prosthesis implantation become the treatment of choice. Our study reveals the alternative of penile prosthesis implantation as first-line treatment in erectile dysfunction after nerve-sparing radical prostatectomy. It also highlights its superiority to the oral PDE5 inhibitor treatment, regarding the erection, frequency, firmness, maintenance and penetration ability. This suggests that a concept of an early penile intervention in the future would be promising for those patients who wish to remain sexually active without depending on oral formulations with doubtful and delayed results. To evaluate the outcome of penile prosthesis surgery in comparison to oral phosphodiesterase type 5 (PDE5) inhibitor administration, in men with erectile dysfunction after nerve-sparing radical prostatectomy, as early penile intervention therapy. A total of 174 patients treated by nerve-sparing retropubic radical prostatectomy (RRP) for clinically localized prostate cancer, between January 2006 and September 2009 enrolled in the study, 153 patients fulfilled the inclusion criteria, and 69 (45%) patients presented with post-RRP erectile dysfunction 6 months after primary surgery. Fifty-four patients were disease-free and subdivided into two arms according to treatment modality, either tadalafil three times/week or penile prosthesis implantation. All patients were evaluated using the International Index of Erectile Function (IIEF) questionnaire preoperatively and at 6, 12 and 24 month postoperatively. Repeated measurements analysis of variance was conducted to evaluate the effect of time and group on IIEF total score. There was a significant reduction in IIEF score from preoperative values to the first measurement after surgery in both treatment groups. The overall degree of change from the first time point immediately after surgery to 2 years was greater in the penile prosthesis group than the tadalafil group (20.4 ± 1.3 vs 8.1 ± 2.4, P < 0.001). The efficacy and satisfaction results of both treatment types are considered acceptable. However, regarding the erection frequency, firmness, penetration ability, maintenance and erection confidence it seems that penile prosthesis implantation is superior to oral treatment. The concept of early penile intervention should be considered and is promising for all patients with post-RRP erectile dysfunction. © 2012 BJU International.
Chung, Eric
2017-02-01
Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades.
2017-01-01
Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades. PMID:28217449
Use of Powered Prosthesis for Children with Upper Limb Deficiency at Hyogo Rehabilitation Center.
Toda, Mitsunori; Chin, Takaaki; Shibata, Yaeko; Mizobe, Futoshi
2015-01-01
There has been no research investigating the use of powered prosthetic for children in Japan. To gain better insight into the state of powered prosthesis usage and identify a ratio of rejection among children. Subjects were 37 unilateral below elbow amputees between the ages of 0 and 16 at the time of their first experienced fitting with a powered prosthesis at our Center. The information was collected from medical records and through face-to-face interviews, and we examined rejection rate and the factors affecting the use of powered prosthesis. The rate of discontinuation was 21.6% as 8 of the 37 children stopped using powered prosthesis. All of them were fitted their prosthesis after 2 years of age, and they rejected prosthesis between 5 to 19 years. We found that the level of amputation had no influence on the use of a powered prosthesis. Children fitted before 2 years of age tend to accept their powered prosthesis than those fitted after 2 years. Multidisciprinary team approach, adequate rehabilitation, detailed follow-up and involvement of parents are quite important for introducing powered prosthesis for children.
Photoelastic analysis of stress distribution in oral rehabilitation.
Turcio, Karina Helga Leal; Goiato, Marcelo Coelho; Gennari Filho, Humberto; dos Santos, Daniela Micheline
2009-03-01
The purpose of this study was to present a literature review about photoelasticity, a laboratory method for evaluation of implants prosthesis behavior. Fixed or removable prostheses function as levers on supporting teeth, allowing forces to cause tooth movement if not carefully planned. Hence, during treatment planning, the dentist must be aware of the biomechanics involved and prevent movement of supporting teeth, decreasing lever-type forces generated by these prosthesis. Photoelastic analysis has great applicability in restorative dentistry as it allows prediction and minimization of biomechanical critical points through modifications in treatment planning.
A Method for the Control of Multigrasp Myoelectric Prosthetic Hands
Dalley, Skyler Ashton; Varol, Huseyin Atakan; Goldfarb, Michael
2012-01-01
This paper presents the design and preliminary experimental validation of a multigrasp myoelectric controller. The described method enables direct and proportional control of multigrasp prosthetic hand motion among nine characteristic postures using two surface electromyography electrodes. To assess the efficacy of the control method, five nonamputee subjects utilized the multigrasp myoelectric controller to command the motion of a virtual prosthesis between random sequences of target hand postures in a series of experimental trials. For comparison, the same subjects also utilized a data glove, worn on their native hand, to command the motion of the virtual prosthesis for similar sequences of target postures during each trial. The time required to transition from posture to posture and the percentage of correctly completed transitions were evaluated to characterize the ability to control the virtual prosthesis using each method. The average overall transition times across all subjects were found to be 1.49 and 0.81 s for the multigrasp myoelectric controller and the native hand, respectively. The average transition completion rates for both were found to be the same (99.2%). Supplemental videos demonstrate the virtual prosthesis experiments, as well as a preliminary hardware implementation. PMID:22180515
Space orientation of total hip prosthesis. A method for three-dimensional determination.
Herrlin, K; Selvik, G; Pettersson, H
1986-01-01
A method for in vivo determination of orientation and relation in space of components of total hip prosthesis is described. The method allows for determination of the orientation of the prosthetic components in well defined anatomic planes of the body. Furthermore the range of free motion from neutral position to the point of contact between the edge of the acetabular opening and the neck of the femoral component can be determined in various directions. To assess the accuracy of the calculations a phantom prosthesis was studied in nine different positions and the measurements of the space oriented parameters according to the present method correlated to measurements of the same parameters according to Selvik's stereophotogrammetric method. Good correlation was found. The role of prosthetic malpositioning and component interaction evaluated with the present method in the development of prosthetic loosening and displacement is discussed.
Early follow-up of a custom non-fluted diaphyseal press-fit tumour prosthesis.
O'Donnell, Patrick W; Griffin, Anthony M; Eward, William C; Sternheim, Amir; Wunder, Jay S; Ferguson, Peter C
2014-01-01
The objective of this study was to evaluate the early results of a custom non-fluted diaphyseal press-fit stem for use with the global modular replacement system (GMRS) tumour prosthesis and the early complications associated with this implant. A total of 53 patients (54 implants) were identified from a prospective database where a custom non-fluted diaphyseal press-fit stem was used as part of the reconstruction of the limb. All patients had a minimum of 22 months of follow-up. The rates of stem revision for any reason were calculated. The median follow-up was 36 months (range 22-85 months). Aseptic loosening was not observed in any patient. At early term follow-up, an uncemented non-fluted stem used with the GMRS tumour endoprosthesis provides a stable bone-prosthesis interface with no evidence of aseptic loosening.
Gutiérrez, Sergio; Greiwe, R Michael; Frankle, Mark A; Siegal, Steven; Lee, William E
2007-01-01
There has been renewed interest in reverse shoulder arthroplasty for the treatment of glenohumeral arthritis with concomitant rotator cuff deficiency. Failure of the prosthesis at the glenoid attachment site remains a concern. The purpose of this study was to examine glenoid component stability with regard to the angle of implantation. This investigation entailed a biomechanical analysis to evaluate forces and micromotion in glenoid components attached to 12 polyurethane blocks at -15 degrees, 0 degrees, and +15 degrees of superior and inferior tilt. The 15 degrees inferior tilt had the most uniform compressive forces and the least amount of tensile forces and micromotion when compared with the 0 degrees and 15 degrees superiorly tilted baseplate. Our results suggest that implantation with an inferior tilt will reduce the incidence of mechanical failure of the glenoid component in a reverse shoulder prosthesis.
Marunick, Mark; Tselios, Nicholas
2004-01-01
This article provides a review of the literature to assist the clinician in determining the efficacy of palatal augmentation prosthesis regarding speech and swallowing for the patient undergoing glossectomy. A MEDLINE search was conducted. Peer-reviewed articles published from 1966 to July 2002 that addressed the question of the efficacy of this prosthesis to improve speech and swallowing after partial or total glossectomy were included. Studies reviewed had to incorporate an objective evaluation of one or both functions. Nine of 130 studies met the selection criteria (4 retrospective, 1 case control, and 4 case reports). A total of 50 subjects were studied, 42 for swallowing and 37 for speech. In 36/42 subjects, treatment was advantageous for swallowing and in 32/37 subjects, it was advantageous for speech. On the basis of the limited evidence available, the functional efficacy of the palatal augmentation prosthesis is supported.
Rosenkrantz, Andrew B; Pujara, Akshat C; Taneja, Samir S
2016-05-01
The purpose of this article is to evaluate the utility of a quality improvement (QI) initiative in achieving long-term adherence to an evolving structured format for reporting the level of suspicion for tumor on prostate MRI examinations. The original QI initiative occurred over a 4-month period in 2010, before which prostate MRI was reported using free text. The initiative consisted of development of a section-wide macro, an initial group training session, ordering physician input regarding the structured report's value, subsequent weekly sessions for ongoing review, and timely individualized feedback in instances of nonuse. The initial structured report included pick lists for describing the level of suspicion for tumor as negative, low, medium, or high. Pick lists were modified in 2011 to incorporate a 5-point Likert scale and again in 2015 to incorporate Prostate Imaging Data and Reporting System (PI-RADS) version 2. These refinements were implemented after accelerated training periods. The frequency of reports providing an MRI-based suspicion level during these periods was assessed. Fifty-five percent of reports provided an MRI-based level of suspicion for tumor before the initiative. For various cohorts evaluated after the initiative (using structured reports based on the low, medium, or high scheme; a numeric Likert scale; or PI-RADS), this frequency improved to 95-100% (p < 0.001). Among reports without a suspicion level, potential confounding factors included marked artifact from hip prosthesis and overt diffuse tumor. The QI initiative achieved excellent adherence in reporting a suspicion level for tumor on prostate MRI examinations. The described components of the initiative were useful for maintaining long-term adherence that persisted after serial modifications to the report lexicon.
Prosthetic management of mid-facial defect with magnet-retained silicone prosthesis.
Buzayan, Muaiyed M
2014-02-01
Mid-facial defect is one of the most disfiguring and impairing defects. A design of prosthesis that is aesthetic and stable can be precious to a patient who has lost part of his face due to surgical excision. Prosthesis can restore the patients' self-esteem and confidence, which affects the patients and their life style. The aim of this case report is to describe a technique of mid-facial silicone prosthesis fabrication. To provide an aesthetic and stable facial prosthesis, the extra-oral prosthesis was fabricated using silicone material, while the intra-oral defect was restored with obturator prosthesis, and then both prostheses were connected and attached to each other using magnets. This clinical report describes the rehabilitation of a large mid-facial defect with a two-piece prosthesis. The silicone facial prosthesis was made hollow and lighter by using an acrylic framework. Two acrylic channels were included within the facial prosthesis to provide the patient with clean and patent airways. A sectional mid-facial prosthesis was made and retained in place by using magnets, which resulted in a significant improvement in the aesthetical and functional outcome without the need for plastic surgery. Silicone prostheses are reliable alternatives to surgery and should be considered in selected cases.
Evaluation of transradial body-powered prostheses using a robotic simulator.
Ayub, Rafi; Villarreal, Dario; Gregg, Robert D; Gao, Fan
2017-04-01
Transradial body-powered prostheses are extensively used by upper-limb amputees. This prosthesis requires large muscle forces and great concentration by the patient, often leading to discomfort, muscle fatigue, and skin breakdown, limiting the capacity of the amputee to conduct daily activities. Since body-powered prostheses are commonplace, understanding their optimal operation to mitigate these drawbacks would be clinically meaningful. To find the optimal operation of the prosthesis where the activation force is minimized and the grip force is maximized. Experimental design. A computer-controlled robotic amputee simulator capable of rapidly testing multiple elbow, shoulder, and scapular combinations of the residual human arm was constructed. It was fitted with a transradial prosthesis and used to systematically test multiple configurations. We found that increased shoulder flexion, scapular abduction, elbow extension, and the placement of the ring harness near the vertebra C7 correlate with higher gripper operation efficiency, defined as the ratio of grip force to cable tension. We conclude that force transmission efficiency is closely related to body posture configuration. These results could help guide practitioners in clinical practice as well as motivate future studies in optimizing the operation of a body-powered prosthesis. Clinical relevance The results from this study suggest that clinicians ought to place the ring harness inferior and to the sound side of the vertebra prominens in order to maximize grip efficiency. The results will also help clinicians better instruct patients in body posture during prosthesis operation to minimize strain.
Iris reconstruction using artificial iris prosthesis for management of aniridia.
Mostafa, Yehia S; Osman, Amr A; Hassanein, Dina H; Zeid, Ashraf M; Sherif, Ahmed M
2018-01-01
To discuss the limitations and benefits of the BrightOcular prosthetic artificial iris device in management of aniridia associated with aphakia or cataract. This is a retrospective study including 5 eyes of 4 patients who underwent implantation of the BrightOcular iris prosthesis (Stellar Devices) for total or partial aniridia. The cases included 2 eyes of 1 patient with congenital aniridia associated with congenital cataract and 3 eyes with traumatic aniridia: 1 with subluxated cataractous lens and 2 with aphakia. In all cases, the iris prosthesis was implanted after a 3-piece acrylic intraocular lens was implanted. We evaluated the clinical course with a minimum follow-up period of 6 months, the intraoperative and postoperative complications, and the cosmetic satisfaction of patients. All patients had improved uncorrected distance visual acuity and best-corrected distance visual acuity. All patients had a transient corneal edema that resolved within the first postoperative week. Only the patient with congenital aniridia had a permanent increase in intraocular pressure and developed a band keratopathy throughout a 2-year follow-up period. The prosthesis was well-centered in all eyes except for one case that required scleral suture fixation after 3 months. All patients had a satisfactory cosmetic appearance. BrightOcular iris prosthesis is a safe and useful tool to correct aniridia associated with pseudophakia or aphakia. Being foldable, it is easy to be implanted through a small incision and placed in the ciliary sulcus without sutures when properly sized. Cosmetic results are satisfactory. Sizing methods should be improved.
Prosthetic use: correlation of clinic team and ergonomic laboratory in predicting its success.
March, H; Cummings, V; Steve, L
1984-12-01
A group of 92 patients with lower limb amputations were evaluated in an effort to determine whether an appropriate clinical decision to prescribe a prosthesis could be made without using elaborate evaluation testing. The assessments were made independently by a clinic team and by an ergonomic laboratory, each applying its own criteria for predicting successful prosthetic use. The high correlation between the two areas indicated that the ergonomic laboratory made no additional contribution toward the decision to supply a patient who had no complicating features with a prosthesis. Nineteen patients had significant ST depressions during exercise testing and of these, nine died within one year. Two patients with no ST segment depressions died within one year.
Multivariate prediction of upper limb prosthesis acceptance or rejection.
Biddiss, Elaine A; Chau, Tom T
2008-07-01
To develop a model for prediction of upper limb prosthesis use or rejection. A questionnaire exploring factors in prosthesis acceptance was distributed internationally to individuals with upper limb absence through community-based support groups and rehabilitation hospitals. A total of 191 participants (59 prosthesis rejecters and 132 prosthesis wearers) were included in this study. A logistic regression model, a C5.0 decision tree, and a radial basis function neural network were developed and compared in terms of sensitivity (prediction of prosthesis rejecters), specificity (prediction of prosthesis wearers), and overall cross-validation accuracy. The logistic regression and neural network provided comparable overall accuracies of approximately 84 +/- 3%, specificity of 93%, and sensitivity of 61%. Fitting time-frame emerged as the predominant predictor. Individuals fitted within two years of birth (congenital) or six months of amputation (acquired) were 16 times more likely to continue prosthesis use. To increase rates of prosthesis acceptance, clinical directives should focus on timely, client-centred fitting strategies and the development of improved prostheses and healthcare for individuals with high-level or bilateral limb absence. Multivariate analyses are useful in determining the relative importance of the many factors involved in prosthesis acceptance and rejection.
Use of Powered Prosthesis for Children with Upper Limb Deficiency at Hyogo Rehabilitation Center
Shibata, Yaeko; Mizobe, Futoshi
2015-01-01
Background There has been no research investigating the use of powered prosthetic for children in Japan. Objective To gain better insight into the state of powered prosthesis usage and identify a ratio of rejection among children. Methods Subjects were 37 unilateral below elbow amputees between the ages of 0 and 16 at the time of their first experienced fitting with a powered prosthesis at our Center. The information was collected from medical records and through face-to-face interviews, and we examined rejection rate and the factors affecting the use of powered prosthesis. Results The rate of discontinuation was 21.6% as 8 of the 37 children stopped using powered prosthesis. All of them were fitted their prosthesis after 2 years of age, and they rejected prosthesis between 5 to 19 years. We found that the level of amputation had no influence on the use of a powered prosthesis. Conclusions Children fitted before 2 years of age tend to accept their powered prosthesis than those fitted after 2 years. Multidisciprinary team approach, adequate rehabilitation, detailed follow-up and involvement of parents are quite important for introducing powered prosthesis for children. PMID:26125974
Laser-assisted fixation of a nitinol stapes prosthesis.
Schrötzlmair, Florian; Suchan, Fabian; Pongratz, Thomas; Krause, Eike; Müller, Joachim; Sroka, Ronald
2018-02-01
Otosclerosis is an inner ear bone disease characterized by fixation of the stapes and consequently progressive hearing loss. One treatment option is the surgical replacement of the stapes by a prosthesis. When so called "smart materials" like nitinol are used, prosthesis fixation can be performed using a laser without manual crimping on the incus. However, specific laser-prosthesis interactions have not been described yet. The aim of the present study was to elucidate the thermo-mechanical properties of the NiTiBOND® prosthesis as a basis for handling instructions for laser-assisted prosthesis fixation. Closure of the NiTiBOND® prosthesis was induced ex vivo by either a diode laser emitting at λ = 940 nm or a CO 2 laser (λ = 10,600 nm). Total energy for closure was determined. Suitable laser parameters (pulse duration, power per pulse, distance between tip of the laser fiber and prosthesis) were assessed. Specific laser-prosthesis interactions were recorded. Especially the diode laser was found to be an appropriate energy source. A total energy deposit of 60 mJ by pulses in near contact application was found to be sufficient for prosthesis closure ex vivo. Energy should be transmitted through a laser fiber equipollent to the prosthesis band diameter. Specific deformation characteristics due to the zonal prosthesis composition have to be taken into account. NiTiBOND® stapes prosthesis can be closed by very little energy when appropriate energy sources like diode lasers are used, suggesting a relatively safe application in vivo. Lasers Surg. Med. 50:153-157, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.
Simultaneous, proportional, multi-axis prosthesis control using multichannel surface EMG.
Yatsenko, Dimitri; McDonnall, Daniel; Guillory, K Shane
2007-01-01
Most upper limb prosthesis controllers only allow the individual selection and control of single joints of the limb. The main limiting factor for simultaneous multi-joint control is usually the availability of reliable independent control signals that can intuitively be used. In this paper, a novel method is presented for extraction of individual muscle source signals from surface EMG array recordings, based on EMG energy orthonormalization along principle movement vectors. In cases where independently-controllable muscles are present in residual limbs, this method can be used to provide simultaneous, multi-axis, proportional control of prosthetic systems. Initial results are presented for simultaneous control of wrist rotation, wrist flexion/extension, and grip open/close for two intact subjects under both isometric and non-isometric conditions and for one subject with transradial amputation.
Savage, Zoliakha; Munjal, Ramesh
2015-10-01
A 47-year-old male suffered a traumatic transtibial amputation; initial limb use was unsuccessful and the short tibial length was thought to be the cause of failure. The patient underwent gradual tibia lengthening using the Ilizarov technique and utilised a weight-bearing prosthesis to expedite bone growth and repair. The patient is now able to use his prosthesis successfully without aids. This case study demonstrates that combining a scientifically based surgical technique with a tailored rehabilitation approach had an improved outcome for the patient. This study reports one case where tibial lengthening using the Ilizarov technique combined with a collaborative team approach has enabled a patient to return to successful prosthetic limb use. © The International Society for Prosthetics and Orthotics 2014.
Zhang, Zhan-feng; Min, Ji-kang; Zhong, Jian-ming; Wang, Dan
2016-06-01
To explore mid-term follow up results of distal fixation prosthesis in treating unstable intertrochanteric fractures in elderly patients. From May 2008 to March 2014,58 elderly patients with unstable intertrochanteric were treated with distal fixation prosthesis, among them, there were 15 males and 43 females aged from 75 to 87 years old with an average of 83.2 years old. Fracture were classified according to Evans classification, 39 cases were type I c and 19 cases were type I d. Surgical risk was evaluated before operation, 9 patients were performed total hip arthroplasty and 49 patients were performed prosthetic replacement hip joint function of patients with different age period, Evans classificaton, prothesis type, fixation method were evaluated respectively by using Harris score. Fifty-six patients were followed up from 13 to 36 months with an average of 21.6 months. Harris score was 83.51 ± 6.40, 5 cases got excellent results, 38 cases good and 13 cases moderate. Harris score of patients aged from 75 to 80 years old was 88.64 ± 2.35, 81.64 ± 6.40 in patients aged more than 80 years old, and had significant differences between two groups; Harris score in patients with type Evans I c was 83.64 ± 6.53, and 83.11 ± 6.08 in type Evans I d, while there was no significant differences between two groups. There was no obvious meaning in Harris score between patients with tension band (83.63 ± 6.15) and without tension band (82.41 ± 6.57). There was no significant meaning in Harris score between patients with normal distal fixation prosthesis (83.34 ± 6.43) and femoral moment reconstruction distal fixation prosthesis (83.92 ± 6.51). There was 1 patient occurred hip joint dislocation on the operative side and re-dislocation after manual reduction, then received open reduction. Two patients occurred femoral osteolysis without clinical symptoms, and treated conservative treatment. Artificial joint replacement for unstable intertrochanteric fractures in elderly patients, hip joint function in patients aged more than 80 years old is worse, while there was no obvious market effect in fracture classification, whether to use tension band and type of distal fixation prosthesis, moreover, proximal femoral osteolysis should be focused on.
Bacchi, Ataís; Consani, Rafael L X; Mesquita, Marcelo F; dos Santos, Mateus B F
2013-09-01
The purpose of this study was to evaluate the influence of superstructure material and vertical misfits on the stresses created in an implant-supported partial prosthesis. A three-dimensional (3-D) finite element model was prepared based on common clinical data. The posterior part of a severely resorbed jaw with two osseointegrated implants at the second premolar and second molar regions was modeled using specific modeling software (SolidWorks 2010). Finite element models were created by importing the solid model into mechanical simulation software (ANSYS Workbench 11). The models were divided into groups according to the prosthesis framework material (type IV gold alloy, silver-palladium alloy, commercially pure titanium, cobalt-chromium alloy, or zirconia) and vertical misfit level (10 µm, 50 µm, and 100 µm) created at one implant-prosthesis interface. The gap of the vertical misfit was set to be closed and the stress values were measured in the framework, porcelain veneer, retention screw, and bone tissue. Stiffer materials led to higher stress concentration in the framework and increased stress values in the retention screw, while in the same circumstances, the porcelain veneer showed lower stress values, and there was no significant difference in stress in the peri-implant bone tissue. A considerable increase in stress concentration was observed in all the structures evaluated within the misfit amplification. The framework material influenced the stress concentration in the prosthetic structures and retention screw, but not that in bone tissue. All the structures were significantly influenced by the increase in the misfit levels.
TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS
Nery, Caio; Fernandes, Túlio Diniz; Réssio, Cibele; Fuchs, Mauro Luiz; Godoy Santos, Alexandre Leme de; Ortiz, Rafael Trevisan
2015-01-01
Ankle arthrosis is becoming more and more common. The search for solutions that preserve joint function has led to a new generation of prosthesis with three components and more degrees of freedom. This paper presents the results achieved for ten patients treated with the HINTEGRA Prosthesis (Integra, New Deal), through collaborative action between the Foot and Ankle Groups of the Orthopedics and Traumatology divisions of Escola Paulista de Medicina, Unifesp, and the School of Medicine of the University of São Paulo (USP). The ten patients (six women and four men, aged between 29 and 66 years), underwent a surgical procedure consisting of Hintermann's technique, between January and June 2005. They were evaluated at prearranged intervals, and the data were subjected to statistical analysis. The surgery led to a significant improvement in ankle mobility. Radiological evaluation showed no signs of loosening or failure in the prosthetic components in any of the patients studied. Although the complication rate in our sample was high, it was equivalent to the rates found by other authors, and directly represents the learning curve associate with this kind of procedure. Four years after the procedure, it was found that the patients pain levels had significantly decreased, and that their functional patterns had significantly improved, with AOFAS and Hintermann scores indicating results that were excellent for 20%, good for 70% and poor for 10%. Treatment of ankle arthritis by means of total arthroplasty using the HINTEGRA prosthesis was capable of providing good results over an average observation period of four years. PMID:27022527
Reynolds, Matthew R; Lei, Yang; Wang, Kaijun; Chinnakondepalli, Khaja; Vilain, Katherine A; Magnuson, Elizabeth A; Galper, Benjamin Z; Meduri, Christopher U; Arnold, Suzanne V; Baron, Suzanne J; Reardon, Michael J; Adams, David H; Popma, Jeffrey J; Cohen, David J
2016-01-05
Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained. In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement [Medtronic CoreValve U.S. Pivotal Trial]; NCT01240902). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Winter, Christian; Pfister, David; Busch, Jonas; Bingöl, Cigdem; Ranft, Ulrich; Schrader, Mark; Dieckmann, Klaus-Peter; Heidenreich, Axel; Albers, Peter
2012-02-01
Residual tumor resection (RTR) after chemotherapy in patients with advanced germ cell tumors (GCT) is an important part of the multimodal treatment. To provide a complete resection of residual tumor, additional surgical procedures are sometimes necessary. In particular, additional vascular interventions are high-risk procedures that require multidisciplinary planning and adequate resources to optimize outcome. The aim was to identify parameters that predict additional vascular procedures during RTR in GCT patients. A retrospective analysis was performed in 402 GCT patients who underwent 414 RTRs in 9 German Testicular Cancer Study Group (GTCSG) centers. Overall, 339 of 414 RTRs were evaluable with complete perioperative data sets. The RTR database was queried for additional vascular procedures (inferior vena cava [IVC] interventions, aortic prosthesis) and correlated to International Germ Cell Cancer Collaborative Group (IGCCCG) classification and residual tumor volume. In 40 RTRs, major vascular procedures (23 IVC resections with or without prosthesis, 11 partial IVC resections, and 6 aortic prostheses) were performed. In univariate analysis, the necessity of IVC intervention was significantly correlated with IGCCCG (14.1% intermediate/poor vs 4.8% good; p=0.0047) and residual tumor size (3.7% size < 5 cm vs 17.9% size ≥ 5 cm; p < 0.0001). In multivariate analysis, IVC intervention was significantly associated with residual tumor size ≥ 5 cm (odds ratio [OR]: 4.61; p=0.0007). In a predictive model combining residual tumor size and IGCCCG classification, every fifth patient (20.4%) with a residual tumor size ≥ 5 cm and intermediate or poor prognosis needed an IVC intervention during RTR. The need for an aortic prosthesis showed no correlation to either IGCCCG (p=0.1811) or tumor size (p=0.0651). The necessity for IVC intervention during RTR is correlated to residual tumor size and initial IGCCCG classification. Patients with high-volume residual tumors and intermediate or poor risk features must initially be identified as high-risk patients for vascular procedures and therefore should be referred to specialized surgical centers with the ad hoc possibility of vascular interventions. Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Mundell, Benjamin F; Kremers, Hilal Maradit; Visscher, Sue; Hoppe, Kurtis M; Kaufman, Kenton R
2016-08-01
Prior studies have identified age as a factor in determining an individual's likelihood of receiving a prosthesis following a lower limb amputation. These studies are limited to specific subsets of the general population and are unable to account for preamputation characteristics within their study populations. Our study seeks to determine the effect of preamputation characteristics on the probability of receiving a prosthesis for the general population in the United States. To identify preamputation characteristics that predict of the likelihood of receiving a prosthesis following an above-knee amputation. A retrospective, population-based cohort study. Olmsted County, Minnesota (2010 population: 144,248). Individuals (n = 93) over the age of 18 years who underwent an above-knee amputation, that is, knee disarticulation or transfemoral amputation, while residing in Olmsted County, MN, between 1987 and 2013. Characteristics affecting the receipt of a prosthesis were analyzed using a logistic regression and a random forest algorithm for classification trees. Preamputation characteristics included age, gender, amputation etiology, year of amputation, mobility, cognitive ability, comorbidities, and time between surgery and the prosthesis decision. The association of preamputation characteristics with the receipt of a prosthesis following an above-knee amputation. Twenty-four of the participants received a prosthesis. The odds of receiving a prosthesis were almost 30 times higher in those able to walk independently prior to an amputation relative to those who could not walk independently. A 10-year increase in age was associated with a 53.8% decrease in the likelihood of being fit for a prosthesis (odds ratio = 0.462, P =.030). Time elapsed between surgery and the prosthesis decision was associated with a rise in probability of receiving a prosthesis for the first 3 months in the random forest algorithm. No other observed characteristics were associated with receipt of a prosthesis. The association of preamputation mobility and age with the likelihood of being fit for a prosthesis is well understood. The effect of age, after controlling for confounders, still persists and is associated with the likelihood of being fit for a prosthesis. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.
Ali, Mujtaba M; Loretz, Lorraine; Shea, Art; Poorvu, Eli; Robinson, William P; Schanzer, Andres; Messina, Louis M; Baril, Donald T
2013-11-01
Despite advances in the treatment of peripheral arterial disease, a significant number of patients ultimately require major amputations. Traditionally, postoperative management of a below-knee amputation involves soft compressive dressings to allow for complete stump healing before initial prosthesis fitting. This technique is associated with a prolonged period of limited mobility, placing patients at risk for deconditioning or fall with a risk of injury to the stump. In contrast, immediate postoperative prosthesis (IPOP) placement allows patients to begin ambulation and rehabilitation on postoperative day 1, which may be of significant physiologic and psychological benefit. The purpose of this study is to compare the outcomes of patients undergoing IPOP placement to those of a historical control group managed with traditional soft compressive dressing placement. Medical records of all consecutive below-knee amputation patients who underwent IPOP (IPOP group; 37 patients, 2007-2010) and all patients who underwent traditional soft compressive dressing placement and were IPOP candidates (non-IPOP group; 35 patients, 2006-2007) were retrospectively reviewed. Patient comorbidities and preoperative ambulation status were compared between the IPOP and the non-IPOP groups. Primary outcomes evaluated included perioperative systemic complications, wound complications, need for surgical revision, and the time until placement of a definitive prosthesis. Data were analyzed using the chi-squared and Student's t-test. Preoperative comorbidities and patient characteristics of the 2 groups were similar, although the IPOP group was younger (61.5 vs. 69.0 years; P=0.01). Immediate perioperative systemic complication rates were not significantly different between the 2 groups (IPOP 29.7% vs. non-IPOP 31.4%; P=0.876). Postoperative wound complication rates were as follows: wound infection (IPOP 18.9% vs. non-IPOP 25.0%; P=0.555), wound dehiscence (IPOP 29.7% vs. non-IPOP 25.0%; P=0.673), and skin breakdown separate from the incision (IPOP 18.9% vs. non-IPOP 3.6%; P=0.062). Patients in the IPOP group trended towards fewer postoperative falls (IPOP 10.8% vs. non-IPOP 21.4%; P=0.240). The need for revision was significantly greater in the non-IPOP group (IPOP 5.4% vs. non-IPOP 27.6%; P=0.013). The time from surgery to placement of the preparatory prosthesis was 51 days in the IPOP group. Patients undergoing IPOP have similar perioperative systemic and wound complication rates compared to those patients undergoing conventional below-knee amputation, but are less likely to require surgical revision. The use of IPOP allows for early ambulation and rehabilitation, which may be of psychological benefit and may decrease the sequelae of prolonged immobilization. IPOP application should be considered for all appropriate candidates requiring below-knee amputation. Copyright © 2013 Elsevier Inc. All rights reserved.
NASA Astrophysics Data System (ADS)
Handford, Matthew L.; Srinivasan, Manoj
2016-02-01
Robotic lower limb prostheses can improve the quality of life for amputees. Development of such devices, currently dominated by long prototyping periods, could be sped up by predictive simulations. In contrast to some amputee simulations which track experimentally determined non-amputee walking kinematics, here, we explicitly model the human-prosthesis interaction to produce a prediction of the user’s walking kinematics. We obtain simulations of an amputee using an ankle-foot prosthesis by simultaneously optimizing human movements and prosthesis actuation, minimizing a weighted sum of human metabolic and prosthesis costs. The resulting Pareto optimal solutions predict that increasing prosthesis energy cost, decreasing prosthesis mass, and allowing asymmetric gaits all decrease human metabolic rate for a given speed and alter human kinematics. The metabolic rates increase monotonically with speed. Remarkably, by performing an analogous optimization for a non-amputee human, we predict that an amputee walking with an appropriately optimized robotic prosthesis can have a lower metabolic cost - even lower than assuming that the non-amputee’s ankle torques are cost-free.
Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human
2014-10-01
Intracortical Visual Prosthesis in a Human PRINCIPAL INVESTIGATOR: Philip R Troyk, PhD... Prosthesis in a Human 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-12-1-0394 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Philip R Troyk...visual prosthesis (ICVP) for testing in a human. No human trial testing of the prosthesis will occur under the funded work. Preparatory tasks include
Titanium clip ball joint: a partial ossicular reconstruction prosthesis.
Beutner, Dirk; Luers, Jan Christoffer; Bornitz, Matthias; Zahnert, Thomas; Huttenbrink, Karl-Bernd
2011-06-01
To describe a new titanium clip prosthesis for partial ossicular reconstruction with a micro ball joint in the headplate for compensation of tympanic membrane displacements. Laboratory experiments followed by 18 consecutive patients. A micro ball joint was implemented into a headplate of titanium middle ear prosthesis. First, the new prosthesis was tested in the laboratory in temporal bone experiments. Second, the new prosthesis was clinically installed in 18 patients. Results of laser Doppler vibrometry and force measurements in the laboratory experiments, analysis of a questionnaire, and preoperative and postoperative pure tone audiometry. The frictional resistance in the joint was measured to be 12 mN that should allow for adequate mobility under physiologic conditions. The effective sound transmission of the prosthesis was demonstrated by laser Doppler vibrometry. Intraoperatively, the installation of the prosthesis was always straightforward with headplate prosthesis shaft angles between 60 and 90 degrees. Postoperatively, pure tone audiometry revealed satisfying hearing results with a remaining average air-bone gap of 18.2 dB over the frequencies 500, 1,000, 2,000, and 3,000 Hz. No signs of prosthesis dislocation were discovered within the follow-up period of approximately 6 months. The experimental data show that the new modified prosthesis headplate fulfills the requirements necessary for sound transmission. The joint allows the plate to follow movements of the tympanic membrane. This characteristic in conjunction with the proven clip design ensure for optimal prosthesis placement and effectiveness.
Propionibacterium acnes infection after shoulder surgery
Kadler, Benjamin K.; Mehta, Saurabh S.; Funk, Lennard
2015-01-01
Propionibacterium acnes has been implicated as a cause of infection following shoulder surgery, may occur up to 2 years after the index operation and has been shown to be responsible for up to 56% of shoulder infections after orthopedic implant. Male patients within the population undergoing shoulder surgery are particularly at risk, especially if their shoulder surgery involved prosthesis or was posttraumatic. P. acnes infection can be difficult to diagnose clinically and laboratory techniques require prolonged and specialized cultures. Usual inflammatory markers are not raised in infection with this low virulence organism. Delayed diagnosis with P. acnes infection can result in significant morbidity prior to prosthesis failure. Early diagnosis of P. acnes infection and appropriate treatment can improve clinical outcomes. It is important to be aware of P. acnes infection in shoulder surgery, to evaluate risk factors, to recognize the signs of P. acnes infection, and to promptly initiate treatment. The signs and symptoms of P. acnes infection are described and discussed. Data were collected from PubMed™, Web of Science, and the NICE Evidence Healthcare Databases - AMED (Ovid), BNI (Ovid), CINAHL (EBSCO), Embase (Ovid), HMIC: DH-Data and Kings Fund (Ovid), Medline (Ovid), and PsycINFO (Ovid). The search terms used were “P. acnes,” “infection,” “shoulder,” and “surgery.” In this review, we summarize the current understanding of the prevention and management of P. acnes infection following shoulder surgery. PMID:26622132
MEMS-based system and image processing strategy for epiretinal prosthesis.
Xia, Peng; Hu, Jie; Qi, Jin; Gu, Chaochen; Peng, Yinghong
2015-01-01
Retinal prostheses have the potential to restore some level of visual function to the patients suffering from retinal degeneration. In this paper, an epiretinal approach with active stimulation devices is presented. The MEMS-based processing system consists of an external micro-camera, an information processor, an implanted electrical stimulator and a microelectrode array. The image processing strategy combining image clustering and enhancement techniques was proposed and evaluated by psychophysical experiments. The results indicated that the image processing strategy improved the visual performance compared with direct merging pixels to low resolution. The image processing methods assist epiretinal prosthesis for vision restoration.
[Imaging of alloplastic ligament implant. An in vivo and in vitro study exemplified by Kevlar].
Wening, J V; Katzer, A; Nicolas, V; Hahn, M; Jungbluth, K H; Kratzer A [corrected to Katzer, A
1994-04-01
Neither native X-ray nor CT or NMR allow to evaluate intraarticular implantation results of Kevlar -49 directly. In animal trials, the course of an artificial ligament may only be presumed from connective tissue ingrowth. Although soft tissue structure appears much better in NMR than in CT, direct proof of ligament continuity is still impossible. As soon as the connective tissue becomes continuous, it appears clearly and allows indirect evaluation of the prosthesis, as integrity can be judged by its shape like in natural cruciate ligament. Anatomic preparations show that connective tissue fills up the small space between the two cords of a Kevlar -49 two bundle prosthesis eight weeks after implantation, so that imaging systems show only one intraarticular bundle.
Permanent Quadriplegia Following Replacement of Voice Prosthesis.
Ozturk, Kayhan; Erdur, Omer; Kibar, Ertugrul
2016-11-01
The authors presented a patient with quadriplegia caused by cervical spine abscess following voice prosthesis replacement. The authors present the first reported permanent quadriplegia patient caused by voice prosthesis replacement. The authors wanted to emphasize that life-threatening complications may be faced during the replacement of voice prosthesis. Care should be taken during the replacement of voice prosthesis and if some problems have been faced during the procedure patients must be followed closely.
Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human
2013-10-01
Intracortical Visual Prosthesis in a Human PRINCIPAL INVESTIGATOR: Philip R Troyk, PhD... Prosthesis in a Human 5a. CONTRACT NUMBER 5b. GRANT NUMBER W81XWH-12-1-0394 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Philip R Troyk, PhD...to prepare an intracortical visual prosthesis (ICVP) for testing in a human. No human trial testing of the prosthesis will occur under the funded
Jemt, T; Henry, P; Lindén, B; Naert, I; Weber, H; Bergström, C
2000-01-01
The purpose of this prospective multicenter study was to evaluate and compare the clinical performance of laser-welded titanium fixed partial implant-supported prostheses with conventional cast frameworks. Forty-two partially edentulous patients were provided with Brånemark system implants and arranged into 2 groups. Group A was provided with a conventional cast framework with porcelain veneers in one side of the jaw and a laser-welded titanium framework with low-fusing porcelain on the other side. The patients in group B had an old implant prosthesis replaced by a titanium framework prosthesis. The patients were followed for 3 years after prosthesis placement. Clinical and radiographic data were collected and analyzed. Only one implant was lost, and all prostheses were still in function after 3 years. The 2 framework designs showed similar clinical performance with few clinical complications. Only one abutment screw (1%) and 9 porcelain tooth units (5%) fractured. Four prostheses experienced loose gold screws (6%). In group A, marginal bone loss was similar for both designs of prostheses, with a mean of 1.0 mm and 0.3 mm in the maxilla and mandible, respectively. No bone loss was observed on average in group B. No significant relationship (P > 0.05) was observed between marginal bone loss and placement of prosthesis margin or prosthesis design. The use of laser-welded titanium frameworks seems to present similar clinical performance to conventional cast frameworks in partial implant situations after 3 years.
Sarı, Cenk; Baştuğ, Serdal; Kasapkara, Hacı Ahmet; Durmaz, Tahir; Keleş, Telat; Akçay, Murat; Aslan, Abdullah Nabi; Bayram, Nihal Akar; Bozkurt, Engin
2015-01-01
Introduction Transcatheter aortic valve implantation for severe symptomatic aortic stenosis in patients with a previous mitral valve prosthesis is technically challenging, and pre-procedural comprehensive assessment of these patients before transcatheter aortic valve implantation is vital for an uncomplicated and successful procedure. Aim We want to share our experience with transcatheter aortic valve implantation in patients with a preexisting functional mitral valve prosthesis and describe a series of important technical and pre-procedural details. Material and methods At our center, 135 patients with symptomatic severe aortic stenosis were treated with transcatheter aortic valve implantation. Six of them with a preexisting mitral valve prosthesis received an Edwards SAPIEN XT valve through the transfemoral route. Results Transcatheter aortic valve implantation was performed successfully in all 6 patients without any deformation of the cobalt-chromium/steel stents of the aortic valve bioprosthesis. Also no distortion or malfunction in the mitral valve prosthesis was observed after the procedure. There were no complications during the hospitalization period. Post-procedural echocardiography revealed no or mild aortic paravalvular regurgitation and normal valve function in all the patients. In addition, serial echocardiographic examination demonstrated that both the stability and function of the aortic and mitral prosthetic valves were normal without any deterioration in the gradients and the degree of the regurgitation at long-term follow-ups. Conclusions Our experience confirms that transcatheter aortic valve implantation is technically feasible in patients with previous mitral valve replacement but comprehensive evaluation of patients by multimodal imaging techniques such as transesophageal echocardiography and multislice computed tomography is mandatory for a successful and safe procedure. PMID:26677380
Agonist-antagonist active knee prosthesis: a preliminary study in level-ground walking.
Martinez-Villalpando, Ernesto C; Herr, Hugh
2009-01-01
We present a powered knee prosthesis with two series-elastic actuators positioned in parallel in an agonist-antagonist arrangement. To motivate the knee's design, we developed a prosthetic knee model that comprises a variable damper and two series-elastic clutch units that span the knee joint. Using human gait data to constrain the model's joint to move biologically, we varied model parameters using an optimization scheme that minimized the sum over time of the squared difference between the model's joint torque and biological knee values. We then used these optimized values to specify the mechanical and control design of the prosthesis for level-ground walking. We hypothesized that a variable-impedance control design could produce humanlike knee mechanics during steady-state level-ground walking. As a preliminary evaluation of this hypothesis, we compared the prosthetic knee mechanics of an amputee walking at a self-selected gait speed with those of a weight- and height-matched nonamputee. We found qualitative agreement between prosthetic and human knee mechanics. Because the knee's motors never perform positive work on the knee joint throughout the level-ground gait cycle, the knee's electrical power requirement is modest in walking (8 W), decreasing the size of the onboard battery required to power the prosthesis.
Leunisse, C; van Weissenbruch, R; Busscher, H J; van der Mei, H C; Dijk, F; Albers, F W
2001-01-01
After total laryngectomy, voice can be restored with a silicone rubber tracheoesophageal voice prosthesis. However, biofilm formation and subsequent deterioration of the silicone material of the prosthesis will limit device life by impairing valve function. To simulate the natural process of biofilm development under dynamic nutrient conditions, a modified Robbins device was used to evaluate the biofilm-related valve dysfunction of the Groningen, Provox2, Blom-Singer indwelling, and VoiceMaster voice prostheses. Obstruction of the semicircular slit-valved Groningen prosthesis leading to increased airway resistance was caused not only by a buildup of deposits on the esophageal flange and valve hat, but also by accumulation of deposits on the semicircular valve seating. The hinged flap valved Provox2 and indwelling Blom-Singer prostheses failed to close sufficiently because of biofilm formation on the valve seating. The esophageal flange of the VoiceMaster prosthesis was affected, but the tripod structure of the ball valve was fully colonized up to the titanium sleeve, which interfered with proper valve opening and closure. These findings on biofilm formation could be used for the further development and modification of critical design features of voice prostheses to facilitate tracheoesophageal speech. Copyright 2001 John Wiley & Sons, Inc.
Ribeiro, Giselle R; Campos, Camila H; Rodrigues Garcia, Renata Cunha Matheus
2017-11-01
Parkinson disease (PD) symptoms, such as muscle rigidity, tremors in the lips and tongue, and involuntary mandibular movements, may cause oral health-related problems, mastication difficulties, and denture discomfort because of the difficulty in controlling a prosthesis with the oral musculature. The purpose of this observational clinical study was to evaluate the influence of oral rehabilitation with a removable prosthesis on oral health-related quality of life (OHRQoL) and masticatory efficiency (ME) in elders with PD. Thirty-four elders with PD (n=17, mean age 69.4 ±4.7 years) or without PD (n=17, mean age 70.7 ±4.7 years) were recruited. All participants first underwent OHRQoL and ME evaluations. Two months after the insertion of new removable prostheses, the participants were reassessed. The OHRQoL was measured with the Oral Health Impact Profile (OHIP-49). ME was evaluated by determining the percentage weight of the comminuted silicone-based artificial material that passed through a 2.8 mm sieve. For each group, data were compared between baseline and after insertion of new removable prostheses by paired t test or Wilcoxon sign test/signed-rank test. Group differences were assessed at each time point by t test (α=.05). After the insertion of removable prostheses, elders with PD showed improved OHRQoL and ME. Controls also showed improvements on both measures after insertion of removable prostheses. At baseline, elders with PD had lower OHRQoL and ME compared with the controls (P<.05). After removable prosthesis insertion, the elders with PD continued to show lower ME values than the controls, but their OHRQoL was similar. Oral rehabilitation with new removable dental prostheses improved the OHRQoL and ME in elders with and without PD, although ME did not reach control levels in elders with PD. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Assunção, Wirley Gonçalves; Gomes, Erica Alves; Rocha, Eduardo Passos; Delben, Juliana Aparecida
2011-01-01
Three-dimensional finite element analysis was used to evaluate the effect of vertical and angular misfit in three-piece implant-supported screw-retained fixed prostheses on the biomechanical response in the peri-implant bone, implants, and prosthetic components. Four three-dimensional models were fabricated to represent a right posterior mandibular section with one implant in the region of the second premolar (2PM) and another in the region of the second molar (2M). The implants were splinted by a three-piece implant-supported metal-ceramic prosthesis and differed according to the type of misfit, as represented by four different models: Control = prosthesis with complete fit to the implants; UAM (unilateral angular misfit) = prosthesis presenting unilateral angular misfit of 100 μm in the mesial region of the 2M; UVM (unilateral vertical misfit) = prosthesis presenting unilateral vertical misfit of 100 μm in the mesial region of the 2M; and TVM (total vertical misfit) = prosthesis presenting total vertical misfit of 100 μm in the platform of the framework in the 2M. A vertical load of 400 N was distributed and applied on 12 centric points by the software Ansys, ie, a vertical load of 150 N was applied to each molar in the prosthesis and a vertical load of 100 N was applied at the 2PM. The stress values and distribution in peri-implant bone tissue were similar for all groups. The models with misfit exhibited different distribution patterns and increased stress magnitude in comparison to the control. The highest stress values in group UAM were observed in the implant body and retention screw. The groups UVM and TVM exhibited high stress values in the platform of the framework and the implant hexagon, respectively. The three types of misfit influenced the magnitude and distribution of stresses. The influence of misfit on peri-implant bone tissue was modest. Each type of misfit increased the stress values in different regions of the system.
Katsoulis, Joannis; Takeichi, Takuro; Sol Gaviria, Ana; Peter, Lukas; Katsoulis, Konstantinos
Compromised fit between the contact surfaces of screw-retained implant-supported fixed dentures (IFDs) is thought to create uncontrolled strains in the prosthetic components and peri-implant tissues, thus evoking biological and technical complications such as bone loss, screw loosening, component fractures and, at worst, loss of implants or prostheses. The aim of this systematic review was to evaluate the impact of marginal misfit on the clinical outcomes of IFDs, and to elucidate definition and assessment methods for passive fit. A systematic review of the literature was conducted with a PICO question: "For partially or complete edentulous subjects with screw-retained IFDs, does the marginal misfit at the implant-prosthesis interfaces have an impact on the clinical outcomes?". A literature search was performed electronically in PubMed (MEDLINE) with the help of Boolean operators to combine key words, and by hand search in relevant journals. English written in vivo studies published before August 31, 2016 that reported on both clinical outcome and related implant prosthesis misfit (gap, strains, torque) were selected using predetermined inclusion criteria. The initial search yielded 2626 records. After screening and a subsequent filtering process, five human and five animal studies were included in the descriptive analysis. The selected studies used different methods to assess misfit (linear distortion, vertical gap, strains, screw torque). While two human studies evaluated the biological response and technical complications prospectively over 6 and 12 months, the animal studies had an observation period < 12 weeks. Four human studies analysed retrospectively the 3 to 32 years' outcomes. Screw-related complications were observed, but biological sequelae could not be confirmed. Although the animal studies had different designs, bone adaptation and implant displacement was found in histological analyses. Due to the small number of studies and the heterogenic designs and misfit assessment methods, no meta-analysis of the data could be performed. The current literature provides insufficient evidence as to the effect of misfit at the prosthesis-implant interface on clinical outcomes of screw-retained implant-supported fixed dentures. Marginal gaps and static strains due to screw tightening were not found to have negative effects on initial osseointegration or peri-implant bone stability over time. Based on two clinical studies, the risk for technical screw-related complications was slightly higher. While the degree of tolerable misfit remains a matter of debate, the present data do not imply that clinicians neglect good fit, but aim to achieve the least misfit possible. Conflict of interest statement: The authors declare no conflict of interest. The review was conducted as part of the 2016 Foundation of Oral Rehabilitation Consensus Conference on "Prosthetic Protocols in Implant-based Oral Rehabilitation".
Intermittent, noncyclic dysfunction of a mechanical aortic prosthesis by pannus formation.
Giroux, Sylvie K; Labinaz, Marino X; Grisoli, Dominique; Klug, Andrew P; Veinot, John P; Burwash, Ian G
2010-01-01
Mechanical aortic prosthesis dysfunction can result from thrombosis or pannus formation. Pannus formation usually restricts systolic excursion of the occluding disk, resulting in progressive stenosis of the aortic prosthesis. Intermittent dysfunction of a mechanical aortic prosthesis is usually ascribed to thrombus formation. We describe an unusual case of intermittent, noncyclic dysfunction of a mechanical aortic prosthesis due to pannus formation in the absence of systolic restriction of disk excursion that presented with intermittent massive aortic regurgitation, severe ischemia, and shock. Pannus formation should be considered as a potential cause of acute intermittent severe aortic regurgitation in a patient with a mechanical aortic prosthesis.
Management of long span partially edentulous maxilla with fixed removable denture prosthesis
Jeyavalan, Mahilan I.; Narasimman, M.; Venkatakrishnan, C. J.; Philip, Jacob M.
2012-01-01
Restoration of a long span partially edentulous maxilla with tooth supported prosthesis is challenging because of inherent anatomic limitations and unfavourable biomechanics present after the loss of teeth. A tooth supported fixed-removable prosthesis is a treatment option for restoration of such long span partially edentulous maxillary arches. This prosthesis meets the requirements for esthetics, phonetics, comfort, and hygiene, as well as favourable biomechanical stress distribution to the remaining natural tooth abutments. This article presents a procedure for fabrication of a fixed-removable prosthesis that has cement-retained custom cast bar metal substructure and a ball attachment retained removable superstructure prosthesis. PMID:23293488
Management of long span partially edentulous maxilla with fixed removable denture prosthesis.
Jeyavalan, Mahilan I; Narasimman, M; Venkatakrishnan, C J; Philip, Jacob M
2012-07-01
Restoration of a long span partially edentulous maxilla with tooth supported prosthesis is challenging because of inherent anatomic limitations and unfavourable biomechanics present after the loss of teeth. A tooth supported fixed-removable prosthesis is a treatment option for restoration of such long span partially edentulous maxillary arches. This prosthesis meets the requirements for esthetics, phonetics, comfort, and hygiene, as well as favourable biomechanical stress distribution to the remaining natural tooth abutments. This article presents a procedure for fabrication of a fixed-removable prosthesis that has cement-retained custom cast bar metal substructure and a ball attachment retained removable superstructure prosthesis.
BIORESORBABLE POLYMERIC MENISCAL PROSTHESIS: STUDY IN RABBITS
Cardoso, Tulio Pereira; de Rezende Duek, Eliana Aparecida; Amatuzzi, Marco Martins; Caetano, Edie Benedito
2015-01-01
Objective: To induce growth of a neomeniscus into the pores of a prosthesis in order to protect the knee joint cartilage. Methods: 70 knees of 35 New Zealand rabbits were operated. The rabbits were five to seven months old, weighed 2 to 3.8 kilograms, and 22 were male and 13 were female. Each animal underwent medial meniscectomy in both knees during a single operation. A bioabsorbable polymeric meniscal prosthesis composed of 70% polydioxanone and 30% L-lactic acid polymer was implanted in one side. The animals were sacrificed after different postoperative time intervals. The femoral condyles and neomeniscus were subjected to histological analysis. Histograms were used to measure the degradation and absorption of the prosthesis, the growth of meniscal tissue in the prosthesis and the degree of degradation of the femoral condyle joint cartilage. Results: The data obtained showed that tissue growth histologically resembling a normal meniscus occurred, with gradual absorption of the prosthesis, and the percentages of chondrocytes on the control side and prosthesis side. Conclusion: Tissue growth into the prosthesis pores that histologically resembled the normal rabbit meniscus was observed. The joint cartilage of the femoral condyles on the prosthesis side presented greater numbers of chondrocytes in all its layers. PMID:27022549
Trouilloud, P; Gonzalvez, M; Martz, P; Charles, H; Handelberg, F; Nyffeler, R W; Baulot, E
2014-05-01
We describe our experience with a new system of patient-specific template called Personal Fit(®), which is unique in shoulder surgery and used in combination with Duocentric(®) prosthesis. The reverse prosthesis's concept is the invention of Paul Grammont, developed with Grammont's team of Dijon University as from 1981, which led to the first reversed total shoulder prosthesis called Trumpet in 1985. The Duocentric(®) prosthesis developed in 2001 is the third-generation prosthesis, coming from the Trumpet and the second-generation prosthesis Delta(®) (DePuy). This prosthesis provides a novel solution to the notching problem with an inferior overhang integrated onto the glenoid baseplate. Personal Fit(®) system is based on reconstructing the shoulder joint bones in three dimensions using CT scan data, placing a landmark on the scapula and locating points on the glenoid and humerus. That will be used as a reference for the patient-specific templates. We study the glenoid position planned with Personal Fit(®) software relative to native glenoid position in 30 cases. On average, the difference between the planned retroversion (or anteversion in one case) and native retroversion was 8.6°.
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 888.3230 - Finger joint polymer constrained prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...
21 CFR 872.3940 - Total temporomandibular joint prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...
21 CFR 872.3940 - Total temporomandibular joint prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...
Alam, Md Shahid; Sugavaneswaran, M; Arumaikkannu, G; Mukherjee, Bipasha
2017-08-01
Ocular prosthesis is either a readymade stock shell or custom made prosthesis (CMP). Presently, there is no other technology available, which is either superior or even comparable to the conventional CMP. The present study was designed to fabricate ocular prosthesis using computer aided design (CAD) and rapid manufacturing (RM) technology and to compare it with custom made prosthesis (CMP). The ocular prosthesis prepared by CAD was compared with conventional CMP in terms of time taken for fabrication, weight, cosmesis, comfort, and motility. Two eyes of two patients were included. Computerized tomography scan of wax model of socket was converted into three dimensional format using Materialize Interactive Medical Image Control System (MIMICS)software and further refined. This was given as an input to rapid manufacturing machine (Polyjet 3-D printer). The final painting on prototype was done by an ocularist. The average effective time required for fabrication of CAD prosthesis was 2.5 hours; and weight 2.9 grams. The same for CMP were 10 hours; and 4.4 grams. CAD prosthesis was more comfortable for both the patients. The study demonstrates the first ever attempt of fabricating a complete ocular prosthesis using CAD and rapid manufacturing and comparing it with conventional CMP. This prosthesis takes lesser time for fabrication, and is more comfortable. Studies with larger sample size will be required to further validate this technique.
Artificial limb representation in amputees
van den Heiligenberg, Fiona M Z; Orlov, Tanya; Macdonald, Scott N; Duff, Eugene P; Henderson Slater, David; Beckmann, Christian F; Johansen-Berg, Heidi; Culham, Jody C; Makin, Tamar R
2018-01-01
Abstract The human brain contains multiple hand-selective areas, in both the sensorimotor and visual systems. Could our brain repurpose neural resources, originally developed for supporting hand function, to represent and control artificial limbs? We studied individuals with congenital or acquired hand-loss (hereafter one-handers) using functional MRI. We show that the more one-handers use an artificial limb (prosthesis) in their everyday life, the stronger visual hand-selective areas in the lateral occipitotemporal cortex respond to prosthesis images. This was found even when one-handers were presented with images of active prostheses that share the functionality of the hand but not necessarily its visual features (e.g. a ‘hook’ prosthesis). Further, we show that daily prosthesis usage determines large-scale inter-network communication across hand-selective areas. This was demonstrated by increased resting state functional connectivity between visual and sensorimotor hand-selective areas, proportional to the intensiveness of everyday prosthesis usage. Further analysis revealed a 3-fold coupling between prosthesis activity, visuomotor connectivity and usage, suggesting a possible role for the motor system in shaping use-dependent representation in visual hand-selective areas, and/or vice versa. Moreover, able-bodied control participants who routinely observe prosthesis usage (albeit less intensively than the prosthesis users) showed significantly weaker associations between degree of prosthesis observation and visual cortex activity or connectivity. Together, our findings suggest that altered daily motor behaviour facilitates prosthesis-related visual processing and shapes communication across hand-selective areas. This neurophysiological substrate for prosthesis embodiment may inspire rehabilitation approaches to improve usage of existing substitutionary devices and aid implementation of future assistive and augmentative technologies. PMID:29534154
Artificial limb representation in amputees.
van den Heiligenberg, Fiona M Z; Orlov, Tanya; Macdonald, Scott N; Duff, Eugene P; Henderson Slater, David; Beckmann, Christian F; Johansen-Berg, Heidi; Culham, Jody C; Makin, Tamar R
2018-05-01
The human brain contains multiple hand-selective areas, in both the sensorimotor and visual systems. Could our brain repurpose neural resources, originally developed for supporting hand function, to represent and control artificial limbs? We studied individuals with congenital or acquired hand-loss (hereafter one-handers) using functional MRI. We show that the more one-handers use an artificial limb (prosthesis) in their everyday life, the stronger visual hand-selective areas in the lateral occipitotemporal cortex respond to prosthesis images. This was found even when one-handers were presented with images of active prostheses that share the functionality of the hand but not necessarily its visual features (e.g. a 'hook' prosthesis). Further, we show that daily prosthesis usage determines large-scale inter-network communication across hand-selective areas. This was demonstrated by increased resting state functional connectivity between visual and sensorimotor hand-selective areas, proportional to the intensiveness of everyday prosthesis usage. Further analysis revealed a 3-fold coupling between prosthesis activity, visuomotor connectivity and usage, suggesting a possible role for the motor system in shaping use-dependent representation in visual hand-selective areas, and/or vice versa. Moreover, able-bodied control participants who routinely observe prosthesis usage (albeit less intensively than the prosthesis users) showed significantly weaker associations between degree of prosthesis observation and visual cortex activity or connectivity. Together, our findings suggest that altered daily motor behaviour facilitates prosthesis-related visual processing and shapes communication across hand-selective areas. This neurophysiological substrate for prosthesis embodiment may inspire rehabilitation approaches to improve usage of existing substitutionary devices and aid implementation of future assistive and augmentative technologies.
21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...
21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...
21 CFR 888.3720 - Toe joint polymer constrained prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...
21 CFR 872.3960 - Mandibular condyle prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...
21 CFR 888.3025 - Passive tendon prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...
21 CFR 888.3025 - Passive tendon prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...
2012-01-01
Background Patellofemoral joint replacement is a successful treatment option for isolated patellofemoral osteoarthritis. However, results of later conversion to total knee replacement may be compromised by periprosthetic bone loss. Previous clinical studies have demonstrated a decrease in distal femoral bone mineral density after patellofemoral joint replacement. It is unclear whether this is due to periprosthetic stress shielding. The main objective of the current study was to evaluate the stress shielding effect of prosthetic replacement with 2 different patellofemoral prosthetic designs and with a total knee prosthesis. Methods We developed a finite element model of an intact patellofemoral joint, and finite element models of patellofemoral joint replacement with a Journey PFJ prosthesis, a Richards II prosthesis, and a Genesis II total knee prosthesis. For each of these 4 finite element models, the average Von Mises stress in 2 clinically relevant regions of interest were evaluated during a simulated squatting movement until 120 degrees of flexion. Results During deep knee flexion, in the anterior region of interest, the average Von Mises stress with the Journey PFJ design was comparable to the physiological knee, while reduced by almost 25% for both the Richards II design and the Genesis II total knee joint replacement design. The average Von Mises stress in the supracondylar region of interest was similar for both patellofemoral prosthetic designs and the physiological model, with slightly lower stress for the Genesis II design. Conclusions Patellofemoral joint replacement results in periprosthetic stress-shielding, although to a smaller degree than in total knee replacement. Specific patellofemoral prosthetic design properties may result in differences in femoral stress shielding. PMID:22704638
Peñarrocha, Miguel; Carrillo, Celia; Boronat, Araceli; Peñarrocha, Maria
2009-01-01
The aim of this study was to evaluate the success rate of implants placed in the pterygomaxillary region using drills and osteotomes with a minimum of 12 months' follow-up. Bone loss after 1 year of loading and patient satisfaction with the prosthesis were evaluated. A retrospective case study was made. The sample was composed of patients rehabilitated with pterygoid implants between January 2000 and January 2006. The inclusion criteria were patients in good general health with severe atrophy of the posterior maxilla who had been rehabilitated with one or two pterygoid implants inserted using drills and osteotomes and had been followed for 12 months after implant loading. Implant success was defined according to the criteria of Albrektsson et al. Bone loss was measured on panoramic radiographs on the mesial and distal of each implant, and the largest value (whether mesial or distal) was selected as the bone loss for the implant in question. Subjects indicated satisfaction with the new prosthesis on a visual analogue scale. Forty-five patients were treated with 268 implants (200 anterior and 68 pterygoid). The success rate of pterygoid implants was 97.05%. The mean bone loss around implants in the pterygomaxillary region after 1 year of loading was 0.71 mm (range, 0 to 3.20). All prostheses were stable at the end of the observation period. Patients were satisfied with comfort and stability, ability to speak, ease of cleaning, and esthetics and functionality of the prosthesis. Placement of implants in the posterior pterygomaxillary region using drills and osteotomes is a viable alternative treatment modality for rehabilitation of atrophic posterior maxilla. Patients were satisfied with a prosthesis supported by pterygoid implants.
Scherer, Michael D; McGlumphy, Edwin A; Seghi, Robert R; Campagni, Wayne V
2013-01-01
The purpose of this investigation was to evaluate the effects of number and distribution of implants upon in vitro dislodging forces to a simulated implant-supported overdenture and to examine differences between several different attachment systems. An experiment was undertaken utilizing a model simulating a mandibular edentulous ridge with dental implants in positions on the model approximating tooth positions in the natural dentition. A cobalt-chromium-cast testing framework was used to measure the peak load required to disconnect an attachment. Four different types of commercially available attachments were used in various positions on the model in sequence to evaluate the effects of retention and stability of overdentures based on implant number and distribution: (1) ERA, (2) O-Ring, (3) Locator, and (4) Ball. For each group, 10 measurements were made of peak dislodging forces. Means were calculated and differences among the systems, directions, and groups were identified using a repeated measured analysis of variance (α = .05). The interactions between the attachment system, direction of force, and implant number and distribution were statistically significant. Vertical dislodging forces of the simulated overdenture prosthesis increased with additional widely spaced implants. Oblique dislodging forces of the simulated prosthesis increased with additional widely spaced implants except in the two-implant model with all attachments, and in the four-implant groups with Locator attachments. Anteroposterior dislodging forces of a simulated overdenture prosthesis increased with additional widely spaced implants except in the four-implant groups with Ball and Locator attachments. Ball attachments reported the highest levels of retention and stability followed by Locator, O-Ring, and ERA. Within the limitations of this study, retention and stability of an implant overdenture prosthesis are significantly affected by implant number, implant distribution, and abutment type.
Transcatheter aortic valve implantation transapical: step by step.
Walther, Thomas; Möllmann, Helge; van Linden, Arnaud; Kempfert, Jörg
2011-01-01
Transcatheter aortic valve implantation (T-AVI) has been introduced into clinical practice to treat high-risk elderly patients with aortic stenosis. T-AVI can be performed by using a retrograde transfemoral (TF), transsubclavian, transaortic, and/or antegrade transapical (TA) approach. For TA-AVI, CE mark approval was granted in 2008 for the Edwards SAPIEN (Edwards Lifesciences, Irvine, CA) prosthesis with the Ascendra delivery system and in 2010 for the second-generation Edwards SAPIEN XT prosthesis and the Ascendra II delivery system, with 23-mm and 26-mm valves. In 2011, CE mark approval has been granted for TA-AVI by using the SAPIEN XT 29-mm prosthesis. Several other devices from different companies (Jenavalve, Jena Valve Inc, Munich, Germany; Embracer, Medtronic Inc, Guilford, CT; Accurate, Symetis Inc, Geneva, Switzerland) have passed "first in man trials" successfully and are being evaluated within multicenter pivotal studies. In this article we will focus on specific aspects of the TA technique for AVI. Copyright © 2011 Elsevier Inc. All rights reserved.
Nie, Kaibao; Ling, Leo; Bierer, Steven M; Kaneko, Chris R S; Fuchs, Albert F; Oxford, Trey; Rubinstein, Jay T; Phillips, James O
2013-06-01
A vestibular neural prosthesis was designed on the basis of a cochlear implant for treatment of Meniere's disease and other vestibular disorders. Computer control software was developed to generate patterned pulse stimuli for exploring optimal parameters to activate the vestibular nerve. Two rhesus monkeys were implanted with the prototype vestibular prosthesis and they were behaviorally evaluated post implantation surgery. Horizontal and vertical eye movement responses to patterned electrical pulse stimulations were collected on both monkeys. Pulse amplitude modulated (PAM) and pulse rate modulated (PRM) trains were applied to the lateral canal of each implanted animal. Robust slow-phase nystagmus responses following the PAM or PRM modulation pattern were observed in both implanted monkeys in the direction consistent with the activation of the implanted canal. Both PAM and PRM pulse trains can elicit a significant amount of in-phase modulated eye velocity changes and they could potentially be used for efficiently coding head rotational signals in future vestibular neural prostheses.
Reverse Shoulder Arthroplasty Prosthesis Design Classification System.
Routman, Howard D; Flurin, Pierre-Henri; Wright, Thomas W; Zuckerman, Joseph D; Hamilton, Matthew A; Roche, Christopher P
2015-12-01
Multiple different reverse total shoulder arthroplasty (rTSA) prosthesis designs are available in the global marketplace for surgeons to perform this growing procedure. Subtle differences in rTSA prosthesis design parameters have been shown to have significant biomechanical impact and clinical consequences. We propose an rTSA prosthesis design classification system to objectively identify and categorize different designs based upon their specific glenoid and humeral prosthetic characteristics for the purpose of standardizing nomenclature that will help the orthopaedic surgeon determine which combination of design configurations best suit a given clinical scenario. The impact of each prosthesis classification type on shoulder muscle length and deltoid wrapping are also described to illustrate how each prosthesis classification type impacts these biomechanical parameters.
Development and clinical application of a new testicular prosthesis
Ning, Ye; Cai, Zhikang; Chen, Huixing; Ping, Ping; Li, Peng; Wang, Zhong; Li, Zheng
2011-01-01
A new type of testicular prosthesis made of silastic with an elliptical shape to mimic a normal testis was developed by our team and submitted for patenting in China. The prosthesis was produced in different sizes to imitate the normal testis of the patient. To investigate the effects and safety of the testicular prosthesis, 20 patients receiving testicular prosthesis implantation were recruited for this study. Follow-up after 6 months revealed no complications in the patients. All the patients answered that they were satisfied with their body image and the position of the implants, 19 patients were satisfied with the size and 16 patients were satisfied with the weight. These results show that the testicular prosthesis used in this study can meet patient's expectations. Patients undergoing orchiectomy should be offered the option to receive a testicular prosthesis implantation. The dimensions and weight of the available prosthetic implants should be further addressed to improve patient satisfaction. PMID:21927041
House, Chad M; Nelson, William B; Kroshus, Timothy J; Dahiya, Ranjan; Pibarot, Philippe
2012-01-01
Prosthesis-patient mismatch (PPM) occurs when an implanted prosthesis is too small relative to the patient's body surface area (BSA). However, mismatch can often be prevented by indexing the expected effective orifice area (EOA) of a prosthesis to the patient's BSA and then selecting the largest implantable prosthesis to avoid mismatch. Previously, prosthesis manufacturers have attempted to simplify this process by providing charts that include the expected EOA for their prosthesis, already indexed into an array of BSA values. One caveat with these charts is that the expected EOA data must truly be reliable, or the charts will misguide the implanting surgeon. Manufacturer-provided charts could be improved by standardizing the EOA data, with one potential source being the hemodynamic data submitted to the United States Food and Drug Administration. This review discusses PPM, manufacturer-provided EOA charts, and the regulation of EOA data.
Primo, Bruno Tochetto; Mezzari, Leonardo Marcos; da Fontoura Frasca, Luís Carlos; Linderman, Raquel; Rivaldo, Elken Gomes
To evaluate and compare the clinical and radiographic outcomes of mandibular rehabilitation with fixed prostheses on three implants with immediate versus delayed loading. The sample comprised 21 patients who underwent treatment with immediate loading and 23 who received delayed loading. All had worn their prostheses for at least 18 months. Radiographic evaluation of bone loss was carried out in Adobe Photoshop CS5 by a single calibrated examiner using digitized panoramic radiographs. Clinical examination of the technical conditions of the prosthetic device assessed the condition of the acrylic resin base, dental occlusion, metal framework, presence of cover screws, screw fixation of the prosthesis and abutments, length of cantilever (effort) and resistance arms, presence of plaque on prosthetic abutments, and hygiene of the prosthesis. One implant failed in each group, resulting in a 95.23% treatment success rate with immediate loading and 95.65% with delayed loading (no statistically significant between-group difference). In the immediate-loading group, the mean bone loss was 1.96 ± 0.73 mm around central implants and 1.64 ± 0.84 mm at distal implants. In the delayed-loading group, the mean bone loss was 1.85 ± 0.67 mm around central implants and 1.70 ± 0.77 mm at distal implants. According to Student t test, there was no significant within-group difference in bone loss and no difference between the immediate-loading and delayed-loading groups. The only prosthesis-related complications that differed significantly between groups were "condition of the acrylic base," "occlusion," and "presence of right cover screw." There was no statistically significant association of lever arm ratio with peri-implant bone loss or bone loss on the mesial surfaces compared to the distal surfaces of the distal implants. The three-implant-supported fixed prosthesis protocol tested in this study proved to be a viable therapeutic strategy for mandibular edentulous patients with maxillary complete dentures, regardless of whether loading was immediate or delayed, with no difference in peri-implant bone loss.
SPEECH EVALUATION WITH AND WITHOUT PALATAL OBTURATOR IN PATIENTS SUBMITTED TO MAXILLECTOMY
de Carvalho-Teles, Viviane; Pegoraro-Krook, Maria Inês; Lauris, José Roberto Pereira
2006-01-01
Most patients who have undergone resection of the maxillae due to benign or malignant tumors in the palatomaxillary region present with speech and swallowing disorders. Coupling of the oral and nasal cavities increases nasal resonance, resulting in hypernasality and unintelligible speech. Prosthodontic rehabilitation of maxillary resections with effective separation of the oral and nasal cavities can improve speech and esthetics, and assist the psychosocial adjustment of the patient as well. The objective of this study was to evaluate the efficacy of the palatal obturator prosthesis on speech intelligibility and resonance of 23 patients with age ranging from 18 to 83 years (Mean = 49.5 years), who had undergone inframedial-structural maxillectomy. The patients were requested to count from 1 to 20, to repeat 21 words and to spontaneously speak for 15 seconds, once with and again without the prosthesis, for tape recording purposes. The resonance and speech intelligibility were judged by 5 speech language pathologists from the tape recordings samples. The results have shown that the majority of patients (82.6%) significantly improved their speech intelligibility, and 16 patients (69.9%) exhibited a significant hypernasality reduction with the obturator in place. The results of this study indicated that maxillary obturator prosthesis was efficient to improve the speech intelligibility and resonance in patients who had undergone maxillectomy. PMID:19089242
Sennes, Luiz Ubirajara
2016-01-01
Maintaining oral function in patients undergoing glossectomy boosts interventions such as prosthetic rehabilitation. However, current literature still fails in the presentation of results of prosthetic rehabilitation in relation to speech or swallowing. The objective of this research is to evaluate the effectiveness of prosthetic rehabilitation on voice, speech, and swallowing in patients undergoing glossectomy by performing a systematic literature review and meta-analysis of individual cases. Studies were identified by relevant electronic database and included all dates available. The criteria used were sample with any n; resection due to malignant tumors, restricted to tongue and/or floor of mouth; type of prosthetic rehabilitation; and description of the oral functions outcomes with prosthesis. For the meta-analysis of individual data, associations between the variables of interest and the type of prosthesis were evaluated. Thirty-three of 471 articles met the selection criteria. Results on speech and/or voice and swallowing were reported in 27 and 28 articles, respectively. There were improvement of speech intelligibility and swallowing in 96 patients and in 73 patients, respectively, with prosthesis. Based on the available evidences, this article showed that prosthetic rehabilitation was able to improve oral functions and can be a strategy used with surgical reconstruction in selected cases. PMID:28042295
Spiers, Adam J; Resnik, Linda; Dollar, Aaron M
2017-07-01
New upper limb prosthetic devices are continuously being developed by a variety of industrial, academic, and hobbyist groups. Yet, little research has evaluated the long term use of currently available prostheses in daily life activities, beyond laboratory or survey studies. We seek to objectively measure how experienced unilateral upper limb prosthesis-users employ their prosthetic devices and unaffected limb for manipulation during everyday activities. In particular, our goal is to create a method for evaluating all types of amputee manipulation, including non-prehensile actions beyond conventional grasp functions, as well as to examine the relative use of both limbs in unilateral and bilateral cases. This study employs a head-mounted video camera to record participant's hands and arms as they complete unstructured domestic tasks within their own homes. A new 'Unilateral Prosthesis-User Manipulation Taxonomy' is presented based observations from 10 hours of recorded videos. The taxonomy addresses manipulation actions of the intact hand, prostheses, bilateral activities, and environmental feature-use (aiïordances). Our preliminary results involved tagging 23 minute segments of the full videos from 3 amputee participants using the taxonomy. This resulted in over 2,300 tag instances. Observations included that non-prehensile interactions outnumbered prehensile interactions in the affected limb for users with more distal amputation that allowed arm mobility.
Fusaro, I; Orsini, S; Stignani, S; Creta, D; Cava, F C; Benedetti, M G
2013-06-01
The purpose of this paper is to provide up-to-date guidelines on rehabilitation after anatomical shoulder prosthesis for concentric shoulder osteoarthritis, as previous guidelines date back to late 1970s and are no longer adequate due to the evolution of prosthesis models and surgical techniques. The physiatric committee of the Italian Society of Shoulder and Elbow Surgery (SICSeG-Società Italiana di Chirurgia della Spalla e del Gomito) performed a search for all the existing literature related to rehabilitation after shoulder replacement. A total of 29 papers concerning shoulder rehabilitation were reviewed. In addition, the main Italian orthopedic surgeons and physiatrists dealing with shoulder surgery and rehabilitation were interviewed to obtain indications when literature was not conclusive. From literature evaluation and expert consultation, we produced guidelines concerning: patient evaluation by means of adequate rating scales, preoperative treatment, early intermediate and advanced postoperative phases, rehabilitation of scapulo-thoracic joint, return to work and sports, length of rehabilitation and follow-up. This proposal for guidelines was presented during the 11th SICSeG Congress on May 2012 and to the main scientific societies concerned in shoulder surgery and rehabilitation. A consensus conference is needed in order to formalize and make them usable from all the professional figures involved in this field.
Prochor, Piotr; Piszczatowski, Szczepan; Sajewicz, Eugeniusz
2016-01-01
The study was aimed at biomechanical evaluation of a novel Limb Prosthesis Osseointegrated Fixation System (LPOFS) designed to combine the advantages of interference-fit and threaded solutions. Three cases, the LPOFS (designed), the OPRA (threaded) and the ITAP (interference-fit) implants were studied. Von-Mises stresses in bone patterns and maximal values generated while axial loading on an implant placed in bone and the force reaction values in contact elements while extracting an implant were analysed. Primary and fully osteointegrated connections were considered. The results obtained for primary connection indicate more effective anchoring of the OPRA, however the LPOFS provides more appropriate stress distribution (lower stress-shielding, no overloading) in bone. In the case of fully osteointegrated connection the LPOFSs kept the most favourable stress distribution in cortical bone which is the most important long-term feature of the implant usage and bone remodelling. Moreover, in fully bound connection its anchoring elements resist extracting attempts more than the ITAP and the OPRA. The results obtained allow us to conclude that in the case of features under study the LPOFS is a more functional solution to direct skeletal attachment of limb prosthesis than the referential implants during short and long-term use.
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...
21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...
21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...
21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...
Prosthesis rejection in acquired major upper-limb amputees: a population-based survey.
Østlie, Kristin; Lesjø, Ingrid Marie; Franklin, Rosemary Joy; Garfelt, Beate; Skjeldal, Ola Hunsbeth; Magnus, Per
2012-07-01
To estimate the rates of primary and secondary prosthesis rejection in acquired major upper-limb amputees (ULAs), to describe the most frequently reported reasons for rejection and to estimate the influence of background factors on the risk of rejection. Cross-sectional study analysing population-based questionnaire data (n = 224). Effects were analysed by logistic regression analyses and Cox regression analyses. Primary prosthesis rejection was found in 4.5% whereas 13.4% had discontinued prosthesis use. The main reasons reported for primary non-wear were a perceived lack of need and discrepancies between perceived need and the prostheses available. The main reasons reported for secondary prosthesis rejection were dissatisfaction with prosthetic comfort, function and control. Primary prosthesis rejection was more likely in ULAs amputated at high age and in ULAs with proximal amputations. Secondary prosthesis rejection was more likely in proximal ULAs and in women. Clinicians should be aware of the increased risk of rejection in proximal ULAs, elderly ULAs and in women. Emphasising individual needs will probably facilitate successful prosthetic fitting. Improved prosthesis quality and individualised prosthetic training may increase long-term prosthesis use. Further studies of the effect of prosthetic training and of the reasons for rejection of different prosthetic types are suggested.
Novel knee joint mechanism of transfemoral prosthesis for stair ascent.
Inoue, Koh; Wada, Takahiro; Harada, Ryuchi; Tachiwana, Shinichi
2013-06-01
The stability of a transfemoral prosthesis when walking on flat ground has been established by recent advances in knee joint mechanisms and their control methods. It is, however, difficult for users of a transfemoral prosthesis to ascend stairs. This difficulty is mainly due to insufficient generation of extension moment around the knee joint of the prosthesis to lift the body to the next step on the staircase and prevent any unexpected flexion of the knee joint in the stance phase. Only a prosthesis with an actuator has facilitated stair ascent using a step-over-step gait (1 foot is placed per step). However, its use has issues associated with the durability, cost, maintenance, and usage environment. Therefore, the purpose of this research is to develop a novel knee joint mechanism for a prosthesis that generates an extension moment around the knee joint in the stance phase during stair ascent, without the use of any actuators. The proposed mechanism is based on the knowledge that the ground reaction force increases during the stance phase when the knee flexion occurs. Stair ascent experiments with the prosthesis showed that the proposed prosthesis can realize stair ascent without any undesirable knee flexion. In addition, the prosthesis is able to generate a positive knee joint moment power in the stance phase even without any power source.
Highsmith, M. Jason; Kahle, Jason T.; Miro, Rebecca M.; Mengelkoch, Larry J.
2016-01-01
Transfemoral amputation (TFA) patients require considerably more energy to walk and run than non-amputees. The purpose of this study was to examine potential bioenergetic differences (oxygen uptake (VO2), heart rate (HR), and ratings of perceived exertion (RPE)) for TFA patients utilizing a conventional running prosthesis with an articulating knee mechanism versus a running prosthesis with a non-articulating knee joint. Four trained TFA runners (n = 4) were accommodated to and tested with both conditions. VO2 and HR were significantly lower (p ≤ 0.05) in five of eight fixed walking and running speeds for the prosthesis with an articulating knee mechanism. TFA demonstrated a trend for lower RPE at six of eight walking speeds using the prosthesis with the articulated knee condition. A trend was observed for self-selected walking speed, self-selected running speed, and maximal speed to be faster for TFA subjects using the prosthesis with the articulated knee condition. Finally, all four TFA participants subjectively preferred running with the prosthesis with the articulated knee condition. These findings suggest that, for trained TFA runners, a running prosthesis with an articulating knee prosthesis reduces ambulatory energy costs and enhances subjective perceptive measures compared to using a non-articulating knee prosthesis. PMID:28066524
Postpneumonectomy syndrome in children: advantages and long-term follow-up of expandable prosthesis.
Podevin, G; Larroquet, M; Camby, C; Audry, G; Plattner, V; Heloury, Y
2001-09-01
Pneumonectomy in children can be complicated by a severe mediastinal shift, which leads to bronchial stretching resulting in severe respiratory failure. This postpneumonectomy syndrome can be corrected by inserting a prosthesis in the empty side of the chest. Forty-two children, from 6 months to 15 years old, underwent a pneumonectomy. Seven of these patients were treated surgically for severe manifestations of postpneumonectomy syndrome. First insertion of an expandable prosthesis was followed up in 5 cases by its replacement with a breast prosthesis in adolescence. The expandable prosthesis was injected periodically with saline solution to maintain the mediastinum in a midline position as the children grew. The mean delay between pneumonectomy and first prosthesis implantation was 5 years (range, 11 months to 8 years). Pulmonary function tests showed a substantial improvement in the obstructive syndrome in all patients except one, in whom the functional improvement was moderate. The mean follow-up after the expandable prosthesis implantation was 6 years (range, 6 months to 10 years) and all patients are doing well. The insertion of an intrathoracic prosthesis can dramatically improve the clinical symptoms and reduce the functional obstructive syndrome. The expandable prosthesis allowed for progressive, well-tolerated recentering of the mediastinum and adjustment for growth. Copyright 2001 by W.B. Saunders Company.
Malrotation of the McGhan Style 510 prosthesis.
Schots, Jeroen M P; Fechner, Maarten R; Hoogbergen, Maarten M; van Tits, Herm W H J
2010-07-01
Anatomically shaped cohesive silicone breast implants are frequently used in aesthetic and reconstructive surgery. After successful results with the Style 410 prosthesis, McGhan (Natrelle, Allergan) introduced the Style 510 prosthesis. After using this novel prosthesis, the authors encountered a high number of prosthesis malrotations on self-reported follow-up. Therefore, a retrospective medical record review was performed to determine the prevalence of malrotation of the Style 510 prosthesis. From January of 2005 to December of 2006, 73 (146 prostheses) aesthetic augmentation mammaplasty procedures were performed using Style 510 prostheses. All prostheses were placed subglandularly through an inframammary incision. The postsurgical protocol for the first 3 weeks involved wearing a nonwired compression bra, abstinence from sports activities, and abstinence from heavy labor. Standard follow-up was at 1 week, 3 months, and if necessary. On self-reported follow-up, 8.2 percent of all prostheses were rotated. These rotations all occurred unilaterally after a mean period of 10 months (range, 3 to 19 months). No relation to an inciting incident or prosthesis volume could be found. The number of rotations of the Style 510 prosthesis seen after primary aesthetic breast augmentation is high. An obvious cause of this major problem has not been found. This led the authors to discontinue using the Style 510 prosthesis for primary aesthetic mammary augmentations in their practice.
Can We Improve the Tolerance of an Ocular Prosthesis by Enhancing Its Surface Finish?
Litwin, Andre S; Worrell, Emma; Roos, Jonathan C P; Edwards, Barry; Malhotra, Raman
Patients who wear an ocular prosthesis frequently suffer with dry eye symptoms and socket discharge, often on a daily basis. The aim of the study was to determine whether a smoother, optical quality polish of the prosthesis' surface could improve symptoms and wear tolerance. The study was designed as single-center, single-masked, prospective randomized controlled trial. Eighty-eight consecutive patients undergoing annual ocular prosthesis maintenance review were approached from the prosthesis clinic. Forty-one out of 49 eligible patients were recruited. Participants were randomized to either a standard or a higher "optical quality" polish of their prosthesis. At entry to the trial, at 1 month, and 12 months they completed a questionnaire covering cleaning, lubricant use, inflammation, discomfort, and discharge. Lower scores indicated better tolerance of the prosthesis. At each visit, the prosthesis was stained and photographed against a standard background to assess deposit build up. Primary outcome measures were 1) a subjective questionnaire score and 2) an objective assessment of surface deposit build-up on prosthetic eyes by standardized photographic grading. Forty-one patients participated in the study. The median age of their prosthesis was 36 months (range 9 months-40 years). There was no statistically significant difference in questionnaire scores or deposit build up between the 2 groups at baseline. By 12-months, the higher optical quality polish showed a statistically significant reduction in symptoms and frequency of discharge (2.19 vs. 3.85; p = 0.05-lower scores better). Scoring of the prosthesis' deposit build-up showed a significant difference at 1 month, but this was not sustained at 12 months. Creating an optical quality finish to an ocular prosthesis reduces deposit build up on artificial eyes. The authors found this modification improved patient tolerance at 12 months.
Chadwell, Alix; Kenney, Laurence; Granat, Malcolm; Thies, Sibylle; Head, John S; Galpin, Adam
2018-02-01
Current outcome measures used in upper limb myoelectric prosthesis studies include clinical tests of function and self-report questionnaires on real-world prosthesis use. Research in other cohorts has questioned both the validity of self-report as an activity assessment tool and the relationship between clinical functionality and real-world upper limb activity. Previously, 1 we reported the first results of monitoring upper limb prosthesis use. However, the data visualisation technique used was limited in scope. Methodology development. To introduce two new methods for the analysis and display of upper limb activity monitoring data and to demonstrate the potential value of the approach with example real-world data. Upper limb activity monitors, worn on each wrist, recorded data on two anatomically intact participants and two prosthesis users over 1 week. Participants also filled in a diary to record upper limb activity. Data visualisation was carried out using histograms, and Archimedean spirals to illustrate temporal patterns of upper limb activity. Anatomically intact participants' activity was largely bilateral in nature, interspersed with frequent bursts of unilateral activity of each arm. At times when the prosthesis was worn prosthesis users showed very little unilateral use of the prosthesis (≈20-40 min/week compared to ≈350 min/week unilateral activity on each arm for anatomically intact participants), with consistent bias towards the intact arm throughout. The Archimedean spiral plots illustrated participant-specific patterns of non-use in prosthesis users. The data visualisation techniques allow detailed and objective assessment of temporal patterns in the upper limb activity of prosthesis users. Clinical relevance Activity monitoring offers an objective method for the assessment of upper limb prosthesis users' (PUs) activity outside of the clinic. By plotting data using Archimedean spirals, it is possible to visualise, in detail, the temporal patterns of upper limb activity. Further work is needed to explore the relationship between traditional functional outcome measures and real-world prosthesis activity.
Gao, Fan; Rodriguez, Johanan; Kapp, Susan
2016-06-01
Harness fitting in the body-powered prosthesis remains more art than science due to a lack of consistent and quantitative evaluation. The aim of this study was to develop a mechanical, human-body-shaped apparatus to simulate body-powered upper limb prosthetic usage and evaluate its capability of quantitative examination of harness configuration. The apparatus was built upon a torso of a wooden mannequin and integrated major mechanical joints to simulate terminal device operation. Sensors were used to register cable tension, cable excursion, and grip force simultaneously. The apparatus allowed the scapula to move up to 127 mm laterally and the load cell can measure the cable tension up to 445 N. Our preliminary evaluation highlighted the needs and importance of investigating harness configurations in a systematic and controllable manner. The apparatus allows objective, systematic, and quantitative evaluation of effects of realistic harness configurations and will provide insightful and working knowledge on harness fitting in upper limb amputees using body-powered prosthesis. © The International Society for Prosthetics and Orthotics 2015.
[Total hip endoprosthesis following resection arthroplasty].
Engelbrecht, E; Siegel, A; Kappus, M
1995-08-01
From 1976 to December 1994, a total of 347 patients underwent implantation of a hip prosthesis at the ENDO-Klinik for treatment of an unsatisfactory condition following resection arthroplasty. From 1976 to 1987, 143 patients were treated and in 1989 the results obtained in these patients were analysed: 99 of them were available for a follow-up examination in 1989, and 64 for a further examination in 1995. In 130 cases infection had been the reason for joint resection. At the time of the prosthesis operation (1-20 years later) intraoperative biopsy revealed that infection was still present in 41 cases (31.5%). Only 15 of these infections had been detected preoperatively by joint aspiration. This shows that the value of resection arthroplasty as a method of treating periprosthetic infection is limited and lends support to the one-stage exchange operation, which is the method we prefer in cases of infected hip prostheses. The operative technique and preparation for implantation of the prosthesis are described, as are septic and aseptic complications and the measures that can be taken to treat them. In spite of the patients' generally poor initial condition and with due consideration for the further revision operations, the medium-term results finally obtained are poor in only 9%.
Binder, M; Eitler, J; Deutschmann, J; Ladstätter, S; Glaser, F; Fiedler, D
2016-03-01
Even though the earliest prosthetic devices date to the Ancient Egyptian Empire and iconographic sources attest their use in the Greco-Roman world, archaeological evidence for this practice prior to 2nd millennium AD is very scant. In 2013, a skeleton dating to the Frankish period (6th century AD) was excavated at the Hemmaberg in southern Austria. The middle adult male was missing his left foot from above the ankle. In its place, an iron-ring and wooden remains were recovered and interpreted as a prosthesis replacing the lost foot. This represents one of the oldest examples of prosthetic limb replacement associated with the skeleton of its wearer in Europe to date. Analysis through macroscopic assessment, radiography and CT-scanning revealed healing of the lesion even though it may have initially been complicated by osteomyelitis. Atrophy of the left lower leg further indicates immobilisation and suggests survival of several years. Osteoarthritis in the knees and shoulder girdle provides tentative indications towards the functionality of the prosthesis, perhaps aided through a crutch. These findings are set against the historic, archaeological, bioarchaeological and social context of the man in order to discuss whether removal of the foot was due to medical, punitive or traumatic causes. Copyright © 2015 Elsevier Inc. All rights reserved.
Determinants of lower extremity amputations: an institutional experience.
Soomro, Nabila; Khan, Mahjabeen; Ahmed, Syed Imran; Minhas, Muhammad Ali
2013-07-01
To determine the determinants of lower extremity amputations in diabetics and non-diabetics in a tertiary care institute. Cross-sectional, analytical study. Outpatients Department of the Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences, Karachi, from January 2007 to December 2010. All patients with amputations reporting at the study centre for prosthesis fitting were included in the study. Patient`s age, level of amputation, stump complications and associated risk factors of amputation were recorded on a structured proforma. Prosthesis and orthotic assessment were carried out. The frequency and determinants were collected to compare diabetic and non-diabetic amputees. The data was analyzed in SPSS windows version 16. A total of 1091 subjects were provided prosthesis, including 847 males (77.6%). Mean age in diabetic and nondiabetics being 49.6 ± 15.2 and 26.6 ± 17.9 years respectively which is significant at (p < 0.001). Socioeconomic status and educational levels were significantly associated with diabetic status (p < 0.001). Amputation was more common in non-diabetic 858 (78.6%) compared to diabetics 233 (21.4%). This study has identified that most common and significant predictors were gender, low social status and educational levels. Other significant predictors of amputation identified were type of lesion, (infections and ischaemia), initial diagnosis acute/chronic arterial insufficiency and diabetic foot.
Nine-year outcome after anatomic stemless shoulder prosthesis: clinical and radiologic results.
Hawi, Nael; Magosch, Petra; Tauber, Mark; Lichtenberg, Sven; Habermeyer, Peter
2017-09-01
Several stemless shoulder implants are available on the market, but only a few studies have presented results with sufficient mid- to long-term follow-up. The present study evaluated clinical and radiologic outcomes 9 years after anatomic stemless shoulder replacement. This is a prospective cohort study evaluating the stemless shoulder prosthesis since 2005. Anatomic stemless shoulder replacement using a single prosthesis was performed in 49 shoulders; 17 underwent total shoulder replacement, and 32 underwent hemiarthroplasty. Forty-three patients were clinically and radiologically monitored after a mean of 9 years (range, 90-127 months; follow-up rate, 88%). The indications for shoulder replacement were primary osteoarthritis in 7 shoulders, post-traumatic in 24, instability in 7, cuff tear arthropathy in 2, postinfectious arthritis in 1, and revision arthroplasty in 2. The Constant-Murley Score improved significantly from 52% to 79% (P < .0001). The active range of motion also increased significantly for flexion from 101° to 118° (P = .022), for abduction from 79° to 105° (P = .02), and for external rotation from 21° to 43° (P < .0001). Radiologic evaluation revealed incomplete radiolucency in 1 patient without clinical significance or further intervention. No revision caused by loosening or countersinking of the humeral implant was observed. The 9-year outcome after stemless shoulder replacement is comparable to that of third- and fourth-generation standard shoulder arthroplasty. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.
Zakkula, Srujana; B, Sreedevi; Anne, Gopinadh; Manne, Prakash; Bindu O, Swetha Hima; Atla, Jyothi; Deepthi, Sneha; Chaitanya A, Krishna
2014-04-01
Prosthodontic treatment involves clinical procedures which influence speech performance directly or indirectly. Prosthetic rehabilitation of missing teeth with partial or complete maxillary removable dentures influences the individual voice characteristics like Phonation, resonance etc. To evaluate the effect of Acrylic palatal plate thickness (1mm-3mm) of maxillary prosthesis on phonation. Twelve subjects were selected randomly between the age group of 20-25 years who have full complement of teeth and have no speech problems. Speech evaluation was done under four experimental conditions i.e. Without any experimental acrylic palatal plate (control), with experimental acrylic palatal plates of thickness 1 mm, 2 mm and 3 mm respectively. The speech material for phonation test consisted of Vowels sounds /a/, /i/, and /o/. Speech analysis to assess phonation was done using digital acoustic analysis (PRAAT software). The obtained results were statistically analyzed by One-way ANOVA and Tukey's multiple post-hoc for comparison of four experimental conditions with respect to different vowel sounds. Mean harmonics to noise ratio (HNR) values obtained for all the Experimental conditions did not show significant difference (p>0.05). In conclusion, an increase in the thickness of the acrylic palatal plate of maxillary prosthesis for about 1 mm - 3mm in complete or partial maxillary removable dentures resulted in no significant effect on phonation of vowel sounds /a/, /i/ and /o/. Increasing the thickness of the palatal plate from 1 mm to 3 mm has not shown any significant effect on the phonation.
Replacement of the valvular prosthesis in a patient with a Bentall procedure.
Panos, A L; Teoh, K T; Wilson, J K; Salerno, T A
1992-09-01
Patients who have had the Bentall-DeBono procedure using a composite conduit with a tissue valvular prosthesis pose a great challenge when problems develop with the tissue prosthesis. We herein report the surgical management of one such case, in which the valvular prosthesis was removed and replaced without replacement of the conduit.
Vacuum form sheet as a guide for fabrication of orbital prosthesis.
Dugad, Jinesh A; Dholam, Kanchan P; Chougule, Arati T
2014-08-01
Rehabilitation with an orbital prosthesis is done when surgical reconstruction is not possible or affordable in patients with orbital exenteration. Fabrication of orbital prosthesis requires precision in placement of the ocular portion of the prosthesis on the facial moulage. This method describes the use of a vacuum formed sheet for making an orbital template that acts as a guide for achieving optimum orientation of the ocular portion of the prosthesis. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Management of an Anophthalmic Patient by the Fabrication of Custom Made Ocular Prosthesis
SINGH, Meenakshi; NAYAK, Meghanand; SOLANKI, Jitender; GUPTA, Sarika; SINGH, Anjali
2015-01-01
The loss or disfigurement of a body parts specially that pertaining to the face has a deep psychological and social impact on the patient. After enucleation, evisceration or exteneration of the eye, the aim of an ocular prosthesis should be to restore the natural appearance, install confidence and a sense social acceptability in the patient. Custom made prosthesis has several advantages over the stock eye prosthesis. This article illustrates rehabilitation of the enucleated right eye of a patient with a custom made ocular prosthesis. PMID:26715901
A New Biologic Prosthesis for Vascular Substitute in Mongrel Dogs
Marquez-Zacarias, Luis A.; Rey, Alejandro R.; Heine, M. Christina; Manrique, Jose J.
1985-01-01
New glutaraldehyde-treated vascular prosthesis tubes of bovine pericardium were placed in the abdominal aortas of 29 mongrel dogs and observed for 30 to 540 days. Clinical evaluation was performed during follow-up, and histologic and arteriographic studies were done at the end of the study. Patency was shown by arteriography in 27 of 29 tubes (93.1%). Neoendothelialization was found in all grafts, and there was a mixed effect, characterized by both rejection and foreign body reaction in the prostheses from 180 days onward. Both the handling and consistency of the grafts were excellent for implantation. Graft procoagulation and animal anticoagulation were not necessary. Images PMID:15227017
Samitier, C Beatriz; Guirao, Lluis; Costea, Maria; Camós, Josep M; Pleguezuelos, Eulogio
2016-02-01
Lower limb amputation leads to impaired balance, ambulation, and transfers. Proper fit of the prosthesis is a determining factor for successful ambulation. Vacuum-assisted socket systems extract air from the socket, which decreases pistoning and probability of soft-tissue injuries and increases proprioception and socket comfort. To investigate the effect of vacuum-assisted socket system on transtibial amputees' performance-based and perceived balance, transfers, and gait. Quasi-experimental before-and-after study. Subjects were initially assessed using their prosthesis with the regular socket and re-evaluated 4 weeks after fitting including the vacuum-assisted socket system. We evaluated the mobility grade using Medicare Functional Classification Level, Berg Balance Scale, Four Square Step Test, Timed Up and Go Test, the 6-Min Walk Test, the Locomotor Capabilities Index, Satisfaction with Prosthesis (SAT-PRO questionnaire), and Houghton Scale. A total of 16 unilateral transtibial dysvascular amputees, mean age 65.12 (standard deviation = 10.15) years. Using the vacuum-assisted socket system, the patients significantly improved in balance, gait, and transfers: scores of the Berg Balance Scale increased from 45.75 (standard deviation = 6.91) to 49.06 (standard deviation = 5.62) (p < 0.01), Four Square Step Test decreased from 18.18 (standard deviation = 3.84) s to 14.97 (3.9) s (p < 0.01), Timed Up and Go Test decreased from 14.3 (standard deviation = 3.29) s to 11.56 (2.46) s (p < 0.01). The distance walked in the 6-Min Walk Test increased from 288.53 (standard deviation = 59.57) m to 321.38 (standard deviation = 72.81) m (p < 0.01). Vacuum-assisted socket systems are useful for improving balance, gait, and transfers in over-50-year-old dysvascular transtibial amputees. This study gives more insight into the use of vacuum-assisted socket systems to improve elderly transtibial dysvascular amputees' functionality and decrease their risk of falls. The use of an additional distal valve in the socket should be considered in patients with a lower activity level. © The International Society for Prosthetics and Orthotics 2014.
Precision assessment of model-based RSA for a total knee prosthesis in a biplanar set-up.
Trozzi, C; Kaptein, B L; Garling, E H; Shelyakova, T; Russo, A; Bragonzoni, L; Martelli, S
2008-10-01
Model-based Roentgen Stereophotogrammetric Analysis (RSA) was recently developed for the measurement of prosthesis micromotion. Its main advantage is that markers do not need to be attached to the implants as traditional marker-based RSA requires. Model-based RSA has only been tested in uniplanar radiographic set-ups. A biplanar set-up would theoretically facilitate the pose estimation algorithm, since radiographic projections would show more different shape features of the implants than in uniplanar images. We tested the precision of model-based RSA and compared it with that of the traditional marker-based method in a biplanar set-up. Micromotions of both tibial and femoral components were measured with both the techniques from double examinations of patients participating in a clinical study. The results showed that in the biplanar set-up model-based RSA presents a homogeneous distribution of precision for all the translation directions, but an inhomogeneous error for rotations, especially internal-external rotation presented higher errors than rotations about the transverse and sagittal axes. Model-based RSA was less precise than the marker-based method, although the differences were not significant for the translations and rotations of the tibial component, with the exception of the internal-external rotations. For both prosthesis components the precisions of model-based RSA were below 0.2 mm for all the translations, and below 0.3 degrees for rotations about transverse and sagittal axes. These values are still acceptable for clinical studies aimed at evaluating total knee prosthesis micromotion. In a biplanar set-up model-based RSA is a valid alternative to traditional marker-based RSA where marking of the prosthesis is an enormous disadvantage.
Hautamäki, Mikko P; Aho, Allan J; Alander, Pasi; Rekola, Jami; Gunn, Jarmo; Strandberg, Niko; Vallittu, Pekka K
2008-08-01
Polymer technology has provided solutions for filling of bone defects in situations where there may be technical or biological complications with autografts, allografts, and metal prostheses. We present an experimental study on segmental bone defect reconstruction using a polymethylmethacrylate-(PMMA-) based bulk polymer implant prosthesis. We concentrated on osteoconductivity and surface characteristics. A critical size segment defect of the rabbit tibia in 19 animals aged 18-24 weeks was reconstructed with a surface porous glass fiber-reinforced (SPF) prosthesis made of polymethylmethacrylate (PMMA). The biomechanical properties of SPF implant material were previously adjusted technically to mimic the properties of normal cortical bone. A plain PMMA implant with no porosity or fiber reinforcement was used as a control. Radiology, histomorphometry, and scanning electron microscopy (SEM) were used for analysis of bone growth into the prosthesis during incorporation. The radiographic and histological incorporation model showed good host bone contact, and strong formation of new bone as double cortex. Histomorphometric evaluation showed that the bone contact index (BCI) at the posterior surface interface was higher with the SPF implant than for the control. The total appositional bone growth over the posterior surface (area %) was also stronger for the SPF implant than for controls. Both bone growth into the porous surface and the BCI results were related to the quality, coverage, and regularity of the microstructure of the porous surface. Porous surface structure enhanced appositional bone growth onto the SPF implant. Under load-bearing conditions the implant appears to function like an osteoconductive prosthesis, which enables direct mobilization and rapid return to full weight bearing.
Sagittal alignment after single cervical disc arthroplasty.
Guérin, Patrick; Obeid, Ibrahim; Gille, Olivier; Bourghli, Anouar; Luc, Stéphane; Pointillart, Vincent; Vital, Jean-Marc
2012-02-01
Prospective study. To analyze the sagittal balance after single-level cervical disc replacement (CDR) and range of motion (ROM). To define clinical and radiologic parameters those have a significant correlation with segmental and overall cervical curvature after CDR. Clinical outcomes and ROM after CDR with Mobi-C (LDR, Troyes, France) prosthesis have been documented in few studies. No earlier report of this prosthesis has studied correlations between static and dynamic parameters or those between static parameters and clinical outcomes. Forty patients were evaluated. Clinical outcome was assessed using the Short Form-36 questionnaire, Neck Disability Index, and a Visual Analog Scale. Spineview software (Surgiview, Paris, France) was used to investigate sagittal balance parameters and ROM. The mean follow-up was 24.3 months (range: 12 to 36 mo). Clinical outcomes were satisfactory. There was a significant improvement of Short Form-36, Neck Disability Index, and Visual Analog Scale scores. Mean ROM was 8.3 degrees preoperatively and 11.0 degrees postoperatively (P=0.013). Mean preoperative C2C7 curvature was 12.8 and 16.0 degrees at last follow-up (P=0.001). Mean preoperative functional spinal unit (FSU) angle was 2.3 and 5.3 degrees postoperatively (P<0.0001). Mean postoperative shell angle was 5.5 degrees. There was a significant correlation between postoperative C2C7 alignment and preoperative C2C7 alignment, change of C2C7 alignment, preoperative and postoperative FSU angle, and prosthesis shell angle. There was also a significant correlation between postoperative FSU angle and preoperative C2C7 alignment, preoperative FSU angle, change of FSU angle, and prosthesis shell angle. Regression analysis showed that prosthesis shell angle and preoperative FSU angle contributed significantly to postoperative FSU angle. Moreover, preoperative C2C7 alignment, preoperative FSU angle, postoperative FSU angle, and prosthesis shell angle contributed significantly to postoperative C2C7 alignment. No significant correlation was observed between ROM and sagittal parameters. Few correlations were found between sagittal alignment and clinical results. CDR with this prosthesis provided favorable clinical outcomes and maintains ROM of the FSU, overall and segmental cervical alignment. Long-term follow-up will be needed to assess the effectiveness and advantages of this procedure.
2010-11-01
mouth are engineered out of the system. Fortunately, the later model of Brainport is wireless, but even so, having a device in the mouth may feel ...E. 2006. Determining the effectiveness of a vibrotactile balance prosthesis . Journal of Vestibular Research. 16: 45-56. 14 Raj, A. K., Suri, N
Ficanha, Evandro M; Rastgaar, Mohammad; Kaufman, Kenton R
2015-01-01
The ankle joint of currently available powered prostheses is capable of controlling one degree of freedom (DOF), focusing on improved mobility in the sagittal plane. To increase agility, the requirements of turning in prosthesis design need to be considered. Ankle kinematics and kinetics were studied during sidestep cutting and straight walking. There were no significant differences between the ankle sagittal plane mechanics when comparing sidestep cutting and straight walking; however, significant differences were observed in ankle frontal plane mechanics. During straight walking, the inversion-eversion (IE) angles were smaller than with sidestep cutting. The ankle that initiated the sidestep cutting showed progressively increasing inversion from 2 to 13 degrees while the following contralateral step showed progressively decreasing inversion from 8 to -4 degrees during normal walking speed. The changes in IE kinematics were the most significant during sidestep cutting compared with straight walking. The IE moments of the step that initiated the sidestep cutting were always in eversion, acting as a braking moment opposing the inverting motion. This suggests that an ankle-foot prosthesis with active DOFs in the sagittal and frontal planes will increase the agility of gait for patients with limb loss.
Hancock, Laura; Correia, Stephen; Ahern, David; Barredo, Jennifer; Resnik, Linda
2017-07-01
Purpose The objectives were to 1) identify major cognitive domains involved in learning to use the DEKA Arm; 2) specify cognitive domain-specific skills associated with basic versus advanced users; and 3) examine whether baseline memory and executive function predicted learning. Method Sample included 35 persons with upper limb amputation. Subjects were administered a brief neuropsychological test battery prior to start of DEKA Arm training, as well as physical performance measures at the onset of, and following training. Multiple regression models controlling for age and including neuropsychological tests were developed to predict physical performance scores. Prosthetic performance scores were divided into quartiles and independent samples t-tests compared neuropsychological test scores of advanced scorers and basic scorers. Baseline neuropsychological test scores were used to predict change in scores on physical performance measures across time. Results Cognitive domains of attention and processing speed were statistically significantly related to proficiency of DEKA Arm use and predicted level of proficiency. Conclusions Results support use of neuropsychological tests to predict learning and use of a multifunctional prosthesis. Assessment of cognitive status at the outset of training may help set expectations for the duration and outcomes of treatment. Implications for Rehabilitation Cognitive domains of attention and processing speed were significantly related to level of proficiencyof an advanced multifunctional prosthesis (the DEKA Arm) after training. Results provide initial support for the use of neuropsychological tests to predict advanced learningand use of a multifunctional prosthesis in upper-limb amputees. Results suggest that assessment of patients' cognitive status at the outset of upper limb prosthetictraining may, in the future, help patients, their families and therapists set expectations for theduration and intensity of training and may help set reasonable proficiency goals.
Controlling a multi-degree of freedom upper limb prosthesis using foot controls: user experience.
Resnik, Linda; Klinger, Shana Lieberman; Etter, Katherine; Fantini, Christopher
2014-07-01
The DEKA Arm, a pre-commercial upper limb prosthesis, funded by the DARPA Revolutionizing Prosthetics Program, offers increased degrees of freedom while requiring a large number of user control inputs to operate. To address this challenge, DEKA developed prototype foot controls. Although the concept of utilizing foot controls to operate an upper limb prosthesis has been discussed for decades, only small-sized studies have been performed and no commercial product exists. The purpose of this paper is to report amputee user perspectives on using three different iterations of foot controls to operate the DEKA Arm. Qualitative data was collected from 36 subjects as part of the Department of Veterans Affairs (VA) Study to Optimize the DEKA Arm through surveys, interviews, audio memos, and videotaped sessions. Three major, interrelated themes were identified using the constant comparative method: attitudes towards foot controls, psychomotor learning and physical experience of using foot controls. Feedback about foot controls was generally positive for all iterations. The final version of foot controls was viewed most favorably. Our findings indicate that foot controls are a viable control option that can enable control of a multifunction upper limb prosthesis (the DEKA Arm). Multifunction upper limb prostheses require many user control inputs to operate. Foot controls offer additional control input options for such advanced devices, yet have had minimal study. This study found that foot controls were a viable option for controlling multifunction upper limb prostheses. Most of the 36 subjects in this study were willing to adopt foot controls to control the multiple degrees of freedom of the DEKA Arm. With training and practice, all users were able to develop the psychomotor skills needed to successfully operate food controls. Some had initial difficulty, but acclimated over time.
Tomaszewski, P K; Verdonschot, N; Bulstra, S K; Rietman, J S; Verkerke, G J
2012-11-01
Direct attachment of an upper leg prosthesis to the skeletal system by a percutaneous implant is an alternative solution to the traditional socket fixation. In this study, we investigated long-term periprosthetic bone changes around two types of fixation implants using two different initial conditions, namely immediate post-amputation implantation and the conventional implantation after considerable time of socket prosthesis use. We questioned the difference in bone modeling response the implants provoked and if it could lead to premature bone fracture. Generic CT-based finite element models of an intact femoral bone and amputated bone implanted with models of two existing direct-fixation implants, the OPRA system (Integrum AB) and the ISP Endo/Exo prosthesis (ESKA Implants AG) were created for this study. Adaptive bone-remodeling simulations used the heel-strike and toe-off loads from a normal walking cycle. The bone loss caused by prolonged use of socket prosthesis had more severe effects on the ultimate bone quality than adaptation induced by the direct-fixation implants. Both implants showed considerable bone remodeling; the titanium screw implant (OPRA system) provoked more bone loss than the porous coated CoCrMo stem (ISP implant). The chance of the peri-prosthetic bone fracture remained higher for the post-socket case as compared to the direct amputation cases. In conclusion, both direct-fixation implants lead to considerable bone loss and bone loss is more severe after a prolonged period of post-socket use. Hence, from a biomechanical perspective it is better to limit the post-socket time and to re-design direct fixation devices to reduce bone loss and the probability of peri-prosthetic bone fractures. Copyright © 2012 Elsevier Ltd. All rights reserved.
Østlie, Kristin; Lesjø, Ingrid Marie; Franklin, Rosemary Joy; Garfelt, Beate; Skjeldal, Ola Hunsbeth; Magnus, Per
2012-11-01
To describe patterns of prosthesis wear and perceived prosthetic usefulness in adult acquired upper-limb amputees (ULAs). To describe prosthetic skills in activities of daily life (ADL) and the actual use of prostheses in the performance of ADL tasks. To estimate the influence of prosthetic skills on actual prosthesis use and the influence of background factors on prosthetic skills and actual prosthesis use. Cross-sectional study analysing population-based questionnaire data (n = 224) and data from interviews and clinical testing in a referred/convenience sample of prosthesis-wearing ULAs (n = 50). Effects were analysed using linear regression. 80.8% wore prostheses. 90.3% reported their most worn prosthesis as useful. Prosthetic usefulness profiles varied with prosthetic type. Despite demonstrating good prosthetic skills, the amputees reported actual prosthesis use in only about half of the ADL tasks performed in everyday life. In unilateral amputees, increased actual use was associated with sufficient prosthetic training and with the use of myoelectric vs cosmetic prostheses, regardless of amputation level. Prosthetic skills did not affect actual prosthesis use. No background factors showed significant effect on prosthetic skills. Most major ULAs wear prostheses. Individualised prosthetic training and fitting of myoelectric rather than passive prostheses may increase actual prosthesis use in ADL.
Kim, Young-Hoo; Yoon, Sung-Hwan; Kim, Jun-Shik
2009-02-01
Although the design features of the Medial Pivot fixed-bearing prosthesis reportedly improve kinematics compared with TKAs using fixed-bearings, clinical improvements have not been reported. We asked whether the clinical and radiographic outcomes, ranges of motion of the knee, patient satisfaction, and complication rates would be better in knees with a Medial Pivot fixed-bearing prosthesis than in those with a PFC Sigma mobile-bearing prosthesis. We compared the results of 92 patients who had a Medial Pivot fixed-bearing prosthesis implanted in one knee and a PFC Sigma mobile-bearing prosthesis implanted in the other. There were 85 women and seven men with a mean age of 69.5 years (range, 55-81 years). The minimum followup was 2 years (mean, 2.6 years; range, 2-3 years). The patients were assessed clinically and radiographically using the rating systems of the Hospital for Special Surgery and the Knee Society at 3 months, 1 year, and annually thereafter. Contrary to expectations, we found worse early clinical outcomes, smaller ranges of knee motion, less patient satisfaction, and a higher complication rate for the Medial Pivot fixed-bearing prosthesis than for the PFC Sigma mobile-bearing prosthesis. Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
Anitua, Eduardo; Flores, Carlos; Piñas, Laura; Alkhraisat, Mohammad
2018-06-05
CAD-CAM technology permits the angular correction of screw emergence into the prosthesis, however there is lack of controlled clinical studies that assess the frequency of technical complications in angled screw channel restorations. This controlled clinical study was designed to assess technical incidences in angled screw channel restorations. Patients having implant prosthesis placed between November, 2014 and December, 2015 were screened. The patients were selected if they received prosthesis with up to 30º correction of the prosthesis screw emergence and had at least one non-angulated prosthesis (screw-retained). All the prostheses were located completely/partially in the posterior region. The frequency of technical complications was the principal variable. A total of 52 patients with a mean age of 62 ± 10 years participated with a total 110 prostheses (55 in the test group and 55 in the control group). A total of 11 technical complications occurred (7 in the test group and 4 in the control group). These differences were not statistically significant. All the prostheses in both groups survived the follow-up. The correction of the screw emergence into the prosthesis has not increased the risk of technical complications in CAD-CAM implant prostheses.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Janik, Gregory
Renders, saves, and analyzes pressure from several sensors in a prosthesis socket. The program receives pressure data from 64 manometers and parses the pressure for each individual sensor. The program can then display those pressures as number in a table. The program also interpolates pressures between manometers to create a larger set of data. This larger set of data is displayed as a simple contour plot. That same contour plot can also be placed on a three-dimensional surface in the shape of a prosthesis.This program allows for easy identification of high pressure areas in a prosthesis to reduce the usersmore » discomfort. The program parses the sensor pressures into a human-readable numeric format. The data may also be used to actively adjust bladders within the prosthesis to spread out pressure in real time, according to changing demands placed on the prosthesis. Interpolation of the pressures to create a larger data set makes it even easier for a human to identify particular areas of the prosthesis that are under high pressure. After identifying pressure points, a prosthetician can then redesign the prosthesis and/or command the bladders in the prosthesis to attempt to maintain constant pressures.« less
Allograft-prosthesis composites after bone tumor resection at the proximal tibia.
Biau, David Jean; Dumaine, Valérie; Babinet, Antoine; Tomeno, Bernard; Anract, Philippe
2007-03-01
The survival of irradiated allograft-prosthesis composites at the proximal tibia is mostly unknown. However, allograft-prosthesis composites have proved beneficial at other reconstruction sites. We presumed allograft-prosthesis composites at the proximal tibia would improve survival and facilitate reattachment of the extensor mechanism compared with that of conventional (megaprostheses) reconstructions. We retrospectively reviewed 26 patients who underwent resection of proximal tibia tumors followed by reconstruction with allo-graft-prosthesis composites. Patients received Guepar massive custom-made fully constrained prostheses. Allografts were sterilized with gamma radiation, and the stems were cemented into the allograft and host bone. The minimum followup was 6 months (median, 128 months; range, 6-195 months). Fourteen patients had one or more components removed. The median allograft-prosthesis composite survival was 102 months (95% confidence interval, 64.2-infinity). Of the 26 allografts, seven fractured, six showed signs of partial resorption, and six had infections develop. Seven allografts showed signs of fusion with the host bone. Six extensor mechanism reconstructions failed. Allograft-prosthesis composites sterilized by gamma radiation yielded poor results for proximal tibial reconstruction as complications and failures were common. We do not recommend irradiated allograft-prosthesis composites for proximal tibia reconstruction.
The Retro-Rectus Prosthesis for Core Myofascial Restoration in Cosmetic Abdominoplasty.
Lincenberg, Sheldon M
2017-09-01
The retro-rectus placement of a prosthesis for reinforcement of a hernia repair is a powerful surgical maneuver and results in reduced hernia recurrence rates in the absence of ventral hernia. Fascial reinforcement theoretically should improve columnar support to the spine and enhance athletic activity. The purpose of this study was to demonstrate the long-term efficacy of the restoration of the cylindrical lumbar abdominal myofascial complex as an adjunct to cosmetic abdominoplasty. A retrospective evaluation of retro-rectus inlay prosthesis during cosmetic abdominoplasty was undertaken to subjectively assess aesthetic and functional benefits. Six patients with severe anterior fascial laxity presenting for abdominoplasty underwent prosthetic augmentation of the posterior rectus sheath. The prosthesis was measured and contoured to provide structural support to the rectus sheath and linea Alba and to restore normal anatomic features to these structures. All procedures were performed via a traditional low abdominal curvilinear incision for optimum cosmesis. All 6 patients had long-term follow up, ranging from 13 to 40 months. All patients reported improved core strength and relief of back pain. All patients were pleased with the cosmetic results. Retro-rectus prosthetic augmentation for cosmetic abdominoplasty is effective in restoring anatomic relationships and can be used to improve core strength and to enhance aesthetic objectives. 4. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com
Simulation of a slope adapting ankle prosthesis provided by semi-active damping.
LaPrè, Andrew K; Sup, Frank
2011-01-01
Modern passive prosthetic foot/ankles cannot adapt to variations in ground slope. The lack of active adaptation significantly compromises an amputee's balance and stability on uneven terrains. To address this deficit, this paper proposes an ankle prosthesis that uses semi-active damping as a mechanism to provide active slope adaptation. The conceptual ankle prosthesis consists of a modulated damper in series with a spring foot that allows the foot to conform to the angle of the surface in the sagittal plane. In support of this approach, biomechanics data is presented showing unilateral transtibial amputees stepping on a wedge with their daily-use passive prosthesis. Based on this data, a simulation of the ankle prosthesis with semi-active damping is developed. The model shows the kinematic adaptation of the prosthesis to sudden changes in ground slope. The results show the potential of an ankle prosthesis with semi-active damping to actively adapt to the ground slope at each step.
Static analysis of C-shape SMA middle ear prosthesis
NASA Astrophysics Data System (ADS)
Latalski, Jarosław; Rusinek, Rafał
2017-08-01
Shape memory alloys are a family of metals with the ability to change specimen shape depending on their temperature. This unique property is useful in many areas of mechanical and biomechanical engineering. A new half-ring middle ear prosthesis design made of a shape memory alloy, that is undergoing initial clinical tests, is investigated in this research paper. The analytical model of the studied structure made of nonlinear constitutive material is solved to identify the temperature-dependent stiffness characteristics of the proposed design on the basis of the Crotti-Engesser theorem. The final integral expression for the element deflection is highly complex, thus the solution has to be computed numerically. The final results show the proposed shape memory C-shape element to behave linearly in the analysed range of loadings and temperatures. This is an important observation that significantly simplifies the analysis of the prototype structure and opens wide perspectives for further possible applications of shape memory alloys.
Review of the socket design and interface pressure measurement for transtibial prosthesis.
Pirouzi, Gh; Abu Osman, N A; Eshraghi, A; Ali, S; Gholizadeh, H; Wan Abas, W A B
2014-01-01
Socket is an important part of every prosthetic limb as an interface between the residual limb and prosthetic components. Biomechanics of socket-residual limb interface, especially the pressure and force distribution, have effect on patient satisfaction and function. This paper aimed to review and evaluate studies conducted in the last decades on the design of socket, in-socket interface pressure measurement, and socket biomechanics. Literature was searched to find related keywords with transtibial amputation, socket-residual limb interface, socket measurement, socket design, modeling, computational modeling, and suspension system. In accordance with the selection criteria, 19 articles were selected for further analysis. It was revealed that pressure and stress have been studied in the last decaeds, but quantitative evaluations remain inapplicable in clinical settings. This study also illustrates prevailing systems, which may facilitate improvements in socket design for improved quality of life for individuals ambulating with transtibial prosthesis. It is hoped that the review will better facilitate the understanding and determine the clinical relevance of quantitative evaluations.
Review of the Socket Design and Interface Pressure Measurement for Transtibial Prosthesis
Pirouzi, Gh.; Abu Osman, N. A.; Eshraghi, A.; Ali, S.; Gholizadeh, H.; Wan Abas, W. A. B.
2014-01-01
Socket is an important part of every prosthetic limb as an interface between the residual limb and prosthetic components. Biomechanics of socket-residual limb interface, especially the pressure and force distribution, have effect on patient satisfaction and function. This paper aimed to review and evaluate studies conducted in the last decades on the design of socket, in-socket interface pressure measurement, and socket biomechanics. Literature was searched to find related keywords with transtibial amputation, socket-residual limb interface, socket measurement, socket design, modeling, computational modeling, and suspension system. In accordance with the selection criteria, 19 articles were selected for further analysis. It was revealed that pressure and stress have been studied in the last decaeds, but quantitative evaluations remain inapplicable in clinical settings. This study also illustrates prevailing systems, which may facilitate improvements in socket design for improved quality of life for individuals ambulating with transtibial prosthesis. It is hoped that the review will better facilitate the understanding and determine the clinical relevance of quantitative evaluations. PMID:25197716
Wear Distribution Detection of Knee Joint Prostheses by Means of 3D Optical Scanners
Affatato, Saverio; Valigi, Maria Cristina; Logozzo, Silvia
2017-01-01
The objective of this study was to examine total knee polyethylene inserts from in vitro simulation to evaluate and display—using a 3D optical scanner—wear patterns and wear rates of inserts exposed to wear by means of simulators. Various sets of tibial inserts have been reconstructed by using optical scanners. With this in mind, the wear behavior of fixed and mobile bearing polyethylene knee configurations was investigated using a knee wear joint simulator. After the completion of the wear test, the polyethylene menisci were analyzed by an innovative 3D optical scanners in order to evaluate the 3D wear distribution on the prosthesis surface. This study implemented a new procedure for evaluating polyethylene bearings of joint prostheses obtained after in vitro wear tests and the proposed new approach allowed quantification of the contact zone on the geometry of total knee prostheses. The results of the present study showed that mobile TKPs (total knee prosthesis) have lower wear resistance with respect to fixed TKPs. PMID:28772725
Current Diagnosis and Management of Erectile Dysfunction
Pastuszak, Alexander W.
2015-01-01
Erectile dysfunction (ED) affects a growing number of men in the USA and abroad, with significant impacts on sexual function and overall quality of life. The risk factors for ED are numerous and include a strong link to cardiovascular disease, such that men with ED should be screened for cardiovascular disease. The evaluation of men presenting with ED includes a comprehensive history and physical exam to aid in the identification of comorbidities as well as laboratory testing to evaluate hormone and lipid levels and sugar metabolism. Adjunct studies are also available, though their utility is often limited to specific subtypes of ED. Once the etiology of ED is established, treatment can be initiated using appropriate medical therapies, including phosphodiesterase type 5 (PDE5) inhibitors, and transurethral or intracavernosal therapies, with surgical intervention via revascularization or penile prosthesis placement in men demonstrating a lack of response to medical therapy. In all cases of ED, a psychogenic component is present and referral for psychological intervention with or without medical therapy should be considered. PMID:25878565
Lou, Jigang; Li, Yuanchao; Wang, Beiyu; Meng, Yang; Wu, Tingkui; Liu, Hao
2017-01-01
Abstract In vitro biomechanical analysis after cervical disc replacement (CDR) with a novel artificial disc prosthesis (mobile core) was conducted and compared with the intact model, simulated fusion, and CDR with a fixed-core prosthesis. The purpose of this experimental study was to analyze the biomechanical changes after CDR with a novel prosthesis and the differences between fixed- and mobile-core prostheses. Six human cadaveric C2–C7 specimens were biomechanically tested sequentially in 4 different spinal models: intact specimens, simulated fusion, CDR with a fixed-core prosthesis (Discover, DePuy), and CDR with a mobile-core prosthesis (Pretic-I, Trauson). Moments up to 2 Nm with a 75 N follower load were applied in flexion–extension, left and right lateral bending, and left and right axial rotation. The total range of motion (ROM), segmental ROM, and adjacent intradiscal pressure (IDP) were calculated and analyzed in 4 different spinal models, as well as the differences between 2 disc prostheses. Compared with the intact specimens, the total ROM, segmental ROM, and IDP at the adjacent segments showed no significant difference after arthroplasty. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment (C5/6) and total ROM than CDR with a fixed-core prosthesis (P > .05). Besides, the difference in IDP at C4/5 after CDR with 2 prostheses was without statistical significance in all the directions of motion. However, the IDP at C6/7 after CDR with a mobile-core prosthesis was lower than CDR with a fixed-core prosthesis in flexion, extension, and lateral bending, with significant difference (P < .05), but not under axial rotation. CDR with a novel prosthesis was effective to maintain the ROM at the target segment and did not affect the ROM and IDP at the adjacent segments. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment and total ROM, but lower IDP at the inferior adjacent segment than CDR with a fixed-core prosthesis. PMID:29019902
Yi, Seong; Kim, Keung Nyun; Yang, Moon Sul; Yang, Joong Won; Kim, Hoon; Ha, Yoon; Yoon, Do Heum; Shin, Hyun Chul
2010-07-15
Retrospective study of the difference of heterotopic ossification (HO) occurrence according to 3 different types of prosthesis. This study was designed to investigate the difference of HO occurrence according to different type of prosthesis. HO is defined as formation of the bone outside the skeletal system. Reported HO occurrence rate in cervical artificial disc replacement (ADR) was unexpectedly high and varied. But the influencing factors of HO in cervical ADR have not been elucidated well. The prosthesis-related factors for making difference of HO occurrence were investigated in this study. A total of 170 patients undergoing cervical arthroplasty with the Bryan cervical disc prosthesis (Medtroic Sofamor Danek, Memphis, TN), Mobi-C disc prosthesis (LDR Medical, Troyes, France), and ProDisc-C (Synthes, Inc., West Chester, PA) were included. Cervical lateral radiographs obtained before and after surgery were used to identify HO. Occurrence rate, occurrence-free period, location, and grade of HOs were investigated according to the different prosthesis. Each prosthesis group included patients as follows: Bryan disc, 81 patients; Mobi-C, 61 patients; and ProDisc-C, 28 patients. Overall HO rate was 40.6% (69 of 170 patients). Each HO occurrence rate by prosthesis was as follows: the Bryan disc group, 21.0%; Mobi-C group, 52.5%; and the ProDisc-C group, 71.4%. In the survival analysis, all patients showed 27.1 +/- 3.7 months as the median survival. The Bryan disc group showed statistically longer survival (48.4 +/- 7.4 months) than the other groups. Occurrence of HO is an inevitable postoperative complication after cervical ADR. The occurrence rate of HO was higher than our expectation. Moreover, definite differences in occurrence rate according to the prosthesis type were identified by this study.
Lewin, Jan S; Hutcheson, Katherine A; Barringer, Denise A; Croegaert, Lindsay E; Lisec, Asher; Chambers, Mark S
2012-08-01
Customization of the tracheoesophageal (TE) voice prosthesis (VP) is often preferred over surgical closure to prevent aspiration around the VP in laryngectomized patients with an enlarged tracheoesophageal puncture (TEP), but it has not been thoroughly evaluated. Single-institution prospective trial. A prospective trial was conducted to evaluate the effectiveness of a customized VP with the addition of an enlarged tracheal and/or esophageal collar in patients with leakage around an enlarged TEP. Absence of leakage around the VP after placement defined immediate effectiveness. Long-term success was defined by the prevention of adverse events related to leakage during the study period. Events that defined failure included: permanent gastrostomy dependence, aspiration pneumonia, and/or surgical TEP closure. Twenty-one patients with enlarged TEP were enrolled (2003-2006). Insertion of a customized VP was unsuccessful in one patient; 145 customizations were performed in the remaining 20 patients (median, 3.5 customizations) during the trial period. Of the customizations, 77% (112/145) prevented leakage immediately after VP insertion. The most common adverse event was dislodgement of the prosthesis (11%) or the collar alone (7%) in 18% (26/145) of customized VP placements. Six patients who died of disease were not evaluable for long-term outcomes. Long-term success was achieved in 80% (12/15) of evaluable patients who avoided permanent gastrostomy, aspiration pneumonia, and surgical TEP closure. Prosthetic customization offers an effective method to prevent leakage around the VP in many patients with an enlarged TEP, thereby preserving TE voice while avoiding surgical closure in this high-risk population. Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.
Lewin, Jan S.; Hutcheson, Katherine A.; Barringer, Denise A.; Croegaert, Lindsay E.; Lisec, Asher; Chambers, Mark S.
2014-01-01
Background Customization of the tracheoesophageal (TE) voice prosthesis (VP) is often preferred over surgical closure to prevent aspiration around the VP in laryngectomized patients with an enlarged tracheoesophageal puncture (TEP), but has not been thoroughly evaluated. Study Design Single-institution prospective trial. Methods A prospective trial was conducted to evaluate the effectiveness of a customized VP with the addition of an enlarged tracheal and/or esophageal collar in patients with leakage around an enlarged TEP. Absence of leakage around the VP after placement defined immediate effectiveness. Long-term success was defined by the prevention of adverse events related to leakage during the study period. Events that defined failure included: permanent gastrostomy dependence, aspiration pneumonia, and/or surgical TEP closure. Results Twenty-one patients with enlarged TEP were enrolled (2003-2006). Insertion of a customized VP was unsuccessful in 1 patient; 145 customizations were performed in the remaining 20 patients (median: 3.5 customizations) during the trial period. Seventy-seven percent (112/145) of customizations prevented leakage immediately after VP insertion. The most common adverse event was dislodgement of the prosthesis (11%) or the collar alone (7%) in 18% (26/145) of customized VP placements. Six patients who died of disease were not evaluable for long-term outcomes. Long-term success was achieved in 80% (12/ 15) of evaluable patients who avoided permanent gastrostomy, aspiration pneumonia, and surgical TEP closure. Conclusions Prosthetic customization offers an effective method to prevent leakage around the VP in many patients with an enlarged TEP, thereby preserving TE voice while avoiding surgical closure in this high risk population. PMID:22753122
The glass spherical hollow orbital implant: a prospective study.
Stephen, B E
1999-06-01
Various types of orbital implants are in use in the rehabilitation of anophthalmic patients. The latest is the expensive hydroxyapatite implant. The study objective was to evaluate the effectiveness of low cost glass spherical hollow implants, as primary and secondary implants. St Michaels and Frazer Private Hospitals, Colombo. 65 patients had glass sphere orbital implants between 1987 and 1995; 51 primary (evisceration 46, enucleation 5) and 14 secondary (evisceration 2, enucleation 12). At 9 to 12 months follow up, patients were evaluated for mobility of implant, prosthesis mobility, lid sulcus deformity, cosmetic results and complications. Primary glass spherical hollow implants provide excellent mobility of the implant (92%), cosmesis (88%), prosthesis mobility (67%), with a low rate of complications (9.5%). Results of primary implant was superior to that of secondary (p < 0.001). Excellent results were obtained with spherical glass spheres as primary implants following evisceration.
Skin problems of the stump in lower limb amputees: 1. A clinical study.
Meulenbelt, Henk E J; Geertzen, Jan H B; Jonkman, Marcel F; Dijkstra, Pieter U
2011-03-01
Use of a prosthesis in lower limb amputees can lead to skin problems of the amputation stump. However, little is known about the epidemiology and type of problems experienced. We conducted a cross-sectional survey consisting of a questionnaire and a clinical assessment of the amputation stump. The aims of the study were to estimate the prevalence of skin problems of the amputation stump, to evaluate the impact of these skin problems and to evaluate differences between clinically observed skin problems and skin problems reported by the amputee. Participants (n = 124) were recruited from among lower limb amputees who visited an orthopaedic workshop. The prevalence of skin problems was 36%. Problems identified were: reduction in prosthesis use, and reduction in walking distance without a break. Significantly more skin problems were reported than observed (p = 0.011). Cold skin and excessive perspiration in particular were significantly more reported than observed.
NASA Astrophysics Data System (ADS)
Lei, Dong; Bai, Pengxiang; Zhu, Feipeng
2018-01-01
Nowadays, acetabulum prosthesis replacement is widely used in clinical medicine. However, there is no efficient way to evaluate the implantation effect of the prosthesis. Based on a modern photomechanics technique called digital image correlation (DIC), the evaluation method of the installation effect of the acetabulum was established during a prosthetic replacement of a hip joint. The DIC method determines strain field by comparing the speckle images between the undeformed sample and the deformed counterpart. Three groups of experiments were carried out to verify the feasibility of the DIC method on the acetabulum installation deformation test. Experimental results indicate that the installation deformation of acetabulum generally includes elastic deformation (corresponding to the principal strain of about 1.2%) and plastic deformation. When the installation angle is ideal, the plastic deformation can be effectively reduced, which could prolong the service life of acetabulum prostheses.
2015-10-01
Modulated Sensory Feedback from, a Hand Prosthesis PRINCIPAL INVESTIGATOR: Bradley Greger, PhD CONTRACTING ORGANIZATION: Arizona State University...Residual Peripheral Nerves to Provide Dextrous Control of, and Modulated Sensory Feedback from, a Hand Prosthesis 5a. CONTRACT NUMBER 5b. GRANT...Peripheral Nerve Interface, Prosthetic Hand, Neural Prosthesis , Sensory Feedback, Micro-stimulation, Electrophysiology, Action Potentials, Micro
Liu, Hongwei; Weng, Yiping; Zhang, Yunkun; Xu, Nanwei; Tong, Jing; Wang, Caimei
2015-09-01
To study the feasibility of preparation of the individualized femoral prosthesis through computer assisted design and electron beammelting rapid prototyping (EBM-RP) metal three-dimensional (3D) printing technology. One adult male left femur specimen was used for scanning with 64-slice spiral CT; tomographic image data were imported into Mimics15.0 software to reconstruct femoral 3D model, then the 3D model of individualized femoral prosthesis was designed through UG8.0 software. Finally the 3D model data were imported into EBM-RP metal 3D printer to print the individualized sleeve. According to the 3D model of individualized prosthesis, customized sleeve was successfully prepared through the EBM-RP metal 3D printing technology, assembled with the standard handle component of SR modular femoral prosthesis to make the individualized femoral prosthesis. Customized femoral prosthesis accurately matching with metaphyseal cavity can be designed through the thin slice CT scanning and computer assisted design technology. Titanium alloy personalized prosthesis with complex 3D shape, pore surface, and good matching with metaphyseal cavity can be manufactured by the technology of EBM-RP metal 3D printing, and the technology has convenient, rapid, and accurate advantages.
Deijs, M; Bongers, R M; Ringeling-van Leusen, N D M; van der Sluis, C K
2016-03-15
The current study examines the relevance of prosthetic wrist movement to facilitate activities of daily living or to prevent overuse complaints. Prosthesis hands with wrist flexion/extension capabilities are commercially available, but research on the users' experiences with flexible wrists is limited. In this study, eight transradial amputees using a myoelectric prosthesis tested two prosthesis wrists with flexion/extension capabilities, the Flex-wrist (Otto Bock) and Multi-flex wrist (Motion Control), in their flexible and static conditions. Differences between the wrists were assessed on the levels of functionality, user satisfaction and compensatory movements after two weeks use. No significant differences between flexible and static wrist conditions were found on activity performance tests and standardized questionnaires on satisfaction. Inter-individual variation was remarkably large. Participants' satisfaction tended to be in favour of flexible wrists. All participants but one indicated that they would choose a prosthesis hand with wrist flexion/extension capabilities if allowed a new prosthesis. Shoulder joint angles, reflecting compensatory movements, showed no clear differences between wrist conditions. Overall, positive effects of flexible wrists are hard to objectify. Users seem to be more satisfied with flexible wrists. A person's needs, work and prosthesis skills should be taken into account when prescribing a prosthesis wrist. Nederlands Trial Register NTR3984 .
Active upper limb prosthesis based on natural movement trajectories.
Ramírez-García, Alfredo; Leija, Lorenzo; Muñoz, Roberto
2010-03-01
The motion of the current prostheses is sequential and does not allow natural movements. In this work, complex natural motion patterns from a healthy upper limb were characterized in order to be emulated for a trans-humeral prosthesis with three degrees of freedom at the elbow. Firstly, it was necessary to define the prosthesis workspace, which means to establish a relationship using an artificial neural network (ANN), between the arm-forearm (3-D) angles allowed by the prosthesis, and its actuators length. The 3-D angles were measured between the forearm and each axis of the reference system attached at the elbow. Secondly, five activities of daily living (ADLs) were analyzed by means of the elbow flexion (EF), the forearm prono-supination (FPS) and the 3-D angles, from healthy subjects, by using a video-based motion analysis system. The 3-D angles were fed to the prosthesis model (ANN) in order to analyze which ADLs could be emulated by the prosthesis. As a result, a prosthesis kinematics approximation was obtained. In conclusion, in spite of the innovative mechanical configuration of the actuators, it was possible to carry out only three of the five ADLs considered. Future work will include improvement of the mechanical configuration of the prosthesis to have greater range of motion.
Vallejo, Luis A; Manzano, María T; Hidalgo, Antonio; Hernández, Alberto; Sabas, Juan; Lara, Hugo; Gil-Carcedo, Elisa; Herrero, David
One of the problems with total ossicular replacement prostheses is their stability. Prosthesis dislocations and extrusions are common in middle ear surgery. This is due to variations in endo-tympanic pressure as well as design defects. The design of this new prosthesis reduces this problem by being joined directly to the malleus handle. The aim of this study is to confirm adequate acoustic-mechanical behaviour in fresh cadaver middle ear of a new total ossicular replacement prosthesis, designed using the finite elements method. Using the doppler vibrometer laser, we analysed the acoustic-mechanical behaviour of a new total ossicular replacement prosthesis in the human middle ear using 10 temporal bones from fresh cadavers. The transfer function of the ears in which we implanted the new prosthesis was superimposed over the non-manipulated ear. This suggests optimum acoustic-mechanical behaviour. The titanium prosthesis analysed in this study demonstrated optimum acoustic-mechanical behaviour. Together with its ease of implantation and post-surgical stability, these factors make it a prosthesis to be kept in mind in ossicular reconstruction. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.
Effect of Framework in an Implant-Supported Full-Arch Fixed Prosthesis: 3D Finite Element Analysis.
Menini, Maria; Pesce, Paolo; Bevilacqua, Marco; Pera, Francesco; Tealdo, Tiziano; Barberis, Fabrizio; Pera, Paolo
2015-01-01
The aim of this study was to analyze through a three-dimensional finite element analysis (3D-FEA) stress distribution on four implants supporting a full-arch implant-supported fixed prosthesis (FFP) using different prosthesis designs. A 3D edentulous maxillary model was created and four implants were virtually placed into the maxilla and splinted, simulating an FFP without framework, with a cast metal framework, and with a carbon fiber framework. An occlusal load of 150 N was applied, stresses were transmitted into peri-implant bone, and prosthodontic components were recorded. 3D-FEA revealed higher stresses on the implants (up to +55.16%), on peri-implant bone (up to +56.93%), and in the prosthesis (up to +70.71%) when the full-acrylic prosthesis was simulated. The prosthesis with a carbon fiber framework showed an intermediate behavior between that of the other two configurations. This study suggests that the presence of a rigid framework in full-arch fixed prostheses provides a better load distribution that decreases the maximum values of stress at the levels of implants, prosthesis, and maxillary bone.
Approaches to a cortical vision prosthesis: implications of electrode size and placement
NASA Astrophysics Data System (ADS)
Christie, Breanne P.; Ashmont, Kari R.; House, Paul A.; Greger, Bradley
2016-04-01
Objective. In order to move forward with the development of a cortical vision prosthesis, the critical issues in the field must be identified. Approach. To begin this process, we performed a brief review of several different cortical and retinal stimulation techniques that can be used to restore vision. Main results. Intracortical microelectrodes and epicortical macroelectrodes have been evaluated as the basis of a vision prosthesis. We concluded that an important knowledge gap necessitates an experimental in vivo performance evaluation of microelectrodes placed on the surface of the visual cortex. A comparison of the level of vision restored by intracortical versus epicortical microstimulation is necessary. Because foveal representation in the primary visual cortex involves more cortical columns per degree of visual field than does peripheral vision, restoration of foveal vision may require a large number of closely spaced microelectrodes. Based on previous studies of epicortical macrostimulation, it is possible that stimulation via surface microelectrodes could produce a lower spatial resolution, making them better suited for restoring peripheral vision. Significance. The validation of epicortical microstimulation in addition to the comparison of epicortical and intracortical approaches for vision restoration will fill an important knowledge gap and may have important implications for surgical strategies and device longevity. It is possible that the best approach to vision restoration will utilize both epicortical and intracortical microstimulation approaches, applying them appropriately to different visual representations in the primary visual cortex.
Holinka, Johannes; Pilz, Magdalena; Hirschl, Alexander M; Graninger, Wolfgang; Windhager, Reinhard; Presterl, Elisabeth
2012-10-01
The purpose of our study was to evaluate and quantify the bacterial adherence on different components of total knee prosthesis with the sonication culture method. Explanted components of all patients with presumptive prosthetic or implant infection were treated by sonication separately in sterile containers to dislodge the adherent bacteria from the surfaces and cultured. The bacterial load of the different knee components (femur, tibia, PE-inlay and patella) was evaluated by counting of colony-forming units (CFU) dislodged from the components surfaces using the sonication culture method. Overall, 27 patients had positive sonication cultures of explanted total knee prostheses. Microorganisms were detected from 88 of 100 explanted components. Twenty femoral components were culture positive and 7 negative, 23 tibial components as well as 23 polyethylene (PE) platforms had positive microorganism detection from the surface. Staphylococcus epidermidis adhered to the highest number of components whereas Staphylococcus aureus yielded the highest load of CFU in the sonication cultures. Although not significant, PE-inlays and tibial components were most often affected. The highest CFU count was detected in polyethylene components. The sonication culture method is a reliable method to detect bacteria from the components. Additionally, the results demonstrate that bacterial adherence is not affecting a single component of knee prosthesis only. Thus, in septic revision surgery partial prosthetic exchange or exchange of single polyethylene components alone may be not sufficient.
Kim, Seong Hwan; Lim, Jung-Won; Ko, Young-Bong; Song, Min-Gu; Lee, Han-Jun
2016-11-01
The purpose of this study was to compare the midterm outcomes between fixed and mobile ultra-congruent (UC) bearings in total knee arthroplasty (TKA). This is a retrospective matched-pairs case-control study of patients who underwent primary navigation-assisted TKA with a minimum 5-year follow-up. A total of 182 cases involved the fixed UC bearing system as Group 1 and 101 cases involved mobile UC bearing system group as Group 2. After 1:1 matching, 73 knees in each group were enrolled. Clinical and radiographic outcomes were evaluated. The overall survival was 143 of 146 cases (97.9 %) at final follow-up, and 72 of 73 cases (96.3 %) in Group 1 and 71 of 73 cases (95.8 %) in Group 2 at final follow-up based on an endpoint of revision surgery. The reasons of revision TKA were periprosthetic fracture in Group 1, infection and bearing dislocation in Group 2. There was no statistical difference in Hospital for Special Surgery (HSS) scores, Knee Society Scores (KSS), WOMAC index score evaluations between groups. This study demonstrated that the fixed-bearing UC prosthesis could provide satisfactory performance compared with that of the mobile-bearing UC prosthesis with minimum 5-year follow-up. The fixed-bearing UC prosthesis could be considered in navigation-assisted TKA with theoretical advantages of UC design. IV.
Assessment of psychosexual adjustment after insertion of inflatable penile prosthesis.
Tefilli, M V; Dubocq, F; Rajpurkar, A; Gheiler, E L; Tiguert, R; Barton, C; Li, H; Dhabuwala, C B
1998-12-01
To evaluate the psychosexual benefit obtained from multicomponent penile implant surgery in patients with erectile dysfunction. A psychosexual questionnaire was given to 35 patients undergoing penile prosthesis implantation before surgery and at 3 months, 6 months, and 1 year after surgery. The questionnaire consisted of 13 questions scored on a scale from 1 through 5. Results of the questionnaire were statistically analyzed for differences among the preoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative period. The general linear model evaluation showed a significant difference for each overall combination of the following pairs: preoperative versus 3 months postoperative (P=0.0005) and 3 months postoperative versus 6 months postoperative (P=0.002). There was no overall difference between psychosexual total score at 6 months after surgery and 1 year after prosthesis implantation (P=0.85). The patients perceived improvement in their erectile ability and libido. Concern about obtaining and maintaining an erection during intercourse was significantly alleviated. There was an increase in the frequency of sexual activity and an improvement in satisfaction with sex life. A decrease in feelings of sadness, depression, anxiety, anger, frustration, and embarrassment related to sexual activity was also noted. The current study demonstrates significant improvement in the psychosexual well being of multicomponent penile implant recipients, with attainment of a high level of patient satisfaction up to 1 year after surgery.
Yi, Na Young; Park, Shin Ae; Jeong, Man Bok; Kim, Won Tae; Kim, Se Eun; Kim, Ji Youn; Chae, Je Min; Jang, Kyoung Jin; Seong, Je Kyung; Seo, Kang Moon
2009-01-01
To evaluate motility of silicone orbital implants and corneoscleral prostheses, with and without use of a motility coupling post (MCP) in dogs. Eighteen mixed-breed dogs. The motility of an orbital silicone implant and corneoscleral prosthesis after enucleation (n = 6), evisceration (n = 6), or use of a MCP with evisceration (n = 6) in dogs were compared. One eye from each dog had surgery whereas the opposite eye was used as a control. Clinical evaluations were performed three times a week. Histopathology of the orbital tissues was performed 8 and 12 weeks after surgery. Implant motility in dogs with evisceration (vertical movement [VM] 8.04 +/- 2.13; horizontal movement [HM] 11 +/- 3.05) and evisceration with MCP (VM 9.61 +/- 1.59); HM was significantly greater than the enucleation group (VM 0.51 +/- 0.5; HM 1.22 +/- 0.68) (P < 0.01). Prosthetic motility in dogs with evisceration with MCP was significantly greater than in dogs with evisceration; dogs with evisceration had significantly greater motility than dogs with enucleation (P < 0.01). No postoperative complications were observed in any of the groups. No significant abnormalities were noted on histopathology. MCP placement in silicone orbital implants significantly enhanced the prosthetic motility in dogs. This study supports the use of MCP in silicone orbital implants to enhance corneoscleral prosthesis motility and cosmetics in dogs.
Timed activity performance in persons with upper limb amputation: A preliminary study.
Resnik, Linda; Borgia, Mathew; Acluche, Frantzy
55 subjects with upper limb amputation were administered the T-MAP twice within one week. To develop a timed measure of activity performance for persons with upper limb amputation (T-MAP); examine the measure's internal consistency, test-retest reliability and validity; and compare scores by prosthesis use. Measures of activity performance for persons with upper limb amputation are needed The time required to perform daily activities is a meaningful metric that implication for participation in life roles. Internal consistency and test-retest reliability were evaluated. Construct validity was examined by comparing scores by amputation level. Exploratory analyses compared sub-group scores, and examined correlations with other measures. Scale alpha was 0.77, ICC was 0.93. Timed scores differed by amputation level. Subjects using a prosthesis took longer to perform all tasks. T-MAP was not correlated with other measures of dexterity or activity, but was correlated with pain for non-prosthesis users. The timed scale had adequate internal consistency and excellent test-retest reliability. Analyses support reliability and construct validity of the T-MAP. 2c "outcomes" research. Published by Elsevier Inc.
Methods for reducing energy dissipation in cosmetic gloves.
Herder, J L; Cool, J C; Plettenburg, D H
1998-06-01
For cosmetic reasons, hand prostheses are provided with cosmetic gloves. Their pleasing appearance, however, is accompanied by poor mechanical behavior, resulting in a negative influence on prosthesis operation. Glove stiffness is high and nonlinear, and internal friction in the glove material causes energy dissipation (hysteresis). In this article, two methods for reducing hysteresis in cosmetic gloves are proposed, that may be applied independently or in combination. Glove modification. Altering the mechanical properties of the glove itself is the first method that is presented. It was found possible to reduce both stiffness and hysteresis about 50% by forming grooves into the inside of the glove. Together with the evaluation of this method, several properties of the cosmetic glove were determined. Motion optimization. Additionally, a second method for reducing hysteresis was developed. The amount of hysteresis is influenced by the way the glove is forced to deform. The prosthesis mechanism, determining this deformation, was designed for minimum hysteresis and maximum cosmesis. For the prosthesis-glove combination used in this study, thumb motion optimization reduced hysteresis by about 65%.
[A primary application and evaluation of temporomandibular joint replacement with stock prosthesis].
Zhang, Xiao-hu; Chen, Min-jie; Qiu, Ya-ting; Yang, Chi
2012-06-01
To evaluate the effect of total joint replacement in treatment of temporomandibular joint(TMJ) osteoarthropathy with stock prostheses. Six female patients involving 10 joints (2 unilateral and 4 bilateral), with an average age of 59 years old, were involved in this study. Three patients (5 joints) were diagnosed as internal derangement in V stage depending on MRI, 3D-CT findings and clinical characteristics. The other 3 patients (5 joints) had histories of failed temporomandibular joint operation using costochondral graft or temporalis fascial flap. The maximal mouth opening was 1.9 cm on average (range, 1.0 to 2.9cm). All the joints were replaced with Biomet standard prosthesis under general anesthesia. The follow-up period was from 7 to 49 months (average, 17.5 months). All the operations were successfully performed. Heterotopic ossification happened in a bilateral case 1 year postoperatively. One patient with bilateral joint disease complained of severe uncomfortable feeling in the region of the ears and the temples, although there was no significant positive signs according to an ENT examination. Pain relief of the joint and mouth opening improvement were significant in 4 patients. No failure was noted secondary to infection or loosening of the prostheses. The occlusal relationship kept stable postoperatively in all cases. Total TMJ joint replacement with standard prosthesis is a good choice for TMJ reconstruction. It can significantly reduce joint pain and the mouth opening limitation resulted from osteoarthritis. Long-term result remains to be evaluated based on a long-term follow-up.
Bagley, Anita M; Molitor, Fred; Wagner, Lisa V; Tomhave, Wendy; James, Michelle A
2006-07-01
The Unilateral Below Elbow Test (UBET) was developed to evaluate function in bimanual activities for both the prosthesis wearer and non-wearer. Nine tasks were chosen for each of four age-specific categories defined by development stages of hand function (2-4y, 5-7y, 8-10y, and 11-21y). Two scales, Completion of Task and Method of Use, were designed to rate performance. To measure reliability, four occupational therapists scored samples of videotaped UBET performances. For Completion of Task, an interval scale, agreement in scoring was measured with interclass correlation coefficients (ICC; n=9; five females, four males). For Method of Use, a nominal scale, chance-adjusted association was calculated with Cohen's kappa coefficients (interobserver n=198; 111 females, 87 males; intraobserver n=93; 56 females, 37 males). For Completion of Task, the average ICC was 0.87 for the prosthesis-on condition, and 0.85 for the prosthesis-off condition. ICCs exceeded 0.80 for eight out of nine tasks for the two older age groups, but for only five out of nine tasks in the younger age groups. Higher inter- and intraobserver kappa coefficients for Method of Use resulted when scoring children with their prostheses on versus off. The oldest age group had lower kappa values than the other three groups. The UBET is recommended for the functional evaluation of Completion of Task in children with unilateral congenital below elbow deficiency with and without their prostheses. Method of Use scoring can evaluate individuals for directed therapy interventions or prosthetic training.
NASA Astrophysics Data System (ADS)
Yang, Jinkyu; Silvestro, Claudio; Sangiorgio, Sophia N.; Borkowski, Sean L.; Ebramzadeh, Edward; De Nardo, Luigi; Daraio, Chiara
2012-01-01
We propose a new biomedical sensing technique based on highly nonlinear solitary waves to assess orthopaedic implant stability in a nondestructive and efficient manner. We assemble a granular crystal actuator consisting of a one-dimensional tightly packed array of spherical particles, to generate acoustic solitary waves. Via direct contact with the specimen, we inject acoustic solitary waves into a biomedical prosthesis, and we nondestructively evaluate the mechanical integrity of the bone-prosthesis interface, studying the properties of the waves reflected from the contact zone between the granular crystal and the implant. The granular crystal contains a piezoelectric sensor to measure the travelling solitary waves, which allows it to function also as a sensor. We perform a feasibility study using total hip arthroplasty (THA) samples made of metallic stems implanted in artificial composite femurs using polymethylmethacrylate for fixation. We first evaluate the sensitivity of the proposed granular crystal sensor to various levels of prosthesis insertion into the composite femur. Then, we impose a sequence of harsh mechanical loading on the THA samples to degrade the mechanical integrity at the stem-cement interfaces, using a femoral load simulator that simulates aggressive, accelerated physiological loading. We investigate the implant stability via the granular crystal sensor-actuator during testing. Preliminary results suggest that the reflected waves respond sensitively to the degree of implant fixation. In particular, the granular crystal sensor-actuator successfully detects implant loosening at the stem-cement interface following violent cyclic loading. This study suggests that the granular crystal sensor and actuator has the potential to detect metal-cement defects in a nondestructive manner for orthopaedic applications.
B, Sreedevi; Anne, Gopinadh; Manne, Prakash; Bindu O, Swetha Hima; Atla, Jyothi; Deepthi, Sneha; Chaitanya A, Krishna
2014-01-01
Background: Prosthodontic treatment involves clinical procedures which influence speech performance directly or indirectly. Prosthetic rehabilitation of missing teeth with partial or complete maxillary removable dentures influences the individual voice characteristics like Phonation, resonance etc. Aim: To evaluate the effect of Acrylic palatal plate thickness (1mm-3mm) of maxillary prosthesis on phonation. Materials and Methods: Twelve subjects were selected randomly between the age group of 20-25 years who have full complement of teeth and have no speech problems. Speech evaluation was done under four experimental conditions i.e. Without any experimental acrylic palatal plate (control), with experimental acrylic palatal plates of thickness 1 mm, 2 mm and 3 mm respectively. The speech material for phonation test consisted of Vowels sounds /a/, /i/, and /o/. Speech analysis to assess phonation was done using digital acoustic analysis (PRAAT software). The obtained results were statistically analyzed by One-way ANOVA and Tukey’s multiple post-hoc for comparison of four experimental conditions with respect to different vowel sounds. Results: Mean harmonics to noise ratio (HNR) values obtained for all the Experimental conditions did not show significant difference (p>0.05). In conclusion, an increase in the thickness of the acrylic palatal plate of maxillary prosthesis for about 1 mm - 3mm in complete or partial maxillary removable dentures resulted in no significant effect on phonation of vowel sounds /a/, /i/ and /o/. Conclusion: Increasing the thickness of the palatal plate from 1 mm to 3 mm has not shown any significant effect on the phonation. PMID:24959508
Jain, Sumeet; Jain, Parul
2016-01-01
Squamous cell carcinoma of the eyelid is the second most common malignant neoplasm of the eye with the incidence of 0.09 and 2.42 cases/100 000 people. Orbital invasion is a rare complication but, if recognized early, can be treated effectively with exenteration. Although with advancements in technology such as computer-aided design and computer-aided manufacturing, material science, and retentive methods like implants, orbital prosthesis with stock ocular prosthesis made of methyl methacrylate retained by anatomic undercuts is quiet effective and should not be overlooked and forgotten. This clinical report describes prosthetic rehabilitation of two male patients with polymethyl methacrylate resin orbital prosthesis after orbital exenteration, for squamous cell carcinoma of the upper eyelid. The orbital prosthesis was sufficiently retained by hard and soft tissue undercuts without any complications. The patients using the prosthesis are quite satisfied with the cosmetic results and felt comfortable attending the social events.
Catastrophic metallosis after tumoral knee prosthesis failure: A case report.
La Verde, Luca; Fenga, Domenico; Spinelli, Maria Silvia; Campo, Francesco Rosario; Florio, Michela; Rosa, Michele Attilio
2017-01-01
Metallosis is a condition characterized by an infiltration of periprosthetic soft tissues and bone by metallic debris resulting from wear or failure of joint arthroplasties. Authors describe a case of a 45-year-old man treated for an osteosarcoma of the distal femur with a modular prosthesis when he was 18 years old, he developed massive metallosis with skin dyspigmentation after 17 years. His medical\\surgical history was remarkable for a left tumoral knee prosthesis implanted 21 years ago. Two years before revision, the patient had a car accident with a two-points prosthesis breakage and despite the surgeon's advice, the patient refused surgery. In two years, prosthesis malfunction caused a progressive catastrophic soft tissues infiltration of metallic debris. Authors suggest that if prosthesis fracture is detected, revision surgery should be attempted as earlier as possible. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
Microbial biofilms on facial prostheses.
Ariani, Nina; Vissink, Arjan; van Oort, Robert P; Kusdhany, Lindawati; Djais, Ariadna; Rahardjo, Tri Budi W; van der Mei, Henny C; Krom, Bastiaan P
2012-01-01
The composition of microbial biofilms on silicone rubber facial prostheses was investigated and compared with the microbial flora on healthy and prosthesis-covered skin. Scanning electron microscopy showed the presence of mixed bacterial and yeast biofilms on and deterioration of the surface of the prostheses. Microbial culturing confirmed the presence of yeasts and bacteria. Microbial colonization was significantly increased on prosthesis-covered skin compared to healthy skin. Candida spp. were exclusively isolated from prosthesis-covered skin and from prostheses. Biofilms from prostheses showed the least diverse band-profile in denaturing gradient gel electrophoresis (DGGE) whereas prosthesis-covered skin showed the most diverse band-profile. Bacterial diversity exceeded yeast diversity in all samples. It is concluded that occlusion of the skin by prostheses creates a favorable niche for opportunistic pathogens such as Candida spp. and Staphylococcus aureus. Biofilms on healthy skin, skin underneath the prosthesis and on the prosthesis had a comparable composition, but the numbers present differed according to the microorganism.
Amputation and prosthesis implantation shape body and peripersonal space representations
Canzoneri, Elisa; Marzolla, Marilena; Amoresano, Amedeo; Verni, Gennaro; Serino, Andrea
2013-01-01
Little is known about whether and how multimodal representations of the body (BRs) and of the space around the body (Peripersonal Space, PPS) adapt to amputation and prosthesis implantation. In order to investigate this issue, we tested BR in a group of upper limb amputees by means of a tactile distance perception task and PPS by means of an audio-tactile interaction task. Subjects performed the tasks with stimulation either on the healthy limb or the stump of the amputated limb, while wearing or not wearing their prosthesis. When patients performed the tasks on the amputated limb, without the prosthesis, the perception of arm length shrank, with a concurrent shift of PPS boundaries towards the stump. Conversely, wearing the prosthesis increased the perceived length of the stump and extended the PPS boundaries so as to include the prosthetic hand, such that the prosthesis partially replaced the missing limb. PMID:24088746
Rezaei, Farshid; Hassani, Kamran; Solhjoei, Nosratollah; Karimi, Alireza
2015-12-01
Total hip replacement (THR) has been ranked within the most typical surgical processes in the world. The durability of the prosthesis and loosening of prosthesis are the main concerns that mostly reported after THR surgeries. In THR, the femoral prosthesis can be fixed by either cement or cementless methods in the patient's bones. In both procedures, the stability of the prosthesis in the hosted bone has a key asset in its long-term durability and performance. This study aimed to execute a comparative finite element simulation to assess the load transfer between the prosthesis, which is made of carbon/PEEK composite and stainless steel/titanium, and the femur bone. The mechanical behavior of the cortical bone was assumed as a linear transverse isotropic while the spongy bone was modeled like a linear isotropic material. The implants were made of stainless steel (316L) and titanium alloy as they are common materials for implants. The results showed that the carbon/PEEK composites provide a flatter load transfer from the upper body to the leg compared to the stainless steel/titanium prosthesis. Furthermore, the results showed that the von Mises stress, principal stress, and the strain in the carbon/PEEK composites prosthesis were significantly lower than that made of the stainless steel/titanium. The results also imply that the carbon/PEEK composites can be applied to introduce a new optimum design for femoral prosthesis with adjustable stiffness, which can decrease the stress shielding and interface stress. These findings will help clinicians and biomedical experts to increase their knowledge about the hip replacement.
Lago, Laura; Rilo, Benito; Fernández-Formoso, Noelia; DaSilva, Luis
2017-08-01
Rehabilitation with implants is a challenge. Having previous evaluation criteria is key to establishing the best treatment for the patient. In addition to clinical and radiological aspects, the prosthetic parameters must be taken into account in the initial workup, since they allow discrimination between fixed and removable rehabilitation. We present a study protocol that analyzes three basic prosthetic aspects. First, denture space defines the need to replace teeth, tissue, or both. Second, lip support focuses on whether or not to include a flange. Third, the smile line warns of potential risks in esthetic rehabilitation. Combining these parameters allows us to make a decision as to the most suitable type of prosthesis. The proposed protocol is useful for assessing the prosthetic parameters that influence decision making as to the best-suited type of restoration. From this point of view, we think it is appropriate for the initial approach to the patient. In any case, other considerations of study may amend the proposal. © 2016 by the American College of Prosthodontists.
Fatone, Stefania; Caldwell, Ryan
2017-06-01
Current transfemoral prosthetic sockets are problematic as they restrict function, lack comfort, and cause residual limb problems. Development of a subischial socket with lower proximal trim lines is an appealing way to address this problem and may contribute to improving quality of life of persons with transfemoral amputation. The purpose of this study was to illustrate the use of a new subischial socket in two subjects. Case series. Two unilateral transfemoral prosthesis users participated in preliminary socket evaluations comparing functional performance of the new subischial socket to ischial containment sockets. Testing included gait analysis, socket comfort score, and performance-based clinical outcome measures (Rapid-Sit-To-Stand, Four-Square-Step-Test, and Agility T-Test). For both subjects, comfort was better in the subischial socket, while gait and clinical outcomes were generally comparable between sockets. While these evaluations are promising regarding the ability to function in this new socket design, more definitive evaluation is needed. Clinical relevance Using gait analysis, socket comfort score and performance-based outcome measures, use of the Northwestern University Flexible Subischial Vaccum Socket was evaluated in two transfemoral prosthesis users. Socket comfort improved for both subjects with comparable function compared to ischial containment sockets.
Chadwell, Alix; Kenney, Laurence; Thies, Sibylle; Galpin, Adam; Head, John
2016-01-01
Users of myoelectric prostheses can often find them difficult to control. This can lead to passive-use of the device or total rejection, which can have detrimental effects on the contralateral limb due to overuse. Current clinically available prostheses are “open loop” systems, and although considerable effort has been focused on developing biofeedback to “close the loop,” there is evidence from laboratory-based studies that other factors, notably improving predictability of response, may be as, if not more, important. Interestingly, despite a large volume of research aimed at improving myoelectric prostheses, it is not currently known which aspect of clinically available systems has the greatest impact on overall functionality and everyday usage. A protocol has, therefore, been designed to assess electromyographic (EMG) skill of the user and predictability of the prosthesis response as significant parts of the control chain, and to relate these to functionality and everyday usage. Here, we present the protocol and results from early pilot work. A set of experiments has been developed. First, to characterize user skill in generating the required level of EMG signal, as well as the speed with which users are able to make the decision to activate the appropriate muscles. Second, to measure unpredictability introduced at the skin–electrode interface, in order to understand the effects of the socket-mounted electrode fit under different loads on the variability of time taken for the prosthetic hand to respond. To evaluate prosthesis user functionality, four different outcome measures are assessed. Using a simple upper limb functional task prosthesis users are assessed for (1) success of task completion, (2) task duration, (3) quality of movement, and (4) gaze behavior. To evaluate everyday usage away from the clinic, the symmetricity of their real-world arm use is assessed using activity monitoring. These methods will later be used to assess a prosthesis user cohort to establish the relative contribution of each control factor to the individual measures of functionality and everyday usage (using multiple regression models). The results will support future researchers, designers, and clinicians in concentrating their efforts on the area that will have the greatest impact on improving prosthesis use. PMID:27597823
[The influence of the stapes prosthesis on the long-term results of stapedectomy (author's transl)].
Schöndorf, J; Pilorget, J; Gräber, S
1980-05-01
In comparing two groups of patients following stapedectomies, significantly better long-term results were obtained by using the Robinson steel piston prosthesis (n = 85) as opposed to the wire prosthesis (n = 74). By so doing, the impairment of sound transmission was reduced and the Carhart depression counterbalanced. This improvement is thought to result from the increased mass and stability of the steel prosthesis as well as from its more correct anatomical positioning.
Schuhbaeck, Annika; Weingartner, Christina; Arnold, Martin; Schmid, Jasmin; Pflederer, Tobias; Marwan, Mohamed; Rixe, Johannes; Nef, Holger; Schneider, Christian; Lell, Michael; Uder, Michael; Ensminger, Stephan; Feyrer, Richard; Weyand, Michael; Achenbach, Stephan
2015-07-01
The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Lu, Minxun; Li, Yongjiang; Luo, Yi; Zhang, Wenli; Zhou, Yong; Tu, Chongqi
2018-03-06
Currently, it is challenging to treat massive bone defects of proximal tibia. Although numerous methods are available for reconstruction with epiphysis preservation, limitations in knee function and complications are noted with these methods. Our paper describes our attempt to reconstruct a marked defect in the proximal tibia with an uncemented three-dimensional (3D)-printed prosthesis and to evaluate the prosthesis design and short-term outcomes. A 15-year-old boy with metaphyseal osteosarcoma of the tibia underwent intercalary allograft reconstruction following wide tumour resection with epiphysis preservation. However, chronic allograft rejection and/or infection occurred after the surgery and a sinus tract was formed. The rejection and/or infection process was successfully stopped by the removal of the graft and implantation of an antibiotic-loaded cement spacer; however, the limb function was poor. Because of the irregular shape of the defect and the excessively short length of the residual proximal tibia, we used the 3D printing technology to design and fabricate a personalised prosthesis to reconstruct the defect, with the preservation of the knee joint. At the last follow-up at 26 months, the patient had satisfactory limb function. The 3D-printed prosthesis may be a feasible option in the reconstruction of tibial metaphyseal defects with the preservation of the knee joint. Moreover, it can result in good postoperative function and low complication rates. However, a long-term follow-up is required to clarify its long-term outcomes.
Filisetti, Claudia; Costanzo, Sara; Marinoni, Federica; Vella, Claudio; Klercy, Catherine; Riccipetitoni, Giovanna
2016-05-01
The use of prosthetic patches of non-absorbable materials represents a valid tool in the treatment of abdominal wall and diaphragmatic defects in pediatric age. In recent years research has developed biological dermal scaffolds made from a sheet of acellular matrix that can provide the desired support and reduce the occurrence of complications from non-absorbable implant. We present our experience and a systematic review to evaluate the use of biologic prosthesis for abdominal wall closure in pediatric patients. The study from January 2009 to January 2015 involved 20 patients treated with Permacol™ implant. We observed postoperative complications only in patients treated for abdominal wall closure, which is the major indication for the use of Permacol™. We conducted a systematic review and meta-analysis (according to PRISMA) on PubMed/Medline, Scopus and EMBASE regarding the use of biological prosthesis in pediatric population considering the incidence of complications as the primary outcome. 3/20 patients experienced complications: 2 patients with skin necrosis healed conservatively and 1 of them developed laparocele. Thus only 1 patient with incisional hernia had significant surgery complication. In patients who were permanently implanted with Permacol™ it has not determined adverse reactions with optimal functional outcome. In accordance with the few data (case reports and case series) reported in literature about pediatric patients, our experience in different pathologies and applications has shown the effectiveness of Permacol™, in particular for the non-occurrence of infections, that often affect the use of prosthesis.
Geruschat, Duane R; Richards, Thomas P; Arditi, Aries; da Cruz, Lyndon; Dagnelie, Gislin; Dorn, Jessy D; Duncan, Jacque L; Ho, Allen C; Olmos de Koo, Lisa C; Sahel, José-Alain; Stanga, Paulo E; Thumann, Gabriele; Wang, Vizhong; Greenberg, Robert J
2016-05-01
The purpose of this analysis was to compare observer-rated tasks in patients implanted with the Argus II Retinal Prosthesis System, when the device is ON versus OFF. The Functional Low-Vision Observer Rated Assessment (FLORA) instrument was administered to 26 blind patients implanted with the Argus II Retinal Prosthesis System at a mean follow-up of 36 months. FLORA is a multi-component instrument that consists in part of observer-rated assessment of 35 tasks completed with the device ON versus OFF. The ease with which a patient completes a task is scored using a four-point scale, ranging from easy (score of 1) to impossible (score of 4). The tasks are evaluated individually and organised into four discrete domains, including 'Visual orientation', 'Visual mobility', 'Daily life and 'Interaction with others'. Twenty-six patients completed each of the 35 tasks. Overall, 24 out of 35 tasks (69 per cent) were statistically significantly easier to achieve with the device ON versus OFF. In each of the four domains, patients' performances were significantly better (p < 0.05) with the device ON versus OFF, ranging from 19 to 38 per cent improvement. Patients with an Argus II Retinal Prosthesis implanted for 18 to 44 months (mean 36 months), demonstrated significantly improved completion of vision-related tasks with the device ON versus OFF. © 2016 The Authors Clinical and Experimental Optometry published by John Wiley & Sons Australia, Ltd on behalf of Optometry Australia.
Ninu, Andrei; Dosen, Strahinja; Muceli, Silvia; Rattay, Frank; Dietl, Hans; Farina, Dario
2014-09-01
In closed-loop control of grasping by hand prostheses, the feedback information sent to the user is usually the actual controlled variable, i.e., the grasp force. Although this choice is intuitive and logical, the force production is only the last step in the process of grasping. Therefore, this study evaluated the performance in controlling grasp strength using a hand prosthesis operated through a complete grasping sequence while varying the feedback variables (e.g., closing velocity, grasping force), which were provided to the user visually or through vibrotactile stimulation. The experiments were conducted on 13 volunteers who controlled the Otto Bock Sensor Hand Speed prosthesis. Results showed that vibrotactile patterns were able to replace the visual feedback. Interestingly, the experiments demonstrated that direct force feedback was not essential for the control of grasping force. The subjects were indeed able to control the grip strength, predictively, by estimating the grasping force from the prosthesis velocity of closing. Therefore, grasping without explicit force feedback is not completely blind, contrary to what is usually assumed. In our study we analyzed grasping with a specific prosthetic device, but the outcomes are also applicable for other devices, with one or more degrees-of-freedom. The necessary condition is that the electromyography (EMG) signal directly and proportionally controls the velocity/grasp force of the hand, which is a common approach among EMG controlled prosthetic devices. The results provide important indications on the design of closed-loop EMG controlled prosthetic systems.
Richards, Thomas P; Arditi, Aries; da Cruz, Lyndon; Dagnelie, Gislin; Dorn, Jessy D; Duncan, Jacque L; Ho, Allen C; Olmos de Koo, Lisa C; Sahel, José‐Alain; Stanga, Paulo E; Thumann, Gabriele; Wang, Vizhong; Greenberg, Robert J
2016-01-01
Abstract Objective The purpose of this analysis was to compare observer‐rated tasks in patients implanted with the Argus II Retinal Prosthesis System, when the device is ON versus OFF. Methods The Functional Low‐Vision Observer Rated Assessment (FLORA) instrument was administered to 26 blind patients implanted with the Argus II Retinal Prosthesis System at a mean follow‐up of 36 months. FLORA is a multi‐component instrument that consists in part of observer‐rated assessment of 35 tasks completed with the device ON versus OFF. The ease with which a patient completes a task is scored using a four‐point scale, ranging from easy (score of 1) to impossible (score of 4). The tasks are evaluated individually and organised into four discrete domains, including ‘Visual orientation’, ‘Visual mobility’, ‘Daily life and ‘Interaction with others’. Results Twenty‐six patients completed each of the 35 tasks. Overall, 24 out of 35 tasks (69 per cent) were statistically significantly easier to achieve with the device ON versus OFF. In each of the four domains, patients’ performances were significantly better (p < 0.05) with the device ON versus OFF, ranging from 19 to 38 per cent improvement. Conclusion Patients with an Argus II Retinal Prosthesis implanted for 18 to 44 months (mean 36 months), demonstrated significantly improved completion of vision‐related tasks with the device ON versus OFF. PMID:26804484
Xu, Xiangliang; Luo, Danmei; Guo, Chuanbin; Rong, Qiguo
2017-08-01
A novel and custom-made selective laser melting (SLM) 3D-printed alloplastic temporomandibular joint (TMJ) prosthesis is proposed. The titanium-6aluminium-4vanadium (Ti-6Al-4V) condyle component and ultra-high molecular weight polyethylene (UHMWPE) fossa component comprised the total alloplastic TMJ replacement prosthesis. For the condyle component, an optimized tetrahedral open-porous scaffold with combined connection structures, i.e. an inlay rod and an onlay plate, between the prosthesis and remaining mandible was designed. The trajectory of movement of the intact condyle was assessed via kinematic analysis to facilitate the design of the fossa component. The behaviours of the intact mandible and mandible with the prosthesis were compared. The biomechanical behaviour was analysed by assessing the stress distribution on the prosthesis and strain distribution on the mandible. After muscle force was applied, the magnitude of the compressive strain on the condyle neck of the mandible with the prosthesis was lower than that on the condyle neck of the intact mandible, with the exception of the area about the screws; additionally, the magnitude of the strain at the scaffold-bone interface was relatively high. Copyright © 2017. Published by Elsevier Ltd.
Aschoff, H H; Clausen, A; Hoffmeister, T
2009-01-01
The implantation of an intramedullary transcutaneously conducted femur prosthesis presents a rather new procedure for the rehabilitation of above-knee amputated patients. The aim of the so-called endo-exo prosthesis is to avoid the well-known problems at the interface between the sleeve of the prosthesis and the soft tissue coat of the femur stump which often impedes an inconspicuous and harmonic gait. The company ERSKA Implants in Lübeck/Germany has developed an intramedullary femur prosthesis with a spongiosa metal-configurated relief surface which, when implanted cementless, enables a secure osseointegration and allows a more direct transmission of muscle power to the lower leg prosthesis. A minimum length of 16-18 cm and a sufficient soft tissue coverage of the femur stump is needed. The problems at the perforation point of the implant through the soft tissue coat can be handled or even be avoided and they do not necessarily provoke an intramedullary infection. We report on 30 cases that were operated between 1999 and 2008. The design of the prosthesis, aspects of the operative procedure and latest results are presented.
Linking of total elbow prosthesis during surgery; a biomechanical analysis.
De Vos, Maarten J; Wagener, Marc L; Hendriks, Jan C M; Eygendaal, Denise; Verdonschot, Nico
2013-09-01
Presently, 2 types of elbow prostheses are used: unlinked and linked. The Latitude total elbow prosthesis allows the surgeon to decide during the implantation whether the prosthesis is placed unlinked or linked, and whether the native radial head is retained, resected, or replaced. The purpose of this study is to assess and to compare the varus and valgus laxity of the unlinked and linked version of the latitude total elbow prosthesis with: (1) the native radial head preserved, (2) the native radial head excised, and (3) the native radial head replaced by a radial head component. Biomechanical testing was performed on 14 fresh-frozen upper limb specimens. Linking the prosthesis predominantly influences the valgus laxity of the elbow. Linking the Latitude total elbow prosthesis results in increased valgus stability. In the linked version of the total elbow prosthesis, the radial head only plays a small part in both valgus and varus stability. An unlinked situation is not advised in absence of a native radial head or in case of inability to replace the radial head. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.
[Osseointegration as a method of direct stabilization of amputation prostheses to the bone].
Rochmiński, Robert; Sibński, Marcin; Synder, Marek
2011-01-01
This article summarizes important advantages, disadvantages and the process of treatment of patients after lower limb amputation on the level of the femur, with osseointegrated prosthesis. In the process of treatment bone-integrated material is implanted to the femur, with allows for structural and functional connection between live tissue and the prosthesis. This solution allows the patient for easy usage and direct steerage of the prosthesis, transferring of body weight to the floor and detection of sensation in the moment of contact between prosthesis and the ground. Osseointegrated prostheses in the femur gives the opportunity not to use the traditional solutions and socket-related problems as: mobility difficulties, skin sores, rush, pain during weight bearing, temporary changes of the stump volume, difficulty donning the prosthesis, unreliability of prosthesis being securely suspended. Osseointegration is possible even in cases, when quality of skin and short stump enables to use the traditional prosthetic socket. It is used after lower and upper limbs amputations. This kind of prosthetic solutions has some disadvantages and limitations. It is expensive and demanding. It can be used in cooperative patients, who take active part in the process of implantation, rehabilitation and in future usage if the prosthesis.
"Bail out" procedures for malpositioning of aortic valve prosthesis (CoreValve).
Vavouranakis, Manolis; Vrachatis, Dimitrios A; Toutouzas, Konstantinos P; Chrysohoou, Christina; Stefanadis, Christodoulos
2010-11-05
Two techniques for correcting malpositioning occurring during percutaneous aortic valve replacement (PAVR) with the CoreValve ReValving™ System are described in this article. The "Removing and Reinserting Technique" was used in 2 patients, in whom the prosthesis was positioned too high. The "Snare Technique" was used in 1 patient, in whom the prosthesis was implanted too low. In all patients the aortic valve prosthesis was successfully re-implanted. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.
A fiber-reinforced composite prosthesis restoring a lateral midfacial defect: a clinical report.
Kurunmäki, Hemmo; Kantola, Rosita; Hatamleh, Muhanad M; Watts, David C; Vallittu, Pekka K
2008-11-01
This clinical report describes the use of a glass fiber-reinforced composite (FRC) substructure to reinforce the silicone elastomer of a large facial prosthesis. The FRC substructure was shaped into a framework and embedded into the silicone elastomer to form a reinforced facial prosthesis. The prosthesis is designed to overcome the disadvantages associated with traditionally fabricated prostheses; namely, delamination of the silicone of the acrylic base, poor marginal adaptation over time, and poor simulation of facial expressions.
Negative Gauge Pressure Moisture Management and Secure Adherence Device for Prosthetic Limbs
2013-03-01
prosthesis feels like it is sliding up and down or falling off when I am active. D. I have been more active than normal as a result of this prosthesis ...temperature. 3. My prosthesis feels like it is sliding up and down or falling off when I am active. 4. I have been more active than normal as a result of...objective of this research was to develop and test a novel prosthesis incorporating a negative gauge pressure moisture management and secure
Development and Application of a Tendon Prosthesis for Early Functional Restoration of the Hand.
1975-09-01
F’A-AOk 322 JEFFERSON MEDICAL COLL PHILADELPHIA PA F/B 6/5 DEVELOPMENT AND APPLICATION OF A TENDON PROSTHESIS FOR EARLY FU--ETC(U) SEP 75 J M HUNTER...LEVEL INVENTORY DEELOPKWTI AND APPLICATION OF A TENDON PROSTHESIS FOR EARLY FUNCTIOKAL RESTORATION OF THE RAND BIDETICATION DISTRIBUTION STATEMENT A...AND RETURN TO DTIC-DDA-2 FORM DOCUMENT PROCESSING SHEETCToc 79 0 AD DEVELOPNDT AND APPLICATION OF A TENDOR PROSTHESIS FOR EARLY FUNCTIONAL
Kinematic analysis of a posterior-stabilized knee prosthesis.
Zhao, Zhi-Xin; Wen, Liang; Qu, Tie-Bing; Hou, Li-Li; Xiang, Dong; Bin, Jia
2015-01-20
The goal of total knee arthroplasty (TKA) is to restore knee kinematics. Knee prosthesis design plays a very important role in successful restoration. Here, kinematics models of normal and prosthetic knees were created and validated using previously published data. Computed tomography and magnetic resonance imaging scans of a healthy, anticorrosive female cadaver were used to establish a model of the entire lower limbs, including the femur, tibia, patella, fibula, distal femur cartilage, and medial and lateral menisci, as well as the anterior cruciate, posterior cruciate, medial collateral, and lateral collateral ligaments. The data from the three-dimensional models of the normal knee joint and a posterior-stabilized (PS) knee prosthesis were imported into finite element analysis software to create the final kinematic model of the TKA prosthesis, which was then validated by comparison with a previous study. The displacement of the medial/lateral femur and the internal rotation angle of the tibia were analyzed during 0-135° flexion. Both the output data trends and the measured values derived from the normal knee's kinematics model were very close to the results reported in a previous in vivo study, suggesting that this model can be used for further analyses. The PS knee prosthesis underwent an abnormal forward displacement compared with the normal knee and has insufficient, or insufficiently aggressive, "rollback" compared with the lateral femur of the normal knee. In addition, a certain degree of reverse rotation occurs during flexion of the PS knee prosthesis. There were still several differences between the kinematics of the PS knee prosthesis and a normal knee, suggesting room for improving the design of the PS knee prosthesis. The abnormal kinematics during early flexion shows that the design of the articular surface played a vital role in improving the kinematics of the PS knee prosthesis.
An integrated CAD/CAM/robotic milling method for custom cementless femoral prostheses.
Wen-ming, Xi; Ai-min, Wang; Qi, Wu; Chang-hua, Liu; Jian-fei, Zhu; Fang-fang, Xia
2015-09-01
Aseptic loosening is the primary cause of cementless femoral prosthesis failure and is related to the primary stability of the cementless femoral prosthesis in the femoral cavity. The primary stability affects both the osseointegration and the long-term stability of cementless femoral prostheses. A custom cementless femoral prosthesis can improve the fit and fill of the prosthesis in the femoral cavity and decrease the micromotion of the proximal prosthesis such that the primary stability of the custom prosthesis can be improved, and osseointegration of the proximal prosthesis is achieved. These results will help to achieve long-term stability in total hip arthroplasty (THA). In this paper, we introduce an integrated CAD/CAM/robotic method of milling custom cementless femoral prostheses. The 3D reconstruction model uses femoral CT images and 3D design software to design a CAD model of the custom prosthesis. After the transformation matrices between two units of the robotic system are calibrated, consistency between the CAM software and the robotic system can be achieved, and errors in the robotic milling can be limited. According to the CAD model of the custom prosthesis, the positions of the robotic tool points are produced by the CAM software of the CNC machine. The normal vector of the three adjacent robotic tool point positions determines the pose of the robotic tool point. In conclusion, the fit rate of custom pig femur stems in the femoral cavities was 90.84%. After custom femoral prostheses were inserted into the femoral cavities, the maximum gaps between the prostheses and the cavities measured less than 1 mm at the diaphysis and 1.3 mm at the metaphysis. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.
Survival of various implant-supported prosthesis designs following 36 months of clinical function.
Rodriguez, A M; Orenstein, I H; Morris, H F; Ochi, S
2000-12-01
The use of endosseous dental implants to replace natural teeth lost to trauma, dental caries, or periodontal disease has become a predictable form of prosthetic treatment since gaining popularity in the early 1980s. While numerous clinical studies have focused on the survival of implants, few address the survival of different prosthesis designs. Beginning in 1991, 882 prostheses supported by more than 2,900 implants (687 patients) were placed by the Department of Veterans Affairs Dental Implant Clinical Research Group (DICRG). These prostheses were divided into five research strata based on arch location. The recommended design for each stratum was: bar-supported overdenture (maxillary completely edentulous); screw-retained hybrid denture (mandibular completely edentulous); screw-retained fixed partial denture (mandibular and maxillary posterior partially edentulous); and cemented single crown (maxillary anterior single tooth). Alternative overdenture designs were utilized in the edentulous arches when the recommended prosthesis could not be fabricated. Prosthesis success rates for the research strata were calculated for an observation time of up to 36 months following prosthesis placement. Success rates for the maxillary edentulous stratum ranged from 94.6% for the bar-retained overdenture supported by five to six fixtures to 81.8% for the cap-retained overdenture. The mandibular edentulous strata produced success rates of 98.1% for the fixed hybrid prosthesis to 91.7% for the cap-retained prosthesis. Success rates for maxillary and mandibular posterior fixed partial dentures were 94.3% and 92.6%, respectively, while the maxillary anterior single-tooth prosthesis yielded a success rate of 98.1% for the 36-month observation period. The recommended prosthesis designs investigated in this study proved to be reliable, with encouraging success rates for an observation period of 36 months following placement.
Next generation shape memory prosthesis (NiTiBOND) for stapedotomy: Short-term results.
Green, J Douglas; McElveen, John T
2017-04-01
To review hearing results and complications for the NiTiBOND next generation shape memory prosthesis and compare them with results for the current shape memory prosthesis (SMart). Retrospective, multicenter chart review. Primary laser stapedotomy was performed using either a NiTiBOND or a SMart prosthesis. Ninety-two ears in 79 patients were included in the study (67.4% female), 52 with the NiTiBOND prosthesis and 40 with the SMart prosthesis. Data collected included demographic variables, pre- and postoperative pure-tone air and bone conduction thresholds, speech discrimination scores, complications, and the need for revision surgery. Pure-tone average (PTA) and PTA air-bone gap (ABG) pre- and postoperative were computed. Success was defined as a postoperative ABG of ≤10 dB. There were no significant differences between groups in hearing results, including improvement in ABG, change in speech discrimination, change in air or bone PTA, or change in high-frequency bone PTA. Short-term (mean = 4.4 and 4.9 weeks, respectively) success rates for the NiTiBOND and SMart prostheses were 84.6% and 70.0%, respectively, with this difference closing at the most recent test (83.7% and 80.0%, respectively). No revision surgery took place in either group, and there were no differences in complications such as dizziness, tinnitus, or taste disturbance, though the NiTiBOND group tended to have a lower rate of transient or permanent vertigo. Compared with the SMart prosthesis, the NiTiBOND prosthesis is a safe prosthesis that achieves at least comparable hearing results and may offer some surgical advantages. 4 Laryngoscope, 127:915-920, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.
Munot, Vimal Kantilal; Nayakar, Ramesh P; Patil, Raghunath
2017-01-01
The restoration of normal function and esthetic appearance with a dental prosthesis is a major challenge in the rehabilitation of patients who have lost their teeth and surrounding bone because of surgery for oral cyst or tumor. Rehabilitation with fixed or removable prosthesis is even more challenging when the edentulous span is long and the ridge is defective. Anatomic deformities and unfavorable biomechanics encountered in the region of resection add to the misery. In such situation, a fixed-removable prosthesis allows favorable biomechanical stress distribution along with restoration of esthetics, phonetics, comfort, hygiene, and better postoperative care and maintenance. This article describes rehabilitation of two cases with mandibular defects with an attachment-retained fixed-removable hybrid prosthesis.
21 CFR 876.3750 - Testicular prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a...
2012-10-01
materials to facilitate dissemination of this technique. 15. SUBJECT TERMS Transfemoral amputation, sub-ischial socket, prosthesis , vacuum-assisted...an appropriate mechanical pump to create suitable vacuum for suspension of the prosthesis ...sockets of highly active prosthesis users
21 CFR 878.3610 - Esophageal prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...
21 CFR 878.3610 - Esophageal prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...
21 CFR 878.3610 - Esophageal prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...
21 CFR 878.3610 - Esophageal prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...
21 CFR 878.3610 - Esophageal prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...
Gordon, Robert; Magee, Christopher; Frazer, Anna; Evans, Craig; McCosker, Kathryn
2010-06-01
This study compared the outcomes of an interim mechanical prosthesis program for lower limb amputees operated under a public and private model of service. Over a two-year period, 60 transtibial amputees were fitted with an interim prosthesis as part of their early amputee care. Thirty-four patients received early amputee care under a public model of service, whereby a prosthetist was employed to provide the interim mechanical prosthesis service. The remaining 26 patients received early amputee care under a private model of service, where an external company was contracted to provide the interim mechanical prosthesis service. The results suggested comparable clinical outcomes between the two patient groups. However, the public model appeared to be less expensive with the average labour cost per patient being 29.0% lower compared with the private model. The results suggest that a public model of service may provide a more comprehensive and less expensive interim prosthesis program for lower limb amputees.
von Schewelov, Thord; Besjakov, Jack; Sanzén, Lennart; Carlsson, Ake
2009-07-01
The press-fit condylar (PFC) cruciate-retaining total knee prosthesis is well documented in the literature. In 1997, a modification of the femoral component was introduced, and the prosthesis was renamed PFC-Sigma. The alteration may influence the migratory and rotational pattern of the tibial component and thus long-time survival rate. In this radiostereometric analysis, we found that the micromotion of the PFC-Sigma prosthesis differs slightly from the original PFC design, an advantage of the PFC-Sigma prosthesis. The median maximum total point motion at 5 years was 0.64 mm for the PFC-Sigma design and 0.79 mm for the previous version of PFC (P = .9). However, the PFC-Sigma rotated less around the transverse (x) axis than did the PFC (medians, 0.22 mm and 0.48 mm, respectively; P = .04). From the radiostereometric, radiographic, and clinical data, we conclude that the PFC-Sigma knee prosthesis can be used with confidence.
Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review
S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi
2016-01-01
Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed. PMID:28959744
Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review.
S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi
2016-06-01
Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed.
Sensory feedback add-on for upper-limb prostheses.
Fallahian, Nader; Saeedi, Hassan; Mokhtarinia, Hamidreza; Tabatabai Ghomshe, Farhad
2017-06-01
Sensory feedback systems have been of great interest in upper-limb prosthetics. Despite tremendous research, there are no commercial modality-matched feedback systems. This article aims to introduce the first detachable and feedback add-on option that can be attached to in-use prostheses. A sensory feedback system was tested on a below-elbow myoelectric prosthesis. The aim was to have the amputee grasp fragile objects without crushing while other accidental feedback sources were blocked. A total of 8 successful trials (out of 10) showed that sensory feedback system decreased the amputee's visual dependency by improving awareness of his prosthesis. Sensory feedback system can be used either as post-fabrication (prosthetic add-on option) or para-fabrication (incorporated into prosthetic design). The use of these direct feedback systems can be explored with a current prosthesis before ordering new high-tech prosthesis. Clinical relevance This technical note introduces the first attach/detach-able sensory feedback system that can simply be added to in-use (myo)electric prosthesis, with no obligation to change prosthesis design or components.
Swamy, Girish N.; Quah, Conal; Bagouri, Elmunzar; Badhe, Nitin P.
2014-01-01
This paper reports a case of fatigue fracture of the femoral component in a cruciate-retaining cemented total knee arthroplasty (TKA). A 64-year-old man had undergone a primary TKA for osteoarthritis 10 years previously at another institution using the PFC-Sigma prosthesis. The patient recovered fully and was back to his regular activities. He presented with a history of sudden onset pain and locking of the left knee since the preceding three months. There was no history of trauma, and the patient was mobilizing with difficulty using crutches. Radiographs revealed fracture of the posterior condyle of the femoral prosthesis. Revision surgery was performed as an elective procedure revealing the broken prosthesis. The TC3RP-PFC revision prosthesis was used with a medial parapatellar approach. The patient recovered fully without any squeal. Mechanical failure of the knee arthroplasty prosthesis is rare, and nontraumatic fracture of the femoral metallic component has not been reported before. PMID:24587928
Swamy, Girish N; Quah, Conal; Bagouri, Elmunzar; Badhe, Nitin P
2014-01-01
This paper reports a case of fatigue fracture of the femoral component in a cruciate-retaining cemented total knee arthroplasty (TKA). A 64-year-old man had undergone a primary TKA for osteoarthritis 10 years previously at another institution using the PFC-Sigma prosthesis. The patient recovered fully and was back to his regular activities. He presented with a history of sudden onset pain and locking of the left knee since the preceding three months. There was no history of trauma, and the patient was mobilizing with difficulty using crutches. Radiographs revealed fracture of the posterior condyle of the femoral prosthesis. Revision surgery was performed as an elective procedure revealing the broken prosthesis. The TC3RP-PFC revision prosthesis was used with a medial parapatellar approach. The patient recovered fully without any squeal. Mechanical failure of the knee arthroplasty prosthesis is rare, and nontraumatic fracture of the femoral metallic component has not been reported before.
Lacerda, Clara Fonseca; Silva, Luciana Oliveira e; de Tavares Canto, Roberto Sérgio; Cheik, Nadia Carla
2012-01-01
Summary Introduction: The aging process provokes structural modifications and functional to it greets, compromising the postural control and central processing. Studies have boarded the necessity to identify to the harmful factors of risk to aged the auditory health and security in stricken aged by auditory deficits and with alterations of balance. Objective: To evaluate the effect of auditory prosthesis in the quality of life, the balance and the fear of fall in aged with bilateral auditory loss. Method: Carried through clinical and experimental study with 56 aged ones with sensorineural auditory loss, submitted to the use of auditory prosthesis of individual sonorous amplification (AASI). The aged ones had answered to the questionnaires of quality of life Short Form Health Survey (SF-36), Falls Efficacy International Scale- (FES-I) and the test of Berg Balance Scale (BBS). After 4 months, the aged ones that they adapted to the use of the AASI had been reevaluated. Results: It had 50% of adaptation of the aged ones to the AASI. It was observed that the masculine sex had greater difficulty in adapting to the auditory device and that the variable age, degree of loss, presence of humming and vertigo had not intervened with the adaptation to auditory prosthesis. It had improvement of the quality of life in the dominance of the State General Health (EGS) and Functional Capacity (CF) and of the humming, as well as the increase of the auto-confidence after adaptation of auditory prosthesis. Conclusion: The use of auditory prosthesis provided the improvement of the domains of the quality of life, what it reflected consequently in one better auto-confidence and in the long run in the reduction of the fear of fall in aged with sensorineural auditory loss. PMID:25991930
Shi, Sheng; Zheng, Shuang; Li, Xin-Feng; Yang, Li-Li; Liu, Zu-De; Yuan, Wen
2016-01-01
Cervical disc arthroplasty (CDA) with Discover prosthesis or anterior cervical discectomy and fusion (ACDF) with Zero-P cage has been widely used in the treatment of cervical spondylotic myelopathy (CSM). However, little is known about the comparison of the 2 zero-profile implants in the treatment of single-level CSM. The aim was to compare the clinical outcomes and radiographic parameters of CDA with Discover prosthesis and ACDF with Zero-P cage for the treatment of single-level CSM. A total of 128 consecutive patients who underwent 1-level CDA with Discover prosthesis or ACDF with Zero-P cage for single-level CSM between September 2009 and December 2012 were included in this study. Clinical outcomes were evaluated using the Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI). For radiographic assessment, the overall sagittal alignment (OSA), functional spinal unit (FSU) angle, and range of motion (ROM) at the index and adjacent levels were measured before and after surgery. Additionally, the complications were also recorded. Both treatments significantly improved all clinical parameters (P < 0.05), without statistically relevant differences between the 2 groups. The OSA and FSU angle increased significantly in both groups (P <0.05). Compared with Zero-P group, ROMs at the index levels were well maintained in the Discover group (P < 0.05). However, there were no statistical differences in the ROMs of adjacent levels between the 2 groups (P > 0.05). Besides, no significant differences existed in dysphagia, subsidence, or adjacent disc degeneration between the 2 groups (P > 0.05). However, significant differences occurred in prosthesis migration in CDA group. The results of this study showed that clinical outcomes and radiographic parameters were satisfactory and comparable with the 2 techniques. However, more attention to prosthesis migration of artificial cervical disc should be paid in the postoperative early-term follow-up.
Endo, Takao; Fujikado, Takashi; Hirota, Masakazu; Kanda, Hiroyuki; Morimoto, Takeshi; Nishida, Kohji
2018-04-20
To evaluate the improvement in targeted reaching movements toward targets of various contrasts in a patient implanted with a suprachoroidal-transretinal stimulation (STS) retinal prosthesis. An STS retinal prosthesis was implanted in the right eye of a 42-year-old man with advanced Stargardt disease (visual acuity: right eye, light perception; left eye, hand motion). In localization tests during the 1-year follow-up period, the patient attempted to touch the center of a white square target (visual angle, 10°; contrast, 96, 85, or 74%) displayed at a random position on a monitor. The distance between the touched point and the center of the target (the absolute deviation) was averaged over 20 trials with the STS system on or off. With the left eye occluded, the absolute deviation was not consistently lower with the system on than off for high-contrast (96%) targets, but was consistently lower with the system on for low-contrast (74%) targets. With both eyes open, the absolute deviation was consistently lower with the system on than off for 85%-contrast targets. With the system on and 96%-contrast targets, we detected a shorter response time while covering the right eye, which was being implanted with the STS, compared to covering the left eye (2.41 ± 2.52 vs 8.45 ± 3.78 s, p < 0.01). Performance of a reaching movement improved in a patient with an STS retinal prosthesis implanted in an eye with residual natural vision. Patients with a retinal prosthesis may be able to improve their visual performance by using both artificial vision and their residual natural vision. Beginning date of the trial: Feb. 20, 2014 Date of registration: Jan. 4, 2014 Trial registration number: UMIN000012754 Registration site: UMIN Clinical Trials Registry (UMIN-CTR) http://www.umin.ac.jp/ctr/index.htm.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Wronski, M; Sarfehnia, A; Sahgal, A
Purpose: To evaluate the interface effects when irradiating through a hip prosthesis in the presence of an orthogonal 1.5 T magnetic field using Monte Carlo simulations. Methods: A 20×20×38 cm virtual phantom with two 5×5×5 cm sections of bilateral titanium hip prosthesis was created in GPU-based Monte Carlo (MC) algorithm (GPUMCD, Elekta AB, Stockholm Sweden). The lateral prosthesis spacing was based on a representative patient CT scan. A treatment SAD of 143.5 cm was chosen, corresponding to the Elekta AB MRI Linac and the beam energy distribution was sampled from a histogram representing the true MRI Linac spectrum. A magneticmore » field of 1.5 T was applied perpendicular to the plane of irradiation. Dose was calculated, in voxels of side 1 mm, for 2×2, 5×5, and 10×10 cm treatment field sizes with normal beam incidence (gantry at 90° or 270°) and at 5° and 10° from normal, representing the range of incidence through the bilateral prosthesis. Results: With magnetic field ON (B-On) and normal beam incidence the backscatter dose at the interfaces of proximal and distal implants is reduced for all the field sizes compared to the magnetic field OFF (B-Off) case. The absolute reduction in doses at the interface was in the range of 12.93% to 13.16% for the proximal implant and 13.57% to 16.12% for the distal implant. Similarly for the oblique incidences of 5o and 10o the dose in the plane adjacent to the prosthetic implants is lower when the magnetic field is ON. Conclusion: The dosimetric effects of irradiating through a hip prosthesis in the presence of a transverse magnetic field have been determined using MC simulation. The backscatter dose reduction translates into significantly lower hot spots at the prosthetic interfaces, which are otherwise substantially high in the absence of the magnetic field. This project was supported through funding provided by ElektaTM.« less
Laryngeal complications after type 1 thyroplasty.
Cotter, C S; Avidano, M A; Crary, M A; Cassisi, N J; Gorham, M M
1995-12-01
Type I thyroplasty has become a primary surgical choice for voice restoration in patients with glottal incompetence. This study examines factors associated with laryngeal complications after type I thyroplasty. Ten laryngoscopic variables were analyzed from preoperative, intraoperative, and postoperative videolaryngoscopies of 51 patients undergoing 58 medialization procedures. Ten patient and operative variables were examined by medical record review. Major complications were defined as wound hemorrhage, airway obstruction, or prosthesis extrusion. Minor complications were defined as vocal fold hematoma without airway obstruction or prosthesis movement. The major complication rate was 8.6%, and the minor complication rate was 29%. No delayed hemorrhage or airway obstruction occurred. Prosthesis extrusion occurred in five (8.6%) patients 1 week to 5 months after surgery. Extrusion was associated with suboptimal prosthesis placement in 80% of cases. Two patients retained excellent glottal closure despite extrusion. Vocal fold hematoma was identified in 14 (24%) cases and resolved within 1 week. Prosthesis movement occurred in three (5%) patients 1 week to 6 months after surgery and resulted in poor glottal closure. All patients with prosthesis extrusion or movement were female. Type I thyroplasty remains a safe outpatient procedure with few major complications. Prosthesis extrusion was associated with suboptimal prosthesis placement and may or may not result in poor glottal closure. Minor vocal fold hematomas were relatively frequent, resolved rapidly, and were not associated with airway obstruction. Female patients may be more prone to complications because of their small laryngeal size.
Biddiss, Elaine; McKeever, Patricia; Lindsay, Sally; Chau, Tom
2011-06-01
While sparsely researched, funding structures may play an important role in use of and satisfaction with prostheses and related health services. The objectives of this study were to (1) quantify the direct costs of prosthesis wear, (2) explore variations in funding distribution, and (3) describe the role of affordability in prosthesis selection and wear. An anonymous, online cross-sectional descriptive survey was administered. Analyses were conducted of qualitative and quantitative data extracted from an international sample of 242 individuals with upper limb absence. Access to prosthesis funding was variable and fluctuated with age, level of limb absence and country of care. Of individuals who gave details on prosthetic costs, 63% (n = 69) were fully reimbursed for their prosthetic expenses, while 37% (n = 40) were financially disadvantaged by the cost of components (mean [SD] US$9,574 [$9,986]) and their ongoing maintenance (US$1,936 [$3,179]). Of the 71 non-wearers in this study, 48% considered cost an influential factor in their decision not to adopt prosthesis use. Prosthesis funding is neither homogeneous nor transparent and can be influential in both the selection and use of a prosthetic device. Inequitable access to prosthesis funding is evident in industrialized nations and may lead to prosthesis abandonment and/or diminished quality of life for individuals with upper limb absences. Increased efforts are required to ensure equitable access to upper limb prosthetics and related services in line with individuals' needs.
Minoda, Yukihide; Ikebuchi, Mitsuhiko; Mizokawa, Shigekazu; Ohta, Yoichi; Nakamura, Hiroaki
2016-11-01
Proper anteroposterior (AP) joint displacement is an important indicator of good clinical outcome following total knee arthroplasty (TKA). We hypothesized that a newly introduced mobile-bearing posterior stabilized (PS) prosthesis reduces the AP joint displacement. The aim of this study is to compare the AP joint displacement between a newly introduced mobile-bearing PS TKA in one knee and a conventional fixed-bearing PS TKA in other knee. 82 knees in 41 patients who had bilateral TKAs were investigated. All the patients received a conventional fixed-bearing PS prosthesis in one knee and a highly congruent mobile-bearing PS prosthesis in the other knee. AP joint displacement was measured using the KT-2000 arthrometer, at 30° and 75° in flexion, at average of 3.3 years after the operation. AP joint displacements at 30° in flexion were 6 ± 3 mm in the knees with the mobile-bearing PS prosthesis and 9 ± 4 mm in the knee with fixed-bearing PS prosthesis (p < 0.001). AP joint displacements at 75° in flexion were 4 ± 2 mm in the knees with the mobile-bearing PS prosthesis and 6 ± 3 mm in the knee with fixed-bearing PS prosthesis (p < 0.001). This study suggested that the design of the prosthesis can improve the AP joint stability in mid-flexion range.
Cavalot, A L; Palonta, F; Preti, G; Nazionale, G; Ricci, E; Vione, N; Albera, R; Cortesina, G
2001-12-01
The insertion of a prosthesis and restoration with pectoralis major myocutaneous flaps for patients subjected to total pharyngolaryngectomy is a technique now universally accepted; however the literature on the subject is lacking. Our study considers 10 patients subjected to total pharyngolaryngectomy and restoration with pectoralis major myocutaneous flaps who were fitted with vocal function prostheses and a control group of 50 subjects treated with a total laryngectomy without pectoralis major myocutaneous flaps and who were fitted with vocal function prostheses. Specific qualitative and quantitative parameters were compared. The quantitative measurement of the levels of voice intensity and the evaluation of the harmonics-to-noise ratio were not statistically significant (p > 0.05) between the two study groups at either high- or low-volume speech. On the contrary, statistically significant differences were found (p < 0.05) for the basic frequency of both the low and the high volume voice. For the qualitative analysis seven parameters were established for evaluation by trained and untrained listeners: on the basis of these parameters the control group had statistically better voices.
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3025 - Passive tendon prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...
21 CFR 888.3025 - Passive tendon prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...
21 CFR 888.3025 - Passive tendon prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...
21 CFR 872.3960 - Mandibular condyle prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular condyle prosthesis. 872.3960 Section 872.3960 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a...
21 CFR 872.3950 - Glenoid fossa prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872.3950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification...
21 CFR 878.3680 - Nose prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...
21 CFR 878.3550 - Chin prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...
21 CFR 878.3720 - Tracheal prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis. (a...
21 CFR 878.3750 - External prosthesis adhesive.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...
21 CFR 878.3750 - External prosthesis adhesive.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...
21 CFR 878.3550 - Chin prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...
21 CFR 878.3750 - External prosthesis adhesive.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...
21 CFR 878.3550 - Chin prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...
21 CFR 878.3550 - Chin prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...
21 CFR 878.3550 - Chin prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...
21 CFR 878.3680 - Nose prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...
21 CFR 878.3750 - External prosthesis adhesive.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...
21 CFR 878.3680 - Nose prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...
21 CFR 878.3680 - Nose prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...
21 CFR 878.3680 - Nose prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...
21 CFR 878.3750 - External prosthesis adhesive.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...
21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...
21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...
21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained uncemented... metal/metal constrained uncemented prosthesis. (a) Identification. A finger joint metal/metal... Administration on or before December 26, 1996 for any finger joint metal/metal constrained uncemented prosthesis...
21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained uncemented... metal/metal constrained uncemented prosthesis. (a) Identification. A finger joint metal/metal... Administration on or before December 26, 1996 for any finger joint metal/metal constrained uncemented prosthesis...
21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an...
21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device...
21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
Facial recognition using enhanced pixelized image for simulated visual prosthesis.
Li, Ruonan; Zhhang, Xudong; Zhang, Hui; Hu, Guanshu
2005-01-01
A simulated face recognition experiment using enhanced pixelized images is designed and performed for the artificial visual prosthesis. The results of the simulation reveal new characteristics of visual performance in an enhanced pixelization condition, and then new suggestions on the future design of visual prosthesis are provided.
21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part...
21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a...
21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...
21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...
21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...
21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...
21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part...
21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an...
21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device...
21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...
21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint patellofemorotibial polymer/metal/metal... § 888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...
21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...