Amputation and prosthesis implantation shape body and peripersonal space representations

PubMed Central

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

Poststapedectomy hearing gain: comparison of a Teflon (fluoroplastic ASTM F 754) prosthesis with a Schuknecht-type wire/Teflon prosthesis.

PubMed

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.

Next generation shape memory prosthesis (NiTiBOND) for stapedotomy: Short-term results.

PubMed

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.

Long-term follow-up of stentless prosthesis.

PubMed

Sansone, Fabrizio; Dato, Guglielmo Mario Actis; Zingarelli, Edoardo; Ferrero, Emanuele; Prot, Sara; Ceresa, Fabrizio; Patanè, Francesco; Casabona, Riccardo

2014-05-01

Stentless prostheses have an interesting hemodynamic performance when compared to stented prostheses and are recommended in cases of small aortic annulus. From January 1996 to January 2004, 138 patients suffering from aortic disease, underwent aortic valve replacement. • Group A: 93 patients underwent stentless aortic valve implantation [stentless Biocor (Biocor Industria e Pesguisa Ltda, Belo Horizonte, Brazil) and stentless Sorin (Sorin Group, Saluggia, Italy)]. • Group B: 45 patients underwent stented aortic valve implantation (stented Biocor). Patients were assessed by clinical evaluation and echocardiography after a mean follow up of 124.5 ± 58.2 months. There was a significant difference in terms of time of extracorporeal circulation and aortic cross clamp. The actuarial survival at 4, 8, 12, and 15 years is 77%, 50%, 21%, and 18%, respectively. Freedom from reoperation at 4, 8, 12, and 14 years was 92%, 83%, 73%, and 63%, respectively. Freedom from all events, death, and reoperation at 4, 8, 12, and 14 years was 70%, 39%, 13%, and 8%, respectively. There is no statistical difference among the two groups in terms of actuarial survival, freedom from reoperation, and freedom from re-hospitalization for prosthesis-related causes. There was a significantly higher incidence of pacemaker implantation in Group A and the causes are not known. The rate of freedom from reoperation is high in both groups for the patients who remained alive. There was no statistical difference about prosthesis dysfunction between the two groups. The higher incidence of death in Group A cannot be explained by causes related to the prosthesis because there is no difference in terms of causes of death. Rates of reoperation did not differ between the two groups. The results obtained with stentless prostheses are encouraging even in long-term follow-up. Copyright © 2013 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

[Our experience with the use of Active-C cervical prosthesis].

PubMed

Misik, Ferenc; Böösi, Martina; Papp, Zoltán; Padányi, Csaba; Banczerowski, Péter

2016-09-30

The most widely used surgical procedure in the treatment of cervical spine disc hernias have been the anterior cervical discectomy and fusion for decades. The usage of cervical disc prostheses enabled us to preserve the movements of the affected segments, hereby reducing the overexertion of the adjacent vertebrae and discs. Our goal is to follow our patients operated with Active-C prosthesis (which is used in the Institute since 2010) to gather information about the change of their complaints and about the functioning and unwanted negative effects of the prostheses. Question - Is the usage of Active-C prosthesis an efficient procedure? Between 2010 and 2013, performing the survey of neurological conditions and functional X-ray examinations. We measured the complaints of the patients using the Visual Analogue Scale, Neck Disability Index and Cervical Spine Outcomes Questionnaire. The control group consisted of patients who were operated in one segment using the fusion technique. In the study group according to the Neck Disability Index scale after 18 months, seven patients had no complaints, while twelve persons reported mild and the remaining six moderate complaints. In the control group, moderate complaints were present in four patients, while twelve patients reported mild complaints. The other eight persons showed no complaints. According to the results of the Visual Analogue Scale in the group of prosthesis, the degree of referred pain decreased from 8.6 to 1.84 one and a half years after the surgery. A decrease was observable in the case of axial pain too, from 6.6 down to 1.92 (p<0.01). In case of three from the twenty-five patients there was no sign of movement in the level of the prosthesis. According to the present short- and mediumterm studies, the usage of the cervical disc prosthesis can be considered as an efficient procedure, but at the same time the advantages can only be determined in the long run, therefore further following and studies are required.

Reading Visual Braille with a Retinal Prosthesis

PubMed Central

Lauritzen, Thomas Z.; Harris, Jordan; Mohand-Said, Saddek; Sahel, Jose A.; Dorn, Jessy D.; McClure, Kelly; Greenberg, Robert J.

2012-01-01

Retinal prostheses, which restore partial vision to patients blinded by outer retinal degeneration, are currently in clinical trial. The Argus II retinal prosthesis system was recently awarded CE approval for commercial use in Europe. While retinal prosthesis users have achieved remarkable visual improvement to the point of reading letters and short sentences, the reading process is still fairly cumbersome. This study investigates the possibility of using an epiretinal prosthesis to stimulate visual braille as a sensory substitution for reading written letters and words. The Argus II retinal prosthesis system, used in this study, includes a 10 × 6 electrode array implanted epiretinally, a tiny video camera mounted on a pair of glasses, and a wearable computer that processes the video and determines the stimulation current of each electrode in real time. In the braille reading system, individual letters are created by a subset of dots from a 3 by 2 array of six dots. For the visual braille experiment, a grid of six electrodes was chosen out of the 10 × 6 Argus II array. Groups of these electrodes were then directly stimulated (bypassing the camera) to create visual percepts of individual braille letters. Experiments were performed in a single subject. Single letters were stimulated in an alternative forced choice (AFC) paradigm, and short 2–4-letter words were stimulated (one letter at a time) in an open-choice reading paradigm. The subject correctly identified 89% of single letters, 80% of 2-letter, 60% of 3-letter, and 70% of 4-letter words. This work suggests that text can successfully be stimulated and read as visual braille in retinal prosthesis patients. PMID:23189036

Reading visual braille with a retinal prosthesis.

PubMed

Lauritzen, Thomas Z; Harris, Jordan; Mohand-Said, Saddek; Sahel, Jose A; Dorn, Jessy D; McClure, Kelly; Greenberg, Robert J

2012-01-01

Retinal prostheses, which restore partial vision to patients blinded by outer retinal degeneration, are currently in clinical trial. The Argus II retinal prosthesis system was recently awarded CE approval for commercial use in Europe. While retinal prosthesis users have achieved remarkable visual improvement to the point of reading letters and short sentences, the reading process is still fairly cumbersome. This study investigates the possibility of using an epiretinal prosthesis to stimulate visual braille as a sensory substitution for reading written letters and words. The Argus II retinal prosthesis system, used in this study, includes a 10 × 6 electrode array implanted epiretinally, a tiny video camera mounted on a pair of glasses, and a wearable computer that processes the video and determines the stimulation current of each electrode in real time. In the braille reading system, individual letters are created by a subset of dots from a 3 by 2 array of six dots. For the visual braille experiment, a grid of six electrodes was chosen out of the 10 × 6 Argus II array. Groups of these electrodes were then directly stimulated (bypassing the camera) to create visual percepts of individual braille letters. Experiments were performed in a single subject. Single letters were stimulated in an alternative forced choice (AFC) paradigm, and short 2-4-letter words were stimulated (one letter at a time) in an open-choice reading paradigm. The subject correctly identified 89% of single letters, 80% of 2-letter, 60% of 3-letter, and 70% of 4-letter words. This work suggests that text can successfully be stimulated and read as visual braille in retinal prosthesis patients.

New synthetic prosthesis for peripheral nerve injuries: an experimental pilot study.

PubMed

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.

Improvements in survival of the uncemented Nottingham Total Shoulder prosthesis: a prospective comparative study

PubMed Central

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

BIORESORBABLE POLYMERIC MENISCAL PROSTHESIS: STUDY IN RABBITS

PubMed Central

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

Fifteen years experience of penile prosthesis insertion.

PubMed

Burns-Cox, N; Burston, A; Gingell, J C

1997-12-01

To review the outcome and patient satisfaction of penile prosthesis insertion over a 15 y period. We reviewed the notes of 172 patients who underwent penile prosthesis insertion between January 1980 and May 1995. From the notes information was determined on age of the patient, type of prosthesis, surgical approach and length of stay. Also noted were risk factors for erectile dysfunction and the aetiology. Twenty patients were known to have died or moved away. To assess the impact the operation had on quality of life, 152 questionnaires were sent of which 103 were returned (67%). The questionnaire gained information about sexual activity, before and after the operation and the overall satisfaction of the patient and his partner and whether they felt the operation was a success. Overall 149 patients were known to have had malleable prostheses inserted and 23 had inflatables. The commonest organic groups were vascular disease, diabetes and Peyronies disease. Fifteen patients had two procedures. Four patients required revision of the prosthesis due to erosion, and there was one death due to pulmonary embolism. One hundred and three completed questionnaires have been returned to date the median time since operation was 4 y, the range being six months to 16 y and 78% thought the operation was a success. The insertion of malleable prostheses is associated with low complication rates, good patient satisfaction and improved quality of life for the couple. Concealment was not a major problem.

[The influence of the stapes prosthesis on the long-term results of stapedectomy (author's transl)].

PubMed

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.

Prosthesis for blepharospasm.

PubMed

Moss, H L

1983-12-01

Following several years of experience with a newly designed spectacle-supported ptosis crutch for ptosis and blepharospasm, the author has developed a new approach to these conditions. In mild to moderate blepharospasm cases, the spectacle-supported prosthesis can still produce satisfactory results. However, in moderate to severe blepharospasm, the force of the spasm moves the entire device forward and downward, making it ineffective or too uncomfortable to wear. To create greater stability and a more effective counterforce to the blepharospasm, the author has developed a simple headband-supported device which does not use a spectacle frame for support. This new prosthesis is constructed of varying diameters of spring tempered diamond drawn stainless steel orthodontic wire, partially or completely covered by Teflon tubing. A silicon rubber cylinder is placed over the center which becomes a bridge and the main support for the device. An elastic head band completes the prosthesis.

Permanent Quadriplegia Following Replacement of Voice Prosthesis.

PubMed

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.

Laser-assisted fixation of a nitinol stapes prosthesis.

PubMed

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.

Evaluation of a new composite prosthesis for the repair of abdominal wall defects.

PubMed

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.

Reverse Shoulder Arthroplasty Prosthesis Design Classification System.

PubMed

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.

Biomechanical Analysis of a Novel Intercalary Prosthesis for Humeral Diaphyseal Segmental Defect Reconstruction.

PubMed

Zhao, Li-Ming; Tian, Dong-Mu; Wei, Yue; Zhang, Jun-Hui; Di, Zheng-Lin; He, Zhi-Yong; Hu, Yong-Cheng

2018-02-01

To study the biomechanical properties of a novel modular intercalary prosthesis for humeral diaphyseal segmental defect reconstruction, to establish valid finite element humerus and prosthesis models, and to analyze the biomechanical differences in modular intercalary prostheses with or without plate fixation. Three groups were set up to compare the performance of the prosthesis: intact humerus, humerus-prosthesis and humerus-prosthesis-plate. The models of the three groups were transferred to finite element software. Boundary conditions, material properties, and mesh generation were set up for both the prosthesis and the humerus. In addition, 100 N or 2 N.m torsion was loaded to the elbow joint surface with the glenohumeral joint surface fixed. Humeral finite element models were established according to CT scans of the cadaveric bone; reverse engineering software Geomagic was used in this procedure. Components of prosthetic models were established using 3-D modeling software Solidworks. To verify the finite element models, the in vitro tests were simulated using a mechanical testing machine (Bionix; MTS Systems Corporation, USA). Starting with a 50 N preload, the specimen was subjected to 5 times tensile (300 N) and torsional (5 N.m) strength; interval time was 30 min to allow full recovery for the next specimen load. Axial tensile and torsional loads were applied to the elbow joint surface to simulate lifting heavy objects or twisting something, with the glenohumeral joint surface fixed. Stress distribution on the humerus did not change its tendency notably after reconstruction by intercalary prosthesis whether with or without a plate. The special design which included a plate and prosthesis effectively diminished stress on the stem where aseptic loosening often takes place. Stress distribution major concentrate upon two stems without plate addition, maximum stress on proximal and distal stem respectively diminish 27.37% and 13.23% under tension, 10

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...

Validation of the Inverted Pendulum Model in standing for transtibial prosthesis users.

PubMed

Rusaw, David F; Ramstrand, Simon

2016-01-01

Often in balance assessment variables associated with the center of pressure are used to draw conclusions about an individual's balance. Validity of these conclusions rests upon assumptions that movement of the center of pressure is inter-dependent on movement of the center of mass. This dependency is mechanical and is referred to as the Inverted Pendulum Model. The following study aimed to validate this model both kinematically and kinetically, in transtibial prosthesis users and a control group. Prosthesis users (n=6) and matched control participants (n=6) stood quietly while force and motion data were collected under three conditions (eyes-open, eyes-closed, and weight-bearing feedback). Correlation coefficients were used to investigate the relationships between height and excursion of markers and center of masses in mediolateral/anteroposterior-directions, difference between center of pressure and center of mass and the center of mass acceleration in mediolateral/anteroposterior directions, magnitude of mediolateral/anteroposterior-component forces and center of mass acceleration, angular position of ankle and excursion in mediolateral/anteroposterior-directions, and integrated force signals. Results indicate kinematic validity of similar magnitudes (mean (SD) marker-displacement) between prosthesis users and control group for mediolateral- (r=0.77 (0.17); 0.74 (0.19)) and anteroposterior-directions (r=0.88 (0.18); 0.88 (0.19)). Correlation between difference of center of pressure and center of mass and the center of mass acceleration was negligible on the prosthetic side (r = 0.08 (0.06)) vs. control group (r=-0.51(0.13)). Results indicate kinematic validity of the Inverted Pendulum Model in transtibial prosthesis users but kinetic validity is questionable, particularly on the side with a prosthesis. Copyright © 2015 Elsevier Ltd. All rights reserved.

Duocentric® reversed shoulder prosthesis and Personal Fit® templates: innovative strategies to optimize prosthesis positioning and prevent scapular notching.

PubMed

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°.

Can We Improve the Tolerance of an Ocular Prosthesis by Enhancing Its Surface Finish?

PubMed

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.

Changes in performance over time while learning to use a myoelectric prosthesis

PubMed Central

2014-01-01

Background Training increases the functional use of an upper limb prosthesis, but little is known about how people learn to use their prosthesis. The aim of this study was to describe the changes in performance with an upper limb myoelectric prosthesis during practice. The results provide a basis to develop an evidence-based training program. Methods Thirty-one able-bodied participants took part in an experiment as well as thirty-one age- and gender-matched controls. Participants in the experimental condition, randomly assigned to one of four groups, practiced with a myoelectric simulator for five sessions in a two-weeks period. Group 1 practiced direct grasping, Group 2 practiced indirect grasping, Group 3 practiced fixating, and Group 4 practiced a combination of all three tasks. The Southampton Hand Assessment Procedure (SHAP) was assessed in a pretest, posttest, and two retention tests. Participants in the control condition performed SHAP two times, two weeks apart with no practice in between. Compressible objects were used in the grasping tasks. Changes in end-point kinematics, joint angles, and grip force control, the latter measured by magnitude of object compression, were examined. Results The experimental groups improved more on SHAP than the control group. Interestingly, the fixation group improved comparable to the other training groups on the SHAP. Improvement in global position of the prosthesis leveled off after three practice sessions, whereas learning to control grip force required more time. The indirect grasping group had the smallest object compression in the beginning and this did not change over time, whereas the direct grasping and the combination group had a decrease in compression over time. Moreover, the indirect grasping group had the smallest grasping time that did not vary over object rigidity, while for the other two groups the grasping time decreased with an increase in object rigidity. Conclusions A training program should spend more

[Experimental study on a novel esophageal prosthesis made of composite biomaterials].

PubMed

Qin, Xiong; Xu, Zhi-fei; Shi, Hong-can; Zhao, Xue-wei; Sun, Kang; Gao, Xiang-yang

2003-07-01

To design and develop a novel esophageal prosthesis by selecting appropriate biomaterials, developing special manufacturing techniques, and investigating the feasibility of replacement of cervical esophagus in mongrel dogs. In accordance with the requirements of ideal esophageal substitutes, we designed a new type of esophageal prostheses. The inner stent were made with polyurethane of medical grade, and the outer surface of the prosthesis was coated with collagen-chitosan sponge. The silicone tube was used as a control. Thirteen adult mongrel dogs that were divided into two groups were used to establish the experimental models. In the experimental group (n = 8), the esophageal prostheses were completely incorporated with the native esophagus and adherent to the surrounding host connective tissues. Epithelial linings of varying degrees were formed on the luminal surface, and complete epithelization was seen in 1 month postoperatively. The granulation at the sites of the anastomosis in this group was less significant than that of the control group. One dog has been surviving for 12 months up to now without any complications. In the control group (n = 5), esophageal epithelial was not observed on the luminal surface, constriction of the regenerated esophagus progressed and all the dogs died within 2 months after operation. These observations suggest that this esophageal prosthesis made of composite biomaterials has high biocompatibility and potential for long-segment esophageal reconstruction, which is promising for the clinical repair of esophageal defects.

Malrotation of the McGhan Style 510 prosthesis.

PubMed

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.

Early outcome of TKA with a medial pivot fixed-bearing prosthesis is worse than with a PFC mobile-bearing prosthesis.

PubMed

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.

Comparison of the effects of alendronate sodium and calcitonin on bone-prosthesis osseointegration in osteoporotic rats.

PubMed

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�

Titanium clip ball joint: a partial ossicular reconstruction prosthesis.

PubMed

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.

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...

[Comparison of early clinical effects of two hip prosthesis designs between ceramics to ceramics and metal to polyethylene].

PubMed

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.

Effect of cement washout on loosening of abutment screws and vice versa in screw- and cement- retained implant-supported dental prosthesis

PubMed Central

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

Survival of various implant-supported prosthesis designs following 36 months of clinical function.

PubMed

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.

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...

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...

Clinical evaluation of satisfaction in patients rehabilitated with an immediately loaded implant-supported prosthesis: a controlled prospective study.

PubMed

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

Aesthetic finger prosthesis with silicone biomaterial

PubMed Central

Raghu, K M; Gururaju, C R; Sundaresh, K J; Mallikarjuna, Rachappa

2013-01-01

The fabrication of finger prosthesis is as much an art as it is science. The ideally constructed prosthesis must duplicate the missing structures so precisely that patients can appear in public without fear of attracting unwanted attraction. A 65-years-old patient reported with loss of his right index finger up to the second phalanx and wanted to get it replaced. An impression of the amputated finger and donor were made. A wax pattern of the prosthesis was fabricated using the donor impression; a trial was performed and flasked. Medical grade silicone was intrinsically stained to match the skin tone, following which it was packed, processed and finished. This clinical report describes a method of attaining retention by selective scoring of the master cast of partially amputated finger to enhance the vacuum effect at par with the proportional distribution of the positive forces on the tissues exerted by the prosthesis. PMID:23975917

An interim prosthesis program for lower limb amputees: comparison of public and private models of service.

PubMed

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.

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 878.3550 - 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 878.3550 - 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 878.3680 - 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 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

21 CFR 878.3590 - Ear prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear prosthesis. 878.3590 Section 878.3590 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3590 Ear prosthesis. (a) Identification. An...

The "caviar" madreporic knee prosthesis.

PubMed

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.

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 888.3780 - 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 888.3230 - 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 888.3780 - 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 888.3230 - 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 888.3780 - 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 888.3230 - 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 888.3780 - 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 888.3230 - 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...

Pattern of External Breast Prosthesis Use by Post Mastectomy Breast Cancer Patients in India: Descriptive Study from Tertiary Care Centre.

PubMed

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

Development and clinical application of a new testicular prosthesis

PubMed Central

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

Femoral Prosthesis Infection by Rhodotorula mucilaginosa▿

PubMed Central

Savini, Vincenzo; Sozio, Federica; Catavitello, Chiara; Talia, Marzia; Manna, Assunta; Febbo, Fabio; Balbinot, Andrea; Di Bonaventura, Giovanni; Piccolomini, Raffaele; Parruti, Giustino; D'Antonio, Domenico

2008-01-01

This case report is a case history of a femoral prosthesis infection caused by Rhodotorula mucilaginosa in a human immunodeficiency virus patient. Though the pathogenicity of this organism for bone tissue has been previously reported, this is the first reported case of an orthopedic prosthesis infection by this species of the genus Rhodotorula. PMID:18753353

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 888.3720 - 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 888.3720 - 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 888.3720 - 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...

MPR-CT Imaging for Stapes Prosthesis: Accuracy and Clinical Significance.

PubMed

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.

Kinematic Analysis of a Posterior-stabilized Knee Prosthesis

PubMed Central

Zhao, Zhi-Xin; Wen, Liang; Qu, Tie-Bing; Hou, Li-Li; Xiang, Dong; Bin, Jia

2015-01-01

Background: 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. Methods: 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. Results: 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. Conclusions: 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. PMID:25591565

Kinematic analysis of a posterior-stabilized knee prosthesis.

PubMed

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.

Prosthetic management of mid-facial defect with magnet-retained silicone prosthesis.

PubMed

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.

Clinical, biomechanical and morphological assessment of anterior cruciate ligament Kevlar®-based artificial prosthesis in rabbit model.

PubMed

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.

A Novel Thermal-activated Shape Memory Penile Prosthesis: Comparative Mechanical Testing.

PubMed

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.

Active upper limb prosthesis based on natural movement trajectories.

PubMed

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.

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 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...

[Phonomechanocardiography in the evaluation of the functional status of valvular prosthesis].

PubMed

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.

Categorization of compensatory motions in transradial myoelectric prosthesis users.

PubMed

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.

[Imaging evaluation on adaptability of proximal humeral anatomy after shoulder replacement with individualized shoulder prosthesis].

PubMed

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

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 878.3750 - 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 878.3750 - 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 878.3750 - 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 878.3750 - 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...

Novel knee joint mechanism of transfemoral prosthesis for stair ascent.

PubMed

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.

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...

Healing characteristics of a new silver-coated, gelatine impregnated vascular prosthesis in the porcine model.

PubMed

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.

Intermittent, noncyclic dysfunction of a mechanical aortic prosthesis by pannus formation.

PubMed

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.

The Evolution and Utility of the Small-Carrion Prosthesis, Its Impact, and Progression to the Modern-Day Malleable Penile Prosthesis.

PubMed

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.

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 888.3770 - 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 888.3770 - 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 888.3750 - 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 888.3760 - 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...

Penile Prosthesis Implantation in Patients with a History of Total Phallic Construction.

PubMed

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.

Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report.

PubMed

Shankaran, Gayatri; Deogade, Suryakant Chhagan; Dhirawani, Rajesh

2016-01-01

Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography.

Fabrication of a Cranial Prosthesis Combined with an Ocular Prosthesis Using Rapid Prototyping: A Case Report

PubMed Central

Shankaran, Gayatri; Dhirawani, Rajesh

2016-01-01

Rapid prototyping (RP) is a technique of manufacturing parts by the additive layer manufacturing technology; where, a three-dimensional (3D) model created in a computer aided design (CAD) system is sectioned into 2D profiles, which are further constructed by RP layer by layer. Its use is not limited to industrial or engineering fields and has extended to the medical field for the manufacturing of custom implants and prostheses, the study of anatomy and surgical planning. Nowadays, dentists are more frequently encountered with the individuals affected with craniofacial defects due to trauma. In such cases, the craniomaxillofacial rehabilitation is a real challenge to bring the patients back to society and promote their well-being. The conventional impression technique for facial prosthesis fabrication has the disadvantage of deforming the soft tissue and causing discomfort for the patient. Herein, we describe the fabrication of a cranial prosthesis combined with an ocular prosthesis with RP and stereolithography. PMID:27536331

Metabolics of stair ascent with a powered transfemoral prosthesis.

PubMed

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.

Computational reverse shoulder prosthesis model: Experimental data and verification.

PubMed

Martins, A; Quental, C; Folgado, J; Ambrósio, J; Monteiro, J; Sarmento, M

2015-09-18

The reverse shoulder prosthesis aims to restore the stability and function of pathological shoulders, but the biomechanical aspects of the geometrical changes induced by the implant are yet to be fully understood. Considering a large-scale musculoskeletal model of the upper limb, the aim of this study is to evaluate how the Delta reverse shoulder prosthesis influences the biomechanical behavior of the shoulder joint. In this study, the kinematic data of an unloaded abduction in the frontal plane and an unloaded forward flexion in the sagittal plane were experimentally acquired through video-imaging for a control group, composed of 10 healthy shoulders, and a reverse shoulder group, composed of 3 reverse shoulders. Synchronously, the EMG data of 7 superficial muscles were also collected. The muscle force sharing problem was solved through the minimization of the metabolic energy consumption. The evaluation of the shoulder kinematics shows an increase in the lateral rotation of the scapula in the reverse shoulder group, and an increase in the contribution of the scapulothoracic joint to the shoulder joint. Regarding the muscle force sharing problem, the musculoskeletal model estimates an increased activity of the deltoid, teres minor, clavicular fibers of the pectoralis major, and coracobrachialis muscles in the reverse shoulder group. The comparison between the muscle forces predicted and the EMG data acquired revealed a good correlation, which provides further confidence in the model. Overall, the shoulder joint reaction force was lower in the reverse shoulder group than in the control group. Copyright © 2015 Elsevier Ltd. All rights reserved.

Association between dental prosthesis need, nutritional status and quality of life of elderly subjects.

PubMed

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.

Validation of the Narrowing Beam Walking Test in Lower Limb Prosthesis Users.

PubMed

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

Penile prosthesis implant: scientific advances and technological innovations over the last four decades.

PubMed

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.

Penile prosthesis implant: scientific advances and technological innovations over the last four decades

PubMed Central

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

Allograft-prosthesis composites after bone tumor resection at the proximal tibia.

PubMed

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.

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.

Sexual Function and Quality of Life Before and After Penile Prosthesis Implantation Following Radial Forearm Flap Phalloplasty.

PubMed

Young, Ezekiel E; Friedlander, Daniel; Lue, Kathy; Anele, Uzoma A; Khurgin, Jacob L; Bivalacqua, Trinity J; Burnett, Arthur L; Redett, Richard J; Gearhart, John P

2017-06-01

To provide sexual function and quality of life outcomes in patients with severe penile deficiency who underwent radial forearm flap phalloplasty with and without penile prosthesis implantation. Patients with history of severe penile deficiency who underwent microsurgical radial forearm flap phalloplasty with and without penile prosthesis implantation between 2007 and 2014 were identified. They completed a set of web-based validated questionnaires including the International Index of Erectile Function, the Pediatric Penile Perception Score, the Sexual Quality of Life for Men, and several items addressing general quality of life. Outcomes were compared between groups. Nine of the 12 identified patients who had prosthesis after phalloplasty and 4 out of the 7 phalloplasty-only patients completed the survey, resulting in an overall response rate of 68%. Among the phalloplasty-prosthesis patients, 66% reported current sexual activity and 78% reported regular masturbation, whereas 1 of the 4 phalloplasty-only patients reported both. Prosthesis patients scored notably higher in all domains of the International Index of Erectile Function except for sexual desire. In contrast, they demonstrated similar scores of penile perception, as well as general and sexual quality of life. Among patients who have undergone flap phalloplasty, the subsequent placement of penile prosthesis appears to effectively allow for both intercourse and masturbation, resulting in measurable improvements in orgasmic function, intercourse satisfaction, and overall sexual satisfaction. Despite these important benefits, prosthesis placement does not appear to result in improvements in penile perception scores, or general or sexual quality of life. Copyright © 2017 Elsevier Inc. All rights reserved.

Linking of total elbow prosthesis during surgery; a biomechanical analysis.

PubMed

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.

Catastrophic metallosis after tumoral knee prosthesis failure: A case report.

PubMed

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.

Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human

DTIC Science & Technology

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

Tracheostomy cannulas and voice prosthesis

PubMed Central

Kramp, Burkhard; Dommerich, Steffen

2011-01-01

Cannulas and voice prostheses are mechanical aids for patients who had to undergo tracheotomy or laryngectomy for different reasons. For better understanding of the function of those artificial devices, first the indications and particularities of the previous surgical intervention are described in the context of this review. Despite the established procedure of percutaneous dilatation tracheotomy e.g. in intensive care units, the application of epithelised tracheostomas has its own position, especially when airway obstruction is persistent (e.g. caused by traumata, inflammations, or tumors) and a longer artificial ventilation or special care of the patient are required. In order to keep the airways open after tracheotomy, tracheostomy cannulas of different materials with different functions are available. For each patient the most appropriate type of cannula must be found. Voice prostheses are meanwhile the device of choice for rapid and efficient voice rehabilitation after laryngectomy. Individual sizes and materials allow adaptation of the voice prostheses to the individual anatomical situation of the patients. The combined application of voice prostheses with HME (Head and Moisture Exchanger) allows a good vocal as well as pulmonary rehabilitation. Precondition for efficient voice prosthesis is the observation of certain surgical principles during laryngectomy. The duration of the prosthesis mainly depends on material properties and biofilms, mostly consisting of funguses and bacteries. The quality of voice with valve prosthesis is clearly superior to esophagus prosthesis or electro-laryngeal voice. Whenever possible, tracheostoma valves for free-hand speech should be applied. Physicians taking care of patients with speech prostheses after laryngectomy should know exactly what to do in case the device fails or gets lost. PMID:22073098

Tracheostomy cannulas and voice prosthesis.

PubMed

Kramp, Burkhard; Dommerich, Steffen

2009-01-01

Cannulas and voice prostheses are mechanical aids for patients who had to undergo tracheotomy or laryngectomy for different reasons. For better understanding of the function of those artificial devices, first the indications and particularities of the previous surgical intervention are described in the context of this review. Despite the established procedure of percutaneous dilatation tracheotomy e.g. in intensive care units, the application of epithelised tracheostomas has its own position, especially when airway obstruction is persistent (e.g. caused by traumata, inflammations, or tumors) and a longer artificial ventilation or special care of the patient are required. In order to keep the airways open after tracheotomy, tracheostomy cannulas of different materials with different functions are available. For each patient the most appropriate type of cannula must be found. Voice prostheses are meanwhile the device of choice for rapid and efficient voice rehabilitation after laryngectomy. Individual sizes and materials allow adaptation of the voice prostheses to the individual anatomical situation of the patients. The combined application of voice prostheses with HME (Head and Moisture Exchanger) allows a good vocal as well as pulmonary rehabilitation. Precondition for efficient voice prosthesis is the observation of certain surgical principles during laryngectomy. The duration of the prosthesis mainly depends on material properties and biofilms, mostly consisting of funguses and bacteries. The quality of voice with valve prosthesis is clearly superior to esophagus prosthesis or electro-laryngeal voice. Whenever possible, tracheostoma valves for free-hand speech should be applied. Physicians taking care of patients with speech prostheses after laryngectomy should know exactly what to do in case the device fails or gets lost.

Management of long span partially edentulous maxilla with fixed removable denture prosthesis

PubMed Central

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.

PubMed

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.

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 888.3730 - 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 888.3730 - 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 888.3730 - 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 888.3730 - 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...

Preparation for the Implantation of an Intracortical Visual Prosthesis in a Human

DTIC Science & Technology

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

Vacuum form sheet as a guide for fabrication of orbital prosthesis.

PubMed

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.

Biocompatible membrane of PDMS for the new chamber prosthesis stapes.

PubMed

Banasik, Katarzyna; Kwacz, Monika

2016-06-30

Stapes protheses are designed for patients with otosclerosis resulting immobilization or significant reduction of the stapes mobility. All currently used prostheses are called - piston prosthesis. However, its use to stimulate the cochlea is still imperfect. New chamber stapes prosthesis allows the perilymph excitation more effective than the piston prothesis. Moreover, the chamber prosthesis eliminates the common causes of piston-stapedotomy failures. The most important element of the new prosthesis is a flexible membrane. The membrane stiffness should be close to the stiffness of normal annular ligament. This work presents the process of selection of the membrane's thickness and its manufacturing technology. Method A 3D model of the chamber stapes prosthesis was build using Autodesk Inventor 2015. The model was imported to Abacus 6.13 computing environment. During numerical simulations, displacements corresponding to applied loads were calculated and the membrane thickness was adjusted so that its stiffness was the same as the ligament stiffness (~ 120 N/m). The compliance ratios calculated from the load-displacement curves for the membrane and the annular ligament were verified using linear regression analysis. After determining the thickness, the manufacturing technology of the membrane was developed. Results The best similarity between the membrane's and annular ligament's stiffness was achieved for PDMS membrane with the 0,15- mm thickness (similarity ratio R2=0,997752). In this work, the technological parameters of spin-coating process for membrane manufacture are also presented. Summary The proper functioning of the chamber stapes prosthesis requires the PDMS membrane with a thickness of 0,15 mm. The 0,15-mm membrane has the tiffness close to the stiffness of the normal annular ligament. Therefore, the chamber stapes prosthesis provides the perilymph stimulation at the level comparable to the healthy ear. New prosthesis is currently under pre

Clinical and Radiographic Outcomes of Unipolar and Bipolar Radial Head Prosthesis in Patients with Radial Head Fracture: A Systemic Review and Meta-Analysis.

PubMed

Chen, Hongwei; Wang, Ziyang; Shang, Yongjun

2018-06-01

To compare clinical outcomes of unipolar and bipolar radial head prosthesis in the treatment of patients with radial head fracture. Medline, Cochrane, EMBASE, Google Scholar databases were searched until April 18, 2016 using the following search terms: radial head fracture, elbow fracture, radial head arthroplasty, implants, prosthesis, unipolar, bipolar, cemented, and press-fit. Randomized controlled trials, retrospective, and cohort studies were included. The Mayo elbow performance score (MEPS), disabilities of the arm, shoulder, and hand (DASH) score, radiologic assessment, ROM, and grip strength following elbow replacement were similar between prosthetic devices. The pooled mean excellent/good ranking of MEPS was 0.78 for unipolar and 0.73 for bipolar radial head arthroplasty, and the pooled mean MEPS was 86.9 and 79.9, respectively. DASH scores for unipolar and bipolar prosthesis were 19.0 and 16.3, respectively. Range of motion outcomes were similar between groups, with both groups have comparable risk of flexion arc, flexion, extension deficit, rotation arc, pronation, and supination (p values <0.001 for both unipolar and bipolar prosthesis). However, bipolar radial head prosthesis was associated with an increased chance of heterotopic ossification and lucency (p values ≤0.049) while unipolar prosthesis was not (p values ≥0.088). Both groups had risk for development of capitellar osteopenia or erosion/wear (p values ≤0.039). Unipolar and bipolar radial head prostheses were similar with respect to clinical outcomes. Additional comparative studies are necessary to further compare different radial head prostheses used to treat radial head fracture.

Design and Control of a Pneumatically Actuated Transtibial Prosthesis.

PubMed

Zheng, Hao; Shen, Xiangrong

2015-04-01

This paper presents the design and control of a pneumatically actuated transtibial prosthesis, which utilizes a pneumatic cylinder-type actuator to power the prosthetic ankle joint to support the user's locomotion. The pneumatic actuator has multiple advantages over the traditional electric motor, such as light weight, low cost, and high power-to-weight ratio. The objective of this work is to develop a compact and lightweight transtibial prosthesis, leveraging the multiple advantages provided by this highly competitive actuator. In this paper, the design details of the prosthesis are described, including the determination of performance specifications, the layout of the actuation mechanism, and the calculation of the torque capacity. Through the authors' design calculation, the prosthesis is able to provide sufficient range of motion and torque capacity to support the locomotion of a 75 kg individual. The controller design is also described, including the underlying biomechanical analysis and the formulation of the finite-state impedance controller. Finally, the human subject testing results are presented, with the data indicating that the prosthesis is able to generate a natural walking gait and sufficient power output for its amputee user.

Design and Control of a Pneumatically Actuated Transtibial Prosthesis

PubMed Central

Zheng, Hao; Shen, Xiangrong

2015-01-01

This paper presents the design and control of a pneumatically actuated transtibial prosthesis, which utilizes a pneumatic cylinder-type actuator to power the prosthetic ankle joint to support the user's locomotion. The pneumatic actuator has multiple advantages over the traditional electric motor, such as light weight, low cost, and high power-to-weight ratio. The objective of this work is to develop a compact and lightweight transtibial prosthesis, leveraging the multiple advantages provided by this highly competitive actuator. In this paper, the design details of the prosthesis are described, including the determination of performance specifications, the layout of the actuation mechanism, and the calculation of the torque capacity. Through the authors’ design calculation, the prosthesis is able to provide sufficient range of motion and torque capacity to support the locomotion of a 75 kg individual. The controller design is also described, including the underlying biomechanical analysis and the formulation of the finite-state impedance controller. Finally, the human subject testing results are presented, with the data indicating that the prosthesis is able to generate a natural walking gait and sufficient power output for its amputee user. PMID:26146497

A laboratory silicone for preclinical training in ear prosthesis.

PubMed

Anand, Vijay; Haribabu; Vimala; Gnanasamband, Vimala

2013-07-01

This article describes an industrial elastic silicone as a material for the laboratory fabrication of ear prosthesis. It has been tested for toxicity in lab animals by the SGS India Pvt. Ltd and approved as a material to pass the parameter of abnormal toxicity. This material therefore can be safely recommended for laboratory exercise to fabricate facial prosthesis. The high cost of the maxillo facial silicone materials prohibits their use for facial prosthesis in pre-clinical training of post-graduate students in maxillofacial prosthodontics. For this reason, pre-clinical laboratory exercise in facial prosthesis is inadequate. A few institutions use polymethyl methacrylate resins which are rigid and do not have elastic characteristics of silicone, which is used for facial defects. This cost-effective industrial silicone material which mimics the elastic and color characteristics of the conventional silicones can be recommended for preclinical exercises.

Prosthesis rejection in acquired major upper-limb amputees: a population-based survey.

PubMed

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.

Complications and Clinical Considerations of the Implant-Retained Zirconia Complete-Arch Prosthesis with Various Opposing Dentitions.

PubMed

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

21 CFR 874.3730 - Laryngeal prosthesis (Taub design).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Laryngeal prosthesis (Taub design). 874.3730 Section 874.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3730 Laryngeal prosthesis (Taub design). (a) Identification. A...

[Tracheobronchial prosthesis in Mounier-Kuhn syndrome: New perspectives].

PubMed

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.

Intermanual transfer in training with an upper-limb myoelectric prosthesis simulator: a mechanistic, randomized, pretest-posttest study.

PubMed

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

Control and Evaluation of a Powered Transfemoral Prosthesis for Stair Ascent.

PubMed

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.

Predictors of retention and attrition in a study of an advanced upper limb prosthesis: implications for adoption of the DEKA Arm.

PubMed

Resnik, Linda; Cancio, Jill; Klinger, Shana; Latlief, Gail; Sasson, Nicole; Smurr-Walters, Lisa

2018-02-01

The purpose was to identify factors associated with completion of the VA home study of the DEKA Arm. Design and methodological procedures used: Differences between groups were examined using chi-square and t-tests. A multivariable logistic regression model predicting completion was generated and odds ratios (OR) for significant variables calculated. Post-hoc analysis was performed to plot the receiver operating characteristics (ROC) curve. Participants who completed were more likely to be prosthesis users at study onset (p = .03), and less likely to have a history of musculoskeletal problems (p = .047). There were no statistically significant differences between groups who completed and those who did not in gender, race, veteran status, age, body mass index (BMI), weight, height, musculoskeletal pain at baseline, satisfaction with current prosthesis, type of prosthesis, or months of prosthesis use. Two variables, prosthesis use and history of musculoskeletal problems were significant at p < .10. The area under the curve (AUC) accuracy index was 0.78. We considered completion of the home use study a reasonable proxy for participant willingness to adopt the device; and believe that findings can be extrapolated to guide DEKA Arm prescription recommendations. Participants most likely to complete the study were already using a personal prosthesis, and without pre-existing musculoskeletal problems. Implications for rehabilitation Data from the VA Study of the DEKA Arm were analysed to determine which factors were associated with likely successful adoption of the DEKA Arm. Participants most likely to complete the study were those who already using a personal prosthesis, and those without pre-existing chronic or re-occurring musculoskeletal problems. This information may be useful when attempting to identify and target the most appropriate candidates for DEKA Arm prescription.

A contemporary comparative analysis of immediate postoperative prosthesis placement following below-knee amputation.

PubMed

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

Simulation of a slope adapting ankle prosthesis provided by semi-active damping.

PubMed

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.

The hydrophilic-coated inflatable penile prosthesis: 1-year experience.

PubMed

Wolter, Christopher E; Hellstrom, Wayne J G

2004-09-01

Penile prosthesis infections are a devastating complication for both patient and surgeon. Efforts to reduce the risk of infection from these elective procedures are a major focus of research and development by the major prosthesis companies. The Titan inflatable penile prosthesis (Mentor Corporation, Santa Barbara, CA) is coated with polyvinylpyrrolidone (PVP), a hydrophilic substance that reduces bacterial adherence and absorbs and elutes the antibiotics the device is immersed in intraoperatively. The Titan device was introduced to the American market in September 2002. This study reports the 1-year experience in the U.S. with the Titan and compares infection rates with the noncoated Alpha-1 IPP made by Mentor. Two thousand three hundred and fifty-seven Titan prostheses were implanted in the U.S. from September 2002 to August 2003, compared with the 482 noncoated Alpha-1 IPPs implanted over the same time period. Infection rates were compared, along with bacterial culture data. All data were collected from Mentor's internal database, as generated from the FDA's mandatory reporting of explanted medical devices, and available on the internet. The infection rate for the coated Titan IPP was 1.06% (25/2,357). During the same time period, the infection rate for the Alpha-1 noncoated prosthesis was 2.07% (10/482). Staphylococcus species predominated in both groups (9/25 Titan, 6/10 Alpha-1). At 1 year of follow-up, the data demonstrate that the hydrophilic coating on the Titan IPP confers a significant advantage in reducing the rate of infection over the noncoated device. Long-term follow-up on this first year database is needed before this innovation is accepted as the standard of care for prosthetic surgery. Nevertheless, the theoretical reduction in bacterial adhesion conferred by the hydrophilic PVP surface and the ability to choose which antibiotic the device is immersed in intraoperatively gives the implanting surgeon distinct advantages with this new product.

Use of Powered Prosthesis for Children with Upper Limb Deficiency at Hyogo Rehabilitation Center

PubMed Central

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

Use of Powered Prosthesis for Children with Upper Limb Deficiency at Hyogo Rehabilitation Center.

PubMed

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.

Prosthesis Prescription Protocol of the Arm (PPP-Arm): The implementation of a national prosthesis prescription protocol.

PubMed

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.

Design of a power-asymmetric actuator for a transtibial prosthesis.

PubMed

Bartlett, Harrison L; Lawson, Brian E; Goldfarb, Michael

2017-07-01

This paper presents the design and characterization of a power-asymmetric actuator for a transtibial prosthesis. The device is designed to provide the combination of: 1) joint locking, 2) high power dissipation, and 3) low power generation. This actuator functionality allows for a prosthesis to be designed with minimal mass and power consumption relative to a fully-powered robotic prosthesis while maintaining much of the functionality necessary for activities of daily living. The actuator achieves these design characteristics while maintaining a small form factor by leveraging a combination of electromechanical and hydraulic components. The design of the actuator is described herein, and results of an experimental characterization are provided that indicate that the actuator is capable of providing the functional capabilities required of an ankle prosthesis in a compact and lightweight package.

Prosthesis Material

NASA Technical Reports Server (NTRS)

2004-01-01

In this photograph, Amputee Amie Bradly uses a NASA-developed prosthesis to paint her fingernails. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

Prosthesis Material

NASA Technical Reports Server (NTRS)

1995-01-01

In this photograph, James Carden uses a NASA-developed prosthesis to moved planks around his home. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

Prosthesis Material

NASA Technical Reports Server (NTRS)

1995-01-01

In this photograph, Sandra Rossi user her NASA-developed prosthesis for the first time. Derived from foam insulation technology used to protect the Space Shuttle External Tank from excessive heat, FAB/CAD, a subsidiary of the Harshberger Prosthetic and Orthotic Center, utilized the technology to replace the heavy, fragile plaster they used to produce master molds for prosthetics. The new material was lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the customer.

Cross-cultural validation of the Prosthesis Evaluation Questionnaire in vascular amputees fitted with prostheses in Spain.

PubMed

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.

Postpneumonectomy syndrome in children: advantages and long-term follow-up of expandable prosthesis.

PubMed

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.

Replacement of the valvular prosthesis in a patient with a Bentall procedure.

PubMed

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.

Implantable multilayer microstrip antenna for retinal prosthesis: antenna testing.

PubMed

Permana, Hans; Fang, Qiang; Rowe, Wayne S T

2012-01-01

Retinal prosthesis has come to a more mature stage and become a very strategic answer to Retinitis Pigmentosa (RP) and Age-related Macular Degeneration (AMD) diseases. In a retinal prosthesis system, wireless link holds a great importance for the continuity of the system. In this paper, an implantable multilayer microstrip antenna was proposed for the retinal prosthesis system. Simulations were performed in High Frequency Structure Simulator (HFSS) with the surrounding material of air and Vitreous Humor fluid. The fabricated antenna was measured for characteristic validation in free space. The results showed that the real antenna possessed similar return loss and radiation pattern, while there was discrepancy with the gain values.

Fitting a hand-glove prosthesis to enhance the reconstructed mutilated hand.

PubMed

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.

TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS.

PubMed

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.

TOTAL ANKLE ARTHROPLASTY: BRAZILIAN EXPERIENCE WITH THE HINTEGRA PROSTHESIS

PubMed Central

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

A new biomechanical hand prosthesis controlled by surface electromyographic signals.

PubMed

Andrade, Nei A; Borges, Geovany A; de O Nascimento, Francisco A; Romariz, Alexandre R S; da Rocha, Adson F

2007-01-01

This paper describes the development of a low-cost hand prosthesis for use in patients with an amputated hand due to congenital problems or to trauma wound, who possess a part or the forearm endowed with muscular activity. The paper covers the constructive aspects of both mechanical and electronic designs. The prototype is controlled by electromyographic signals measured at the remaining part of the injured limb of the patient. The EMG signals are measured at the surface of the skin, at a point that is close to a working muscle of the amputated arm. The prosthesis allows the patient to hold objects by means of a three finger clamp. The prosthesis presented an excellent performance in preliminary tests with an amputated patient. These tests showed that the prosthesis had a very good performance regarding force and speed.

Rehabilitation with dental prosthesis can increase cerebral regional blood volume.

PubMed

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.

Tracheal replacement in rabbits with a new composite silicone-metallic prosthesis.

PubMed

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.

Design and Characterization of a Quasi-Passive Pneumatic Foot-Ankle Prosthesis.

PubMed

Lee, Jeffrey D; Mooney, Luke M; Rouse, Elliott J

2017-07-01

The majority of commercially available passive prosthetic feet are not capable of providing joint mechanics that match that of the intact human ankle. Due to their cantilever design, their stiffness characteristics contrast with what has been observed in the biological ankle, namely, an increase in stiffness during the stance phase of walking. In this paper, we introduce the design and control of a pneumatic foot-ankle prosthesis that attempts to provide biomimetic mechanics. The prosthesis is comprised of a pneumatic cylinder in series with a fiberglass leaf spring, and a solenoid valve to control the flow of air between the two sides of the cylinder. The solenoid valve acts as a mechanical clutch, enabling resetting of the ankle's equilibrium position. By adjusting the pressure inside the cylinder, the prosthesis can be customized to provide a range of ankle mechanics. A mechanical testing machine is used to compare the torque-angle curve of the pneumatic prosthesis with a low-profile passive prosthetic foot. Finally, data are presented of one transtibial amputee walking with the prosthesis at 1.2 m/s. The testing shows that the pneumatic prosthesis is capable of providing an appropriate range of motion as well a maximum torque of 94 Nm, while returning approximately 11.5 J of energy.

Aortic root replacement using a biovalsalva prosthesis in comparison to a "handsewn" composite bioprosthesis.

PubMed

Moorjani, Narain; Modi, Amit; Mattam, Kavita; Barlow, Clifford; Tsang, Geoffrey; Haw, Marcus; Livesey, Steven; Ohri, Sunil

2010-05-01

The Biovalsalva aortic root prosthesis incorporates an Elan porcine stentless biological aortic valve suspended within a triple-layered vascular conduit with preformed aortic sinuses of Valsalva. This study compared implantation of the Biovalsalva prosthesis with a "handsewn" composite bioprosthetic graft (CE Perimount bovine bioprosthesis anastomosed to a gelatin-impregnated gelweave Dacron graft). Between December 2004 and January 2009, 39 patients underwent elective or urgent aortic root replacement (modified Bentall procedure with coronary button reimplantation) using a Biovalsalva (n = 21) or a handsewn bioprosthesis (n = 18) for aortic root dilatation. There was no significant difference in the preoperative variables between the two study groups including age (70.7 +/- 1.7 vs. 67.6 +/- 2.9 years, p > 0.05). There was no in-hospital mortality. Three patients in each group underwent concomitant aortic hemi-arch replacement. Patients who underwent Biovalsalva implantation had a reduced need for transfusion of blood (1.25 +/- 0.32 vs. 3.17 +/- 0.71 units, p < 0.05) and fresh frozen plasma (2.78 +/- 0.39 vs. 1.85 +/- 0.31, p < 0.05), and reduced mediastinal blood loss (416 +/- 52 vs. 583 +/- 74 mL, p < 0.05) compared to those with a handsewn bioprosthesis. Cardiopulmonary bypass time (141 +/- 6 vs. 170 +/- 17 minutes, p = NS) and aortic cross-clamp time (113 +/- 6 vs. 115 +/- 7 minutes, p = NS) were similar. Postoperative echocardiography demonstrated excellent hemodynamic function of the Biovalsalva prosthesis (mean size 25.1 +/- 0.4 mm valved conduit) with a peak pressure gradient of 26.2 +/- 1.9 mmHg and no or trivial valvular regurgitation. The Biovalsalva prosthesis should be considered for patients requiring a biological aortic root replacement. It offers an "off-the-shelf" preassembled composite biological valve conduit with excellent hemostatic and hemodynamic properties.

Simplified technique for orbital prosthesis fabrication: a clinical report.

PubMed

Veerareddy, Chandrika; Nair, K Chandrasekharan; Reddy, G Ramaswamy

2012-10-01

Loss of orbital content can cause functional impairment, disfigurement of the face, and psychological distress. Rehabilitation of an orbital defect is a complex task, and if reconstruction by plastic surgery is not possible or not desired by the patient, the defect can be rehabilitated by an orbital prosthesis. The prosthetic rehabilitation in such cases depends on the precisely retained, user-friendly removable maxillofacial prosthesis. Many times, making an impression of the orbital area with an accurate record of surface details can be a difficult procedure. The critical areas are making a facial moulage, mold preparation, and attaching the retention device, particularly when eyeglass frames are used. This case focuses on these hindrance factors. A simple basket was used for the impression tray to obtain the facial moulage. A putty mold was used, and attachment of the prosthesis to a retention device was accomplished with positional distance. This method proves to be an economical and simple way of making an orbital prosthesis. © 2012 by the American College of Prosthodontists.

Custom-made silicone hand prosthesis: A case study.

PubMed

Nayak, S; Lenka, P K; Equebal, A; Biswas, A

2016-09-01

Up to now, a cosmetic glove was the most common method for managing transmetacarpal (TMC) and carpometacarpal (CMC) amputations, but it is devoid of markings and body color. At this amputation level, it is very difficult to fit a functional prosthesis because of the short available length, unsightly shape, grafted skin, contracture and lack of functional prosthetic options. A 30-year-old male came to our clinic with amputation at the 1st to 4th carpometacarpal level and a 5th metacarpal that was projected laterally and fused with the carpal bone. The stump had grafted skin, redness, and an unhealed suture line. He complained of pain projected over the metacarpal and suture area. The clinical team members decided to fabricate a custom-made silicone hand prosthesis to accommodate the stump, protect the grafted skin, improve the hand's appearance and provide some passive function. The custom silicone hand prosthesis was fabricated with modified flexible wires to provide passive interphalangeal movement. Basic training, care and maintenance instructions for the prosthesis were given to the patient. The silicone hand prosthesis was able to restore the appearance of the lost digits and provide some passive function. His pain (VAS score) was reduced. Improvement in activities of daily living was found in the DASH questionnaire and Jebsen-Taylor Hand Function test. A silicone glove is a good option for more distal amputations, as it can accommodate any deformity, protect the skin, enhance the appearance and provide functional assistance. This case study provides a simple method to get passively movable fingers after proximal hand amputation. Copyright © 2016. Published by Elsevier Masson SAS.

"Bail out" procedures for malpositioning of aortic valve prosthesis (CoreValve).

PubMed

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.

Clinical and Radiographic Assessment of Three-Implant-Supported Fixed-Prosthesis Rehabilitation of the Edentulous Mandible: Immediate Versus Delayed Loading.

PubMed

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

Management of an Anophthalmic Patient by the Fabrication of Custom Made Ocular Prosthesis

PubMed Central

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

Rehabilitation of a missing ear with an implant retained auricular prosthesis

PubMed Central

Guttal, Satyabodh Sheshraj; Shanbhag, Shruti; Kulkarni, Sudhindra S.; Thakur, Srinath L.

2015-01-01

Burns can leave a patient with a severely debilitating disability even after treatment. The objectives of burn rehabilitation are to minimize the adverse effects caused by the injury while rehabilitating the patient's physical and psychological well-being, maximizing social integration. Long-term success of maxillofacial prostheses mainly depends on the retention. Extra oral implant retained prostheses have proved to be a predictable treatment option for maxillofacial rehabilitation. Replacement of a severely deformed external ear with burned tissues may be satisfactorily accomplished by a cosmetic prosthesis anchored by implants integrated in the skull. The use of such implants is now a well-recognized method for creating a stable result in maxillofacial rehabilitation. This case report describes a safe, simple and economical method for the rehabilitation of a patient with missing right auricle using an implant supported silicone prosthesis. The implant was placed in the mastoid region of the temporal bone. Reconstruction of the ear was done with auricular silicone prosthesis, retained using magnets incorporated in an autopolymerizing resin shim to decrease the weight of the prosthesis on a single implant. This method eliminates the need of tedious laboratory procedures and exact casting and fitting requirements of a metal substructure while minimizing the overall weight and cost of the prosthesis while maintaining adequate support, esthetics and retention of the prosthesis. PMID:26929490

Rehabilitation of orbital cavity after orbital exenteration using polymethyl methacrylate orbital prosthesis.

PubMed

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.

Bilateral electromyogram response latency following platform perturbation in unilateral transtibial prosthesis users: influence of weight distribution and limb position.

PubMed

Rusaw, David; Hagberg, Kerstin; Nolan, Lee; Ramstrand, Nerrolyn

2013-01-01

Appropriate muscular response following an external perturbation is essential in preventing falls. Transtibial prosthesis users lack a foot-ankle complex and associated sensorimotor structures on the side with the prosthesis. The effect of this lack on rapid responses of the lower limb to external surface perturbations is unknown. The aim of the present study was to compare electromyogram (EMG) response latencies of otherwise healthy, unilateral, transtibial prosthesis users (n = 23, mean +/- standard deviation [SD] age = 48 +/- 14 yr) and a matched control group (n = 23, mean +/- SD age = 48 +/- 13 yr) following sudden support-surface rotations in the pitch plane (toes-up and toes-down). Perturbations were elicited in various weight-bearing and limb-perturbed conditions. The results indicated that transtibial prosthesis users have delayed responses of multiple muscles of the lower limb following perturbation, both in the intact and residual limbs. Weight-bearing had no influence on the response latency in the residual limb, but did on the intact limb. Which limb received the perturbation was found to influence the muscular response, with the intact limb showing a significantly delayed response when the perturbation was received only on the side with a prosthesis. These delayed responses may represent an increased risk of falling for individuals who use transtibial prostheses.

Facial recognition using enhanced pixelized image for simulated visual prosthesis.

PubMed

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.

Research, design & development project Myoelectric Prosthesis of Upper Limb

NASA Astrophysics Data System (ADS)

Galiano, L.; Montaner, E.; Flecha, A.

2007-11-01

A Research Design and Development Project was developed of a myoelectric prosthesis for a pediatric patient presenting congenital amputation of the left forearm below the elbow. A multidisciplinary work-team was formed for this goal, in order to solve the several (/various) aspects regarding this project (mechanical, ergonomics, electronics, physical). The prosthesis as an electromechanical device was divided in several blocks, trying to achieve a focused development for each stage, acording to requisites. A mechanical prototype of the prothesis was designed and built along with the circuitry needed for EMG aquisition, control logic and drivers. Having acomplished the previuos stages, the project is now dealing with the definitions of the interface between the prosthesis and the patient, with promising perspectives.

[Rehabilitation by hollow obturator prosthesis immediately after total maxillectomy for malignant tumor].

PubMed

Li, Xiao-ye; Yan, Ai-hui; Hao, Shuai; Li, Wei; Jiang, Xue-jun; Lu, Li; Qin, Xing-jun; Yan, Hai-xin

2011-05-01

The feasibility and clinical effects of hollow obturator prosthesis for the repair of maxillofacial defect immediately after maxillectomy for cancer were assessed. Thirteen patients with T3-4aN0M0 maxillary neoplasm were treated by the prostheses immediately after maxillectomy. According to the 3D-CT reconstruction of nasal sinus, the 3D stereoscopic prototype was constructed before the surgery. Simulating surgery with Surgicare 5.0 software and then the prosthesis 3D stereoscopic model was shaped. The prosthesis was made quickly and precisely with methacrylate resins according to the model and the print mold before surgery, with supplementary tooth at the bottom of prosthesis. In the surgery, the prosthesis was installed instantly after maxillectomy. The patients were followed up at 1, 3 and 6 month after the surgery, respectively. The facial features and the pronunciation clarity were examined and the questionnaires were carried out in the patients, with comparation by paired t-test. The hollow obturator prosthesis would be replaced by permanent prosthesis made of methacrylate resins at 6 month after the surgery. The hollow obturator prostheses were installed accurately and maxillofacial defects were repaired immediately after maxillectomy in the 13 patients. Postoperative follow-up showed there were significant differences in eyeball sagging (t = 4.67, P < 0.05), mid-facial region collapse (t = 5.67, P < 0.05), and pronunciation clarity (t = 16.38, P < 0.05) between patients with and without prostheses. Questionnaires showed that all the patients were satisfied with the retention of prostheses, the improvement of appearance, the improvement of the symptom of water choking and speech definition. Six months after the surgery, the hollow obturator prostheses were replaced smoothly by permanent prostheses in 11 of the 13 patients. The precise and instant repair of maxillofacial defect by prosthesis after maxillectomy can improve survival quality of patient.

Do CTA measurements of annular diameter, perimeter and area result in different TAVI prosthesis sizes?

PubMed

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.

Multidisciplinary approach for in-deep assessment of joint prosthesis failure.

PubMed

Tessarolo, F; Caola, I; Piccoli, F; Dorigotti, P; Demattè, E; Molinari, M; Malavolta, M; Barbareschi, M; Caciagli, P; Nollo, G

2009-01-01

In spite of advancement in biomaterials and biomechanics, in development of new osteo-integrative materials and coatings, and in macro- micro- component design, a non negligible fraction of the implanted prosthesis fails before the expected lifetime. A prospective observational clinical study has been conducted to define and apply a set of experimental techniques to in-deep assess the failure of joint prosthesis. Microbiological, histological and micro-structural techniques were implemented to specifically address phenomena occurring at the tissue-implant interface. Results obtained from 27 cases of prosthetic joint failure are discussed in terms of sensitivity and specificity. A procedural flow-chart is finally proposed for the assessment of joint prosthesis failure.

Utilization of penile prosthesis and male incontinence prosthetics in Saudi Arabia.

PubMed

Alwaal, Amjad; Al-Sayyad, Ahmad J

2017-01-01

Erectile dysfunction is a prevalent disease affecting over 50% of men between the ages of 40 and 70 years. Penile prosthesis represents the end of the line treatment when other less invasive therapies fail or are contraindicated. Male stress urinary incontinence can significantly diminish quality of life and lead to embarrassment and social withdrawal. Surgical therapies, such as male urethral slings and artificial urinary sphincters (AUS), are considered effective and safe treatments for male stress incontinence. No data exist on the utilization of penile prosthesis or male incontinence surgical treatment in Saudi Arabia. Generally, urological prosthetic surgery is performed either in private hospitals or in government hospitals. Our aim was to assess the trend of penile prosthesis and male incontinence device utilization in Saudi Arabia. We utilized sales' data of penile prosthetics, male slings, and AUS from the only two companies selling these devices in Saudi Arabia (AMS ® and Coloplast ® ), from January 2013 to December 2016. There were 2599 penile prosthesis implantation procedures done in the study period, with 67% of them performed in private institutions. There was a progressively increased use of penile prosthetics which nearly doubled from 2013 to 2016. The main type of prosthesis utilized was the semirigid type 70% versus 11% of the 2-piece inflatable and 17% of the 3-piece inflatable device. Only 10 slings and 31 AUS were inserted during the same study period. There is an increased utilization of penile prosthetics in Saudi Arabia. The private sector performs the majority of penile prosthesis procedures, and most of them are of the semirigid type. The governmental sector is more likely to perform inflatable penile prosthesis and male incontinence device procedures. Male incontinence prosthetics' use is very limited in Saudi Arabia.

Manufacturer-provided effective orifice area index charts and the prevention of prosthesis-patient mismatch.

PubMed

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.

Production of porous coating on a prosthesis

DOEpatents

Sump, Kenneth R.

1987-01-01

Preselected surface areas of a prosthesis are covered by a blend of matching primary metallic particles and expendable particles. The particles are compressed and heated to assure that deformation and metallurgical bonding occurs between them and between the primary particles and the surface boundaries of the prosthesis. Porosity is achieved by removal of the expendable material. The result is a coating including discrete bonded particles separated by a network of interconnected voids presenting a homogeneous porous coating about the substrate. It has strength suitable for bone implant usage without intermediate adhesives, and adequate porosity to promote subsequent bone ingrowth.

A proposed intracortical visual prosthesis image processing system.

PubMed

Srivastava, N R; Troyk, P

2005-01-01

It has been a goal of neuroprosthesis researchers to develop a system, which could provide artifical vision to a large population of individuals with blindness. It has been demonstrated by earlier researches that stimulating the visual cortex area electrically can evoke spatial visual percepts, i.e. phosphenes. The goal of visual cortex prosthesis is to stimulate the visual cortex area and generate a visual perception in real time to restore vision. Even though the normal working of the visual system is not been completely understood, the existing knowledge has inspired research groups to develop strategies to develop visual cortex prosthesis which can help blind patients in their daily activities. A major limitation in this work is the development of an image proceessing system for converting an electronic image, as captured by a camera, into a real-time data stream for stimulation of the implanted electrodes. This paper proposes a system, which will capture the image using a camera and use a dedicated hardware real time image processor to deliver electrical pulses to intracortical electrodes. This system has to be flexible enough to adapt to individual patients and to various strategies of image reconstruction. Here we consider a preliminary architecture for this system.

Towards a Completely Implantable, Light-Sensitive Intraocular Retinal Prosthesis

DTIC Science & Technology

2001-10-25

electronic retinal prosthesis is under development to treat retinitis pigmentosa and age-related macular degeneration, two presently incurable...34Preservation of the inner retina in retinitis pigmentosa . A morphometric analysis," Arch Ophthalmol, vol. 115, no. 4, pp. 511-515, Apr.1997...Towards a completely implantable, light-sensitive intraocular retinal prosthesis. M.S. Humayun, J.D. Weiland, B. Justus1, C. Merrit1, J. Whalen, D

System training and assessment in simultaneous proportional myoelectric prosthesis control

PubMed Central

2014-01-01

Background Pattern recognition control of prosthetic hands take inputs from one or more myoelectric sensors and controls one or more degrees of freedom. However, most systems created allow only sequential control of one motion class at a time. Additionally, only recently have researchers demonstrated proportional myoelectric control in such systems, an option that is believed to make fine control easier for the user. Recent developments suggest improved reliability if the user follows a so-called prosthesis guided training (PGT) scheme. Methods In this study, a system for simultaneous proportional myoelectric control has been developed for a hand prosthesis with two motor functions (hand open/close, and wrist pro-/supination). The prosthesis has been used with a prosthesis socket equivalent designed for normally-limbed subjects. An extended version of PGT was developed for use with proportional control. The control system’s performance was tested for two subjects in the Clothespin Relocation Task and the Southampton Hand Assessment Procedure (SHAP). Simultaneous proportional control was compared with three other control strategies implemented on the same prosthesis: mutex proportional control (the same system but with simultaneous control disabled), mutex on-off control, and a more traditional, sequential proportional control system with co-contractions for state switching. Results The practical tests indicate that the simultaneous proportional control strategy and the two mutex-based pattern recognition strategies performed equally well, and superiorly to the more traditional sequential strategy according to the chosen outcome measures. Conclusions This is the first simultaneous proportional myoelectric control system demonstrated on a prosthesis affixed to the forearm of a subject. The study illustrates that PGT is a promising system training method for proportional control. Due to the limited number of subjects in this study, no definite conclusions can be

Transtibial prosthesis suspension failure during skydiving freefall: a case report.

PubMed

Gordon, Assaf T; Land, Rebekah M

2009-01-01

This report describes the unusual case of an everyday-use prosthesis suspension system failure during the freefall phase of a skydiving jump. The case individual was a 53-year-old male with a left transtibial amputation secondary to trauma. He used his everyday prosthesis, a transtibial endoskeleton with push-button, plunger-releasing, pin-locking silicon liner suction suspension and a neoprene knee suspension sleeve, for a standard recreational tandem skydive. Within seconds of exiting the plane, the suspension systems failed, resulting in the complete prosthesis floating away. Several factors may have led to suspension system failure, including an inadequate seal and material design of the knee suspension sleeve and liner, lack of auxiliary suspension mechanisms, and lack of a safety cover overlying the push-button release mechanism. This is the first report, to our knowledge, to discuss prosthetic issues specifically related to skydiving. While amputees are to be encouraged to participate in this extreme sport, special modifications to everyday components may be necessary to reduce the possibility of prosthesis failure during freefall, parachute deployment, and landing.

Referral of sensation to an advanced humanoid robotic hand prosthesis.

PubMed

Rosén, Birgitta; Ehrsson, H Henrik; Antfolk, Christian; Cipriani, Christian; Sebelius, Fredrik; Lundborg, Göran

2009-01-01

Hand prostheses that are currently available on the market are used by amputees to only a limited extent, partly because of lack of sensory feedback from the artificial hand. We report a pilot study that showed how amputees can experience a robot-like advanced hand prosthesis as part of their own body. We induced a perceptual illusion by which touch applied to the stump of the arm was experienced from the artificial hand. This illusion was elicited by applying synchronous tactile stimulation to the hidden amputation stump and the robotic hand prosthesis in full view. In five people who had had upper limb amputations this stimulation caused referral touch sensation from the stump to the artificial hand, and the prosthesis was experienced more like a real hand. We also showed that this illusion can work when the amputee controls the movements of the artificial hand by recordings of the arm muscle activity with electromyograms. These observations indicate that the previously described "rubber hand illusion" is also valid for an advanced hand prosthesis, even when it has a robotic-like appearance.

Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease.

PubMed

van Slooten, Ymkje J; van Melle, Joost P; Freling, Hendrik G; Bouma, Berto J; van Dijk, Arie Pj; Jongbloed, Monique Rm; Post, Martijn C; Sieswerda, Gertjan T; Huis In 't Veld, Anna; Ebels, Tjark; Voors, Adriaan A; Pieper, Petronella G

2016-01-01

To report the prevalence of aortic valve prosthesis-patient mismatch (PPM) in an adult population with congenital heart disease (CHD) and its impact on exercise capacity. Adults with congenital heart disease (ACHD) with a history of aortic valve replacement may outgrow their prosthesis later in life. However, the prevalence and clinical consequences of aortic PPM in ACHD are presently unknown. From the national Dutch Congenital Corvitia (CONCOR) registry, we identified 207 ACHD with an aortic valve prosthesis for this cross-sectional cohort study. Severe PPM was defined as an indexed effective orifice area ≤0.65 cm2/m2 and moderate PPM as an indexed orifice area ≤0.85 cm2/m2 measured using echocardiography. Exercise capacity was reported as percentage of predicted exercise capacity (PPEC). Of the 207 patients, 68% was male, 71% had a mechanical prosthesis and mean age at inclusion was 43.9 years ±11.4. The prevalence of PPM was 42%, comprising 23% severe PPM and 19% moderate PPM. Prevalence of PPM was higher in patients with mechanical prostheses (p<0.001). PPM was associated with poorer exercise capacity (mean PPEC 84% vs. 92%; p=0.048, mean difference =-8.3%, p=0.047). Mean follow-up was 2.6±1.1 years during which New York Heart Association (NYHA) class remained stable in most patients. PPM showed no significant effect on death or hospitalisation during follow-up (p=0.218). In this study we report a high prevalence (42%) of PPM in ACHD with an aortic valve prosthesis and an independent association of PPM with diminished exercise capacity. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Design and characterization of a powered elbow prosthesis.

PubMed

Bennett, Daniel A; Mitchell, Jason; Goldfarb, Michael

2015-01-01

This paper describes the design of a powered elbow prosthesis, which incorporates a belt and cable drive transmission with a brushless DC motor to achieve an output torque of approximately 18.4 Nm, a backdrive torque of 1.5 Nm, and a speed of up to 360 deg/s while remaining within the anthropomorphic envelope with regard to mass and size. The measured torque and speed of the prosthesis is commensurate with nominal capability of the natural limb (for purposes of performing activities of daily living).

A Simplified Technique for Fabrication of Orbital Prosthesis

PubMed Central

Thakral, G.K.; Mohapatra, Abhilash; Seth, Jyotsna; Vashisht, Pallavi

2014-01-01

Eye is a vital organ not only for vision, but also an important component of facial expression, and over-all personality of a person. Loss of eye, apart from leading to impaired vision has a crippling effect on the psychology of the patient. Prosthodontic rehabilitation of such cases includes fabrication of prosthesis by acrylic resin, silicone and implants. However, not all patients are willing to use implants for maxillofacial rehabilitation. Therefore, a custom made orbital prosthesis serves as an affordable and satisfactory alternative. PMID:25121068

Bionic ankle–foot prosthesis normalizes walking gait for persons with leg amputation

PubMed Central

Herr, Hugh M.; Grabowski, Alena M.

2012-01-01

Over time, leg prostheses have improved in design, but have been incapable of actively adapting to different walking velocities in a manner comparable to a biological limb. People with a leg amputation using such commercially available passive-elastic prostheses require significantly more metabolic energy to walk at the same velocities, prefer to walk slower and have abnormal biomechanics compared with non-amputees. A bionic prosthesis has been developed that emulates the function of a biological ankle during level-ground walking, specifically providing the net positive work required for a range of walking velocities. We compared metabolic energy costs, preferred velocities and biomechanical patterns of seven people with a unilateral transtibial amputation using the bionic prosthesis and using their own passive-elastic prosthesis to those of seven non-amputees during level-ground walking. Compared with using a passive-elastic prosthesis, using the bionic prosthesis decreased metabolic cost by 8 per cent, increased trailing prosthetic leg mechanical work by 57 per cent and decreased the leading biological leg mechanical work by 10 per cent, on average, across walking velocities of 0.75–1.75 m s−1 and increased preferred walking velocity by 23 per cent. Using the bionic prosthesis resulted in metabolic energy costs, preferred walking velocities and biomechanical patterns that were not significantly different from people without an amputation. PMID:21752817

Advanced engineering tools for design and fabrication of a custom nasal prosthesis

NASA Astrophysics Data System (ADS)

Oliveira, Inês; Leal, Nuno; Silva, Pedro; da Costa Ferreira, A.; Neto, Rui J.; Lino, F. Jorge; Reis, Ana

2012-09-01

Unexpected external defects resulting from neoplasms, burns, congenital malformations, trauma or other diseases, particularly when involving partial or total loss of an external organ, can be emotionally devastating. These defects can be restored with prosthesis, obtained by different techniques, materials and methods. The increase of patient numbers and cost constraints lead to the need of exploring new techniques that can increase efficiency. The main goal of this project was to develop a full engineering-based manufacturing process to obtain soft-tissue prosthesis that could provide faster and less expensive options in the manufacturing of customized prosthesis, and at the same time being able to reproduce the highest degree of details, with the maximum comfort for the patient. Design/methodology/approach - This case report describes treatment using silicone prosthesis with an anatomic retention for an 80-years-old woman with a rhinectomy. The proposed methodology integrates non-contact structured light scanning, CT and reverse engineering with CAD/CAM and additive manufacturing technology. Findings - The proposed protocol showed encouraging results since reveals being a better solution for fabricating custom-made facial prostheses for asymmetrical organs than conventional approaches. The process allows the attainment of prosthesis with the minimum contact and discomfort for the patient, disclosing excellent results in terms of aesthetic, prosthesis retention and in terms of time and resources consumed.

Prosthesis Material

NASA Technical Reports Server (NTRS)

1995-01-01

FAB/CAM, a subsidiary of the Harshberger Prosthetic and Orthotic Center, Inc., approached Marshall for help in replacing the heavy, fragile plaster they used to produce master molds for prosthetics. Concurrently, Marshall and Martin Marietta were creating a commercial derivative of the foam insulation used to protect the Space Shuttle External Tank from excessive heat. FAB/CAM found the foam blanks to be lighter, cheaper and easier to manufacture than plaster, resulting in lower costs to the consumer. Martin Marietta markets the foam system, MARCORE, for the prosthesis market. The system also has commercial potential in high temperature insulation and structural applications.

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 888.3220 - 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 888.3220 - 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...

Predictors of Receiving a Prosthesis for Adults With Above-Knee Amputations in a Well-Defined Population.

PubMed

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

[Lessons from a heart valve prosthesis controversy].

PubMed

Vandenbroucke, J P; Grobbee, D E

1998-07-18

Two lessons are to be learnt from the Björk-Shiley heart valve prosthesis tragedy. In the first place pharmacoepidemiologic studies are seriously hampered by recent privacy legislation. Individual patients carrying such a prosthesis cannot be traced and advised as to their health risks any more, because their legal autonomy has to be respected. This is clearly not to their advantage. In the second place the atmosphere of marketing and litigation and the increasing dependency of researchers on money from sources with conflicting interests is not conducive to a well-informed and balanced judgement of the epidemiological evidence of safety and efficacy of medical treatments.

21 CFR 878.3720 - Tracheal prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The...

Standing stability enhancement with an intelligent powered transfemoral prosthesis.

PubMed

Lawson, Brian Edward; Varol, Huseyin Atakan; Goldfarb, Michael

2011-09-01

The authors have developed a ground-adaptive standing controller for a powered knee and ankle prosthesis which is intended to enhance the standing stability of transfemoral amputees. The finite-state-based controller includes a ground-searching phase, a slope estimation phase, and a joint impedance modulation phase, which together enable the prosthesis to quickly conform to the ground and provide stabilizing assistance to the user. In order to assess the efficacy of the ground-adaptive standing controller, the control approach was implemented on a powered knee and ankle prosthesis, and experimental data were collected on an amputee subject for a variety of standing conditions. Results indicate that the controller can estimate the ground slope within ±1° over a range of ±15°, and that it can provide appropriate joint impedances for standing on slopes within this range.

The psychosocial benefits of secondary hydroxyapatite orbital implant insertion and prosthesis wearing for patients with anophthalmia.

PubMed

Wang, Junming; Zhang, Hong; Chen, Wei; Li, Guigang

2012-01-01

Anophthalmia is associated with a range of psychosocial difficulties and hydroxyapatite orbital implant insertion and prosthesis wearing is the predominant rehabilitation therapy for anophthalmia. However, few articles have compared preoperative and postoperative psychosocial outcomes using standardized questionnaires. This study aimed to investigate the psychosocial benefits of hydroxyapatite orbital implant insertion and prosthesis wearing in this patient population. In all, 36 participants were tested preoperatively and 6-months postoperatively using standardized measures of anxiety and depression (Hospital Anxiety and Depression Scale), social anxiety and social avoidance (Derriford Appearance Scale-Short Form), and quality of life (World Health Organization Quality of Life Scale-Short Form). Before treatment, levels of depression were comparable with population norms; however, levels of general anxiety were slightly raised, levels of social anxiety, social avoidance, and quality of life were significantly poorer than population norms. Treatment resulted in significant improvement in psychosocial adjustment with improvements in all study variables for the participant group as a whole. Hydroxyapatite orbital implant insertion and prosthesis wearing offers significant improvements in psychological and physical functioning for patients with anophthalmia.

Wide-awake Anesthesia No Tourniquet Trapeziometacarpal Joint Prosthesis Implantation.

PubMed

Müller, Camillo Theo; Christen, Thierry; Heidekruger, Paul I; Lamouille, Jessie; Raffoul, Wassim; McKee, Daniel; Lalonde, Donald H; Durand, Sébastien

2018-04-01

Wide awake local anesthesia no tourniquet (WALANT) hand surgery is a rapidly growing in popularity. WALANT has been used by hand surgeons when operating on bones, tendons, ligaments, nerve entrapments. We offer a case report of the first case in the literature describing WALANT technique when performing trapeziometacarpal joint arthroplasty with prosthesis implantation. We offer technical points on how to perform this procedure and the advantages that are associated with using WALANT for prosthesis arthroplasty.

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...

Midterm results of "thrust plate" prosthesis.

PubMed

Fink, Bernd; Wessel, Stephanie; Deuretzbacher, Georg; Protzen, Michael; Ruther, Wolfgang

2007-08-01

The aim of this investigation was to analyze the midterm results obtained with the metaphyseal fixation principle of the thrust plate prosthesis (TPP). Survival of 214 implants in 204 patients was analyzed. Clinical (Harris hip score) and radiologic examinations were carried out on 157 of 190 TPP with a postimplantation follow-up period of at least 5 years. Failure rate was 7.0% (9 aseptic and 6 septic loosening). Harris hip score increased from 36.9 +/- 13.5 points preoperatively to 91.2 +/- 13.1 points at follow-up. Eleven TPPs showed radiolucent lines not indicating prosthetic loosening. Thrust plate prosthesis is not an alternative to stemmed endoprostheses. It may be rarely indicated in very young patients where, because of their age, several revision operations can be expected.

Candida albicans, Staphylococcus aureus and Streptococcus mutans colonization in patients wearing dental prosthesis.

PubMed

Baena-Monroy, Tania; Moreno-Maldonado, Víctor; Franco-Martínez, Fernando; Aldape-Barrios, Beatriz; Quindós, Guillermo; Sánchez-Vargas, Luis Octavio

2005-04-01

Denture stomatitis is associated to Candida albicans, different bacteria and other co-factors such as an acid pH, a carbohydrate ingestion increase, different systemic illnesses and pharmacological treatments. The aim of this study was to determine Candida albicans, Staphylococcus aureus and Streptococcus mutans prevalence in the mucous membrane and prosthesis of patients with and without atrophic denture stomatitis and its relationship with other potential clinical co-factors. Saliva was collected from 105 patients (62 female and 43 male) wearing dental prosthesis in order to measure their pH. Oral samples of the mucous membrane and the internal surface of dental prosthesis were taken with sterile cotton to proceed with the microbiological study. The identification of the isolated microorganisms was performed using conventional microbiological methods. Diabetes and Hypertension were the most frequent systemic illnesses. High carbohydrate ingestion was observed in numerous patients. Atrophic denture stomatitis was reported in 50 patients and the pH average in saliva was of 5.2. The presence of C albicans, S. aureus and S. mutans in the mucous membrane and prosthesis was of 51.4%, 52.4% and 67.6%, respectively. C. albicans was isolated in 66.7% from the prosthesis, whereas S. aureus and S. mutans were isolated in 49.5% of those same prosthesis. C. albicans was isolated in 86% of the patients with atrophic denture stomatitis and S. aureus was isolated in a similar percentage (84% of patients). The isolation of S. mutans was less frequent, and it was observed in 16% of the oral samples of these patients. C. albicans, S. aureus and S. mutans frequently colonize the oral mucous of patients wearing dental prosthesis. This illness-bearing condition is more frequent in patients with denture stomatitis, even though dental prosthesis colonization is lower than in the oral mucous.

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

21 CFR 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Elbow joint radial (hemi-elbow) polymer prosthesis. 888.3170 Section 888.3170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-elbow) polymer prosthesis. (a) Identification. An elbow joint radial (hemi-elbow) polymer...

Variable Cadence Walking and Ground Adaptive Standing with a Powered Ankle Prosthesis

PubMed Central

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

Actinomyces gerencseriae hip prosthesis infection: a case report.

PubMed

Dubourg, Grégory; Delord, Marion; Gouriet, Frédérique; Fournier, Pierre-Edouard; Drancourt, Michel

2015-09-28

Actinomyces bacteria are part of the human oropharyngeal microbiota. They have been associated with abdominal, cervicofacial and thoracic infections and a few cases of joint infections have also been described. In particular, Actinomyces gerencseriae, formerly described as Actinomyces israelii serovar II, has rarely been associated with human infections, mostly involving cervicofacial lesions and periodontal diseases. Here, we report one case of hip prosthesis infection due to A. gerencseriae. A 72-year-old Caucasian male developed an inflammatory collection on the outside of the right thigh where a hip prosthesis had been implanted for 11 years. Culturing a fluid sample from the collection puncture found Staphylococcus hominis and a Gram-positive bacillus unidentified by matrix-assisted laser desorption ionization time-of-flight mass-spectrometry (MALDI-TOF). Sequencing the 16S rRNA gene amplified from both the specimen and the isolate identified A. gerencseriae. Treatment adjusted with amoxicillin and trimethropim-sulfamethoxazole cured the infection. The recently described A. gerencseriae has rarely been involved in human infections. We report the first case of A. gerencseriae joint infection in a hip prosthesis.

Quantifying risk of penile prosthesis infection with elevated glycosylated hemoglobin.

PubMed

Wilson, S K; Carson, C C; Cleves, M A; Delk, J R

1998-05-01

Elevation of glycosylated hemoglobin above levels of 11.5 mg.% has been considered a contraindication to penile prosthesis implantation in diabetic patients. We determine the predictive value of glycosylated hemoglobin A1C in penile prosthesis infections in diabetic and nondiabetic patients to confirm or deny this prevalent opinion. We conducted a 2-year prospective study of 389 patients, including 114 diabetics, who underwent 3-piece penile prosthesis implantation. All patients had similar preoperative preparation without regard to diabetic status, control or glycosylated hemoglobin A1C level. Risk of infection was statistically analyzed for diabetics versus nondiabetics, glycosylated hemoglobin A1C values above and below 11.5 mg.%, insulin dependent versus oral medication diabetics, and fasting blood sugars above and below 180 mg.%. Prosthesis infections developed in 10 diabetics (8.7%) and 11 nondiabetics (4.0%). No increased infection rate was observed in diabetics with high fasting sugars or diabetics on insulin. There was no statistically significant increased infection risk with increased levels of glycosylated hemoglobin A1C among all patients or among only the diabetics. In fact, there was no meaningful difference in the median or mean level of glycosylated hemoglobin A1C in the infected and noninfected patients regardless of diabetes. Use of glycosylated hemoglobin A1C values to identify and exclude surgical candidates with increased risk of infections is not proved by this study. Elevation of fasting sugar or insulin dependence also does not increase risk of infection in diabetics undergoing prosthesis implantation.

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.

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

A fiber-reinforced composite prosthesis restoring a lateral midfacial defect: a clinical report.

PubMed

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.

Comparison of two different rehabilitation programmes for thrust plate prosthesis: a randomized controlled study.

PubMed

Unver, Bayram; Karatosun, Vasfi; Gunal, Izge; Angin, Salih

2004-02-01

Weight bearing after total hip arthroplasty is postponed in order to prevent early loosening, but this negatively affects the rehabilitation programme. For the force transfer characteristics of thrust plate prosthesis (TPP), a new type of hip prosthesis used without cement is similar to the normal hip. We evaluated the possibilities of early weight bearing after TPP by comparing early partial with early full weight bearing. Randomized controlled study. Department of orthopaedics and traumatology in a university hospital. Sixty hips of 51 patients who underwent total hip arthroplasty with TPP were randomly assigned into two groups. Both groups received accelerated rehabilitation programmes: group 1 with early partial weight bearing and group 2 with early full weight bearing. Patients were evaluated by a blind observer preoperatively, at three months after surgery by clinical (measurement of range of hip motion (universal goniometry), muscle strength (Manual Muscle Test), functional test (6-minute walk test), hip function (Harris Hip Scoring System)) and radiographical parameters and one year after surgery by clinical (Harris Hip Scoring System) and radiographical parameters. Group 2 performed transfer activities earlier, had more walking distance at the time of discharge and shorter hospital stay than group 1. At three months, Harris Hip Score, muscle strength, 6-minute walk test, and duration of crutch use were significantly (p < 0.05) in favour of group 2. None of the patients in either group showed signs of loosening one year after the operation. These results suggest that patients with TPP can tolerate an accelerated rehabilitation programme with early weight bearing and will gain the goals of rehabilitation earlier.

A Dental Prosthesis from the Early Modern Age in Tuscany (Italy).

PubMed

Minozzi, Simona; Panetta, Daniele; De Sanctis, Massimo; Giuffra, Valentina

2017-04-01

During archaeological excavation, carried out in the S. Francesco Monastery at Lucca (Tuscany, Italy), a golden dental appliance was discovered. The prosthesis was found, together with commingled human remains, in the collective tomb of the aristocratic family of the Guinigi, a powerful family who governed Lucca from 1392 until 1429. The exact archaeological dating of the prosthesis was not possible, but some elements suggest a dating to the beginning of the 17th century. Aim of the paper is to study and describe the dental appliance trough a multidisciplinary approach. Macroscopical and micro-CT examinations were performed to investigate the technics used for the realization of the dental prosthesis. SEM analysis was performed to study alloy composition of the metallic fixing lamina and microstructure of the deposits on the dental surface. The dental prosthesis consists in five mandibular teeth: three central incisors and two lateral canines linked together by a golden band inserted into the dental roots to replace the anterior arch of the jaw. Micro-CT scan revealed the presence of two small golden pins inserted into each tooth crossing the root and fixing the teeth to the internal gold band. SEM examination of the lamina indicated a homogeneous composition, with average contents of 73 wt% gold, 15.6 wt% Ag, and 11.4 wt% Cu. Apposition of dental calculus on the teeth indicated that the prosthesis had been worn for a long period. This dental prosthesis provides a unique finding of technologically advanced dentistry in this period. In fact, during the Early Modern Age, some authors described gold band technology for the replacement of missing teeth; nevertheless, no direct evidences of these devices have been brought to light up so far. © 2016 Wiley Periodicals, Inc.

Adjuvant Maneuvers for Residual Curvature Correction During Penile Prosthesis Implantation in Men with Peyronie's Disease.

PubMed

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.

A new malleostapedotomy prosthesis. Experimental analysis by laser doppler vibrometer in fresh cadaver temporal bones.

PubMed

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.

Insidious strut fractures in a DeBakey-Surgitool aortic valve prosthesis.

PubMed

Scott, S M; Sethi, G K; Paulson, D M; Takaro, T

1978-04-01

Recent reports of cage wear occurring in DeBakey-Surgitool aortic valve prostheses prompted us to examine with image intensification all our patients who have had this type of prosthesis implanted. One patient, who was asymptomatic, was discovered to have a prosthesis with two fractured struts. This patient's prosthetic valve was replaced successfully with a stented porcine heterograft prosthesis. Including the valve removed from this patient, 8 DeBakey-Surgitool aortic valves with structural defects have been reported to the manufacturer. In the absence of a catastrophic event, patients with valves having fractured or worn struts may be totally asymptomatic, and routine periodic roentgenographic examination may be the only way of detecting strut wear or fracture.

Studying Upper-Limb Amputee Prosthesis Use to Inform Device Design

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-14-1-0277 TITLE: Studying Upper-Limb Amputee Prosthesis Use to Inform Device Design PRINCIPAL INVESTIGATOR: Aaron...Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No. 0704...Amputee Prosthesis Use to Inform Device Design 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Aaron Dollar, Adam Spiers

The M6-C Cervical Disk Prosthesis: First Clinical Experience in 33 Patients.

PubMed

Thomas, Sam; Willems, Karel; Van den Daelen, Luc; Linden, Patrick; Ciocci, Maria-Cristina; Bocher, Philippe

2016-05-01

Retrospective study. To determine the short-term clinical succesrate of the M6-C cervical disk prosthesis in primary and secondary surgery. Cervical disk arthroplasty (CDA) provides an alternative to anterior cervical decompression and fusion for the treatment of spondylotic radiculopathy or myelopathy. The prevention of adjacent segment disease (ASD), a possible complication of anterior cervical decompression and fusion, is its most cited--although unproven--benefit. Unlike older arthroplasty devices that rely on a ball-and-socket-type design, the M6-C cervical disk prosthesis represents a new generation of unconstrained implants, developed to achieve better restoration of natural segmental biomechanics. This device should therefore optimize clinical performance of CDA and reduce ASD. All patients had preoperative computed tomography or magnetic resonance imaging and postoperative x-rays. Clinical outcome was assessed using the Neck Disability Index, a Visual Analog Scale, and the SF-36 questionnaire. Patients were asked about overall satisfaction and whether they would have the surgery again. Thirty-three patients were evaluated 17.1 months after surgery, on average. Nine patients had a history of cervical interventions. Results for Neck Disability Index, Visual Analog Scale, and SF-36 were significantly better among patients who had undergone primary surgery. In this group, 87.5% of patients reported a good or excellent result and 91.7% would have the procedure again. In contrast, all 4 device-related complications occurred in the small group of patients who had secondary surgery. The M6-C prosthesis appears to be a valuable addition to the CDA armatorium. It generates very good results in patients undergoing primary surgery, although its use in secondary surgery should be avoided. Longer follow-up is needed to determine to what measure this device can prevent ASD.

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 888.3510 - 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 888.3660 - 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 888.3650 - 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 888.3680 - 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 888.3100 - 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...

Optimization of Visual Information Presentation for Visual Prosthesis.

PubMed

Guo, Fei; Yang, Yuan; Gao, Yong

2018-01-01

Visual prosthesis applying electrical stimulation to restore visual function for the blind has promising prospects. However, due to the low resolution, limited visual field, and the low dynamic range of the visual perception, huge loss of information occurred when presenting daily scenes. The ability of object recognition in real-life scenarios is severely restricted for prosthetic users. To overcome the limitations, optimizing the visual information in the simulated prosthetic vision has been the focus of research. This paper proposes two image processing strategies based on a salient object detection technique. The two processing strategies enable the prosthetic implants to focus on the object of interest and suppress the background clutter. Psychophysical experiments show that techniques such as foreground zooming with background clutter removal and foreground edge detection with background reduction have positive impacts on the task of object recognition in simulated prosthetic vision. By using edge detection and zooming technique, the two processing strategies significantly improve the recognition accuracy of objects. We can conclude that the visual prosthesis using our proposed strategy can assist the blind to improve their ability to recognize objects. The results will provide effective solutions for the further development of visual prosthesis.

Optimization of Visual Information Presentation for Visual Prosthesis

PubMed Central

Gao, Yong

2018-01-01

Visual prosthesis applying electrical stimulation to restore visual function for the blind has promising prospects. However, due to the low resolution, limited visual field, and the low dynamic range of the visual perception, huge loss of information occurred when presenting daily scenes. The ability of object recognition in real-life scenarios is severely restricted for prosthetic users. To overcome the limitations, optimizing the visual information in the simulated prosthetic vision has been the focus of research. This paper proposes two image processing strategies based on a salient object detection technique. The two processing strategies enable the prosthetic implants to focus on the object of interest and suppress the background clutter. Psychophysical experiments show that techniques such as foreground zooming with background clutter removal and foreground edge detection with background reduction have positive impacts on the task of object recognition in simulated prosthetic vision. By using edge detection and zooming technique, the two processing strategies significantly improve the recognition accuracy of objects. We can conclude that the visual prosthesis using our proposed strategy can assist the blind to improve their ability to recognize objects. The results will provide effective solutions for the further development of visual prosthesis. PMID:29731769

21 CFR 888.3340 - Hip 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 Hip joint metal/composite semi-constrained cemented prosthesis. 888.3340 Section 888.3340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Hip joint metal/composite semi-constrained cemented prosthesis. (a) Identification. A hip joint metal...

21 CFR 888.3110 - Ankle joint 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 Ankle joint metal/polymer semi-constrained cemented prosthesis. 888.3110 Section 888.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal...

21 CFR 888.3160 - Elbow joint 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 Elbow joint metal/polymer semi-constrained cemented prosthesis. 888.3160 Section 888.3160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal...

21 CFR 888.3800 - Wrist 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 Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...

21 CFR 888.3110 - Ankle 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 Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...

21 CFR 888.3120 - Ankle 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 Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was in...

21 CFR 888.3160 - Elbow 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 Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...

21 CFR 888.3800 - Wrist joint 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 Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...

21 CFR 888.3340 - Hip 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 Hip joint metal/composite semi-constrained... Hip joint metal/composite semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a...

21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... substantially equivalent to an ankle joint metal/polymer non-constrained cemented prosthesis that was in... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non...

21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... substantially equivalent to an ankle joint metal/polymer non-constrained cemented prosthesis that was in... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non...

21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... substantially equivalent to an ankle joint metal/polymer non-constrained cemented prosthesis that was in... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non...

21 CFR 888.3110 - Ankle joint 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 Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...

21 CFR 888.3160 - Elbow joint 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 Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...

21 CFR 888.3110 - Ankle joint metal/polymer semi-constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...

21 CFR 888.3800 - Wrist joint 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 Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...

21 CFR 888.3800 - Wrist joint metal/polymer semi-constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...

21 CFR 888.3120 - Ankle joint metal/polymer non-constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ankle joint metal/polymer non-constrained cemented... metal/polymer non-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer non... December 26, 1996 for any ankle joint metal/polymer non-constrained cemented prosthesis that was in...

21 CFR 888.3160 - Elbow joint metal/polymer semi-constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...

21 CFR 888.3160 - Elbow joint 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 Elbow joint metal/polymer semi-constrained... Elbow joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow...

21 CFR 888.3110 - Ankle joint 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 Ankle joint metal/polymer semi-constrained... Ankle joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle...

21 CFR 888.3800 - Wrist joint 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 Wrist joint metal/polymer semi-constrained... Wrist joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint...

Development and Application of a Tendon Prosthesis for Early Functional Restoration of the Hand.

DTIC Science & Technology

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

Residual standard deviation: Validation of a new measure of dual-task cost in below-knee prosthesis users.

PubMed

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.

21 CFR 888.3370 - Hip joint (hemi-hip) acetabular metal cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint (hemi-hip) acetabular metal cemented... (hemi-hip) acetabular metal cemented prosthesis. (a) Identification. A hip joint (hemi-hip) acetabular metal cemented prosthesis is a device intended to be implanted to replace a portion of the hip joint...

21 CFR 888.3350 - Hip joint 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 Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...

21 CFR 888.3350 - Hip 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 Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...

21 CFR 888.3350 - Hip joint 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 Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...

21 CFR 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...

21 CFR 888.3350 - Hip joint 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 Hip joint metal/polymer semi-constrained cemented prosthesis. 888.3350 Section 888.3350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... metal/polymer semi-constrained cemented prosthesis. (a) Identification. A hip joint metal/polymer semi...

[Distal fixation prosthesis for unstable intertrochanteric fractures in elderly patients: a mid-term follow-up study].

PubMed

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

[Tripolar arthroplasty for recurrent total hip prosthesis dislocation].

PubMed

Beaulé, P-E; Roussignol, X; Schmalzried, T-P; Udomkiat, P; Amstutz, H-C; Dujardin, F-H

2003-05-01

The purpose of this study was to assess the results of revision surgery for recurrent total hip prosthesis dislocation using a tripolar prosthesis composed of a conventional stem with a mobile head of an intermediary prosthesis measuring more than 40 mm and a modified cup. This technique was used in two centers in Rouen France and Los Angeles USA. Twenty-one hips in 21 patients were operated on. The mobile heads measured 40 to 47 mm. Mean patient age was 70 years (range 29-92). The indication for the tripolar prosthesis was reserved for extremely unstable hips in patients with major risk factors for recurrent dislocation. These 21 patients had experienced 95 dislocations. The acetabular cup was custom-made for the large-diameter heads. A cemented polyethylene cup was used in 14 cases and a press-fit metal-backed around a polyethylene insert in 7. The polyethylene thickness varied from 6.5 to 16 mm for the cemented cups and 4 to 5 mm for the press-fit cups. Fourteen femoral stems were left in place as were two press-fit cups where only the inserts were changed. Mean follow-up was 5.4 years (range 3-11.8). There has been no recurrent dislocation for 20 hips. One patient experienced a dislocation one week after surgery which required a second revision procedure to reposition the acetabular implant. Final outcome was good at 7.6 years for this hip. One patient who had not had any recurrent dislocation died 4 years after the revision surgery due to a cause unrelated to the prosthesis. Two patients were lost to follow-up at 3.7 and 6 years, both were pain free and had no radiological anomalies. Infection occurred in one patient undergoing chemotherapy for a myeloma; the head and neck had to be resected. For the 20 other patients, functional outcome, assessed with the UCLA score, showed improvement in pain (5.8 preoperatively, 9.2 at last follow-up), walking (4.8 and 8 respectively), function (4 and 6 respectively), and daily activities (3.3 and 5.2 respectively). A

Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study

PubMed Central

Henry, Gerard; Karpman, Edward; Brant, William; Jones, LeRoy; Khera, Mohit; Kohler, Tobias; Christine, Brian; Rhee, Eugene; Kansas, Bryan; Bella, Anthony J.

2017-01-01

is a moderate correlation with pre-operative flaccid penile length (r=0.30; P<0.01). Conclusions Implanted penile prosthesis length is negatively correlated with some ethnic groups, prostatectomy, and incontinence. Positive correlates include CV disease, preoperative stretched penile length, and flaccid penile length. PMID:29354506

21 CFR 872.3950 - Glenoid fossa prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular...

21 CFR 872.3950 - Glenoid fossa prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... A glenoid fossa prosthesis is a device that is intended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular...

A sectional denture as the optimal prosthesis.

PubMed

Cohen, K

1989-08-01

A case is described where because of various local factors--anterior ridge loss, Class III skeletal relationship, survey lines, appearance, retention and support problems--a sectional prosthesis was found to be the optimal restoration.

A custom-made temporomandibular joint prosthesis for fabrication by selective laser melting: Finite element analysis.

PubMed

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.

[Tests of hand functionality in upper limb amputation with prosthesis].

PubMed

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.

A new mouthstick prosthesis for handicapped patients.

PubMed

Lutwak, E

1977-01-01

Most mouthstick prostheses previously described in the literature have severely limited application or availability. They are either highly specific and sophisticated and difficult to fabricate or very crude and unifunctional. Most do not conform to basic functional and physiologic criteria as outlined, nor are they sufficiently flexible to meet the various needs and physical capabilities of of a wide spectrum of patients. The prosthesis described is adaptable, and with the basic bite-stick and the friction-grip lock, the patient can change the form and function of the device to perform various tasks independently. The prosthesis is simple, inexpensive, and easy to fabricate and repair, and it needs no specialized or sophisticated parts. It enables handicapped patients to attain a greater degree of self-sufficiency than was previously possible, which improves their mental outlook.

Teflon-wire piston or stainless-steel bucket stapes prosthesis: does it make a difference?

PubMed

Farrior, J B; Temple, A E

1999-04-01

The goal of this study was to determine whether postoperative (implantation of a stapes prosthesis) hearing gain and the amount of air-bone gap overclosure are more improved with the Teflon-wire piston or with the stainless-steel bucket prosthesis. We retrospectively reviewed the outcomes of 82 surgeries that had been performed by the primary author; 41 of these patients had received a Fisch Teflon-wire piston, and 41 had received a Bailey-modified Robinson stainless-steel bucket prosthesis. The mean hearing gain for the patients who received the Teflon-wire piston was 23.3 dB after primary stapes surgery and 20.5 dB after revision surgery. Patients who received the stainless-steel bucket prosthesis experienced a mean hearing gain of 20.7 and 20.3 dB, respectively. Following primary stapes surgery, the air-bone gap overclosure was 4.4 dB with the Teflon-wire piston and 5.2 dB with the stainless-steel bucket prosthesis. There was no statistically significant difference in either hearing gain or air-bone gap overclosure between the two prostheses.

Visualisation of upper limb activity using spirals: A new approach to the assessment of daily prosthesis usage.

PubMed

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

Customization of stock eye prosthesis for a pediatric patient by a simplified technique.

PubMed

Jurel, Sunit Kumar; Talwar, Naina; Chand, Pooran; Singh, Raghuwar D; Gupta, Durga Shanker

2012-05-01

The unfortunate loss or absence of an eye may be caused by congenital defect , irreparable trauma, tumor or blind eye. The role of the maxillofacial prosthodontist in fabricating an ocular prosthesis to restore facial symmetry and normal appearance for the anophthalmic patient becomes essential. A custom-made ocular prosthesis is an excellent alternative for the people who lose their eye especially in young age. It has acceptable fit, retention and esthetics but is technically difficult to fabricate. On the other hand the stock eye has compromised fit and poor esthetics. Our case report presents a simple technique of customization of stock eye prosthesis to provide accurate fit and acceptable esthetics. How to cite this article: Jurel SK, Talwar N, Chand P, Singh RD, Gupta DS. Customization of Stock Eye Prosthesis for a Pediatric Patient by a Simplified Technique. Int J Clin Pediatr Dent 2012;5(2):155-158.

Customization of Stock Eye Prosthesis for a Pediatric Patient by a Simplified Technique

PubMed Central

Talwar, Naina; Chand, Pooran; Singh, Raghuwar D; Gupta, Durga Shanker

2012-01-01

ABSTRACT The unfortunate loss or absence of an eye may be caused by congenital defect , irreparable trauma, tumor or blind eye. The role of the maxillofacial prosthodontist in fabricating an ocular prosthesis to restore facial symmetry and normal appearance for the anophthalmic patient becomes essential. A custom-made ocular prosthesis is an excellent alternative for the people who lose their eye especially in young age. It has acceptable fit, retention and esthetics but is technically difficult to fabricate. On the other hand the stock eye has compromised fit and poor esthetics. Our case report presents a simple technique of customization of stock eye prosthesis to provide accurate fit and acceptable esthetics. How to cite this article: Jurel SK, Talwar N, Chand P, Singh RD, Gupta DS. Customization of Stock Eye Prosthesis for a Pediatric Patient by a Simplified Technique. Int J Clin Pediatr Dent 2012;5(2):155-158. PMID:25206159

Penile Prosthesis Surgery: Current Recommendations From the International Consultation on Sexual Medicine.

PubMed

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

Viscous Flow Structures Downstream of a Model Tracheoesophageal Prosthesis

NASA Astrophysics Data System (ADS)

Hemsing, Frank; Erath, Byron

2013-11-01

In tracheoesophageal speech (TES), the glottis is replaced by the tissue of the pharyngeoesophageal segment (PES) as the vibrating element of speech production. During TES air is forced from the lungs into the esophagus via a prosthetic tube that connects the trachea with the esophagus. Air moving up the esophagus incites self-sustained oscillations of the surgically created PES, generating sound analogous to voiced speech. Despite the ubiquity with which TES is employed as a method for restoring speech to laryngectomees, the effect of viscous flow structures on voice production in TES is not well understood. Of particular interest is the flow exiting the prosthetic connection between the trachea and esophagus, because of its influence on the total pressure loss (i.e. effort required to produce speech), and the fluid-structure energy exchange that drives the PES. Understanding this flow behavior can inform prosthesis design to enhance beneficial flow structures and mitigate the need for adjustment of prosthesis placement. This study employs a physical model of the tracheoesophageal geometry to investigate the flow structures that arise in TES. The geometry of this region is modeled at three times physiological scale using water as the working fluid to obtain nondimensional numbers matching flow in TES. Modulation of the flow is achieved with a computer controlled gate valve at a scaled frequency of 0.22 Hz to mimic the oscillations of the PES. Particle image velocimetry is used to resolve flow characteristics at the tracheoesophageal prosthesis. Data are acquired for three cases of prosthesis insertion angle.

Influence of type of aortic valve prosthesis on coronary blood flow velocity.

PubMed

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.

Effect of Framework in an Implant-Supported Full-Arch Fixed Prosthesis: 3D Finite Element Analysis.

PubMed

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.

A second prosthesis as a procedural rescue option in trans-apical aortic valve implantation.

PubMed

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.

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 888.3550 - Knee joint patellofemorotibial polymer/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 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 888.3565 - 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 888.3550 - Knee joint patellofemorotibial polymer/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 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 888.3490 - 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...

21 CFR 888.3550 - Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

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 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 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 888.3550 - Knee joint patellofemorotibial polymer/metal/metal 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 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 888.3550 - Knee joint patellofemorotibial polymer/metal/metal 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 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...

Clinical acceptability of metal-ceramic fixed partial dental prosthesis fabricated with direct metal laser sintering technique-5 year follow-up.

PubMed

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.

A Canadian Electric-Arm Prosthesis for Children

PubMed Central

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

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...

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 888.3540 - 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...

21 CFR 888.3520 - Knee joint femorotibial 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 Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...

21 CFR 888.3590 - Knee joint tibial (hemi-knee) metallic resurfacing 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 tibial (hemi-knee) metallic resurfacing... Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted...

21 CFR 888.3580 - Knee joint patellar (hemi-knee) metallic resurfacing 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 patellar (hemi-knee) metallic... § 888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis. (a) Identification. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of...

21 CFR 888.3520 - Knee joint femorotibial metal/polymer 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/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...

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 888.3500 - 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 888.3530 - 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...

21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Knee joint femorotibial metal/polymer non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...

21 CFR 888.3530 - Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 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 888.3520 - Knee joint femorotibial metal/polymer non-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 non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...

21 CFR 888.3520 - Knee joint femorotibial metal/polymer non-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 non... § 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to...

Bacterial colonization of penile prosthesis after its withdrawal due to mechanical failure.

PubMed

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.

Influence of Inter-Training Intervals on Intermanual Transfer Effects in Upper-Limb Prosthesis Training: A Randomized Pre-Posttest Study.

PubMed

Romkema, Sietske; Bongers, Raoul M; van der Sluis, Corry K

2015-01-01

Improvement in prosthetic training using intermanual transfer (the transfer of motor skills from the trained, “unaffected” hand to the untrained, “affected” hand) has been shown in previous studies. The aim of this study is to determine the influence of the inter-training interval on the magnitude of the intermanual transfer effects. This was done using a mechanistic, randomized, single-blinded pretest-posttest design. Sixty-four able-bodied, right-handed participants were randomly assigned to the Short and Long Interval Training Groups and the Short and Long Interval Control Groups. The Short and Long Interval Training Groups used a prosthesis simulator in their training program. The Short and Long Interval Control Groups executed a sham training program, that is, a dummy training program in which the same muscles were trained as with the prosthesis simulator. The Short Interval Training Group and the Short Interval Control Groups trained on consecutive days, while the Long Interval Training Group and Long Interval Control Group trained twice a week. To determine the improvement in skills, a test was administered before, immediately after, and at two points in time after the training. Training was performed with the “unaffected” arm; tests were performed with the “affected” arm. The outcome measurements were: the movement time (the time from the beginning of the movement until completion of the task); the duration of maximum hand opening, (the opening of the prosthetic hand while grasping an object); and the grip-force control (the error from the required grip-force during a tracking task). Intermanual transfer was found in movement times, but not in hand opening or grip-force control. The length of the inter-training interval did not affect the magnitude of intermanual transfer effects. No difference in the intermanual transfer effect in upper-limb prosthesis training was found for training on a daily basis as compared to training twice a week

Influence of Inter-Training Intervals on Intermanual Transfer Effects in Upper-Limb Prosthesis Training: A Randomized Pre-Posttest Study

PubMed Central

Romkema, Sietske; Bongers, Raoul M.; van der Sluis, Corry K.

2015-01-01

Improvement in prosthetic training using intermanual transfer (the transfer of motor skills from the trained, “unaffected” hand to the untrained, “affected” hand) has been shown in previous studies. The aim of this study is to determine the influence of the inter-training interval on the magnitude of the intermanual transfer effects. This was done using a mechanistic, randomized, single-blinded pretest-posttest design. Sixty-four able-bodied, right-handed participants were randomly assigned to the Short and Long Interval Training Groups and the Short and Long Interval Control Groups. The Short and Long Interval Training Groups used a prosthesis simulator in their training program. The Short and Long Interval Control Groups executed a sham training program, that is, a dummy training program in which the same muscles were trained as with the prosthesis simulator. The Short Interval Training Group and the Short Interval Control Groups trained on consecutive days, while the Long Interval Training Group and Long Interval Control Group trained twice a week. To determine the improvement in skills, a test was administered before, immediately after, and at two points in time after the training. Training was performed with the “unaffected” arm; tests were performed with the “affected” arm. The outcome measurements were: the movement time (the time from the beginning of the movement until completion of the task); the duration of maximum hand opening, (the opening of the prosthetic hand while grasping an object); and the grip-force control (the error from the required grip-force during a tracking task). Intermanual transfer was found in movement times, but not in hand opening or grip-force control. The length of the inter-training interval did not affect the magnitude of intermanual transfer effects. No difference in the intermanual transfer effect in upper-limb prosthesis training was found for training on a daily basis as compared to training twice a week

21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...

21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...

21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...

21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...

21 CFR 888.3310 - Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hip joint metal/polymer constrained cemented or... Hip joint metal/polymer constrained cemented or uncemented prosthesis. (a) Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to...

Restoring Proprioception via a Cortical Prosthesis: A Novel Learning-Based Approach

DTIC Science & Technology

2015-10-01

AWARD NUMBER: W81XWH-14-1-0510 TITLE: Restoring Proprioception via a Cortical Prosthesis : A Novel Learning-Based Approach PRINCIPAL INVESTIGATOR...Proprioception via a Cortical Prosthesis : A Novel Learning-Based Approach 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Philip Sabes, PhD 5d...component of this lost sensation is proprioception, the feeling of where the body is in space. The importance of proprioception is often not appreciated

Same-session dorsal vein ligation and testing by intracavernous injection prior to penile prosthesis implantation (DVL-ICI-PPI).

PubMed

Shaeer, Osama; Shaeer, Kamal

2014-09-01

Complications of penile prosthesis implantation (PPI) are rare, nevertheless can be grave. In cases with veno-occlusive dysfunction (VOD), alternative surgical techniques such as dorsal vein ligation (DVL) are controversial. Some patients may opt for trial at DVL to avoid the possible complications of PPI. However, this may be associated with disappointment if DVL fails and another procedure is required. The aim if this study is to evaluate the results of a combined approach involving DVL, same-session testing by intracavernous injection (ICI) of prostaglandin E1 (PGE1), and immediate implantation of a penile prosthesis (PPI) in case of poor response to DVL. Long-term erectile function in cases with favorable intraoperative response to DVL. Twenty-six patients with refractory VOD were operated upon. Through a peno-pubic incision, DVL was performed, followed by ICI of 20 µg PGE1 in two divided doses, 10 µg each, 15 minutes apart. Group 1 exhibited full rigidity in response to the first dose. Group 2 exhibited full rigidity in response to the second dose. PPI was not performed for either. Group 3 exhibited suboptimal response to both doses, and PPI was performed through the same incision. Patients were followed up from 24 to 48 months using International Index of Erectile Function-5 scoring. For Group 1 (n = 8), six patients experienced normal erectile function following DVL throughout the whole follow-up period of 48 months (23.1% of all patients), and two patients relapsed. Group 2 (n = 6) (23.1%) reported normal erectile function for an average of 6 months, then relapsed. Group 3 (n = 12) had a penile prosthesis implanted in the same setting. Combined DVL-ICI-PPI can spare around 23.1% of young patients with VOD from PPI, at no additional risk. Full response to 10 µg PGE1 at intraoperative testing carries good prognosis to DVL on the long run. Investigation of a larger number of patients is necessary before reaching a final conclusion. © 2014

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.

Three-dimensional precise orientation of bilateral auricular trial prosthesis using a facebow for a young adult with Crouzon syndrome.

PubMed

Rathee, Manu; Tamrakar, Amit Kumar; Kundu, Renu; Yunus, Nadeem

2014-08-05

Facial deformity can be debilitating, especially in the psychological and cosmetic aspects. Although surgical correction or replacement of deformed or missing parts is the ideal treatment, prosthetic replacement serves the purpose in case of surgical limitations. Prosthetic rehabilitation of a missing auricle is an acceptable option as it provides better control over the tortuous anatomical shape and shade of the missing portion. Improper spatial orientation of the prosthetic ear on the face can damage the results of even the most aesthetic prosthesis. This case report describes a simple and innovative method for precise spatial orientation of auricular trial prosthesis using a facebow and custom-made adjustable mechanical retention design using stainless steel wire. 2014 BMJ Publishing Group Ltd.

Flexible and static wrist units in upper limb prosthesis users: functionality scores, user satisfaction and compensatory movements.

PubMed

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 .

An innovative method of ocular prosthesis fabrication by bio-CAD and rapid 3-D printing technology: A pilot study.

PubMed

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.

An investigation into vascular prosthesis modified with an electron beam.

PubMed

Lowkis, B; Szymonowicz, M; Rutkowski, J

1997-01-01

The present paper shows the results of an investigation into the effect of implanted electric charge on blood platelet adhesion to woven surfaces of "Dallon" polyester vascular prosthesis. The electrets were formed using the electron beam method. The assessment of the electret effect on blood platelet adhesion was performed on the basis of microscopic studies. It was shown that an implanted negative electric charge remarkably suppresses thrombocyte adhesion to the prosthesis surface. The electret effect was found to play a significant role in the process of preparing nonthrombogenic surfaces.

Game-Based Rehabilitation for Myoelectric Prosthesis Control.

PubMed

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

Game-Based Rehabilitation for Myoelectric Prosthesis Control

PubMed Central

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

[The endo-exo femur prosthesis--a new concept of bone-guided, prosthetic rehabilitation following above-knee amputation].

PubMed

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.

A cognitive prosthesis for complex decision-making.

PubMed

Tremblay, Sébastien; Gagnon, Jean-François; Lafond, Daniel; Hodgetts, Helen M; Doiron, Maxime; Jeuniaux, Patrick P J M H

2017-01-01

While simple heuristics can be ecologically rational and effective in naturalistic decision making contexts, complex situations require analytical decision making strategies, hypothesis-testing and learning. Sub-optimal decision strategies - using simplified as opposed to analytic decision rules - have been reported in domains such as healthcare, military operational planning, and government policy making. We investigate the potential of a computational toolkit called "IMAGE" to improve decision-making by developing structural knowledge and increasing understanding of complex situations. IMAGE is tested within the context of a complex military convoy management task through (a) interactive simulations, and (b) visualization and knowledge representation capabilities. We assess the usefulness of two versions of IMAGE (desktop and immersive) compared to a baseline. Results suggest that the prosthesis helped analysts in making better decisions, but failed to increase their structural knowledge about the situation once the cognitive prosthesis is removed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Visual prosthesis wireless energy transfer system optimal modeling.

PubMed

Li, Xueping; Yang, Yuan; Gao, Yong

2014-01-16

Wireless energy transfer system is an effective way to solve the visual prosthesis energy supply problems, theoretical modeling of the system is the prerequisite to do optimal energy transfer system design. On the basis of the ideal model of the wireless energy transfer system, according to visual prosthesis application condition, the system modeling is optimized. During the optimal modeling, taking planar spiral coils as the coupling devices between energy transmitter and receiver, the effect of the parasitic capacitance of the transfer coil is considered, and especially the concept of biological capacitance is proposed to consider the influence of biological tissue on the energy transfer efficiency, resulting in the optimal modeling's more accuracy for the actual application. The simulation data of the optimal model in this paper is compared with that of the previous ideal model, the results show that under high frequency condition, the parasitic capacitance of inductance and biological capacitance considered in the optimal model could have great impact on the wireless energy transfer system. The further comparison with the experimental data verifies the validity and accuracy of the optimal model proposed in this paper. The optimal model proposed in this paper has a higher theoretical guiding significance for the wireless energy transfer system's further research, and provide a more precise model reference for solving the power supply problem in visual prosthesis clinical application.

Clinical acceptability of metal-ceramic fixed partial dental prosthesis fabricated with direct metal laser sintering technique-5 year follow-up

PubMed Central

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

Nontraumatic Fracture of the Femoral Condylar Prosthesis in a Total Knee Arthroplasty Leading to Mechanical Failure

PubMed Central

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

Nontraumatic fracture of the femoral condylar prosthesis in a total knee arthroplasty leading to mechanical failure.

PubMed

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.

Carbon/PEEK composite materials as an alternative for stainless steel/titanium hip prosthesis: a finite element study.

PubMed

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.

Development and performance of a new prosthesis system using ultrasonic sensor for wrist movements: a preliminary study

PubMed Central

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

Biomechanical Evaluation of a Prototype Foot/Ankle Prosthesis

PubMed Central

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

Prevention of longitudinal crack propagation around a femoral prosthesis: a study of cerclage wire fixation.

PubMed

Difazio, F A; Incavo, S J; Howe, J D

1993-09-01

This study examined the effect of single versus triple-wrap cerclage fixation techniques in preventing propagation of a longitudinal fracture around a cementless femoral prosthesis. A proximal filling femoral component was implanted in 14 matched pairs of fresh-frozen bovine femora, following placement of a 45-mm longitudinal crack in the anteromedial cortical wall of the proximal femur. In one group of seven pairs, a single cerclage wire was applied to one specimen of each pair. A triple-wrap of a single cerclage wire was similarly placed in one specimen of each of the other seven pairs. All specimens were axially loaded on a materials testing system machine and the force required to propagate the fracture of the proximal femur was recorded. A triple-wrap cerclage technique required a significant increase in the force to propagate a proximal femur fracture around a non-cemented prosthesis when compared to a single cerclage wire. Copyright © 1993. Published by Elsevier Ltd.

Iris reconstruction using artificial iris prosthesis for management of aniridia.

PubMed

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.

Practical management of periprosthetic leakage in patients rehabilitated with a Provox® 2 voice prosthesis after total laryngectomy.

PubMed

Friedlander, Eviatar; Pinacho Martínez, Paloma; Poletti Serafini, Daniel; Martín-Oviedo, Carlos; Martínez Guirado, Tomás; Scola Yurrita, Bartolomé

Periprosthetic leakage of liquids is a common complication in patients rehabilitated with voice prostheses. Our objective was to describe and review the results of procedures for treating periprosthetic leakage. This was a retrospective analysis of 41 patients rehabilitated with Provox® 2 voice prostheses between 1997 and 2015. We describe 3 techniques: periprosthetic silicon collar placement, injection of hyaluronic acid into the tracheoesophageal wall and the combination of the 2 techniques. We present a method to reduce the diameter of the tracheoesophageal fistula by removing the voice prosthesis and placing a nasogastric tube through the fistula. In the 3 groups treated with silicone collar (n=5, 13 procedures), hyaluronic acid injection (n=5, 9 procedures) and the combination of both techniques (n=3, 5 procedures), we observed an increase in prosthesis lifespan of an average of 56 days (range 7-118 days), 32 days (range 3-55 days) and 63 days (range 28-136 days), respectively. The tracheoesophageal fistula diameter reduction was performed in 100% (n=6) of patients. The use of silicone collars, injection of hyaluronic acid into the tracheoesophageal wall and the combination of both techniques for the treatment of periprosthesis leakage increase the lifespan of the prosthesis. Temporary prosthesis removal and placement of nasogastric tube has also been shown effective in our experience. These techniques are simple, inexpensive and reproducible, thereby reducing healthcare costs. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

The Evolution of Dental Materials for Hybrid Prosthesis

PubMed Central

Gonzalez, Jorge

2014-01-01

Since the immemorial, the replacement of missing teeth has been a medical and cosmetic necessity for human kind. Nowadays, middle-aged population groups have experienced improved oral health, as compared to previous generations, and the percentage of edentulous adults can be expected to further decline. However, with the continued increase in the number of older adult population, it is anticipated that the need for some form of full-mouth restoration might increase from 53.8 million in 1991 to 61 million in 2020 [1]. Denture prosthetics has undergone many development stages since the first dentures were fabricated. The introduction of computer-aided design/computer aided manufacturing (CAD/CAM) has resulted in a more accurate manufacturing of prosthetic frameworks, greater accuracy of dental restorations, and in particular, implant supported prosthesis. PMID:24893781

Survey of upper limb prosthesis users in Sweden, the United Kingdom and Canada.

PubMed

Kyberd, Peter J; Hill, Wendy

2011-06-01

As part of the process of improving prosthetic arms, it is important to obtain the opinions of the user population. To identify factors that should be focused on to improve prosthesis provision. Postal questionnaire. The questionnaire was sent to 292 adults (aged 18 to 70 years) with upper-limb loss or absence at five centres (four in Europe) Participants were identified as regular attendees of the centres. This questionnaire received a response from 180 users (response rate 62%) of different types of prosthetic devices. Responses showed that the type of prosthesis generally used was associated with gender, level of loss and use for work (Pearson chi-square, p-values below 0.05). The type of prosthesis was not associated with cause, side, usage (length per day, sports or driving) or reported problems. The findings did not identify any single factor requiring focus for the improvement of prostheses or prosthetic provision. Every part of the process of fitting a prosthesis can be improved, which will have an effect for some of the population who use their devices regularly. There is, however, no single factor that would bring greater improvement to all users. Based on information gained from a broad range of prosthesis users, no single aspect of prosthetic provision will have a greater impact on the use of upper limb prostheses than any other. Efforts to improve the designs of prosthetic systems can cover any aspect of provision.

21 CFR 870.3450 - Vascular graft prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular graft...

Photovoltaic Retinal Prosthesis with High Pixel Density

PubMed Central

Mathieson, Keith; Loudin, James; Goetz, Georges; Huie, Philip; Wang, Lele; Kamins, Theodore I.; Galambos, Ludwig; Smith, Richard; Harris, James S.; Sher, Alexander; Palanker, Daniel

2012-01-01

Retinal degenerative diseases lead to blindness due to loss of the “image capturing” photoreceptors, while neurons in the “image processing” inner retinal layers are relatively well preserved. Electronic retinal prostheses seek to restore sight by electrically stimulating surviving neurons. Most implants are powered through inductive coils, requiring complex surgical methods to implant the coil-decoder-cable-array systems, which deliver energy to stimulating electrodes via intraocular cables. We present a photovoltaic subretinal prosthesis, in which silicon photodiodes in each pixel receive power and data directly through pulsed near-infrared illumination and electrically stimulate neurons. Stimulation was produced in normal and degenerate rat retinas, with pulse durations from 0.5 to 4 ms, and threshold peak irradiances from 0.2 to 10 mW/mm2, two orders of magnitude below the ocular safety limit. Neural responses were elicited by illuminating a single 70 μm bipolar pixel, demonstrating the possibility of a fully-integrated photovoltaic retinal prosthesis with high pixel density. PMID:23049619

Short-Term Effect of Prosthesis Transforming Sensory Modalities on Walking in Stroke Patients with Hemiparesis

PubMed Central

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

21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...

21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...

21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...

21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...

21 CFR 888.3640 - Shoulder joint metal/metal or 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 Shoulder joint metal/metal or metal/polymer... § 888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis. (a) Identification. A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device...

Literature Review on Needs of Upper Limb Prosthesis Users.

PubMed

Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

2016-01-01

The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses.

Literature Review on Needs of Upper Limb Prosthesis Users

PubMed Central

Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

2016-01-01

The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses. PMID:27242413

Incidence and impact of prosthesis-patient mismatch after transcatheter aortic valve implantation.

PubMed

Bleiziffer, Sabine; Hettich, Ina; Hutter, Andrea; Wagner, Anke; Deutsch, Marcus-André; Piazza, Nicolo; Lange, Rüdiger

2013-05-01

The study aim was to investigate the incidence of patient-prosthesis mismatch (PPM) with new catheter valves, and its influence on the patients' clinical state. At present, few echocardiographic data are available on the incidence and impact of PPM with the CoreValve and Sapien prostheses for transcatheter aortic valve implantation (TAVI). The reliability of effective orifice area (EOA) measurements was assured by awaiting an interval of six months after TAVI. Of 256 survivors after TAVI, 149 complete echocardiographic data sets were available for the assessment of the indexed EOA (iEOA). In total, 106 CoreValve prostheses and 43 Sapien prostheses were implanted in this high-risk cohort (mean age 81 +/- 6 years, mean logistic EuroSCORE 20 +/- 13%). The overall incidence of PPM (iEOA < 0.85 cm2/m2) was 61%. Patients with a larger body surface area were more likely to develop PPM (p = 0.001), while the prosthesis type, native annulus diameter, preoperative EOA, gender and prosthesis size had no influence. The mean aortic gradient was significantly higher in patients with PPM. A reduction in the left ventricular end-diastolic diameter was seen in all patients, without significant differences between groups. There were no differences in postoperative NYHA class or self-assessed health state between patients with or without PPM. PPM was common after TAVI in the presented cohort, presumably because the native calcium masses narrow the outflow area available for blood flow. As expected for low gradients, there was no impairment of left ventricular dimension regression or clinical state of the patients, even if severe PPM was present. Based on the presented data, it is assumed that PPM might be less relevant in TAVI patients.

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.

Good results in postoperative and hematogenous deep infections of 89 stable total hip and knee replacements with retention of prosthesis and local antibiotics.

PubMed

Geurts, Jan A P; Janssen, Daniël M C; Kessels, Alfons G H; Walenkamp, Geert H I M

2013-12-01

Deep postoperative and hematogenous prosthesis infections may be treated with retention of the prosthesis, if the prosthesis is stable. How long the infection may be present to preclude a good result is unclear. We retrospectively studied 89 deep-infected stable prostheses from 69 total hip replacements and 20 total knee replacements. There were 83 early or delayed postoperative infections and 6 hematogenous. In the postoperative infections, treatment had started 12 days to 2 years after implantation. In the hematogenous infections, symptoms had been present for 6 to 9 days. The patients had been treated with debridement, prosthesis retention, systemic antibiotics, and local antibiotics: gentamicin-PMMA beads or gentamicin collagen fleeces. The minimum follow-up time was 1.5 years. We investigated how the result of the treatment had been influenced by the length of the period the infection was present, and by other variables such as host characteristics, infection stage, and type of bacteria. In postoperative infections, the risk of failure increased with a longer postoperative interval: from 0.2 (95% CI: 0.1-0.3) if the treatment had started ≥ 4 weeks postoperatively to 0.5 (CI: 0.2-0.8) if it had started at ≥ 8 weeks. The relative risk for success was 0.6 (CI: 0.3-0.95) if the treatment had started ≥ 8 weeks. In the hematogenous group, 5 of 6 infections had been treated successfully. A longer delay before the start of the treatment caused an increased failure rate, but this must be weighed against the advantage of keeping the prosthesis. We consider a failure rate of < 50% to be acceptable, and we therefore advocate keeping the prosthesis for up to 8 weeks postoperatively, and in hematogenous infections with a short duration of symptoms.

Increased alertness, better than posture prioritization, explains dual-task performance in prosthesis users and controls under increasing postural and cognitive challenge.

PubMed

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.

Implications of prosthesis funding structures on the use of prostheses: experiences of individuals with upper limb absence.

PubMed

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.

[COMPUTER ASSISTED DESIGN AND ELECTRON BEAMMELTING RAPID PROTOTYPING METAL THREE-DIMENSIONAL PRINTING TECHNOLOGY FOR PREPARATION OF INDIVIDUALIZED FEMORAL PROSTHESIS].

PubMed

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.

Visual prosthesis wireless energy transfer system optimal modeling

PubMed Central

2014-01-01

Background Wireless energy transfer system is an effective way to solve the visual prosthesis energy supply problems, theoretical modeling of the system is the prerequisite to do optimal energy transfer system design. Methods On the basis of the ideal model of the wireless energy transfer system, according to visual prosthesis application condition, the system modeling is optimized. During the optimal modeling, taking planar spiral coils as the coupling devices between energy transmitter and receiver, the effect of the parasitic capacitance of the transfer coil is considered, and especially the concept of biological capacitance is proposed to consider the influence of biological tissue on the energy transfer efficiency, resulting in the optimal modeling’s more accuracy for the actual application. Results The simulation data of the optimal model in this paper is compared with that of the previous ideal model, the results show that under high frequency condition, the parasitic capacitance of inductance and biological capacitance considered in the optimal model could have great impact on the wireless energy transfer system. The further comparison with the experimental data verifies the validity and accuracy of the optimal model proposed in this paper. Conclusions The optimal model proposed in this paper has a higher theoretical guiding significance for the wireless energy transfer system’s further research, and provide a more precise model reference for solving the power supply problem in visual prosthesis clinical application. PMID:24428906

The decision to have a prosthesis: A qualitative study of men with testicular cancer.

PubMed

Chapple, A; McPherson, A

2004-09-01

The aim of this paper is to understand why some men decide to have a testicular prosthesis while others reject the idea and to explore the extent to which the option of a testicular prosthesis is adequately presented. Forty-five men with testicular cancer were interviewed about all aspects of their illness. Some men decided against a prosthesis for a number of reasons; they thought that the loss of a testicle was not visibly obvious, did not affect self-image, was not a long-term threat to masculinity, and that living with one testicle was comfortable. Some did not want additional surgery and others were concerned about safety issues. The men who decided to have a prosthesis were concerned about self-image and a threat to masculinity. They had a desire to look 'normal' and a wish to keep the orchidectomy secret. Some men felt that the decision had been rushed. Others wished that they had had information about the possibility of implants before the orchidectomy or they considered the information presented inadequate. We conclude that it is important to counsel men with testicular cancer about the advantages and disadvantages of having a testicular prosthesis and to give them time to consider issues such as cosmetic appearance, self-image, comfort, possible short term complications and long-term safety. Copyright 2003 John Wiley & Sons, Ltd.

A computer simulation of the plasma leakage through a vascular prosthesis made of expanded polytetrafluoroethylene.

PubMed

Tabata, R; Kobayashi, T; Mori, A; Matsuno, S; Watarida, S; Onoe, M; Sugita, T; Shiraisi, S; Nojima, T

1993-04-01

We explored the blood-retaining mechanism of a vascular prosthesis made of expanded polytetrafluoroethylene through analysis of its structure and physicochemical properties. Plasma leakage through this vascular prosthesis was simulated by computer to explore its etiology. These examinations disclosed that leakage is dependent upon the inner pressure and the density of fibers. In other words, the study revealed that the mean distance between fibers constituting the wall of the expanded polytetrafluoroethylene vascular prosthesis is increased by tension (that is, inner pressure), resulting in an increased probability of leakage. It was additionally found that a thin membrane is formed on the polytetrafluoroethylene surface if blood in contact with the surface is dried. This membrane was found to reduce the water-repelling property of polytetrafluoroethylene and to make it impossible to preserve the inter-fiber liquid surface, thus causing leakage through the expanded polytetrafluoroethylene vascular prosthesis.

[Total hip replacement with isoelastic prosthesis in animals (author's transl)].

PubMed

Muhr, O; Stockhusen, H; Müller, O

1976-10-08

Uncemented fixation and low-fraction materials are the basis of this experiment. Plastics with an elasticity similar to the bone ("isoelasticity") show very propitious material qualities. The direct cementless incorporation of test bodies must be checked. In 63 sheep isoelastic total hip joints were implanted. After 2 till 51 weeks the animals were sacrificed and 44 specimen of hips and organs were explored macroscopically, radiologically, spherimetrically and histologically. The result was: 1. Plastic hip prosthesis are incorporated in the bone, but the boundary layer is built by a collagenous fiber tissue. 2. Loosening brings resoption of the bone and expansion of the structural changed soft tissue. 3. The transformation of the femoral cortex to osteoporosis is considered possibly as the consequence of an insufficient biological transfer of the weight. 4. Fractures of the femoral prosthesis-stem could not be observed. 5. The radiology allows at the pelvis prosthesis a concret statement concerning stability, on the femoral part a probable one. 6. The abrasion is minimal, the tissue reaction to abrasion products is unessential. 7. Small abrasion particles are carried of by the lymph tract and stored in the first regional gland. A more distant spreading is not demonstrable.

An analytical approach to test and design upper limb prosthesis.

PubMed

Veer, Karan

2015-01-01

In this work the signal acquiring technique, the analysis models and the design protocols of the prosthesis are discussed. The different methods to estimate the motion intended by the amputee from surface electromyogram (SEMG) signals based on time and frequency domain parameters are presented. The experiment proposed that the used techniques can help significantly in discriminating the amputee's motions among four independent activities using dual channel set-up. Further, based on experimental results, the design and working of an artificial arm have been covered under two constituents--the electronics design and the mechanical assembly. Finally, the developed hand prosthesis allows the amputated persons to perform daily routine activities easily.

Design and Control of a New Biomimetic Transfemoral Knee Prosthesis Using an Echo-Control Scheme

PubMed Central

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

A functional speech impression used to fabricate a maxillary speech prosthesis for a partial glossectomy patient.

PubMed

Knowles, J C; Chalian, V A; Shanks, J C

1984-02-01

Surgery for cancer of the floor of the mouth often results in alteration of the muscles of the tongue and floor of the mouth. Both primary and secondary surgical procedures often result in scar formation with reduced mobility of the tongue during speech and deglutition. Speech is often used as a diagnostic tool in the placement of the anterior teeth during fabrication of a prosthesis. Speech can similarly be used to help determine the proper placement of a speech portion of the prosthesis. The prosthetic rehabilitation approach described lowers the palatal vault with a false palate to enable the tongue to function against it during speech (Fig. 15). Group studies have shown that the design and fabrication of speech prostheses for partial glossectomy patients have significantly improved speech and swallowing for these patients. A speech pathologist is helpful during diagnosis, and speech therapy is necessary for significant speech improvement. Prosthetic rehabilitation alone cannot be expected to improve speech.

New protocol for construction of eyeglasses-supported provisional nasal prosthesis using CAD/CAM techniques.

PubMed

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.

Perivalvular pannus and valve thrombosis: two concurrent mechanisms of mechanical valve prosthesis dysfunction.

PubMed

Arnáiz-García, María Elena; González-Santos, Jose María; Bueno-Codoñer, María E; López-Rodríguez, Javier; Dalmau-Sorlí, María José; Arévalo-Abascal, Adolfo; Arribas-Jiménez, Antonio; Diego-Nieto, Alejandro; Rodríguez-Collado, Javier; Rodríguez-López, Jose María

2015-02-01

A 78-year-old woman was admitted to our institution with progressive dyspnea. She had previously been diagnosed with rheumatic heart disease and had undergone cardiac surgery for mechanical mitral valve replacement ten years previously. Transesophageal echocardiography revealed blockage of the mechanical prosthesis and the patient was scheduled for surgery, in which a thrombus was removed from the left atrial appendage. A partial thrombosis of the mechanical prosthesis and circumferential pannus overgrowth were concomitantly detected. Prosthetic heart valve blockage is a rare but life-threatening complication, the main causes of which are thrombosis and pannus formation. The two conditions are different but both are usually misdiagnosed. Two concurrent mechanisms of prosthesis blockage were found in this patient. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Engineering platform and experimental protocol for design and evaluation of a neurally-controlled powered transfemoral prosthesis.

PubMed

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.

Bioelectronic retinal prosthesis

NASA Astrophysics Data System (ADS)

Weiland, James D.

2016-05-01

Retinal prosthesis have been translated to clinical use over the past two decades. Currently, two devices have regulatory approval for the treatment of retinitis pigmentosa and one device is in clinical trials for treatment of age-related macular degeneration. These devices provide partial sight restoration and patients use this improved vision in their everyday lives to navigate and to detect large objects. However, significant vision restoration will require both better technology and improved understanding of the interaction between electrical stimulation and the retina. In particular, current retinal prostheses do not provide peripheral visions due to technical and surgical limitations, thus limiting the effectiveness of the treatment. This paper reviews recent results from human implant patients and presents technical approaches for peripheral vision.

Preclinical evaluation of hydrogel sealed fluropassivated indigenous vascular prosthesis.

PubMed

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.

Seventeen-millimeter St. Jude Medical Regent valve in patients with small aortic annulus: dose moderate prosthesis-patient mismatch matter?

PubMed

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) prosthesis-patient mismatch early after implantation of a 17-mm Regent valve at aortic position were included. Both clinical and echocardiographic assessments were performed preoperatively, at discharge and during follow-up period (mean follow-up time 52.6 ± 11.9 months). The prevalence of moderate prosthesis-patient mismatch was documented in 46 patients (43.4%) at discharge. During the follow-up period, no difference in the regression of left ventricular mass, decrease of transvalvular pressure gradients, mortality and prosthesis-related complications was observed between patients with and without moderate prosthesis-patient mismatch. After adjustment for several risk factors, moderate prosthesis-patient mismatch was associated with increased midterm mortality in patients with baseline left ventricular ejection fraction<50% (HR: 1.80, p=0.02), but with normal prognosis in those with preserved LV function. Younger age (cut off value=65 years) was not an independent predictor of increased midterm mortality and valve-related complications in patients with moderate prosthesis-patient mismatch. Moderate prosthesis-patient mismatch after aortic valve replacement with a small mechanical prosthesis is associated with increased mortality and adverse events in patients with pre-existing left ventricular dysfunction. Selected patients with small aortic annulus can experience satisfactory clinical improvements and midterm survival after aortic valve replacement with a 17-mm Regent valve.

Prognostic Impact of Calcium Score after Transcatheter Aortic Valve Implantation Performed With New Generation Prosthesis.

PubMed

Akodad, Mariama; Lattuca, Benoit; Agullo, Audrey; Macia, Jean-Christophe; Gandet, Thomas; Marin, Grégory; Iemmi, Anaïs; Vernhet, Hélène; Schmutz, Laurent; Nagot, Nicolas; Albat, Bernard; Cayla, Guillaume; Leclercq, Florence

2018-05-15

Calcium score (CS) is a well-known prognostic factor after transcatheter aortic valve implantation (TAVI) performed with first generation prosthesis but few data are available concerning new generation valves. The aim of this study was to evaluate if CS remains a prognostic factor after Sapien 3 and Evolut R valves implantation. Agatston CS was evaluated on multislice computed tomography before TAVI in 346 patients implanted with Sapien XT (n = 61), CoreValve (n = 57) devices, (group 1, n = 118), and with new generation Sapien 3 (n = 147), Evolut R (n = 81) prosthesis, (group 2, n = 228). Major adverse cardiovascular events and aortic regurgitation (AR) were evaluated at 1 month. The 2 groups were similar at baseline except for logistic Euroscore (20.1% in group 1 vs 15.0 % in group 2; p = 0.001), chronic renal failure (44.1% vs 37.2% respectively, p = 0.007) and preprocedural CS (4,092 ± 2,176 vs 3,682 ± 2,109 respectively, p = 0.022). In group 1, 28 patients (23.7%) had adverse clinical events vs 21 (9.2%) in group 2 (p <0.01). In multivariate analysis, a higher CS was predictive of adverse events in group 1 (5,785 ± 3,285 vs 3,565 ± 1,331 p <0.0001) but not in group 2 (p = 0.28). A higher CS was associated with AR in group 1 (6,234 ± 2711 vs 3,429 ± 1,505; p <0.001) and in patients implanted with an Evolut R device from group 2 (4,085 ± 3,645 vs 2,551 ± 1,356; p = 0.01). In conclusion, CS appears as an important prognostic factor of major events after TAVI with first generation valves but not with new generation devices. CS remains associated with AR only with new generation self-expandable Evolut R devices. Copyright © 2018 Elsevier Inc. All rights reserved.

Early prosthetic hip joint infection treated with debridement, prosthesis retention and biofilm-active antibiotics: functional outcomes, quality of life and complications.

PubMed

Aboltins, C; Dowsey, M M; Peel, T; Lim, W K; Parikh, S; Stanley, P; Choong, P F

2013-07-01

Patients treated for early prosthetic joint infection (PJI) with surgical debridement, prosthesis retention and biofilm-active antibiotics, such as rifampicin or fluoroquinolones have a rate of successful infection eradication that is similar to patients treated with the traditional approach of prosthesis exchange. It is therefore important to consider other outcomes after PJI treatment that may influence management decisions, such as function, quality of life (QOL) and treatment-associated complications. To describe rates of successful treatment for patients with PJI undergoing surgical debridement, prosthesis retention and biofilm-active antibiotics and compare their functional outcomes, QOL and complication rates to patients without PJI. Nineteen patients treated for PJI after hip arthroplasty with debridement, prosthesis retention and biofilm-active antibiotics were matched to 76 controls who underwent hip arthroplasty with no infection. Cumulative survival free from treatment failure at 2 years was 88% (95% confidence interval, 59-97%). PJI cases had significant improvement from pre-arthroplasty to 12-months post-arthroplasty in function according to Harris Hip Score and QOL according to the 12-item Short Form Health Survey Physical Component Summary. There was no significant difference in the improvement between controls and cases. PJI was not a risk factor for poor function or QOL. Medical complications occurred more frequently in cases (6/19 (32%)) than controls (9/76 (12%); P = 0.04), with this difference being accounted for by drug reactions. Surgical complications were the same in the two groups. Treatment of PJI with debridement, prosthesis retention and biofilm-active antibiotics is successful, well tolerated and results in significant improvements in function and QOL, which are similar to patients without PJI. © 2013 The Authors; Internal Medicine Journal © 2013 Royal Australasian College of Physicians.

Transtibial prosthesis suspension systems: systematic review of literature.

PubMed

Gholizadeh, H; Abu Osman, N A; Eshraghi, A; Ali, S; Razak, N A

2014-01-01

Today a number of prosthetic suspension systems are available for transtibial amputees. Consideration of an appropriate suspension system can ensure that amputee's functional needs are satisfied. The higher the insight to suspension systems, the easier would be the selection for prosthetists. This review attempted to find scientific evidence pertaining to various transtibial suspension systems to provide selection criteria for clinicians. Databases of PubMed, Web of Science, and ScienceDirect were explored to find related articles. Search terms were as follows: "Transtibial prosthesis (32), prosthetic suspension (48), lower limb prosthesis (54), below-knee prosthesis (58), prosthetic liner (20), transtibial (193), and prosthetic socket (111)". Two reviewers separately examined the papers. Study design (case series of five or more subjects, retrospective or prospective), research instrument, sampling method, outcome measures and protocols were reviewed. Based on the selection criteria, 22 articles (15 prospective studies, and 7 surveys) remained. Sweat control was found to be a major concern with the available suspension liners. Donning and doffing procedures for soft liners are also problematic for some users, particularly those with upper limb weakness. Moreover, the total surface bearing (TSB) socket with pin/lock system is favored by the majority of amputees. In summary, no clinical evidence is available to suggest what kind of suspension system could have an influential effect as a "standard" system for all transtibial amputees. However, among various suspension systems for transtibial amputees, the Iceross system was favored by the majority of users in terms of function and comfort. © 2013. Published by Elsevier Ltd. All rights reserved.

[Radiological analysis of the thrust plate prosthesis (TPP)].

PubMed

Ishaque, B A; Wienbeck, S; Basad, E; Stürz, H

2004-01-01

The various radiological changes after implantation of the thrust plate prosthesis (TPP) are demonstrated and, with the help of a standardized radiological classification, divided in pathological and non-pathological findings. The radiological follow-ups of 167 TPP implanted between 1993 and 1998 was analyzed in this study. The follow-up examination was carried out postoperatively, after 6 months and subsequently every year. The radiological assessment was carried out in an exact a.p. view. We subdivided the images into four sectors: A corresponds to the femoral neck stump, B to the bony stock cranial (=1) and caudal (=2) to the mandrel of the prosthesis, C is the region above and under the bolt and D the cortical area around the lateral plate. Radiolucencies were especially seen in sector A (A 1 = 34.7 %; A 2 = 18%) and sector C (44 %). As a pathological finding, we saw progressive radiolucencies of sector B (6 %), which were interpreted to be a sign of loosening, when they showed a thickness of = 2 mm. Furthermore, in some cases we observed extended atrophy under the lateral plate, which was also judged to be a sign of loosening. The radiological changes of the bony stock of the TPP can be divided into physiological adaptation processes because of changed biomechanics and signs of loosening. As a stress-shielding phenomenon we see a progressive atrophy under the thrust plate and simultaneously a sclerosis of the spongious bone above the calcar femoris. An indication for a loosening of the prosthesis is a progressive radiolucency of sector B.

Finite element analysis of a condylar support prosthesis to replace the temporomandibular joint.

PubMed

Abel, Eric W; Hilgers, André; McLoughlin, Philip M

2015-04-01

This paper presents a finite element study of a temporomandibular joint (TMJ) prosthesis in which the mandibular component sits on the condyle after removal of only the diseased articular surface and minimal amount of condylar bone. The condylar support prosthesis (CSP) is customised to fit the patient and allows a large part of the joint force to be transmitted through the condyle to the ramus, rather than relying only on transfer of the load by the screws that fix the prosthesis to the ramus. The 3-dimensional structural finite element analysis compared a design of CSP with a standard commercial prosthesis and one that was modified to fit the ramus, to relate the findings to the different designs and geometrical features. The models simulated an incisal bite under high loading. In the CSP and in its fixation screws, the stresses were much lower than those in the other 2 prostheses and the bone strains were at physiological levels. The CSP gives a more physiological form of load transfer than is possible without the condylar contact, and considerably reduces the amount of strain on the bone around the screws. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Dextran/Albumin hydrogel sealant for Dacron(R) vascular prosthesis.

PubMed

Lisman, Anna; Butruk, Beata; Wasiak, Iga; Ciach, Tomasz

2014-05-01

In this paper, the authors describe a novel type of hydrogel coating prepared from the copolymer of human serum albumin and oxidized dextran. The material was designed as a hydrogel sealant for polyester (Dacron®)-based vascular grafts. Dextran was chosen as a coating material due to its anti-thrombogenic properties. Prepared hydrogels were compared with similar, already known biomaterial made from gelatine with the same cross-linking agent. Obtained hydrogels, prepared from various ratios of oxidized dextran/albumin or oxidized dextran/gelatine, showed different cross-linking densities, which caused differences in swelling, degradation rate and mechanical properties. Permeability tests confirmed the complete tightness of the hydrogel-modified prosthesis. Results showed that application of the hydrogel coating provided leakage-free prosthesis and eliminated the need of pre-clotting.

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.

The Angelchik prosthesis for gastro-oesophageal reflux: symptomatic and objective assessment.

PubMed Central

Weaver, R. M.; Temple, J. G.

1985-01-01

Twenty-three patients with intractable gastro-oesophageal reflux were treated by insertion of the Angelchik antireflux prosthesis. Good symptomatic relief was achieved in over 80% of patients reviewed up to 28 months after operation and there was marked resolution of oesophagitis as seen on endoscopy. Oesophageal manometry and pH studies performed preoperatively and at 3 and 12 months after operation, showed a significant increase in lower oesophageal sphincter pressure with decreased acid reflux. Some technical problems were encountered, but the prosthesis is potentially a simple and effective means of controlling gastro-oesophageal reflux. Images Fig. 1 PMID:4051424

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained 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 Hip joint metal/polymer/metal semi-constrained... Devices § 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. (a) Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device...

21 CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hip joint femoral (hemi-hip) metal/polymer... § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. (a) Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part...

Prosthetic Rehabilitation of Completely Blind Subject with Bilateral Customised Ocular Prosthesis: A Case Report

PubMed Central

Pawah, Salil; Singh, Gurpreet; Yadav, Ila; Kundra, Shrey

2017-01-01

The special sensory organs play significant role in our daily lives. Until one of them is totally or partially lost, its real value is not fully appreciated. The most tragic, yet common loss of sensory organ is that of an eye. Restoration of unilateral ocular defects is very challenging for a maxillofacial prosthodontist and requires great skill to mimic bilateral eye. Restoration of bilateral defects using customized eye prosthesis presents even more difficult task for clinician especially in communication with patient, impression procedures, and patient education regarding insertion, removal and maintenance of prosthesis. Such loss of eyes may have a tremendous emotional and psychological impact on the patient. This article presents a technique for fabrication of bilateral ocular prosthesis of completely blind patient. PMID:28274064

Choosing a Breast Prosthesis: A Survivor's Perspective

MedlinePlus

... Q: Do you have any tips for other women who might be trying to decide if a breast prosthesis is right for them? Andrea: You can always meet with ... out what kind of surgical options might be right for you. Q: Is there anything else you think women with breast cancer should know? Andrea: I think ...

Prosthetic Rehabilitation of Mandibular Defects with Fixed-removable Partial Denture Prosthesis Using Precision Attachment: A Twin Case Report

PubMed Central

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. PMID:29042738

Prosthetic Rehabilitation of Mandibular Defects with Fixed-removable Partial Denture Prosthesis Using Precision Attachment: A Twin Case Report.

PubMed

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.

Design and Development of a Novel Upper-Limb Cycling Prosthesis

PubMed Central

Soni-Sadar, Shivam; Rowbottom, Jack; Patel, Shilen; Mathewson, Edward; Pearson, Samuel; Hutchins, David; Head, John; Hutchins, Stephen

2017-01-01

The rise in popularity of the Paralympics in recent years has created a need for effective, low-cost sports-prosthetic devices for upper-limb amputees. There are various opportunities for lower-limb amputees to participate in cycling; however, there are only few options for those with upper-limb amputations. If the individual previously participated in cycling, a cycling-specific prosthesis could allow these activities to be integrated into rehabilitation methods. This article describes the processes involved with designing, developing and manufacturing such a prosthesis. The fundamental needs of people with upper-limb amputation were assessed and realised in the prototype of a transradial terminal device with two release mechanisms, including a sliding mechanism (for falls and minor collisions) and clamping mechanism (for head-on collisions). The sliding mechanism requires the rider to exert approximately 200 N, while the clamping mechanism requires about 700 N. The force ranges can be customised to match rider requirements. Experiments were conducted in a controlled environment to demonstrate stability of the device during normal cycling. Moreover, a volunteer test-rider was able to successfully activate the release mechanism during a simulated emergency scenario. The development of this prosthesis has the potential to enable traumatic upper-limb amputees to participate in cycling for rehabilitation or recreation. PMID:29144392

Design and Development of a Novel Upper-Limb Cycling Prosthesis.

PubMed

Tiele, Akira; Soni-Sadar, Shivam; Rowbottom, Jack; Patel, Shilen; Mathewson, Edward; Pearson, Samuel; Hutchins, David; Head, John; Hutchins, Stephen

2017-11-16

The rise in popularity of the Paralympics in recent years has created a need for effective, low-cost sports-prosthetic devices for upper-limb amputees. There are various opportunities for lower-limb amputees to participate in cycling; however, there are only few options for those with upper-limb amputations. If the individual previously participated in cycling, a cycling-specific prosthesis could allow these activities to be integrated into rehabilitation methods. This article describes the processes involved with designing, developing and manufacturing such a prosthesis. The fundamental needs of people with upper-limb amputation were assessed and realised in the prototype of a transradial terminal device with two release mechanisms, including a sliding mechanism (for falls and minor collisions) and clamping mechanism (for head-on collisions). The sliding mechanism requires the rider to exert approximately 200 N, while the clamping mechanism requires about 700 N. The force ranges can be customised to match rider requirements. Experiments were conducted in a controlled environment to demonstrate stability of the device during normal cycling. Moreover, a volunteer test-rider was able to successfully activate the release mechanism during a simulated emergency scenario. The development of this prosthesis has the potential to enable traumatic upper-limb amputees to participate in cycling for rehabilitation or recreation.

Oral hygiene in patients with oral cancer undergoing chemotherapy and/or radiotherapy after prosthesis rehabilitation: protocol proposal.

PubMed

Rapone, B; Nardi, G M; DI Venere, D; Pettini, F; Grassi, F R; Corsalini, M

2016-01-01

This study was aimed at assessing the effectiveness and the importance of an oral hygiene (OH) protocol in patients undergoing radiation therapy and chemotherapy after prosthesis rehabilitation, in order to reduce or minimize oral complications. This study was carried out at the Department of Dental Science, at the University of Bari-Italy from December 2012 to December 2015 on 34 selected patients with primary oral cancer undergoing chemotherapy and radiotherapy after prosthesis rehabilitation. They were divided into 2 groups according to their age, sex and cancer therapy. Seventeen patients were assigned to the control group and seventeen in the experimental one. In the experimental group (Table 1), patients underwent an oral hygiene protocol whereas in the control group (Table 2) patients received the usual care provided within the clinical setting. All the patients gave written informed consent. It has been asked and obtained the authorisation from the Ethics Committee of the Dental Science and Surgery Department. Results show that in patients undergoing the oral hygiene protocol, the complications and the risks of infection and permanent dental problems have been minimized. Indeed, of the seventeen patients undergoing the OH protocol, 70% obtained positive results and were satisfied with the program outcome. The role of the health care providers is essential to educate patients to adhere to the prescribed treatments and reinforce their motivation in oral hygiene. The oral hygiene procedures prevent and ameliorate oral complications due to the radiation therapy and chemotherapy.

The Influence of Artificial Cervical Disc Prosthesis Height on the Cervical Biomechanics: A Finite Element Study.

PubMed

Yuan, Wei; Zhang, Haiping; Zhou, Xiaoshu; Wu, Weidong; Zhu, Yue

2018-05-01

Artificial cervical disc replacement is expected to maintain normal cervical biomechanics. At present, the effect of the Prestige LP prosthesis height on cervical biomechanics has not been thoroughly studied. This finite element study of the cervical biomechanics aims to predict how the parameters, like range of motion (ROM), adjacent intradiscal pressure, facet joint force, and bone-implant interface stress, are affected by different heights of Prestige LP prostheses. The finite element model of intact cervical spine (C3-C7) was obtained from our previous study, and the model was altered to implant Prestige LP prostheses at the C5-C6 level. The effects of the height of 5, 6, and 7 mm prosthesis replacement on ROM, adjacent intradiscal pressure, facet joint force, as well as the distribution of bone-implant interface stress were examined. ROM, adjacent intradiscal pressure, and facet joint force increased with the prosthesis height, whereas ROM and facet joint force decreased at C5-C6. The maximal stress on the inferior surface of the prostheses was greater than that on the superior surface, and the stresses increased with the prosthesis height. The biomechanical changes were slightly affected by the height of 5 and 6 mm prostheses, but were strongly affected by the 7-mm prosthesis. An appropriate height of the Prestige LP prosthesis can preserve normal ROM, adjacent intradiscal pressure, and facet joint force. Prostheses with a height of ≥2 mm than normal can lead to marked changes in the cervical biomechanics and bone-implant interface stress. Copyright © 2018 Elsevier Inc. All rights reserved.

Tackling the Issue of High Postoperative Pacemaker Implantation Rates in Sutureless Aortic Valve Replacement: Should Balloon Inflation be Removed from the Implantation Method of the Perceval Prosthesis?

PubMed

Charles Blouin, Mathieu; Bouhout, Ismail; Demers, Philippe; Carrier, Michel; Perrault, Louis; Lamarche, Yoan; El-Hamamsy, Ismail; Bouchard, Denis

2017-05-01

Sutureless aortic valve replacement (AVR) is an emerging alternative to standard AVR in elderly and high-risk patients. This procedure is associated with a high rate of postoperative permanent pacemaker implantation (PPI). The study aim was to assess the impact on the rate of PPI of implanting the Perceval prosthesis without using balloon inflation. A total of 159 patients who underwent sutureless AVR using the Perceval prosthesis was included. Balloon inflation was used in 132 patients (Balloon group) and not used in the remaining 27 (No-Balloon group). Clinical, echocardiographic and electrocardiographic outcomes were assessed. There was no significant difference in PPI rate between the two groups (26% for Balloon group versus 22% in No-Balloon group; p = 0.700). Balloon inflation had no significant impact on the incidence of paravalvular leaks (p = 0.839), or on the need to return to cardiopulmonary bypass (CPB) intraoperatively due to paravalvular leak or unsatisfactory deployment (p >0.999). Mean and peak transaortic pressure gradients were similar between the two groups (p = 0.417 and p = 0.522, respectively). Cross-clamp and CPB times were shorter in the No-Balloon group (49.6 ± 15.9 min versus 61.1 ± 25.6 min and 64.1 ± 26.3 min versus 79.6 ± 35.4 min, respectively; p = 0.027 and p = 0.012, respectively). The two groups had similar postoperative PPI rates. Implanting the Perceval prosthesis without balloon inflation is safe and had no impact on paravalvular leaks, intraoperative complications or hemodynamic results. Reductions in aortic cross-clamp time and CPB time were observed when the balloon was not used.

21 CFR 872.3940 - Total temporomandibular joint prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total temporomandibular joint prosthesis. 872.3940 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint...

21 CFR 878.3800 - External aesthetic restoration prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3800...

21 CFR 878.3800 - External aesthetic restoration prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3800...

21 CFR 878.3800 - External aesthetic restoration prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3800...

21 CFR 878.3800 - External aesthetic restoration prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3800...

21 CFR 878.3800 - External aesthetic restoration prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External aesthetic restoration prosthesis. 878.3800 Section 878.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3800...

Effects of Prosthesis Stem Tapers on Stress Distribution of Cemented Hip Arthroplasty

NASA Astrophysics Data System (ADS)

Abdullah, Abdul Halim; Nor, Mohd Asri Mohd; Saman, Alias Mohd; Tamin, Mohd Nasir; Kadir, Mohammed Rafiq Abdul

2010-10-01

Aseptic loosening effects are critical issues in encouraging long term stability of cemented hip arthroplasty. Stress shielding is believed to be an important factor that contributes to the aseptic loosening problems. The numerous changes in the prosthesis stem design are intended to minimize the stress shielding and aseptic loosening problems and to improve the long term performance of the implants. In this study, the stress distribution in cemented hip arthroplasty is established using finite element method. The taper of the prosthesis is designed to be 3° at anterior/posterior, 3° at medial/lateral and 10° from wide lateral to narrow medial. Major muscle loads and contact forces are simulated for walking (toe-off phase) and stair climbing load cases. Effects of prosthesis stem tapers on the resulting stress distribution are investigated. Results show that compressive stress dominates in the medial plane while tensile stress in the lateral plane of the femur. The corresponding stress levels of intact femur for walking and stair-climbing load cases are 22 and 29 MPa, respectively. The magnitude of Tresca stress for the THA femur in stair-climbing load case remains higher in the region of 85 MPa while the walking load case induces around 40 MPa. The stress range in the straight and single taper stem prosthesis is lower than 260 MPa, while localized Tresca stress is in the order of the yield strength of Ti-6Al-4V alloy for double and triple taper stem design.

Effect of joining the sectioned implant-supported prosthesis on the peri-implant strain generated in simulated mandibular model.

PubMed

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.

A novel open-tray impression technique for fabrication of a provisional prosthesis on immediate load implants in a completely edentulous arch.

PubMed

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.

[The esthetics of lower limb prosthesis].

PubMed

Gardrat, Franck

2015-01-01

The amputation, which is upper or lower limb, entails important consequences and often traumatic into subject amputee from a physical, psychological, interpersonal and social point of view. It acts on the body image unleashing different psychological disorders and alterations in the social and professional reality. The aesthetic prosthesis can be considered a good support to help the person regain a new body image of themselves, facilitating the process of physical rehabilitation and social integration.

A cortical neural prosthesis for restoring and enhancing memory

NASA Astrophysics Data System (ADS)

Berger, Theodore W.; Hampson, Robert E.; Song, Dong; Goonawardena, Anushka; Marmarelis, Vasilis Z.; Deadwyler, Sam A.

2011-08-01

A primary objective in developing a neural prosthesis is to replace neural circuitry in the brain that no longer functions appropriately. Such a goal requires artificial reconstruction of neuron-to-neuron connections in a way that can be recognized by the remaining normal circuitry, and that promotes appropriate interaction. In this study, the application of a specially designed neural prosthesis using a multi-input/multi-output (MIMO) nonlinear model is demonstrated by using trains of electrical stimulation pulses to substitute for MIMO model derived ensemble firing patterns. Ensembles of CA3 and CA1 hippocampal neurons, recorded from rats performing a delayed-nonmatch-to-sample (DNMS) memory task, exhibited successful encoding of trial-specific sample lever information in the form of different spatiotemporal firing patterns. MIMO patterns, identified online and in real-time, were employed within a closed-loop behavioral paradigm. Results showed that the model was able to predict successful performance on the same trial. Also, MIMO model-derived patterns, delivered as electrical stimulation to the same electrodes, improved performance under normal testing conditions and, more importantly, were capable of recovering performance when delivered to animals with ensemble hippocampal activity compromised by pharmacologic blockade of synaptic transmission. These integrated experimental-modeling studies show for the first time that, with sufficient information about the neural coding of memories, a neural prosthesis capable of real-time diagnosis and manipulation of the encoding process can restore and even enhance cognitive, mnemonic processes.

Preclinical evaluation of hydrogel sealed fluropassivated indigenous vascular prosthesis

PubMed Central

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

Impact of removable partial denture prosthesis on chewing efficiency

PubMed Central

BESSADET, Marion; NICOLAS, Emmanuel; SOCHAT, Marine; HENNEQUIN, Martine; VEYRUNE, Jean-Luc

2013-01-01

Removable partial denture prostheses are still being used for anatomic, medical and economic reasons. However, the impact on chewing parameters is poorly described. Objectives The objective of this study was to estimate the impact of removable partial denture prosthesis on masticatory parameters. Material and Methods Nineteen removable partial denture prosthesis (RPDP) wearers participated in the study. Among them, 10 subjects were Kennedy Class III partially edentulous and 9 with posterior edentulism (Class I). All presented a complete and full dentate opposing arch. The subjects chewed samples of carrots and peanuts with and without their prosthesis. The granulometry of the expectorated boluses from carrot and peanuts was characterized by median particle size (D50), determined at the natural point of swallowing. Number of chewing cycles (CC), chewing time (CT) and chewing frequency (CF=CC/CT) were video recorded. Results With RPDP, the mean D50 values for carrot and peanuts were lower [Repeated Model Procedures (RMP), F=15, p<0.001] regardless of the type of Kennedy Class. For each food, mean CC, CT and CF values recorded decreased (RMP, F=18, F=9, and F=20 respectively, p<0.01). With or without RPD, the boluses' granulometry values were above the masticatory normative index (MNI) determined as 4,000 µm. Conclusion RPDP rehabilitation improves the ability to reduce the bolus particle size, but does not reestablish fully the masticatory function. Clinical relevance This study encourages the clinical improvement of oral rehabilitation procedure. PMID:24212983

Comparison of efficacy and satisfaction profile, between penile prosthesis implantation and oral PDE5 inhibitor tadalafil therapy, in men with nerve-sparing radical prostatectomy erectile dysfunction.

PubMed

Megas, Georgios; Papadopoulos, Georgios; Stathouros, Georgios; Moschonas, Dimitrios; Gkialas, Ioannis; Ntoumas, Konstantinos

2013-07-01

-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.

21 CFR 874.3495 - Total ossicular replacement prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates the...

21 CFR 874.3450 - Partial ossicular replacement prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Partial ossicular replacement prosthesis. 874.3450 Section 874.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the...

21 CFR 878.3530 - Silicone inflatable breast prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530 Silicone...

21 CFR 878.3530 - Silicone inflatable breast prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530 Silicone...

21 CFR 878.3530 - Silicone inflatable breast prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530 Silicone...

21 CFR 878.3530 - Silicone inflatable breast prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530 Silicone...

21 CFR 878.3530 - Silicone inflatable breast prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Silicone inflatable breast prosthesis. 878.3530 Section 878.3530 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3530 Silicone...

21 CFR 874.3495 - Total ossicular replacement prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total ossicular replacement prosthesis. 874.3495 Section 874.3495 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the total functional reconstruction of the ossicular chain and facilitates the...

21 CFR 874.3450 - Partial ossicular replacement prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Partial ossicular replacement prosthesis. 874.3450 Section 874.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the...

An implantable myoelectric sensor based prosthesis control system.

PubMed

DeMichele, Glenn A; Troyk, Philip R; Kerns, Douglas A; Weir, Richard

2006-01-01

We present progress on the design and testing of an upper-extremity prosthesis control system based on implantable myoelectric sensors. The implant consists of a single silicon chip packaged with transmit and receive coils. Forward control telemetry to, and reverse EMG data telemetry from multiple implants has been demonstrated.

Debridement, antibiotics, irrigation, and retention (DAIR) of the prosthesis after hip hemiarthroplasty infections. Does it work?

PubMed

Kazimoglu, Cemal; Yalcin, Nadir; Onvural, Burak; Akcay, Serkan; Agus, Haluk

2015-08-01

Debridement, antibiotic, and implant retention (DAIR) is an attractive treatment modality after hip hemiarthroplasty (HA) infections. Data about the success of the procedure after acute onset infections is lacking. The aim of this study was to analyze the clinical outcome and associated risk factors. A multicenter, retrospective cohort study was designed, including 39 patients with acute onset prosthetic infection who had undergone debridement and irrigation with prosthesis retention. The primary outcome measure was infection eradication without prosthesis removal. We also analyzed how the success rate was influenced by the length of the interval between implantation of the prosthesis and the beginning of the treatment. The overall success rate was 41%. Sedimentation rate over 60 mm/h and the longer duration (2 weeks) after prosthesis implantation were found as factors negatively influencing the success rate. Our results indicated limited success to DAIR- treated patients with infected HA. The high failure rate of DAIR treatment after 2 weeks from the implantation should be taken into consideration.

Chest-wall reconstruction with a customized titanium-alloy prosthesis fabricated by 3D printing and rapid prototyping.

PubMed

Wen, Xiaopeng; Gao, Shan; Feng, Jinteng; Li, Shuo; Gao, Rui; Zhang, Guangjian

2018-01-08

As 3D printing technology emerge, there is increasing demand for a more customizable implant in the repair of chest-wall bony defects. This article aims to present a custom design and fabrication method for repairing bony defects of the chest wall following tumour resection, which utilizes three-dimensional (3D) printing and rapid-prototyping technology. A 3D model of the bony defect was generated after acquiring helical CT data. A customized prosthesis was then designed using computer-aided design (CAD) and mirroring technology, and fabricated using titanium-alloy powder. The mechanical properties of the printed prosthesis were investigated using ANSYS software. The yield strength of the titanium-alloy prosthesis was 950 ± 14 MPa (mean ± SD), and its ultimate strength was 1005 ± 26 MPa. The 3D finite element analyses revealed that the equivalent stress distribution of each prosthesis was unifrom. The symmetry and reconstruction quality contour of the repaired chest wall was satisfactory. No rejection or infection occurred during the 6-month follow-up period. Chest-wall reconstruction with a customized titanium-alloy prosthesis is a reliable technique for repairing bony defects.

Standardization of Protocol for the Sampling, Testing and abatement of Asbestos Containing Joint Compound

DTIC Science & Technology

1994-09-01

vi A b stract...5-2 Proposed Decision Tree for ACJC Abatement Activities 5-10 Vi AFIT/GEE/ENV/94S-23 ABSTRACT This study investigated the differing regulatory...specific amount. According to 29 CFR 1910.58(k)(2)( vi )(B), labeling provisions do not apply unless asbestos is present in a product in concentrations

The clinical relevance of advanced artificial feedback in the control of a multi-functional myoelectric prosthesis.

PubMed

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

Biomechanical evaluation of two types of short-stemmed hip prostheses compared to the trust plate prosthesis by three-dimensional measurement of micromotions.

PubMed

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.

Virtual transplantation in designing a facial prosthesis for extensive maxillofacial defects that cross the facial midline using computer-assisted technology.

PubMed

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.

Identification of overlengthening after replacement of the radial head with a bipolar prosthesis.

PubMed

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.

Development of a patient-specific temporomandibular joint prosthesis according to the Groningen principle through a cadaver test series.

PubMed

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.

21 CFR 874.3695 - Mandibular implant facial prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... intended to be implanted for use in the functional reconstruction of mandibular deficits. The device is...

21 CFR 874.3695 - Mandibular implant facial prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... intended to be implanted for use in the functional reconstruction of mandibular deficits. The device is...

Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment

PubMed Central

Lee, Christine; Tu, Hong Anh; Weir, Mark; Holubowich, Corinne

2016-01-01

Background Retinitis pigmentosa is a group of genetic disorders that involves the breakdown and loss of photoreceptors in the retina, resulting in progressive retinal degeneration and eventual blindness. The Argus II Retinal Prosthesis System is the only currently available surgical implantable device approved by Health Canada. It has been shown to improve visual function in patients with severe visual loss from advanced retinitis pigmentosa. The objective of this analysis was to examine the clinical effectiveness, cost-effectiveness, budget impact, and safety of the Argus II system in improving visual function, as well as exploring patient experiences with the system. Methods We performed a systematic search of the literature for studies examining the effects of the Argus II retinal prosthesis system in patients with advanced retinitis pigmentosa, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on visual function, functional outcomes, quality of life, and adverse events. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care over a 10-year time horizon. We also conducted a 5-year budget impact analysis. We used a qualitative design and an interview methodology to examine patients’ lived experience, and we used a modified grounded theory methodology to analyze information from interviews. Transcripts were coded, and themes were compared against one another. Results One multicentre international study and one single-centre study were included in the clinical review. In both studies, patients showed improved visual function with the Argus II system. However, the sight-threatening surgical complication rate was substantial. In the base-case analysis, the Argus II system was cost-effective compared with standard care only if willingness-to-pay was more than $207,616 per quality-adjusted life

Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment.

PubMed

2016-01-01

Retinitis pigmentosa is a group of genetic disorders that involves the breakdown and loss of photoreceptors in the retina, resulting in progressive retinal degeneration and eventual blindness. The Argus II Retinal Prosthesis System is the only currently available surgical implantable device approved by Health Canada. It has been shown to improve visual function in patients with severe visual loss from advanced retinitis pigmentosa. The objective of this analysis was to examine the clinical effectiveness, cost-effectiveness, budget impact, and safety of the Argus II system in improving visual function, as well as exploring patient experiences with the system. We performed a systematic search of the literature for studies examining the effects of the Argus II retinal prosthesis system in patients with advanced retinitis pigmentosa, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on visual function, functional outcomes, quality of life, and adverse events. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care over a 10-year time horizon. We also conducted a 5-year budget impact analysis. We used a qualitative design and an interview methodology to examine patients' lived experience, and we used a modified grounded theory methodology to analyze information from interviews. Transcripts were coded, and themes were compared against one another. One multicentre international study and one single-centre study were included in the clinical review. In both studies, patients showed improved visual function with the Argus II system. However, the sight-threatening surgical complication rate was substantial. In the base-case analysis, the Argus II system was cost-effective compared with standard care only if willingness-to-pay was more than $207,616 per quality-adjusted life-year. The 5-year budget

Initial Clinical Experience with an Endoluminal Spiral Prosthesis for Treating Complicated Venous Thrombosis and Preventing Pulmonary Embolism

PubMed Central

Jakob, H.; Oelert, H.; Schmiedt, W.; Teusch, P.; Iversen, S.; Hake, U.; Schild, H.; Maass, D.

1989-01-01

Fourteen patients with complicated venous thrombosis or recurrent pulmonary embolism were treated by implantation of an endoluminal spiral prosthesis subsequent to balloon angioplasty, surgical thrombectomy or embolectomy, a combination of these, or, in 2 cases, no other treatment. The patients were divided into 2 groups, based on their primary diagnosis and the purpose of the prosthesis. Group I included 8 patients with extensive iliofemoral or caval thrombosis, caused by congenital caval stenosis (1 case) or extravascular compression or retraction (7 cases); 7 of these patients had had previous operations, and the remaining patient had undergone thrombolysis, which failed. The current treatment consisted of balloon angioplasty and surgical thrombectomy or embolectomy, and implantation of an endoluminal spiral stent to prevent elastic recoil of the vessel. In 4 cases, an arteriovenous fistula was constructed and was taken down 3 months later; in 1 additional patient, a bilateral arteriovenous fistula was created. Group II comprised 6 patients with recurrent pulmonary embolism (4 cases), massive pulmonary embolism (1 case), or paradoxical bilateral carotid artery embolism (1 case). Four of these patients underwent surgical thrombectomy or embolectomy, while 2 had no treatment other than filter implantation. All 6 underwent transluminal implantation of a helix caval filter (a modification of the endoluminal spiral stent). All but 1 implantation was accomplished by means of either a transfemoral or a transjugular cutdown; the remaining implantation was performed transatrially after a pulmonary embolectomy. The only device-related complication was a retroperitoneal hematoma in Group I, resulting from perforation of the inferior vena cava by the guidewire during device implantation. This complication necessitated an emergency laparotomy and takedown of the arteriovenous fistula, which resulted in rethrombosis of the left iliofemoral vein. The other 7 stented veins were

Limb Position Tolerant Pattern Recognition for Myoelectric Prosthesis Control with Adaptive Sparse Representations From Extreme Learning.

PubMed

Betthauser, Joseph L; Hunt, Christopher L; Osborn, Luke E; Masters, Matthew R; Levay, Gyorgy; Kaliki, Rahul R; Thakor, Nitish V

2018-04-01

Myoelectric signals can be used to predict the intended movements of an amputee for prosthesis control. However, untrained effects like limb position changes influence myoelectric signal characteristics, hindering the ability of pattern recognition algorithms to discriminate among motion classes. Despite frequent and long training sessions, these deleterious conditional influences may result in poor performance and device abandonment. We present a robust sparsity-based adaptive classification method that is significantly less sensitive to signal deviations resulting from untrained conditions. We compare this approach in the offline and online contexts of untrained upper-limb positions for amputee and able-bodied subjects to demonstrate its robustness compared against other myoelectric classification methods. We report significant performance improvements () in untrained limb positions across all subject groups. The robustness of our suggested approach helps to ensure better untrained condition performance from fewer training conditions. This method of prosthesis control has the potential to deliver real-world clinical benefits to amputees: better condition-tolerant performance, reduced training burden in terms of frequency and duration, and increased adoption of myoelectric prostheses.

Excessive strut wear allowing ball-poppet embolization in a DeBakey-Surgitool aortic valve prosthesis.

PubMed

Sutherland, R D; Guynes, W A; Nichols, C T; Martinez, H E

1982-01-01

Excessive cage strut wear allowing ball-poppet embolization caused the sudden death of a 47 year old lady in whom a DeBakey-Surgitool aortic prosthesis had been implanted nine years earlier. Patients with this type of prosthesis should have periodic valvular cine fluoroscopy with image intensification to allow visualization of significant strut wear or fracture, and appropriate prosthetic valve replacement.

Design and experimental analysis of a new malleovestibulopexy prosthesis using a finite element model of the human middle ear.

PubMed

Vallejo Valdezate, Luis A; Hidalgo Otamendi, Antonio; Hernández, Alberto; Lobo, Fernando; Gil-Carcedo Sañudo, Elisa; Gil-Carcedo García, Luis M

2015-01-01

Many designs of prostheses are available for middle ear surgery. In this study we propose a design for a new prosthesis, which optimises mechanical performance in the human middle ear and improves some deficiencies in the prostheses currently available. Our objective was to design and assess the theoretical acoustic-mechanical behaviour of this new total ossicular replacement prosthesis. The design of this new prosthesis was based on an animal model (an iguana). For the modelling and mechanical analysis of the new prosthesis, we used a dynamic 3D computer model of the human middle ear, based on the finite elements method (FEM). The new malleovestibulopexy prosthesis design demonstrates an acoustical-mechanical performance similar to that of the healthy human middle ear. This new design also has additional advantages, such as ease of implantation and stability in the middle ear. This study shows that computer simulation can be used to design and optimise the vibroacoustic characteristics of middle ear implants and demonstrates the effectiveness of a new malleovestibulopexy prosthesis in reconstructing the ossicular chain. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

Transition from a fixed implant dental prosthesis to an implant overdenture in an edentulous patient: a clinical report.

PubMed

Ali, Bolouri; Bhavani, Venkatachalam

2014-09-01

The lack of planning before implant placement and restoration in edentulous patients can lead to a number of problems. Prosthodontists are often faced with the challenge of re-treating patients who have only recently been treated. Although many reports discuss retreatment by fabricating all new prosthetic components, few discuss salvaging parts of the patient's existing prosthesis. This report details the treatment of an edentulous patient who presented with an implant-retained fixed dental prosthesis in the maxillary arch and no opposing prosthesis. The transition from an implant-retained fixed dental prosthesis to a removable implant- and tissue-supported overdenture that uses the patient's existing computer-aided design/computer-aided manufacturing milled titanium substructure is described. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Patient Management with Metallic Valve Prosthesis during Pregnancy and Postpartum Period.

PubMed

Garcez, Juliane Dantas Seabra; Rosa, Vitor Emer Egypto; Lopes, Antonio Sergio de Santis Andrade; Accorsi, Tarso Augusto Duenhas; Fernandes, João Ricardo Cordeiro; Pomerantzeff, Pablo Maria; Avila, Walkiria Samuel; Tarasoutchi, Flavio

2015-10-01

Prosthetic thrombosis is a rare complication, but it has high mortality and morbidity. Young women of childbearing age that have prosthetic heart valves are at increased risk of thrombosis during pregnancy due to changes in coagulation factors. Anticoagulation with adequate control and frequent follow-up if pregnancy occurs must be performed in order to prevent complications related to anticoagulant use. Surgery remains the treatment of choice for prosthetic heart valve thrombosis in most clinical conditions. Patients with metallic prosthetic valves have an estimated 5% risk of thrombosis during pregnancy and maternal mortality of 1.5% related to the event. Anticoagulation with vitamin K antagonists during pregnancy is related to varying degrees of complications at each stage of the pregnancy and postpartum periods. Warfarin sodium crosses the placental barrier and when used in the first trimester of pregnancy is a teratogenic agent, causing 1-3% of malformations characterized by fetal warfarin syndrome and also constitutes a major cause of miscarriage in 10-30% of cases. In the third trimester and at delivery, the use of warfarin is associated with maternal and neonatal bleeding in approximately 5 to 15% of cases, respectively. On the other hand, inadequate anticoagulation, including the suspension of the oral anticoagulants aiming at fetal protection, carries a maternal risk of about 25% of metallic prosthesis thrombosis, particularly in the mitral valve. This fact is also due to the state of maternal hypercoagulability with activation of coagulation factors V, VI, VII, IX, X, platelet activity and fibrinogen synthesis, and decrease in protein S levels. The Registry of Pregnancy and Cardiac Disease (ROPAC), assessing 212 pregnant women with metal prosthesis, showed that prosthesis thrombosis occurred in 10 (4.7%) patients and maternal hemorrhage in 23.1%, concluding that only 58% of patients with metallic prosthesis had a complication-free pregnancy.

Shortened penis post penile prosthesis implantation treated with subcutaneous soft silicone penile implant: case report.

PubMed

Shirvanian, V; Lemperle, G; Araujo Pinto, C; Elist, J J

2014-01-01

Penile prosthesis surgery for erectile dysfunction has the highest satisfaction rates among all treatment options but is often associated with subjective and objective loss of penile length and girth following surgery. To present a novel technique using a subcutaneous soft silicone implant for reversal of penile shortening and narrowing after prosthesis surgery, with additional gains in overall penile length and girth. Nine patients were treated with the insertion of a subcutaneous soft silicone penile implant. All patients had previously reported a loss in penile length (0.5-2 cm), and seven of nine patients also reported a loss in penile girth (0.5-2.6 cm) after penile prosthesis surgery. During a follow-up period of 4-24 months, penile length and girth measurements showed a mean increase in length of 2.4 cm (±0.75 cm) and a mean increase in girth of 3.4 cm (±0.94 cm). The additional insertion of a subcutaneous soft silicone implant in patients with decreased penile length and girth after penile prosthesis surgery is an effective treatment option that provides reversal of lost penile length and girth.

Narrowing beam-walking is a clinically feasible approach for assessing balance ability in lower-limb prosthesis users.

PubMed

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.

The effects of indwelling voice prosthesis on the quality of life, depressive symptoms, and self-esteem in patients with total laryngectomy.

PubMed

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.

Hearing and Otoacoustic Emissions Outcome of Stapedotomy: Does the Prosthesis Diameter Matter?

PubMed

Faranesh, Nabil; Magamseh, Ebrahim; Zaaroura, Suliman; Zeidan, Reem; Shupak, Avi

2017-08-01

To compare the hearing and otoacoustic emissions (OAE) outcome of stapedotomy employing 0.4 and 0.6 mm diameter prostheses. In total, 18 patients with otosclerosis participated in a prospective, double-armed, randomized cohort study. All the patients underwent small fenestra drill stapedotomy employing the Causse fluroplastic large loop piston prostheses. The patients were randomly assigned to groups of 0.4 mm (n=9) and 0.6 mm (n=9) diameter prostheses. The results of pure tone air and bone audiometries, speech audiometry, and OAE conducted 12 months post operatively were compared within and between the groups. The within-group analysis showed significant post-stapedotomy improvements in the average air conduction pure tone thresholds in both groups (52.9±9.6 vs. 25.6±5.2 dB HL; p<0.0001 and 54.6±10.4 vs. 22.2±8.2 dB HL; p<0.0001 for the 0.4 and 0.6 mm groups, respectively) and average air-bone gap (ABG; 37.1±8.5 vs. 8.1±3.9 dB HL; p<0.0001 and 38.3±7.5 vs. 9.9±4.5 dB HL; p<0.0001 in the 0.4 and 0.6 mm groups, respectively). No significant differences were found between the groups in these outcome measures, as well as in the rate of ABG closure within 10 dB HL and the word recognition scores. Favorable outcome in the post-stapedotomy bone conduction (BC) was found for the 0.6 mm prosthesis group, reflecting superior cancellation of the Carhart phenomenon for the 500-3000 Hz pure tone thresholds average (-1.7±3.7 vs. 3.9±6.2 dB HL for the 0.4 and 0.6 mm groups, respectively; p<0.04) and 1000, 2000, and 4000 Hz average (-2.6±4.33 vs. 3.9±7.8 dB HL for the 0.4 and 0.6 mm groups, respectively; p<0.05). Small signal-to-noise ratio (SNR) values of the transient-evoked OAE (TEOAE) and distortion product OAE (DPOAE) were found at baseline and follow-up evaluation with no consistent changes post stapedotomy. Similar post-stapedotomy hearing results were found for the 0.4 and 0.6 mm prostheses with small but statistically significant advantage in BC gain and the

[Questionnaire of the psychosocial profile of the patient with anophthalmia with indication of ocular prosthesis].

PubMed

Nicodemo, Denise; Ferreira, Lydia Masako

2006-01-01

The patient with anophthalmia may present feelings of inferiority and rejection. Knowing his/her needs and expectations contribute to a better technical intervention. To elaborate a questionnaire of the psychosocial profile of the patient with anophthalmia with indication of ocular prosthesis. An exploratory research was used to elaborate the questionnaire, by means of a guided interview followed by writing down what was said by the interviewees, who were adult patients of the Bucco-Maxillo-Facial Prosthesis Center of FOSJC - UNESP. The guided interview was made up of 14 items directly related to the future outline of the profile. Each item of the interview resulted in questions of the questionnaire, which was pretested twice before reaching its final version. The patients reported, in the exploratory research, unpleasant feelings with the loss of the eye; relationship shyness; expectations regarding surgery and prosthesis use; a wish to receive explanations and to hold their opinion about the treatment. The questionnaire of the psychosocial profile of the patient with anophthalmia with indication of ocular prosthesis is, therefore, made of 43 questions divided into 5 blocks in order to aid the comprehension of the inquired aspects and to facilitate both the computation of data and discussion, and also to improve the selection of questions according to the objective of the researcher or professional. It was concluded that the questionnaire was viable, can be used in full or by selecting blocks and provide a panorama of the patient's history related to the problem he/she faces, from the loss of the ocular globe to the confection of the prosthesis.

Three-dimensional-printed upper limb prosthesis for a child with traumatic amputation of right wrist: A case report.

PubMed

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.

Use of digital technologies for nasal prosthesis manufacturing.