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 configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis. Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

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

Success and complications of implant-retained prostheses provided by the Post-Doctoral Prosthodontics Program, University of Puerto Rico: a cross-sectional study.

PubMed

Loza-Herrero, María A; Rivas-Tumanyan, Sona; Morou-Bermudez, Evangelia

2015-11-01

The success rate of implant-retained prostheses in a postdoctoral prosthodontics program was unknown and could not be related to any set of potential clinical issues or patient characteristics. The purpose of this study was to determine the success rate of implant-retained prostheses placed by prosthodontic residents between 1997 and 2012 and to evaluate the associations between patient classifications and specific restoration characteristics as related to prosthesis success or failure. A total of 272 prostheses in 119 patients were clinically evaluated. Success was defined as the absence of prosthetic complications or any implant-related complication that affected prosthesis survival. Logistic regression was used to evaluate associations between prosthesis success/failure and a wide array of study variables, adjusting for patient age, sex, and prosthesis longevity. The overall success rate was 71%, with a mean prosthesis age of 4.5 years (range: 4 months to 16.8 years). Implant single crowns were the most successful prosthesis type (81% success). The most common complications observed were porcelain fractures in fixed dental prostheses (15%) and lack of stability (31%) and retention (29%) in removable dental prostheses. Having a removable prosthesis (versus natural dentition) in the opposing occlusion significantly decreased the odds of success (OR=0.26, 95% CI: 0.11-0.64). Definitively cemented fixed prostheses were more successful than those cemented with an interim cement (OR=4.56, 95% CI: 1.37-15.22). The overall success rate of the implant-retained prostheses placed in the program was low compared with previously published studies. This study revealed the need for an efficient, comprehensive recall system for patients receiving implant-retained prostheses, either fixed or removable. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

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.

Interdisciplinary interface between fixed prosthodontics and periodontics.

PubMed

Abduo, Jaafar; Lyons, Karl M

2017-06-01

Although periodontal factors do not usually have a direct effect on the survival of a fixed prosthesis, harmony between the prosthesis and the periodontium is critical otherwise esthetics, the longevity of the prosthesis and the periodontium will be compromised. A close interdisciplinary relationship between periodontics and prosthodontics is therefore necessary to avoid an unsatisfactory treatment outcome, requiring extensive and expensive retreatment. The design of the prosthesis, the number and quality of the abutment teeth, the preparation and the pontic, the occlusion and the material need to be considered when planning prosthodontic treatment. The location of the preparation margin and the contour and emergence profile of the prosthesis will influence the response of the gingival tissues to the prosthesis. Pontic design and cleansibility also contribute to the response of the gingival tissues as well as to the clinical and esthetic outcome. Even an optimal pontic design will not prevent inflammation of the mucosa adjacent to the pontic if pontic hygiene is not maintained by removal of plaque. Case selection and the patients' ability to carry out adequate oral hygiene are therefore essential for longevity of the prosthesis, and regular reviews provide an opportunity for early detection and treatment of failures. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A new prosthesis for the metacarpophalangeal joint. Study of materials and biomechanics.

PubMed

Petrolati, M; Abbiati, G; Delaria, G; Soffiatti, R; Robotti, P; Guerriero, C

1999-02-01

This report discusses the Daphne prosthesis for the metacarpophalangeal joint on the basis of the mechanical, chemical and biological performance of the materials employed. The Daphne prosthesis is a mobile device. The main body is made of a new generation polymethylmetacrylate, while the hinge is made of AISI 316 L stainless steel. Biocompatibility tests were performed on the materials employed. Systemic toxicity, cytotoxicity and contact tests have given favourable results. Mechanical engineering tests have been used to investigate the performances and reliability of the selected materials. The polymethylmetacrylate used in Daphne behaves in a ductile fashion. No mechanical failures were encountered in fatigue tests after 10 million cycles.

Engineering long term clinical success of advanced ceramic prostheses.

PubMed

Rekow, Dianne; Thompson, Van P

2007-01-01

Biocompatability and, in some applications, esthetics make all-ceramic prostheses compelling choices but despite significant improvements in materials properties and toughening mechanisms, these still have significant failure rates. Factors that contribute to the degradation in strength and survival include material selection and prosthesis design which set the upper limit for performance. However, fabrication operations introduce damage that can be exacerbated by environmental conditions and clinical function. Using all-ceramic dental crowns as an example, experimentally derived models provide insight into the relationships between materials properties and initial critical loads to failure. Analysis of fabrication operations suggests strategies to minimize damage. Environmental conditions can create viscoplastic flow of supporting components which can contribute additional stress within the prosthesis. Fatigue is a particularly challenging problem, not only providing the energy to propagate existing damage but, when combined with the wet environment, can create new damage modes. While much is known, the influence of these new damage modes has not been completely elucidated. The role of complex prosthesis geometry and its interaction with other factors on damage initiation and propagation has yet to be well characterized.

Mini-implants: alternative for oral rehabilitation of a child with ectodermal dysplasia.

PubMed

Mello, Bianca Zeponi Fernandes; Silva, Thiago Cruvinel; Rios, Daniela; Machado, Maria Aparecida Andrade Moreira; Valarelli, Fabrício Pinelli; Oliveira, Thais Marchini

2015-01-01

Ectodermal dysplasia is a rare congenital disease that affects several structures of ectodermal origin. The most commonly related oral characteristics are hypodontia, malformed teeth and underdeveloped alveolar ridges. New alternative treatments are needed due to the failure of the conventional prosthesis retention. This case report outlines the oral rehabilitation treatment of a 9-year-old girl with ectodermal dysplasia. The treatment was performed with conventional prosthesis upon mini-implants. The mini-implants provided prosthetic retention. The patient reported a good adaptation of the dental prosthesis and satisfaction with the treatment. The increased self-esteem improved the socialization skills of the girl. In this case report, use of prosthesis with mini-implants was satisfactory for prosthetic retention. However, clinical studies with long-term follow-up are needed to test the mini-implants as an alternative for oral rehabilitation of children with ectodermal dysplasia.

An Exotendon Orthosis to Improve Mobility for Military Personnel Recovering from Combat-Related Injuries

DTIC Science & Technology

2011-12-01

the data we feel that it is less a failure of the exotendon technology and more a failure of the wrong tests with the wrong types of subjects...from incomplete spinal cord injuries. Additionally, a proposal to the National Institutes of Health seeking to develop an exotendon prosthesis for

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.

An integrated CAD/CAM/robotic milling method for custom cementless femoral prostheses.

PubMed

Wen-ming, Xi; Ai-min, Wang; Qi, Wu; Chang-hua, Liu; Jian-fei, Zhu; Fang-fang, Xia

2015-09-01

Aseptic loosening is the primary cause of cementless femoral prosthesis failure and is related to the primary stability of the cementless femoral prosthesis in the femoral cavity. The primary stability affects both the osseointegration and the long-term stability of cementless femoral prostheses. A custom cementless femoral prosthesis can improve the fit and fill of the prosthesis in the femoral cavity and decrease the micromotion of the proximal prosthesis such that the primary stability of the custom prosthesis can be improved, and osseointegration of the proximal prosthesis is achieved. These results will help to achieve long-term stability in total hip arthroplasty (THA). In this paper, we introduce an integrated CAD/CAM/robotic method of milling custom cementless femoral prostheses. The 3D reconstruction model uses femoral CT images and 3D design software to design a CAD model of the custom prosthesis. After the transformation matrices between two units of the robotic system are calibrated, consistency between the CAM software and the robotic system can be achieved, and errors in the robotic milling can be limited. According to the CAD model of the custom prosthesis, the positions of the robotic tool points are produced by the CAM software of the CNC machine. The normal vector of the three adjacent robotic tool point positions determines the pose of the robotic tool point. In conclusion, the fit rate of custom pig femur stems in the femoral cavities was 90.84%. After custom femoral prostheses were inserted into the femoral cavities, the maximum gaps between the prostheses and the cavities measured less than 1 mm at the diaphysis and 1.3 mm at the metaphysis. Copyright © 2015 IPEM. Published by Elsevier Ltd. All rights reserved.

Five-year results after valve replacement with the Björk-Shiley 70 degrees convexo-concave prosthesis.

PubMed

Koldsland, S; Svennevig, J L; Abdelnoor, M; Aas, H; Semb, G

1992-01-01

In the 18 months up to July 1983, 120 Björk-Shiley convexo-concave prostheses with 70 degrees opening angle were implanted in 47 women and 61 men aged 19-78 (mean 58.6) years. The prosthetic valves were aortic in 65 cases, mitral in 23 and both aortic and mitral in 20 cases. Emergency operation was required in ten cases, and concomitant surgery was performed in 43 (39.8%). The early mortality was 5.5%. A follow-up study, comprising 498 patient years, revealed 73.1% 5-year survival. There were three mechanical failures of prosthesis, in one of which re-replacement was successful. Elective prosthesis replacement was performed in four other cases judged to be at high risk of strut fracture.

Fracture and embolization of a Björk-Shiley disc. Fatal failure of a prosthetic mitral valve.

PubMed

Norenberg, D D; Evans, R W; Gundersen, A E; Abellera, R M

1977-12-01

A case of fracture of the disc occluder of a Bjork-Shiley mitral prosthesis with embolization of the disc fragments to distal aorta is presented. The possibility of valve dysfunction and the diagnostic value of echocardiography should be considered whenever acute heart failure occurs in a patient with an artificial valve.

Total prosthetic replacement of atrioventricular valves in the dog

PubMed Central

Den Otter, G.

1968-01-01

The free-floating cone and cage valve, described in a previous study as being successful as a substitute for the right atrioventricular valve, does not perform well when it is inserted in the mitral ostium. A tilting cone or disc was constructed and tested in a series of 15 dogs. This prosthesis gave excellent results in 12 animals. The reasons for its failure in the remaining three is discussed. The prosthesis presented has advantages over any ball and cage valve, mainly because of its smaller volume. Images PMID:5654076

[Strut fracture of a convex-concave 60 degree Björk-Shiley mitral valve prosthesis 5 years after implantation--metallurgic analysis of the prosthesis strut].

PubMed

Lemke, B; Rathmann, J; Wiebe, V; Witzel, U

1991-08-01

Acute mechanical failure of prosthetic heart valves is rare, but associated with high mortality when occurring. For convexo-concave Björk-Shiley prostheses only fractures of the outlet strut are reported. We present a case of lethal mechanical complication 5 years after implantation. By additional metallurgic analysis we were able to identify a sequential course of the outlet strut fracture. This could lead to new approaches for early detection of this complication.

A dual-center review of compressive osseointegration for fixation of massive endoprosthetics: 2- to 9-year followup.

PubMed

Calvert, George T; Cummings, Judd E; Bowles, Austin J; Jones, Kevin B; Wurtz, L Daniel; Randall, R Lor

2014-03-01

Aseptic failure of massive endoprostheses used in the reconstruction of major skeletal defects remains a major clinical problem. Fixation using compressive osseointegration was developed as an alternative to cemented and traditional press-fit fixation in an effort to decrease aseptic failure rates. The purpose of this study was to answer the following questions: (1) What is the survivorship of this technique at minimum 2-year followup? (2) Were patient demographic variables (age, sex) or anatomic location associated with implant failure? (3) Were there any prosthesis-related variables (eg, spindle size) associated with failure? (4) Was there a discernible learning curve associated with the use of the new device as defined by a difference in failure rate early in the series versus later on? The first 50 cases using compressive osseointegration fixation from two tertiary referral centers were retrospectively studied. Rates of component removal for any reason and for aseptic failure were calculated. Demographic, surgical, and oncologic factors were analyzed using regression analysis to assess for association with implant failure. Minimum followup was 2 years with a mean of 66 months. Median age at the time of surgery was 14.5 years. A total of 15 (30%) implants were removed for any reason. Of these revisions, seven (14%) were the result of aseptic failure. Five of the seven aseptic failures occurred at less than 1 year (average, 8.3 months), and none occurred beyond 17 months. With the limited numbers available, no demographic, surgical, or prosthesis-related factors correlated with failure. Most aseptic failures of compressive osseointegration occurred early. Longer followup is needed to determine if this technique is superior to other forms of fixation.

[Lysis of the incus long process and incudostapedial rebridging ossiculoplasty: comparative study of titanium-gold angle prosthesis Plester-type versus Martin Incudo prosthesis hydroxylapatite].

PubMed

Faye, M B; Martin, C; Schmerber, S

2013-01-01

We report two surgical techniques devised to restore a disrupted incudostapedial joint. Thirty patients underwent rebridging of distal portion of incus long process in the ENT Department of University of Grenoble and Saint-Etienne, between October 1998 and September 2002. Two types of ossicular prostheses were used: A titanium-gold angle prosthesis according to Plester Winkel Kurz (n = 16 patients), and a hydroxylapatite prosthesis as Martin Incudo Prosthesis (n = 14 patients). The average hearing gain in short term is of 8.30 dB for the Martin-Incudo group. It is of 5.23 dB in the Winkel group. Seven and three cases of failures (Residual Rinne > 20 dB) were noticed respectively in the groups Martin-Incudo and Winkel. Seven and four cases of labyrinthisation were observed respectively in the groups Martin-Incudo and Winkel. The average hearing gain in long term is 3.43 dB in the Martin-Incudo group; and 2.85 dB among patients with Winkel Kurz prosthesis. Average residual Rinne is higher than 20 dB in the Winkel group. The hearing gain is not statistically significant between the two groups (p > 0.05). The titanium partial prosthesis did not give good functional results. In the case of a limited lysis (< 2 mm) of the distal portion of incus, we use the cement or cartilage interposition. When ossicular chain cannot be preserved entirely, we privilege incus transposition or a titanium PORP. The Martin-Incudo prosthesis seems interesting in the event of lysis of 2 mm of the long process of incus, nevertheless engineering changes are necessary in order to make rigid the incudostapedial joint.

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.

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 investigation to optimize the shape of the inner chamber's surface.

Revision of a Fractured Uncemented Revision Stem Using a Custom Designed Punch and Retrograde Through-Knee Approach

PubMed Central

Nasr, P. J.; Keene, G. S.

2015-01-01

We report a unique case of a fractured modular cobalt chromium connection taper Revitan (Zimmer, Warsaw, IN) revision prosthesis. Macroscopic examination revealed a fracture at the diaphyseal-metaphyseal junction of this modular component. This report highlights that fractures can still occur with modern modular prostheses. We are not aware of any published failures of the Revitan revision prosthesis. We also describe a unique method of retrieval for a broken well fixed uncemented femoral stem, using a custom designed extraction instrument via a through-knee approach. PMID:25793134

[Sudden and fatal malfunction of a Björk-Shiley prosthesis in mitral position due to rupture of the ventricular bracket and disk embolization].

PubMed

Casarotto, D; Motta, A; Fabbri, A; Pugliese, P; Muneretto, C; Zanini, M; Sheiban, I

1985-04-01

Mechanical complications of prosthetic valves are increasing. The following report describes a case of fracture of a Björk-Shiley mitral prosthetic strut with dislogment of the valve occluder into the thoracic aorta. At the reoperation a new prosthesis was implanted but the patient died of acute heart failure. The diagnosis of valve disfunction must be made non invasively, because the time required for cardiac catherization usually constitutes a lethal delay. The only hope for survival is prompt surgical treatment.

Compress knee arthroplasty has 80% 10-year survivorship and novel forms of bone failure.

PubMed

Healey, John H; Morris, Carol D; Athanasian, Edward A; Boland, Patrick J

2013-03-01

Compliant, self-adjusting compression technology is a novel approach for durable prosthetic fixation of the knee. However, the long-term survival of these constructs is unknown. We therefore determined the survival of the Compress prosthesis (Biomet Inc, Warsaw, IN, USA) at 5 and 10 actuarial years and identified the failure modes for this form of prosthetic fixation. We retrospectively reviewed clinical and radiographic records for all 82 patients who underwent Compress knee arthroplasty from 1998 to 2008, as well as one patient who received the device elsewhere but was followed at our institution. Prosthesis survivorship and modes of failure were determined. Followup was for a minimum of 12 months or until implant removal (median, 43 months; range, 6-131 months); 28 patients were followed for more than 5 years. We found a survivorship of 85% at 5 years and 80% at 10 years. Eight patients required prosthetic revision after interface failure due to aseptic loosening alone (n = 3) or aseptic loosening with periprosthetic fracture (n = 5). Additionally, five periprosthetic bone failures occurred that did not require revision: three patients had periprosthetic bone failure without fixation compromise and two exhibited irregular prosthetic osteointegration patterns with concomitant fracture due to mechanical insufficiency. Compress prosthetic fixation after distal femoral tumor resection exhibits long-term survivorship. Implant failure was associated with patient nonadherence to the recommended weightbearing proscription or with bone necrosis and fracture. We conclude this is the most durable FDA-approved fixation method for distal femoral megaprostheses. Level IV, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

A technique for transferring a patient's smile line to a cone beam computed tomography (CBCT) image.

PubMed

Bidra, Avinash S

2014-08-01

Fixed implant-supported prosthodontic treatment for patients requiring a gingival prosthesis often demands that bone and implant levels be apical to the patient's maximum smile line. This is to avoid the display of the prosthesis-tissue junction (the junction between the gingival prosthesis and natural soft tissues) and prevent esthetic failures. Recording a patient's lip position during maximum smile is invaluable for the treatment planning process. This article presents a simple technique for clinically recording and transferring the patient's maximum smile line to cone beam computed tomography (CBCT) images for analysis. The technique can help clinicians accurately determine the need for and amount of bone reduction required with respect to the maximum smile line and place implants in optimal positions. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Pelvic reconstructions following peri-acetabular bone tumour resections using a cementless ice-cream cone prosthesis with dual mobility cup.

PubMed

Issa, Samir-Pierre; Biau, David; Babinet, Antoine; Dumaine, Valérie; Le Hanneur, Malo; Anract, Philippe

2018-01-27

Despite numerous reconstructive techniques and prosthetic devices, pelvic reconstructions following peri-acetabular malignant tumours resections are highly challenging. In the present study, we describe our experience with the Integra® (Lépine, Genay, France) ice-cream cone prosthesis in such indications. The objective was to assess the mid-term outcomes of this device. Twenty-four patients' chart with peri-acetabular malignant tumours, who underwent types II or II + III peri-acetabular resections according to Enneking and Dunham with subsequent reconstruction using the Integra® prosthesis between February 2009 and February 2015, were reviewed. Seventeen cases were primary surgeries and seven cases were revisions (i.e., failures of previous reconstructions for pelvic tumours). All living patients with the prosthesis implanted were functionally assessed, using the musculoskeletal tumour society (MSTS) and Postel-Merle d'Aubigné (PMA) scores. After a mean follow-up of 49 ± 26 months (range, 8 to 94 months), 21 patients were alive (88%), including 15 patients continuously disease-free (63%). MSTS and PMA scores averaged 72 ± 13% (range, 43 to 87%) and 14.6 ± 2.6 (range, 9 to 18), respectively. Fourteen patients (58%) presented at least one complication during follow-up, including four cases of deep infection (17%), four cases of dislocation (17%), and two mechanical failures (8%). At 5 years, the implant survival rate was 75%. In comparison to previous reconstructive techniques that we used in similar indications, functional and oncologic outcomes were improved with the Integra® implant. However, as commonly observed in pelvic bone tumour surgery, complication rates remain significant. Therapeutic, Level IV-Retrospective Cases Series.

Soft-Tissue Reconstruction of the Complicated Knee Arthroplasty: Principles and Predictors of Salvage.

PubMed

Colen, David L; Carney, Martin J; Shubinets, Valeriy; Lanni, Michael A; Liu, Tiffany; Levin, L Scott; Lee, Gwo-Chin; Kovach, Stephen J

2018-04-01

Total knee arthroplasty is a common orthopedic procedure in the United States and complications can be devastating. Soft-tissue compromise or joint infection may cause failure of prosthesis requiring knee fusion or amputation. The role of a plastic surgeon in total knee arthroplasty is critical for cases requiring optimization of the soft-tissue envelope. The purpose of this study was to elucidate factors associated with total knee arthroplasty salvage following complications and clarify principles of reconstruction to optimize outcomes. A retrospective review of patients requiring soft-tissue reconstruction performed by the senior author after total knee arthroplasty over 8 years was completed. Logistic regression and Fisher's exact tests determined factors associated with the primary outcome, prosthesis salvage versus knee fusion or amputation. Seventy-three knees in 71 patients required soft-tissue reconstruction (mean follow-up, 1.8 years), with a salvage rate of 61.1 percent, mostly using medial gastrocnemius flaps. Patients referred to our institution with complicated periprosthetic wounds were significantly more likely to lose their knee prosthesis than patients treated only within our system. Patients with multiple prior knee operations before definitive soft-tissue reconstruction had significantly decreased rates of prosthesis salvage and an increased risk of amputation. Knee salvage significantly decreased with positive joint cultures (Gram-negative greater than Gram-positive organisms) and particularly at the time of definitive reconstruction, which also trended toward an increased risk of amputation. In revision total knee arthroplasty, prompt soft-tissue reconstruction improves the likelihood of success, and protracted surgical courses and contamination increase failure and amputations. The authors show a benefit to involving plastic surgeons early in the course of total knee arthroplasty complications to optimize genicular soft tissues. Therapeutic, III.

Comparison of mode of failure between primary and revision total knee arthroplasties.

PubMed

Liang, H; Bae, J K; Park, C H; Kim, K I; Bae, D K; Song, S J

2018-04-01

Cognizance of common reasons for failure in primary and revision TKA, together with their time course, facilitates prevention. However, there have been few reports specifically comparing modes of failure for primary vs. revision TKA using a single prosthesis. The goal of the study was to compare the survival rates, modes of failure, and time periods associated with each mode of failure, of primary vs. revision TKA. The survival rates, modes of failure, time period for each mode of failure, and risk factors would differ between primary and revision TKA. Data from a consecutive cohort comprising 1606 knees (1174 patients) of primary TKA patients, and 258 knees (224 patients) of revision TKA patients, in all of whom surgery involved a P.F.C ® prosthesis (Depuy, Johnson & Johnson, Warsaw, IN), was retrospectively reviewed. The mean follow-up periods of primary and revision TKAs were 9.2 and 9.8 years, respectively. The average 10- and 15-year survival rates for primary TKA were 96.7% (CI 95%,±0.7%) and 85.4% (CI 95%,±2.0%), and for revision TKA 91.4% (CI 95%,±2.5%) and 80.5% (CI 95%,±4.5%). Common modes of failure included polyethylene wear, loosening, and infection. The most common mode of failure was polyethylene wear in primary TKA, and infection in revision TKA. The mean periods (i.e., latencies) of polyethylene wear and loosening did not differ between primary and revision TKAs, but the mean period of infection was significantly longer for revision TKA (1.2 vs. 4.8 years, P=0.003). Survival rates decreased with time, particularly more than 10 years post-surgery, for both primary and revision TKAs. Continuous efforts are required to prevent and detect the various modes of failure during long-term follow-up. Greater attention is necessary to detect late infection-induced failure following revision TKA. Case-control study, Level III. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Implant Failure After Motec Wrist Joint Prosthesis Due to Failure of Ball and Socket-Type Articulation-Two Patients With Adverse Reaction to Metal Debris and Polyether Ether Ketone.

PubMed

Karjalainen, Teemu; Pamilo, Konsta; Reito, Aleksi

2018-04-21

We describe 2 cases of articulation-related failures resulting in revision surgery after a Motec total wrist arthroplasty: one with an adverse reaction to metal debris and the other with an adverse reaction to polyether ether ketone. In the first patient, blood cobalt and chrome levels were elevated and magnetic resonance imaging showed clear signs of a pseudotumor. The other patient had an extensive release of polyether ether ketone particles into the surrounding synovia due to adverse wear conditions in the cup, leading to the formation of a fluid-filled cyst sac with a black lining and diffuse lymphocyte-dominated inflammation in the synovia. We recommend regular follow-up including x-rays, monitoring of cobalt and chrome ion levels, and a low threshold for cross-sectional imaging in patients who have undergone total wrist arthroplasty with a Motec joint prosthesis. Wear-related problems can also develop in implants in which polyether ether ketone is the bulk material. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

In vitro leakage susceptibility of tracheoesophageal shunt prostheses in the absence and presence of a biofilm.

PubMed

Oosterhof, Janine J H; van der Mei, Henny C; Busscher, Henk J; Free, Rolien H; Kaper, Hans J; van Weissenbruch, Ranny; Albers, Frans W J

2005-04-01

Although leakage through a tracheoesophageal shunt prosthesis is the main cause of prosthesis failure in a laryngectomy patient, this has never been the subject of in vitro evaluation. The aim of this study was to compare three commercially available voice prostheses by comparison of their in vitro leakage patterns, in absence or presence of a biofilm. To compare in vitro leakage patterns, a model comprised of an artificial throat equipped with a single prosthesis coupled to a water reservoir was developed. By varying the height of the water reservoir, different pressures on the voice prosthesis can be obtained. Both in absence and presence of a biofilm, the Blom Singer voice prosthesis demonstrated the lowest leakage, followed by Groningen Low Resistance. The Provox2 showed significantly the most leakage, however, in presence of a biofilm the leakage of the Provox2 significantly decreased. Regular airflow during biofilm formation significantly increased leakage through the Provox2. Out of 746 clinical replacements, Provox2 showed 76% and Groningen Low Resistance 57% replacements due to leakage. The model used in this study showed significant differences in leakage of the three types of voice prostheses used. Leakage occurred more readily through Provox2 than through Groningen Low Resistance and Blom Singer prostheses, which is in line with clinical observations and enforces the model. (c) 2005 Wiley Periodicals, Inc.

Experimental and failure analysis of the prosthetic finger joint implants

NASA Astrophysics Data System (ADS)

Naidu, Sanjiv H.

Small joint replacement arthroplasty of the hand is a well accepted surgical procedure to restore function and cosmesis in an individual with a crippled hand. Silicone elastomers have been used as prosthetic material in various small hand joints for well over three decades. Although the clinical science aspects of silicone elastomer failure are well known, the physical science aspects of prosthetic failure are scant and vague. In the following thesis, using both an animal model, and actual retrieved specimens which have failed in human service, experimental and failure analysis of silicone finger joints are presented. Fractured surfaces of retrieved silicone trapezial implants, and silicone finger joint implants were studied with both FESEM and SEM; the mode of failure for silicone trapezium is by wear polishing, whereas the finger joint implants failed either by fatigue fracture or tearing of the elastomer, or a combination of both. Thermal analysis revealed that the retrieved elastomer implants maintained its viscoelastic properties throughout the service period. In order to provide for a more functional and physiologic arthroplasty a novel finger joint (Rolamite prosthesis) is proposed using more recently developed thermoplastic polymers. The following thesis also addresses the outcome of the experimental studies of the Rolamite prosthesis in a rabbit animal model, in addition to the failure analysis of the thermoplastic polymers while in service in an in vivo synovial environment. Results of retrieved Rolamite specimens suggest that the use for thermoplastic elastomers such as block copolymer based elastomers in a synovial environment such as a mammalian joint may very well be limited.

Relationship between radiotherapy and gastroesophageal reflux disease in causing tracheoesophageal voice rehabilitation failure.

PubMed

Cocuzza, Salvatore; Bonfiglio, Marco; Chiaramonte, Rita; Serra, Agostino

2014-03-01

The objective was to analyze the association of radiotherapy with gastroesophageal reflux as determinant of fistula related pathology, in voice prosthesis patients. Retrospective study. Sixty-one laryngectomy patients were enrolled between 2005 and 2012. All patients underwent phonatory rehabilitation with voice prosthesis, along with evidence of gastroesophageal reflux disease, for which proton pump inhibitors (PPIs) were prescribed. We analyzed the occurrence of fistula-related problems among patients who received postoperative radiotherapy and those patients who did not. We observed a higher rate of failure of speech rehabilitation in laryngectomy patients with gastroesphageal reflux: this occurred when they had a history of postoperative radiotherapy (45%) compared with patients who did not (17%) (P < 0.05), although all patients were treated with PPIs. Our results seem to confirm the importance of postoperative radiotherapy with gastroesophageal reflux for the determinism of fistula-related problems. Copyright © 2014 The Voice Foundation. Published by Mosby, Inc. All rights reserved.

[Minor strut fracture of the Björk-Shiley mitral valve].

PubMed

Sugita, T; Yasuda, R; Watarida, S; Onoe, M; Tabata, R; Mori, A

1990-06-01

In May, 1982, a 49-year-old man underwent mitral valve replacement (MVR) in our hospital with a 31 mm Björk-Shiley prosthesis for mitral regurgitation. He had been doing well until his episode of palpitation and dyspnea of sudden onset, and was transferred to our ICU with severe cardiogenic shock in Aug, 1986. Chest X-ray film revealed pulmonary edema and breakage of the valve with migration of the disc and the minor strut of the prosthesis. He was operated upon 5 hours after the onset of his complaints. The minor strut was removed from the left upper pulmonary vein and mitral valve re-replacement was done with a 29 mm Björk-Shiley Monostrut valve. The disc which had dislocated into the abdominal aorta was also recovered on the twenty-third post operative day. His postoperative course was uneventful. Immediate diagnosis and subsequent re-operation is absolute indication for rescue from acute cardiac failure due to mechanical failure of any prosthetic valve.

Curved-stem Hip Resurfacing

PubMed Central

2008-01-01

Hip resurfacing is an attractive concept because it preserves rather than removes the femoral head and neck. Most early designs had high failure rates, but one unique design had a femoral stem. Because that particular device appeared to have better implant survival, this study assessed the clinical outcome and long-term survivorship of a hip resurfacing prosthesis. Four hundred forty-five patients (561 hips) were retrospectively reviewed after a minimum of 20 years’ followup or until death; 23 additional patients were lost to followup. Patients received a metal femoral prosthesis with a small curved stem. Three types of acetabular reconstructions were used: (1) cemented polyurethane; (2) metal-on-metal; and (3) polyethylene secured with cement or used as the liner of a two-piece porous-coated implant. Long-term results were favorable with the metal-on-metal combination only. The mean overall Harris hip score was 92 at 2 years of followup. None of the 121 patients (133 hips) who received metal-on-metal articulation experienced failure. The failure rate with polyurethane was 100%, and the failure rate with cemented polyethylene was 41%. Hip resurfacing with a curved-stem femoral component had a durable clinical outcome when a metal-on-metal articulation was used. Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18338217

The role of dental implant abutment design on the aesthetic outcome: preliminary 3-month post-loading results from a multicentre split-mouth randomised controlled trial comparing two different abutment designs.

PubMed

Esposito, Marco; Cardaropoli, Daniele; Gobbato, Luca; Scutellà, Fabio; Fabianelli, Andrea; Mascellani, Saverio; Delli Ficorelli, Gianluca; Mazzocco, Fabio; Sbricoli, Luca; Trullenque-Eriksson, Anna

To evaluate whether there are aesthetic and clinical benefits to using a newly designed abutment (Curvomax), over a conventional control abutment (GingiHue). A total of 49 patients, who required at least two implants, had two sites randomised according to a split-mouth design to receive one abutment of each type at seven different centres. The time of loading (immediate, early or delayed) and of prosthesis (provisional crowns of fixed prosthesis) was decided by the clinicians, but they had to restore both implants in a similar way. Provisional prostheses were replaced by definitive ones 3 months after initial loading, when the follow-up for the initial part of this study was completed. Outcome measures were: prosthesis failures, implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, and patient preference. In total, 49 Curvomax and 49 GingiHue abutments were delivered. Two patients dropped out. No implant failure, prosthesis failure or complication was reported. There were no differences at 3 months post-loading for PES (difference = -0.15, 95% CI -0.55 to 0.25; P (paired t test) = 0.443) and marginal bone level changes (difference = -0.02 mm, 95% CI -0.20 to 0.16; P (paired t test) = 0.817). The majority of the patients (30) had no preference regarding the two abutment designs; 11 patients preferred the Curvomax, while five patients preferred the GingiHue abutments (P (McNemar test) = 0.210). The preliminary results of the comparison between two different abutment designs did not disclose any statistically significant differences between the evaluated abutments. However the large number of missing radiographs and clinical pictures casts doubt on the reliability of the results. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two abutment designs. Conflict of interest statement: This research project was originally partially funded by Biomax (Andover, MA, USA), the manufacturer of the Curvomax abutments evaluated in this investigation. Biomax, under pressure from some investigators, asked to modify the original agreed protocol. In a following phase, Zimmer-Biomet (Palm Beach Gardens, Florida, USA), the manufacturer of the implants and the GingiHue abutments, took over the funding of this project. Data belonged to the authors and the sponsors did not interfere with the publication of results.

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.

Implant prostheses for convertibility, stress control, esthetics, and hygiene.

PubMed

Garfield, R E

1988-07-01

A method of connecting "fixed partial denture" prostheses to osseointegrated implant fixtures has been described. The advantages of this system of restoration for partially and fully edentulous mouths are that it is more effective in addressing the problems of (1) stress-control on abutments, (2) a back-up system for abutment failures, (3) esthetics, and (4) control of bacterial plaques around abutments. To accomplish this procedure, the application of convertible periodontal prosthesis techniques with modifications to some existing implant systems is undertaken. The disadvantages of this method seem insignificant when one considers the complexities and risks involved with the present array of implant prosthesis alternatives. Some patients and dentists might consider the necessity of the prosthesis being detachable as one disadvantage. In reality, the prosthesis can be used as a fixed restoration until the patient has fully adapted to the new proprioception and appearance. A large percentage of patients feel uncomfortable with the word "removable" because it immediately creates a perception of unsightly metallic clasp display, palatal coverage, tongue interference, and negative body image. The use of the term "detachable" coupled with the doctor's offer to perform this task for the patient "whenever necessary" will usually relieve the patient's anxiety and allow the treatment to proceed. Once neuromuscular and esthetic adaptation have occurred and the patient has accepted the prosthesis, daily detaching and home-care hygiene by the patient will follow without incident. Esthetic improvement is obvious (Fig. 3).

Total nasal reconstruction with 3D custom made porous titanium prosthesis and free thoracodorsal artery perforator flap: A case report.

PubMed

Qassemyar, Quentin; Assouly, Nathaniel; Madar, Yoni; Temam, Stéphane; Kolb, Frédéric

2018-02-21

Total nasal reconstruction is a challenging surgical procedure which usually involves a free flap, forehead flap, and cartilage grafts. In certain failure situations where patients do not accept the idea of anaplastology, possibilities become very limited. We report the case of a patient who underwent several reconstruction steps with multiple failures including free and local flaps and cartilage harvests which showed recurrent episodes of necrosis and infection leading to melting and collapse of reconstructed structures. Furthermore, the patient did not want any anaplastological rehabilitation. We proposed to the patient an innovative method that consists to print a three-dimensional custom-made porous titanium prosthesis, based on the original shape of his nose, to replace the cartilage support. This implant was first inserted in a thoracodorsal artery perforator flap for primary integration before the free transfer of the complete structure, two months later. The free transfer was successful without any complication. A stable reconstruction and satisfying result was obtained. The patient did not want additional surgical improvement 24 months post-operatively, and resumed his professional activities. The possibility of using three-dimensional custom titanium prostheses to replace the bone and cartilage support seems to be an interesting alternative for patients in the failure situation of nasal reconstruction. © 2018 Wiley Periodicals, Inc.

Tardive Dyskinesia, Oral Parafunction, and Implant-Supported Rehabilitation.

PubMed

Lumetti, S; Ghiacci, G; Macaluso, G M; Amore, M; Galli, C; Calciolari, E; Manfredi, E

2016-01-01

Oral movement disorders may lead to prosthesis and implant failure due to excessive loading. We report on an edentulous patient suffering from drug-induced tardive dyskinesia (TD) and oral parafunction (OP) rehabilitated with implant-supported screw-retained prostheses. The frequency and intensity of the movements were high, and no pharmacological intervention was possible. Moreover, the patient refused night-time splint therapy. A series of implant and prosthetic failures were experienced. Implant failures were all in the maxilla and stopped when a rigid titanium structure was placed to connect implants. Ad hoc designed studies are desirable to elucidate the mutual influence between oral movement disorders and implant-supported rehabilitation.

Tardive Dyskinesia, Oral Parafunction, and Implant-Supported Rehabilitation

PubMed Central

Amore, M.

2016-01-01

Oral movement disorders may lead to prosthesis and implant failure due to excessive loading. We report on an edentulous patient suffering from drug-induced tardive dyskinesia (TD) and oral parafunction (OP) rehabilitated with implant-supported screw-retained prostheses. The frequency and intensity of the movements were high, and no pharmacological intervention was possible. Moreover, the patient refused night-time splint therapy. A series of implant and prosthetic failures were experienced. Implant failures were all in the maxilla and stopped when a rigid titanium structure was placed to connect implants. Ad hoc designed studies are desirable to elucidate the mutual influence between oral movement disorders and implant-supported rehabilitation. PMID:28050290

Feasibility of the runt cow for in vivo testing of a spinal interbody prosthesis with preliminary results.

PubMed

Buttermann, Glenn R; Mendenhall, H Vincent

2012-04-01

The optimal lumbar spinal disc prosthesis has yet to be developed. Failures of clinical device studies may be minimized by appropriate large animal preclinical studies. The lumbar spine of the mature "runt" cow, Corrientes breed, has been shown to have a number of desirable characteristics to the human. This study assessed the feasibility of the "runt" cow for in vivo testing of human-sized lumbar interbody implants and the ability to perform common analyses of explants. Eight cows (four experimental and four controls) were compared. The experimental animals had transosseous implantation of the disc prosthesis at L4-L5, and their spines were harvested at four or six months. They were evaluated for the ease of surgical access and healing, motion segment mobility, ability to remove the implant nondestructively, and microradiography and histomorphology. All animals had successful implantation. All explantations were performed without alteration to the devices. All animals had surgical healing and intended device motion, and histology found device stability by demonstrating bone ingrowth into the device's porous plates. There was a significant 46% increase in the amount of trabecular bone adjacent to the implants. The mature runt cow allows for implantation of human-sized interbody and intrabody spinal prostheses. This animal model allowed for macro- and histological analysis of the implant and surrounding tissues. In vivo stability was demonstrated for the disc prosthesis while also allowing for evaluation of intended mobility. Additionally, this is the first study to suggest increased bone density supporting an interbody prosthesis.

Incidence of Prosthetic Complications associated with Implant-borne Prosthesis in a Sleep Disorder Center.

PubMed

Suneel, Venkatesh B; Kotian, Santhosh; Jujare, Ravikanth H; Shetty, Adarsh K; Nidhi, Sneh; Grover, Shehkar

2017-09-01

Obstructive sleep apnea (OSA) is one of the common prevalent conditions present worldwide. The process of abnormal habits related to clenching and grinding of teeth is referred to as bruxism and is characterized under the heading of parafunctional activity of the masticatory system. Osseointegrated dental implants represent advancements in the field of odontology. Despite its high success rate, failure and complications are often associated with dental implant treatment due to a number of factors. Hence, we aimed for the present study to assess the incidence of prosthetic complications in patients rehabilitated with implant-borne prosthesis in a sleep disorder unit. The present study included the assessment of all the patients who underwent prosthetic rehabilitation by dental implants. An experienced registered prosthodontist was given duty for examination of all the cases from the record file data. Prosthetic complications in the patients were identified using photographs, radiographs, and all other relevant data of the patients obtained from the record files. All types of complications and other factors were recorded separately and analyzed. While correlating the prosthetic complications in OSA patients grouped based on number of dental implants, nonsignificant results were obtained. Significant correlation was observed while comparing the prosthetic complications divided based on type of prosthesis. Fracture of the porcelain was observed in four and eight cases respectively, of screwed and cemented dental implant cases. Some amount of significant correlation existed between the incidences of prosthetic complications and OSA. Proper history of the patients undergoing dental implant procedures should be taken to avoid failure.

Reverse Shoulder Arthroplasty for the Treatment of 3 and 4- Part Fractures of the Humeral Head in the Elderly

PubMed Central

Gigis, Ioannis; Nenopoulos, Alexandros; Giannekas, Dimitrios; Heikenfeld, Roderich; Beslikas, Theodoros; Hatzokos, Ippokratis

2017-01-01

Background: Proximal humeral fractures in elderly patients present with severe comminution and osteoporotic bone quality. Reverse shoulder arthroplasty has lately been proven beneficial in treating patients with complex proximal humeral fractures. The above technique is recommended and has better results in elderly than in younger individuals. Methods: We performed a literature search in the databases Pubmed, Medline, EMBASE and Cochrane Library for published articles between 1970 and 2016 using the terms: proximal humerus fractures and reverse shoulder arthroplasty. Results: Significant benefits with the use of reverse prosthesis, especially in patients older than 70 years with a proximal humeral fracture, include reduced rehabilitation time as well as conservation of a fixed fulcrum for deltoid action in case of rotator cuff failure. Compared with hemiarthroplasty and internal fixation, reverse prosthesis may be particularly useful and give superior outcomes in older patients, due to comminuted fractures in osteopenic bones. However, significant disadvantages of this technique are potential complications and a demanding learning curve.Therefore, trained surgeons should follow specific indications when applying the particular treatment of proximal humeral fractures and be familiar with the surgical technique. Conclusion: Although long-term results and randomized studies for reverse prosthesis are lacking, short and mid- term outcomes have given promising results encouraging more shoulder surgeons to use this type of prosthesis in proximal humeral fractures. PMID:28400879

Temporary implant-supported prosthesis for immediate loading according to a chair-side concept: technical note and results from 37 consecutive cases.

PubMed

Ostman, Pär-Olov; Hellman, Mats; Sennerby, Lars; Wennerberg, Ann

2008-05-01

During the last years, focus has been paid to implant treatment using immediate function protocols, and different approaches to provide patients with temporary constructions have been presented. Most of these techniques involve dental technicians producing the temporary construction, for example, rebuilding existing dentures, acrylic bridges, etc. The purpose of this prospective clinical study was to evaluate the clinical outcome of a chair-side technique of a cost-effective temporary prosthesis. Fixture survival rate and risk of temporary bridge failure were analyzed. Thirty-seven partially or totally edentate patients (18 female and 19 male; mean age: 66.7 years) treated with chair-side manufactured temporary restorations (QuickBridge, BIOMET 3i, Palm Beach, Fl, USA) for immediate loading have been evaluated. The prostheses extended from two unit bridges supported by two implants to full-arch construction supported by six implants. The temporary prostheses were monitored from the day of surgery and delivery to the time of replacement with a permanent prosthetic construction 3 to 6 months later. No implants were lost during the observation time. One (3%) temporary prosthesis fractured and additional two (6%) loosened during the follow-up time. The study indicated that the tested chair-side concept for manufacturing of temporary prosthesis for immediate loading of dental implants is a viable approach.

Technical complications of implant-causes and management: A comprehensive review

PubMed Central

Gupta, Swati; Gupta, Hemant; Tandan, Amrit

2015-01-01

Given the increasing popularity of dental implants, the number of failures due to late implant fracture is also expected to increase. Hence, the scope for prevention and management needs to be emphasized. The objective of this review article is to analyze the various causes of failure of dental implants due to implant fixture/abutment screw fractures and also to enumerate the management and the preventive options for these failures, thereby aiming to help the clinicians to properly plan the implant-supported prosthesis treatment by considering the important biomechanical aspects of this type of rehabilitation. The present review emphasizes the causes and management of technical complications and not the incidence of such complications. PMID:26668445

Long-Term Survival of Dental Implants with Different Prosthetic Loading Times in Healthy Patients: A 5-Year Retrospective Clinical Study.

PubMed

Muelas-Jiménez, M Isabel; Olmedo-Gaya, Maria Victoria; Manzano-Moreno, Francisco J; Reyes-Botella, Candela; Vallecillo-Capilla, Manuel

2017-02-01

To compare survival rates among dental implants restored with immediate, early, and conventional loading protocols, also comparing between maxillary and mandibular implants, and to evaluate the influence of implant length and diameter and the type of prosthesis on treatment outcomes. This retrospective cohort study initially included all 52 patients receiving dental implants between July 2006 and February 2008 at a private oral surgery clinic in Granada (Southern Spain). Clinical and radiographic examinations were performed, including periapical or panoramic radiographs, and incidences during completion of the restoration were recorded at 1 week, 3 months, 6 months, and at 1, 2, 3, 4, and 5 years. After a 5-year follow-up, 1 patient had died, 3 were lost to follow-up, and 6 required grafting before implant placement; therefore, the final study sample comprised 42 patients with 164 implants. Variables associated with the survival/failure of the restoration were: number of implants (higher failure rate with fewer implants), bone type (higher failure rate in type III or IV bone), and type of prosthesis (higher failure rate with single crowns). No significant association was found in univariate or multivariate analyses between survival rate and the loading protocol, implant length or diameter, or maxillary/mandibular location. Immediate occlusal loading, immediate provisionalization without occlusal loading, and early loading are viable treatment options with similar survival rates to those obtained with conventional loading. Bone quality and number of implants per patient were the most influential factors. © 2015 by the American College of Prosthodontists.

Multidisciplinary team approach to residual limb lengthening using the Ilizarov technique: A case study.

PubMed

Savage, Zoliakha; Munjal, Ramesh

2015-10-01

A 47-year-old male suffered a traumatic transtibial amputation; initial limb use was unsuccessful and the short tibial length was thought to be the cause of failure. The patient underwent gradual tibia lengthening using the Ilizarov technique and utilised a weight-bearing prosthesis to expedite bone growth and repair. The patient is now able to use his prosthesis successfully without aids. This case study demonstrates that combining a scientifically based surgical technique with a tailored rehabilitation approach had an improved outcome for the patient. This study reports one case where tibial lengthening using the Ilizarov technique combined with a collaborative team approach has enabled a patient to return to successful prosthetic limb use. © The International Society for Prosthetics and Orthotics 2014.

Transapical tricuspid valve-in-ring implantation: An alternative approach to a challenging clinical scenario.

PubMed

Girdauskas, Evaldas; Lauer, Bernward; Kuntze, Thomas

2018-04-01

We report on a transapical tricuspid valve-in-ring implantation performed via right ventricular apex using the Sapien-XT-prosthesis. A 57-year-old woman with recurrent episodes of right heart failure and three previous sternotomies, including tricuspid valve repair with a 32 mm Carpentier-Edwards-Classic annuloplasty ring was admitted due to recurrent severe tricuspid regurgitation. Given the excessive surgical risk, a 29 mm Sapien-XT-prosthesis was selected for valve-in-ring implantation. Transapical valve-in-ring implantation procedure was uneventful. Predischarge echocardiography showed only trace paravalvular tricuspid regurgitation in the septal region. Transapical approach via right ventricular apex is a viable alternative for tricuspid valve-in-ring implantation in selected high-risk patients. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

[Surgical silicone prostheses in the treatment of biliary tract cancers: long prostheses or short prostheses? Results apropos of 500 cases].

PubMed

Kron, B

1992-10-01

The interest of surgical prostheses in the palliative treatment of biliary tract cancer is well established, on the basis of their good tolerance, the more than 15 year follow up experience and the number of patients operated upon. After exeresis, they allow re-establishment of continuity, either by use of a prosthesis in Y when the right and let ducts can be dissected, or by using two prostheses, a multiperforated long prosthesis reimplanted in the duodenum and a short prosthesis reimplanted in the common bile duct without attaining the sphincter of Oddi. Of the 1000 cases treated, 500 were the object of a statistical analysis, 46 being operated upon by the author, in 60% of cases for biliary tract cancer, either primary or as an extension from the gallbladder. One-third of the patients had advanced lesions and a short survival of less than 3 months. Two-thirds a median survival of 9 months. In 10%, a radical exeresis was performed with survival of more than one year without recurrence of jaundice. Failure of treatment with persistence of jaundice was due to advanced disease for which surgery is unsatisfactory. Essential complications were premature bile leaks (5%) without serious consequences if sufficient drainage was maintained, since it stopped spontaneously, and angiocholitis (6%), the result of territory exclusion or reflux. Recurrence of jaundice was related to extension of the neoplasm to the secondary bile ducts, and to hepatic metastases. Obstruction of the prosthesis before two months was rare (6%) and was preceded by angiocholitis. In the absence of recurrence of the cancer the prosthesis can be replaced surgically without difficulty.

A study to assess whether fixed-width beam walking provides sufficient challenge to assess balance ability across lower limb prosthesis users.

PubMed

Sawers, Andrew; Hafner, Brian J

2018-04-01

To evaluate the feasibility of fixed-width beam walking for assessing balance in lower limb prosthesis users. Cross-sectional. Laboratory. Lower limb prosthesis users. Participants attempted 10 walking trials on three fixed-width beams (18.6, 8.60, and 4.01 wide; 5.5 m long; 3.8 cm high). Beam-walking performance was quantified using the distance walked to balance failure. Heuristic rules applied to each participant's beam-walking distance to classify each beam as "too easy," "too hard," or "appropriately challenging" and determine whether any single beam provided an appropriate challenge to all participants. The number of trials needed to achieve stable beam-walking performance was quantified for appropriately challenging beams by identifying the last inflection point in the slope of each participant's trial-by-trial cumulative performance record. In all, 30 unilateral lower limb prosthesis users participated in the study. Each of the fixed-width beams was either too easy or too hard for at least 33% of the sample. Thus, no single beam was appropriately challenging for all participants. Beam-walking performance was stable by trial 8 for all participants and by trial 6 for 90% of participants. There was no significant difference in the number of trials needed to achieve stable performance among beams ( P = 0.74). Results suggest that a clinical beam-walking test would require multiple beams to evaluate balance across a range of lower limb prosthesis users, emphasizing the need for adaptive or progressively challenging balance tests. While the administrative burden of a multiple-beam balance test may limit clinical feasibility, alternatives to ease this administrative burden are proposed.

Candida periprosthetic joint infection: A rare and difficult-to-treat infection.

PubMed

Escolà-Vergé, Laura; Rodríguez-Pardo, Dolors; Lora-Tamayo, Jaime; Morata, Laura; Murillo, Oscar; Vilchez, Helem; Sorli, Luisa; Carrión, Laura Guío; Barbero, José Mª; Palomino-Nicás, Julián; Bahamonde, Alberto; Jover-Sáenz, Alfredo; Benito, Natividad; Escudero, Rosa; Sampedro, Marta Fernandez; Vidal, Rafael Pérez; Gómez, Lucía; Corona, Pablo S; Almirante, Benito; Ariza, Javier; Pigrau, Carles

2018-05-08

Candida periprosthetic joint infection (CPJI) is a rare, difficult-to-treat disease. The purpose of this study was to evaluate the clinical characteristics and outcomes of CPJI treated with various surgical and antifungal strategies. We conducted a multicenter retrospective study of all CPJI diagnosed between 2003 and 2015 in 16 Spanish hospitals. Forty-three patients included: median age, 75 years, and median Charlson Comorbidity Index score, 4. Thirty-four (79.1%) patients had ≥1 risk factor for Candida infection. Most common causative species were C. albicans and C. parapsilosis. Thirty-five patients were evaluable for outcome: overall, treatment succeeded in 17 (48.6%) and failed in 18 (51.4%). Success was 13/20 (67%) in patients with prosthesis removal and 4/15 (27%) with debridement and prosthesis retention (p = 0.041). All 3 patients who received an amphotericin B-impregnated cement spacer cured. In the prosthesis removal group, success was 5/6 (83%) with an antibiofilm regimen and 8/13 (62%) with azoles (p = 0.605). In the debridement and prosthesis retention group, success was 3/10 (30%) with azoles and 1/5 (20%) with antibiofilm agents. Therapeutic failure was due to relapse in 9 patients, need for suppressive treatment in 5, persistent infection in 2, and CPJI-related death in 2; overall attributable mortality was 6%. CPJI is usually a chronic disease in patients with comorbidities and risk factors for Candida infection. Treatment success is low, and prosthesis removal improves outcome. Although there is insufficient evidence that use of antifungals with antibiofilm activity has additional benefits, our experience indicates it may be recommendable. Copyright © 2018 Elsevier Ltd. All rights reserved.

Good quality of life outcomes after treatment of prosthetic joint infection with debridement and prosthesis retention.

PubMed

Aboltins, Craig; Dowsey, Michelle; Peel, Trish; Lim, Wen K; Choong, Peter

2016-05-01

Patients treated for early prosthetic joint infection (PJI) with surgical debridement and prosthesis retention 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 prosthetic joint infection treatment that may influence management decisions, such as quality of life (QOL). Our aim was to describe infection cure rates and quality of life for patients with prosthetic joint infection treated with debridement and prosthesis retention and to determine if treatment with this approach was a risk factor for poor quality of life outcomes. Prospectively collected pre and post-arthroplasty data were available for 2,134 patients, of which PJI occurred in 41. For patients treated for prosthetic joint infection, the 2-year survival free of treatment failure was 87% (95%CI 84-89). Prosthetic joint infection cases treated with debridement and retention had a similar improvement from pre-arthroplasty to 12-months post-arthroplasty as patients without PJI in QOL according to the SF-12 survey. Prosthetic joint infection treated with debridement and retention was not a risk factor for poor quality of life on univariate or multivariate analysis. Prosthetic joint infection treated with debridement and prosthesis retention results in good cure rates and quality of life. Further studies are required that directly compare quality of life for different surgical approaches for prosthetic joint infection to better inform management decisions. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:898-902, 2016. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

Björk-Shiley strut fracture and disc escape: literature review and a method of disc retrieval.

PubMed

Hendel, P N

1989-03-01

Embolization of a prosthetic valve poppet is a rare but life-threatening event. It was reported sporadically before the introduction of the Björk-Shiley 70-degree convexoconcave prosthesis in 1980. Since that time, there have been a large number of reported mechanical failures with disc escape. The rate for the 29-mm to 33-mm mitral valves is estimated as 5.2%. In 29 of 35 patients (including the 2 presented here) in whom the site of disc lodgment could be determined, the disc was in the descending or abdominal aorta. Fifteen of these patients died. Six survivors had the disc removed at the same operation and 6 at a later operation. In 2 patients, the disc was not removed. In 2 patients in whom the disc was not removed initially, it was thought to contribute to postoperative complications. Two more cases of structural failure of the Björk-Shiley convexoconcave prosthesis are presented. A transpericardial approach to the descending aorta on bypass is described. It allows easy removal of the disc and eliminates the need for a second operation.

Clinical and Radiographic Assessment of Reasons for Replacement of Metal- Ceramic Fixed Dental Prostheses in Patients Referring to Dental School.

PubMed

Al Refai, Roa'a; Saker, Samah

2018-01-01

The expected length of service and reasons for fixed dental prostheses (FDPs) replacement are a frequent inquiry by patients while the answers were mainly based on studies reports that was conducted outside the middle east region. This clinical and radiographic survey was constructed to assess and survey clinically and radiographically the reasons of replacement of metal-ceramic fixed dental prostheses, amongst patients reporting at dental school in Taibah University. Between January and May 2016, 151 patients were recruited for this study. Interview (include questions pertained to the length of service of the prosthesis, the nature of complaint as told by patient in her own words), clinical examination, intra-oral photographs, and periapical radiographs, were done by the researchers. The parameters assessed were secondary caries, open margins, loss of retention, failure of endodontic treatment of the abutment and periodontal diseases. A total number of 249 failed fixed dental prostheses were evaluated. Of which 180 (39.7%) were single crowns, 159 (35.0%) were retainers and 117 (25.8%) were pontics in 69 fixed partial denture. The most common reason for replacement of fixed restorations was periodontal diseases affecting 92.8% of all types' restorations, followed by defective margin in 90.4% of examined restoration, poor aesthetic in 88% of restorations, while periapical involvement was found in 85.5% of fixed dental prosthesis. The survival rates of fixed prostheses were not predictable, and no association was found between number of years in service and the number of restorations. The most common reasons for replacing single unit fixed dental prostheses are periodontal diseases and periapical involvement, while defective margins and poor aesthetic mainly associated with multi-unit fixed dental prostheses. Key words: Failure, Fixed dental prosthesis, Survival, Replacement.

[Supramacroparticulate polyethylene in inflammation of synovial-like interface membranes: Characterization and suggested nomenclature].

PubMed

Krenn, V; Hopf, F; Thomas, P; Thomsen, M; Usbeck, S; Boettner, F; Müller, S; Saberi, D; Hügle, T; Huber, M; Scheuber, L; Hopf, J C; Kretzer, J P

2016-03-01

The identification of particles of prosthesis material components in the histopathological diagnosis of synovialitis is of great importance in the evaluation of implant failure. In histopathological particle algorithms, polyethylene (PE) particles with a maximum length of less than 100 µm are designated with the term macroparticles; however, a systematic investigation and characterization are lacking. In SLIM knee specimens (n = 24) a minimum value of 210 µm and a maximum value of 2100 µm were measured; the mathematical mean length varied between 235 µm and 1416 µm. In SLIM hip specimens (n = 11) the minimum value was 290 µm and the maximum value was 1806 µm; the mean length varied between 353 and 1726 µm. Because of this conspicuous size, and to distinguish from PE macroparticles, the designation PE supra-macroparticulate is suggested. This new terminology acknowledges the fact that these PE particles are visible under magnification (e.g., × 12.5) and also macroscopically. The particles were also indirectly proven as there were completely separate and optically clear, column-shaped cavities corresponding to the shape of the PE particles (PE vacuoles). The life of the prosthesis is highly variable at between 12 and 300 months. In all cases loosening of the prosthesis, misalignment of the PE components, and/or damage to the PE inlay occurred. The cause and existence of these supra-macroparticulate PE particles (more than 100 µm) is still unclear. A mechanical malfunction seems probable and should be discussed. In prostheses with short lives the proof of supra-macroparticulate PE in SLIM could be a sign of an early mechanical problem. In the wider histopathological particle algorithm supra-macroparticulate PE was considered to fall in the category of macroparticles and should be considered in the histopathological diagnosis of implant failure.

First metatarsophalangeal joint replacement with modular three-component press-fit implant. Preliminary report.

PubMed

Kolodziej, L; Bohatyrewicz, A; Zietek, P

2013-01-01

The aim of this retrospective study was to assess functional and radiographic results of the first metatarsophalangeal joint replacement with use of unconstrained, modular, three components, porous titanium and hydroxyapatite coated, press-fit METIS® prosthesis. According to author's knowledge, results of that type of prosthesis have never been published before. 25 prosthesis were implanted in 24 patients between February 2009 and May 2011. American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal Interphalangeal scoring system (AOFAS-HMI) was used to assess functional results. Patients were also asked if they would undergo procedure again or recommend it to other people. Weight bearing radiographs ware made at final follow up and analyzed for presence of osteolysis and radiolucencies. In 8 patients total joint replacement was introduced as a salvage after failure of previous surgery like Keller resection arthroplasty, failed arthrodesis, avascular necrosis and postoperative arthritis. In 11 patients the reason for prosthetic replacement were hallux rigidus, in 4 cases rheumatoid arthritis and gout in one patient. In two patients additional procedures like Akin phalangeal osteotomy and in one case fifth metatarsal osteotomy, was performed. There were 20 females and 4 males in presented group. The mean age at the operation was 56 years. The average follow up period was 18 months (from 12 to 36 months). The median postoperative value of AOFAS-HMI scores was 88 points (from 75 to 95 points). First metatarsophalangeal joint motion (dorsiflexion plus plantarflexion) was classified according to AOFAS-HMI ranges as: moderately restricted (between 30 to 70 degrees) in 19 patients 80% (20 prosthesis) and severely restricted (less then 30 degrees) in 5 patients (20%). 15 (64%) patients were completely satisfied, 5 (20%) reported moderate satisfaction and (16%) 4 were totally disappointed and would not undergo this procedure again. A limited hallux dorsiflexion was the main dissatisfaction reason. Partial radiolucent line was seen in one patient (4%). Authors noticed two serious complications. In one patient, with rheumatoid arthritis, deep infection occurred 12 months after prosthesis implantation. In second case phalangeal implant was revised due to misalignment. METIS® metatarsophalangeal joint replacement allows alleviate of pain relating to hallux rigidus and partial restoration of joint movement, even in patients after failures of primary metatarsophalangeal joint surgery. AOFAS-HMI results are better than previously reported in the literature in assessment of the first metatarsophalangeal joint replacement. Radiographic results imply satisfactory bone ingrowth into the cementless implants.

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.

Natural Tooth Pontic: An Instant Esthetic Option for Periodontally Compromised Teeth—A Case Series

PubMed Central

Raj, Rishi; Narayan, Ipshita; Gowda, Triveni Mavinakote; Mehta, D. S.

2016-01-01

Sudden tooth loss in the esthetic zone of the maxillary or mandibular anterior region can be due to trauma, periodontal disease, or endodontic failure. The treatment options for replacing the missing tooth can vary between removable prosthesis, tooth-supported prosthesis, and implant-supported prosthesis. Irrespective of the final treatment, the first line of management would be to provisionally restore the patient's esthetic appearance at the earliest, while functionally stabilizing the compromised arch. Using the patient's own natural tooth as a pontic offers the benefits of being the right size, shape, and color and provides exact repositioning in its original intraoral three-dimensional position. Additionally, using the patient's platelet concentrate (platelet rich fibrin) facilitates early wound healing and preservation of alveolar ridge shape following tooth extraction. The abutment teeth can also be preserved with minimal or no preparation, thus keeping the technique reversible, and can be completed at the chair side thereby avoiding laboratory costs. This helps the patient better tolerate the effect of tooth loss psychologically. The article describes a successful, immediate, and viable technique for rehabilitation of three different patients requiring replacement of a single periodontally compromised tooth in an esthetic region. PMID:27994892

Early failure mechanisms of constrained tripolar acetabular sockets used in revision total hip arthroplasty.

PubMed

Cooke, Christopher C; Hozack, William; Lavernia, Carlos; Sharkey, Peter; Shastri, Shani; Rothman, Richard H

2003-10-01

Fifty-eight patients received an Osteonics constrained acetabular implant for recurrent instability (46), girdlestone reimplant (8), correction of leg lengthening (3), and periprosthetic fracture (1). The constrained liner was inserted into a cementless shell (49), cemented into a pre-existing cementless shell (6), cemented into a cage (2), and cemented directly into the acetabular bone (1). Eight patients (13.8%) required reoperation for failure of the constrained implant. Type I failure (bone-prosthesis interface) occurred in 3 cases. Two cementless shells became loose, and in 1 patient, the constrained liner was cemented into an acetabular cage, which then failed by pivoting laterally about the superior fixation screws. Type II failure (liner locking mechanism) occurred in 2 cases. Type III failure (femoral head locking mechanism) occurred in 3 patients. Seven of the 8 failures occurred in patients with recurrent instability. Constrained liners are an effective method for treatment during revision total hip arthroplasty but should be used in select cases only.

Leaflet escape in a new bileaflet mechanical valve: TRI technologies.

PubMed

Bottio, Tomaso; Casarotto, Dino; Thiene, Gaetano; Caprili, Luca; Angelini, Annalisa; Gerosa, Gino

2003-05-13

Leaflet escape is a mode of structural valve failure for mechanical prostheses. This complication previously has been reported for both monoleaflet and bileaflet valve models. We report 2 leaflet escape occurrences observed in 2 patients who underwent valve replacement with a TRI Technologies valve prosthesis. At the University of Padua, between November 2000 and February 2002, 36 TRI Technologies valve prostheses (26 aortic and 10 mitral) were implanted in 34 patients (12 women and 22 men) with a mean age of 59.9+/-10.3 years (range, 30 to 75 years). There were 5 deaths: 3 in hospital, 1 early after discharge, and 1 late. Two patients experienced a catastrophic prosthetic leaflet escape; the first patient was a 52-year-old man who died 10 days after aortic valve and ascending aorta replacement, and the second was a 58-year-old man who underwent a successful emergency reoperation 20 months after mitral valve replacement. Examination of the explanted prostheses showed in both cases a leaflet escape caused by a leaflet's pivoting system fracture. Prophylactic replacement was then successfully accomplished so far in 12 patients, without evidence of structural valve failure in any of them. Among other significant postoperative complications, we observed 3 major thromboembolisms, 1 hemorrhage, and 1 paravalvular leak. These catastrophes prompted us to interrupt the implantation program, and they cast a shadow on the durability of the TRI Technologies valve prosthesis because of its high risk of structural failure.

Usefulness of magnetic resonance imaging in the postsurgical assessment of patients with inflatable penile prostheses.

PubMed

Pacheco Usmayo, A; Torregrosa Andrés, A; Flores Méndez, J; Luján Marco, S; Rogel Bertó, R

To describe the types of penile prostheses and their components, to review the appropriate magnetic resonance imaging (MRI) acquisition protocol, and to describe the normal imaging findings and possible complications in patients with inflatable penile implants. Three-piece inflatable penile prostheses are the last link in the treatment chain for erectile dysfunction. They can develop complications, which are classified as non-infectious related to the surgical technique, infectious, or due to mechanical failure of the device. MRI is the most appropriate imaging technique for the postsurgical evaluation of penile prostheses. Images are acquired in three planes using sequences with high spatial resolution, first with the prosthesis at rest and then with the prosthesis activated. Copyright © 2017 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

PubMed

Gulino, Simona; Barbanti, Marco; Deste, Wanda; Immè, Sebastiano; Aruta, Patrizia; Bottari, Vera; Benvenuto, Emanuele; Tamburino, Claudia; Di Landro, Alessio; Liberto, Daria; Santonoceto, Letizia; Sicuso, Rita; Di Stefano, Daniele; Todaro, Denise; Di Simone, Emanuela; Indelicato, Antonino; Giannazzo, Daniela; Sgroi, Carmelo; Tamburino, Corrado

2016-10-10

Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Evaluation of the onset of failure under mechanical and thermal stresses on luting agent for metal–ceramic and metal crowns by finite element analysis

PubMed Central

Agnihotri, Hema; Bhatnagar, Naresh; Rao, G. Venugopal; Jain, Veena; Parkash, Hari; Kar, Aswini Kumar

2010-01-01

Long-term clinical failures of cemented prosthesis depend, to a large extent, on the integrity of the luting agent. The causative factors that lead to microfracture and, hence, failure of the luting agents are the stresses acting inside the oral cavity. Therefore, the present study was designed to develop an understanding of the relationship between stresses in the tooth and the failure potential of the luting agent. Two-dimensional finite element stress analysis was performed on the mandibular second premolar. The behavior of zinc-phosphate and glass-ionomer were studied under different crowns (metal–ceramic and metal crown) and loading conditions (mechanical force of 450 N acting vertically over the occlusal surface, thermal loads of 60° and 0°C). It was observed from the study that failure threshold of the luting agent was influenced both by the elastic modulus of the luting agent and by the type of the crown. PMID:22114426

[Application of a tape-like bandage for the ascending aorta in its poststenotic dilation and correction of the aortal valve stenosis].

PubMed

Popov, V V; Bol'shak, A A

2014-06-01

The aortal valve prosthesis in combination with a tape-like bandage of ascending aorta application was performed in 106 patients, suffering a failure with predominance of the aortal valve stenosis in conjunction with the ascending aorta poststenotic dilation, in a 2005 - 2014 yrs period in the clinic. The hospital lethality have constituted 0.9%. In accordance to echocardiography, the ascending aorta diameter preoperatively have constituted (48.7 +/- 1.4) mm at average, before discharge from the hospital--(40.1 +/- 1.2) mm, in late follow-up period--(41.3 +/- 1.2) mm. It is expedient to recommend the original method of a tape-like bandage of ascending aorta from the base of noncoronary sinus in the aortal sinuses dilation (45 mm and more) in combination with the aortal valve prosthesis in poststenotic dilation of ascending aorta.

Complete denture base assessments using holograms: dimensional alterations after different activation methods

NASA Astrophysics Data System (ADS)

Dughir, Ciprian; Popovschi, Ana Maria; Cojocariu, Andreea Codruta; Topala, Florin Ionel; Negrutiu, Meda Lavinia; Sinescu, Cosmin; de Sabata, Aldo; Duma, Virgil-Florin

2016-03-01

Holography is a well-developed method with a large range of applications, including dentistry. This study uses holographic methods for the study of total dental prosthesis. The issue is that the transformation of wax denture base in polymethylacrylate causes dimensional alterations and retractions in the final dental constructs. These could cause the failure of the stability of the complete denture in the oral cavity. Thus, the aim of this study is to determine and to compare using holography, total prosthesis obtained using three different manufacturing methods: pressing, injection, and polymerization. Each of the three types of dentures thus produced were recorded over the previously wax complete base holographic plates. The dimensional alterations that appear after using the different activation methods were thus determined. The most significant modification was remarked in the custom press technology, while the smallest variations were detected in the injection alternative.

Bar versus ball attachments for implant-supported overdentures in complete edentulism: A systematic review.

PubMed

Anas El-Wegoud, Marwah; Fayyad, Ahmed; Kaddah, Amal; Nabhan, Ashraf

2018-04-01

Implant-supported overdenture is one of the most predictable treatment options used in complete edentulism. However, differences have been reported between bar and ball attachments used to retain overdentures in terms of patient satisfaction and prosthesis retention. The purpose of this study is to compare the effectiveness of bar and ball attachments for conventionally loaded implant-supported overdentures in completely edentulous patients to improve patient satisfaction and prosthesis retention. We conducted the review according to the Cochrane methods and following MECIR standards. We searched Cochrane Oral Health Group Trial register, Cochrane Central Register of Controlled Trials, MEDLINE, and the WHO ICTRP (March 31, 2017). Two review authors assessed trials for inclusion and risk of bias, extracted data, and checked for accuracy. We have expressed results as risk ratio or mean differences, together with their 95% confidence intervals. We included 10 trials (465 participants). After 5 y, one trial reported higher patient satisfaction when bar attachment was used (MD 1.30, 95% CI 0.20-2.40), and reported no difference between both systems in prosthesis retention (MD -0.90, 95% CI -1.90 to 0.10). Two trials reported no implant failures after 1 and 5 y in both attachments. Downgrading of evidence was based on the unclear risk of bias of included studies and the wide CI crossing the line of no effect. There is insufficient evidence to support bar or ball attachment to be used with implant-supported overdentures in completely edentulous patients to improve patient satisfaction and prosthesis retention (PROSPERO 2014:CRD42014014594). © 2017 Wiley Periodicals, Inc.

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

Immediate two-stage prosthetic breast reconstruction failure: radiation is not the only culprit.

PubMed

Lam, Thomas C; Borotkanics, Robert; Hsieh, Frank; Salinas, James; Boyages, John

2018-03-15

Immediate prosthetic breast reconstruction produces a satisfactory aesthetic result with high levels of patient satisfaction. However, with the broader indication for post-mastectomy adjuvant radiation, many patients are advised against immediate breast reconstruction because of concerns of implant loss and infection particularly as most patients also require chemotherapy. This retrospective cohort study examines outcomes for patients who underwent immediate two-stage prosthetic breast reconstruction after mastectomy with or without adjuvant chemotherapy or radiotherapy (RT). Between 1998 and 2010, 452 patients undergoing two-stage prosthetic immediate breast reconstruction involving a total of 562 breasts were included in this study. Stage one was defined as insertion of the temporary expander and stage two insertion of the final silicone implant. Post-operative adjuvant radiotherapy was recommended with tissue expander in-situ for 114 patients. Complications, including loss of prosthesis, seroma and infection were recorded and analysed. Cosmetic result was assessed using a 4-point scale. Post-operative prosthesis loss was 2.7%, 5.3% for patients undergoing adjuvant chemotherapy increasing to 11.3% for patients receiving chemotherapy+RT. Chemotherapy and radiotherapy independently were the main, statistically significant, risk factors for expander or implant loss; IRR: 13.85 (p=0.012) and 2.23 (p=0.027), respectively. Prosthesis loss for patients undergoing combination chemotherapy+RT was also significant; IRR: 4.791 (p<0.001). These findings serve to better inform patients on risk in weighing treatment options. Post-mastectomy radiation doubles the risk of prosthesis loss over and above adjuvant chemotherapy but is an acceptable option following immediate prosthetic breast reconstruction in a multidisciplinary setting.

A Multi-channel Semicircular Canal Neural Prosthesis Using Electrical Stimulation to Restore 3D Vestibular Sensation

PubMed Central

Della Santina, Charles C.; Migliaccio, Americo A.; Patel, Amit H.

2009-01-01

Bilateral loss of vestibular sensation can be disabling. Those afflicted suffer illusory visual field movement during head movements, chronic disequilibrium and postural instability due to failure of vestibulo-ocular and vestibulo-spinal reflexes. A neural prosthesis that emulates the normal transduction of head rotation by semicircular canals could significantly improve quality of life for these patients. Like the 3 semicircular canals in a normal ear, such a device should at least transduce 3 orthogonal (or linearly separable) components of head rotation into activity on corresponding ampullary branches of the vestibular nerve. We describe the design, circuit performance and in vivo application of a head-mounted, semi-implantable multi-channel vestibular prosthesis that encodes head movement in 3 dimensions as pulse-frequency-modulated electrical stimulation of 3 or more ampullary nerves. In chinchillas treated with intratympanic gentamicin to ablate vestibular sensation bilaterally, prosthetic stimuli elicited a partly compensatory angular vestibulo-ocular reflex in multiple planes. Minimizing misalignment between the axis of eye and head rotation, apparently caused by current spread beyond each electrode’s targeted nerve branch, emerged as a key challenge. Increasing stimulation selectivity via improvements in electrode design, surgical technique and stimulus protocol will likely be required to restore AVOR function over the full range of normal behavior. PMID:17554821

The AES total ankle arthroplasty analysis of failures and survivorship at ten years.

PubMed

Di Iorio, Alexandre; Viste, Anthony; Fessy, Michel Henry; Besse, Jean Luc

2017-12-01

AES mobile-bearing total ankle replacement was developed from the Buechel Pappas model. It was withdrawn in 2009, after identification of a higher than expected complication rate. The purpose of the current study was to analyse clinical outcomes, failures and survival of the initial series of 50 AES published in 2009. In this single-centre continuous prospective study (2003-2006), 50 AES prostheses were included. Pre-operative osteoarthritis was mainly post-traumatic (50%) and secondary to instability (36%). All patients were assessed with clinical and radiographic follow-up at six months, one year, two years and every two to three years thereafter. A CT-scan was systematically performed before procedure, and at two years, five years and ten years. At last follow-up, all patients with TAR had a functional (SF 36, AOFAS) and clinical assessment. All complications or surgical events were analysed. The mean follow-up was ten ± two years (range, 9-13). The mean AOFAS score was 75 points (range, 26-100). The mean SF 36 score was 69 points (range, 35-97). There was a significant deterioration in AOFAS score at five years and at last follow-up (p < 0.05). Fifteen TARs underwent reoperation for cyst curettage-graft because of development of periprosthetic lesions. Six of them ended up with prosthesis removal-arthrodesis. At the last follow-up, 14 TARs were removed for arthrodesis. Of the 30 prostheses seen at last follow-up, four are awaiting prosthesis removal-arthrodesis and one for cyst curettage-graft. The ten year survivorships free of any prosthesis removal or arthrodesis and free of any reoperation were 68% (95% CI, 55-85) and 57% (95% CI, 44-74), respectively. Our data suggested a high rate of reoperation. Overall ten year survival was lower than with other designs, particularly due to cyst lesions. Level IV, prospective case series.

Evaluation of metal-polymeric fixed partial prosthesis using optical coherence tomography

NASA Astrophysics Data System (ADS)

Sinescu, C.; Negrutiu, M. L.; Duma, V. F.; Marcauteanu, C.; Topala, F. I.; Rominu, M.; Bradu, A.; Podoleanu, A. Gh.

2013-11-01

Metal-Polymeric fixed partial prosthesis is the usual prosthetic treatment for many dental patients. However, during the mastication the polymeric component of the prosthesis is fractured and will be lost. This fracture is caused by the material defects or by the fracture lines trapped inside the esthetic components of the prosthesis. This will finally lead to the failure of the prosthetic treatment. Nowadays, there is no method of identification and forecast for the materials defects of the polymeric materials. The aim of this paper is to demonstrate the capability of Optical Coherence Tomography (OCT) as a non-invasive clinical method that can be used for the evaluation of metal-polymeric fixed partial prostheses. Twenty metal-polymeric fixed partial prostheses were used for this study. The esthetic component of the prostheses has been Adoro (Ivoclar). Optical investigations of the metal prostheses have revealed no material defects or fracture lines. All the prostheses were temporary cemented in the oral cavities of the patients for six month. The non-invasive method used for the investigations was OCT working in Time Domain mode at 1300 nm. The evaluations of the prostheses were performed before and after their cementation in the patient mouths. All the imagistic results were performed in 2D and than in 3D, after the reconstruction. The results obtained after the OCT evaluation allowed for the identification of 4 metal-polymeric fixed partial prostheses with material defects immediately after finishing the technological procedures. After 6 month in the oral environment other 3 fixed partial prostheses revealed fracture lines. In conclusion, OCT proved to be a valuable tool for the noninvasive evaluation of the metal-polymeric fixed partial prostheses.

Tubing erosion of an inflatable penile prosthesis long after implantation.

PubMed

Morales, Alvaro

2014-06-01

Erosion through skin of connecting tubing of an inflatable penile prosthesis (IPP) has not been previously reported. The aim of this study was to present a case of tubing erosion, review the pertinent literature, and discuss the possible causes and management options, including preservation of the device and its components. A 42-year-old male failing to respond to medical treatment for erectile dysfunction underwent insertion of an AMS 700 IPP in 1986. Six years later, a revision was necessary because of a leak in the right cylinder and 4 years after, the pump was replaced. Fourteen years after the original implant, he presented with a portion of the tube connecting the pump to the right cylinder eroding through the skin. There was no infection. The skin area involved was resected and the original pump and tubing were buried in a new scrotal pocket after thorough irrigation. The IPP remained in place, allowing vaginal penetration and without infection for another 11 years. Three years later, it was de-functionalized, converted into a fixed volume device. It eventually was replaced 25 years after originally implanted with a semirigid prosthesis because it did not provide sufficient rigidity and because of concerns about the presence of "screws" detected during pelvic imaging. Mechanical failures in the early IPP models, as illustrated in this case, were expected. However, the long survival of the device is remarkable. Erosion of the connecting tubing through the skin is unique and, under exceptional circumstances, may be managed conservatively without replacing components of the IPP. Clinicians unfamiliar with procedures involving inflatable devices need to be aware of "foreign bodies" visible in radiological examinations in men who have had revisions of an IPP. Morales A. Tubing erosion of an inflatable penile prosthesis long after implantation. Sex Med 2014;2:103-106.

Acinetobacter Prosthetic Joint Infection Treated with Debridement and High-Dose Tigecycline.

PubMed

Vila, Andrea; Pagella, Hugo; Amadio, Claudio; Leiva, Alejandro

2016-12-01

Prosthesis retention is not recommended for multidrug-resistant Acinetobacter prosthetic joint infection due to its high failure rate. Nevertheless, replacing the prosthesis implies high morbidity and prolonged hospitalization. Although tigecycline is not approved for the treatment of prosthetic joint infection due to multidrug resistant Acinetobacter baumannii, its appropriate use may preclude prosthesis exchange. Since the area under the curve divided by the minimum inhibitory concentration is the best pharmacodynamic predictor of its efficacy, we used tigecycline at high dose, in order to optimize its efficacy and achieve implant retention in 3 patients who refused prosthesis exchange. All patients with prosthetic joint infections treated at our Institution are prospectively registered in a database. Three patients with early prosthetic joint infection of total hip arthroplasty due to multidrug resistant A. baumannii were treated with debridement, antibiotics and implant retention, using a high maintenance dose of tigecycline (100 mg every 12 hours). The cases were retrospectively reviewed. All patients signed informed consent for receiving off-label use of tigecycline. Tigecycline was well tolerated, allowing its administration at high maintenance dose for a median of 40 days (range 30-60). Two patients were then switched to minocycline at standard doses for a median of 3.3 months in order to complete treatment. Currently, none of the patients showed relapse. Increasing the dose of tigecycline could be considered as a means to better attain pharmacodynamic targets in patients with severe or difficult-to-treat infections. Tigecycline at high maintenance dose might be useful when retention of the implant is attempted for treatment for prosthetic joint infections due to multidrug resistant Acinetobacter. Although this approach might be promising, off-label use of tigecycline should be interpreted cautiously until prospective data are available. Tigecycline is probably under-dosed for the treatment of implant and biofilm associated infections.

Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis.

PubMed

Lemos, Cleidiel Aparecido Araujo; Ferro-Alves, Marcio Luiz; Okamoto, Roberta; Mendonça, Marcos Rogério; Pellizzer, Eduardo Piza

2016-04-01

The purpose of the present systematic review and meta-analysis was to compare short implants (equal or less than 8mm) versus standard implants (larger than 8mm) placed in posterior regions of maxilla and mandible, evaluating survival rates of implants, marginal bone loss, complications and prosthesis failures. This review has been registered at PROSPERO under the number CRD42015016588. Main search terms were used in combination: dental implant, short implant, short dental implants, short dental implants posterior, short dental implants maxilla, and short dental implants mandible. An electronic search for data published up until September/2015 was undertaken using the PubMed/Medline, Embase and The Cochrane Library databases. Eligibility criteria included clinical human studies, randomized controlled trials and/or prospective studies, which evaluated short implants in comparison to standard implants in the same study. The search identified 1460 references, after inclusion criteria 13 studies were assessed for eligibility. A total of 1269 patients, who had received a total of 2631 dental implants. The results showed that there was no significant difference of implants survival (P=.24; RR:1.35; CI: 0.82-2.22), marginal bone loss (P=.06; MD: -0.20; CI: -0.41 to 0.00), complications (P=.08; RR:0.54; CI: 0.27-1.09) and prosthesis failures (P=.92; RR:0.96; CI: 0.44-2.09). Short implants are considered a predictable treatment for posterior jaws. However, short implants with length less than 8 mm (4-7 mm) should be used with caution because they present greater risks to failures compared to standard implants. Short implants are frequently placed in the posterior area in order to avoid complementary surgical procedures. However, clinicians need to be aware that short implants with length less than 8mm present greater risk of failures. Copyright © 2016. Published by Elsevier Ltd.

[The development of research in tribology of artificial joints].

PubMed

Dai, Zhendong; Gong, Juanqing

2006-06-01

Aseptic loosening of the prosthesis is a major form for the failure of artificial joints, which results in the conglomeration of wear particles at the bone-implant interface. This paper briefly reviews the recent development of tribology of artificial joints preserving good lubrication, enhancing the wear resistance of materials for the joints, reducing the generation of sensitive-size particles and depressing the debris-tissue reactions. Suggestion for improvement in the design of artificial joints is presented.

Graphene nanoplatelet-reinforced silicone for the valvular prosthesis application.

PubMed

Lordeus, Makensley; Estrada, Angie; Stewart, Danique; Dua, Rupak; Zhang, Cheng; Agarwal, Arvind; Ramaswamy, Sharan

2015-01-01

Newly developed elastomer heart valves have been shown to better re-create the flow physics of native heart valves, resulting in preferable hemodynamic responses. This emergence has been motivated in part by the recent introduction of percutaneous valve approaches in the clinic. Unfortunately, elastomers such as silicone are prone to structural failure, which drastically limits their applicability the development of a valve prosthesis. To produce a mechanically more robust silicone substrate, we reinforced it with graphene nanoplatelets (GNPs). The nanoplatelets were introduced into a two-part silicone mixture and allowed to cure. Cytotoxicity and hemocompatibility tests revealed that the incorporation of GNPs did not adversely affect cell proliferation or augment adhesion of platelets on the surface of the composite materials. Static mechanical characterization by loading in the tensile direction subsequently showed no observable effect when graphene was utilized. However, cyclic tensile testing (0.05 Hz) demonstrated that silicone samples containing 250 mg graphene/L of uncured silicone significantly improved (p<0.05) material fatigue properties compared with silicone-only controls. This finding suggests that for the silicone-graphene composite, static loads were principally transferred onto the matrix. On the other hand, in cyclic loading conditions, the GNPs were recruited effectively to delay failure of the bulk material. We conclude that application of GNPs to extend silicone durability is useful and warrants further evaluation at the trileaflet valve configuration.

PubMed Central

DI MAURO, P.; SPATARO, D.; MAIOLINO, L.; COCUZZA, S.

2015-01-01

SUMMARY This study reports our 15-year experience, in Sicily, with the use of voice prostheses, analysing the different variables that have influenced the success or failure of speech rehabilitation. The retrospective clinical analysis was carried out by reviewing the clinical histories of 95 patients with laryngeal cancer, in whom a voice prosthesis had been placed by trachea-oesophageal puncture between 1998 and 2013. Age, type of tumour, type of surgery, use of prior radiation therapy, type of puncture, prosthesis used and its duration, number of replacements, complications and causes for prosthetic success or failure were analysed. The results showed a mean of Harrison-Robillard-Schultz (HRS) TEP rating scale of 11.8 in primary TEP and 12.6 in secondary TEP (P =0.613). PORT did not affect overall rehabilitation success. In these patients, the mean HRS rating scale was 11.2, with long-term success of 85% (P =0.582). In patients over 70 years old, long-term success was 82.5%, with 78% in primary and 86% in secondary TEP, the mean HRS was 11.2 in primary and 12 in secondary TEP (P =0.648). In total, long-term success was 87.5%, with 84% in primary and 91% in secondary TEP. The results obtained by retrospective analysis of 15 years of prosthetic rehabilitation in the Sicilian territory highlighted standard rehabilitation, in terms of intra and postoperative complications, fistula related pathology and overall success. PMID:26900247

Long-term outcome of acute prosthetic joint infections due to gram-negative bacilli treated with retention of prosthesis.

PubMed

Jaén, N; Martínez-Pastor, J C; Muñoz-Mahamud, E; García-Ramiro, S; Bosch, J; Mensa, J; Soriano, A

2012-09-01

To update the clinical information of the 47 patients with a prosthetic joint infection due to Gram-negative bacilli included in a previous study and to reassess the predictors of failure after a longer follow-up. Using the electronic files of our hospital, all the information regarding readmissions to the hospital, new surgical procedures and the reason for the new surgery (infection, aseptic loosening), and the last visit in the hospital were registered. The medical chart of the 35 patients that were considered in remission in the previous publication was reviewed. In 30 patients no clinical evidence of failure was detected and no additional surgery on the previously infected prosthesis was necessary and they were considered in long-term remission. In 5 cases a late complication was identified. One case had a reinfection due to coagulase-negative staphylococci after 22 months from the open debridement and required a 2-stage revision surgery. The other 4 cases developed an aseptic loosening and it was necessary to perform a 1-stage exchange. Receiving a fluoroquinolone when all the Gram-negatives involved in the infection were susceptible to fluoroquinolones was the only factor associated with remission in the univariate analysis (p=0.002). After a long-term follow-up, our results support the importance of using fluoroquinolones in acute PJI due to Gram-negative bacilli.

Framework design and pontics of fiber-reinforced composite fixed dental prostheses - An overview.

PubMed

Perea-Lowery, Leila; Vallittu, Pekka K

2018-05-11

Fiber-reinforced composite (FRC) fixed dental prostheses (FDPs) have shown good performance in clinical applications due to their good mechanical properties and minimally invasive approach. However, typical failure patterns of FRC FDPs are often localized at the pontic site. That reflects the structural considerations at the framework and pontic location that need to be examined when creating these kinds of prostheses. Peer-reviewed articles and other scientific literature were reviewed for providing up-to-date information on how pontics of FRC FDPs can be made. A thorough literature search was done using PubMed and Google Scholar. Two individuals did an assessment of the articles in order to include those related to pontics and framework design of FRC FDPs. The search terms used were "fiber-reinforced dental prosthesis" and "Pontics of fiber-reinforced dental prosthesis". These findings indicate that a cross-sectional fiber design, substructure and thicker pontics made of a variety of materials might reduce failures at the pontic site. The thickness of pontics of FRC FDPs interrelated with the vertical positioning of the FRC framework influences the load-bearing capacities of prostheses of these kinds. The understanding of the factors involved in the fabrication of pontics of FRC FDPs may overcome the drawbacks identified in these prostheses, thus extending their longevity. Copyright © 2018 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

[Tumor prostheses : Important in modern revision arthroplasty].

PubMed

Hillmann, A; Ipach, I

2015-05-01

Due to demographic aging, an increasing number of revision arthroplasty procedures is expected during upcoming years. While the use of a megaprosthesis for bone reconstruction after tumor resection is gold standard, this type of prosthesis still meets with reservation in the field of revision arthroplasty because of numerous risk factors. The purpose of this article is to present the importance of modular megaprostheses in revision arthroplasty, taking into consideration the risks of periprosthetic infection, aseptic loosening, material failure, and hip dislocation. Because of improvements in the field of megaprostheses during the last 30 years, the risks after implantation of this type of prosthesis have significantly decreased. The risk of periprosthetic infection has been reduced about 1/3 by the use of silver surface coating. Improvements in stem design, cement technique, and the additional use of locking screws have minimized the risk of aseptic loosening. Improvements in material composition have reduced the risk of material failure. The risk of hip dislocation could also be minimized by careful tissue preparation and appropriate suture technique. There is no need for the conservative use of megaprostheses in revision arthroplasty. There are many benefits in the use of megaprostheses in multimorbid patients (i.e., reduced operating time, the possibility of early full weight bearing, and a reduced risk of periprosthetic infection by the use of silver surface coating) instead of complex bone reconstruction during revision arthroplasty.

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. Most of the women are used home made prosthesis like cloth and cotton (44.4 %). Education, age and urban status are the strong factors which influences use of prosthesis. Prosthesis users are those who are more concerned about their body image. There is a palpable need to develop better prosthesis at affordable price.

An Investigation into a Gear-Based Knee Joint Designed for Lower Limb Prosthesis.

PubMed

Bhuiyan, M S H; Choudhury, I A; Dahari, M; Nukman, Y; Dawal, S Z

2017-01-01

A gear-based knee joint is designed to improve the performance of mechanical-type above-knee prostheses. The gear set with the help of some bracing, and bracket arrangement, is used to enable the prosthesis to follow the residual limb movement. The motion analysis and finite-element analysis (FEA) of knee joint components are carried out to assess the feasibility of the design. The maximum stress of 29.74 MPa and maximum strain of 2.393e-004 are obtained in the gear, whereas the maximum displacement of 7.975 mm occurred in the stopper of the knee arrangement. The factor of safety of 3.5 obtained from the FE analysis indicated no possibility of design failure. The results obtained from the FE analysis are then compared with the real data obtained from the literature for a similar subject. The pattern of motion analysis results has shown a great resemblance with the gait cycle of a healthy biological limb.

An Investigation into a Gear-Based Knee Joint Designed for Lower Limb Prosthesis

PubMed Central

2017-01-01

A gear-based knee joint is designed to improve the performance of mechanical-type above-knee prostheses. The gear set with the help of some bracing, and bracket arrangement, is used to enable the prosthesis to follow the residual limb movement. The motion analysis and finite-element analysis (FEA) of knee joint components are carried out to assess the feasibility of the design. The maximum stress of 29.74 MPa and maximum strain of 2.393e−004 are obtained in the gear, whereas the maximum displacement of 7.975 mm occurred in the stopper of the knee arrangement. The factor of safety of 3.5 obtained from the FE analysis indicated no possibility of design failure. The results obtained from the FE analysis are then compared with the real data obtained from the literature for a similar subject. The pattern of motion analysis results has shown a great resemblance with the gait cycle of a healthy biological limb. PMID:28584518

A rare presentation of haematuria: hip prosthesis in the bladder.

PubMed

Phan, Yih Chyn; Eli, Nnaemeka; Pillai, Praveen; O'Dair, Jonathan

2018-03-22

An 80-year-old woman presented to our department with visible haematuria and stage II acute kidney injury (AKI). She had stage IIB cervical cancer, for which she received chemotherapy and external beam radiotherapy in 2003. Four years later, she had a left dynamic hip screw for an extracapsular neck of femur fracture following a fall. In 2010, she underwent a right total hip replacement owing to osteoarthritis, and it was subsequently revised in 2012 owing to a right acetabular component failure. In this admission, her AKI improved with intravenous fluid administration and her haematuria settled following catheterisation with a three-way catheter and bladder irrigation with saline. She underwent a flexible cystoscopy which revealed that a part of her right hip prosthesis was in the bladder, having eroded through the right bony pelvis. However, she declined any surgical interventions. © BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[The bionic hand].

PubMed

Surke, Carsten; Ducommun Dit Boudry, Pascal; Vögelin, Esther

2015-08-01

The loss of the upper extremity implicates a grave insult in the life of the involved person. To compensate for the loss of function different powered prosthetic devices are available. Ever since their first development 70 years ago numerous improvements in terms of size, weight and wearing comfort have been developed, but issues regarding the control of upper extremity prostheses remain. Slow grasping speed, limited grip positions and especially failure to provide a sensory feedback limit the acceptance in patients. Recent developments are aimed to allow a more intuitive control of the prosthetic device and to provide a sensory feedback to the amputee. Targeted reinnervation reassignes existing muscles to different peripheral nerves thereby enabling them to fulfill alternate functions. Implanting electrodes into muscle bellies of the forearm allows a more accurate control of the prosthesis. Promising results are being achieved by implanting nerve electrodes by establishing bilateral communication between patient and prosthesis. The following review summarizes the current developments of bionic prostheses in the upper extremity.

Percutaneous re-revalvulation of the tricuspid valve.

PubMed

Gewillig, Marc; Dubois, Christophe

2011-04-01

We report a successful percutaneous revalvulation of a dysfunctional tricuspid bioprothesis in an 8-year-old child. Five years after implanting a 25-mm Carpentier-Edwards valve in the tricuspid position, the prosthesis showed significant dysfunction with clinical right heart failure. A 26-mm Edwards-Sapien XT inverted aortic valve was successfully implanted through a 19F sheath using a jugular approach. Such procedure can significantly postpone the need for surgical replacement of a biological valve. Copyright © 2011 Wiley-Liss, Inc.

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.

A Review of Periprosthetic Femoral Fractures Associated With Total Hip Arthroplasty

PubMed Central

Marsland, Daniel; Mears, Simon C.

2012-01-01

Periprosthetic fractures of the femur in association with total hip arthroplasty are increasingly common and often difficult to treat. Patients with periprosthetic fractures are typically elderly and frail and have osteoporosis. No clear consensus exists regarding the optimal management strategy because there is limited high-quality research. The Vancouver classification facilitates treatment decisions. In the presence of a stable prosthesis (type-B1 and -C fractures), most authors recommend surgical stabilization of the fracture with plates, strut grafts, or a combination thereof. In up to 20% of apparent Vancouver type-B1 fractures, the femoral stem is loose, which may explain the high failure rates associated with open reduction and internal fixation. Some authors recommend routine opening and dislocation of the hip to perform an intraoperative stem stability test to rule out a loose component. Advances in plating techniques and technology are improving the outcomes for these fractures. For fractures around a loose femoral prosthesis (types B2 and 3), revision using an extensively porous-coated uncemented long stem, with or without additional fracture fixation, appears to offer the most reliable outcome. Cement-in-cement revision using a long-stem prosthesis is feasible in elderly patients with a well-fixed cement mantle. It is essential to treat the osteoporosis to help fracture healing and to prevent further fractures. We provide an overview of the causes, classification, and management of periprosthetic femoral fractures around a total hip arthroplasty based on the current best available evidence. PMID:23569704

Custom-made ocular prosthesis.

PubMed

Gunaseelaraj, Rajkumar; Karthikeyan, Suma; Kumar, Mohan N; Balamurugan, T; Jagadeeshwaran, A R

2012-08-01

An ocular defect may affect a patient psychologically. An ocular prosthesis is given to uplift the patient psychologically and improve the confidence. Ocular prosthesis can be custom made or a stock shell. To improve the comfort and matching of the prosthesis with that of the adjacent natural eye an custom made ocular prosthesis is preferred. Different techniques are available to fabricate a custom ocular prosthesis, here we have used paper iris disk technique.

Experiences in the provision, fitting and supply of external breast prostheses: findings from a national survey.

PubMed

Gallagher, P; Buckmaster, A; O'Carroll, S; Kiernan, G; Geraghty, J

2009-11-01

A good-quality external breast prosthesis and prosthesis-fitting service is integral to recovery post-mastectomy. However, this area of care has minimal information or research available. The aim of this study was to investigate women's experience of the provision, fitting, supply and use of breast prostheses in Ireland. Three national surveys were undertaken with women (n = 527), breast care nurses (BCNs) (n = 32) and retail prosthesis fitters (n = 12). The findings identified the importance of the prosthesis for shape, appearance to self, appearance to others, sense of well-being, self-confidence and femininity. Dissatisfaction with weight, comfort and movement of the prosthesis was identified. Cost and travel distance were found to influence the replacement of the prosthesis. Dissatisfaction emerged with the display and choice of products, and brochure availability at the prosthesis fitting. Women preferred to be fitted for the first silicone prosthesis by a BCN in a hospital setting whereas for the replacement prosthesis they preferred a trained fitter at a specialized prosthesis supplier. BCNs and retail fitters identified the need for service guidelines and increased availability of professional development opportunities in prosthesis-fitting. These findings contributed to the development of standards of care for breast prosthesis-fitting services to benefit women and to provide guidelines for those providing the service.

Arthrodesis for failed knee arthroplasty. A report of 20 cases.

PubMed

Knutson, K; Lindstrand, A; Lidgren, L

1985-01-01

Twenty consecutive patients treated by arthrodesis for failed knee arthroplasty are reviewed. Eight hinged, five stabilised and seven compartmental prostheses were removed, for infection (15 cases), loosening (4) and instability (1). One patient refused a second-stage operation but the remainder gained sound fusion. Infected knees had a two-stage procedure with temporary insertion of gentamicin-loaded beads after removal of the prosthesis; all infections healed. Six arthrodeses using a Hoffmann-Vidal external fixator resulted in two temporary failures. One Ace-Fischer external fixation was successful. Of 10 primary attempts at arthrodesis with an intramedullary Küntscher nail, nine were successful; the tenth fused after two more attempts by the same method. The two failures of external fixation and two failures after Charnley single-frame compression done elsewhere were successfully fused with intramedullary nails. Delayed union in three cases fused after prolonged fixation and repeated bone grafts. The indications for and methods of arthrodesis after failed knee arthroplasty are discussed.

Late leaflet fracture and embolization of a Duromedics mitral prosthesis.

PubMed

Sudo, K; Sasagawa, N; Ide, H; Nunokawa, M; Fujiki, T; Tonari, K

2000-08-01

A case of leaflet fracture and embolization of a mitral prosthetic valve is described. A 54-year-old man had received mitral valve replacement with an Edwards-Duromedics 29M prosthetic valve, at 10 years ago. Emergency mitral valve replacement was performed because the patient had severe congestive left heart failure with severe acute mitral regurgitation caused by a fracture in one of the mitral valve leaflets. The leaflet, which was fractured into 2 pieces, was removed from the right common iliac artery at 3 months after valve replacement. Visual inspection revealed that the leaflet contained a midline fracture. The fracture originated within a cavitary erosion pit near the major radius of the leaflet. The patient recovered from acute renal failure, requiring hemodialysis for 80 days, and is currently without complaints. We have used a Duromedics mitral valve in 11 patients, from April 1987 to April 1988. No subsequent valve failure has occurred. The diagnosis, treatment and cause of a mechanical valve fracture are discussed.

Bone Graft Substitute Provides Metaphyseal Fixation for a Stemless Humeral Implant.

PubMed

Kim, Myung-Sun; Kovacevic, David; Milks, Ryan A; Jun, Bong-Jae; Rodriguez, Eric; DeLozier, Katherine R; Derwin, Kathleen A; Iannotti, Joseph P

2015-07-01

Stemless humeral fixation has become an alternative to traditional total shoulder arthroplasty, but metaphyseal fixation may be compromised by the quality of the trabecular bone that diminishes with age and disease, and augmentation of the fixation may be desirable. The authors hypothesized that a bone graft substitute (BGS) could achieve initial fixation comparable to polymethylmethacrylate (PMMA) bone cement. Fifteen fresh-frozen human male humerii were randomly implanted using a stemless humeral prosthesis, and metaphyseal fixation was augmented with either high-viscosity PMMA bone cement (PMMA group) or a magnesium-based injectable BGS (OsteoCrete; Bone Solutions Inc, Dallas, Texas) (OC group). Both groups were compared with a control group with no augmentation. Initial stiffness, failure load, failure displacement, failure cycle, and total work were compared among groups. The PMMA and OC groups showed markedly higher failure loads, failure displacements, and failure cycles than the control group (P<.01). There were no statistically significant differences in initial stiffness, failure load, failure displacement, failure cycle, or total work between the PMMA and OC groups. The biomechanical properties of magnesium-based BGS fixation compared favorably with PMMA bone cement in the fixation of stemless humeral prostheses and may provide sufficient initial fixation for this clinical application. Future work will investigate the long-term remodeling characteristics and bone quality at the prosthetic-bone interface in an in vivo model to evaluate the clinical efficacy of this approach. Copyright 2015, SLACK Incorporated.

Survival of dental implants in patients with Down syndrome: A case series.

PubMed

Limeres Posse, Jacobo; López Jiménez, Julian; Ruiz Villandiego, José C; Cutando Soriano, Antonio; Fernández Feijoo, Javier; Linazasoro Elorza, Maialen; Diniz Freitas, Márcio; Diz Dios, Pedro

2016-12-01

The need for tooth replacement in individuals with Down syndrome (DS) is explained by the high prevalence of dental agenesis and by the premature loss of teeth through severe periodontal disease. Dental implants may be the dental procedure of choice in some of these patients. The purpose of this clinical study was to analyze dental implant survival in a series of patients with DS. This was a multicenter, retrospective, observational study. Information on patients was gathered using a standardized questionnaire designed specifically for this study, including personal details, oral health status, information on the surgical and prosthetic phases, and follow-up visits. The questionnaire was sent to centers registered with the research network of the Spanish Society of Special Needs Dentistry (SEOENE). Patients with DS aged 18 years or older were included in the study if they had at least 1 dental implant and the corresponding prosthesis and had been followed up for at least a year. The study population was formed of 25 adult patients (13 men and 12 women) aged between 19 and 60 years. The interventions were performed by 5 different dental surgeons, usually under general anesthesia or deep sedation (n=17 patients). A total of 73 implants were inserted, 30 in the maxilla and 43 in the mandible, most commonly in the anterior region (n=51). The mean time to loading the implants was 4.1 ±1.3 months after surgery (range, 1 to 7 months). All patients completed prosthetic rehabilitation; the most frequent design used was the single fixed prosthesis (n=13 patients). A total of 17 (23.2%) implants failed in 8 (32%) patients; the majority (n=14 implants) failed in the postsurgical period before implant loading. The distribution by patients was 1 implant failure in 6 patients, 3 failures in 1 patient, and 8 failures in 1 patient. Dental implant survival is lower in individuals with DS than in the general population. The reasons for early implant failure in these patients have still not been clearly identified. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Sockets Manufactured by CAD/CAM Method Have Positive Effects on the Quality of Life of Patients With Transtibial Amputation.

PubMed

Karakoç, Mehmet; Batmaz, İbrahim; Sariyildiz, Mustafa Akif; Yazmalar, Levent; Aydin, Abdülkadir; Em, Serda

2017-08-01

Patients with amputation need prosthesis to comfortably move around. One of the most important parts of a good prosthesis is the socket. Currently, the most commonly used method is the traditional socket manufacturing method, which involves manual work; however, computer-aided design/computer-aided manufacturing (CAD/CAM) is also being used in the recent years. The present study aimed to investigate the effects of sockets manufactured by traditional and CAD/CAM method on clinical characteristics and quality of life of patients with transtibial amputation. The study included 72 patients with transtibial amputation using prosthesis, 36 of whom had CAD/CAM prosthetic sockets (group 1) and 36 had traditional prosthetic sockets (group 2). Amputation reason, prosthesis lifetime, walking time and distance with prosthesis, pain-free walking time with prosthesis, production time of the prosthesis, and adaptation time to the prosthesis were questioned. Quality of life was assessed using the 36-item Short Form Health Survey questionnaire and the Trinity Amputation and Prosthesis Experience Scales. Walking time and distance and pain-free walking time with prosthesis were significantly better in group 1 than those in group 2. Furthermore, the prosthesis was applied in a significantly shorter time, and socket adaptation time was significantly shorter in group 1. Except emotional role limitation, all 36-item Short Form Healthy Survey questionnaire parameters were significantly better in group 1 than in group 2. Trinity Amputation and Prosthesis Experience Scales activity limitation scores of group 1 were lower, and Trinity Amputation and Prosthesis Experience Scales satisfaction with the prosthesis scores were higher than those in group 2. Our study demonstrated that the sockets manufactured by CAD/CAM methods yield better outcomes in quality of life of patients with transtibial amputation than the sockets manufactured by the traditional method.

PubMed Central

Caron, C.; Luneau, C.; Gervais, M. H.; Plante, G. E.; Sanchez, G.; Blain, G.

1979-01-01

In patients with cerebrospinal fluid internal shunts, immune complex glomerulonephritis sometimes develops. Of two new cases the first was classic, while the second was in an adult who had had a ventriculoatril shunt for 8 years; furthermore, the patient had acute renal failure and is the first to have been reported to have Peptococcus septicemia. Shunt glomerulonephritis is characterized by the following: (a) its occurrence following, most often, Staphylococcus albus infection in a patient who usually has a ventriculoatrial shunt; (b) transitory improvement of the symptoms by antibiotherapy only; and (c) full recovery if the prosthesis is removed. Laboratory studies show a low serum concentration of the C3 component of complement, the presence of cryoglobulins and a positive rheumatoid factor test. These abnormalities are reversible with removal of the prosthesis. Optical microscopy of a renal biopsy specimen in the two cases showed cellular proliferation of the glomerular tuft, electron microscopy demonstrated subepithelial deposits and immunofluorescent studies revealed intramembranous and intramesangial immune complexes. These features are similar to those observed in experimental nephritis induced in animals by foreign protein. Images FIG. 3 FIG. 4 FIG. 5 FIG. 6 FIG. 7 PMID:436034

Primary tracheoesophageal puncture and cricopharyngeal myotomy in stapler-assisted total laryngectomy.

PubMed

Beswick, D M; Damrose, E J

2016-07-01

To evaluate the utility of the hybrid tracheoesophageal puncture procedure in stapler-assisted laryngectomy. Patients who underwent total laryngectomy at a single institution from 2009 to 2015 were reviewed. The interventions assessed were surgical creation of a tracheoesophageal puncture and placement of a voice prosthesis. The outcomes measured included voicing ability and valve failure. Thirty-nine patients underwent total laryngectomy or pharyngolaryngectomy. Of these, nine underwent stapler-assisted laryngectomy; seven of the nine patients underwent concurrent stapler-assisted laryngectomy, cricopharyngeal myotomy and a hybrid tracheoesophageal puncture procedure. These seven patients were the focus of this review. Successful voicing and oral alimentation was achieved in all patients. Mean time to phonation was 30 days (range, 7-77 days) and mean time to first valve change was 90 days (range, 35-117 days). Primary tracheoesophageal puncture with concurrent voice prosthesis placement and cricopharyngeal myotomy is easily performed with stapler-assisted laryngectomy. The hybrid tracheoesophageal puncture procedure is a simple method that enables a single operator to achieve primary tracheoesophageal puncture and valve placement; in addition, it facilitates concurrent cricopharyngeal myotomy.

Use of Ligament Advanced Reinforcement System tube in stabilization of proximal humeral endoprostheses

PubMed Central

Stavropoulos, Nikolaos A; Sawan, Hassan; Dandachli, Firas; Turcotte, Robert E

2016-01-01

AIM: To review outcomes following usage of the Ligament Advanced Reinforcement System (LARS®) in shoulder tumors. METHODS: Medical records of nineteen patients (19 shoulders) that underwent tumor excisional procedure and reconstruction with the LARS synthetic fabric, were retrospectively reviewed. RESULTS: Patients’ median age was 58 years old, while the median length of resection was 110 mm (range 60-210 mm). Compared to immediate post-operative radiographs, the prosthesis mean end-point position migrated superiorly at a mean follow up period of 26 mo (P = 0.002). No statistical significant correlations between the prosthesis head size (P = 0.87); the implant stem body length (P = 0.949); and the length of resection (P = 0.125) with the position of the head, were found at last follow up. Two cases of radiological dislocation were noted but only one was clinically symptomatic. A minor superficial wound dehiscence, healed without surgery, occurred. There was no evidence of aseptic loosening either, and no prosthetic failure. CONCLUSION: LARS® use ensured stability of the shoulder following endoprosthetic reconstruction in most patients. PMID:27114934

Women's Satisfaction with Their Breast Prosthesis: What Determines a Quality Prosthesis?

ERIC Educational Resources Information Center

Livingston, Patricia M.; White, Victoria M.; Roberts, Susan B.; Pritchard, Emma; Hayman, Jane; Gibbs, Anne; Hill, David J.

2005-01-01

The aim of this study is to determine what factors constitute a quality prosthesis and ascertain which factors affect prosthesis satisfaction. Sixty-four women who received full funding for their prosthesis and 38 women who received their hospital's usual funding were recruited. Women rated the information provided about breast prostheses very…

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

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.

Failure of total knee arthroplasty with or without patella resurfacing

PubMed Central

2011-01-01

Background and purpose Patella resurfacing during primary total knee arthroplasty (TKA) is disputed and new prosthesis designs have been introduced without documentation of their survival. We assessed the impact on prosthesis survival of patella resurfacing and of prosthesis brand, based on data from the Norwegian Arthroplasty Register. Patients and methods 5 prosthesis brands in common use with and without patella resurfacing from 1994 through 2009 were included n = 11,887. The median follow-up times were 9 years for patella-resurfaced implants and 7 years for implants without patella resurfacing. For comparison of prosthesis brands, also brands in common use with only one of the two treatment options were included in the study population (n = 25,590). Cox regression analyses were performed with different reasons for revision as endpoints with adjustment for potential confounders. Results We observed a reduced overall risk of revision for patella resurfaced (PR) TKAs, but the statistical significance was borderline (RR = 0.84, p = 0.05). At 15 years, 92% of PR and 91% of patella non resurfaced (NR) prostheses were still unrevised. However, PR implants had a lower risk of revision due to pain alone (RR = 0.1, p < 0.001), but a higher risk of revision due to loosening of the tibial component (RR = 1.4, p = 0.03) and due to a defective polyethylene insert (RR = 3.2, p < 0.001). At 10 years, the survival for the reference NR brand AGC Universal was 93%. The NR brands Genesis I, Duracon, and Tricon (RR = 1.4–1.7) performed statistically significantly worse than NR AGC Universal, while the NR prostheses e.motion, Profix, and AGC Anatomic (RR = 0.1–0.7), and the PR prostheses NexGen and AGC Universal (RR = 0.4–0.5) performed statistically significantly better. LCS, NexGen, LCS Complete (all NR), and Tricon, Genesis I, LCS, and Kinemax (all PR) showed no differences in this respect from the reference brand. A lower risk of revision (crude) was found for TKAs performed after 2000 as compared to those performed earlier (RR = 0.8, p = 0.001). Interpretation Although revision risk was similar for PR and NR TKAs, we found important differences in reasons for revision. Our results also indicate that survivorship of TKAs has improved. PMID:21619502

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.

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.

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.

Failure of a novel ceramic-on-ceramic hip resurfacing prosthesis.

PubMed

Matharu, Gulraj S; Daniel, Joseph; Ziaee, Hena; McMinn, Derek J W

2015-03-01

We report the early failure of five ceramic-on-ceramic hip resurfacings (CoCHRs). The ceramic used for the acetabular liner was a novel ceramic-composite (two thirds polyurethane and one third alumina ceramic). All cases were revised for increasing metal ion levels (blood cobalt 3.93-208.0 μg/l and chromium 1.57-17.5 μg/l) due to ceramic liner fracture and/or accelerated wear of the ceramic femoral head coating. Patients underwent bearing exchange and revision using primary hip arthroplasty implants at a mean of 3.0 years following CoCHR. Intraoperatively all patients had metallosis. At 1 to 2 years of follow-up blood metal ions normalized with no complications. We do not recommend this particular type of ceramic-on-ceramic bearing for hip resurfacing. Copyright © 2014 Elsevier Inc. All rights reserved.

Multivariate prediction of upper limb prosthesis acceptance or rejection.

PubMed

Biddiss, Elaine A; Chau, Tom T

2008-07-01

To develop a model for prediction of upper limb prosthesis use or rejection. A questionnaire exploring factors in prosthesis acceptance was distributed internationally to individuals with upper limb absence through community-based support groups and rehabilitation hospitals. A total of 191 participants (59 prosthesis rejecters and 132 prosthesis wearers) were included in this study. A logistic regression model, a C5.0 decision tree, and a radial basis function neural network were developed and compared in terms of sensitivity (prediction of prosthesis rejecters), specificity (prediction of prosthesis wearers), and overall cross-validation accuracy. The logistic regression and neural network provided comparable overall accuracies of approximately 84 +/- 3%, specificity of 93%, and sensitivity of 61%. Fitting time-frame emerged as the predominant predictor. Individuals fitted within two years of birth (congenital) or six months of amputation (acquired) were 16 times more likely to continue prosthesis use. To increase rates of prosthesis acceptance, clinical directives should focus on timely, client-centred fitting strategies and the development of improved prostheses and healthcare for individuals with high-level or bilateral limb absence. Multivariate analyses are useful in determining the relative importance of the many factors involved in prosthesis acceptance and rejection.

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

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

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.

Press-fit bipolar radial head arthroplasty, midterm results.

PubMed

Kodde, Izaäk F; Heijink, Andras; Kaas, Laurens; Mulder, Paul G H; van Dijk, C Niek; Eygendaal, Denise

2016-08-01

Theoretical advantages of bipolar compared with monopolar radial head arthroplasty include better accommodation of radiocapitellar malalignment, reduction of capitellar abrasion, and reduction of stress at the bone-implant interfaces. Our purpose was to report the midterm results of press-fit bipolar radial head arthroplasty. Thirty patients were treated by press-fit bipolar radial head arthroplasty for acute fracture of the radial head, failed earlier treatment, or post-traumatic sequelae. Three patients were lost to follow-up. Results are presented for the remaining 27 patients. At mean follow-up of 48 months (range, 28-73), there had been 3 (11%) revisions. Two involved conversion to prosthetic radiocapitellar hemiarthroplasty for symptomatic capitellar abrasion; a third involved exchange of the articular component (ie, head) for instability. In all, the stems appeared well fixed. A prosthesis in a subluxed position accounted for the 1 (4%) additional radiologic failure. The average flexion-extension arc was 136° (range, 120°-145°), and the average pronation-supination arc was 138° (range, 70°-180°). According to the Mayo Elbow Performance Score, the combined excellent and good results accounted for 70%. The overall midterm outcome of this series of 30 press-fit bipolar radial head arthroplasties can be considered favorable. Although the revision rate was 11%, the stems were well fixed in all. There was 1 (4%) additional radiologic failure. We suggest considering a press-fit bipolar radial head prosthesis for acute comminuted radial head fractures with limited bone loss of the proximal radius. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Revision shoulder arthroplasty from resurfacing to non-cemented short-stem reverse prosthesis.

PubMed

Natera, L; Bruguera, J; Atoun, E; Levy, O

2016-01-01

To assess the surgical parameters and the clinical and radiological outcomes of revisions of resurfacing shoulder arthroplasty to non-cemented short-stem reverse total shoulder arthroplasty. A total of 23 revisions from resurfacing shoulder arthroplasty to reverse total shoulder arthroplasty were performed. The mean age was 70.3±11.95 years. The patients included 82.6% (19/23) revised for cuff failure; 13.04% (3/23) cuff failure and aseptic loosening, and 4.35% (1/23) peri-prosthetic fracture. The need for humeral osteotomy or structural allograft, operation length, blood loss, blood transfusions and intraoperative fractures were recorded. Minimum follow-up 25 months. No humeral osteotomy or humeral structural allograft was required, and 2/23 (8.69%) required allograft for glenoid reconstruction. The mean operation time was 113.35±21.30minutes. Intra-operative blood loss was 374±245.09 mls. Blood transfusion was required in one case. Intra-operative fracture occurred in 1 case. The Constant score improved from 17.32 to 59.78 (age/sex adjusted, 84). Overall satisfaction improved from 1.37 to 8.04. The range of motion increased 79.57° in forward elevation; 72.88° in abduction; 38.06° in internal rotation; and 13.57° in external rotation. There was no evidence of radiolucency, subsidence, or bone resorption. Revisions of resurfacing implants to non-cemented short-stem reverse prosthesis show good clinical and radiological outcomes, with minimal intra-operative complexities. IV, case series. Copyright © 2016 SECOT. Published by Elsevier Espana. All rights reserved.

Immediate versus early loading of two implants placed with a flapless technique supporting mandibular bar-retained overdentures: a single-blinded, randomised controlled clinical trial.

PubMed

Cannizzaro, Gioacchino; Leone, Michele; Esposito, Marco

2008-01-01

To evaluate the efficacy of immediate loading versus early loading at 6 weeks of bar-retained mandibular overdentures supported by two implants placed with a flapless technique. Sixty patients were randomised: 30 to the immediately loaded group and 30 to the early loaded group. To be immediately loaded, implants had to be inserted with a minimum torque > 48 Ncm. Outcome measures were prosthesis and implant failures, biological and biomechanical complications, patient satisfaction, and Implant Stability Quotient (ISQ) assessed with a resonance frequency analysis instrument. Sixty implants were placed in each group. Flaps had to be raised in nine patients to check drill direction or to better visualise the area after multiple teeth extraction. Two implants in two patients did not reach the planned insertion torque and were immediately replaced by larger diameters ones. After 1 year no drop out occurred and two early loaded implants failed in two patients. There were no statistically significant differences between groups for prosthesis failures, implant losses, complications, and mean ISQ values; however, patients in the immediately loaded group were significantly more satisfied than those loaded early. When comparing mean ISQ values taken 6 weeks after placement with 1-year data within each group, values decreased significantly. Mandibular overdentures can be successfully loaded the same day of implant placement with a minimally invasive surgery, increasing patient satisfaction while decreasing treatment time and patient discomfort. No apparent advantages were seen when loading the overdentures at 6 weeks.

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 of a prosthesis. The association of preamputation mobility and age with the likelihood of being fit for a prosthesis is well understood. The effect of age, after controlling for confounders, still persists and is associated with the likelihood of being fit for a prosthesis. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Post-treatment glenoid classification system for total shoulder arthroplasty.

PubMed

Churchill, R Sean

2012-04-01

Over the past 10 years, numerous advancements in glenoid preparation and resurfacing have occurred. Current glenoid classification systems are either focused solely on the patient's preoperative glenoid bone configuration or on the available glenoid bone stock in revision arthroplasty cases. While these systems provide value in preoperative planning, they fail to properly classify the surgical reconstruction completed. A literature review of common bone preparation methods and sources of glenoid prosthetic failure was performed. Based upon this review, a classification system for grading the status of the glenoid after prosthetic implantation was developed. A 6 category, post-treatment, glenoid classification system is proposed: type 0: no reaming; type I: glenoid reaming into but not through the subchondral bone; type II: glenoid reaming which perforates through <50% of the subchondral bone surface area; type III: glenoid reaming which perforates through >50% of the subchondral bone surface area; type IV: use of structural bone graft; and type V: use of a posterior augmented glenoid prosthesis. Types I-III are further subdivided into subtype A which have 100% bone support of the prosthesis, and subtype B which have a region of unsupported prosthesis. The classification system proposed addresses the surgical management of the glenoid during prosthetic replacement. This unique approach to classifying the glenoid following surgical intervention will allow direct follow-up comparison of similarly treated glenoid replacements. Future multicenter studies, possibly through joint registry databases, could then determine the long-term efficacy of the various glenoid preparation methods. Copyright © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Biomechanical interactions of endodontically treated tooth implant-supported prosthesis under fatigue test with acoustic emission monitoring.

PubMed

Huang, Shao-Fu; Chen, Wan-Rung; Lin, Chun-Li

2016-02-24

This study investigated the biomechanical interactions in endodontically treated tooth implant-supported prosthesis (TISP) with implant system variations under dynamic cyclic loads monitored using the acoustic emission (AE) technique. Macrostructure implants using a taper integrated screw-in (TIS; 2-piece implant) and a retaining-screw (RS; 3-piece implant) connected to an abutment were used for this investigation and their corresponding mechanical resistances in conformity with the ISO 14801 standard were evaluated. The endodontically treated TISP samples were constructed containing TIS and RS implants splinted to the second premolar with fatigue tests performed by applying occlusal force onto the premolar simulating the bending moment effect. The numbers of accumulated AE signals in the fatigue tests and failure modes for the sample were recorded to evaluate the mechanical resistance. The maximum load in the static test for RS (3-piece) implant (797N) was significantly higher than that for the TIS (2-piece) implant (559N). Large deformations were found at abutment screws in both RS and TIS implants. Although the numbers of accumulated AE signals for the TIS implant (72511) were higher than those for the RS implant (437), statistical non-significant differences were found between TIS and RS implants. No obvious damage was noted in endodontically treated TISP samples using RS implants but two of the corresponding TIS implants fractured in the abutment screws. Splints with RS (3-piece) implant prosthesis produce better mechanical responses than the TIS (2-piece) implant when connected to an endodontically treated tooth restored with a post core and crown.

[A primary application and evaluation of temporomandibular joint replacement with stock prosthesis].

PubMed

Zhang, Xiao-hu; Chen, Min-jie; Qiu, Ya-ting; Yang, Chi

2012-06-01

To evaluate the effect of total joint replacement in treatment of temporomandibular joint(TMJ) osteoarthropathy with stock prostheses. Six female patients involving 10 joints (2 unilateral and 4 bilateral), with an average age of 59 years old, were involved in this study. Three patients (5 joints) were diagnosed as internal derangement in V stage depending on MRI, 3D-CT findings and clinical characteristics. The other 3 patients (5 joints) had histories of failed temporomandibular joint operation using costochondral graft or temporalis fascial flap. The maximal mouth opening was 1.9 cm on average (range, 1.0 to 2.9cm). All the joints were replaced with Biomet standard prosthesis under general anesthesia. The follow-up period was from 7 to 49 months (average, 17.5 months). All the operations were successfully performed. Heterotopic ossification happened in a bilateral case 1 year postoperatively. One patient with bilateral joint disease complained of severe uncomfortable feeling in the region of the ears and the temples, although there was no significant positive signs according to an ENT examination. Pain relief of the joint and mouth opening improvement were significant in 4 patients. No failure was noted secondary to infection or loosening of the prostheses. The occlusal relationship kept stable postoperatively in all cases. Total TMJ joint replacement with standard prosthesis is a good choice for TMJ reconstruction. It can significantly reduce joint pain and the mouth opening limitation resulted from osteoarthritis. Long-term result remains to be evaluated based on a long-term follow-up.

Fixed and mobile-bearing total ankle prostheses: Effect on tibial bone strain.

PubMed

Terrier, Alexandre; Fernandes, Caroline Sieger; Guillemin, Maïka; Crevoisier, Xavier

2017-10-01

Total ankle replacement is associated to a high revision rate. To improve implant survival, the potential advantage of prostheses with fixed bearing compared to mobile bearing is unclear. The objective of this study was to test the hypothesis that fixed and mobile bearing prostheses are associated with different biomechanical quantities typically associated to implant failure. With a validated finite element model, we compared three cases: a prosthesis with a fixed bearing, a prosthesis with a mobile bearing in a centered position, and a prosthesis with mobile bearing in an eccentric position. Both prostheses were obtained from the same manufacturer. They were tested on seven tibias with maximum axial compression force during walking. We tested the hypothesis that there was a difference of bone strain, bone-implant interfacial stress, and bone support between the three cases. We also evaluated, for the three cases, the correlations between bone support, bone strain and bone-implant interfacial stress. There were no statistically significant differences between the three cases. Overall, bone support was mainly trabecular, and less effective in the posterior side. Bone strain and bone-implant interfacial stress were strongly correlated to bone support. Even if slight differences are observed between fixed and mobile bearing, it is not enough to put forward the superiority of one of these implants regarding their reaction to axial compression. When associated to the published clinical results, our study provides no argument to warn surgeons against the use of two-components fixed bearing implants. Copyright © 2017 Elsevier Ltd. All rights reserved.

Robotic lower limb prosthesis design through simultaneous computer optimizations of human and prosthesis costs

NASA Astrophysics Data System (ADS)

Handford, Matthew L.; Srinivasan, Manoj

2016-02-01

Robotic lower limb prostheses can improve the quality of life for amputees. Development of such devices, currently dominated by long prototyping periods, could be sped up by predictive simulations. In contrast to some amputee simulations which track experimentally determined non-amputee walking kinematics, here, we explicitly model the human-prosthesis interaction to produce a prediction of the user’s walking kinematics. We obtain simulations of an amputee using an ankle-foot prosthesis by simultaneously optimizing human movements and prosthesis actuation, minimizing a weighted sum of human metabolic and prosthesis costs. The resulting Pareto optimal solutions predict that increasing prosthesis energy cost, decreasing prosthesis mass, and allowing asymmetric gaits all decrease human metabolic rate for a given speed and alter human kinematics. The metabolic rates increase monotonically with speed. Remarkably, by performing an analogous optimization for a non-amputee human, we predict that an amputee walking with an appropriately optimized robotic prosthesis can have a lower metabolic cost - even lower than assuming that the non-amputee’s ankle torques are cost-free.

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

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

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.

Long-term role of external breast prostheses after total mastectomy.

PubMed

Glaus, Simone W; Carlson, Grant W

2009-01-01

After total mastectomy, many women choose to wear external breast prosthesis rather than undergo breast reconstruction. The purpose of this study was to evaluate long-term satisfaction among external breast prosthesis wearers and the impact of satisfaction on prosthesis use. A questionnaire was designed to assess demographic information, prosthesis information provision, prosthesis use, and satisfaction with prosthesis. Fifty-nine women who had undergone total mastectomy without breast reconstruction completed the questionnaire. The majority of women (68%) were at least 5 years out from mastectomy. Approximately half (49%) of the women had received information about breast prostheses prior to mastectomy; 29% received information from the surgeon performing the operation. Frequent and prolonged prosthesis use was prevalent with 64% of participants reporting prosthesis use all the time, 6-7 days/week. Participants showed high rates (83%) of overall satisfaction. However, women who wore their prosthesis out in public only were less satisfied than more frequent wearers (50% versus 89%, chi(2) = 8.83, d.f. = 1, alpha = 0.05). Satisfaction increased over time, as women who were greater than 5 years out from mastectomy were more satisfied than women less that 5 years post-mastectomy (90% versus 67%, chi(2) = 4.43, d.f. = 1, alpha = 0.05). The vast majority of women are satisfied with their external breast prosthesis several years after mastectomy. Most women used their prosthesis all the time and overall satisfaction contributed to higher levels of prosthesis use. Given the long-term importance of external breast prostheses for women who have undergone mastectomy, a greater effort to inform patients about external breast prostheses prior to surgery is needed.

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.

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.

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

Refractory metabolic acidosis in patients with sepsis following hemiarthroplasty for femoral neck fracture: a causative role for paracetamol and flucloxacillin?

PubMed Central

Amer, Halima; Dockery, Frances; Barrett, Nicholas; George, Marc; Witek, Karolina; Stanton, Jeremy; Back, Diane

2011-01-01

The authors report two cases of pyroglutamic acidosis as a result of paracetamol and flucloxacillin therapy in patients with prosthesis infection following hemiarthroplasty for neck of femur fractures. Pyroglutamic acidosis is an important and often unrecognised cause of refractory metabolic acidosis that disproportionately affects older women, and can be caused by drugs such as paracetamol and flucloxacillin in the setting of sepsis, renal failure and malnutrition. Although relatively rare, the widespread use of these drugs in orthopaedic patients confirms the importance of this disorder. PMID:22689665

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.

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.

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

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°.

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 872.3940 - Total temporomandibular joint prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...

21 CFR 872.3940 - Total temporomandibular joint prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...

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.

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.

Artificial limb representation in amputees

PubMed Central

van den Heiligenberg, Fiona M Z; Orlov, Tanya; Macdonald, Scott N; Duff, Eugene P; Henderson Slater, David; Beckmann, Christian F; Johansen-Berg, Heidi; Culham, Jody C; Makin, Tamar R

2018-01-01

Abstract The human brain contains multiple hand-selective areas, in both the sensorimotor and visual systems. Could our brain repurpose neural resources, originally developed for supporting hand function, to represent and control artificial limbs? We studied individuals with congenital or acquired hand-loss (hereafter one-handers) using functional MRI. We show that the more one-handers use an artificial limb (prosthesis) in their everyday life, the stronger visual hand-selective areas in the lateral occipitotemporal cortex respond to prosthesis images. This was found even when one-handers were presented with images of active prostheses that share the functionality of the hand but not necessarily its visual features (e.g. a ‘hook’ prosthesis). Further, we show that daily prosthesis usage determines large-scale inter-network communication across hand-selective areas. This was demonstrated by increased resting state functional connectivity between visual and sensorimotor hand-selective areas, proportional to the intensiveness of everyday prosthesis usage. Further analysis revealed a 3-fold coupling between prosthesis activity, visuomotor connectivity and usage, suggesting a possible role for the motor system in shaping use-dependent representation in visual hand-selective areas, and/or vice versa. Moreover, able-bodied control participants who routinely observe prosthesis usage (albeit less intensively than the prosthesis users) showed significantly weaker associations between degree of prosthesis observation and visual cortex activity or connectivity. Together, our findings suggest that altered daily motor behaviour facilitates prosthesis-related visual processing and shapes communication across hand-selective areas. This neurophysiological substrate for prosthesis embodiment may inspire rehabilitation approaches to improve usage of existing substitutionary devices and aid implementation of future assistive and augmentative technologies. PMID:29534154

Artificial limb representation in amputees.

PubMed

van den Heiligenberg, Fiona M Z; Orlov, Tanya; Macdonald, Scott N; Duff, Eugene P; Henderson Slater, David; Beckmann, Christian F; Johansen-Berg, Heidi; Culham, Jody C; Makin, Tamar R

2018-05-01

The human brain contains multiple hand-selective areas, in both the sensorimotor and visual systems. Could our brain repurpose neural resources, originally developed for supporting hand function, to represent and control artificial limbs? We studied individuals with congenital or acquired hand-loss (hereafter one-handers) using functional MRI. We show that the more one-handers use an artificial limb (prosthesis) in their everyday life, the stronger visual hand-selective areas in the lateral occipitotemporal cortex respond to prosthesis images. This was found even when one-handers were presented with images of active prostheses that share the functionality of the hand but not necessarily its visual features (e.g. a 'hook' prosthesis). Further, we show that daily prosthesis usage determines large-scale inter-network communication across hand-selective areas. This was demonstrated by increased resting state functional connectivity between visual and sensorimotor hand-selective areas, proportional to the intensiveness of everyday prosthesis usage. Further analysis revealed a 3-fold coupling between prosthesis activity, visuomotor connectivity and usage, suggesting a possible role for the motor system in shaping use-dependent representation in visual hand-selective areas, and/or vice versa. Moreover, able-bodied control participants who routinely observe prosthesis usage (albeit less intensively than the prosthesis users) showed significantly weaker associations between degree of prosthesis observation and visual cortex activity or connectivity. Together, our findings suggest that altered daily motor behaviour facilitates prosthesis-related visual processing and shapes communication across hand-selective areas. This neurophysiological substrate for prosthesis embodiment may inspire rehabilitation approaches to improve usage of existing substitutionary devices and aid implementation of future assistive and augmentative technologies.

21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...

21 CFR 888.3790 - Wrist joint metal constrained cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint metal constrained cemented prosthesis... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3790 Wrist joint metal constrained cemented prosthesis. (a) Identification. A wrist joint metal constrained cemented prosthesis is a...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...

Fluorescence and UV-vis Spectroscopy of Synovial Fluids

NASA Astrophysics Data System (ADS)

Pinti, Marie J.; Stojilovic, Nenad; Kovacik, Mark W.

2009-10-01

Total joint arthroplasty involves replacing the worn cartilaginous surfaces of the joint with man-made materials that are designed to be biocompatible and to withstand mechanical stresses. Commonly these bearing materials consist of metallic alloys (TiAlV or CoCrMo) and UHMWPE. Following joint arthroplasty, the normal generation of micro-metallic wear debris particles that dislodge from the prosthesis has been shown to cause inflammatory aseptic osteolysis (bone loss) that ultimately results in the failure of the implant. Here we report our results on the novel use of Fluorescence and UV-vis spectroscopy to investigate the metallic content of synovial fluid specimens taken from postoperative total knee arthroplasties. Preliminary finding showed presence of alumina and chromium is some specimens. The ability to detect and monitor the wear rate of these implants could have far reaching implications in the prevention of metallic wear-debris induced osteolysis and impending implant failure.

Red flag in the emergency department: fracture and primary failure of a prosthetic valve.

PubMed

Ozsarac, Murat; Karcioglu, Ozgur; Ayrik, Cuneyt; Bozkurt, Seyran; Turkcuer, Ibrahim; Gumrukcu, Serhat

2005-07-01

This case report concerns a patient with fracture and primary dysfunction of a prosthetic valve. A 40-year-old man presented to the Emergency Department with a chief complaint of breakthrough pleuritic back pain and shortness of breath. Past surgical history was significant only for an aortic valve replacement and mitral valve replacement performed 16 years prior. The transthoracic echocardiography raised suspicion of prosthesis malposition. The patient was taken to the operating room by cardiothoracic surgeons for valve replacement. Operative findings revealed that a prosthetic valve leaflet in the mitral position had broken off. Primary prosthetic valve failure should not be overlooked in the differential diagnosis of patients with valve replacement and a rapidly deteriorating clinical course. Emergency echocardiography is a guide to convenient diagnosis and management. Early surgical consultation and early reparative surgery might prevent unnecessary morbidity and mortality.

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.

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

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.

21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...

21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...

21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...

21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...

21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...

21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...

21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...

21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...

21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...

21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...

21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...

21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...

21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...

21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...

21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...

21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...

21 CFR 888.3750 - Wrist joint carpal lunate polymer prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal lunate polymer prosthesis. 888.3750 Section 888.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... lunate polymer prosthesis. (a) Identification. A wrist joint carpal lunate prosthesis is a one-piece...

21 CFR 888.3730 - Toe joint phalangeal (hemi-toe) polymer prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint phalangeal (hemi-toe) polymer prosthesis. 888.3730 Section 888.3730 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... (hemi-toe) polymer prosthesis. (a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis...

21 CFR 888.3760 - Wrist joint carpal scaphoid polymer prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint carpal scaphoid polymer prosthesis. 888.3760 Section 888.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... scaphoid polymer prosthesis. (a) Identification. A wrist joint carpal scaphoid polymer prosthesis is a one...

21 CFR 888.3770 - Wrist joint carpal trapezium polymer prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint carpal trapezium polymer prosthesis. 888.3770 Section 888.3770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... trapezium polymer prosthesis. (a) Identification. A wrist joint carpal trapezium polymer prosthesis is a one...

[Virtual Planning of Prosthetic Treatment of the Orbit].

PubMed

Veit, Johannes A; Thierauf, Julia; Egner, Kornelius; Wiggenhauser, Paul Severin; Friedrich, Daniel; Greve, Jens; Schuler, Patrick J; Hoffmann, Thomas K; Schramm, Alexander

2017-06-01

Optimal positioning of bone-anchored implants in the treatment of patients with orbital prosthesis is challenging. The definition of implant axis as well as the positioning of the implants is important to prevent failures in prosthetic rehabilitation in these patients. We performed virtual planning of enossal implants at a base of a standard fan beam CT scan using the software CoDiagnostiX™ (DentalWings, Montréal, Canada). By 3D-printing a surgical guide for drilling and implant insertion was manufactured (Med-610™, Stratasys, Rehovot, Israel). An orbital exenteration was performed in a patient after shrinkage of the eyelids 20 years after enucleation and radiation of the orbit due to rhabdomyosarcoma. 4 Vistafix-3 implants (Cochlear™, Cochlea, Centennial, USA) were primarily inserted after resection with the help of the 3D-surgical guide. Prosthetic rehabilitation could be achieved as preplanned to a predictable result. The individual prosthesis of the orbit showed good functional and esthetic outcome. The virtual 3D-planning of endosseous implants for prosthetic orbital and periorbital reconstruction is easy to use and facilitates optimal placement of implants especially in posttherapeutically altered anatomic situations. © Georg Thieme Verlag KG Stuttgart · New York.

Zirconia in fixed prosthesis. A literature review

PubMed Central

Román-Rodríguez, Juan L.; Ferreiroa, Alberto; Solá-Ruíz, María F.; Fons-Font, Antonio

2014-01-01

Statement of problem: Evidence is limited on the efficacy of zirconia-based fixed dental prostheses. Objective: To carry out a literature review of the behavior of zirconium oxide dental restorations. Material and Methods: This literature review searched the Pubmed, Scopus, Medline and Cochrane Library databases using key search words “zirconium oxide,” “zirconia,” “non-metal restorations,” “ceramic oxides,” “veneering ceramic,” “zirconia-based fixed dental prostheses”. Both in vivo and in vitro studies into zirconia-based prosthodontic restoration behavior were included. Results: Clinical studies have revealed a high rate of fracture for porcelain-veneered zirconia-based restorations that varies between 6% and 15% over a 3- to 5-year period, while for ceramo-metallic restorations the fracture rate ranges between 4 and 10% over ten years. These results provoke uncertainty as to the long-term prognosis for this material in the oral medium. The cause of veneering porcelain fractures is unknown but hypothetically they could be associated with bond failure between the veneer material and the zirconia sub-structure. Key words:Veneering ceramic, zirconia-based ceramic restoration, crown, zirconia, tooth-supported fixed prosthesis. PMID:24596638

Rapid Molecular Microbiologic Diagnosis of Prosthetic Joint Infection

PubMed Central

Cazanave, Charles; Greenwood-Quaintance, Kerryl E.; Hanssen, Arlen D.; Karau, Melissa J.; Schmidt, Suzannah M.; Gomez Urena, Eric O.; Mandrekar, Jayawant N.; Osmon, Douglas R.; Lough, Lindsay E.; Pritt, Bobbi S.; Steckelberg, James M.

2013-01-01

We previously showed that culture of samples obtained by prosthesis vortexing and sonication was more sensitive than tissue culture for prosthetic joint infection (PJI) diagnosis. Despite improved sensitivity, culture-negative cases remained; furthermore, culture has a long turnaround time. We designed a genus-/group-specific rapid PCR assay panel targeting PJI bacteria and applied it to samples obtained by vortexing and sonicating explanted hip and knee prostheses, and we compared the results to those with sonicate fluid and periprosthetic tissue culture obtained at revision or resection arthroplasty. We studied 434 subjects with knee (n = 272) or hip (n = 162) prostheses; using a standardized definition, 144 had PJI. Sensitivities of tissue culture, of sonicate fluid culture, and of PCR were 70.1, 72.9, and 77.1%, respectively. Specificities were 97.9, 98.3, and 97.9%, respectively. Sonicate fluid PCR was more sensitive than tissue culture (P = 0.04). PCR of prosthesis sonication samples is more sensitive than tissue culture for the microbiologic diagnosis of prosthetic hip and knee infection and provides same-day PJI diagnosis with definition of microbiology. The high assay specificity suggests that typical PJI bacteria may not cause aseptic implant failure. PMID:23658273

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.

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.

BIOENERGETIC DIFFERENCES DURING WALKING AND RUNNING IN TRANSFEMORAL AMPUTEE RUNNERS USING ARTICULATING AND NON-ARTICULATING KNEE PROSTHESES

PubMed Central

Highsmith, M. Jason; Kahle, Jason T.; Miro, Rebecca M.; Mengelkoch, Larry J.

2016-01-01

Transfemoral amputation (TFA) patients require considerably more energy to walk and run than non-amputees. The purpose of this study was to examine potential bioenergetic differences (oxygen uptake (VO2), heart rate (HR), and ratings of perceived exertion (RPE)) for TFA patients utilizing a conventional running prosthesis with an articulating knee mechanism versus a running prosthesis with a non-articulating knee joint. Four trained TFA runners (n = 4) were accommodated to and tested with both conditions. VO2 and HR were significantly lower (p ≤ 0.05) in five of eight fixed walking and running speeds for the prosthesis with an articulating knee mechanism. TFA demonstrated a trend for lower RPE at six of eight walking speeds using the prosthesis with the articulated knee condition. A trend was observed for self-selected walking speed, self-selected running speed, and maximal speed to be faster for TFA subjects using the prosthesis with the articulated knee condition. Finally, all four TFA participants subjectively preferred running with the prosthesis with the articulated knee condition. These findings suggest that, for trained TFA runners, a running prosthesis with an articulating knee prosthesis reduces ambulatory energy costs and enhances subjective perceptive measures compared to using a non-articulating knee prosthesis. PMID:28066524

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.

Adventure sports and sexual freedom hip replacement: the tripolar hip.

PubMed

Pritchett, James W

2018-01-01

Certain athletic activities and lifestyles require a completely stable and very mobile hip. Total hip replacement with a natural femoral head size and two mobile-bearing surfaces (i.e., a "tripolar" prosthesis) is the most stable prosthesis. Elegant design and wear-resistant bearing surfaces are the keys to long-term implant survivorship. The hypothesis is that a ceramic-coated tripolar prosthesis using highly cross-linked polyethylene can provide full function and complete stability with low wear. This study sought to determine: (1) patient-reported outcomes, (2) functional outcomes, (3) implant survivorship and complications, and (4) postoperative sexual limitations. Between 1998 and 2011, the author performed 160 primary total hip replacements using tripolar prostheses in patients participating in adventure sports and other physically demanding activities. The institutional review board approved this study. The inclusion criteria were patients who needed unrestricted activity and who were not candidates for or did not choose hip resurfacing. Patients were followed every second year and assessed with radiographs, Harris Hip Score, WOMAC, SF-12, and UCLA functional outcome scores. Patients were asked about symptoms of instability and satisfaction with their hip replacement. Patients were asked both preoperatively and 2 years postoperatively four questions about their sexual activity. Mean follow-up was 11 years. At 2 years' postoperatively, 98% of patients reported their satisfaction as excellent or good and 99% were not limited for sexual activity following surgery. Seventy-four percent of patients reported they were recovered within 6 weeks of surgery. There were no dislocations. There were three revision procedures for implant loosening, infection, and periprosthetic fracture, but there were no failures of the tripolar articulation. The mean postoperative UCLA score was the highly athletic score of 8. There were no signs of osteolysis, wear, or metal sensitivity reactions. The range of motion achieved, sexual, and functional outcomes were higher than with other types of total hip replacement. This ceramic-coated tripolar prosthesis using highly cross-linked polyethylene provides full function, complete stability, and low wear to younger, active patients, thus confirming the hypothesis and clinical relevance.

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.

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.

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 patterns of upper limb activity. Further work is needed to explore the relationship between traditional functional outcome measures and real-world prosthesis activity.

Functional evaluation of a CAD/CAM prosthesis for immediate defect repair after total maxillectomy: a case series of 18 patients with maxillary sinus cancer.

PubMed

Jiang, Fei-Fei; Hou, Yan; Lu, Li; Ding, Xiao-Xu; Li, Wei; Yan, Ai-Hui

2015-01-01

To evaluate the facial profiles and functional recovery of 18 patients treated by a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis) after total maxillectomy for malignant maxillary sinus tumor. A retrospective observational study was performed to evaluate the facial profiles and functional recovery of 18 patients with T3-4a N0 M0 maxillary sinus cancer, who were treated by total maxillectomy and simultaneous implantation of a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis). Follow-ups were performed 1, 3, 6, and 12 months after surgery. Facial measurements, speech intelligibility, and chewing and swallowing functions were examined. Thirteen patients converted to a permanent prosthesis 6 months after surgery. Comparisons were made between patients with and without the CAD/CAM or permanent prosthesis at various times using SPSS13.0 statistical software (SPSS Inc., Chicago, IL, USA). Speech intelligibility, facial depression, and eyeball prolapse results showed improvements with prosthesis use at 1, 3, and 6 months after surgery (p < 0.05). Swallowing function improved from level V to level II-IV with prosthesis use at 1, 3, and 6 months, and reached level I or II with permanent prosthesis use at 12 months after surgery. Simultaneous CAD/CAM prosthesis implantation recovered the facial profile, enhanced the speaking, swallowing, and chewing functions, and improved the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. Therefore, this operation is recommended for simultaneous excision repair and functional reconstruction after total maxillectomy. This surgical treatment of maxillary sinus cancer is applied rarely in China, but it has a good effect based on our observation. Simultaneous CAD/CAM prosthesis implantation after total maxillectomy can recover the facial profile, enhance the speaking, swallowing, and chewing functions, and improve the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. This technique avoids the need for dental implants because the bottom part of the prosthesis contains a palatal plate with dentures. © 2014 Wiley Periodicals, Inc.

Survival of modern knee tumor megaprostheses: failures, functional results, and a comparative statistical analysis.

PubMed

Pala, Elisa; Trovarelli, Giulia; Calabrò, Teresa; Angelini, Andrea; Abati, Caterina N; Ruggieri, Pietro

2015-03-01

Modular megaprostheses are now the most common method of reconstruction after segmental resection of the long bones in the lower extremities. Previous studies reported variable outcome and failure rates after knee megaprosthetic reconstructions. The objectives of this study were to analyze the results of a modular tumor prosthesis after resection of bone tumor around the knee with respect to (1) survivorship; (2) failure rate; (3) comparative survivorship against different sites of reconstructions and of primary and revision implants; and (4) functional results on the Musculoskeletal Tumor Society (MSTS) scoring system. Between 2003 and 2010, 247 rotating-hinge Global Modular Reconstruction System (GMRS) knee prostheses were implanted in our institute for malignant and aggressive benign tumors. During this time, that group represented 23% of the patients who had oncologic megaprosthesis reconstruction about the knee after resection of primary or metastatic bone tumors (247 of 1086 patients). In the other 77% of cases we used other types of oncologic prostheses. Before 2003 we used the older Howmedica Modular Resection System and Kotz Modular Femur/Tibia Replacement from 2003 we used mostly the GMRS but we continued to use the HMRS in some cases such as patients with poor prognoses, elderly patients, or metastatic patients. Sites included 187 distal femurs and 60 proximal tibias. Causes of megaprosthesis failure were classified according to Henderson et al. in five types: Type 1 (soft tissue failure), Type 2 (aseptic loosening), Type 3 (structural failure), Type 4 (infection), and Type 5 (tumor progression). Followup was at a minimum oncologic followup of 2 years (mean, 4 years; range, 2-8 years). Kaplan-Meier actuarial curves of implant survival to major failures were done. Functional results were analyzed according to the MSTS II system; 223 of the 247 were available for functional scoring (81%). At latest followup, among 175 treated patients for primary reconstruction, 117 are continuously disease-free, 26 have no evidence of disease after treatment of relapse, eight are alive with disease, and 24 died from disease. The overall failure rate of the megaprostheses in our series was 29.1% (72 of 247). Type 1 failure occurred in 8.5% (21 of 247) cases, Type 2 in 5.6% (14 of 247), Type 3 in 0%, Type 4 in 9.3% (23 of 247), and Type 5 in 5.6% (14 of 247). Kaplan-Meier curve showed an overall implant survival rate for all types of failures of 70% at 4 years and 58% at 8 years. Prosthetic survivorship for revisions was 80% at 5 years and for primary reconstructions was 60% at 5 years (p = 0.013). Survivorship to infection was 95% at 5 years for revision patients and 84% at 5 years for primary patients (p = 0.475). The mean MSTS score was 84 (25.2; range, 8-30) with no difference between sites of localization (24.7 in proximal tibia versus 25.4 in distal femur reconstruction; p = 0.306). Results at a minimum of 2 years with this modular prosthesis are satisfactory in terms of survivorship (both oncologic and reconstructive) and causes and rates of failure. Although these results seem comparable with other like implants, we will continue to follow this cohort, and we believe that comparative trials among the available megaprosthesis designs are called for. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Development and application of biomimetic electrospun nanofibers in total joint replacement

NASA Astrophysics Data System (ADS)

Song, Wei

Failure of osseointegration (direct anchorage of an implant by bone formation at the bone-implant surface) and implant infection (such as that caused by Staphylococcus aureus, S. aureus) are the two main causes of implant failure and loosening. There is a critical need for orthopedic implants that promote rapid osseointegration and prevent bacterial colonization, particularly when placed in bone compromised by disease or physiology of the patients. A better understanding of the key factors that influence cell fate decisions at the bone-implant interface is required. Our study is to develop a class of "bone-like" nanofibers (NFs) that promote osseointegration while preventing bacterial colonization and subsequent infections. This research goal is supported by our preliminary data on the preparation of coaxial electrospun NFs composed of polycaprolactone (PCL) and polyvinyl alcohol (PVA) polymers arranged in a core-sheath shape. The PCL/PVA NFs are biocompatible and biodegradable with appropriate fiber diameter, pore size and mechanical strength, leading to enhanced cell adhesion, proliferation and differentiation of osteoblast precursor cells. The objective is to develop functionalized "bone-like" PCL/PVA NFs matrix embedded with antibiotics (doxycycline (Doxy), bactericidal and anti-osteoclastic) on prosthesis surface. Through a rat tibia implantation model, the Doxy incorporated coaxial NFs has demonstrated excellent in promoting osseointegration and bacteria inhibitory efficacy. NFs coatings significantly enhanced the bonding between implant and bone remodeling within 8 weeks. The SA-induced osteomyelitis was prevented by the sustained release of Doxy from NFs. The capability of embedding numerous bio-components including proteins, growth factors, drugs, etc. enables NFs an effective solution to overcome the current challenged issue in Total joint replacement. In summary, we proposed PCL/PVA electrospun nanofibers as promising biomaterials that can be applied on joint replacement prosthesis to improve osseointegration and prevent osteomyelitis.

Vertical augmentation with interpositional blocks of anorganic bovine bone vs. 7-mm-long implants in posterior mandibles: 1-year results of a randomized clinical trial.

PubMed

Felice, Pietro; Pellegrino, Gerardo; Checchi, Luigi; Pistilli, Roberto; Esposito, Marco

2010-12-01

To evaluate whether 7-mm-long implants could be an alternative to longer implants placed in vertically augmented posterior mandibles. Sixty patients with posterior mandibular edentulism with 7-8 mm bone height above the mandibular canal were randomized to either vertical augmentation with anorganic bovine bone blocks and delayed 5-month placement of ≥10 mm implants or to receive 7-mm-long implants. Four months after implant placement, provisional prostheses were delivered, replaced after 4 months, by definitive prostheses. The outcome measures were prosthesis and implant failures, any complications and peri-implant marginal bone levels. All patients were followed to 1 year after loading. One patient dropped out from the short implant group. In two augmented mandibles, there was not sufficient bone to place 10-mm-long implants possibly because the blocks had broken apart during insertion. One prosthesis could not be placed when planned in the 7 mm group vs. three prostheses in the augmented group, because of early failure of one implant in each patient. Four complications (wound dehiscence) occurred during graft healing in the augmented group vs. none in the 7 mm group. No complications occurred after implant placement. These differences were not statistically significant. One year after loading, patients of both groups lost an average of 1 mm of peri-implant bone. There no statistically significant differences in bone loss between groups. When residual bone height over the mandibular canal is between 7 and 8 mm, 7 mm short implants might be a preferable choice than vertical augmentation, reducing the chair time, expenses and morbidity. These 1-year preliminary results need to be confirmed by follow-up of at least 5 years. © 2010 John Wiley & Sons A/S.

Tilted Implants for Full-Arch Rehabilitations in Completely Edentulous Maxilla: A Retrospective Study

PubMed Central

Cavalli, Nicolò; Barbaro, Bruno; Spasari, Davide; Azzola, Francesco; Ciatti, Alberto; Francetti, Luca

2012-01-01

Purpose. The aims of this study were to assess the treatment outcome of immediately loaded full-arch fixed bridges anchored to both tilted and axially placed implants in the edentulous maxilla and to evaluate the incidence of biological and prosthetic complications. Materials and Methods. Thirty-four patients (18 women and 16 men) were included in the study. Each patient received a maxillary full-arch fixed bridge supported by two axial implants and two distal tilted implants. A total of 136 implants were inserted. Loading was applied within 48 hours of surgery and definitive restorations were placed 4 to 6 months later. Patients were scheduled for followup at 6, 12, 18, and 24 months and annually up to 5 years. At each followup plaque level and bleeding scores were assessed and every complication was recorded. Results. The overall follow-up range was 12 to 73 months (mean 38.8 months). No implant failures were recorded to date, leading to a cumulative implant survival rate of 100%. Biological complications were recorded such as alveolar mucositis (11.8% patients), peri-implantitis (5.9% patients), and temporomandibular joint pain (5.9% patients). The most common prosthetic complications were the fracture or detachment of one or multiple acrylic teeth in both the temporary (20.6% patients) and definitive (17.7% patients) prosthesis and the minor acrylic fractures in the temporary (14.7% patients) and definitive (2.9% patients) prosthesis. Hygienic complications occurred in 38.2% patients. No patients' dissatisfactions were recorded. Conclusions. The high cumulative implant survival rate indicates that this technique could be considered a viable treatment option. An effective recall program is important to early intercept and correct prosthetic and biologic complications in order to avoid implant and prosthetic failures. PMID:23133453

Antibiotic Prophylaxis after Immediate Breast Reconstruction: The Reality of Its Efficacy.

PubMed

Ranganathan, Kavitha; Sears, Erika D; Zhong, Lin; Chung, Ting-Ting; Chung, Kevin C; Kozlow, Jeffrey H; Momoh, Adeyiza O; Waljee, Jennifer F

2018-04-01

Numerous techniques are used to prevent infection after immediate implant-based breast reconstruction. Postoperative antibiotic prophylaxis is commonly prescribed to decrease the risk of reconstructive failure, despite conflicting evidence regarding its effectiveness. The authors studied whether postoperative antibiotic prophylaxis decreases the risk of infection-related explantation in the setting of immediate prosthesis-based breast reconstruction. Using Truven MarketScan databases, the authors identified all patients who underwent immediate implant reconstruction between January of 2010 and June of 2014 with at least 6 months of follow-up. Postoperative antibiotic prophylaxis was defined as any oral antibiotic course to be taken postoperatively based on prescriptions filled within 14 days preoperatively through 24 hours after discharge. Reconstructive failure, defined as explantation because of infection, was the primary outcome. Secondary outcomes of interest included wound complications, infection, and readmission for infection. Multivariable regression analyses controlled for demographic variables/comorbidities. Of the 7443 patients, 6049 (81 percent) filled prescriptions for postoperative antibiotic prophylaxis. These patients were equally likely to develop a wound complication (OR, 0.93; 95 percent CI, 0.71 to 1.23) or infection (OR, 0.89; 95 percent CI, 0.70 to 1.14), undergo explantation because of infection (OR, 0.82; 95 percent CI, 0.57 to 1.18), or require readmission for infection (OR, 1.21; 95 percent CI, 0.82 to 1.78) compared with those who did not receive antibiotics. There was no significant difference in the risk of infection-related outcomes based on postoperative antibiotic prophylaxis duration. Postoperative antibiotic prophylaxis was not associated with a reduced risk of infection or explantation following prosthesis-based breast reconstruction. Given rising rates of antibiotic resistance, focusing instead on technical considerations and the management of comorbid conditions may more effectively enhance the safety of breast reconstruction. Therapeutic, III.

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.

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.

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

A new three-dimensional, print-on-demand temporomandibular prosthetic total joint replacement system: Preliminary outcomes.

PubMed

Dimitroulis, George; Austin, Stephen; Sin Lee, Peter Vee; Ackland, David

2018-05-16

The aim of this study is to present the preliminary clinical data on the OMX Temporomandibular Joint (TMJ) Prosthetic total joint replacement system. A prospective, cohort, clinical study was undertaken of consecutive adult patients with Category 5 end-stage joint disease who were implanted with the OMX TMJ prosthesis between May 2015 and April 2017. A total of 50 devices were implanted in 38 patients, with 12 patients receiving bilateral prosthetic joints. There were 31 females and 7 males in this cohort, who ranged in age from 20 to 66 years, with a mean of 43.8 years (±14.0 years). Ten of the 50 prosthetic joints (20%) were fully customized, while the remaining were patient matched using virtual planning software. Based on a mean follow-up period of 15.3 months (range 12-24 months) following the TMJ total joint replacement, preliminary results suggest the OMX TMJ prosthesis has made a positive impact on clinical outcomes, with a mean 74.4% reduction in joint pain levels and significant improvements (p < 0.05) in jaw function as measured by the visual analogue scales for mouth opening (30.8%), diet (77.1%), and function (59.2%). No device failures were reported during the study period. This study suggests that the print-on-demand OMX TMJ prosthesis, designed for rapid delivery of both patient-matched and fully customize devices, represents a safe, reliable and versatile implantable joint replacement system for the treatment of category 5 end-stage TMJ disease. Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Younger age increases the risk of early prosthesis failure following primary total knee replacement for osteoarthritis. A follow-up study of 32,019 total knee replacements in the Finnish Arthroplasty Register.

PubMed

Julin, Jaakko; Jämsen, Esa; Puolakka, Timo; Konttinen, Yrjö T; Moilanen, Teemu

2010-08-01

Total knee replacements (TKRs) are being increasingly performed in patients aged < or = 65 years who often have high physical demands. We investigated the relation between age of the patient and prosthesis survival following primary TKR using nationwide data collected from the Finnish Arthroplasty Register. From Jan 1, 1997 through Dec 31, 2003, 32,019 TKRs for primary or secondary osteoarthritis were reported to the Finnish Arthroplasty Register. The TKRs were followed until the end of 2004. During the follow-up, 909 TKRs were revised, 205 (23%) due to infection and 704 for other reasons. Crude overall implant survival improved with increasing age between the ages of 40 and 80. The 5-year survival rates were 92% and 95% in patients aged < or = 55 and 56-65 years, respectively, compared to 97% in patients who were > 65 years of age (p < 0.001). The difference was mainly attributable to reasons other than infections. Sex, diagnosis, type of TKR (condylar, constrained, or hinge), use of patellar component, and fixation method were also associated with higher revision rates. However, the differences in prosthesis survival between the age groups < or = 55, 56-65, and > 65 years remained after adjustment for these factors (p < 0.001). Young age impairs the prognosis of TKR and is associated with increased revision rates for non-infectious reasons. Diagnosis, sex, type of TKR, use of patellar component, and fixation method partly explain the differences, but the effects of physical activity, patient demands, and obesity on implant survival in younger patients warrant further research.

Initial experience with xenograft bioconduit for the treatment of complex prosthetic valve endocarditis.

PubMed

Roubelakis, Apostolos; Karangelis, Dimos; Sadeque, Syed; Yanagawa, Bobby; Modi, Amit; Barlow, Clifford W; Livesey, Steven A; Ohri, Sunil K

2017-07-01

The treatment of complex prosthetic valve endocarditis (PVE) with aortic root abscess remains a surgical challenge. Several studies support the use of biological tissues to minimize the risk of recurrent infection. We present our initial surgical experience with the use of an aortic xenograft conduit for aortic valve and root replacement. Between October 2013 and August 2015, 15 xenograft bioconduits were implanted for complex PVE with abscess (13.3% female). In 6 patients, concomitant procedures were performed: coronary bypass (n=1), mitral valve replacement (n=5) and tricuspid annuloplasty (n=1). The mean age at operation was 60.3±15.5 years. The mean Logistic European system for cardiac operating risk evaluation (EuroSCORE) was 46.6±23.6. The median follow-up time was 607±328 days (range: 172-1074 days). There were two in-hospital deaths (14.3% mortality), two strokes (14.3%) and seven patients required permanent pacemaker insertion for conduction abnormalities (46.7%). The mean length of hospital stay was 26 days. At pre-discharge echocardiography, the conduit mean gradient was 9.3±3.3mmHg and there was either none (n=6), trace (n=6) or mild aortic insufficiency (n=1). There was no incidence of mid-term death, prosthesis-related complications or recurrent endocarditis. Xenograft bioconduits may be safe and effective for aortic valve and root replacement for complex PVE with aortic root abscess. Although excess early mortality reflects the complexity of the patient population, there was good valve hemodynamics, with no incidence of recurrent endocarditis or prosthesis failure in the mid-term. Our data support the continued use and evaluation of this biological prosthesis in this high-risk patient cohort.

Post-marketing surveillance of CustomBone Service implanted in children under 7 years old.

PubMed

Frassanito, Paolo; Tamburrini, Gianpiero; Massimi, Luca; Di Rocco, Concezio; Nataloni, Angelo; Fabbri, Greta; Caldarelli, Massimo

2015-01-01

The CustomBone Service is a bioceramic implant suitable for cranial repair in both adults and children, although there are no clinical data about its use in children under 7 years of age. This surveillance study investigates the outcome in this age group. Twenty-eight children under 7 years old (range, 2.5-6 years) received CustomBone Service from July 2006 to May 2013 in 16 international hospitals. Data of 23 children (12 males and 11 females), harboring 24 prosthesis, were available with a minimum follow-up of 1 year. Sites of the cranial defect were frontal or parietal (20.8 % each), parieto-temporal (16.7 %), fronto-parietal or occipital (12.5 % each), fronto-parieto-temporal or fronto-temporal (8.3 % each). Initial diseases were trauma (54.2 %), malformation (37.5 %), or tumor of the bone/skin (8.3 %). Rupture of the implant occurred in a single case during the implant (1/26 surgeries, 3.8 %) and the cranial repair was achieved by means of the back-up prosthesis. Five adverse events were registered during the follow-up period consisting of three cases of fracture and two of exposure/infection of the prosthesis. All cases required the removal of the device (20.8 %). The failure rate of CustomBone Service under 7 years of age was higher than reported in adults and children over 7 years old (20.8 vs. 3.8 %), However, CustomBone Service may be considered a valid option under 7 years old since other materials are burdened by more significant rates of complications in the long-term period. Due to specific properties of this material, indication to CustomBone Service in toddlers should be carefully evaluated by the surgeon on a case-by-case basis.

Customization of the voice prosthesis to prevent leakage from the enlarged tracheoesophageal puncture: results of a prospective trial.

PubMed

Lewin, Jan S; Hutcheson, Katherine A; Barringer, Denise A; Croegaert, Lindsay E; Lisec, Asher; Chambers, Mark S

2012-08-01

Customization of the tracheoesophageal (TE) voice prosthesis (VP) is often preferred over surgical closure to prevent aspiration around the VP in laryngectomized patients with an enlarged tracheoesophageal puncture (TEP), but it has not been thoroughly evaluated. Single-institution prospective trial. A prospective trial was conducted to evaluate the effectiveness of a customized VP with the addition of an enlarged tracheal and/or esophageal collar in patients with leakage around an enlarged TEP. Absence of leakage around the VP after placement defined immediate effectiveness. Long-term success was defined by the prevention of adverse events related to leakage during the study period. Events that defined failure included: permanent gastrostomy dependence, aspiration pneumonia, and/or surgical TEP closure. Twenty-one patients with enlarged TEP were enrolled (2003-2006). Insertion of a customized VP was unsuccessful in one patient; 145 customizations were performed in the remaining 20 patients (median, 3.5 customizations) during the trial period. Of the customizations, 77% (112/145) prevented leakage immediately after VP insertion. The most common adverse event was dislodgement of the prosthesis (11%) or the collar alone (7%) in 18% (26/145) of customized VP placements. Six patients who died of disease were not evaluable for long-term outcomes. Long-term success was achieved in 80% (12/15) of evaluable patients who avoided permanent gastrostomy, aspiration pneumonia, and surgical TEP closure. Prosthetic customization offers an effective method to prevent leakage around the VP in many patients with an enlarged TEP, thereby preserving TE voice while avoiding surgical closure in this high-risk population. Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.

Customization of the Voice Prosthesis to Prevent Leakage from the Enlarged Tracheoesophageal Puncture: Results of a Prospective Trial

PubMed Central

Lewin, Jan S.; Hutcheson, Katherine A.; Barringer, Denise A.; Croegaert, Lindsay E.; Lisec, Asher; Chambers, Mark S.

2014-01-01

Background Customization of the tracheoesophageal (TE) voice prosthesis (VP) is often preferred over surgical closure to prevent aspiration around the VP in laryngectomized patients with an enlarged tracheoesophageal puncture (TEP), but has not been thoroughly evaluated. Study Design Single-institution prospective trial. Methods A prospective trial was conducted to evaluate the effectiveness of a customized VP with the addition of an enlarged tracheal and/or esophageal collar in patients with leakage around an enlarged TEP. Absence of leakage around the VP after placement defined immediate effectiveness. Long-term success was defined by the prevention of adverse events related to leakage during the study period. Events that defined failure included: permanent gastrostomy dependence, aspiration pneumonia, and/or surgical TEP closure. Results Twenty-one patients with enlarged TEP were enrolled (2003-2006). Insertion of a customized VP was unsuccessful in 1 patient; 145 customizations were performed in the remaining 20 patients (median: 3.5 customizations) during the trial period. Seventy-seven percent (112/145) of customizations prevented leakage immediately after VP insertion. The most common adverse event was dislodgement of the prosthesis (11%) or the collar alone (7%) in 18% (26/145) of customized VP placements. Six patients who died of disease were not evaluable for long-term outcomes. Long-term success was achieved in 80% (12/ 15) of evaluable patients who avoided permanent gastrostomy, aspiration pneumonia, and surgical TEP closure. Conclusions Prosthetic customization offers an effective method to prevent leakage around the VP in many patients with an enlarged TEP, thereby preserving TE voice while avoiding surgical closure in this high risk population. PMID:22753122

Incidence and Determinants of Dental Implant Failure: A Review of Electronic Health Records in a U.S. Dental School.

PubMed

Hickin, Matthew Parker; Shariff, Jaffer A; Jennette, Philip J; Finkelstein, Joseph; Papapanou, Panos N

2017-10-01

The aim of this study was to use electronic health care records (EHRs) to examine retrospectively the incidence of and attributes associated with dental implant failures necessitating implant removal in a large cohort of patients treated in the student clinics of a U.S. dental school over three and a half years. EHRs were searched for all patients who received dental implants between July 1, 2011, and December 31, 2014. Characteristics of patients and implants that were actively removed due to irrevocable failure of any etiology ("failure cohort") during this period were compared to those of all other patients who received dental implants during the same time frame ("reference cohort"). Differences in the frequency distribution of various characteristics between the failure and reference cohorts were compared. Of a total 6,129 implants placed in 2,127 patients during the study period, 179 implants (2.9%) in 120 patients (5.6%) were removed. In the multivariate analysis, presence of a removable (OR=2.86) or fixed temporary prosthesis (OR=3.71) was statistically significantly associated with increased risk for implant failure. In contrast, antibiotic coverage (pre- and post-surgery OR=0.16; post-surgery only OR=0.38) and implants of certain manufacturers were associated with lower risk of implant failure. In this sizeable cohort of patients receiving care in dental student clinics, the review of EHRs facilitated identification of multiple variables associated with implant failure resulting in removal; however, these findings do not suggest causative relationships. The adopted analytical approach can enhance quality assurance measures and may contribute to the identification of true risk factors for dental implant failure.

Design and preliminary biomechanical analysis of artificial cervical joint complex.

PubMed

Jian, Yu; Lan-Tao, Liu; Zhao, Jian-ning; Jian-ning, Zhao

2013-06-01

To design an artificial cervical joint complex (ACJC) prosthesis for non-fusion reconstruction after cervical subtotal corpectomy, and to evaluate the biomechanical stability, preservation of segment movements and influence on adjacent inter-vertebral movements of this prosthesis. The prosthesis was composed of three parts: the upper/lower joint head and the middle artificial vertebrae made of Cobalt-Chromium-Molybdenum (Co-Cr-Mo) alloy and polyethylene with a ball-and-socket joint design resembling the multi-axial movement in normal inter-vertebral spaces. Biomechanical tests of intact spine (control), Orion locking plate system and ACJC prosthesis were performed on formalin-fixed cervical spine specimens from 21 healthy cadavers to compare stability, range of motion (ROM) of the surgical segment and ROM of adjacent inter-vertebral spaces. As for stability of the whole lower cervical spine, there was no significant difference of flexion, extension, lateral bending and torsion between intact spine group and ACJC prosthesis group. As for segment movements, difference in flexion, lateral bending or torsion between ACJC prosthesis group and control group was not statistically significant, while ACJC prosthesis group showed an increase in extension (P < 0.05) compared to that of the control group. In addition, ACJC prosthesis group demonstrated better flexion, extension and lateral bending compared to those of Orion plating system group (P < 0.05). Difference in adjacent inter-vertebral ROM of the ACJC prosthesis group was not statistically significant compared to that of the control group. After cervical subtotal corpectomy, reconstruction with ACJC prosthesis not only obtained instant stability, but also reserved segment motions effectively, without abnormal gain of mobility at adjacent inter-vertebral spaces.

Use of prostheses in lower limb amputee patients due to peripheral arterial disease

PubMed Central

Chamlian, Therezinha Rosane

2014-01-01

Objective To evaluate the indication of prosthesis during rehabilitation and the maintenance of their use or abandonment rate after discharge, as well as mortality of lower limb amputees due to peripheral arterial disease. Methods A retrospective and cross-sectional study carried out with lower limb amputee patients, at transfemoral and transtibial levels, due to vascular conditions. The sample was composed of 310 patients (205 men, 105 women, mean age 61.8 years), transfemoral (142) and transtibial (150) levels, unilateral or bilateral (18). A total of 217 were fitted with prosthesis and 93 did not. Nonparametric statistical tests with equality of two proportions, 95% confidence interval and p value <0,05 were used. Results Out of 195 patients we contacted, 151 were fitted with prosthesis and 44 not. Of those that were fitted with prosthesis, 54 still use it, 80 abandoned and 17 died. In the group without prosthesis, 27 were on wheelchair and 17 died. Mortality is statistically higher among patients who were not fitted with prosthesis and 34 death occur, on average, 3.91 years after amputation. Survival time of patients who were not fitted with prosthesis was smaller than those were fitted. Conclusion The use of prosthesis in lower limb amputees, due to vascular conditions, during rehabilitation is high. However, maintenance of prosthesis is not frequent after discharge. Early and high mortality is observed mainly among diabetic patients. PMID:25628194

Prosthesis use in adult acquired major upper-limb amputees: patterns of wear, prosthetic skills and the actual use of prostheses in activities of daily life.

PubMed

Østlie, Kristin; Lesjø, Ingrid Marie; Franklin, Rosemary Joy; Garfelt, Beate; Skjeldal, Ola Hunsbeth; Magnus, Per

2012-11-01

To describe patterns of prosthesis wear and perceived prosthetic usefulness in adult acquired upper-limb amputees (ULAs). To describe prosthetic skills in activities of daily life (ADL) and the actual use of prostheses in the performance of ADL tasks. To estimate the influence of prosthetic skills on actual prosthesis use and the influence of background factors on prosthetic skills and actual prosthesis use. Cross-sectional study analysing population-based questionnaire data (n = 224) and data from interviews and clinical testing in a referred/convenience sample of prosthesis-wearing ULAs (n = 50). Effects were analysed using linear regression. 80.8% wore prostheses. 90.3% reported their most worn prosthesis as useful. Prosthetic usefulness profiles varied with prosthetic type. Despite demonstrating good prosthetic skills, the amputees reported actual prosthesis use in only about half of the ADL tasks performed in everyday life. In unilateral amputees, increased actual use was associated with sufficient prosthetic training and with the use of myoelectric vs cosmetic prostheses, regardless of amputation level. Prosthetic skills did not affect actual prosthesis use. No background factors showed significant effect on prosthetic skills. Most major ULAs wear prostheses. Individualised prosthetic training and fitting of myoelectric rather than passive prostheses may increase actual prosthesis use in ADL.

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.

Frequency of technical complications in fixed implant prosthesis: the effect of prosthesis screw emergence correction by CAD-CAM.

PubMed

Anitua, Eduardo; Flores, Carlos; Piñas, Laura; Alkhraisat, Mohammad

2018-06-05

CAD-CAM technology permits the angular correction of screw emergence into the prosthesis, however there is lack of controlled clinical studies that assess the frequency of technical complications in angled screw channel restorations. This controlled clinical study was designed to assess technical incidences in angled screw channel restorations. Patients having implant prosthesis placed between November, 2014 and December, 2015 were screened. The patients were selected if they received prosthesis with up to 30º correction of the prosthesis screw emergence and had at least one non-angulated prosthesis (screw-retained). All the prostheses were located completely/partially in the posterior region. The frequency of technical complications was the principal variable. A total of 52 patients with a mean age of 62 ± 10 years participated with a total 110 prostheses (55 in the test group and 55 in the control group). A total of 11 technical complications occurred (7 in the test group and 4 in the control group). These differences were not statistically significant. All the prostheses in both groups survived the follow-up. The correction of the screw emergence into the prosthesis has not increased the risk of technical complications in CAD-CAM implant prostheses.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Janik, Gregory

Renders, saves, and analyzes pressure from several sensors in a prosthesis™ socket. The program receives pressure data from 64 manometers and parses the pressure for each individual sensor. The program can then display those pressures as number in a table. The program also interpolates pressures between manometers to create a larger set of data. This larger set of data is displayed as a simple contour plot. That same contour plot can also be placed on a three-dimensional surface in the shape of a prosthesis.This program allows for easy identification of high pressure areas in a prosthesis to reduce the user™smore » discomfort. The program parses the sensor pressures into a human-readable numeric format. The data may also be used to actively adjust bladders within the prosthesis to spread out pressure in real time, according to changing demands placed on the prosthesis. Interpolation of the pressures to create a larger data set makes it even easier for a human to identify particular areas of the prosthesis that are under high pressure. After identifying pressure points, a prosthetician can then redesign the prosthesis and/or command the bladders in the prosthesis to attempt to maintain constant pressures.« less

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.

[Analysis of the failures of a cemented constrained liner model in patients with a high dislocation risk].

PubMed

Gallart, X; Gomez, J C; Fernández-Valencia, J A; Combalía, A; Bori, G; García, S; Rios, J; Riba, J

2014-01-01

To evaluate the short-term results of an ultra high molecular weight polyethylene retentive cup in patients at high risk of dislocation, either primary or revision surgery. Retrospective review of 38 cases in order to determine the rate of survival and failure analysis of a constrained cemented cup, with a mean follow-up of 27 months. We studied demographic data, complications, especially re-dislocations of the prosthesis and, also the likely causes of system failure analyzed. In 21.05% (8 cases) were primary surgery and 78.95% were revision surgery (30 cases). The overall survival rate by Kaplan-Meier method was 70.7 months. During follow-up 3 patients died due to causes unrelated to surgery and 2 infections occurred. 12 hips had at least two previous surgeries done. It wasn't any case of aseptic loosening. Four patients presented dislocation, all with a 22 mm head (P=.008). Our statistical analysis didn't found relationship between the abduction cup angle and implant failure (P=.22). The ultra high molecular weight polyethylene retentive cup evaluated in this series has provided satisfactory short-term results in hip arthroplasty patients at high risk of dislocation. Copyright © 2014 SECOT. Published by Elsevier Espana. All rights reserved.

In vitro biomechanical comparison after fixed- and mobile-core artificial cervical disc replacement versus fusion

PubMed Central

Lou, Jigang; Li, Yuanchao; Wang, Beiyu; Meng, Yang; Wu, Tingkui; Liu, Hao

2017-01-01

Abstract In vitro biomechanical analysis after cervical disc replacement (CDR) with a novel artificial disc prosthesis (mobile core) was conducted and compared with the intact model, simulated fusion, and CDR with a fixed-core prosthesis. The purpose of this experimental study was to analyze the biomechanical changes after CDR with a novel prosthesis and the differences between fixed- and mobile-core prostheses. Six human cadaveric C2–C7 specimens were biomechanically tested sequentially in 4 different spinal models: intact specimens, simulated fusion, CDR with a fixed-core prosthesis (Discover, DePuy), and CDR with a mobile-core prosthesis (Pretic-I, Trauson). Moments up to 2 Nm with a 75 N follower load were applied in flexion–extension, left and right lateral bending, and left and right axial rotation. The total range of motion (ROM), segmental ROM, and adjacent intradiscal pressure (IDP) were calculated and analyzed in 4 different spinal models, as well as the differences between 2 disc prostheses. Compared with the intact specimens, the total ROM, segmental ROM, and IDP at the adjacent segments showed no significant difference after arthroplasty. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment (C5/6) and total ROM than CDR with a fixed-core prosthesis (P > .05). Besides, the difference in IDP at C4/5 after CDR with 2 prostheses was without statistical significance in all the directions of motion. However, the IDP at C6/7 after CDR with a mobile-core prosthesis was lower than CDR with a fixed-core prosthesis in flexion, extension, and lateral bending, with significant difference (P < .05), but not under axial rotation. CDR with a novel prosthesis was effective to maintain the ROM at the target segment and did not affect the ROM and IDP at the adjacent segments. Moreover, CDR with a mobile-core prosthesis presented a little higher values of target segment and total ROM, but lower IDP at the inferior adjacent segment than CDR with a fixed-core prosthesis. PMID:29019902

Adaptation of NASA technology for the optimization of orthopedic knee implants

NASA Technical Reports Server (NTRS)

Saravanos, D. A.; Mraz, P. J.; Hopkins, D. A.

1991-01-01

The NASA technology originally developed for the optimization of composite structures (engine blades) is adapted and applied to the optimization of orthopedic knee implants. A method is developed enabling the tailoring of the implant for optimal interaction with the environment of the tibia. The shape of the implant components are optimized, such that the stresses in the bone are favorably controlled to minimize bone degradation and prevent failures. A pilot tailoring system is developed and the feasibility of the concept is elevated. The optimization system is expected to provide the means for improving knee prosthesis and individual implant tailoring for each patient.

A Simple Device for Morphofunctional Evaluation During Aortic Valve-Sparing Surgery.

PubMed

Leone, Alessandro; Bruno, Piergiorgio; Cammertoni, Federico; Massetti, Massimo

2015-07-01

Valve-sparing operations for the treatment of aortic root disease with a structurally normal aortic valve are increasingly performed as they avoid prosthesis-related complications. Short- and long-term results are critically dependent on perfect intraoperative restoration of valve anatomy and function. Residual aortic regurgitation is the main cause of early failure, and it is the most common motive for reoperation. However, intraoperative morphofunctional valve assessment requires expertise, and only transesophageal echocardiography can provide reliable information. We describe a simple, economic, reproducible hydrostatic test to intraoperatively evaluate valve competency under direct visualization. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Difference in occurrence of heterotopic ossification according to prosthesis type in the cervical artificial disc replacement.

PubMed

Yi, Seong; Kim, Keung Nyun; Yang, Moon Sul; Yang, Joong Won; Kim, Hoon; Ha, Yoon; Yoon, Do Heum; Shin, Hyun Chul

2010-07-15

Retrospective study of the difference of heterotopic ossification (HO) occurrence according to 3 different types of prosthesis. This study was designed to investigate the difference of HO occurrence according to different type of prosthesis. HO is defined as formation of the bone outside the skeletal system. Reported HO occurrence rate in cervical artificial disc replacement (ADR) was unexpectedly high and varied. But the influencing factors of HO in cervical ADR have not been elucidated well. The prosthesis-related factors for making difference of HO occurrence were investigated in this study. A total of 170 patients undergoing cervical arthroplasty with the Bryan cervical disc prosthesis (Medtroic Sofamor Danek, Memphis, TN), Mobi-C disc prosthesis (LDR Medical, Troyes, France), and ProDisc-C (Synthes, Inc., West Chester, PA) were included. Cervical lateral radiographs obtained before and after surgery were used to identify HO. Occurrence rate, occurrence-free period, location, and grade of HOs were investigated according to the different prosthesis. Each prosthesis group included patients as follows: Bryan disc, 81 patients; Mobi-C, 61 patients; and ProDisc-C, 28 patients. Overall HO rate was 40.6% (69 of 170 patients). Each HO occurrence rate by prosthesis was as follows: the Bryan disc group, 21.0%; Mobi-C group, 52.5%; and the ProDisc-C group, 71.4%. In the survival analysis, all patients showed 27.1 +/- 3.7 months as the median survival. The Bryan disc group showed statistically longer survival (48.4 +/- 7.4 months) than the other groups. Occurrence of HO is an inevitable postoperative complication after cervical ADR. The occurrence rate of HO was higher than our expectation. Moreover, definite differences in occurrence rate according to the prosthesis type were identified by this study.

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) 

Long-term outcome of giant cell tumors of bone around the knee treated by en bloc resection of tumor and reconstruction with prosthesis.

PubMed

Yu, Xiu-chun; Xu, Ming; Song, Ruo-xian; Fu, Zhi-hou; Liu, Xiao-ping

2010-08-01

To study the long-term outcomes and complications of giant cell tumors around the knee treated with en bloc resection and reconstruction with prosthesis. From January 1991 to March 2005, 19 patients (11 men, 8 women, average age 35.4 years) were treated in our hospital with en bloc resection and reconstruction with domestic prosthesis (15 hinge knee and 4 rotating-hinge knee). The distal femur was involved in 12 and the proximal tibia in 7 cases. Nine tumors were primary and 10 recurrent. All cases were Campanacci grade III. The affected limb functions were evaluated by the Musculoskeletal Tumor Society scoring system. All patients underwent operation successfully with no complications. The mean follow-up time was 128.9 months (60 to 216 months). Apart from one patient who underwent amputation because of wound infection two years after reoperation, the range of knee motion of 18 patients was 30°-110°. The mean functional score of the affected limb was 22.7 (15 to 27 points). The length of the lower extremities was equal in nine cases; the affected limb was 2-9 cm shorter in the other ten cases. Prosthesis fracture and loosening developed in one, prosthesis aseptic loosening in three, and delayed deep infection and prosthesis loosening in two cases. The prosthesis loosening rate was 31.6%. One patient developed a proximal femur fracture. En bloc resection and reconstruction with prosthesis is a feasible method for treating giant cell tumor of bone around the knee. Complications related to the prosthesis, mainly prosthesis loosening and limb shortening, increase gradually with longer survival time. © 2010 Tianjin Hospital and Blackwell Publishing Asia Pty Ltd.

Is laparoscopic reoperation for failed antireflux surgery feasible?

PubMed

Floch, N R; Hinder, R A; Klingler, P J; Branton, S A; Seelig, M H; Bammer, T; Filipi, C J

1999-07-01

Laparoscopic techniques can be used to treat patients whose antireflux surgery has failed. Case series. Two academic medical centers. Forty-six consecutive patients, of whom 21 were male and 25 were female (mean age, 55.6 years; range, 15-80 years). Previous antireflux procedures were laparoscopic (21 patients), laparotomy (21 patients), thoracotomy (3 patients), and thoracoscopy (1 patient). The cause of failure, operative and postoperative morbidity, and the level of follow-up satisfaction were determined for all patients. The causes of failure were hiatal herniation (31 patients [67%]), fundoplication breakdown (20 patients [43%]), fundoplication slippage (9 patients [20%]), tight fundoplication (5 patients [11%]), misdiagnosed achalasia (2 patients [4%]), and displaced Angelchik prosthesis (2 patients [4%]). Twenty-two patients (48%) had more than 1 cause. Laparoscopic reoperative procedures were Nissen fundoplication (n = 22), Toupet fundoplication (n = 13), paraesophageal hernia repair (n = 4), Dor procedure (n = 2), Angelchik prosthesis removal (n = 2), Heller myotomy (n = 2), and the takedown of a wrap (n = 1). In addition, 18 patients required crural repair and 13 required paraesophageal hernia repair. The mean +/- SEM duration of surgery was 3.5+/-1.1 hours. Operative complications were fundus tear (n = 8), significant bleeding (n = 4), bougie perforation (n = 1), small bowel enterotomy (n = 1), and tension pneumothorax (n = 1). The conversion rate (from laparoscopic to an open procedure) was 20% overall (9 patients) but 0% in the last 10 patients. Mortality was 0%. The mean +/- SEM hospital stay was 2.3+/-0.9 days for operations completed laparoscopically. Follow-up was possible in 35 patients (76%) at 17.2+/-11.8 months. The well-being score (1 best; 10, worst) was 8.6+/-2.1 before and 2.9+/-2.4 after surgery (P<.001). Thirty-one (89%) of 35 patients were satisfied with their decision to have reoperation. Antireflux surgery failures are most commonly associated with hiatal herniation, followed by the breakdown of the fundoplication. The laparoscopic approach may be used successfully to treat patients with failed antireflux operations. Good results were achieved despite the technical difficulty of the procedures.

Single vs two implant-retained overdentures for edentulous mandibles: a systematic review.

PubMed

Alqutaibi, Ahmed Yaseen; Esposito, Marco; Algabri, Radwan; Alfahad, Adnan; Kaddah, Amal; Farouk, Mohammed; Alsourori, Ali

To compare prosthesis and implant failure, patient satisfaction, prosthetic complications and peri-implant marginal bone loss of mandibular overdentures (IOD) supported by a single or two implants. Manual and electronic database (PubMed and Cochrane) searches were performed to identify randomised controlled trials, without language restriction, comparing single vs two implant supported mandibular overdentures. Two investigators extracted data independently. The Cochrane tool was used for assessing the quality of included studies. Meta-analyses were performed for the included RCTs. Six publications corresponding to four RCTs were identified. Three RCTs (corresponding to five publications) were included and one trial was excluded. Follow-ups in function were 1, 3 and 5 years after loading. All included studies were considered to be at a high risk of bias. The pooled result revealed more prosthesis failures at overdentures supported by two implants at 1 year (three trials) (P = 0.02; Risk Difference: -0.12, 95% CI: -0.22, -0.02), however, there were non-significant differences at 3 years (two trials) (P = 0.22; Risk Difference: -0.32, 95% CI: -0.83, 0.19) and at 5 years (one trial) (P = 0.95; Risk Difference: 0.01, 95% CI: -0.22, 0.24). Regarding implant failures, there were more implant losses in overdentures supported by two implants at 1 year (three trials) (P = 0.02; Risk Difference: -0.12, 95% CI: -0.22, -0.02) and at 5 years (one trial) (P = 0.95; Risk Difference: -0.15, 95% CI: -0.28, -0.02), however, there were non-significant difference at 3 years (two trials) (P = 0.2; Risk Difference: -0.33, 95% CI: -0.84, 0.18). After 5 years in function, meta-analyses revealed that there were non-significant differences regarding overall prosthetic complications when mandibular overdentures supported by a single implant were compared with overdentures supported by two implants (P = 0.43; RD: 0.04, 95% CI: -0.06, 0.15). Mandibular overdentures retained by a single implant have comparable results to those retained by two implants. However, this should be interpreted with caution as all the included studies were considered at a high risk of bias.

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.

Using Arrays of Microelectrodes Implanted in Residual Peripheral Nerves to Provide Dextrous Control of, and Modulated Sensory Feedback from, a Hand Prosthesis

DTIC Science & Technology

2015-10-01

Modulated Sensory Feedback from, a Hand Prosthesis PRINCIPAL INVESTIGATOR: Bradley Greger, PhD CONTRACTING ORGANIZATION: Arizona State University...Residual Peripheral Nerves to Provide Dextrous Control of, and Modulated Sensory Feedback from, a Hand Prosthesis 5a. CONTRACT NUMBER 5b. GRANT...Peripheral Nerve Interface, Prosthetic Hand, Neural Prosthesis , Sensory Feedback, Micro-stimulation, Electrophysiology, Action Potentials, Micro

[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.

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 .

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.

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.

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.

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.

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.

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.

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.

Microbial biofilms on facial prostheses.

PubMed

Ariani, Nina; Vissink, Arjan; van Oort, Robert P; Kusdhany, Lindawati; Djais, Ariadna; Rahardjo, Tri Budi W; van der Mei, Henny C; Krom, Bastiaan P

2012-01-01

The composition of microbial biofilms on silicone rubber facial prostheses was investigated and compared with the microbial flora on healthy and prosthesis-covered skin. Scanning electron microscopy showed the presence of mixed bacterial and yeast biofilms on and deterioration of the surface of the prostheses. Microbial culturing confirmed the presence of yeasts and bacteria. Microbial colonization was significantly increased on prosthesis-covered skin compared to healthy skin. Candida spp. were exclusively isolated from prosthesis-covered skin and from prostheses. Biofilms from prostheses showed the least diverse band-profile in denaturing gradient gel electrophoresis (DGGE) whereas prosthesis-covered skin showed the most diverse band-profile. Bacterial diversity exceeded yeast diversity in all samples. It is concluded that occlusion of the skin by prostheses creates a favorable niche for opportunistic pathogens such as Candida spp. and Staphylococcus aureus. Biofilms on healthy skin, skin underneath the prosthesis and on the prosthesis had a comparable composition, but the numbers present differed according to the microorganism.

Amputation and prosthesis implantation shape body and peripersonal space representations

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

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

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.

[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.

Functional Performance Evaluation of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket for Persons with Transfemoral Amputation

DTIC Science & Technology

2016-10-01

satisfaction with device’’ (i.e. prosthesis) than the IC Socket. During year 1, we received all required IRB approvals, registered the clinical... satisfaction with device” (i.e. prosthesis) than the IC Socket. 2. KEYWORDS: Prosthetic Socket, Artificial Limbs, Prosthesis, Transfemoral Amputee, Gait...FlexSIV Socket will result in better quality of life and “ satisfaction with device” (i.e. prosthesis) than the IC socket. Accomplishments under

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.

Aortic annulus eccentricity before and after transcatheter aortic valve implantation: Comparison of balloon-expandable and self-expanding prostheses.

PubMed

Schuhbaeck, Annika; Weingartner, Christina; Arnold, Martin; Schmid, Jasmin; Pflederer, Tobias; Marwan, Mohamed; Rixe, Johannes; Nef, Holger; Schneider, Christian; Lell, Michael; Uder, Michael; Ensminger, Stephan; Feyrer, Richard; Weyand, Michael; Achenbach, Stephan

2015-07-01

The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Technique for systematic bone reduction for fixed implant-supported prosthesis in the edentulous maxilla.

PubMed

Bidra, Avinash S

2015-06-01

Bone reduction for maxillary fixed implant-supported prosthodontic treatment is often necessary to either gain prosthetic space or to conceal the prosthesis-tissue junction in patients with excessive gingival display (gummy smile). Inadequate bone reduction is often a cause of prosthetic failure due to material fractures, poor esthetics, or inability to perform oral hygiene procedures due to unfavorable ridge lap prosthetic contours. Various instruments and techniques are available for bone reduction. It would be helpful to have an accurate and efficient method for bone reduction at the time of surgery and subsequently create a smooth bony platform. This article presents a straightforward technique for systematic bone reduction by transferring the patient's maximum smile line, recorded clinically, to a clear radiographic smile guide for treatment planning using cone beam computed tomography (CBCT). The patient's smile line and the amount of required bone reduction are transferred clinically by marking bone with a sterile stationery graphite wood pencil at the time of surgery. This technique can help clinicians to accurately achieve the desired bone reduction during surgery, and provide confidence that the diagnostic and treatment planning goals have been achieved. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Evaluation and comparison of dimensional accuracy of newly introduced elastomeric impression material using 3D laser scanners: an in vitro study.

PubMed

Pandita, Amrita; Jain, Teerthesh; Yadav, Naveen S; Feroz, S M A; Pradeep; Diwedi, Akankasha

2013-03-01

Aim of the present study was to comparatively evaluate dimensional accuracy of newely introduced elastomeric impression material after repeated pours at different time intervals. In the present study a total of 20 (10 + 10) impressions of master model were made from vinyl polyether silicone and vinyl polysiloxane impression material. Each impression was repeatedly poured at 1, 24 hours and 14 days. Therefore, a total of 60 casts were obtained. Casts obtained were scanned with three-dimensional (3D) laser scanner and measurements were done. Vinyl polyether silicone produced overall undersized dies, with greatest change being 0.14% only after 14 days. Vinyl polysiloxane produced smaller dies after 1 and 24 hours and larger dies after 14 days, differing from master model by only 0.07% for the smallest die and to 0.02% for the largest die. All the deviations measured from the master model with both the impression materials were within a clinically acceptable range. In a typical fixed prosthodontic treatment accuracy of prosthesis is critical as it determines the success, failure and the prognosis of treatment including abutments. This is mainly dependent upon fit of prosthesis which in turn is dependent on dimensional accuracy of dies, poured from elastomeric impressions.

Mondani intraoral welding: historical process and main practical applications.

PubMed

Dal Carlo, L; Pasqualini, M E; Mondani, P M; Rossi, F; Moglioni, E; Shulman, M

2017-01-01

The intraoral welder was invented by Dr. Pierluigi Mondani during the early 70’s to weld titanium needle implants to a titanium bar in patient’s mouth and to load them immediately by means of resin prosthesis. The clinical use documented dates back to 1972. Over the years, many practical applications have been added to the initial one, which have expanded the use of this device. In this scientific work, main applications are described. The aim of the work was to trace the historical process of intra-oral welding according to Mondani and describe the main practical applications. Intra-oral welding is a process introduced by dr. Pier Luigi Mondani of Genova (Italy) which allows to firmly conjoin titanium implants of any shape by means of a titanium bar or also directly between them in the mouth during surgery. The immediate stabilization achieved by intraoral welding increases implants success rate, allows immediate loading even in situations of bone atrophy, saves implants that are running into failure, re-evaluates fractured implants, allows to stabilize submerged implants postponing prosthesis management, allows to achieve efficient rehabilitation protocols to deal with difficult cases. The 40-years’ experience with intra-oral welding described in this article, confirms the ease of use and efficiency in providing immediate stabilization of titanium implants of all types.

Novel technique for laparoscopic harvesting of latissimus dorsi flap with prosthesis implantation for breast reconstruction

PubMed Central

Xu, Shuman; Tang, Peng; Chen, Xianchun; Yang, Xi; Pan, Qinwen; Gui, Yu; Chen, Li

2016-01-01

Abstract Backgroud: An important drawback of the traditional technique for harvesting latissimus dorsi (LD) myocutaneous flap is a long, posterior donor-site incision. Current techniques involve endoscopic or robotic harvesting via a combined approach of open and closed surgery, which necessitates an open axillary incision and the use of special retractors. In this paper, we introduce a fully enclosed laparoscopic technique for harvesting LD flap (LDF) using only 3 small trocar ports. This technique eliminates the need for axillary and donor-site incisions and specialized retractors and considerably reduces the incision size. Methods: We performed laparoscopic harvesting of LDF with prosthesis implantation for immediate breast reconstruction (IBR) after nipple-sparing mastectomy in 2 patients with malignant breast neoplasm who wished to avoid a long scar on the back. Results: IBR using this technique was uneventful in both cases, without any donor-site complications or flap failure. Both patients were satisfied with the esthetic results of the procedure, especially the absence of a visible scar on the back. Conclusion: Enclosed laparoscopic harvesting of LDF is simpler and less invasive than the traditional methods. These preliminary results warrant further evaluation in a larger population to validate the benefits of this technique. PMID:27861385

Experience with the use of a partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft.

PubMed

Birk, Stephanie; Brase, Christoph; Hornung, Joachim

2014-08-01

In the further development of alloplastic prostheses for use in middle ear surgery, the Dresden and Cologne University Hospitals, working together with a company, introduced a new partial ossicular replacement prosthesis in 2011. The ball-and-socket joint between the prosthesis and the shaft mimics the natural articulations between the malleus and incus and between the incus and stapes, allowing reaction to movements of the tympanic membrane graft, particularly during the healing process. Retrospective evaluation To reconstruct sound conduction as part of a type III tympanoplasty, partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft was implanted in 60 patients, with other standard partial ossicular replacement prosthesis implanted in 40 patients and 64 patients. Pure-tone audiometry was carried out, on average, 19 and 213 days after surgery. Results of the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft were compared with those of the standard prostheses. Early measurements showed a mean improvement of 3.3 dB in the air-bone gap (ABG) with the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft, giving similar results than the standard implants (6.6 and 6.0 dB, respectively), but the differences were not statistically significant. Later measurements showed a statistically significant improvement in the mean ABG, 11.5 dB, compared with 4.4 dB for one of the standard partial ossicular replacement prosthesis and a tendency of better results to 6.9 dB of the other standard prosthesis. In our patients, we achieved similarly good audiometric results to those already published for the partial ossicular replacement prosthesis with a ball-and-socket joint between the plate and the shaft. Intraoperative fixation posed no problems, and the postoperative complication rate was low.

Comparative experimental re-evaluation of the two implanting methods of silicone gel testicular prostheses in beagle dogs

PubMed Central

2011-01-01

Background Testicular prosthesis has been applied clinically for decades, and implantation of testis prosthesis under the tunica albuginea has been considered to be the standard method in the most of the reports. However, postoperative scrotal appearance, the mobilization and the palpitation of the prosthesis are not always satisfactory to all the patients. Modifications in surgical techniques might be necessary to bring improvements to the clinical outcomes in testicular prosthesis implantation. Findings In a group of 9 beagle dogs in this study, an orchiectomy succeeded with a testicular prosthesis implantation under the tunica vaginalis, and a complete mechanical denudation of the testicular parenchyma succeeded with an implantation under the tunica albuginea were performed, respectively. Histopathological evaluations of the scrotal tissues and the implants, which were made at the end of the follow-up, showed that all the tested animals lived uneventful lives during the follow-up period, and no rejections or infections were found. Prostheses implanted under the tunica vaginalis showed a more satisfying mobilization and palpation than those implanted under the tunica albuginea. Chronic inflammation in the para-prosthesis tissues with vascular proliferation and fibrinogenesis were more common in the "under tunica albuginea" group than that in the "under tunica vaginalis" group, although differences in fibrinogenesis between the two groups were found to be statistically insignificant. Conclusions In this comparative study, we have re-evaluated the two most popular implantation methods of testicular prosthesis, the "under the tunica albuginea" and the "under the tunica vaginalis" pathways, in animal models. We found that the testicular prosthesis were all well tolerated, but the prosthesis implanted under the tunica vaginalis showed a more satisfying result concerning appearance, palpability, and histopathological findings than that of the "under the tunica albuginea" group. The "under the tunica vaginalis" method might become a more practical method for future testicular prosthesis implantation. PMID:21457571

[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 replacement.

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.

Evaluation of direct and indirect additive manufacture of maxillofacial prostheses.

PubMed

Eggbeer, Dominic; Bibb, Richard; Evans, Peter; Ji, Lu

2012-09-01

The efficacy of computer-aided technologies in the design and manufacture of maxillofacial prostheses has not been fully proven. This paper presents research into the evaluation of direct and indirect additive manufacture of a maxillofacial prosthesis against conventional laboratory-based techniques. An implant/magnet-retained nasal prosthesis case from a UK maxillofacial unit was selected as a case study. A benchmark prosthesis was fabricated using conventional laboratory-based techniques for comparison against additive manufactured prostheses. For the computer-aided workflow, photogrammetry, computer-aided design and additive manufacture (AM) methods were evaluated in direct prosthesis body fabrication and indirect production using an additively manufactured mould. Qualitative analysis of position, shape, colour and edge quality was undertaken. Mechanical testing to ISO standards was also used to compare the silicone rubber used in the conventional prosthesis with the AM material. Critical evaluation has shown that utilising a computer-aided work-flow can produce a prosthesis body that is comparable to that produced using existing best practice. Technical limitations currently prevent the direct fabrication method demonstrated in this paper from being clinically viable. This research helps prosthesis providers understand the application of a computer-aided approach and guides technology developers and researchers to address the limitations identified.

[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.

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.

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.

[Osseointegration as a method of direct stabilization of amputation prostheses to the bone].

PubMed

Rochmiński, Robert; Sibński, Marcin; Synder, Marek

2011-01-01

This article summarizes important advantages, disadvantages and the process of treatment of patients after lower limb amputation on the level of the femur, with osseointegrated prosthesis. In the process of treatment bone-integrated material is implanted to the femur, with allows for structural and functional connection between live tissue and the prosthesis. This solution allows the patient for easy usage and direct steerage of the prosthesis, transferring of body weight to the floor and detection of sensation in the moment of contact between prosthesis and the ground. Osseointegrated prostheses in the femur gives the opportunity not to use the traditional solutions and socket-related problems as: mobility difficulties, skin sores, rush, pain during weight bearing, temporary changes of the stump volume, difficulty donning the prosthesis, unreliability of prosthesis being securely suspended. Osseointegration is possible even in cases, when quality of skin and short stump enables to use the traditional prosthetic socket. It is used after lower and upper limbs amputations. This kind of prosthetic solutions has some disadvantages and limitations. It is expensive and demanding. It can be used in cooperative patients, who take active part in the process of implantation, rehabilitation and in future usage if the prosthesis.

The Measurement Of Total Joint Loosening By X-Ray Photogrammetry

NASA Astrophysics Data System (ADS)

Lippert, Frederick G.; Veress, Sandor A.; Tiwari, Rama S.; Harrington, Richard M.

1980-07-01

Failure of total joint replacement due to loosening of the composents either between the implant and cement or between the cement and bone is emerging as a late complication with an incidence as high as 20 percent. Loosening may not only cause pain but progressive loss of support for the prosthesis with eventual structural failure. Early diagnosis is important so that revision may be carried when deterioration or pain occurs. No method is currently available which clearly establishes loosening at an early stage except surgical exploration. We have devised a method based on our in vivo photogrammetry studies of patellar tracking patterns using metallic markers placed in bone near both components of the total joint. Stereo x-rays taken with the joint loaded and unloaded are measured for relative motion between the implant and the metallic markers. Laboratory studies using prosthetic hip components mounted in plastic bone have revealed the ability of this method to detect pistoning movements as small as 80 microns. These findings were confirmed by physical measurements.

"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.

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.

Negative Gauge Pressure Moisture Management and Secure Adherence Device for Prosthetic Limbs

DTIC Science & Technology

2013-03-01

prosthesis feels like it is sliding up and down or falling off when I am active. D. I have been more active than normal as a result of this prosthesis ...temperature. 3. My prosthesis feels like it is sliding up and down or falling off when I am active. 4. I have been more active than normal as a result of...objective of this research was to develop and test a novel prosthesis incorporating a negative gauge pressure moisture management and secure

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

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

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.

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.

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.

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.

Predicting Failure in Early Acute Prosthetic Joint Infection Treated With Debridement, Antibiotics, and Implant Retention: External Validation of the KLIC Score.

PubMed

Löwik, Claudia A M; Jutte, Paul C; Tornero, Eduard; Ploegmakers, Joris J W; Knobben, Bas A S; de Vries, Astrid J; Zijlstra, Wierd P; Dijkstra, Baukje; Soriano, Alex; Wouthuyzen-Bakker, Marjan

2018-03-27

Debridement, antibiotics, and implant retention (DAIR) is a widely used treatment modality for early acute prosthetic joint infection (PJI). A preoperative risk score was previously designed for predicting DAIR failure, consisting of chronic renal failure (K), liver cirrhosis (L), index surgery (I), cemented prosthesis (C), and C-reactive protein >115 mg/L (KLIC). The aim of this study was to validate the KLIC score in an external cohort. We retrospectively evaluated patients with early acute PJI treated with DAIR between 2006 and 2016 in 3 Dutch hospitals. Early acute PJI was defined as <21 days of symptoms and DAIR performed within 90 days after index surgery. Failure was defined as the need for (1) second DAIR, (2) implant removal, (3) suppressive antimicrobial treatment, or (4) infection-related death within 60 days after debridement. A total of 386 patients were included. Failure occurred in 148 patients (38.3%). Patients with KLIC scores of ≤2, 2.5-3.5, 4-5, 5.5-6.5, and ≥7 had failure rates of 27.9%, 37.1%, 49.3%, 54.5%, and 85.7%, respectively (P < .001). The receiver-operating characteristic curve showed an area under the curve of 0.64 (95% confidence interval 0.59-0.69). A KLIC score higher than 6 points showed a specificity of 97.9%. The KLIC score is a relatively good preoperative risk score for DAIR failure in patients with early acute PJI and appears to be most useful in clinical practice for patients with low or high KLIC scores. Copyright © 2018 Elsevier Inc. All rights reserved.

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.

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.

10-year prospective cohort follow-up of immediately restored XiVE implants.

PubMed

Degidi, Marco; Nardi, Diego; Piattelli, Adriano

2016-06-01

The aim of this prospective cohort study was to assess the ten-year performance of the condensing thread, self-tapping apex and internal hexagonal connection XiVE implant supporting partial fixed prostheses placed with an immediate restoration approach. All patients received a fixed two- to four-unit partial provisional restoration supported by immediately loaded implants. The final gold alloy/ceramic restorations were cemented approximately 28 weeks after implant insertion. Marginal bone level, pocket probing depth and percentage of bleeding on probing, biological or technical complications and any other adverse events were measured annually up to ten years after surgery. The overall success and survival rates at implant level were evaluated following the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference criteria. Implant placement in post-extractive or healed sites, smoking and a history of periodontal treatment were evaluated to assess whether they had an influence on bone resorption or on implant survival. Of 114 patients, for a total of 284 implants, fulfilled all the inclusion criteria and were enrolled in the study. 78 (27.5%) implants placed in 30 (26.3%) patients were lost to follow-up. Eight of 284 (2.8%) implants failed in 8 of 114 (7.0%) patients: one (12.5% of losses) due to failure to achieve osseointegration and seven (87.5% of losses) due to peri-implantitis. No cluster implant failures were assessed. The failure of the implant caused the failure of the prosthesis due to the strategic position of the implant in four patients. At the final ten-year follow-up, 121 (61.4%) implants exhibited a "full success" status with an optimal health condition, 21 (10.9%) implants scored a "satisfactory survival" condition, while 49 (25.49%) of the implants were classified as "compromised survival" status (Misch et al. 2008). Smoking was found to be statistically associated with "implant failure" (P = 0.010), while no association was found for patients treated for periodontal disease (P = 0.679) and post-extractive surgical sites (P = 0.664). Statistically significant more marginal bone loss was found in patients treated for periodontal disease (P < 0.0001). An increased bone loss was also observed in smokers, but the difference with the non-smokers was not statistically significant (P = 0.06). The XiVE implants can be successfully used to support immediate prosthesis. Patients with a history of periodontitis show increased bone loss and risk to develop peri-implant disease. Smoking seems to jeopardize the long-term implant survival. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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...

Development of Subischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

DTIC Science & Technology

2012-10-01

materials to facilitate dissemination of this technique. 15. SUBJECT TERMS Transfemoral amputation, sub-ischial socket, prosthesis , vacuum-assisted...an appropriate mechanical pump to create suitable vacuum for suspension of the prosthesis ...sockets of highly active prosthesis users

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

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.

A clinical and radiostereometric study of the cemented PFC-sigma prosthesis: a 5-year study of 29 cases with a fixed bearing.

PubMed

von Schewelov, Thord; Besjakov, Jack; Sanzén, Lennart; Carlsson, Ake

2009-07-01

The press-fit condylar (PFC) cruciate-retaining total knee prosthesis is well documented in the literature. In 1997, a modification of the femoral component was introduced, and the prosthesis was renamed PFC-Sigma. The alteration may influence the migratory and rotational pattern of the tibial component and thus long-time survival rate. In this radiostereometric analysis, we found that the micromotion of the PFC-Sigma prosthesis differs slightly from the original PFC design, an advantage of the PFC-Sigma prosthesis. The median maximum total point motion at 5 years was 0.64 mm for the PFC-Sigma design and 0.79 mm for the previous version of PFC (P = .9). However, the PFC-Sigma rotated less around the transverse (x) axis than did the PFC (medians, 0.22 mm and 0.48 mm, respectively; P = .04). From the radiostereometric, radiographic, and clinical data, we conclude that the PFC-Sigma knee prosthesis can be used with confidence.

Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review

PubMed Central

S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi

2016-01-01

Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed. PMID:28959744

Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review.

PubMed

S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi

2016-06-01

Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed.

Sensory feedback add-on for upper-limb prostheses.

PubMed

Fallahian, Nader; Saeedi, Hassan; Mokhtarinia, Hamidreza; Tabatabai Ghomshe, Farhad

2017-06-01

Sensory feedback systems have been of great interest in upper-limb prosthetics. Despite tremendous research, there are no commercial modality-matched feedback systems. This article aims to introduce the first detachable and feedback add-on option that can be attached to in-use prostheses. A sensory feedback system was tested on a below-elbow myoelectric prosthesis. The aim was to have the amputee grasp fragile objects without crushing while other accidental feedback sources were blocked. A total of 8 successful trials (out of 10) showed that sensory feedback system decreased the amputee's visual dependency by improving awareness of his prosthesis. Sensory feedback system can be used either as post-fabrication (prosthetic add-on option) or para-fabrication (incorporated into prosthetic design). The use of these direct feedback systems can be explored with a current prosthesis before ordering new high-tech prosthesis. Clinical relevance This technical note introduces the first attach/detach-able sensory feedback system that can simply be added to in-use (myo)electric prosthesis, with no obligation to change prosthesis design or components.

Laryngeal complications after type 1 thyroplasty.

PubMed

Cotter, C S; Avidano, M A; Crary, M A; Cassisi, N J; Gorham, M M

1995-12-01

Type I thyroplasty has become a primary surgical choice for voice restoration in patients with glottal incompetence. This study examines factors associated with laryngeal complications after type I thyroplasty. Ten laryngoscopic variables were analyzed from preoperative, intraoperative, and postoperative videolaryngoscopies of 51 patients undergoing 58 medialization procedures. Ten patient and operative variables were examined by medical record review. Major complications were defined as wound hemorrhage, airway obstruction, or prosthesis extrusion. Minor complications were defined as vocal fold hematoma without airway obstruction or prosthesis movement. The major complication rate was 8.6%, and the minor complication rate was 29%. No delayed hemorrhage or airway obstruction occurred. Prosthesis extrusion occurred in five (8.6%) patients 1 week to 5 months after surgery. Extrusion was associated with suboptimal prosthesis placement in 80% of cases. Two patients retained excellent glottal closure despite extrusion. Vocal fold hematoma was identified in 14 (24%) cases and resolved within 1 week. Prosthesis movement occurred in three (5%) patients 1 week to 6 months after surgery and resulted in poor glottal closure. All patients with prosthesis extrusion or movement were female. Type I thyroplasty remains a safe outpatient procedure with few major complications. Prosthesis extrusion was associated with suboptimal prosthesis placement and may or may not result in poor glottal closure. Minor vocal fold hematomas were relatively frequent, resolved rapidly, and were not associated with airway obstruction. Female patients may be more prone to complications because of their small laryngeal size.

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.

Mobile-bearing TKA improved the anteroposterior joint stability in mid-flexion range comparing to fixed-bearing TKA.

PubMed

Minoda, Yukihide; Ikebuchi, Mitsuhiko; Mizokawa, Shigekazu; Ohta, Yoichi; Nakamura, Hiroaki

2016-11-01

Proper anteroposterior (AP) joint displacement is an important indicator of good clinical outcome following total knee arthroplasty (TKA). We hypothesized that a newly introduced mobile-bearing posterior stabilized (PS) prosthesis reduces the AP joint displacement. The aim of this study is to compare the AP joint displacement between a newly introduced mobile-bearing PS TKA in one knee and a conventional fixed-bearing PS TKA in other knee. 82 knees in 41 patients who had bilateral TKAs were investigated. All the patients received a conventional fixed-bearing PS prosthesis in one knee and a highly congruent mobile-bearing PS prosthesis in the other knee. AP joint displacement was measured using the KT-2000 arthrometer, at 30° and 75° in flexion, at average of 3.3 years after the operation. AP joint displacements at 30° in flexion were 6 ± 3 mm in the knees with the mobile-bearing PS prosthesis and 9 ± 4 mm in the knee with fixed-bearing PS prosthesis (p < 0.001). AP joint displacements at 75° in flexion were 4 ± 2 mm in the knees with the mobile-bearing PS prosthesis and 6 ± 3 mm in the knee with fixed-bearing PS prosthesis (p < 0.001). This study suggested that the design of the prosthesis can improve the AP joint stability in mid-flexion range.

21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...

21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...

21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...

21 CFR 888.3220 - Finger joint metal/polymer constrained cemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint metal/polymer constrained cemented... metal/polymer constrained cemented prosthesis. (a) Identification. A finger joint metal/polymer..., 1996 for any finger joint metal/polymer constrained cemented prosthesis that was in commercial...

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular condyle prosthesis. 872.3960 Section 872.3960 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a...

21 CFR 872.3950 - Glenoid fossa prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872.3950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3720 - Tracheal prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheal prosthesis. 878.3720 Section 878.3720 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3720 Tracheal prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3550 - Chin prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Chin prosthesis. 878.3550 Section 878.3550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3550 Chin prosthesis. (a...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3680 - Nose prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nose prosthesis. 878.3680 Section 878.3680 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3680 Nose prosthesis. (a...

21 CFR 878.3750 - External prosthesis adhesive.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External prosthesis adhesive. 878.3750 Section 878.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3750 External prosthesis...

Biomechanical Behavior of Bioprosthetic Heart Valve Heterograft Tissues: Characterization, Simulation, and Performance

PubMed Central

Soares, Joao S.; Feaver, Kristen R.; Zhang, Will; Kamensky, David; Aggarwal, Ankush; Sacks, Michael S.

2017-01-01

The use of replacement heart valves continues to grow due to the increased prevalence of valvular heart disease resulting from an ageing population. Since bioprosthetic heart valves (BHVs) continue to be the preferred replacement valve, there continues to be a strong need to develop better and more reliable BHVs through and improved the general understanding of BHV failure mechanisms. The major technological hurdle for the lifespan of the BHV implant continues to be the durability of the constituent leaflet biomaterials, which if improved can lead to substantial clinical impact. In order to develop improved solutions for BHV biomaterials, it is critical to have a better understanding of the inherent biomechanical behaviors of the leaflet biomaterials, including chemical treatment technologies, the impact of repetitive mechanical loading, and the inherent failure modes. This review seeks to provide a comprehensive overview of these issues, with a focus on developing insight on the mechanisms of BHV function and failure. Additionally, this review provides a detailed summary of the computational biomechanical simulations that have been used to inform and develop a higher level of understanding of BHV tissues and their failure modes. Collectively, this information should serve as a tool not only to infer reliable and dependable prosthesis function, but also to instigate and facilitate the design of future bioprosthetic valves and clinically impact cardiology. PMID:27507280

21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...

21 CFR 888.3210 - Finger joint metal/metal constrained cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained cemented... metal/metal constrained cemented prosthesis. (a) Identification. A finger joint metal/metal constrained..., 1996 for any finger joint metal/metal constrained cemented prosthesis that was in commercial...

21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint metal/metal constrained uncemented... metal/metal constrained uncemented prosthesis. (a) Identification. A finger joint metal/metal... Administration on or before December 26, 1996 for any finger joint metal/metal constrained uncemented prosthesis...

21 CFR 888.3200 - Finger joint metal/metal constrained uncemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint metal/metal constrained uncemented... metal/metal constrained uncemented prosthesis. (a) Identification. A finger joint metal/metal... Administration on or before December 26, 1996 for any finger joint metal/metal constrained uncemented prosthesis...

21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device...

21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part...

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...

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.

21 CFR 888.3510 - Knee joint femorotibial metal/polymer constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/polymer constrained... Knee joint femorotibial metal/polymer constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...

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

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...

21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/polymer semi-constrained... Shoulder joint metal/polymer semi-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a...

21 CFR 888.3540 - Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint patellofemoral polymer/metal semi... § 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part...

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 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint metal/polymer non-constrained... Shoulder joint metal/polymer non-constrained cemented prosthesis. (a) Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Knee joint femorotibial metal/polymer semi... § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended...

21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...

21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...

21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...

21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...

21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

21 CFR 888.3680 - Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint glenoid (hemi-shoulder) metallic... Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis. (a) Identification. A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component...

21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

21 CFR 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Shoulder joint humeral (hemi-shoulder) metallic... Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium...

21 CFR 888.3500 - Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite semi... § 888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part...

21 CFR 888.3100 - Ankle joint metal/composite semi-constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ankle joint metal/composite semi-constrained... Ankle joint metal/composite semi-constrained cemented prosthesis. (a) Identification. An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an...

21 CFR 888.3490 - Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Knee joint femorotibial metal/composite non... § 888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis. (a) Identification. A knee joint femorotibial metal/composite non-constrained cemented prosthesis is a device...

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...

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

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Knee joint patellofemorotibial metal/polymer... Devices § 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. (a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device...

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 888.3530 - 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 888.3530 - 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 888.3565 - 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...

Development of Sub-Ischial Prosthetic Sockets with Vacuum-Assisted Suspension for Highly Active Persons with Transfemoral Amputations

DTIC Science & Technology

2013-10-01

15. SUBJECT TERMS Transfemoral amputation, sub-ischial socket, prosthesis , vacuum-assisted suspension 16. SECURITY CLASSIFICATION OF: 17...vacuum for suspension of the prosthesis ...14 Task 6 Determine range of volumes to be evacuated from transfemoral sockets of highly active prosthesis users

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...

21 CFR 888.6 - Degree of constraint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... replacement and prevents dislocation of the prosthesis in more than one anatomic plane and consists of either... translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces... total joint replacement and restricts minimally prosthesis movement in one or more planes. Its...

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

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.

Consumer design priorities for upper limb prosthetics.

PubMed

Biddiss, Elaine; Beaton, Dorcas; Chau, Tom

2007-11-01

To measure consumer satisfaction with upper limb prosthetics and provide an enumerated list of design priorities for future developments. A self-administered, anonymous survey collected information on participant demographics, history of and goals for prosthesis use, satisfaction, and design priorities. The questionnaire was available online and in paper format and was distributed through healthcare providers, community support groups, and one prosthesis manufacturer; 242 participants of all ages and levels of upper limb absence completed the survey. Rates of rejection for myoelectric hands, passive hands, and body-powered hooks were 39%, 53%, and 50%, respectively. Prosthesis wearers were generally satisfied with their devices while prosthesis rejecters were dissatisfied. Reduced prosthesis weight emerged as the highest priority design concern of consumers. Lower cost ranked within the top five design priorities for adult wearers of all device types. Life-like appearance is a priority for passive/cosmetic prostheses, while improved harness comfort, wrist movement, grip control and strength are required for body-powered devices. Glove durability, lack of sensory feedback, and poor dexterity were also identified as design priorities for electric devices. Design priorities reflect consumer goals for prosthesis use and vary depending on the type of prosthesis used and age. Future design efforts should focus on the development of more light-weight, comfortable prostheses.

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

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.

Developing an Ear Prosthesis Fabricated in Polyvinylidene Fluoride by a 3D Printer with Sensory Intrinsic Properties of Pressure and Temperature

PubMed Central

Suaste-Gómez, Ernesto; Rodríguez-Roldán, Grissel; Reyes-Cruz, Héctor; Terán-Jiménez, Omar

2016-01-01

An ear prosthesis was designed in 3D computer graphics software and fabricated using a 3D printing process of polyvinylidene fluoride (PVDF) for use as a hearing aid. In addition, the prosthesis response to pressure and temperature was observed. Pyroelectric and piezoelectric properties of this ear prosthesis were investigated using an astable multivibrator circuit, as changes in PVDF permittivity were observed according to variations of pressure and temperature. The results show that this prosthesis is reliable for use under different conditions of pressure (0 Pa to 16,350 Pa) and temperature (2 °C to 90 °C). The experimental results show an almost linear and inversely proportional behavior between the stimuli of pressure and temperature with the frequency response. This 3D-printed ear prosthesis is a promising tool and has a great potentiality in the biomedical engineering field because of its ability to generate an electrical potential proportional to pressure and temperature, and it is the first time that such a device has been processed by the additive manufacturing process (3D printing). More work needs to be carried out to improve the performance, such as electrical stimulation of the nervous system, thereby extending the purpose of a prosthesis to the area of sensory perception. PMID:26959026

Developing an Ear Prosthesis Fabricated in Polyvinylidene Fluoride by a 3D Printer with Sensory Intrinsic Properties of Pressure and Temperature.

PubMed

Suaste-Gómez, Ernesto; Rodríguez-Roldán, Grissel; Reyes-Cruz, Héctor; Terán-Jiménez, Omar

2016-03-04

An ear prosthesis was designed in 3D computer graphics software and fabricated using a 3D printing process of polyvinylidene fluoride (PVDF) for use as a hearing aid. In addition, the prosthesis response to pressure and temperature was observed. Pyroelectric and piezoelectric properties of this ear prosthesis were investigated using an astable multivibrator circuit, as changes in PVDF permittivity were observed according to variations of pressure and temperature. The results show that this prosthesis is reliable for use under different conditions of pressure (0 Pa to 16,350 Pa) and temperature (2 °C to 90 °C). The experimental results show an almost linear and inversely proportional behavior between the stimuli of pressure and temperature with the frequency response. This 3D-printed ear prosthesis is a promising tool and has a great potentiality in the biomedical engineering field because of its ability to generate an electrical potential proportional to pressure and temperature, and it is the first time that such a device has been processed by the additive manufacturing process (3D printing). More work needs to be carried out to improve the performance, such as electrical stimulation of the nervous system, thereby extending the purpose of a prosthesis to the area of sensory perception.

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.

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.

Dual-energy CT and ceramic or titanium prostheses material reduce CT artifacts and provide superior image quality of total knee arthroplasty.

PubMed

Kasparek, Maximilian F; Töpker, Michael; Lazar, Mathias; Weber, Michael; Kasparek, Michael; Mang, Thomas; Apfaltrer, Paul; Kubista, Bernd; Windhager, Reinhard; Ringl, Helmut

2018-06-07

To evaluate the influence of different scan parameters for single-energy CT and dual-energy CT, as well as the impact of different material used in a TKA prosthesis on image quality and the extent of metal artifacts. Eight pairs of TKA prostheses from different vendors were examined in a phantom set-up. Each pair consisted of a conventional CoCr prosthesis and the corresponding anti-allergic prosthesis (full titanium, ceramic, or ceramic-coated) from the same vendor. Nine different (seven dual-energy CT and two single-energy CT) scan protocols with different characteristics were used to determine the most suitable CT protocol for TKA imaging. Quantitative image analysis included assessment of blooming artifacts (metal implants appear thicker on CT than they are, given as virtual growth in mm in this paper) and streak artifacts (thick dark lines around metal). Qualitative image analysis was used to investigate the bone-prosthesis interface. The full titanium prosthesis and full ceramic knee showed significantly fewer blooming artifacts compared to the standard CoCr prosthesis (mean virtual growth 0.6-2.2 mm compared to 2.9-4.6 mm, p < 0.001). Dual-energy CT protocols showed less blooming (range 3.3-3.8 mm) compared to single-energy protocols (4.6-5.5 mm). The full titanium and full ceramic prostheses showed significantly fewer streak artifacts (mean standard deviation 77-86 Hounsfield unit (HU)) compared to the standard CoCr prosthesis (277-334 HU, p < 0.001). All dual-energy CT protocols had fewer metal streak artifacts (215-296 HU compared to single-energy CT protocols (392-497 HU)). Full titanium and ceramic prostheses were ranked superior with regard to the image quality at the bone/prosthesis interface compared to a standard CoCr prosthesis, and all dual-energy CT protocols were ranked better than single-energy protocols. Dual-energy CT and ceramic or titanium prostheses reduce CT artifacts and provide superior image quality of total knee arthroplasty at the bone/prosthesis interface. These findings support the use of dual-energy CT as a solid imaging base for clinical decision-making and the use of full-titanium or ceramic prostheses to allow for better CT visualization of the bone-prosthesis interface.

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, 10.66% and 11.16% under torsion after plate allied. The novel intercalary prosthesis has excellent ability to reconstruct humeral diaphyseal defects. The accessory fixation system, which included a plate and prosthesis, improved the rigidity of anti-tension and anti-torsion, and diminished the risk of prosthetic loosening and dislocation. A finite element analysis is a kind of convenient and practicable method to be used as the confirmation of experimental biomechanics study. © 2018 Chinese Orthopaedic Association and John Wiley & Sons Australia, Ltd.

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.

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.

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 888.3370 - 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 888.3310 - 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 888.3350 - 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 888.3340 - 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 888.3640 - 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 888.3120 - 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 888.3350 - 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 888.3520 - 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 888.3160 - 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 888.3310 - 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 888.3170 - 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 888.3590 - 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 888.3170 - 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 888.3800 - 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 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...

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...

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...

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 888.3170 - 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 888.3350 - 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 888.3310 - 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 888.3350 - 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 888.3110 - 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 888.3310 - 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 888.3800 - 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 888.3520 - 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 888.3310 - 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...

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 888.3110 - 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 888.3350 - 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...

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...

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...

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...

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...

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

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.

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.

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 hollow definitive obturator fabrication technique for management of partial maxillectomy.

PubMed

Patil, Pravinkumar Gajanan; Patil, Smita Pravinkumar

2012-11-01

Maxillary obturator prosthesis is the most frequent treatment option for management of partial or total maxillectomy. Heavy weight of the obturators is often a dislocating factor. Hollowing the prosthesis to reduce its weight is the well established fact. The alternate technique to hollow-out the prosthesis has been described in this article which is a variation of previously described processing techniques. A pre-shaped wax-bolus was incorporated inside the flasks during packing of the heat-polymerized acrylic resin to automatically create the hollow space. The processing technique described is a single step flasking procedure to construct a closed-hollow-obturator prosthesis as a single unit. To best understand the technique, this article describes management of a patient who had undergone partial maxillectomy secondary to squamous cell carcinoma rehabilitated with a hollow-obturator prosthesis.

A hollow definitive obturator fabrication technique for management of partial maxillectomy

PubMed Central

Patil, Smita Pravinkumar

2012-01-01

Maxillary obturator prosthesis is the most frequent treatment option for management of partial or total maxillectomy. Heavy weight of the obturators is often a dislocating factor. Hollowing the prosthesis to reduce its weight is the well established fact. The alternate technique to hollow-out the prosthesis has been described in this article which is a variation of previously described processing techniques. A pre-shaped wax-bolus was incorporated inside the flasks during packing of the heat-polymerized acrylic resin to automatically create the hollow space. The processing technique described is a single step flasking procedure to construct a closed-hollow-obturator prosthesis as a single unit. To best understand the technique, this article describes management of a patient who had undergone partial maxillectomy secondary to squamous cell carcinoma rehabilitated with a hollow-obturator prosthesis. PMID:23236579

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.

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.

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.

Short-term and mid-term results with the Sorin Freedom Solo aortic valve.

PubMed

Ustunsoy, Hasim; Yasim, Alptekin; Deniz, Hayati; Gokaslan, Gokhan; Ozcaliskan, Ozerdem

2013-03-01

The study aim was to present the short- and mid-term results for patients who underwent aortic valve replacement (AVR) with the Sorin Freedom Solo third-generation stentless prosthetic valve. AVR with a Sorin Freedom Solo valve was performed in 14 patients between March 2006 and March 2011. Patients aged > or = 60 years (male:female ratio 6:8; mean age 73.28 +/- 5.42 years) who required AVR with the Sorin Freedom Solo valve according to the surgeon's choice were included in the study. The valvular prosthesis was implanted in the supra-annular position, using a single suture line. Eight patients underwent an isolated AVR; combined interventions were carried out in the other patients due to concomitant cardiac disease. One patient died during the immediate perioperative period, and two more during the follow up, from non-cardiac causes. The mean maximum transvalvular gradient of patients with aortic stenosis was 88.1 +/- 20.2 mmHg, and this fell to 26.4 +/- 7.6 mmHg during the early postoperative period. The mean gradient at one year of follow up was further decreased to 19.4 +/- 5.3 mmHg. The left ventricular end-diastolic and end-systolic diameters were also significantly reduced, from 4.8 +/- 0.9 to 4.3 +/- 0.6 cm and from 3.2 +/- 0.6 to 2.8 +/- 5.3 cm, respectively. The average left ventricular ejection fraction was 60.2 +/- 4.9% preoperatively, and 63.2 +/- 2.1% at one year after surgery (p = NS). No paravalvular leakage, endocarditis, prosthesis failure or neurologic events were reported among patients. The Sorin Freedom Solo stentless valve has provided good early and intermediate-term results. Implantation of the prosthesis is straightforward, with low rates of morbidity and mortality. However, these data require further support from larger patient series and long-term follow up.

Uncovertebral hypertrophy is a significant risk factor for the occurrence of heterotopic ossification after cervical disc replacement: survivorship analysis of Bryan disc for single-level cervical arthroplasty.

PubMed

Chung, Sang-Bong; Muradov, Johongir M; Lee, Sun-Ho; Eoh, Whan; Kim, Eun-Sang

2012-06-01

The purpose of this study is to investigate the incidence of heterotopic ossification (HO) in the Bryan cervical arthroplasty group and to identify associations between preoperative factors and the development of HO. We performed a retrospective review of clinical and radiological data on patients who underwent single-level cervical arthroplasty with Bryan prosthesis between January 2005 and September 2007. Patients were postoperatively followed-up at 1, 3, 6, 12 months and every year thereafter. The clinical assessment was conducted using Odom's criteria. The presence of HO was evaluated on the basis of X-ray at each time-point according to the McAfee classification. In this study, we focused on survivorship of Bryan prosthesis for single-level arthroplasty. The occurrence of ROM-affecting HO was defined as a functional failure and was used as an endpoint for determining survivorship. Through the analysis of 19 cases of Bryan disc arthroplasty for cervical radiculopathy and/or myelopathy, we revealed that ROM-affecting HO occurs in as many as 36.8% of cases and found that 37% of patients had ROM-affecting HO within 24 months following surgery. The overall survival time to the occurrence of ROM-affecting HO was 36.4 ± 4.4 months. Survival time of the prosthesis in the patient group without preoperative uncovertebral hypertrophy was significantly longer than that in the patient group with preoperative uncovertebral hypertrophy (47.2 months vs 25.5 months, p = 0.02). Cox regression proportional hazard analysis illustrated that preoperative uncovertebral hypertrophy was determined as a significant risk factor for the occurrence of ROM-affecting HO (hazard ratio = 12.30; 95% confidential interval = 1.10-137.03; p = 0.04). These findings suggest that the condition of the uncovertebral joint must be evaluated in preoperative planning for Bryan cervical arthroplasty.

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.

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

[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.

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.

[Treatment of periprosthetic femoral fractures after total hip arthroplasty with specially constructed retrograde hollow nails].

PubMed

Szalay, G; Meyer, C; Mika, J; Schnettler, R; Thormann, U

2014-12-01

Treatment of periprosthetic fractures by implantation of a specially constructed, retrograde hollow nail which fits over the tip of the prosthesis and becomes locked on it. Periprosthetic femoral fractures with firmly anchored prosthesis shaft after total hip arthroplasty of types B1 and C according to the Vancouver classification. Loosened prosthesis (type B2/B3) and trochanteric fractures (type A). Broken or damaged prosthesis, florid inflammation and soft tissue injuries in the operation field, contracted knee joint, advanced deformation in the knee joint and distal femur, enclosed prosthesis and general contraindications. In a supine position the periprosthetic fracture is exposed via a lateral access. For cemented prostheses the cement is removed around the tip of the prosthesis (at least 2-3 cm) and medullary cavity. Arthrotomy with flexion of the knee joint and marking of the nail entry point. Drill the medullary cavity, retrograde introduction of the nail, visually fit the nail over the tip of the prosthesis and lock the nail with the prosthesis. If necessary use additional spongiosaplasty or also placement of additional cerclages depending on fracture type and size of the defect zone. Lock the nail distally. Use intraoperative radiological imaging to control correct positioning and length of the nail. Close the wound layer by layer with placement of suction drainage devices and dressing. Partial loading for 6 weeks with a subsequent pain-adapted loading gradient until full loading is possible. If selective partial loading is not possible, a decision must be made in individual cases as to whether the intraoperative findings allow immediate full loading. From 2004 to 2011 a total of 25 periprosthetic femoral fractures in 25 patients were treated in 2 locations using specially constructed slotted hollow nails. Within the framework of a retrospective study 20 of these patients (16 female and 4 male; average age 77.2 [72-84] years) were clinically and radiologically re-examined on average 19.3 (7-31) months postoperatively. No postoperative bleeding, wound healing disorders and infections. In all patients there was a loading stable consolidation of the fracture in the correct femoral axis, length and rotation with no evidence for radiological signs of loosening of the prosthesis or dislocation of the nails. In one case there was loosening of the prosthesis which had obviously occurred during the operative procedure. After consolidation of the fracture it was necessary to exchange the prosthesis for a long shafted prosthesis. A comparable situation to the preoperative degree of mobility was found in 12 out of the 20 patients, a moderate deterioration in 5 patients, a substantial residual impairment in 2 patients and an improvement of the situation in 1 patient.

Time-dependent fracture probability of bilayer, lithium-disilicate-based, glass-ceramic, molar crowns as a function of core/veneer thickness ratio and load orientation.

PubMed

Anusavice, Kenneth J; Jadaan, Osama M; Esquivel-Upshaw, Josephine F

2013-11-01

Recent reports on bilayer ceramic crown prostheses suggest that fractures of the veneering ceramic represent the most common reason for prosthesis failure. The aims of this study were to test the hypotheses that: (1) an increase in core ceramic/veneer ceramic thickness ratio for a crown thickness of 1.6mm reduces the time-dependent fracture probability (Pf) of bilayer crowns with a lithium-disilicate-based glass-ceramic core, and (2) oblique loading, within the central fossa, increases Pf for 1.6-mm-thick crowns compared with vertical loading. Time-dependent fracture probabilities were calculated for 1.6-mm-thick, veneered lithium-disilicate-based glass-ceramic molar crowns as a function of core/veneer thickness ratio and load orientation in the central fossa area. Time-dependent fracture probability analyses were computed by CARES/Life software and finite element analysis, using dynamic fatigue strength data for monolithic discs of a lithium-disilicate glass-ceramic core (Empress 2), and ceramic veneer (Empress 2 Veneer Ceramic). Predicted fracture probabilities (Pf) for centrally loaded 1.6-mm-thick bilayer crowns over periods of 1, 5, and 10 years are 1.2%, 2.7%, and 3.5%, respectively, for a core/veneer thickness ratio of 1.0 (0.8mm/0.8mm), and 2.5%, 5.1%, and 7.0%, respectively, for a core/veneer thickness ratio of 0.33 (0.4mm/1.2mm). CARES/Life results support the proposed crown design and load orientation hypotheses. The application of dynamic fatigue data, finite element stress analysis, and CARES/Life analysis represent an optimal approach to optimize fixed dental prosthesis designs produced from dental ceramics and to predict time-dependent fracture probabilities of ceramic-based fixed dental prostheses that can minimize the risk for clinical failures. Copyright © 2013 Academy of Dental Materials. All rights reserved.

Ten-Year Results of the Press Fit Condylar Sigma Cobalt-Chrome Total Knee Replacement.

PubMed

Keenan, Oisin; Brenkel, Ivan; Walmsley, Phil

2018-04-10

Total knee arthroplasty (TKA) is reliant on safe and effective implants. The Press Fit Condylar Sigma Cobalt-Chrome (PFCSCC) was introduced in 2006, but no reports have examined long-term failure rates and patient-reported outcome measures (PROMs). The primary aim of this study was to assess survival outcomes of the PFCSCC at 10 years after implantation. Prospective data collection was performed on all patients undergoing primary TKA in one orthopaedic department using this prosthesis exclusively from February 1, 2006, to January 31, 2007. Follow-up was at 10 years. Survival analysis was performed using two primary outcome measures: (1) all-cause joint revision and (2) aseptic revision. Secondary outcomes measures included the American Knee Society Score (AKSS) and Oxford Knee Score (OKS). In total, 249 knees of 233 patients underwent primary TKA. Mean patient age was 66.7 years (range 34-80), and mean body mass index (BMI) was 30 kg/m 2 (20.7-40.1). Reviewing all causes of revisions, 14 joints (5.6%) of 14 patients required reoperation. Of these, nine were for deep infection, including six in the first year. Four (1.6%) underwent aseptic revision. Mean AKSS changed from 47.6 to 90.4 ( n  = 140; p  < 0.001) at 10 years, and mean OKS changed from 38.3 to 23.2 ( n  = 149; p  < 0.001). Prospective analysis of consecutive TKA cases using this design of prosthesis demonstrated high survival rates of 94.4% (all-cause revision) and 98.4% (aseptic revision) at 10 years. Postoperative gains in PROMs were sustained at 10 years. These real-world data represent a substantial extension to previous reports for the PFCSCC and suggest that it is not prone to late mechanical failure. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Time-dependent fracture probability of bilayer, lithium-disilicate-based glass-ceramic molar crowns as a function of core/veneer thickness ratio and load orientation

PubMed Central

Anusavice, Kenneth J.; Jadaan, Osama M.; Esquivel–Upshaw, Josephine

2013-01-01

Recent reports on bilayer ceramic crown prostheses suggest that fractures of the veneering ceramic represent the most common reason for prosthesis failure. Objective The aims of this study were to test the hypotheses that: (1) an increase in core ceramic/veneer ceramic thickness ratio for a crown thickness of 1.6 mm reduces the time-dependent fracture probability (Pf) of bilayer crowns with a lithium-disilicate-based glass-ceramic core, and (2) oblique loading, within the central fossa, increases Pf for 1.6-mm-thick crowns compared with vertical loading. Materials and methods Time-dependent fracture probabilities were calculated for 1.6-mm-thick, veneered lithium-disilicate-based glass-ceramic molar crowns as a function of core/veneer thickness ratio and load orientation in the central fossa area. Time-dependent fracture probability analyses were computed by CARES/Life software and finite element analysis, using dynamic fatigue strength data for monolithic discs of a lithium-disilicate glass-ceramic core (Empress 2), and ceramic veneer (Empress 2 Veneer Ceramic). Results Predicted fracture probabilities (Pf) for centrally-loaded 1,6-mm-thick bilayer crowns over periods of 1, 5, and 10 years are 1.2%, 2.7%, and 3.5%, respectively, for a core/veneer thickness ratio of 1.0 (0.8 mm/0.8 mm), and 2.5%, 5.1%, and 7.0%, respectively, for a core/veneer thickness ratio of 0.33 (0.4 mm/1.2 mm). Conclusion CARES/Life results support the proposed crown design and load orientation hypotheses. Significance The application of dynamic fatigue data, finite element stress analysis, and CARES/Life analysis represent an optimal approach to optimize fixed dental prosthesis designs produced from dental ceramics and to predict time-dependent fracture probabilities of ceramic-based fixed dental prostheses that can minimize the risk for clinical failures. PMID:24060349

Calfplasty.

PubMed

Felício, Y

2000-01-01

The author describes a method of calf augmentation by a silicone prosthesis implant for correction of asymmetrical legs or aesthetic problems. Preference is given to the placement of soft silicone implants (Glitzentein implants); they are more natural looking than hard implants. The implants are placed over both heads of the gastrocnemius muscle or beneath the fascia cruris superficialis. Operations were performed from November 1985 to August 1999. One hundred patients were studied: 95 female and 5 male. Two hundred calf implants were performed: 188 soft implants (Glitzenstein), 6 hard implants (Aiache), and 6 together on the same leg (Glitzenstein and Aiache implants). No infection problems, prosthesis rupture, or hematomas occurred. There were four seromas, but they disappeared in 15 days. Four prostheses were removed in two patients who did not like the final result. One prosthesis changed place, to the upper part of the calf. The operation is performed under sedative and local anesthesia, with an incision of approximately 4 to 5 cm in the popliteal pleat, at the same height as the fascia cruris. To date, no functional problem or muscular dysfunction has been provoked by silicone prosthesis implants. The patient walks 8 h after the surgery. We selected 500 patients who received implants in the legs with calf prostheses, fat implants, and prosthesis and fat implant together, during 14 years of follow-up, but the focus of this paper is a calf implant with prosthesis in 100 patients with 200 calf prosthesis implants.

Function of obturator prosthesis after maxillectomy and prosthetic obturator rehabilitation.

PubMed

Chen, Cheng; Ren, Wenhao; Gao, Ling; Cheng, Zheng; Zhang, Linmei; Li, Shaoming; Zhi, Pro Ke-qian

2016-01-01

Maxillary defects are usually rehabilitated by a prosthetic obturator. This study aimed to evaluate the functioning of obturators prosthesis in patients with unilateral defects after maxillectomy. Of 49 patients, 28 underwent to maxillectomy as a result of tumor ablative surgery, and acquired unilateral maxillary defects. Evaluation of the function was performed by applying the Obturator Functional Scale (OFS). From a total of 49 patients, 28 were treated as follows: 9 with a conventional retained obturator prosthesis (COP), 11 (39%) with an enhanced retentive obturator prosthesis with stud attachment (POP) and 8 (28%) with an enhanced retentive obturator prosthesis with magnetic attachment (POM). The mean OFS score was 80. Scores on functions of speech, swallowing and chewing reached statistical significances (p<0.05) among these three subgroups. Comparing COP and MOP groups, the scores of OFS in the domains of "Speech-ability to speak in public" and "Swallowing-leakage with liquids" were significantly higher in AOP group. Comparing COP group, the scores of OFS in "Swallowing-leakage with solid" and "Chewing/eating" domains were increased significantly (p<0.05) both in MOP and AOP groups. Obturator prosthesis improves oral function of patients after maxillary defects; the retention of the obturator prosthesis enhanced by the addition of attachments showed more benefits in oral function. Copyright © 2015 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Percutaneous coronary angioplasty of a left anterior descending artery implanted on a Dacron coronary prosthesis on an aortic conduit.

PubMed

Drobinski, G; Thomas, D; Funck, F; Metzger, J P; Canny, M; Grosgogeat, Y

1986-08-01

Certain surgical techniques may make it difficult to catheterize the coronary ostia and perform percutaneous coronary angioplasty. We report the case of a 48 year old patient who developed unstable angina four years after a Bentall's procedure with reimplantation of the coronary arteries on a Dacron coronary prosthesis. The anginal pain was related to very severe stenosis of the proximal segment of the left anterior descending artery. The difficulties encountered during the dilatation procedure were due to: (a) the ectopic position of the ostium of the prosthesis on the anterior aortic wall; (b) the forces exerted on the aortic prosthesis wall and on the valvular prosthesis during positioning of the guiding catheter which were poorly tolerated and induced a vagal reaction; (c) the direction taken by the distal tip of the guiding catheter, perpendicular to the wall of the aortic prosthesis; (d) the sinuosity of the arterial trajectory: the left coronary segment of the coronary prosthesis was directed towards the left circumflex artery rather than towards the left anterior descending artery. Coronary angioplasty succeeded after relatively complex technical procedures: special guiding catheter, unusual intra-aortic manoeuvres for positioning the guiding catheter, dilatation catheter change on a 3-metre long guide wire in order to cross the stenotic segment; this was performed with a super low-profiled dilatation catheter. There were no complications and anginal pain disappeared.

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

[Pelvic reconstructions after bone tumor resection].

PubMed

Anract, Philippe; Biau, David; Babinet, Antoine; Tomeno, Bernard

2014-02-01

The three more frequent primitive malignant bone tumour which concerned the iliac bone are chondrosarcoma, following Ewing sarcoma and osteosarcoma. Wide resection remains the most important part of the treatment associated with chemotherapy for osteosarcoma and the Ewing sarcoma. Iliac wing resections and obdurate ring don't required reconstruction. However, acetabular resections and iliac wing resection with disruption of the pelvic ring required reconstruction to provide acceptable functional result. Acetabular reconstruction remains high technical demanding challenge. After isolated acetabular resection or associated to obdurate ring, our usual method of reconstruction is homolateral proximal femoral autograft and total hip prosthesis but it is possible to also used : saddle prosthesis, Mac Minn prosthesis with auto or allograft, modular prosthesis or custom made prosthesis, massive allograft with or without prosthesis and femoro-ilac arthrodesis. After resection of the iliac wing plus acetabulum, reconstruction can be performed by femoro-obturatrice and femora-sacral arthrodesis, homolateral proximal femoral autograft and prosthesis, femoral medialisation, massive allograft and massive allograft. Carcinological results are lesser than resection for distal limb tumor, local recurrence rate range 17 to 45%. Functional results after Iliac wing and obdurate ring are good. However, acetabular reconstruction provide uncertain functional results. The lesser results arrive after hemipelvic or acetabular and iliac wing resection-reconstruction, especially when gluteus muscles were also resected. The most favourable results arrive after isolated acetabular or acetabular plus obturateur ring resection-reconstruction.

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...

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

Clinical Outcome of Medial Pivot Compared With Press-Fit Condylar Sigma Cruciate-Retaining Mobile-Bearing Total Knee Arthroplasty.

PubMed

Kim, Young-Hoo; Park, Jang-Won; Kim, Jun-Shik

2017-10-01

The purpose of this study was to compare the long-term clinical results, radiographic results, range of knee motion, patient satisfaction, and the survival rate of Medial-Pivot posterior cruciate-substituting, knee prosthesis and a press-fit condylar (PFC) Sigma cruciate-retaining mobile-bearing knee prosthesis in the same patients. One hundred eighty-two patients received Medial-Pivot knee prosthesis in one knee and a PFC Sigma knee prosthesis in the contralateral knee. The minimum duration of follow-up was 11 years (range, 11-12.6 years). The knees with a Medial-Pivot knee prosthesis had significantly worse results than those with a PFC Sigma knee prosthesis at the final follow-up with regard to the mean postoperative Knee Society knee scores (90 compared with 95 points), Western Ontario and McMaster Universities Osteoarthritis Index score (25 compared with 18 points), and range of knee motion (117° compared with 128°). Patients were more satisfied with PFC Sigma knee prosthesis (93%) than with Medial-Pivot knee prosthesis (75%). Complication rates were significantly higher in the Medial-Pivot knee group (26%) than those in the PFC Sigma knee group (6.5%). Radiographic results and survival rates (99% compared with 99.5%) were similar between the 2 groups. Although the long-term fixation and survival rate of both Medial-Pivot and PFC Sigma prostheses were similar, we observed a worse knee score, worse range of knee motion, and patient satisfaction was less in the Medial-Pivot knee group than in the PFC Sigma knee group. Furthermore, complication rate was also higher in the Medial-Pivot knee group than the other group. Copyright © 2017 Elsevier Inc. All rights reserved.

[The length of the piston in otosclerosis surgery].

PubMed

Portmann, D; Alcantara, M; Vianna, M

2007-01-01

The measurement of the piston is always described as a significant stage of the surgery but its length is never clearly defined. The goal of this work is to determine the length of the prosthesis. From May 2003 to May 2005, 128 patients with otosclerosis, diagnosed on the basis of their clinical history and their audiogram, were included in this prospective study. Some of them were revision surgeries. The prosthesis generally used was the Portmann piston clip (Medtronic Xomed Inc Portmann Piston Clip Stainless Steel/Fluoroplastic). In stapedectomies, a Teflon piston of 0.6 mm of diameter was used (Pouret Company Fluoroplastic Stapes Prosthesis). These prostheses must be trimmed before their installation. The measurement technique is described. The length of the prosthesis was increased by 0.5 mm to include the thickness of the footplate. The Portmann piston clip was used 116 times (100 initial surgeries and 16 revisions surgeries) and the Teflon prosthesis of 0.6 mm of diameter only 13 times (6 primary stapedectomies and 7 revisions stapedectomies). The length of the prosthesis was between 3,5 mm and 5 mm. In the majority of cases, the length of the prosthesis was 4.75 mm (62 patients, 48.1%), followed by 4.5 mm (29 patients, 22.5%) and 5 mm (27 patients, 20.9%). In eleven cases (8.5%) the prosthesis measured less than 4,5 mm. None of the patients in this study experienced a postoperative sensorineural hearing loss. The measurement of the length of the piston is very significant, and in our study the majority of the pistons were cut at 4.75 mm which indicates an incus-footplate measurement of 4.25 mm.

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.

[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.

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.

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.

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

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.

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

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

A Comparative Finite-Element Analysis of Bone Failure and Load Transfer of Osseointegrated Prostheses Fixations

PubMed Central

Tomaszewski, P. K.; Verdonschot, N.; Bulstra, S. K.

2010-01-01

An alternative solution to conventional stump–socket prosthetic limb attachment is offered by direct skeletal fixation. This study aimed to assess two percutaneous trans-femoral implants, the OPRA system (Integrum AB, Göteborg, Sweden), and the ISP Endo/Exo prosthesis (ESKA Implants AG, Lübeck, Germany) on bone failure and stem–bone interface mechanics both early post-operative (before bony ingrowth) and after full bone ingrowth. Moreover, mechanical consequences of implantation of those implants in terms of changed loading pattern within the bone and potential consequences on long-term bone remodeling were studied using finite-element models that represent the intact femur and implants fitted in amputated femora. Two experimentally measured loads from the normal walking cycle were applied. The analyses revealed that implantation of percutaneous prostheses had considerable effects on stress and strain energy density levels in bone. This was not only caused by the implant itself, but also by changed loading conditions in the amputated leg. The ISP design promoted slightly more physiological strain energy distribution (favoring long-term bone maintenance), but the OPRA design generated lower bone stresses (reducing bone fracture risk). The safety factor against mechanical failure of the two percutaneous designs was relatively low, which could be improved by design optimization of the implants. PMID:20309731

[The complications of skin expansion in paediatrics: Diagnostic, taking over and prevention].

PubMed

Pascal, S; Philandrianos, C; Bertrand, B; Bardot, J; Degardin, N; Casanova, D

2016-10-01

Skin expansion is a difficult and long process in which can occur more or less serious complications. Overall complications rates describe in the literature vary between 13 and 37%. We can categorize them in major complications, which can lead to a failure maybe even an aggravation of the anterior status, and in minor complications that do not compromise the expansion process but can alter it. The main major complications are infection, skin suffering and necrosis which can lead to prosthesis exposition, leaks and technical problems with equipment dysfunctions that may cause difficulties or a failure of the inflations. The main minor complications are hematomas, seromas, valve or tube exposition, pains with paraesthesias caused by neighbouring organs compression, pathologic and unsightly scares and can lead to an important psychological impact. These complications can be due to a precarious skin's state, a material dysfunction or unpredictable technical problems but also by an inappropriate preoperative indication or planning. The emerging of a complication, however, is not synonymous to a failure of the procedure; a satisfactory reconstruction may still be obtained in 75% of all cases. The purpose of this article is to help to identify the situations at risk of complications in order to prevent, detect and treat them early. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Propionibacterium acnes infection after shoulder surgery

PubMed Central

Kadler, Benjamin K.; Mehta, Saurabh S.; Funk, Lennard

2015-01-01

Propionibacterium acnes has been implicated as a cause of infection following shoulder surgery, may occur up to 2 years after the index operation and has been shown to be responsible for up to 56% of shoulder infections after orthopedic implant. Male patients within the population undergoing shoulder surgery are particularly at risk, especially if their shoulder surgery involved prosthesis or was posttraumatic. P. acnes infection can be difficult to diagnose clinically and laboratory techniques require prolonged and specialized cultures. Usual inflammatory markers are not raised in infection with this low virulence organism. Delayed diagnosis with P. acnes infection can result in significant morbidity prior to prosthesis failure. Early diagnosis of P. acnes infection and appropriate treatment can improve clinical outcomes. It is important to be aware of P. acnes infection in shoulder surgery, to evaluate risk factors, to recognize the signs of P. acnes infection, and to promptly initiate treatment. The signs and symptoms of P. acnes infection are described and discussed. Data were collected from PubMed™, Web of Science, and the NICE Evidence Healthcare Databases - AMED (Ovid), BNI (Ovid), CINAHL (EBSCO), Embase (Ovid), HMIC: DH-Data and Kings Fund (Ovid), Medline (Ovid), and PsycINFO (Ovid). The search terms used were “P. acnes,” “infection,” “shoulder,” and “surgery.” In this review, we summarize the current understanding of the prevention and management of P. acnes infection following shoulder surgery. PMID:26622132

The evolution of viscous flow structures in the esophagus during tracheoesophageal speech

NASA Astrophysics Data System (ADS)

Erath, Byron; Hemsing, Frank

2015-11-01

A laryngectomy is an invasive surgical procedure whereby the entire larynx is removed, usually as a result of cancer. Removal of the larynx renders conventional voiced speech impossible, with the most common remediation following surgery being tracheoeosphageal (TE) speech. TE speech is produced by inserting a one-way valve to connect the posterior wall of the trachea with the anterior wall of the esophagus. As air is forced up from the lungs it passes through the prosthesis and into the esophagus. The resulting esophageal pressure field incites self-sustained oscillations of the pharyngoesophageal segment (PES), which ultimately produces sound. Unfortunately, the physics of TE speech are not well understood, with up to 50% of individuals unable to produce intelligible sound. This failure can be related to a lack of understanding regarding the esophageal flow field, where all previous scientific investigations have assumed the flow is one-dimensional and steady. An experimental TE speech flow facility was constructed and particle image velocimetry measurements were acquired at the exit of the model prosthesis (entrance of the esophagus). The flow is observed to be highly unsteady, and the formation and propagation of vortical flow structures through the esophageal tract are identified. Observations regarding the influence of the flow dynamics on the esophageal pressure field and its relation to the successful production of TE speech are discussed.

[Mid-term results after post-traumatic knee joint replacement in elderly patients].

PubMed

Weber, O; Goost, H; Mueller, M; Burger, C; Wirtz, D; Pagenstert, G; Gravius, S

2011-04-01

Due to the increasing prevalence of elderly people in Germany, the number of geriatric fractures will continue to increase. Typical geriatric skeletal and physical changes are osteoporosis, arthrosis, and reduced ability of coordination. Altogether, these factors may lead to a failure of a performed osteosynthesis, or may make the classical fracture treatment of reduction and internal fixation appear to be impossible. The aim of this study was to examine the results of peri-knee fractures treated directly or within 3 months by implantation of a knee prosthesis. 15 geriatric patients could be identified who were treated in the described way in the last 4 years. The follow-up time was 39 months. The knee injury occurred in all cases after a banal trauma. 14 patients could be examined by applying the HSS scoring system. We furthermore checked the operative management and postoperative course. The patients reached a good score level and showed few complications. For elderly patients, the primary knee arthroplasty after periarticular fractures of the knee is a valid treatment option. Nevertheless, the surgeon has to identify those fractures which are impossible to treat by a classical osteosynthesis. Furthermore, the application of the appropriate knee prosthesis, regarding the degree of hinge constrainment or augmentation of the tibial or femoral bone stock, is important. © Georg Thieme Verlag KG Stuttgart · New York.

Bionic Running for Unilateral Transtibial Military Amputees

DTIC Science & Technology

2010-01-01

Bellman, R., 2010, “An Active Ankle-Foot Prosthesis With Biomechanical Energy Regeneration”, Transactions of the ASME Journal...Lefeber, D., 2008, “A Biomechanical Transtibial Prosthesis Powered by Pleated Pneumatic Artificial Muscles,” Model Identification and Control, 4, 394- 405. ...Inc., have designed, built, and demonstrated a first of its kind motor powered, single board computer controlled, running prosthesis for military

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.

Fabrication of an interim complete removable dental prosthesis with an in-office digital light processing three-dimensional printer: A proof-of-concept technique.

PubMed

Lin, Wei-Shao; Harris, Bryan T; Pellerito, John; Morton, Dean

2018-04-30

This report describes a proof of concept for fabricating an interim complete removable dental prosthesis with a digital light processing 3-dimensional (3D) printer. Although an in-office 3D printer can reduce the overall production cost for an interim complete removable dental prosthesis, the process has not been validated with clinical studies. This report provided a preliminary proof of concept in developing a digital workflow for the in-office additively manufactured interim complete removable dental prosthesis. Copyright © 2018 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Responses evoked by a vestibular implant providing chronic stimulation.

PubMed

Thompson, Lara A; Haburcakova, Csilla; Gong, Wangsong; Lee, Daniel J; Wall, Conrad; Merfeld, Daniel M; Lewis, Richard F

2012-01-01

Patients with bilateral vestibular loss experience dehabilitating visual, perceptual, and postural difficulties, and an implantable vestibular prosthesis that could improve these symptoms would be of great benefit to these patients. In previous work, we have shown that a one-dimensional, unilateral canal prosthesis can improve the vestibulooccular reflex (VOR) in canal-plugged squirrel monkeys. In addition to the VOR, the potential effects of a vestibular prosthesis on more complex, highly integrative behaviors, such as the perception of head orientation and posture have remained unclear. We tested a one-dimensional, unilateral prosthesis in a rhesus monkey with bilateral vestibular loss and found that chronic electrical stimulation partially restored the compensatory VOR and also that percepts of head orientation relative to gravity were improved. However, the one-dimensional prosthetic stimulation had no clear effect on postural stability during quiet stance, but sway evoked by head-turns was modestly reduced. These results suggest that not only can the implementation of a vestibular prosthesis provide partial restitution of VOR but may also improve perception and posture in the presence of bilateral vestibular hypofunction (BVH). In this review, we provide an overview of our previous and current work directed towards the eventual clinical implementation of an implantable vestibular prosthesis.

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.

Intermanual Transfer Effects in Below-Elbow Myoelectric Prosthesis Users.

PubMed

de Boer, Errit; Romkema, Sietske; Cutti, Andrea G; Brouwers, Michael A; Bongers, Raoul M; van der Sluis, Corry K

2016-11-01

To determine intermanual transfer effects in patients with a below-elbow amputation using a myoelectric prosthesis and to establish whether laterality affects these effects. Case-control. A standardized setting in a rehabilitation clinic. A convenience sample (N=44) of experienced myoelectric prosthesis users (n=22) and matched controls (n=22). Controls were matched on sex, age (±5y), and hand dominance. Both the experienced group and the control group performed several tasks using a prosthesis simulator attached to their nonaffected arm. Movement time, force control, Box and Block test (BBT) scores, and duration of hand opening. Movement times of myoelectric prosthesis users were shorter, and these users had significantly higher BBT scores and shorter hand opening durations than those of controls. No intermanual transfer effects on force control and no laterality effects were found. Intermanual transfer effects were present in experienced myoelectric prosthesis users with a below-elbow amputation, independent of laterality. These findings support the clinical relevance of intermanual transfer training, which may facilitate persons with an upper limb amputation to start training directly after the amputation. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Comparison of mechanical energy profiles of passive and active below-knee prostheses: a case study.

PubMed

Takahashi, Kota Z; Horne, John R; Stanhope, Steven J

2015-04-01

With the recent technological advancements of prosthetic lower limbs, there is currently a great desire to objectively evaluate existing prostheses. Using a novel biomechanical analysis, the purpose of this case study was to compare the mechanical energy profiles of anatomical and two disparate prostheses: a passive prosthesis and an active prosthesis. An individual with a transtibial amputation who customarily wears a passive prosthesis (Elation, Össur) and an active prosthesis (BiOM, iWalk, Inc.) and 11 healthy subjects participated in an instrumented gait analysis. The total mechanical power and work of below-knee structures during stance were quantified using a unified deformable segment power analysis. Active prosthesis generated greater peak power and total positive work than passive prosthesis and healthy anatomical limbs. The case study will enhance future efforts to objectively evaluate prosthetic functions during gait in individuals with transtibial amputations. A prosthetic limb should closely replicate the mechanical energy profiles of anatomical limbs. The unified deformable (UD) analysis may be valuable to facilitate future clinical prescription and guide fine adjustments of prosthetic componentry to optimize gait outcomes. © The International Society for Prosthetics and Orthotics 2014.

Fatigue fracture of a proximally modular, distally tapered fluted implant with diaphyseal fixation.

PubMed

Buttaro, Martín A; Mayor, Michael B; Van Citters, Douglas; Piccaluga, Francisco

2007-08-01

We report and analyze the causes of a fracture in a proximally modular, distally tapered fluted MP stem in a 48-year-old woman (168 cm, 67 kg) with severe proximal bone deficiency. Evidence of fatigue failure with striations initiated laterally was observed in the laser etching of the tensile aspect of the prosthesis. However, metallurgical analysis suggested that laser engraving did not alter the microstructure of the stem. Stress due to the absence of proximal femoral bone support may have been sufficiently high to put this particular stem at risk for fatigue fracture. This important complication should be addressed when choosing this therapeutic option in cases with substantial proximal femoral bone loss. Strut allograft support should be recommended in such cases.

Dissection of the atrial wall after mitral valve replacement.

PubMed Central

Lukács, L; Kassai, I; Lengyel, M

1996-01-01

We describe an unusual sequela of mitral valve replacement in a 50-year-old woman who had undergone a closed mitral commissurotomy in 1975. She was admitted to our hospital because of mitral restenosis in November 1993, at which time her mitral valve was replaced with a mechanical prosthesis. On the 8th postoperative day, the patient developed symptoms of heart failure; transesophageal echocardiography revealed dissection and rupture of the left atrial wall. At prompt reoperation, we found an interlayer dissection and rupture of the atrial wall into the left atrium. We repaired the ruptured atrial wall with a prosthetic patch. The postoperative course was uneventful, and postoperative transesophageal echocardiography showed normal prosthetic valve function and no dissection. Images PMID:8680278