21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/metal semi-constrained, with a cemented acetabular component, prosthesis. 888.3320 Section 888.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic...

21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/metal semi-constrained, with a cemented acetabular component, prosthesis. 888.3320 Section 888.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic...

21 CFR 888.3320 - Hip joint metal/metal semi-constrained, with a cemented acetabular component, 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/metal semi-constrained, with a cemented acetabular component, prosthesis. 888.3320 Section 888.3320 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic...

All-polyethylene tibial components in distal femur limb-salvage surgery: a finite element analysis based on promising clinical outcomes.

PubMed

Tang, Fan; Zhou, Yong; Zhang, Wenli; Min, Li; Shi, Rui; Luo, Yi; Duan, Hong; Tu, Chongqi

2017-04-04

Whether all-polyethylene tibial (APT) components are beneficial to patients who received distal femur limb-salvage surgery lacks high-quality clinical follow-up and mechanical evidence. This study aimed to investigate the biomechanics of the distal femur reconstructed with APT tumor knee prostheses using finite element (FE) analysis based on our previous, promising clinical outcome. Three-dimensional FE models that use APT and metal-backed tibial (MBT) prostheses to reconstruct distal femoral bone defects were developed and input into the Abaqus FEA software version 6.10.1. Mesh refinement tests and gait simulation with a single foot both in the upright and 15°-flexion positions with mechanical loading were conducted. Stress distribution analysis was compared between APT and MBT at the two static positions. For both prosthesis types, the stress was concentrated on the junction of the stem and shaft, and the maximum stress in the femoral axis base was more than 100 Mpa. The stress on the tibial surface was relatively distributed, which was 1-19 MPa. The stress on the tibial bone-cement layer of the APT prosthesis was approximately 20 times higher than that on the MBT prosthesis in the same region. The stress on the proximal tibial cancellous bone and cortical bone of the APT prosthesis was 3-5 times greater than that of the MBT prosthesis, and it was more distributed. Although the stress of bone-cement around the APT component is relatively high, the stress was better distributed at the polyethylene-cement-bone interface in APT than in MBT prosthesis, which effectively protects the proximal tibia in distal femur tumor knee prosthesis replacement. These results should be considered when selecting the appropriate tibial component for a patient, especially under the foreseeable conditions of osteoporosis.

Space orientation of total hip prosthesis. A method for three-dimensional determination.

PubMed

Herrlin, K; Selvik, G; Pettersson, H

1986-01-01

A method for in vivo determination of orientation and relation in space of components of total hip prosthesis is described. The method allows for determination of the orientation of the prosthetic components in well defined anatomic planes of the body. Furthermore the range of free motion from neutral position to the point of contact between the edge of the acetabular opening and the neck of the femoral component can be determined in various directions. To assess the accuracy of the calculations a phantom prosthesis was studied in nine different positions and the measurements of the space oriented parameters according to the present method correlated to measurements of the same parameters according to Selvik's stereophotogrammetric method. Good correlation was found. The role of prosthetic malpositioning and component interaction evaluated with the present method in the development of prosthetic loosening and displacement is discussed.

Biomechanical comparison of component position and hardware failure in the reverse shoulder prosthesis.

PubMed

Gutiérrez, Sergio; Greiwe, R Michael; Frankle, Mark A; Siegal, Steven; Lee, William E

2007-01-01

There has been renewed interest in reverse shoulder arthroplasty for the treatment of glenohumeral arthritis with concomitant rotator cuff deficiency. Failure of the prosthesis at the glenoid attachment site remains a concern. The purpose of this study was to examine glenoid component stability with regard to the angle of implantation. This investigation entailed a biomechanical analysis to evaluate forces and micromotion in glenoid components attached to 12 polyurethane blocks at -15 degrees, 0 degrees, and +15 degrees of superior and inferior tilt. The 15 degrees inferior tilt had the most uniform compressive forces and the least amount of tensile forces and micromotion when compared with the 0 degrees and 15 degrees superiorly tilted baseplate. Our results suggest that implantation with an inferior tilt will reduce the incidence of mechanical failure of the glenoid component in a reverse shoulder prosthesis.

Differential bacterial load on components of total knee prosthesis in patients with prosthetic joint infection.

PubMed

Holinka, Johannes; Pilz, Magdalena; Hirschl, Alexander M; Graninger, Wolfgang; Windhager, Reinhard; Presterl, Elisabeth

2012-10-01

The purpose of our study was to evaluate and quantify the bacterial adherence on different components of total knee prosthesis with the sonication culture method. Explanted components of all patients with presumptive prosthetic or implant infection were treated by sonication separately in sterile containers to dislodge the adherent bacteria from the surfaces and cultured. The bacterial load of the different knee components (femur, tibia, PE-inlay and patella) was evaluated by counting of colony-forming units (CFU) dislodged from the components surfaces using the sonication culture method. Overall, 27 patients had positive sonication cultures of explanted total knee prostheses. Microorganisms were detected from 88 of 100 explanted components. Twenty femoral components were culture positive and 7 negative, 23 tibial components as well as 23 polyethylene (PE) platforms had positive microorganism detection from the surface. Staphylococcus epidermidis adhered to the highest number of components whereas Staphylococcus aureus yielded the highest load of CFU in the sonication cultures. Although not significant, PE-inlays and tibial components were most often affected. The highest CFU count was detected in polyethylene components. The sonication culture method is a reliable method to detect bacteria from the components. Additionally, the results demonstrate that bacterial adherence is not affecting a single component of knee prosthesis only. Thus, in septic revision surgery partial prosthetic exchange or exchange of single polyethylene components alone may be not sufficient.

Design Studies of Cardiac Valve Prostheses

PubMed Central

Liotta, Domingo

1985-01-01

This paper indicates the vital importance of considering prosthesis articulation in the design of cardiac valves. The prosthesis articulation interrelates with the fixed and the movable prosthetic components. Two basic physiological hemodynamic principles are reviewed: [List: see text] A bileaflet, free-tilting, swivelling prosthesis with a central articular mechanism is undergoing investigation. The four articulations have their own perennial preserving mechanisms to prevent potential failure mode by collecting blood elements in the valve tilting design. PMID:15227041

Measurement of Forces and Moments Transmitted to the Residual Limb

DTIC Science & Technology

2008-08-01

leg and residual limb, the condition of your residual limb including touch and pressure sensation, and the type of components used in your prosthesis ...measured by a tri-axial transducer mounted on the pylon of a transtibial prosthesis distal to the socket can be used to estimate the intra-socket...alignment has been developed, and IRB approval has been obtained. 15. SUBJECT TERMS Amputees, prosthesis alignment, socket pressure, gait, force and moment

Technical note: validation of a motion analysis system for measuring the relative motion of the intermediate component of a tripolar total hip arthroplasty prosthesis.

PubMed

Chen, Qingshan; Lazennec, Jean Yves; Guyen, Olivier; Kinbrum, Amy; Berry, Daniel J; An, Kai-Nan

2005-07-01

Tripolar total hip arthroplasty (THA) prosthesis had been suggested as a method to reduce the occurrence of hip dislocation and microseparation. Precisely measuring the motion of the intermediate component in vitro would provide fundamental knowledge for understanding its mechanism. The present study validates the accuracy and repeatability of a three-dimensional motion analysis system to quantitatively measure the relative motion of the intermediate component of tripolar total hip arthroplasty prostheses. Static and dynamic validations of the system were made by comparing the measurement to that of a potentiometer. Differences between the mean system-calculated angle and the angle measured by the potentiometer were within +/-1 degrees . The mean within-trial variability was less than 1 degrees . The mean slope was 0.9-1.02 for different angular velocities. The dynamic noise was within 1 degrees . The system was then applied to measure the relative motion of an eccentric THA prosthesis. The study shows that this motion analysis system provides an accurate and practical method for measuring the relative motion of the tripolar THA prosthesis in vitro, a necessary first step towards the understanding of its in vivo kinematics.

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

DTIC Science & Technology

2015-10-01

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

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.

A Simplified Technique for Fabrication of Orbital Prosthesis

PubMed Central

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

2014-01-01

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

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

PubMed

Biau, David Jean; Dumaine, Valérie; Babinet, Antoine; Tomeno, Bernard; Anract, Philippe

2007-03-01

The survival of irradiated allograft-prosthesis composites at the proximal tibia is mostly unknown. However, allograft-prosthesis composites have proved beneficial at other reconstruction sites. We presumed allograft-prosthesis composites at the proximal tibia would improve survival and facilitate reattachment of the extensor mechanism compared with that of conventional (megaprostheses) reconstructions. We retrospectively reviewed 26 patients who underwent resection of proximal tibia tumors followed by reconstruction with allo-graft-prosthesis composites. Patients received Guepar massive custom-made fully constrained prostheses. Allografts were sterilized with gamma radiation, and the stems were cemented into the allograft and host bone. The minimum followup was 6 months (median, 128 months; range, 6-195 months). Fourteen patients had one or more components removed. The median allograft-prosthesis composite survival was 102 months (95% confidence interval, 64.2-infinity). Of the 26 allografts, seven fractured, six showed signs of partial resorption, and six had infections develop. Seven allografts showed signs of fusion with the host bone. Six extensor mechanism reconstructions failed. Allograft-prosthesis composites sterilized by gamma radiation yielded poor results for proximal tibial reconstruction as complications and failures were common. We do not recommend irradiated allograft-prosthesis composites for proximal tibia reconstruction.

21 CFR 888.3480 - Knee joint femorotibial metallic 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 metallic constrained... Knee joint femorotibial metallic constrained cemented prosthesis. (a) Identification. A knee joint... knee joint. The device prevents dislocation in more than one anatomic plane and has components that are...

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.

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

PubMed

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

2009-01-01

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

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.

The Influence Of Component Alignment On The Life Of Total Knee Prostheses

NASA Astrophysics Data System (ADS)

Bugariu, Delia; Bereteu, Liviu

2012-12-01

An arthritic knee affects the patient's life by causing pain and limiting movement. If the cartilage and the bone surfaces are severely affected, the natural joint is replaced with an artificial joint. The procedure is called total knee arthroplasty (TKA). Lately, the numbers of implanted total knee prostheses grow steadily. An important factor in TKA is the perfect alignment of the total knee prosthesis (TKP) components. Component misalignment can lead to the prosthesis loss by producing wear particles. The paper proposes a study on mechanical behaviors of a TKP based on numerical analysis, using ANSYS software. The numerical analysis is based on both the normal and the changed angle of the components alignment.

Outcome of prosthesis matched and unmatched patella components in primary and revision total knee replacement.

PubMed

Lewis, Peter L; Gamboa, Ai E; Campbell, David G; Lorimer, Michelle

2017-10-01

Although knee replacements have specifically designed patella prostheses that correspond to the geometry of their femoral components, a patella prosthesis that is unmatched to the femoral component may occasionally be inserted. In revision total knee arthroplasty (TKA), an originally resurfaced patella may be left, but the femoral component revised to one that does not match the patella. Few studies have compared the outcome of matched and unmatched patella components in TKA. This study compared the primary or revision TKA outcome of procedures where patella components matched to their femoral counterparts were inserted, with procedures using patella and femoral components that were unmatched. Data on all primary and revision TKA procedures without a patella component or a matched or an unmatched patella component were obtained from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). Revision surgery was the outcome measure. Cumulative percent revised (CPR) were calculated and Hazard ratios with p values were used to test statistical significance. In primary TKA, there were higher rates of revision where unmatched patella components were used, regardless of implant design. There was no difference in the second revision rates of unmatched versus matched patella component groups. This was evident where delayed resurfacing was carried out, and where the patella prosthesis was left alone but the femoral component was changed. All primary TKA procedures require a patella component corresponding to the femoral component if the patella is resurfaced. Conversely, revision knee arthroplasties are not affected by the use of dissimilar patella and femoral components. Copyright © 2017 Elsevier B.V. All rights reserved.

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

Mobile-bearing total knee arthroplasty: a full traumatic rotation of 180°.

PubMed

Sudanese, Alessandra; Castiello, Emanuela; Affatato, Saverio

2013-06-25

From February 2008 to September 2012 we implanted 204 mobile-bearing knee prostheses in 192 patients. All the prostheses were cemented (both femoral and tibial components), and the patella was not replaced. Only one early complication of the implants (1/204 = 0.004%) occurred after a traumatic event as a full 180° rotation of the mobile-bearing polyethylene insert. A 78-year-old woman presented with swelling and severe pain at her right knee. This traumatic event was the only case among our mobile-bearing insert patients. 
The failed polyethylene inserts were retrieved and studied using a scanning electron microscope (SEM, ZEISS EVO 50 EP, Cambridge, UK) operating at 20 kV. 
Scratching and pitting were found on the UHMWPE insert perpendicular to the machining tracks for the concave surface. SEM micrographs of the insert showed burnishing on the concave surfaces and longitudinal scratches were clearly detectable and well-marked on the analyzed surfaces. 
A traumatic, fully rotating, polyethylene insert is rare and our case is the first report describing a traumatic event with a complete 180 degree rotation mobile-bearing in a total knee prosthesis. 
In the literature few reports discuss clinical outcomes after total knee arthroplasty in patients with Parkinson's disease and they cite mixed results. However, some authors suggest that posterior-stabilized and cruciate-retaining TKA should work well while others prefer cruciate-retaining, condylar constrained kinetics, or hinged devices. Although we did not implant a posterior-stabilized mobile-bearing total knee prosthesis or a constrained prosthesis, we obtained good clinical and radiological results at the 2-year followup.

[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.

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.

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

PubMed

Scala, Rudy; Cucchi, Alessandro; Ghensi, Paolo; Vartolo, Francesco

2012-01-01

The purpose of this controlled prospective study was to compare the satisfaction of patients rehabilitated with an immediately loaded implant-supported prosthesis and patients rehabilitated with a conventional denture in the mandible. Selected mandibular partially or totally edentulous patients were included in this prospective study. Patients' mandibles were completely rehabilitated with immediately loaded implants supporting a screw-retained full-arch prosthesis (test group) or with a conventional denture (control group). The Satisfaction Profile (SAT-P), which investigates a number of psychologic aspects related to the function and esthetics of the stomatognathic apparatus, was administered to each patient 1 month before and 3 months after provisional prosthetic rehabilitation. The questionnaire comprised four different SAT-P items: quality of eating, eating behavior, mood, and self-confidence. A visual analog scale was used to elicit patient responses. SAT-P item scores were analyzed statistically by means of the Student t test and the chi-square test (or the Mann-Whitney nonparametric test), with P < .05 considered significant. Forty-one patients were consecutively treated with 205 immediately loaded implants supporting a screw-retained full-arch prosthesis (test group); 38 patients were consecutively treated with a conventional denture (control group). Statistically significant differences were observed between the test and control groups for all four SAT-P items. The test group reported greater satisfaction for all items versus the control group. In both groups, the differences between pre- and postrehabilitation values were statistically significant. Each patient was satisfied with their treatment outcomes, but patients who received an implant-supported prosthesis were more satisfied than the patients who received a conventional denture. The results suggest that a screw-retained full-arch prosthesis on immediately loaded implants is a predictable means of enhancing patient satisfaction.

Model-based Roentgen stereophotogrammetry of orthopaedic implants.

PubMed

Valstar, E R; de Jong, F W; Vrooman, H A; Rozing, P M; Reiber, J H

2001-06-01

Attaching tantalum markers to prostheses for Roentgen stereophotogrammetry (RSA) may be difficult and is sometimes even impossible. In this study, a model-based RSA method that avoids the attachment of markers to prostheses is presented and validated. This model-based RSA method uses a triangulated surface model of the implant. A projected contour of this model is calculated and this calculated model contour is matched onto the detected contour of the actual implant in the RSA radiograph. The difference between the two contours is minimized by variation of the position and orientation of the model. When a minimal difference between the contours is found, an optimal position and orientation of the model has been obtained. The method was validated by means of a phantom experiment. Three prosthesis components were used in this experiment: the femoral and tibial component of an Interax total knee prosthesis (Stryker Howmedica Osteonics Corp., Rutherfort, USA) and the femoral component of a Profix total knee prosthesis (Smith & Nephew, Memphis, USA). For the prosthesis components used in this study, the accuracy of the model-based method is lower than the accuracy of traditional RSA. For the Interax femoral and tibial components, significant dimensional tolerances were found that were probably caused by the casting process and manual polishing of the components surfaces. The largest standard deviation for any translation was 0.19mm and for any rotation it was 0.52 degrees. For the Profix femoral component that had no large dimensional tolerances, the largest standard deviation for any translation was 0.22mm and for any rotation it was 0.22 degrees. From this study we may conclude that the accuracy of the current model-based RSA method is sensitive to dimensional tolerances of the implant. Research is now being conducted to make model-based RSA less sensitive to dimensional tolerances and thereby improving its accuracy.

Custom hip prostheses by integrating CAD and casting technology

NASA Astrophysics Data System (ADS)

Silva, Pedro F.; Leal, Nuno; Neto, Rui J.; Lino, F. Jorge; Reis, Ana

2012-09-01

Total Hip Arthroplasty (THA) is a surgical intervention that is being achieving high rates of success, leaving room to research on long run durability, patient comfort and costs reduction. Even so, up to the present, little research has been done to improve the method of manufacturing customized prosthesis. The common customized prostheses are made by full machining. This document presents a different approach methodology which combines the study of medical images, through CAD (Computer Aided Design) software, SLadditive manufacturing, ceramic shell manufacture, precision foundry with Titanium alloys and Computer Aided Manufacturing (CAM). The goal is to achieve the best comfort for the patient, stress distribution and the maximum lifetime of the prosthesis produced by this integrated methodology. The way to achieve this desiderate is to make custom hip prosthesis which are adapted to each patient needs and natural physiognomy. Not only the process is reliable, but also represents a cost reduction comparing to the conventional full machined custom hip prosthesis.

Precision assessment of model-based RSA for a total knee prosthesis in a biplanar set-up.

PubMed

Trozzi, C; Kaptein, B L; Garling, E H; Shelyakova, T; Russo, A; Bragonzoni, L; Martelli, S

2008-10-01

Model-based Roentgen Stereophotogrammetric Analysis (RSA) was recently developed for the measurement of prosthesis micromotion. Its main advantage is that markers do not need to be attached to the implants as traditional marker-based RSA requires. Model-based RSA has only been tested in uniplanar radiographic set-ups. A biplanar set-up would theoretically facilitate the pose estimation algorithm, since radiographic projections would show more different shape features of the implants than in uniplanar images. We tested the precision of model-based RSA and compared it with that of the traditional marker-based method in a biplanar set-up. Micromotions of both tibial and femoral components were measured with both the techniques from double examinations of patients participating in a clinical study. The results showed that in the biplanar set-up model-based RSA presents a homogeneous distribution of precision for all the translation directions, but an inhomogeneous error for rotations, especially internal-external rotation presented higher errors than rotations about the transverse and sagittal axes. Model-based RSA was less precise than the marker-based method, although the differences were not significant for the translations and rotations of the tibial component, with the exception of the internal-external rotations. For both prosthesis components the precisions of model-based RSA were below 0.2 mm for all the translations, and below 0.3 degrees for rotations about transverse and sagittal axes. These values are still acceptable for clinical studies aimed at evaluating total knee prosthesis micromotion. In a biplanar set-up model-based RSA is a valid alternative to traditional marker-based RSA where marking of the prosthesis is an enormous disadvantage.

Embodied prosthetic arm stabilizes body posture, while unembodied one perturbs it.

PubMed

Imaizumi, Shu; Asai, Tomohisa; Koyama, Shinichi

2016-10-01

Senses of ownership (this arm belongs to me) and agency (I am controlling this arm) originate from sensorimotor system. External objects can be integrated into the sensorimotor system following long-term use, and recognized as one's own body. We examined how an (un)embodied prosthetic arm modulates whole-body control, and assessed the components of prosthetic embodiment. Nine unilateral upper-limb amputees participated. Four frequently used their prosthetic arm, while the others rarely did. Their postural sway was measured during quiet standing with or without their prosthesis. The frequent users showed greater sway when they removed the prosthesis, while the rare users showed greater sway when they fitted the prosthesis. Frequent users reported greater everyday feelings of postural stabilization by prosthesis and a larger sense of agency over the prosthesis. We suggest that a prosthetic arm maintains or perturbs postural control, depending on the prosthetic embodiment, which involves sense of agency rather than ownership. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical results of Hi-tech Knee II total knee arthroplasty in patients with rheumatoid athritis: 5- to 12-year follow-up.

PubMed

Yamanaka, Hajime; Goto, Ken-ichiro; Suzuki, Munetaka

2012-02-22

Total knee arthroplasty (TKA) is a common form of treatment to relieve pain and improve function in cases of rheumatoid arthritis (RA). Good clinical outcomes have been reported with a variety of TKA prostheses. The cementless Hi-Tech Knee II cruciate-retaining (CR)-type prosthesis, which has 6 fins at the anterior of the femoral component, posterior cruciate ligament (PCL) retention, flat-on-flat surface component geometry, all-polyethylene patella, strong initial fixation by the center screw of the tibial base plate, 10 layers of titanium alloy fiber mesh, and direct compression molded ultra high molecular weight polyethylene (UHMWPE), is appropriate for TKA in the Japanese knee.The present study was performed to evaluate the clinical results of primary TKA in RA using the cementless Hi-Tech Knee II CR-type prosthesis. We performed 32 consecutive primary TKAs using cementless Hi-Tech Knee II CR-type prosthesis in 31 RA patients. The average follow-up period was 8 years 3 months. Clinical evaluations were performed according to the American Knee Society (KS) system, knee score, function score, radiographic evaluation, and complications. The mean postoperative maximum flexion angle was 115.6°, and the KS knee score and function score improved to 88 and 70 after surgery, respectively. Complications, such as infection, occurred in 1 patient and revision surgery was performed. There were no cases of loosening in this cohort, and prosthesis survival rate was 96.9% at 12 years postoperatively. These results suggest that TKA using the cementless Hi-Tech Knee II CR-type prosthesis is a very effective form of treatment in RA patients at 5 to 12 years postoperatively. Further long-term follow-up studies are required to determine the ultimate utility of this type of prosthesis.

Posterior Shift of Contact Point between Femoral Component and Polyethylene in the LCS Rotating Platform Implant under Weight Bearing Condition.

PubMed

Oh, Won Seok; Lee, Yong Seuk; Kim, Byung Kak; Sim, Jae Ang; Lee, Beom Koo

2016-06-01

To analyze the contact mechanics of the femoral component and polyethylene of the Low Contact Stress rotating platform (LCS-RP) in nonweight bearing and weight bearing conditions using full flexion lateral radiographs. From May 2009 to December 2013, 58 knees in 41 patients diagnosed with osteoarthritis and treated with total knee arthroplasty (TKA) were included in this study. TKA was performed using an LCS-RP knee prosthesis. Full flexion lateral radiographs in both weight bearing and nonweight bearing condition were taken at least one month postoperatively (average, 28.8 months). Translation of femoral component was determined by the contact point between the femoral component and polyethylene. Maximum flexion was measured as the angle between the lines drawn at the midpoint of the femur and tibia. Posterior shift of the contact point in LCS-RP TKA was observed under weight bearing condition, which resulted in deeper flexion compared to LCS-RP TKA under nonweight bearing condition. In the LCS-RP TKA, the contact point between the femoral component and polyethylene moved posteriorly under weight bearing condition, and the joint was more congruent and maximum flexion increased with weight bearing.

Macroscopic and microscopic evaluation of a new implant design supporting immediately loaded full arch rehabilitation

PubMed Central

Tetè, Stefano; Zizzari, Vincenzo; De Carlo, Alessandro; Sinjari, Bruna; Gherlone, Enrico

2012-01-01

Summary The purpose of this study is to evaluate macroscopic and microscopic appearance of a new implant design, with particular emphasis given to the type of prosthesis connection. Two dental implants of the same type (Torque Type®, WinSix®, BioSAFin. S.r.l. - Ancona, Italy), with sandblasted and acid etched surfaces (Micro Rough Surface®), but differing from each other for the prosthesis connection system, were examined by scanning electron microscope (SEM) analysis at different magnifications: TTI implant, with a hexagonal internal connection, and TTX implant, with a hexagonal external connection. SEM analysis showed that the Torque Type® implant is characterized by a truncated cone shape with tapered tips. The implant body showed a double loop thread and double pitch with blunt tips. For both types of connection, the implant neck was 0.7 mm in height with a 3% taper. This implant design may be able to guarantee osteotomic properties at the time of insertion in a surgical site suitably prepared, a facilitated screwing, thanks to the thread pitch and to the broad and deep draining grooves, thereby ensuring a good primary stability. The different connection design appears defined and precise, in order to ensure a good interface between the fixture and the prosthetic components. Therefore, this design appears to be particularly suitable in cases where a good primary stability is necessary and a precise coupling between endosseous and prosthetic components, as it allows an easy insertion of the fixture even in conditions of reduced bone availability, and in cases of immediately loaded full-arch rehabilitations. PMID:23087785

Macroscopic and microscopic evaluation of a new implant design supporting immediately loaded full arch rehabilitation.

PubMed

Tetè, Stefano; Zizzari, Vincenzo; De Carlo, Alessandro; Sinjari, Bruna; Gherlone, Enrico

2012-04-01

The purpose of this study is to evaluate macroscopic and microscopic appearance of a new implant design, with particular emphasis given to the type of prosthesis connection. Two dental implants of the same type (Torque Type(®), WinSix(®), BioSAFin. S.r.l. - Ancona, Italy), with sandblasted and acid etched surfaces (Micro Rough Surface(®)), but differing from each other for the prosthesis connection system, were examined by scanning electron microscope (SEM) analysis at different magnifications: TTI implant, with a hexagonal internal connection, and TTX implant, with a hexagonal external connection. SEM analysis showed that the Torque Type(®) implant is characterized by a truncated cone shape with tapered tips. The implant body showed a double loop thread and double pitch with blunt tips. For both types of connection, the implant neck was 0.7 mm in height with a 3% taper. This implant design may be able to guarantee osteotomic properties at the time of insertion in a surgical site suitably prepared, a facilitated screwing, thanks to the thread pitch and to the broad and deep draining grooves, thereby ensuring a good primary stability. The different connection design appears defined and precise, in order to ensure a good interface between the fixture and the prosthetic components. Therefore, this design appears to be particularly suitable in cases where a good primary stability is necessary and a precise coupling between endosseous and prosthetic components, as it allows an easy insertion of the fixture even in conditions of reduced bone availability, and in cases of immediately loaded full-arch rehabilitations.

Do the radial head prosthesis components fit with the anatomical structures of the proximal radioulnar joint?

PubMed

Wegmann, Kilian; Hain, Moritz K; Ries, Christian; Neiss, Wolfram F; Müller, Lars P; Burkhart, Klaus J

2015-09-01

The fitting accuracy of radial head components has been investigated in the capitulo-radial joint, and reduced contact after prosthetic replacement of the radial head has been observed. The kinematics of the proximal radioulnar joint (PRUJ) are affected by radial head arthroplasty as well, but have not yet been investigated in this regard. The elbow joints of 60 upper extremities of formalin-fixed body donors were disarticulated to obtain a good view of the PRUJ. Each specimen was mounted on the examining table and radial head position in the native PRUJ was assessed in neutral position, full pronation, and full supination. Measurements were repeated after implantation of mono- and bi-polar prostheses. Analysis of the distribution of the joint contacts in the compartments showed significant differences after radial head replacement. In comparison to the native joint, after bipolar and monopolar radial head replacement, the physiological shift of the proximal radius was altered. The physiological shift of the joint contact of the radial head from anterior to posterior during forearm rotation that was found in the native joint in our cadaver model was not observed after prosthetic replacement. With higher conformity and physiological kinematic of radial head prostheses, possibly lower shear forces and lower contact pressures would be generated. The tested radial head prostheses do not replicate the physiological kinematics of the radial head. Further development in the prosthesis design has to be made. The meticulous reconstruction of the annular ligament seems to be of importance to increase joint contact.

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.

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.

[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.

Technology efficacy in active prosthetic knees for transfemoral amputees: a quantitative evaluation.

PubMed

El-Sayed, Amr M; Hamzaid, Nur Azah; Abu Osman, Noor Azuan

2014-01-01

Several studies have presented technological ensembles of active knee systems for transfemoral prosthesis. Other studies have examined the amputees' gait performance while wearing a specific active prosthesis. This paper combined both insights, that is, a technical examination of the components used, with an evaluation of how these improved the gait of respective users. This study aims to offer a quantitative understanding of the potential enhancement derived from strategic integration of core elements in developing an effective device. The study systematically discussed the current technology in active transfemoral prosthesis with respect to its functional walking performance amongst above-knee amputee users, to evaluate the system's efficacy in producing close-to-normal user performance. The performances of its actuator, sensory system, and control technique that are incorporated in each reported system were evaluated separately and numerical comparisons were conducted based on the percentage of amputees' gait deviation from normal gait profile points. The results identified particular components that contributed closest to normal gait parameters. However, the conclusion is limitedly extendable due to the small number of studies. Thus, more clinical validation of the active prosthetic knee technology is needed to better understand the extent of contribution of each component to the most functional development.

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

PubMed

Gordon, Assaf T; Land, Rebekah M

2009-01-01

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

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

21 CFR 888.3330 - Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP...

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.

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.

Development of a Magnetic Attachment Method for Bionic Eye Applications.

PubMed

Fox, Kate; Meffin, Hamish; Burns, Owen; Abbott, Carla J; Allen, Penelope J; Opie, Nicholas L; McGowan, Ceara; Yeoh, Jonathan; Ahnood, Arman; Luu, Chi D; Cicione, Rosemary; Saunders, Alexia L; McPhedran, Michelle; Cardamone, Lisa; Villalobos, Joel; Garrett, David J; Nayagam, David A X; Apollo, Nicholas V; Ganesan, Kumaravelu; Shivdasani, Mohit N; Stacey, Alastair; Escudie, Mathilde; Lichter, Samantha; Shepherd, Robert K; Prawer, Steven

2016-03-01

Successful visual prostheses require stable, long-term attachment. Epiretinal prostheses, in particular, require attachment methods to fix the prosthesis onto the retina. The most common method is fixation with a retinal tack; however, tacks cause retinal trauma, and surgical proficiency is important to ensure optimal placement of the prosthesis near the macula. Accordingly, alternate attachment methods are required. In this study, we detail a novel method of magnetic attachment for an epiretinal prosthesis using two prostheses components positioned on opposing sides of the retina. The magnetic attachment technique was piloted in a feline animal model (chronic, nonrecovery implantation). We also detail a new method to reliably control the magnet coupling force using heat. It was found that the force exerted upon the tissue that separates the two components could be minimized as the measured force is proportionately smaller at the working distance. We thus detail, for the first time, a surgical method using customized magnets to position and affix an epiretinal prosthesis on the retina. The position of the epiretinal prosthesis is reliable, and its location on the retina is accurately controlled by the placement of a secondary magnet in the suprachoroidal location. The electrode position above the retina is less than 50 microns at the center of the device, although there were pressure points seen at the two edges due to curvature misalignment. The degree of retinal compression found in this study was unacceptably high; nevertheless, the normal structure of the retina remained intact under the electrodes. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

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

Use of Orbital Conformer to Improve Speech in Patients with Confluent Maxillectomy and Orbital Defects

PubMed Central

Colebeck, Amanda C.; Kase, Michael T.; Nichols, Cindy B.; Golden, Marjorie; Huryn, Joseph M.

2016-01-01

The basic objective in prosthetic restoration of confluent maxillary and orbital defects is to achieve a comfortable, cosmetically acceptable prosthesis that restores speech, deglutition, and mastication. It is a challenging task complicated by the size and shape of the defects. The maxillary obturator prosthesis often satisfies the objective of adequate deglutition; however, orbital defects that are not obturated in the medial septal or posterior walls allow air to escape, negatively impacting phonation. This article describes a technique to achieve favorable prosthetic rehabilitation in a patient with a maxillectomy and ipsilateral orbital exenteration. The prosthetic components include maxillary obturator, orbital conformer, and orbital prosthesis connected using rigid magnetic attachments. PMID:25953143

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

PubMed

Kraeima, J; Merema, B J; Witjes, M J H; Spijkervet, F K L

2018-05-01

Patients suffering from osteoarthritis, ankylosis (e.g. post-trauma or tumour) in the temporomandibular joint (TMJ) can present with symptoms such as severely restricted mouth opening, pain or other dynamic restrictions of the mandible. To alleviate the symptoms, a total joint prosthesis can be indicated, such as the Groningen TMJ prosthesis. This was developed as a stock device with a lowered centre of rotation for improved translational and opening capacity. This study aimed to improve the design of the prosthesis, and produce a workflow for a customized Groningen TMJ prosthesis, in order to make it more accurate and predictable. The fossa and mandibular components of the Groningen TMJ prosthesis were customized. A series of five human cadavers was operated and bilateral TMJ prostheses were placed using custom cutting and drilling guides. Placement accuracy was evaluated based on post-operative CT data. A total of N = 10 prostheses were placed and analysed. The average Euclidean distance deviation from planned to actual position was 0.81 mm (SD 0.21). All prostheses were placed according to the routine surgical approaches and had an excellent alignment with the bony structures. The newly developed custom Groningen TMJ prosthesis can be placed with great accuracy and is the first step for improving TMJ total joint replacement surgery. Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Clinical results of Hi-tech Knee II total knee arthroplasty in patients with rheumatoid athritis: 5- to 12-year follow-up

PubMed Central

2012-01-01

Background Total knee arthroplasty (TKA) is a common form of treatment to relieve pain and improve function in cases of rheumatoid arthritis (RA). Good clinical outcomes have been reported with a variety of TKA prostheses. The cementless Hi-Tech Knee II cruciate-retaining (CR)-type prosthesis, which has 6 fins at the anterior of the femoral component, posterior cruciate ligament (PCL) retention, flat-on-flat surface component geometry, all-polyethylene patella, strong initial fixation by the center screw of the tibial base plate, 10 layers of titanium alloy fiber mesh, and direct compression molded ultra high molecular weight polyethylene (UHMWPE), is appropriate for TKA in the Japanese knee. The present study was performed to evaluate the clinical results of primary TKA in RA using the cementless Hi-Tech Knee II CR-type prosthesis. Materials and methods We performed 32 consecutive primary TKAs using cementless Hi-Tech Knee II CR-type prosthesis in 31 RA patients. The average follow-up period was 8 years 3 months. Clinical evaluations were performed according to the American Knee Society (KS) system, knee score, function score, radiographic evaluation, and complications. Results The mean postoperative maximum flexion angle was 115.6°, and the KS knee score and function score improved to 88 and 70 after surgery, respectively. Complications, such as infection, occurred in 1 patient and revision surgery was performed. There were no cases of loosening in this cohort, and prosthesis survival rate was 96.9% at 12 years postoperatively. Conclusion These results suggest that TKA using the cementless Hi-Tech Knee II CR-type prosthesis is a very effective form of treatment in RA patients at 5 to 12 years postoperatively. Further long-term follow-up studies are required to determine the ultimate utility of this type of prosthesis. PMID:22356935

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

PubMed Central

Rosenberg, Nahum; Neumann, Lars; Modi, Amit; Mersich, Istvan J; Wallace, Angus W

2007-01-01

Background The uncemented Nottingham Total Shoulder Replacement prosthesis system (Nottingham TSR) was developed from the previous BioModular® shoulder prosthesis taking into consideration the causes of the initial implant's failure. We investigated the impact of changes in the design of Nottingham TSR prosthesis on its survivorship rate. Methods Survivorship analyses of three types of uncemented total shoulder arthroplasty prostheses (BioModular®, initial Nottingham TSR and current Nottingham TSR systems with 11, 8 and 4 year survivorship data respectively) were compared. All these prostheses were implanted for the treatment of disabling pain in the shoulder due to primary and secondary osteoarthritis or rheumatoid arthritis. Each type of the prosthesis studied was implanted in consecutive group of patients – 90 patients with BioModular® system, 103 with the initial Nottingham TSR and 34 patients with the current Nottingham TSR system. The comparison of the annual cumulative survivorship values in the compatible time range between the three groups was done according to the paired t test. Results The 8-year and 11-year survivorship rates for the initially used modified BioModular® uncemented prosthesis were relatively low (75.6% and 71.7% respectively) comparing to the reported survivorship of the conventional cemented implants. The 8-year survivorship for the uncemented Nottingham TSR prosthesis was significantly higher (81.8%), but still not in the desired range of above 90%, that is found in other cemented designs. Glenoid component loosening was the main factor of prosthesis failure in both prostheses and mainly occurred in the first 4 postoperative years. The 4-year survivorship of the currently re-designed Nottingham TSR prosthesis, with hydroxylapatite coating of the glenoid baseplate, was significantly higher, 93.1% as compared to 85.1% of the previous Nottingham TSR. Conclusion The initial Nottingham shoulder prosthesis showed significantly higher survivorship than the BioModular® uncemented prosthesis, but lower than expected. Subsequently re-designed Nottingham TSR system presented a high short term survivorship rate that encourages its ongoing use PMID:17683577

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.

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

Code of Federal Regulations, 2014 CFR

2014-04-01

... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...

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

Code of Federal Regulations, 2013 CFR

2013-04-01

... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high...

Technology Efficacy in Active Prosthetic Knees for Transfemoral Amputees: A Quantitative Evaluation

PubMed Central

El-Sayed, Amr M.; Abu Osman, Noor Azuan

2014-01-01

Several studies have presented technological ensembles of active knee systems for transfemoral prosthesis. Other studies have examined the amputees' gait performance while wearing a specific active prosthesis. This paper combined both insights, that is, a technical examination of the components used, with an evaluation of how these improved the gait of respective users. This study aims to offer a quantitative understanding of the potential enhancement derived from strategic integration of core elements in developing an effective device. The study systematically discussed the current technology in active transfemoral prosthesis with respect to its functional walking performance amongst above-knee amputee users, to evaluate the system's efficacy in producing close-to-normal user performance. The performances of its actuator, sensory system, and control technique that are incorporated in each reported system were evaluated separately and numerical comparisons were conducted based on the percentage of amputees' gait deviation from normal gait profile points. The results identified particular components that contributed closest to normal gait parameters. However, the conclusion is limitedly extendable due to the small number of studies. Thus, more clinical validation of the active prosthetic knee technology is needed to better understand the extent of contribution of each component to the most functional development. PMID:25110727

A forensic identification case and DPid - can it be a useful tool?

PubMed

Queiroz, Cristhiane Leão de; Bostock, Ellen Marie; Santos, Carlos Ferreira; Guimarães, Marco Aurélio; Silva, Ricardo Henrique Alves da

2017-01-01

The aim of this study was to show DPid as an important tool of potential application to solve cases with dental prosthesis, such as the forensic case reported, in which a skull, denture and dental records were received for analysis. Human identification is still challenging in various circumstances and Dental Prosthetics Identification (DPid) stores the patient's name and prosthesis information and provides access through an embedded code in dental prosthesis or an identification card. All of this information is digitally stored on servers accessible only by dentists, laboratory technicians and patients with their own level of secure access. DPid provides a complete single-source list of all dental prosthesis features (materials and components) under complete and secure documentation used for clinical follow-up and for human identification. If DPid tool was present in this forensic case, it could have been solved without requirement of DNA exam, which confirmed the dental comparison of antemortem and postmortem records, and concluded the case as a positive identification.

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.

Referral of sensation to an advanced humanoid robotic hand prosthesis.

PubMed

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

2009-01-01

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

No difference in in vivo polyethylene wear particles between oxidized zirconium and cobalt-chromium femoral component in total knee arthroplasty.

PubMed

Minoda, Yukihide; Hata, Kanako; Iwaki, Hiroyoshi; Ikebuchi, Mitsuhiko; Hashimoto, Yusuke; Inori, Fumiaki; Nakamura, Hiroaki

2014-03-01

Polyethylene wear particle generation is one of the most important factors affecting mid- to long-term results of total knee arthroplasties. Oxidized zirconium was introduced as a material for femoral components to reduce polyethylene wear generation. However, an in vivo advantage of oxidized zirconium on polyethylene wear particle generation is still controversial. The purpose of this study was to compare in vivo polyethylene wear particles between oxidized zirconium total knee prosthesis and conventional cobalt-chromium (Co-Cr) total knee prosthesis. Synovial fluid was obtained from the knees of 6 patients with oxidized zirconium total knee prosthesis and from 6 patients with conventional cobalt-chromium (Co-Cr) total knee prosthesis 12 months after the operation. Polyethylene particles were isolated and examined using a scanning electron microscope and image analyser. Total number of particles in each knee was 3.3 ± 1.3 × 10(7) in the case of oxidized zirconium (mean ± SD) and 3.4 ± 1.2 × 10(7) in that of Co-Cr (n.s.). The particle size (equivalent circle diameter) was 0.8 ± 0.3 μm in the case of oxidized zirconium and 0.6 ± 0.1 μm in that of Co-Cr (n.s.). The particle shape (aspect ratio) was 1.4 ± 0.0 in the case of oxidized zirconium and 1.4 ± 0.0 in that of metal Co-Cr (n.s). Although newly introduced oxidized zirconium femoral component did not reduce the in vivo polyethylene wear particles in early clinical stage, there was no adverse effect of newly introduced material. At this moment, there is no need to abandon oxidized zirconium femoral component. However, further follow-up of polyethylene wear particle generation should be performed to confirm the advantage of the oxidized zirconium femoral component. Therapeutic study, Level III.

External breast prostheses. A survey of their use by women after mastectomy.

PubMed

Tanner, R; Abraham, S F; Llewellyn-Jones, D

1983-03-19

Women who have had a mastectomy for breast cancer have to cope with two major problems: first, that they have cancer, and second, that they have lost their physical appearance. The provision of an appropriate prosthesis can reduce the sense of disfigurement. If women were to obtain the full psychological benefit of wearing a breast prosthesis, they need to be informed about the available breast forms, have an opportunity to choose between them, and to be satisfied with their choice. In this study of 49 women, only 44% had had the opportunity to choose a prosthesis, 28% were dissatisfied with their prostheses, and 17% were still using temporary prostheses.

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

Code of Federal Regulations, 2012 CFR

2012-04-01

...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...

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

Code of Federal Regulations, 2011 CFR

2011-04-01

...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...

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

Code of Federal Regulations, 2013 CFR

2013-04-01

...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...

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

Code of Federal Regulations, 2014 CFR

2014-04-01

...-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a...-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the...

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.

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

PubMed

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

2015-04-01

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

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

PubMed

Xu, Guisheng; Gao, Liang; Tao, Ke; Wan, Shengxiang; Lin, Yuning; Xiong, Ao; Kang, Bin; Zeng, Hui

2017-12-01

For traumatic upper limb amputees, the prohibitive cost of a custom-made prosthesis brings an insufferable financial burden for their families in developing countries. Three-dimensional (3D) printing allows for creating affordable, lightweight, customized, and well-fitting prosthesis, especially for the growing children. We presented a case of an 8-year-old boy, who suffered a traumatic right wrist amputation as result of a mincing machine accident. The patient was immediately sent to the emergency orthopedics department after the accident. He was diagnosed as severed mangled limb crash injury at the level of the right wrist with a Mangled Extremity Severity Score of 8. A wrist disarticulation was performed and a 3D-printed prosthetic hand was designed and manufactured for this child. A personalized prosthetic rehabilitation training was applied after the prosthesis installation at 6 months postoperatively. The function of the prosthesis was evaluated at 1-month and 3-month follow-up using the Children Amputee Prosthetics Projects (CAPP) score and the University Of New Brunswick Test Of Prosthetic Function for Unilateral Amputees (UNB test). The materials cost <20 dollars. The printing took <8 hours and the component assembling was completed within 20 minutes. During the 3-month follow-up, the child's parents were satisfied with the prosthesis and the UNB test showed the significantly improved function of the prosthesis. This novel 3D-printed upper limb prosthesis in a child with the traumatic wrist amputation might serve as a practical and affordable alternative for children in developing countries and those lacking access to health care providers. A personalized prosthetic rehabilitation needs to be undertaken and more clinical studies are warranted to validate the potential superiority of similar 3D-printed prostheses. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Torsion and bending imposed on a new anterior cruciate ligament prosthesis during knee flexion: an evaluation method.

PubMed

Gely, P; Drouin, G; Thiry, P S; Tremblay, G R

1984-11-01

A new composite prosthesis was recently proposed for the anterior cruciate ligament. It is implanted in the femur and the tibia through two anchoring channels. Its intra-articular portion, composed of a fiber mesh sheath wrapped around a silicone rubber cylindrical core, reproduces satisfactorily the ligament response in tension. However, the prosthesis does not only undergo elongation. In addition, it is submitted to torsion in its intra-articular portion and bending at its ends. This paper presents a new method to evaluate these two types of deformations throughout a knee flexion by means of a geometric model of the implanted prosthesis. Input data originate from two sources: (i) a three-dimensional anatomic topology of the knee joint in full extension, providing the localization of the prosthesis anchoring channels, and ii) a kinematic model of the knee describing the motion of these anchoring channels during a physiological flexion of the knee joint. The evaluation method is independent of the way input data are obtained. This method, applied to a right cadaveric knee, shows that the orientation of the anchoring channels has a large effect on the extent of torsion and bending applied to the implanted prosthesis throughout a knee flexion, especially on the femoral side. The study suggests also the best choice for the anchoring channel axes orientation.

A forensic identification case and DPid - can it be a useful tool?

PubMed Central

de QUEIROZ, Cristhiane Leão; BOSTOCK, Ellen Marie; SANTOS, Carlos Ferreira; GUIMARÃES, Marco Aurélio; da SILVA, Ricardo Henrique Alves

2017-01-01

Abstract Objective The aim of this study was to show DPid as an important tool of potential application to solve cases with dental prosthesis, such as the forensic case reported, in which a skull, denture and dental records were received for analysis. Material and Methods Human identification is still challenging in various circumstances and Dental Prosthetics Identification (DPid) stores the patient’s name and prosthesis information and provides access through an embedded code in dental prosthesis or an identification card. All of this information is digitally stored on servers accessible only by dentists, laboratory technicians and patients with their own level of secure access. DPid provides a complete single-source list of all dental prosthesis features (materials and components) under complete and secure documentation used for clinical follow-up and for human identification. Results and Conclusion If DPid tool was present in this forensic case, it could have been solved without requirement of DNA exam, which confirmed the dental comparison of antemortem and postmortem records, and concluded the case as a positive identification. PMID:28678955

Development of an Implantable Myoelectric Sensor for Advanced Prosthesis Control

PubMed Central

Merrill, Daniel R.; Lockhart, Joseph; Troyk, Phil R.; Weir, Richard F.; Hankin, David L.

2013-01-01

Modern hand and wrist prostheses afford a high level of mechanical sophistication, but the ability to control them in an intuitive and repeatable manner lags. Commercially available systems using surface electromyographic (EMG) or myoelectric control can supply at best two degrees of freedom (DOF), most often sequentially controlled. This limitation is partially due to the nature of surface-recorded EMG, for which the signal contains components from multiple muscle sources. We report here on the development of an implantable myoelectric sensor using EMG sensors that can be chronically implanted into an amputee’s residual muscles. Because sensing occurs at the source of muscle contraction, a single principal component of EMG is detected by each sensor, corresponding to intent to move a particular effector. This system can potentially provide independent signal sources for control of individual effectors within a limb prosthesis. The use of implanted devices supports inter-day signal repeatability. We report on efforts in preparation for human clinical trials, including animal testing, and a first-in-human proof of principle demonstration where the subject was able to intuitively and simultaneously control two DOF in a hand and wrist prosthesis. PMID:21371058

Vibration of middle ear with shape memory prosthesis - Experimental and numerical study

NASA Astrophysics Data System (ADS)

Rafal, Rusinek; Szymanski, Marcin; Lajmert, Pawel

2018-01-01

The paper presents experimental investigations of ossicular chain vibrations using a Laser Doppler Vibrometer (LDV) for the intact middle ear and a reconstructed one by means of the new designed shape memory prosthesis. Vibrations of the round window are measured with the Laser Doppler vibrometer and studied classically by the transfer function analysis. Moreover, the recurrence plot technique and the Hilbert vibration decomposition method are used to extend the classical analysis. The new methods show additional vibrations components and provide more information about middle ear behaviour.

The effect of total knee arthroplasty on body weight.

PubMed

Lee, Gwo-Chin; Cushner, Fred D; Cannella, Laura Y; Scott, W Norman

2005-03-01

This prospective study quantified the weight change in 20 consecutive patients undergoing total knee arthroplasty. Resected bone, soft tissues, and bone reamings were collected during surgery and weighed using a digital scale at the end of the procedure. Results were compared to the cumulative weights of the prosthesis, bone cement, patellar component, and polyethylene liner. Average weight of the resected bone and soft tissues was 167.71 g for men and 130.13 g for women. Mean weight of the implanted prosthesis and cement used was 509.92 g for men and 422.56 g for women. Men tended to receive a larger-sized prosthesis than women. Overall, the average weight gain as a result of knee arthroplasty was 345.54 g for men and 292.44 g for women. This translates to an insignificant increase in body weight.

Cerclage wires or cables for the management of intraoperative fracture associated with a cementless, tapered femoral prosthesis: results at 2 to 16 years.

PubMed

Berend, Keith R; Lombardi, Adolph V; Mallory, Thomas H; Chonko, Douglas J; Dodds, Kathleen L; Adams, Joanne B

2004-10-01

Initial stability is critical for fixation and survival of cementless total hip arthroplasty. Occasionally, a split of the calcar occurs intraoperatively. A review of 1,320 primary total hip arthroplasties with 2-year follow-up, performed between August 1985 and February 2001 using the Mallory-Head Porous tapered femoral component, revealed 58 hips in 55 patients with an intraoperative calcar fracture managed with single or multiple cerclage wires or cables and immediate full weight bearing. At 7.5 years average follow-up (range, 2-16 years), there were no revisions of the femoral component, radiographic failures, or patients with severe thigh pain, for a stem survival rate of 100%. Average Harris hip score improvement was 33.8 points. Fracture of the proximal femur occurs in approximately 4% of primary THAs using the Mallory-Head Porous femoral component. When managed intraoperatively with cerclage wire or cable, the mid- to long-term results appear unaffected with 100% femoral component survival at up to 16 years.

Sensor fusion and computer vision for context-aware control of a multi degree-of-freedom prosthesis

NASA Astrophysics Data System (ADS)

Markovic, Marko; Dosen, Strahinja; Popovic, Dejan; Graimann, Bernhard; Farina, Dario

2015-12-01

Objective. Myoelectric activity volitionally generated by the user is often used for controlling hand prostheses in order to replicate the synergistic actions of muscles in healthy humans during grasping. Muscle synergies in healthy humans are based on the integration of visual perception, heuristics and proprioception. Here, we demonstrate how sensor fusion that combines artificial vision and proprioceptive information with the high-level processing characteristics of biological systems can be effectively used in transradial prosthesis control. Approach. We developed a novel context- and user-aware prosthesis (CASP) controller integrating computer vision and inertial sensing with myoelectric activity in order to achieve semi-autonomous and reactive control of a prosthetic hand. The presented method semi-automatically provides simultaneous and proportional control of multiple degrees-of-freedom (DOFs), thus decreasing overall physical effort while retaining full user control. The system was compared against the major commercial state-of-the art myoelectric control system in ten able-bodied and one amputee subject. All subjects used transradial prosthesis with an active wrist to grasp objects typically associated with activities of daily living. Main results. The CASP significantly outperformed the myoelectric interface when controlling all of the prosthesis DOF. However, when tested with less complex prosthetic system (smaller number of DOF), the CASP was slower but resulted with reaching motions that contained less compensatory movements. Another important finding is that the CASP system required minimal user adaptation and training. Significance. The CASP constitutes a substantial improvement for the control of multi-DOF prostheses. The application of the CASP will have a significant impact when translated to real-life scenarious, particularly with respect to improving the usability and acceptance of highly complex systems (e.g., full prosthetic arms) by amputees.

Sensor fusion and computer vision for context-aware control of a multi degree-of-freedom prosthesis.

PubMed

Markovic, Marko; Dosen, Strahinja; Popovic, Dejan; Graimann, Bernhard; Farina, Dario

2015-12-01

Myoelectric activity volitionally generated by the user is often used for controlling hand prostheses in order to replicate the synergistic actions of muscles in healthy humans during grasping. Muscle synergies in healthy humans are based on the integration of visual perception, heuristics and proprioception. Here, we demonstrate how sensor fusion that combines artificial vision and proprioceptive information with the high-level processing characteristics of biological systems can be effectively used in transradial prosthesis control. We developed a novel context- and user-aware prosthesis (CASP) controller integrating computer vision and inertial sensing with myoelectric activity in order to achieve semi-autonomous and reactive control of a prosthetic hand. The presented method semi-automatically provides simultaneous and proportional control of multiple degrees-of-freedom (DOFs), thus decreasing overall physical effort while retaining full user control. The system was compared against the major commercial state-of-the art myoelectric control system in ten able-bodied and one amputee subject. All subjects used transradial prosthesis with an active wrist to grasp objects typically associated with activities of daily living. The CASP significantly outperformed the myoelectric interface when controlling all of the prosthesis DOF. However, when tested with less complex prosthetic system (smaller number of DOF), the CASP was slower but resulted with reaching motions that contained less compensatory movements. Another important finding is that the CASP system required minimal user adaptation and training. The CASP constitutes a substantial improvement for the control of multi-DOF prostheses. The application of the CASP will have a significant impact when translated to real-life scenarious, particularly with respect to improving the usability and acceptance of highly complex systems (e.g., full prosthetic arms) by amputees.

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

Cementless fixation of "isoelastic" hip endoprostheses manufactured from plastic materials.

PubMed

Morscher, E W; Dick, W

1983-06-01

Nine years of clinical experience with an "isoelastic" shaft prosthesis manufactured using polyacetal resin reveal that for the transmission of forces from the pelvis through the femoral head and neck into the femoral shaft, some rigidity of the proximal part of the prosthesis is necessary. The object is to eliminate micromovements, which lead to bone resorption and implant loosening. However, elasticity greater than that present in metallic implants prevents stress concentrations and disuse stress protection atrophy of the bone. Greater elasticity of the prosthesis, which can be achieved by plastic materials, makes possible a more even, harmonious distribution of the forces transmitted from the implant to the bone and vice versa. A more elastic implant can also act as a better shock absorber than a rigid one. The results in 627 cementless polyethylene cups after a maximum observation period of 5.5 years reveal good incorporation and no aseptic loosening. Especially favorable results occurred in 61 cases by replacing loosened cemented cups with bone grafts and cementless polyethylene cups. On the femoral shaft side too high an elasticity in the proximal part of the prosthesis led to bone resorption and loosening with the first model of the prosthesis. By reinforcing the proximal part of the femoral component, much better results were obtained. The isoelastic femoral shaft, however, is in an early stage of experimentation.

Full Mouth Oral Rehabilitation by Maxillary Implant Supported Hybrid Denture Employing a Fiber Reinforced Material Instead of Conventional PMMA.

PubMed

Qamheya, Ala Hassan A; Yeniyol, Sinem; Arısan, Volkan

2015-01-01

Many people have life-long problems with their dentures, such as difficulties with speaking and eating, loose denture, and sore mouth syndrome. The evolution of dental implant supported prosthesis gives these patients normal healthy life for their functional and esthetic advantages. This case report presents the fabrication of maxillary implant supported hybrid prosthesis by using Nanofilled Composite (NFC) material in teeth construction to rehabilitate a complete denture wearer patient.

Full Mouth Oral Rehabilitation by Maxillary Implant Supported Hybrid Denture Employing a Fiber Reinforced Material Instead of Conventional PMMA

PubMed Central

Qamheya, Ala Hassan A.; Arısan, Volkan

2015-01-01

Many people have life-long problems with their dentures, such as difficulties with speaking and eating, loose denture, and sore mouth syndrome. The evolution of dental implant supported prosthesis gives these patients normal healthy life for their functional and esthetic advantages. This case report presents the fabrication of maxillary implant supported hybrid prosthesis by using Nanofilled Composite (NFC) material in teeth construction to rehabilitate a complete denture wearer patient. PMID:26557392

An animal model to evaluate skin-implant-bone integration and gait with a prosthesis directly attached to the residual limb

PubMed Central

Farrell, Brad J; Prilutsky, Boris I; Kistenberg, Robert S; Dalton, John F; Pitkin, Mark

2014-01-01

Background Despite the number of advantages of bone-anchored prostheses, their use in patients is limited due to the lack of complete skin-implant integration. The objective of the present study was to develop an animal model that would permit both detailed investigations of gait with a bone-anchored limb prosthesis and histological analysis of the skin-implant-bone interface after physiological loading of the implant during standing and walking. Methods Full-body mechanics of walking in two cats was recorded and analyzed before and after implantation of a percutaneous porous titanium pylon into the right tibia and attachment of a prosthesis. The rehabilitation procedures included initial limb casting, progressively increasing loading of implant, and standing and locomotor training. Detailed histological analysis of bone and skin ingrowth into implant was performed at the end of the study. Findings The two animals adopted the bone-anchored prosthesis for standing and locomotion, although loads on the prosthetic limb during walking decreased by 22% and 62%, respectively, 4 months after implantation. The animals shifted body weight to the contralateral side and increased propulsion forces by the contralateral hindlimb. Histological analysis of the limb implants demonstrated bone and skin ingrowth. Interpretation The developed animal model to study prosthetic gait and tissue integration with the implant demonstrated that porous titanium implants may permit bone and skin integration and prosthetic gait with a prosthesis. Future studies with this model will help optimize the implant and prosthesis properties. PMID:24405567

SUBCOMMISSURAL IMPLANTATION OF AORTIC PROSTHESES WITH THE USE OF THE NONCORONARY SINUS AND THE FIBROUS TRIGONES

PubMed Central

Liotta, Domingo; Haller, Jordan D.; Pisanu, Amadeo; Bracco, Daniel; Bertolozzi, Enrique

1979-01-01

The technique described here permits insertion of a large prosthesis into a small aortic annulus and avoids the necessity of additional procedures for enlarging the aortic ring. Inspection of the fibrous skeleton of the heart reveals that the large intervalvular trigone and the noncoronary sinus of Valsalva are remarkably elastic. Full advantage of this natural elasticity is achieved by suturing the prosthesis to the base of these structures from outside the aorta. Sutures are placed in the sinuses of the right and left cusps in the usual manner. Judicious application of this procedure allows the implantation of a No. 23 or No. 24 prosthesis in cases that would require a No. 19 or No. 21 with the use of conventional methods. Images PMID:15216322

Cadaveric and three-dimensional computed tomography study of the morphology of the scapula with reference to reversed shoulder prosthesis

PubMed Central

Torrens, Carlos; Corrales, Monica; Gonzalez, Gemma; Solano, Alberto; Cáceres, Enrique

2008-01-01

Purpose The purpose of this study is to analyze the morphology of the scapula with reference to the glenoid component implantation in reversed shoulder prosthesis, in order to improve primary fixation of the component. Methods Seventy-three 3-dimensional computed tomography of the scapula and 108 scapular dry specimens were analyzed to determine the anterior and posterior length of the glenoid neck, the angle between the glenoid surface and the upper posterior column of the scapula and the angle between the major craneo-caudal glenoid axis and the base of the coracoid process and the upper posterior column. Results The anterior and posterior length of glenoid neck was classified into two groups named "short-neck" and "long-neck" with significant differences between them. The angle between the glenoid surface and the upper posterior column of the scapula was also classified into two different types: type I (mean 50°–52°) and type II (mean 62,50°–64°), with significant differences between them (p < 0,001). The angle between the major craneo-caudal glenoid axis and the base of the coracoid process averaged 18,25° while the angle with the upper posterior column of the scapula averaged 8°. Conclusion Scapular morphological variability advices for individual adjustments of glenoid component implantation in reversed total shoulder prosthesis. Three-dimensional computed tomography of the scapula constitutes an important tool when planning reversed prostheses implantation. PMID:18847487

Cadaveric and three-dimensional computed tomography study of the morphology of the scapula with reference to reversed shoulder prosthesis.

PubMed

Torrens, Carlos; Corrales, Monica; Gonzalez, Gemma; Solano, Alberto; Cáceres, Enrique

2008-10-10

The purpose of this study is to analyze the morphology of the scapula with reference to the glenoid component implantation in reversed shoulder prosthesis, in order to improve primary fixation of the component. Seventy-three 3-dimensional computed tomography of the scapula and 108 scapular dry specimens were analyzed to determine the anterior and posterior length of the glenoid neck, the angle between the glenoid surface and the upper posterior column of the scapula and the angle between the major craneo-caudal glenoid axis and the base of the coracoid process and the upper posterior column. The anterior and posterior length of glenoid neck was classified into two groups named "short-neck" and "long-neck" with significant differences between them. The angle between the glenoid surface and the upper posterior column of the scapula was also classified into two different types: type I (mean 50 degrees-52 degrees ) and type II (mean 62.50 degrees-64 degrees ), with significant differences between them (p < 0.001). The angle between the major craneo-caudal glenoid axis and the base of the coracoid process averaged 18,25 degrees while the angle with the upper posterior column of the scapula averaged 8 degrees . Scapular morphological variability advices for individual adjustments of glenoid component implantation in reversed total shoulder prosthesis. Three-dimensional computed tomography of the scapula constitutes an important tool when planning reversed prostheses implantation.

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

Development of a Mandibular Motion Simulator for Total Joint Replacement

PubMed Central

Celebi, Nukhet; Rohner, E. Carlos; Gateno, Jaime; Noble, Philip C.; Ismaily, Sabir K.; Teichgraeber, John F.; Xia, James J.

2015-01-01

Purpose The purpose of this study was to develop a motion simulator capable of recreating and recording the full range of mandibular motions in a cadaveric preparation for an intact temporomandibular joint (TMJ) and after total joint replacement. Material and Methods A human cadaver head was used. Two sets of tracking balls were attached to the forehead and mandible, respectively. Computed tomographic (CT) scan was performed and 3-dimensional CT models of the skull were generated. The cadaver head was then dissected to attach the muscle activation cables and mounted onto the TMJ simulator. Realistic jaw motions were generated through the application of the following muscle forces: lateral pterygoid muscle, suprahyoid depressors (geniohyoid, mylohyoid, and digastric muscles), and elevator muscles. To simulate muscle contraction, cables were inserted into the mandible at the center area of each muscle's attachment. To provide a minimum mouth closing force at the initial position, the elevator muscles were combined at the anterior mandible. During mandibular movement, each motion was recorded using a high-resolution laser scanner. The right TMJ of the same head was reconstructed with a total TMJ prosthesis. The same forces were applied and the jaw motions were recorded again. CT scan was performed and 3-dimensional CT models of the skull with TMJ prosthesis were generated. Results Mandibular motions, before and after TMJ replacement, with and without lateral pterygoid muscle reattachment, were re-created in a cadaveric preparation. The laser-scanned data during the mandibular motion were used to drive 3-dimensional CT models. A movie for each mandibular motion was subsequently created for motion path analysis. Compared with mandibular motion before TMJ replacement, mandibular lateral and protrusive motions after TMJ replacement, with and without lateral pterygoid muscle reattachment, were greatly limited. The jaw motion recorded before total joint replacement was applied to the mandibular and prostheses models after total TMJ replacement. The condylar component was observed sinking into the fossa during jaw motion. Conclusion A motion simulator capable of re-creating and recording full range of mandibular motions in a cadaveric preparation has been developed. It can be used to simulate mandibular motions for the intact TMJ and total joint prosthesis, and to re-create and record their full range of mandibular motions. In addition, the full range of the recorded motion can be re-created as motion images in a computer. These images can be used for motion path analysis and to study the causation of limited range of motion after total joint replacement and strategies for improvement. PMID:21050636

Transition from a failing dentition to a removable implant-supported prosthesis: a staged approach.

PubMed

Cordaro, Luca; Torsello, Ferruccio; Ribeiro, Carlos Accorsi

2010-05-01

Patients with hopeless dentition often present difficulties in the management of the transitional phase to the final restoration. This article describes a staged approach to achieve a full-arch, implant-supported, removable prosthesis in patients with a hopeless dentition. The approach described allows the clinician to proceed in a staged manner and facilitate prosthetic steps by keeping fixed references for vertical dimension. This technique includes initial conservative periodontal care and, afterward, extraction of some strategic teeth, while others are temporarily maintained. At this point, the implants are positioned, and during the healing period, the remaining natural abutments are used for occlusal reference and to stabilize the removable provisional prosthesis. After osseointegration of the implants, the residual teeth are extracted and the final prosthesis is delivered. The main advantages of the technique include maintenance of function during treatment, stabilization of the removable provisional (especially in the mandibular arch), prosthetic-guided insertion of implants, and easier retrieval of prosthetic references. The main drawbacks are longer treatment time and the need for two surgical steps.

Design and clinical outcome of a novel 3D-printed prosthetic joint replacement for the human temporomandibular joint.

PubMed

Ackland, David; Robinson, Dale; Lee, Peter Vee Sin; Dimitroulis, George

2018-05-11

Stock prosthetic temporomandibular joint replacements come in limited sizes, and do not always encompass the joint anatomy that presents clinically. The aims of this study were twofold. Firstly, to design a personalized prosthetic total joint replacement for the treatment of a patient's end-stage temporomandibular joint osteoarthritis, to implant the prosthesis into the patient, and assess clinical outcome 12-months post-operatively; and secondly, to evaluate the influence of changes in prosthetic condyle geometry on implant load response during mastication. A 48-year-old female patient with Grade-5 osteoarthritis to the left temporomandibular joint was recruited, and a prosthesis developed to match the native temporomandibular joint anatomy. The prosthesis was 3D printed, sterilized and implanted into the patient, and pain and function measured 12-months post-operatively. The prosthesis load response during a chewing-bite and maximum-force bite was evaluated using a personalized multi-body musculoskeletal model. Simulations were performed after perturbing condyle thickness, neck length and head sphericity. Increases in prosthetic condyle neck length malaligned the mandible and perturbed temporomandibular joint force. Changes in condylar component thickness greatly influenced fixation screw stress response, while a more eccentric condylar head increased prosthetic joint-contact loading. Post-operatively, the prosthetic temporomandibular joint surgery reduced patient pain from 7/10 to 1/10 on a visual analog scale, and increased intercisal opening distance from 22 mm to 38 mm. This study demonstrates effectiveness of a personalized prosthesis that may ultimately be adapted to treat a wide-range of end-stage temporomandibular joint conditions, and highlights sensitivity of prosthesis load response to changes in condylar geometry. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

Rusaw, David F; Ramstrand, Simon

2016-01-01

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

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.

Noninvasive radioisotopic technique for detection of platelet deposition in mitral valve prostheses and quantitation of visceral microembolism in dogs

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

Dewanjee, M.K.; Fuster, V.; Rao, S.A.

1983-05-01

A noninvasive technique has been developed in the dog model for imaging, with a gamma camera, the platelet deposition on Bjoerk-Shiley mitral valve prostheses early postoperatively. At 25 hours after implantation of the prosthesis and 24 hours after intravenous administration of 400 to 500 microCi of platelets labeled with indium-111, the platelet deposition in the sewing ring and perivalvular cardiac tissue can be clearly delineated in a scintiphotograph. An in vitro technique was also developed for quantitation of visceral microemboli in brain, lungs, kidneys, and other tissues. Biodistribution of the labeled platelets was quantitated, and the tissue/blood radioactivity ratio wasmore » determined in 22 dogs in four groups: unoperated normal dogs, sham-operated dogs, prosthesis-implanted dogs, and prosthesis-implanted dogs treated with dipyridamole before and aspirin and dipyridamole immediately after operation. Fifteen to 20% of total platelets were consumed as a consequence of the surgical procedure. On quantitation, we found that platelet deposition on the components of the prostheses was significantly reduced in prosthesis-implanted animals treated with dipyridamole and aspirin when compared with prosthesis-implanted, untreated dogs. All prosthesis-implanted animals considered together had a twofold to fourfold increase in tissue/blood radioactivity ratio in comparison with unoperated and sham-operated animals, an indication that the viscera work as filters and trap platelet microemboli that are presumably produced in the region of the mitral valve prostheses. In the dog model, indium-111-labeled platelets thus provide a sensitive marker for noninvasive imaging of platelet deposition on mechanical mitral valve prostheses, in vitro evaluation of platelet microembolism in viscera, in vitro quantitation of surgical consumption of platelets, and evaluation of platelet-inhibitor drugs.« less

[Ceramic-ceramic articulation in uncemented total hip arthroplasty].

PubMed

Synder, Marek; Drobniewski, Marek; Kozłowski, Piotr; Grzegorzewski, Andrzej

2005-01-01

The main problem in total hip arthroplasty (THA) surgery is aseptic loosening of prosthesis components. In most cases the phagocytes reaction against the wear particle during the hip movement is responsible for aseptic prosthesis loosening. To prevent this reaction different hip articulation are invented to reduce this reaction. One of these solutions is ceramic-ceramic hip prosthesis articulation. The aim of this study was to evaluate the long-term results in patients who were treated because of coxarthrosis by means of ceramic-ceramic hip prosthesis. We analyzed 258 primary THA (222 patients, 116 women and 106 men) who were treated because of advanced coxarthrosis by Mittelmeier type hip endoprosthesis (ceramic-ceramic articulation). The mean age of patients at the surgery was 45.6 years and a mean follow-up 10.2 years. In most of our cases the idiopathic, traumatic and dysplastic coxarthrosis was noted. For clinical evaluation the classification system proposed by Merle d'Aubigne and Postel with Charnley modification was used. For radiological evaluation of the steam implantation the classification system proposed by De Lee and Charnley was used and for the cup implantation the system by Gruen and Moreland. In 87 patients (33.7%) the final results was graded as very good, in 96 (37.2%) as good, in 47 (18.2%) as satisfactory and in 28 patients (10.9%) the final results was poor. In analyzed group in 13 patients (5.0%) the revision surgery was necessary. The long-term results of THA with the use of Mittelmeier type of hip prosthesis presented a very low percentage of aseptic loosening. This type of prosthesis gives very high patients satisfaction.

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.

The quality of life analysis of knee prosthesis with complete microprocessor control in trans-femoral amputees.

PubMed

Saglam, Yavuz; Gulenc, Baris; Birisik, Fevzi; Ersen, Ali; Yilmaz Yalcinkaya, Ebru; Yazicioglu, Onder

2017-12-01

The aim of this study was to analyze the patient demographics, etiology of limb loss as well as reporting SF-36 scores for microprocessor prosthesis users in Turkish population. We reviewed 72 patients (61 male and 11 female; mean age: 37.7 ± 10.7) with uni-lateral, above knee amputation and a history of regular and microprocessor prosthesis use. All patients were called back for a last follow-up and they were asked to fill a self-administered general health status questionnaire (SF-36). According to the SF-36 results; physical component score (PCS) score was 46 ± 7.3 and mental components summary (MCS) score was 46.5 ± 9.1. These scores have statistical similarity with Turkish healthy controls, except SF (social functioning) sub-dimension. PCS score for women microprocessor users were significantly lower than men (43.3 vs. 48.7, p = 0.03), but MCS scores were similar in between genders (46 vs. 48.2, p = 0.13). Conventional prostheses usage time was positively correlated with physical function (PF) scores (r = 0.322, p = 0.010). Microprocessor prosthesis usage time was negatively correlated with role limitations due to emotional problem (RE) scores (r = -0,313, p = 0.009). The quality of life surveys were showed that the loss of an extremity have higher physical and psychological impact on women's physical scores. Overall, SF-36 results were similar in microprocessor using amputee's and Turkish normal controls. Level IV, therapeutic study. Copyright © 2017 Turkish Association of Orthopaedics and Traumatology. Production and hosting by Elsevier B.V. All rights reserved.

Effects of alignment on the roll-over shapes of prosthetic feet.

PubMed

Hansen, Andrew

2008-12-01

Recent work suggests that a prosthetic ankle-foot component's roll-over shape - the effective rocker it conforms to between initial contact and opposite initial contact (the 'roll-over' interval of walking) - is closely linked to its final alignment in the prosthesis (as determined by a skilled prosthetist using heuristic techniques). If true, this information may help to determine the appropriate alignment for a lower limb prosthesis before it is built, or a priori. Knowledge is needed for future models that will incorporate the roll-over shape including the relative effect of alignment on the roll-over shape's radius of curvature and arc length. The purpose of this study was to evaluate the hypotheses that: (i) Changes in prosthesis alignment alter the position and orientation of a foot's roll-over shape in prosthesis-based coordinates, and (ii) these changes occur without changing the radius of curvature or arc length of the roll-over shape. To examine the hypotheses, this study examined the effects of nine alignment settings on the roll-over shapes of two prosthetic feet. The idea that alignment changes move and rotate roll-over shapes of prosthetic feet in prosthesis coordinates is supported by this work, but the hypothesis that the radius of curvature and arc length do not change for different alignments is not strongly supported by the data. A revised approach is presented that explains some of the changes to the roll-over shape parameters due to changes in rotational alignment.

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

PubMed

Nicodemo, Denise; Ferreira, Lydia Masako

2006-01-01

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

Relationship between prosthodontic status and nutritional intake in the elderly in Korea: National Health and Nutrition Examination Survey (NHANES IV).

PubMed

Choi, Y K; Park, D Y; Kim, Y

2014-11-01

Many health issues have been reported to be associated with poor nutritional status. We sought to examine the association between nutritional intake and oral health status in elderly people. The association between perceived disability in mastication and prosthodontic status was analysed using multiple logistic regression. Multiple linear regression was used to analyse the association between prosthodontic status and nutritional intake. The elderly subjects with partial or full dentures reported chewing difficulties 1.62-fold more frequently (95% CI: 1.06-2.49) than those with natural teeth or a fixed prosthesis after adjusting for gender, TMD (temporomandibular disorder), household income and education level. Additionally, daily nutritional intakes of energy, protein, fat, ash, calcium, phosphorus and thiamine were decreased significantly in elderly with partial or full dentures compared with those with no prosthesis or with a fixed prosthesis (P < 0.05). Our findings underline oral health status and perceived disability in mastication are associated with dietary imbalances in the elderly. We suggest that the evaluation of patients' nutritional status should be considered as a part of an overall plan for dental hygiene care. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Principal components analysis based control of a multi-DoF underactuated prosthetic hand.

PubMed

Matrone, Giulia C; Cipriani, Christian; Secco, Emanuele L; Magenes, Giovanni; Carrozza, Maria Chiara

2010-04-23

Functionality, controllability and cosmetics are the key issues to be addressed in order to accomplish a successful functional substitution of the human hand by means of a prosthesis. Not only the prosthesis should duplicate the human hand in shape, functionality, sensorization, perception and sense of body-belonging, but it should also be controlled as the natural one, in the most intuitive and undemanding way. At present, prosthetic hands are controlled by means of non-invasive interfaces based on electromyography (EMG). Driving a multi degrees of freedom (DoF) hand for achieving hand dexterity implies to selectively modulate many different EMG signals in order to make each joint move independently, and this could require significant cognitive effort to the user. A Principal Components Analysis (PCA) based algorithm is used to drive a 16 DoFs underactuated prosthetic hand prototype (called CyberHand) with a two dimensional control input, in order to perform the three prehensile forms mostly used in Activities of Daily Living (ADLs). Such Principal Components set has been derived directly from the artificial hand by collecting its sensory data while performing 50 different grasps, and subsequently used for control. Trials have shown that two independent input signals can be successfully used to control the posture of a real robotic hand and that correct grasps (in terms of involved fingers, stability and posture) may be achieved. This work demonstrates the effectiveness of a bio-inspired system successfully conjugating the advantages of an underactuated, anthropomorphic hand with a PCA-based control strategy, and opens up promising possibilities for the development of an intuitively controllable hand prosthesis.

Limited rotation of the mobile-bearing in a rotating platform total knee prosthesis.

PubMed

Garling, E H; Kaptein, B L; Nelissen, R G H H; Valstar, E R

2007-01-01

The hypothesis of this study was that the polyethylene bearing in a rotating platform total knee prosthesis shows axial rotation during a step-up motion, thereby facilitating the theoretical advantages of mobile-bearing knee prostheses. We examined 10 patients with rheumatoid arthritis who had a rotating platform total knee arthroplasty (NexGen LPS mobile, Zimmer Inc. Warsaw, USA). Fluoroscopic data was collected during a step-up motion six months postoperatively. A 3D-2D model fitting technique was used to reconstruct the in vivo 3D kinematics. The femoral component showed more axial rotation than the polyethylene mobile-bearing insert compared to the tibia during extension. In eight knees, the femoral component rotated internally with respect to the tibia during extension. In the other two knees the femoral component rotated externally with respect to the tibia. In all 10 patients, the femur showed more axial rotation than the mobile-bearing insert indicating the femoral component was sliding on the polyethylene of the rotating platform during the step-up motion. Possible explanations are a too limited conformity between femoral component and insert, the anterior located pivot location of the investigated rotating platform design, polyethylene on metal impingement and fibrous tissue formation between the mobile-bearing insert and the tibial plateau.

Kinematic Measurement of Knee Prosthesis from Single-Plane Projection Images

NASA Astrophysics Data System (ADS)

Hirokawa, Shunji; Ariyoshi, Shogo; Takahashi, Kenji; Maruyama, Koichi

In this paper, the measurement of 3D motion from 2D perspective projections of knee prosthesis is described. The technique reported by Banks and Hodge was further developed in this study. The estimation was performed in two steps. The first-step estimation was performed on the assumption of orthogonal projection. Then, the second-step estimation was subsequently carried out based upon the perspective projection to accomplish more accurate estimation. The simulation results have demonstrated that the technique archived sufficient accuracies of position/orientation estimation for prosthetic kinematics. Then we applied our algorithm to the CCD images, thereby examining the influences of various artifacts, possibly incorporated through an imaging process, on the estimation accuracies. We found that accuracies in the experiment were influenced mainly by the geometric discrepancies between the prosthesis component and computer generated model and by the spacial inconsistencies between the coordinate axes of the positioner and that of the computer model. However, we verified that our algorithm could achieve proper and consistent estimation even for the CCD images.

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

PubMed

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

1993-09-01

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

[Knee arthrodesis using a customized intramedullary nail: 14 cases].

PubMed

Volpi, R; Dehoux, E; Touchard, P; Mensa, C; Segal, P

2004-02-01

We report our experience with knee arthrodesis using a customized intramedullary nail implanted in 14 patients. Indications for knee arthrodesis were: recurrent prosthesis infection (n=11), post-traumatic septic arthritis (n=1), aseptic loosening of a hinge prosthesis (n=1), and nonunion (n=1). A two-stage procedure was used for the 12 patients with infected joints. Mean follow-up was 19 months. Weight bearing began during the first week after arthrodesis in 13 patients. First intention bone healing was achieved in 13 patients. Mean time to healing was three months. All patients rapidly recovered full independence. Complications were: one misinsertion of the tibial stem, one nonunion which fused after repeated grafting, and two recurrent infections (controlled chronic fistulae) which required skin flaps for cover. We have found that this customized nail is a useful method for achieving bone fusion in patients with difficult indications for arthrodesis, particularly recurrent prosthesis infection.

Periprosthetic Fractures Following Total Knee Arthroplasty

PubMed Central

Kim, Nam Ki

2015-01-01

Periprosthetic fractures after total knee arthroplasty may occur in any part of the femur, tibia and patella, and the most common pattern involves the supracondylar area of the distal femur. Supracondylar periprosthetic fractures frequently occur above a well-fixed prosthesis, and risk factors include anterior femoral cortical notching and use of the rotational constrained implant. Periprosthetic tibial fractures are frequently associated with loose components and malalignment or malposition of implants. Fractures of the patella are much less common and associated with rheumatoid arthritis, use of steroid, osteonecrosis and malalignment of implants. Most patients with periprosthetic fractures around the knee are the elderly with poor bone quality. There are many difficulties and increased risk of nonunion after treatment because reduction and internal fixation is interfered with by preexisting prosthesis and bone cement. Additionally, previous soft tissue injury is another disadvantageous condition for bone healing. Many authors reported good clinical outcomes after non-operative treatment of undisplaced or minimally displaced periprosthetic fractures; however, open reduction or revision arthroplasty was required in displaced fractures or fractures with unstable prosthesis. Periprosthetic fractures around the knee should be prevented by appropriate technique during total knee arthroplasty. Nevertheless, if a periprosthetic fracture occurs, an appropriate treatment method should be selected considering the stability of the prosthesis, displacement of fracture and bone quality. PMID:25750888

Shielding of the Hip Prosthesis During Radiation Therapy for Heterotopic Ossification is Associated with Increased Failure of Prophylaxis

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

Balboni, Tracy A.; Gaccione, Peter; Gobezie, Reuben

2007-04-01

Purpose: Radiation therapy (RT) is frequently administered to prevent heterotopic ossification (HO) after total hip arthroplasty (THA). The purpose of this study was to determine if there is an increased risk of HO after RT prophylaxis with shielding of the THA components. Methods and Materials: This is a retrospective analysis of THA patients undergoing RT prophylaxis of HO at Brigham and Women's Hospital between June 1994 and February 2004. Univariate and multivariate logistic regressions were used to assess the relationships of all variables to failure of RT prophylaxis. Results: A total of 137 patients were identified and 84 were eligiblemore » for analysis (61%). The median RT dose was 750 cGy in one fraction, and the median follow-up was 24 months. Eight of 40 unshielded patients (20%) developed any progression of HO compared with 21 of 44 shielded patients (48%) (p = 0.009). Brooker Grade III-IV HO developed in 5% of unshielded and 18% of shielded patients (p 0.08). Multivariate analysis revealed shielding (p = 0.02) and THA for prosthesis infection (p = 0.03) to be significant predictors of RT failure, with a trend toward an increasing risk of HO progression with age (p = 0.07). There was no significant difference in the prosthesis failure rates between shielded and unshielded patients. Conclusions: A significantly increased risk of failure of RT prophylaxis for HO was noted in those receiving shielding of the hip prosthesis. Shielding did not appear to reduce the risk of prosthesis failure.« less

Three-dimensional finite element analysis of vertical and angular misfit in implant-supported fixed prostheses.

PubMed

Assunção, Wirley Gonçalves; Gomes, Erica Alves; Rocha, Eduardo Passos; Delben, Juliana Aparecida

2011-01-01

Three-dimensional finite element analysis was used to evaluate the effect of vertical and angular misfit in three-piece implant-supported screw-retained fixed prostheses on the biomechanical response in the peri-implant bone, implants, and prosthetic components. Four three-dimensional models were fabricated to represent a right posterior mandibular section with one implant in the region of the second premolar (2PM) and another in the region of the second molar (2M). The implants were splinted by a three-piece implant-supported metal-ceramic prosthesis and differed according to the type of misfit, as represented by four different models: Control = prosthesis with complete fit to the implants; UAM (unilateral angular misfit) = prosthesis presenting unilateral angular misfit of 100 μm in the mesial region of the 2M; UVM (unilateral vertical misfit) = prosthesis presenting unilateral vertical misfit of 100 μm in the mesial region of the 2M; and TVM (total vertical misfit) = prosthesis presenting total vertical misfit of 100 μm in the platform of the framework in the 2M. A vertical load of 400 N was distributed and applied on 12 centric points by the software Ansys, ie, a vertical load of 150 N was applied to each molar in the prosthesis and a vertical load of 100 N was applied at the 2PM. The stress values and distribution in peri-implant bone tissue were similar for all groups. The models with misfit exhibited different distribution patterns and increased stress magnitude in comparison to the control. The highest stress values in group UAM were observed in the implant body and retention screw. The groups UVM and TVM exhibited high stress values in the platform of the framework and the implant hexagon, respectively. The three types of misfit influenced the magnitude and distribution of stresses. The influence of misfit on peri-implant bone tissue was modest. Each type of misfit increased the stress values in different regions of the system.

A prospective 24 months follow-up of a three component press-fit prosthesis for hallux rigidus.

PubMed

Wassink, S; Burger, B J; Saragas, N P; Asunción Márquez, J; Trtik, L; Harlaar, J

2017-09-01

The aim of this study was to evaluate the results following total first metatarsophalangeal (FMTP) joint replacement arthroplasty using a modular three component press fit prosthesis at two year follow up. All patient data was collected in a prospective way in four study centres. Both preoperative and postoperative evaluation consisted of an assessment using the AOFAS-HMI score, visual analogue scale for pain, evaluation of the range of motion and patient satisfaction scores. Postoperative X-rays were reviewed for loosening and radiolucency up to two years. Fifty-five feet were available for analysis at 24 months. Two implants were removed during the study. Six more feet had additional surgery due to stiffness or malalignment. Postoperative AOFAS-HMI scores improved significantly by 32.4 points at two year follow-up (p<0.001). The visual analogue scale for pain improved significantly from 6.8 (std 1,6) preoperatively to 1.6 (std 1,9) postoperatively (p<0.0001). Mean dorsiflexion improved from 12.6 (std 10,1) degrees preoperatively to 31.2 (std 16,8) degrees postoperatively. Eighty-seven percent of patients were moderately to well satisfied with the end result. Eighteen prostheses showed radiolucency at 24 months. Implantation of a Metis ® modular three component press fit prosthesis for the metatarsophalangeal joint in hallux rigidus shows significant improvement in AOFAS-HMI scores and a decrease in pain. Concerns remain with regard to early reoperation rate (14.5%) and long term survival of the implant. Future studies will have to address these aspects. Copyright © 2016 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Factors affecting the achievement of Japanese-style deep knee flexion after total knee arthroplasty using posterior-stabilized prosthesis with high-flex knee design.

PubMed

Niki, Yasuo; Takeda, Yuki; Harato, Kengo; Suda, Yasunori

2015-11-01

Achievement of very deep knee flexion after total knee arthroplasty (TKA) can play a critical role in the satisfaction of patients who demand a floor-sitting lifestyle and engage in high-flexion daily activities (e.g., seiza-sitting). Seiza-sitting is characterized by the knees flexed >145º and feet turned sole upwards underneath the buttocks with the tibia internally rotated. The present study investigated factors affecting the achievement of seiza-sitting after TKA using posterior-stabilized total knee prosthesis with high-flex knee design. Subjects comprised 32 patients who underwent TKA with high-flex knee prosthesis and achieved seiza-sitting (knee flexion >145º) postoperatively. Another 32 patients served as controls who were capable of knee flexion >145º preoperatively, but failed to achieve seiza-sitting postoperatively. Accuracy of femoral and tibial component positions was assessed in terms of deviation from the ideal position using a two-dimensional to three-dimensional matching technique. Accuracies of the component position, posterior condylar offset ratio and intraoperative gap length were compared between the two groups. The proportion of patients with >3º internally rotated tibial component was significantly higher in patients who failed at seiza-sitting (41 %) than among patients who achieved it (13 %, p = 0.021). Comparison of intraoperative gap length between patient groups revealed that gap length at 135º flexion was significantly larger in patients who achieved seiza-sitting (4.2 ± 0.4 mm) than in patients who failed at it (2.7 ± 0.4 mm, p = 0.007). Conversely, no significant differences in gap inclination were seen between the groups. From the perspective of surgical factors, accurate implant positioning, particularly rotational alignment of the tibial component, and maintenance of a sufficient joint gap at 135º flexion appear to represent critical factors for achieving >145º of deep knee flexion after TKA.

Provision of Prosthetic Services Following Lower Limb Amputation in Malaysia

PubMed Central

Arifin, Nooranida; Hasbollah, Hasif Rafidee; Hanafi, Muhammad Hafiz; Ibrahim, Al Hafiz; Rahman, Wan Afezah Wan Abdul; Aziz, Roslizawati Che

2017-01-01

The incidence of lower limb amputation is high across the globe and continues to be a major threat to morbidity and mortality. Consequently, the provision of high quality and effective prosthetics services have been known as an essential component for a successful rehabilitation outcome. In Malaysia, amputation prevalence has been increasing in which several main components of service delivering aspects (such as service intervention, prosthetic personnel) should be anticipated to accommodate for the increasing demand. This article highlights the hurdles experienced in providing prosthetic services in Malaysia from multiple aspects such as financial burden to acquire the prosthesis and lack of expertise to produce quality prosthesis. This paramount issues consequently justify for the urgency to carry out national level survey on the current statistics of lower limb amputation and to ascertain the available workforce to provide a quality prosthetics services. Only with accurate and current information from the national survey, strategies and policies aimed at enhancing the outcome from prosthetics services can be achieved. PMID:29386978

Shoulder Arthroplasty Imaging: What’s New

PubMed Central

Gregory, T.M

2017-01-01

Background: Shoulder arthroplasty, in its different forms (hemiarthroplasty, total shoulder arthroplasty and reverse total shoulder arthroplasty) has transformed the clinical outcomes of shoulder disorders. Improvement of general clinical outcome is the result of stronger adequacy of the treatment to the diagnosis, enhanced surgical techniques, specific implanted materials, and more accurate follow up. Imaging is an important tool in each step of these processes. Method: This article is a review article declining recent imaging processes for shoulder arthroplasty. Results: Shoulder imaging is important for shoulder arthroplasty pre-operative planning but also for post-operative monitoring of the prosthesis and this article has a focus on the validity of plain radiographs for detecting radiolucent line and on new Computed Tomography scan method established to eliminate the prosthesis metallic artefacts that obscure the component fixation visualisation. Conclusion: Number of shoulder arthroplasties implanted have grown up rapidly for the past decade, leading to an increase in the number of complications. In parallel, new imaging system have been established to monitor these complications, especially component loosening PMID:29152007

Provision of Prosthetic Services Following Lower Limb Amputation in Malaysia.

PubMed

Arifin, Nooranida; Hasbollah, Hasif Rafidee; Hanafi, Muhammad Hafiz; Ibrahim, Al Hafiz; Rahman, Wan Afezah Wan Abdul; Aziz, Roslizawati Che

2017-10-01

The incidence of lower limb amputation is high across the globe and continues to be a major threat to morbidity and mortality. Consequently, the provision of high quality and effective prosthetics services have been known as an essential component for a successful rehabilitation outcome. In Malaysia, amputation prevalence has been increasing in which several main components of service delivering aspects (such as service intervention, prosthetic personnel) should be anticipated to accommodate for the increasing demand. This article highlights the hurdles experienced in providing prosthetic services in Malaysia from multiple aspects such as financial burden to acquire the prosthesis and lack of expertise to produce quality prosthesis. This paramount issues consequently justify for the urgency to carry out national level survey on the current statistics of lower limb amputation and to ascertain the available workforce to provide a quality prosthetics services. Only with accurate and current information from the national survey, strategies and policies aimed at enhancing the outcome from prosthetics services can be achieved.

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.

Femoral component rotation in patellofemoral joint replacement.

PubMed

van Jonbergen, Hans-Peter W; Westerbeek, Robin E

2018-06-01

Clinical outcomes in patellofemoral joint replacement may be related to femoral component rotation. Assessment of rotational alignment is however difficult as patients with isolated patellofemoral osteoarthritis often have trochlear dysplasia. The use of the medial malleolus as a landmark to guide rotation has been suggested. The purpose of our study was to evaluate this technique with regard to femoral component rotation, and to correlate rotation with clinical outcomes at one-year follow-up. Forty-one knees in 39 patients had patellofemoral joint replacement using the Zimmer Gender-Solutions patellofemoral prosthesis. Intraoperatively, we determined femoral component rotational alignment using an extramedullary rod aimed at the inferior tip of the medial malleolus. Postoperatively, we measured the angle between the femoral component and the anatomical transepicondylar axis using CT. The amount of rotation was correlated with clinical outcomes at one-year follow-up. Forty knees in 38 patients were available for one-year follow-up. Mean femoral component rotation relative to the anatomical transepicondylar axis was 1.4° external rotation (range, -3.8 to 5.7°). We found no statistically significant correlation between femoral component rotation and change from baseline KOOS subscales at one-year follow-up. Our findings show that when using the medial malleolus as a landmark to guide rotation, the femoral component of the patellofemoral prosthesis was oriented in external rotation relative to the anatomical transepicondylar axis in 80% of knees. Our study did not show a relation between the amount of external rotation and clinical outcomes. Level III. Copyright © 2018 Elsevier B.V. All rights reserved.

Influence of Total Knee Arthroplasty on Patellar Kinematics and Patellofemoral Pressure.

PubMed

Tanikawa, Hidenori; Tada, Mitsunori; Harato, Kengo; Okuma, Kazunari; Nagura, Takeo

2017-01-01

Patellofemoral complications are one of the main problems after total knee arthroplasty (TKA). The design of the TKA component may affect the patellar biomechanics, which may be associated with this postoperative complication. The purpose of this study was to assess the influence of TKA and prosthesis designs on the patellar kinematics and patellofemoral pressure. Using fresh-frozen cadavers, we measured the patellofemoral pressure, patella offset, and patella tilt in the following 4 conditions: normal knee (patella replacement only), cruciate-retaining TKA, condylar-stabilizing TKA, and posterior-stabilized TKA. The patellofemoral pressure increased significantly after the cruciate-retaining TKA and condylar-stabilizing TKA compared with the normal knee. The patella offset in the normal knee decreased with increasing knee flexion angles, while the patella offset in the TKA knees did not change significantly through the full range of motion. The amount of lateral patella tilt in the normal knee was significantly larger than the TKA knees in the full range of motion. Although the femoral components are designed to reproduce an anatomical patellar tracking, the physiological patellar kinematics were not observed. Relatively high patellofemoral pressure and kinematic change after TKA may be associated with postoperative complications such as the anterior knee pain. Copyright © 2016 Elsevier Inc. All rights reserved.

[Revision hip arthroplasty by Waldemar Link custom-made total hip prosthesis].

PubMed

Medenica, Ivica; Luković, Milan; Radoicić, Dragan

2010-02-01

The number of patients undergoing hip arthroplasty revision is constantly growing. Especially, complex problem is extensive loss of bone stock and pelvic discontinuity that requires reconstruction. The paper presented a 50-year old patient, who ten years ago underwent a total cement artrhroplasty of the left hip. A year after the primary operation the patient had difficulties in walking without crutches. Problems intensified in the last five years, the patient had severe pain, totally limited movement in the left hip and could not walk at all. Radiographically, we found loose femoral component, massive loss of bone stock of proximal femur, acetabular protrusion and a consequent pelvic discontinuity. Clinically, a completely disfunctional left hip joint was registered (Harris hip score--7.1). We performed total rearthroplasty by a custom-made Waldemar Link total hip prosthesis with acetabular antiprotrusio cage and compensation of bone defects with a graft from the bone bank. A year after the operation, we found clinically an extreme improvement in Harris hip score--87.8. Radiographically, we found stability of implanted components, a complete graft integration and bone bridging across the site of pelvic discontinuity. Pelvic discontinuity and massive loss of proximal femoral bone stock is a challenging and complex entity. Conventional prostheses cannot provide an adequate fixation and stability of the hip. Application of custom-made prosthesis (measured specificaly for a patient) and additional alografting bone defects is a good method in revision surgery after unsuccessful hip arthroplasty with extensive bone defects.

Comparative Evaluation of a Four-Implant-Supported Polyetherketoneketone Framework Prosthesis: A Three-Dimensional Finite Element Analysis Based on Cone Beam Computed Tomography and Computer-Aided Design.

PubMed

Lee, Ki-Sun; Shin, Sang-Wan; Lee, Sang-Pyo; Kim, Jong-Eun; Kim, Jee-Hwan; Lee, Jeong-Yol

The purpose of this pilot study was to evaluate and compare polyetherketoneketone (PEKK) with different framework materials for implant-supported prostheses by means of a three-dimensional finite element analysis (3D-FEA) based on cone beam computed tomography (CBCT) and computer-aided design (CAD) data. A geometric model that consisted of four maxillary implants supporting a prosthesis framework was constructed from CBCT and CAD data of a treated patient. Three different materials (zirconia, titanium, and PEKK) were selected, and their material properties were simulated using FEA software in the generated geometric model. In the PEKK framework (ie, low elastic modulus) group, the stress transferred to the implant and simulated adjacent tissue was reduced when compressive stress was dominant, but increased when tensile stress was dominant. This study suggests that the shock-absorbing effects of a resilient implant-supported framework are limited in some areas and that rigid framework material shows a favorable stress distribution and safety of overall components of the prosthesis.

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.

Sensitivity of biomechanical outcomes to independent variations of hindfoot and forefoot stiffness in foot prostheses.

PubMed

Adamczyk, Peter Gabriel; Roland, Michelle; Hahn, Michael E

2017-08-01

Many studies have reported the effects of different foot prostheses on gait, but most results cannot be generalized because the prostheses' properties are seldom reported. We varied hindfoot and forefoot stiffness in an experimental foot prosthesis, in increments of 15N/mm, and tested the parametric effects of these variations on treadmill walking in unilateral transtibial amputees, at speeds from 0.7 to 1.5m/s. We computed outcomes such as prosthesis energy return, center of mass (COM) mechanics, ground reaction forces, and joint mechanics, and computed their sensitivity to component stiffness. A stiffer hindfoot led to reduced prosthesis energy return, increased ground reaction force (GRF) loading rate, and greater stance-phase knee flexion and knee extensor moment. A stiffer forefoot resulted in reduced prosthetic-side ankle push-off and COM push-off work, and increased knee extension and knee flexor moment in late stance. The sensitivity parameters obtained from these tests may be useful in clinical prescription and further research into compensatory mechanisms of joint function. Copyright © 2017 Elsevier B.V. All rights reserved.

Relationship between the use of full dentures and mucosal alterations among elderly Brazilians.

PubMed

Freitas, J B; Gomez, R S; De Abreu, M H N G; Ferreira E Ferreira, E

2008-05-01

The objective of the present study was to evaluate the prevalence of oral mucosal lesions associated with the use of full dentures (FD) among non-institutionalized individuals of 60 or more years of age in a rural Brazilian population. The sample consisted of 344 individuals aged 60 or more from two rural communities of Brazil. Of this total, 146 were FD users and 198 FD, non-users. Angular cheilitis, denture stomatitis and inflammatory fibrous hyperplasia were statistically associated with prosthesis use. Hygiene and integrity of the prosthesis were related to the presence of oral lesions. While inflammatory fibrous hyperplasia was positively related to FD integrity, denture stomatitis was associated with time of use, hygiene status and integrity of FD. The results indicate the need for oral health care programmes for the elderly and show a relationship between time of use, quality and hygiene of oral prostheses with the presence of mucosal lesions.

Immediate loading with fixed full-arch prostheses in the maxilla: Review of the literature

PubMed Central

Peñarrocha-Oltra, David; Covani, Ugo; Peñarrocha-Diago, Miguel

2014-01-01

Objectives: To critically review the evidence-based literature on immediate loading of implants with fixed full-arch prostheses in the maxilla to determine 1) currently recommended performance criteria and 2) the outcomes that can be expected with this procedure. Study Desing: Studies from 2001 to 2011 on immediate loading with fixed full-arch maxillary prostheses were reviewed. Clinical series with at least 5 patients and 12 months of follow-up were included. Case reports, studies with missing data and repeatedly published studies were excluded. In each study the following was assessed: type of study, implant type, number of patients, number of implants, number of implants per patient, use of post-extraction implants, minimum implant length and diameter, type of prosthesis, time until loading, implant survival rate, prosthesis survival rate, marginal bone loss, complications andmean follow-up time. Criteria for patient selection, implant primary stability and bone regeneration were also studied. Results: Thirteen studies were included, reporting a total of 2484 immediately loaded implants in 365 patients. Currently accepted performance criteria regarding patient and implant selection, and surgical and prosthetic procedures were deduced from the reviewed articles. Implant survival rates went from 87.5% to 100%, prosthesis survival rates from 93.8% to 100% and radiographic marginal bone loss from 0.8 mm to 1.6 mm.No intraoperative complications and only minor prosthetic complications were reported. Conclusions: The literature on immediate loading with fixed full-arch prostheses in the maxilla shows that a successful outcome can be expected if adequate criteria are used to evaluate the patient, choose the implant and perform the surgical and prosthetic treatment. Lack of homogeneity within studies limits the relevance of the conclusions that can be drawn, and more controlled randomized studies are necessary to enable comparison between the immediate and the conventional loading procedures. Key words:Immediate loading, full-arch, dental implants, loading protocols. PMID:24880445

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.

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

PubMed

Shaeer, Osama; Shaeer, Kamal

2014-09-01

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

Patient-related and financial outcomes analysis of conventional full-arch rehabilitation versus the All-on-4 concept: a cohort study.

PubMed

Babbush, Charles A; Kanawati, Ali; Kotsakis, Georgios A; Hinrichs, James E

2014-04-01

Patient-related variables such as cost of treatment, length of the treatment period, and comfort provided by the interim prosthesis when treatment planning for full-arch rehabilitation are often neglected in dental publications. Two patient cohorts were followed up longitudinally in this study: the "All-on-4 treatment concept group" and the "historical group." The number of implants, total treatment time, number of surgical procedures, number of sinus grafts, necessity for immediate provisional implants, adjusted cost associated for treatment in each group, and the quality of interim prosthesis were compared. The total adjusted cost for patients receiving All-on-4 treatment concept averaged at $42,422 ± 3860 (&OV0556;31,392 ± 2856), whereas the mean total adjusted cost for the historical group was $57,944 ± 20,198 (&OV0556;42,879 ± 2113) (P = 0.01). The difference in cost had a mean value of $7307 (&OV0556;5407) per jaw. Factors associated with complexity of treatment and patient comfort, such as the quality of interim prosthesis, number of surgeries, and duration of treatment time, all significantly favored the All-on-4 treatment concept group in comparison with conventional treatment modalities. When implant rehabilitation of the total jaw is sought, the All-on-4 treatment concept should be considered the least costly and least time consuming treatment option.

An analysis of observer-rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years.

PubMed

Geruschat, Duane R; Richards, Thomas P; Arditi, Aries; da Cruz, Lyndon; Dagnelie, Gislin; Dorn, Jessy D; Duncan, Jacque L; Ho, Allen C; Olmos de Koo, Lisa C; Sahel, José-Alain; Stanga, Paulo E; Thumann, Gabriele; Wang, Vizhong; Greenberg, Robert J

2016-05-01

The purpose of this analysis was to compare observer-rated tasks in patients implanted with the Argus II Retinal Prosthesis System, when the device is ON versus OFF. The Functional Low-Vision Observer Rated Assessment (FLORA) instrument was administered to 26 blind patients implanted with the Argus II Retinal Prosthesis System at a mean follow-up of 36 months. FLORA is a multi-component instrument that consists in part of observer-rated assessment of 35 tasks completed with the device ON versus OFF. The ease with which a patient completes a task is scored using a four-point scale, ranging from easy (score of 1) to impossible (score of 4). The tasks are evaluated individually and organised into four discrete domains, including 'Visual orientation', 'Visual mobility', 'Daily life and 'Interaction with others'. Twenty-six patients completed each of the 35 tasks. Overall, 24 out of 35 tasks (69 per cent) were statistically significantly easier to achieve with the device ON versus OFF. In each of the four domains, patients' performances were significantly better (p < 0.05) with the device ON versus OFF, ranging from 19 to 38 per cent improvement. Patients with an Argus II Retinal Prosthesis implanted for 18 to 44 months (mean 36 months), demonstrated significantly improved completion of vision-related tasks with the device ON versus OFF. © 2016 The Authors Clinical and Experimental Optometry published by John Wiley & Sons Australia, Ltd on behalf of Optometry Australia.

An analysis of observer‐rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years

PubMed Central

Richards, Thomas P; Arditi, Aries; da Cruz, Lyndon; Dagnelie, Gislin; Dorn, Jessy D; Duncan, Jacque L; Ho, Allen C; Olmos de Koo, Lisa C; Sahel, José‐Alain; Stanga, Paulo E; Thumann, Gabriele; Wang, Vizhong; Greenberg, Robert J

2016-01-01

Abstract Objective The purpose of this analysis was to compare observer‐rated tasks in patients implanted with the Argus II Retinal Prosthesis System, when the device is ON versus OFF. Methods The Functional Low‐Vision Observer Rated Assessment (FLORA) instrument was administered to 26 blind patients implanted with the Argus II Retinal Prosthesis System at a mean follow‐up of 36 months. FLORA is a multi‐component instrument that consists in part of observer‐rated assessment of 35 tasks completed with the device ON versus OFF. The ease with which a patient completes a task is scored using a four‐point scale, ranging from easy (score of 1) to impossible (score of 4). The tasks are evaluated individually and organised into four discrete domains, including ‘Visual orientation’, ‘Visual mobility’, ‘Daily life and ‘Interaction with others’. Results Twenty‐six patients completed each of the 35 tasks. Overall, 24 out of 35 tasks (69 per cent) were statistically significantly easier to achieve with the device ON versus OFF. In each of the four domains, patients’ performances were significantly better (p < 0.05) with the device ON versus OFF, ranging from 19 to 38 per cent improvement. Conclusion Patients with an Argus II Retinal Prosthesis implanted for 18 to 44 months (mean 36 months), demonstrated significantly improved completion of vision‐related tasks with the device ON versus OFF. PMID:26804484

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.

Repair of bone segment defects with surface porous fiber-reinforced polymethyl methacrylate (PMMA) composite prosthesis: histomorphometric incorporation model and characterization by SEM.

PubMed

Hautamäki, Mikko P; Aho, Allan J; Alander, Pasi; Rekola, Jami; Gunn, Jarmo; Strandberg, Niko; Vallittu, Pekka K

2008-08-01

Polymer technology has provided solutions for filling of bone defects in situations where there may be technical or biological complications with autografts, allografts, and metal prostheses. We present an experimental study on segmental bone defect reconstruction using a polymethylmethacrylate-(PMMA-) based bulk polymer implant prosthesis. We concentrated on osteoconductivity and surface characteristics. A critical size segment defect of the rabbit tibia in 19 animals aged 18-24 weeks was reconstructed with a surface porous glass fiber-reinforced (SPF) prosthesis made of polymethylmethacrylate (PMMA). The biomechanical properties of SPF implant material were previously adjusted technically to mimic the properties of normal cortical bone. A plain PMMA implant with no porosity or fiber reinforcement was used as a control. Radiology, histomorphometry, and scanning electron microscopy (SEM) were used for analysis of bone growth into the prosthesis during incorporation. The radiographic and histological incorporation model showed good host bone contact, and strong formation of new bone as double cortex. Histomorphometric evaluation showed that the bone contact index (BCI) at the posterior surface interface was higher with the SPF implant than for the control. The total appositional bone growth over the posterior surface (area %) was also stronger for the SPF implant than for controls. Both bone growth into the porous surface and the BCI results were related to the quality, coverage, and regularity of the microstructure of the porous surface. Porous surface structure enhanced appositional bone growth onto the SPF implant. Under load-bearing conditions the implant appears to function like an osteoconductive prosthesis, which enables direct mobilization and rapid return to full weight bearing.

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.

Hospital ownership: a risk factor for nosocomial infection rates?

PubMed

Schröder, C; Behnke, M; Geffers, C; Gastmeier, P

2018-03-26

In some countries, a relationship between hospital ownership and the occurrence of healthcare-associated infection (HCAI) rates has been described. To investigate the association between hospital ownership and occurrence of HCAI in Germany. Five different components of the German national nosocomial infection surveillance system were analysed with regard to the influence of hospital ownership in the period 2014-2016. Endpoints included ventilator-associated pneumonia, central-venous-catheter-associated bloodstream infections, urinary-catheter-associated urinary tract infections, surgical site infections (SSI) following hip prosthesis and colon surgery, meticillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile infections (CDI) and hand rub consumption per 1000 patient-days. Three hospital ownership types (public, non-profit and private) were analysed using univariate and multi-variate methods. The distribution of hospitals according to the three ownership types was similar in all components. In total, 661 intensive care units (ICUs), 149 departments performing colon procedures, and 349 departments performing hip prosthesis were included. In addition, 568 hospitals provided their MRSA rates and 236 provided their CDI rates, and 1833 ICUs and 12,934 non-ICUs provided their hand rub consumption data. In general, the differences between the hospital types were rather small and not significant for the ICUs. In the multi-variate analysis, public hospitals had a lower SSI rate following hip prosthesis (odds ratio 0.80, 95% confidence interval 0.65-0.99). Hospital ownership was not found to have a major influence on the incidence of HCAI in Germany. Copyright © 2018 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

A 3D Kinematic Measurement of Knee Prosthesis Using X-ray Projection Images

NASA Astrophysics Data System (ADS)

Hirokawa, Shunji; Ariyoshi, Shogo; Hossain, Mohammad Abrar

We have developed a technique for estimating 3D motion of knee prosthesis from its 2D perspective projections. As Fourier descriptors were used for compact representation of library templates and contours extracted from the prosthetic X-ray images, the entire silhouette contour of each prosthetic component was required. This caused such a problem as our algorithm did not function when the silhouettes of tibio and femoral components overlapped with each other. Here we planned a novel method to overcome it; which was processed in two steps. First, the missing part of silhouette contour due to overlap was interpolated using a free-formed curvature such as Bezier. Then the first step position/orientation estimation was performed. In the next step, a clipping window was set in the projective coordinate so as to separate the overlapped silhouette drawn using the first step estimates. After that the localized library whose templates were clipped in shape was prepared and the second step estimation was performed. Computer model simulation demonstrated sufficient accuracies of position/orientation estimation even for overlapped silhouettes; equivalent to those without overlap.

Alignment of the femoral component in a mobile-bearing unicompartmental knee arthroplasty: a study in 10 cadaver femora.

PubMed

Kort, N P; van Raay, J J A M; Thomassen, B J W

2007-08-01

Use of an intramedullary rod is advised for the alignment of the femoral component of an Oxford phase-III prosthesis. There are users moving toward extramedullary alignment, which is merely an indicator of frustration with accuracy of intramedullary alignment. The results of our study with 10 cadaver femora demonstrate that use of a short and long intramedullary femoral rod may result in excessive flexion alignment error of the femoral component. Understanding of the extramedullary alignment possibility and experience with the visual alignment of the femoral drill guide is essential toward minimizing potential errors in the alignment of the femoral component.

Virtual surgical planning and 3D printing in prosthetic orbital reconstruction with percutaneous implants: a technical case report

PubMed Central

Huang, Yu-Hui; Seelaus, Rosemary; Zhao, Linping; Patel, Pravin K; Cohen, Mimis

2016-01-01

Osseointegrated titanium implants to the cranial skeleton for retention of facial prostheses have proven to be a reliable replacement for adhesive systems. However, improper placement of the implants can jeopardize prosthetic outcomes, and long-term success of an implant-retained prosthesis. Three-dimensional (3D) computer imaging, virtual planning, and 3D printing have become accepted components of the preoperative planning and design phase of treatment. Computer-aided design and computer-assisted manufacture that employ cone-beam computed tomography data offer benefits to patient treatment by contributing to greater predictability and improved treatment efficiencies with more reliable outcomes in surgical and prosthetic reconstruction. 3D printing enables transfer of the virtual surgical plan to the operating room by fabrication of surgical guides. Previous studies have shown that accuracy improves considerably with guided implantation when compared to conventional template or freehand implant placement. This clinical case report demonstrates the use of a 3D technological pathway for preoperative virtual planning through prosthesis fabrication, utilizing 3D printing, for a patient with an acquired orbital defect that was restored with an implant-retained silicone orbital prosthesis. PMID:27843356

Virtual surgical planning and 3D printing in prosthetic orbital reconstruction with percutaneous implants: a technical case report.

PubMed

Huang, Yu-Hui; Seelaus, Rosemary; Zhao, Linping; Patel, Pravin K; Cohen, Mimis

2016-01-01

Osseointegrated titanium implants to the cranial skeleton for retention of facial prostheses have proven to be a reliable replacement for adhesive systems. However, improper placement of the implants can jeopardize prosthetic outcomes, and long-term success of an implant-retained prosthesis. Three-dimensional (3D) computer imaging, virtual planning, and 3D printing have become accepted components of the preoperative planning and design phase of treatment. Computer-aided design and computer-assisted manufacture that employ cone-beam computed tomography data offer benefits to patient treatment by contributing to greater predictability and improved treatment efficiencies with more reliable outcomes in surgical and prosthetic reconstruction. 3D printing enables transfer of the virtual surgical plan to the operating room by fabrication of surgical guides. Previous studies have shown that accuracy improves considerably with guided implantation when compared to conventional template or freehand implant placement. This clinical case report demonstrates the use of a 3D technological pathway for preoperative virtual planning through prosthesis fabrication, utilizing 3D printing, for a patient with an acquired orbital defect that was restored with an implant-retained silicone orbital prosthesis.

Implant retained auricular prosthesis with a modified hader bar: a case report.

PubMed

Lovely, M; Dathan, Pradeep C; Gopal, Dinesh; George, Biji Thomas; Chandrasekharan Nair, K

2014-06-01

Auricular prostheses for defects of external ear are retained either by mechanical means or implants. All implant retained prostheses are retained by various means such as bar and clip, magnetic attachments or a combination of bar, clip and magnets. The commonest problem encountered with the bar and clip system is loosening of the clip after 3-4 months. When magnets are used as retaining component they tend to corrode over a period of time. So various alternative retention methods which possess good retentive qualities, ease of reparability and patient friendly were tried. In the present case a newly modified Hader bar design which can act as an additional retentive feature apart from the clip is employed to increase retention. The major advantages in the modified Hader bar system were that only two implants were employed, the additional loops in the Hader bar prevented micro movements and the retentive acrylic locks were easy to repair if broken. The modified Hader bar has anti-rotational slots which prevents the sliding or rotation of the prosthesis which gave new confidence to the patient who was otherwise worried of inadvertent displacement of the ear prosthesis while playing.

[Navigated implantation of total knee endoprostheses--a comparative study with conventional instrumentation].

PubMed

Jenny, J Y; Boeri, C

2001-01-01

A navigation system should improve the quality of a total knee prosthesis implantation in comparison to the classical, surgeon-controlled operative technique. The authors have implanted 40 knee total prostheses with an optical infrared navigation system (Orthopilot AESCULAP, Tuttlingen--group A). The quality of implantation was studied on postoperative long leg AP and lateral X-rays, and compared to a control group of 40 computer-paired total knee prostheses o the same model (Search Prosthesis, AESCULAP, Tuttlingen) implanted with a classical, surgeon-controlled technique (group B). An optimal mechanical femorotibial angle (3 degrees valgus to 3 degrees varus) was obtained by 33 cases in group A and 31 cases in group B (p > 0.05). Better results were seen for the coronal and sagittal orientation of both tibial and femoral components in group A. Globally, 26 cases of the group A and 12 cases of the group B were implanted in an optimal manner for all studied criteria (p < 0.01). The used navigation system allows a significant improvement of the quality of implantation of a knee total prosthesis in comparison to a classical, surgeon-controlled instrumentation. Long-term outcome could be consequently improved.

Deformation of the Durom Acetabular Component and Its Impact on Tribology in a Cadaveric Model—A Simulator Study

PubMed Central

Gu, Yanqing; Wang, Qing; Cui, Weiding; Fan, Weimin

2012-01-01

Background Recent studies have shown that the acetabular component frequently becomes deformed during press-fit insertion. The aim of this study was to explore the deformation of the Durom cup after implantation and to clarify the impact of deformation on wear and ion release of the Durom large head metal-on-metal (MOM) total hips in simulators. Methods Six Durom cups impacted into reamed acetabula of fresh cadavers were used as the experimental group and another 6 size-paired intact Durom cups constituted the control group. All 12 Durom MOM total hips were put through a 3 million cycle (MC) wear test in simulators. Results The 6 cups in the experimental group were all deformed, with a mean deformation of 41.78±8.86 µm. The average volumetric wear rate in the experimental group and in the control group in the first million cycle was 6.65±0.29 mm3/MC and 0.89±0.04 mm3/MC (t = 48.43, p = 0.000). The ion levels of Cr and Co in the experimental group were also higher than those in the control group before 2.0 MC. However there was no difference in the ion levels between 2.0 and 3.0 MC. Conclusions This finding implies that the non-modular acetabular component of Durom total hip prosthesis is likely to become deformed during press-fit insertion, and that the deformation will result in increased volumetric wear and increased ion release. Clinical Relevance This study was determined to explore the deformation of the Durom cup after implantation and to clarify the impact of deformation on wear and ion release of the prosthesis. Deformation of the cup after implantation increases the wear of MOM bearings and the resulting ion levels. The clinical use of the Durom large head prosthesis should be with great care. PMID:23144694

Deformation of the Durom acetabular component and its impact on tribology in a cadaveric model--a simulator study.

PubMed

Liu, Feng; Chen, Zhefeng; Gu, Yanqing; Wang, Qing; Cui, Weiding; Fan, Weimin

2012-01-01

Recent studies have shown that the acetabular component frequently becomes deformed during press-fit insertion. The aim of this study was to explore the deformation of the Durom cup after implantation and to clarify the impact of deformation on wear and ion release of the Durom large head metal-on-metal (MOM) total hips in simulators. Six Durom cups impacted into reamed acetabula of fresh cadavers were used as the experimental group and another 6 size-paired intact Durom cups constituted the control group. All 12 Durom MOM total hips were put through a 3 million cycle (MC) wear test in simulators. The 6 cups in the experimental group were all deformed, with a mean deformation of 41.78 ± 8.86 µm. The average volumetric wear rate in the experimental group and in the control group in the first million cycle was 6.65 ± 0.29 mm(3)/MC and 0.89 ± 0.04 mm(3)/MC (t = 48.43, p = 0.000). The ion levels of Cr and Co in the experimental group were also higher than those in the control group before 2.0 MC. However there was no difference in the ion levels between 2.0 and 3.0 MC. This finding implies that the non-modular acetabular component of Durom total hip prosthesis is likely to become deformed during press-fit insertion, and that the deformation will result in increased volumetric wear and increased ion release. This study was determined to explore the deformation of the Durom cup after implantation and to clarify the impact of deformation on wear and ion release of the prosthesis. Deformation of the cup after implantation increases the wear of MOM bearings and the resulting ion levels. The clinical use of the Durom large head prosthesis should be with great care.

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.

Vestibulo-Ocular Reflex Responses to a Multichannel Vestibular Prosthesis Incorporating a 3D Coordinate Transformation for Correction of Misalignment

PubMed Central

Fridman, Gene Y.; Davidovics, Natan S.; Dai, Chenkai; Migliaccio, Americo A.

2010-01-01

There is no effective treatment available for individuals unable to compensate for bilateral profound loss of vestibular sensation, which causes chronic disequilibrium and blurs vision by disrupting vestibulo-ocular reflexes that normally stabilize the eyes during head movement. Previous work suggests that a multichannel vestibular prosthesis can emulate normal semicircular canals by electrically stimulating vestibular nerve branches to encode head movements detected by mutually orthogonal gyroscopes affixed to the skull. Until now, that approach has been limited by current spread resulting in distortion of the vestibular nerve activation pattern and consequent inability to accurately encode head movements throughout the full 3-dimensional (3D) range normally transduced by the labyrinths. We report that the electrically evoked 3D angular vestibulo-ocular reflex exhibits vector superposition and linearity to a sufficient degree that a multichannel vestibular prosthesis incorporating a precompensatory 3D coordinate transformation to correct misalignment can accurately emulate semicircular canals for head rotations throughout the range of 3D axes normally transduced by a healthy labyrinth. PMID:20177732

/sup 99m/Tc-methylene diphosphonate bone imaging in the evaluation of total hip prostheses

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

Weiss, P.E.; Mall, J.C.; Hoffer, P.B.

1979-12-01

A retrospective study was performed to determine the accuracy of /sup 99m/Tc-methylene diphosphonate bone imaging in the evaluation of total hip arthroplasty for loosening and/or infection. Using focally increased activity at the tip of the femoral component or in the region of the acetabular component as a criterion, the examination was 77% specific and 100% sensitive for loosening and/or infection. A possible explanation for the increased uptake at the tip of the femoral component and the role of this examination in the management of a painful total hip prosthesis are discussed.

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.

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.

A personalized 3D-printed prosthetic joint replacement for the human temporomandibular joint: From implant design to implantation.

PubMed

Ackland, David C; Robinson, Dale; Redhead, Michael; Lee, Peter Vee Sin; Moskaljuk, Adrian; Dimitroulis, George

2017-05-01

Personalized prosthetic joint replacements have important applications in cases of complex bone and joint conditions where the shape and size of off-the-shelf components may not be adequate. The objective of this study was to design, test and fabricate a personalized 3D-printed prosthesis for a patient requiring total joint replacement surgery of the temporomandibular joint (TMJ). The new 'Melbourne' prosthetic TMJ design featured a condylar component sized specifically to the patient and fixation screw positions that avoid potential intra-operative damage to the mandibular nerve. The Melbourne prosthetic TMJ was developed for a 58-year-old female recipient with end-stage osteoarthritis of the TMJ. The load response of the prosthesis during chewing and a maximum-force bite was quantified using a personalized musculoskeletal model of the patient's masticatory system developed using medical images. The simulations were then repeated after implantation of the Biomet Microfixation prosthetic TMJ, an established stock device. The maximum condylar stresses, screw stress and mandibular stress at the screw-bone interface were lower in the Melbourne prosthetic TMJ (259.6MPa, 312.9MPa and 198.4MPa, respectively) than those in the Biomet Microfixation device (284.0MPa, 416.0MPa and 262.2MPa, respectively) during the maximum-force bite, with similar trends also observed during the chewing bite. After trialing surgical placement and evaluating prosthetic TMJ stability using cadaveric specimens, the prosthesis was fabricated using 3D printing, sterilized, and implanted into the female recipient. Six months post-operatively, the prosthesis recipient had a normal jaw opening distance (40.0 mm), with no complications identified. The new design features and immediate load response of the Melbourne prosthetic TMJ suggests that it may provide improved clinical and biomechanical joint function compared to a commonly used stock device, and reduce risk of intra-operative nerve damage during placement. The framework presented may be useful for designing and testing customized devices for the treatment of debilitating bone and joint conditions. Copyright © 2017 Elsevier Ltd. All rights reserved.

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.

Comparison of Clinical Results and Injury Risk of Posterior Tibial Cortex Between Attune and Press Fit Condylar Sigma Knee Systems.

PubMed

Song, Sang Jun; Park, Cheol Hee; Liang, Hu; Kang, Se Gu; Park, Jong Jun; Bae, Dae Kyung

2018-02-01

We compared clinical and radiographic results after total knee arthroplasty (TKA) using Attune and Press Fit Condylar Sigma, and investigated whether use of the current prosthesis increased injury risk to the tibial cortex in Asian patients. We also assessed whether a preoperative posterior tibial slope angle (PSA) is associated with the injury when using the current prosthesis. The 300 TKAs with Attune (group A) were compared to the 300 TKAs with Press Fit Condylar Sigma (group B). Demographics were not different, except follow-up periods (24.8 vs 33.3 months, P < .001). The Western Ontario and McMaster Universities Index and range of motion were compared. A minimum distance between tibial component stem and posterior tibial cortex (mDSC) was compared. The correlation between preoperative PSA and mDSC was analyzed in group A. The postoperative Western Ontario and McMaster Universities Index and range of motion of group A were better than those of group B (17.7 vs 18.8, P = .004; 131.4° vs 129.0°, P = .008). The mDSC was shorter in group A (6.3 vs 7.0 mm, P < .001), which made up a higher proportion of the high-risk group for posterior tibial cortical injury with an mDSC of <4 mm (20.0% vs 10.7%, P = .002). A negative correlation was found between the preoperative PSA and mDSC in group A (r = -0.205, P < .001). The TKA using the current prosthesis provided more satisfactory results than the TKA using the previous prosthesis. However, the injury risk to the posterior tibial cortex increased in the knees with a large PSA when using the current prosthesis for Asian patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Artificial aortic valve dysfunction due to pannus and thrombus – different methods of cardiac surgical management

PubMed Central

Marcinkiewicz, Anna; Kośmider, Anna; Walczak, Andrzej; Zwoliński, Radosław; Jaszewski, Ryszard

2015-01-01

Introduction Approximately 60 000 prosthetic valves are implanted annually in the USA. The risk of prosthesis dysfunction ranges from 0.1% to 4% per year. Prosthesis valve dysfunction is usually caused by a thrombus obstructing the prosthetic discs. However, 10% of prosthetic valves are dysfunctional due to pannus formation, and 12% of prostheses are damaged by both fibrinous and thrombotic components. The authors present two patients with dysfunctional aortic prostheses who were referred for cardiac surgery. Different surgical solutions were used in the treatment of each case. Case study 1 The first patient was a 71-year-old woman whose medical history included arterial hypertension, stable coronary artery disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), and hypercholesterolemia; she had previously undergone left-sided mastectomy and radiotherapy. The patient was admitted to the Cardiac Surgery Department due to aortic prosthesis dysfunction. Transthoracic echocardiography revealed complete obstruction of one disc and a severe reduction in the mobility of the second. The mean transvalvular gradient was very high. During the operation, pannus covering the discs’ surface was found. A biological aortic prosthesis was reimplanted without complications. Case study 2 The second patient was an 87-year-old woman with arterial hypertension, persistent atrial fibrillation, and COPD, whose past medical history included gastric ulcer disease and ischemic stroke. As in the case of the first patient, she was admitted due to valvular prosthesis dysfunction. Preoperative transthoracic echocardiography revealed an obstruction of the posterior prosthetic disc and significant aortic regurgitation. Transesophageal echocardiography and fluoroscopy confirmed the prosthetic dysfunction. During the operation, a thrombus growing around a minor pannus was found. The thrombus and pannus were removed, and normal functionality of the prosthetic valve was restored. Conclusions Precise and modern diagnostic methods facilitated selection of the treatment method. However, the intraoperative view also seems to be crucial in individualizing the surgical approach. PMID:26702274

Artificial aortic valve dysfunction due to pannus and thrombus - different methods of cardiac surgical management.

PubMed

Ostrowski, Stanisław; Marcinkiewicz, Anna; Kośmider, Anna; Walczak, Andrzej; Zwoliński, Radosław; Jaszewski, Ryszard

2015-09-01

Approximately 60 000 prosthetic valves are implanted annually in the USA. The risk of prosthesis dysfunction ranges from 0.1% to 4% per year. Prosthesis valve dysfunction is usually caused by a thrombus obstructing the prosthetic discs. However, 10% of prosthetic valves are dysfunctional due to pannus formation, and 12% of prostheses are damaged by both fibrinous and thrombotic components. The authors present two patients with dysfunctional aortic prostheses who were referred for cardiac surgery. Different surgical solutions were used in the treatment of each case. The first patient was a 71-year-old woman whose medical history included arterial hypertension, stable coronary artery disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), and hypercholesterolemia; she had previously undergone left-sided mastectomy and radiotherapy. The patient was admitted to the Cardiac Surgery Department due to aortic prosthesis dysfunction. Transthoracic echocardiography revealed complete obstruction of one disc and a severe reduction in the mobility of the second. The mean transvalvular gradient was very high. During the operation, pannus covering the discs' surface was found. A biological aortic prosthesis was reimplanted without complications. The second patient was an 87-year-old woman with arterial hypertension, persistent atrial fibrillation, and COPD, whose past medical history included gastric ulcer disease and ischemic stroke. As in the case of the first patient, she was admitted due to valvular prosthesis dysfunction. Preoperative transthoracic echocardiography revealed an obstruction of the posterior prosthetic disc and significant aortic regurgitation. Transesophageal echocardiography and fluoroscopy confirmed the prosthetic dysfunction. During the operation, a thrombus growing around a minor pannus was found. The thrombus and pannus were removed, and normal functionality of the prosthetic valve was restored. Precise and modern diagnostic methods facilitated selection of the treatment method. However, the intraoperative view also seems to be crucial in individualizing the surgical approach.

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.

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.

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

PubMed

Molt, Mats; Toksvig-Larsen, Sören

2014-10-01

The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

Comparison of patellofemoral outcomes after TKA using two prostheses with different patellofemoral design features.

PubMed

Bae, Dae Kyung; Baek, Jong Hun; Yoon, Kyung Tack; Son, Hyuck Sung; Song, Sang Jun

2017-12-01

The purpose of the present study was to compare the clinical and radiographic results after TKA using two prostheses with different sagittal patellofemoral design features, including outcomes related to compatibility of the patellofemoral joint. The clinical and radiographic results of 81 patients (100 knees) who underwent TKA using the specific prosthesis (group A) were compared with those in a control group who underwent TKA using the other prosthesis (group B). The presence of anterior knee joint pain, patellar crepitation, and patellar clunk syndrome was also checked. The function score and maximum flexion angle at the last follow-up were slightly better in group A than those in group B (92.0 ± 2.3 vs. 90.6 ± 4.2) (133.6° ± 8.4° vs. 129.6° ± 11.4°). Anterior knee pain was observed in 6 knees and patellar crepitation in four knees in group A. In group B, these symptoms were observed in 22 knees and 18 knees, respectively. There was no patellar clunk syndrome in either group. The alignment was corrected with satisfactory positioning of components. The patellar height remained unchanged after TKA in the two groups. The differences between preoperative and postoperative patellar tilt angle and patellar translation were small. When comparing the clinical and radiographic results after TKA using two prostheses with different sagittal patellofemoral design features, TKA using the specific prosthesis provided satisfactory results with less clinical symptoms related to the patellofemoral kinematics with TKA using the other prosthesis. III.

Metal injection molding as enabling technology for the production of metal prosthesis components: electrochemical and in vitro characterization.

PubMed

Melli, Virginia; Rondelli, Gianni; Sandrini, Enrico; Altomare, Lina; Bolelli, Giovanni; Bonferroni, Benedetta; Lusvarghi, Luca; Cigada, Alberto; De Nardo, Luigi

2013-10-01

Industrial manufacturing of prosthesis components could take significant advantage by the introduction of new, cost-effective manufacturing technologies with near net-shape capabilities, which have been developed during the last years to fulfill the needs of different technological sectors. Among them, metal injection molding (MIM) appears particularly promising for the production of orthopedic arthroplasty components with significant cost saving. These new manufacturing technologies, which have been developed, however, strongly affect the chemicophysical structure of processed materials and their resulting properties. In order to investigate this relationship, here we evaluated the effects on electrochemical properties, ion release, and in vitro response of medical grade CoCrMo alloy processed via MIM compared to conventional processes. MIM of the CoCrMo alloy resulted in coarser polygonal grains, with largely varying sizes; however, these microstructural differences between MIM and forged/cast CoCrMo alloys showed a negligible effect on electrochemical properties. Passive current densities values observed were 0.49 µA cm(-2) for MIM specimens and 0.51 µA cm(-2) for forged CoCrMo specimens, with slightly lower transpassive potential in the MIM case; open circuit potential and Rp stationary values showed no significant differences. Moreover, in vitro biocompatibility tests resulted in cell viability levels not significantly different for MIM and conventionally processed alloys. Although preliminary, these results support the potential of MIM technology for the production of CoCrMo components of implantable devices. Copyright © 2013 Wiley Periodicals, Inc.

Scintigraphy of infected total hip arthroplasty (THA): A canine model

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

Merkel, K.D.; Brown, M.L.; Fitzgerald, R.H.

1984-01-01

Differentiating low-grade sepsis from aseptic loosening of an orthopedic prosthesis is difficult. This study was designed to compare the ability of Tc-99m-HMDP, Ga-67, and In-111 leukocytes (WC) to differentiate low-grade sepsis from aseptic THA component loosening in a canine model. A canine THA was implanted in 14 dogs. Six dogs were given infected femoral components by injecting 10/sup 5/ colony-forming units of Staphylococcus aureus into the femoral canal 6y0 to 90 seconds prior to cementing. Four dogs had an aseptic loose femoral component, and four dogs had an aseptic tight femoral component (control). At six months all dogs were evaluatedmore » with X-ray, lab scintigraphy, and tissue quantitation of each tracer. Diagnosis was confirmed by histology and quantitative microbiology. White blood cell counts and differentials were normal in all dogs, and in only one out of six infected dogs was the sedimentation rate abnormal. X-rays were interpreted as possible infection in five dogs and probable infection in only one dog. In-111 WBC scans were more accurate than sequential Tc-Ga scans (sensitivity 94% vs 61%, specificity 86% vs 71% accuracy 90% vs 67%). Quantitative counting of gamma camera data and tissue samples demonstrated significantly (P < .01) higher accumulation of In-111 WBC about the infected than the loose or control component. No significant difference was demonstrated between the loose and septic components with TC-HMDP or Ga. These results correlate well and confirm our clinical data that In-111 WBC scanning is accurate and useful in the workup of the painful orthopedic prosthesis.« less

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.

["Bionic" arm prostheses. State of the art in research and development].

PubMed

Pylatiuk, C; Döderlein, L

2006-11-01

A new generation of arm prostheses is being developed worldwide. These so-called bionic prostheses are intended to offer additional functions, such as sensory feedback, extended range of possible movement, intuitive movement control as far as possible, and a more natural cosmetic appearance. In recent years, prosthetic components with much enhanced performance have been developed for use at various levels of the upper limb. Artificial hands that allow for additional grips are are being tested in clinical settings. Innovative methods of signal acquisition and communication with the patient are being intensively researched. Several patients have been provided with prototypes of new arm prostheses. At the moment, the results are limited by the restricted communication between patient and prosthesis. However, we can expect the options for prosthesis control to be extended in the near future.

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.

Two Bilateral Zygomatic Implants Placed and Immediately Loaded: A Retrospective Chart Review with Up-to-54-Month Follow-up.

PubMed

Neugarten, Jay; Tuminelli, Frank J; Walter, Leora

To report on the outcome of placement of two bilateral zygomatic implants with an immediately loaded prosthesis. A retrospective chart review was conducted of all patients treated with zygomatic implants between August 1, 2011 and June 6, 2016. All patients had at least two zygomatic implants placed bilaterally and immediately loaded with a provisional prosthesis the same day of implant placement. The implants were Nobel Biocare TiUnite or machined surface with lengths of 30 to 52.5 mm. All patients were treated by a team consisting of one surgeon, a restorative dentist or prosthodontist, an anesthesiologist, and a laboratory technician. Implant success was defined as successful integration of the implant; prosthetic success was defined as retention of the prosthesis under normal function. One hundred five zygomatic implants were placed and immediately loaded in 28 patients over a period of 1 to 60 months. Ages ranged from 46 to 81 years, with 26 female and 2 male patients. All the implants were placed by one surgeon. The immediate load on the day of implant placement was completed by either one of 2 prosthodontists or 11 restorative dentists. Implant success was 96% (101/105). All four failed implants were in one patient and were TiUnite surface coated. This study demonstrated that two zygomatic implants bilaterally placed and immediately loaded with a full-arch splinted prosthesis will provide a predictable outcome.

Impact of removable partial denture prosthesis on chewing efficiency

PubMed Central

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

2013-01-01

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

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.

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.

[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.

Survival of the Scandinavian total ankle replacement (STAR): results of ten to nineteen years follow-up.

PubMed

Frigg, Arno; Germann, Ursula; Huber, Martin; Horisberger, Monika

2017-10-01

The purpose of this study was to evaluate survival and clinical outcome of the Scandinavian total ankle replacement (STAR) prosthesis after a minimum of ten years up to a maximum of 19 years. Fifty STAR prostheses in 46 patients with end stage ankle osteoarthritis operated between 1996 and 2006 by the same surgeon (MH) were included. Minimal follow-up was ten years (median 14.6 years, 95% confidence interval [CI] 12.9-16.4). Clinical (Kofoed score) and radiological assessments were taken before the operation and at one, ten (+2), and 16 (±3) years after implantation. The primary endpoint was defined as exchange of the whole prosthesis or conversion to arthrodesis (def. 1), exchange of at least one metallic component (def. 2), or exchange of any component including the inlay (due to breakage or wear) (def. 3). Survival was estimated according to Kaplan-Meier. Further reoperations related to STAR were also recorded. The ten year survival rate was (def. 1) 94% (CI 82-98%), (def. 2) 90% (CI, 77-96%), and (def. 3) 78% (CI 64-87%). The 19-year survival rate was (def. 1) 91% (CI 78-97%), (def. 2) 75% (CI 53-88%), and (def. 3) 55% (CI 34-71%). Considering any re-operations related to STAR, 52% (26/50) of prostheses were affected by re-operations. Mean pre-operative Kofoed score was 49, which improved to 84 after one year (n = 50), to 90 after ten years (n = 46), and to 89 after 16 years (n = 28). The survival rate for def. 1 and 2 was high. However, re-operations occurred in 52% of all STAR prosthesis. Retrospective cohort study, evidence Level 4.

Validation of a measuring technique with computed tomography for cement penetration into trabecular bone underneath the tibial tray in total knee arthroplasty on a cadaver model

PubMed Central

2014-01-01

Background In total knee arthroplasty (TKA), cement penetration between 3 and 5 mm beneath the tibial tray is required to prevent loosening of the tibia component. The objective of this study was to develop and validate a reliable in vivo measuring technique using CT imaging to assess cement distribution and penetration depth in the total area underneath a tibia prosthesis. Methods We defined the radiodensity ranges for trabecular tibia bone, polymethylmethacrylate (PMMA) cement and cement-penetrated trabecular bone and measured the percentages of cement penetration at various depths after cementing two tibia prostheses onto redundant femoral heads. One prosthesis was subsequently removed to examine the influence of the metal tibia prostheses on the quality of the CT images. The percentages of cement penetration in the CT slices were compared with percentages measured with photographs of the corresponding transversal slices. Results Trabecular bone and cement-penetrated trabecular bone had no overlap in quantitative scale of radio-density. There was no significant difference in mean HU values when measuring with or without the tibia prosthesis. The percentages of measured cement-penetrated trabecular bone in the CT slices of the specimen were within the range of percentages that could be expected based on the measurements with the photographs (p = 0.04). Conclusions CT scan images provide valid results in measuring the penetration and distribution of cement into trabecular bone underneath the tibia component of a TKA. Since the proposed method does not turn metal elements into artefacts, it enables clinicians to assess the width and density of the cement mantle in vivo and to compare the results of different cementing methods in TKA. PMID:25158996

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

The Effects of the Inertial Properties of Above-Knee Prostheses on Optimal Stiffness, Damping, and Engagement Parameters of Passive Prosthetic Knees.

PubMed

Narang, Yashraj S; Murthy Arelekatti, V N; Winter, Amos G

2016-12-01

Our research aims to design low-cost, high-performance, passive prosthetic knees for developing countries. In this study, we determine optimal stiffness, damping, and engagement parameters for a low-cost, passive prosthetic knee that consists of simple mechanical elements and may enable users to walk with the normative kinematics of able-bodied humans. Knee joint power was analyzed to divide gait into energy-based phases and select mechanical components for each phase. The behavior of each component was described with a polynomial function, and the coefficients and polynomial order of each function were optimized to reproduce the knee moments required for normative kinematics of able-bodied humans. Sensitivity of coefficients to prosthesis mass was also investigated. The knee moments required for prosthesis users to walk with able-bodied normative kinematics were accurately reproduced with a mechanical system consisting of a linear spring, two constant-friction dampers, and three clutches (R2=0.90 for a typical prosthetic leg). Alterations in upper leg, lower leg, and foot mass had a large influence on optimal coefficients, changing damping coefficients by up to 180%. Critical results are reported through parametric illustrations that can be used by designers of prostheses to select optimal components for a prosthetic knee based on the inertial properties of the amputee and his or her prosthetic leg.

Humeral windows in revision total elbow arthroplasty.

PubMed

Peach, Chris A; Salama, Amir; Stanley, David

2016-04-01

The use of cortical windows for revision elbow arthroplasty has not previously been widely reported. Their use aids safe revision of a well fixed humeral prosthesis and can be used in the setting of dislocation, periprosthetic fracture or aseptic loosening of the ulnar component. We describe our technique and results of cortical windows in the distal humerus for revision elbow arthroplasty surgery.

3D-printed tracheoesophageal puncture and prosthesis placement simulator.

PubMed

Barber, Samuel R; Kozin, Elliott D; Naunheim, Matthew R; Sethi, Rosh; Remenschneider, Aaron K; Deschler, Daniel G

A tracheoesophageal prosthesis (TEP) allows for speech after total laryngectomy. However, TEP placement is technically challenging, requiring a coordinated series of steps. Surgical simulators improve technical skills and reduce operative time. We hypothesize that a reusable 3-dimensional (3D)-printed TEP simulator will facilitate comprehension and rehearsal prior to actual procedures. The simulator was designed using Fusion360 (Autodesk, San Rafael, CA). Components were 3D-printed in-house using an Ultimaker 2+ (Ultimaker, Netherlands). Squid simulated the common tracheoesophageal wall. A Blom-Singer TEP (InHealth Technologies, Carpinteria, CA) replicated placement. Subjects watched an instructional video and completed pre- and post-simulation surveys. The simulator comprised 3D-printed parts: the esophageal lumen and superficial stoma. Squid was placed between components. Ten trainees participated. Significant differences existed between junior and senior residents with surveys regarding anatomy knowledge(p<0.05), technical details(p<0.01), and equipment setup(p<0.01). Subjects agreed that simulation felt accurate, and rehearsal raised confidence in future procedures. A 3D-printed TEP simulator is feasible for surgical training. Simulation involving multiple steps may accelerate technical skills and improve education. Copyright © 2017 Elsevier Inc. All rights reserved.

A Hermetic Wireless Subretinal Neurostimulator for Vision Prostheses

PubMed Central

Shire, Douglas B.; Chen, Jinghua; Doyle, Patrick; Gingerich, Marcus D.; Cogan, Stuart F.; Drohan, William A.; Behan, Sonny; Theogarajan, Luke; Wyatt, John L.; Rizzo, Joseph F.

2016-01-01

A miniaturized, hermetically encased, wirelessly operated retinal prosthesis has been developed for preclinical studies in the Yucatan minipig, and includes several design improvements over our previously reported device. The prosthesis attaches conformally to the outside of the eye and electrically drives a microfabricated thin-film polyimide array of sputtered iridium oxide film electrodes. This array is implanted into the subretinal space using a customized ab externo surgical technique. The implanted device includes a hermetic titanium case containing a 15-channel stimulator chip and discrete circuit components. Feedthroughs in the case connect the stimulator chip to secondary power and data receiving coils on the eye and to the electrode array under the retina. Long-term in vitro pulse testing of the electrodes projected a lifetime consistent with typical devices in industry. The final assembly was tested in vitro to verify wireless operation of the system in physiological saline using a custom RF transmitter and primary coils. Stimulation pulse strength, duration, and frequency were programmed wirelessly from a Peripheral Component Interconnect eXtensions for Instrumentation (PXI) computer. Operation of the retinal implant has been verified in two pigs for up to five and a half months by detecting stimulus artifacts generated by the implanted device. PMID:21859595

The Ball Welding Bar: A New Solution for the Immediate Loading of Screw-Retained, Mandibular Fixed Full Arch Prostheses

PubMed Central

Bacchiocchi, Danilo

2017-01-01

Purpose To present a new intraoral welding technique, which can be used to manufacture screw-retained, mandibular fixed full-arch prostheses. Methods Over a 4-year period, all patients with complete mandibular edentulism or irreparably compromised mandibular dentition, who will restore the masticatory function with a fixed mandibular prosthesis, were considered for inclusion in this study. The “Ball Welding Bar” (BWB) technique is characterised by smooth prosthetic cylinders, interconnected by means of titanium bars which are adjustable in terms of distance from ball terminals and are inserted in the rotating rings of the cylinders. All the components are welded and self-posing. Results Forty-two patients (18 males; 24 females; mean age 64.2 ± 6.7 years) were enrolled and 210 fixtures were inserted to support 42 mandibular screw-retained, fixed full-arch prostheses. After two years of loading, 2 fixtures were lost, for an implant survival rate of 97.7%. Five implants suffered from peri-implant mucositis and 3 implants for peri-implantitis. Three of the prostheses (3/42) required repair for fracture (7.1%): the prosthetic success was 92.9%. Conclusions The BWB technique seems to represent a reliable technique for the fabrication of screw-retained mandibular fixed full-arch prostheses. This study was registered in the ISRCTN register with number ISRCTN71229338. PMID:28835752

Computed tomography: a powerful imaging technique in the fields of dimensional metrology and quality control

NASA Astrophysics Data System (ADS)

Probst, Gabriel; Boeckmans, Bart; Dewulf, Wim; Kruth, Jean-Pierre

2016-05-01

X-ray computed tomography (CT) is slowly conquering its space in the manufacturing industry for dimensional metrology and quality control purposes. The main advantage is its non-invasive and non-destructive character. Currently, CT is the only measurement technique that allows full 3D visualization of both inner and outer features of an object through a contactless probing system. Using hundreds of radiographs, acquired while rotating the object, a 3D representation is generated and dimensions can be verified. In this research, this non-contact technique was used for the inspection of assembled components. A dental cast model with 8 implants, connected by a screwed retained bar made of titanium. The retained bar includes a mating interface connection that should ensure a perfect fitting without residual stresses when the connection is fixed with screws. CT was used to inspect the mating interfaces between these two components. Gaps at the connections can lead to bacterial growth and potential inconvenience for the patient who would have to face a new surgery to replace his/hers prosthesis. With the aid of CT, flaws in the design or manufacturing process that could lead to gaps at the connections could be assessed.

Adaptive sports ankle prosthetics. Interview by Sarah A. Curran.

PubMed

Lyle, David K

2012-09-01

Participating in sport at all levels is gaining a dedicated following and this is also apparent in individuals with an amputation. Currently, there is a wide variety of ankle prostheses available which attempt to provide function, control, and comfort, as well as good aesthetic appeal. Participation in sport, however, increases the demands placed upon ankle prostheses. This can compromise function and performance, and constrain the opportunities of participation in various outdoor and water sports. In acknowledging this limitation and the need to develop more versatile ankle prostheses, this article introduces the evolution of a prototype ankle prosthesis referred to as "Adaptive Sports Ankle." The ankle prosthesis, which is compatible with any foot pyramid adapter, offers the same range of motion as the normal human ankle joint and is made up of components that are chemical and corrosion resistant. These design features that are specifically created to accommodate below-the-knee amputees provide an ideal prosthesis for those wishing to lead an active lifestyle and participate in aquatic (i.e. swimming, surfing, and scuba diving), snowboarding, and equestrian activities. Although it is acknowledged that there is a need to establish research on the Adaptive Sports Ankle, its introduction to the market will enhance and expand opportunities of those individuals with a lower limb amputation to lead an active and healthy lifestyle.

Thirty years of stapes surgery.

PubMed

Shea, J J

1988-01-01

The modern stapedectomy with prosthesis insertion and living oval window seal, like the modern cataract extraction with lens replacement, is now performed, very much the same, throughout the world. I have reviewed the evolution of stapes surgery during these last thirty years and tried to gain some agreement for several important facts about otosclerosis and several basic principals of stapes surgery. While a well-performed stapedectomy can eliminate the conductive component, the sensorineural hearing loss continues and, in about one-third, will progress till the patient, after age 65, must return to a hearing aid. A piston prosthesis gives the best hearing results: 0.6 mm diameter, when half the footplate is removed and a living oval window seal interposed, and 0.6 mm diameter when a small opening is made in the footplate obliterated by otosclerosis. I prefer a teflon prosthesis to stainless steel because it can be altered by the surgeon at operation, and vein as an oval window seal. I have presented a rare group of patients who develop facial palsy 5-1/2 days after uncomplicated stapedectomy, of whom all recover quickly and completely. I am confident that progress will continue to be made in the understanding of otosclerosis, and the performance of stapes surgery, but in these last thirty years we have made a good beginning.

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.

The Evolution of Dental Materials for Hybrid Prosthesis

PubMed Central

Gonzalez, Jorge

2014-01-01

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

Instant loading with intraoral welding technique and PRAMA implants: a new prosthetic approach.

PubMed

Celletti, R; Fanali, S; Laici, C U; Santori, C; Pignatelli, P; Sinjari, B

2017-01-01

When splinting multiple implants passive fit of the framework should be achieved to avoid excessive force distribution on the implants. Recently, a protocol was suggested for immediate loading of multiple implants by welding a titanium bar to implant abutments directly in the oral cavity so as to create a customized, precise and passive metal-reinforced provisional restoration. The intraoral welding technique subsequently proves to be a successful option in the full-arch immediate restorations of the mandible and maxilla. The aim of this article is to present a case report in which a new prosthetic approach, using trans-mucosal implants, is described. Dental implants are instantly loaded with a provisional prosthesis supported by an intraoral welded titanium framework to obtain a precise passive fit of the immediate loaded prosthesis.

How do the outcomes of the DEKA Arm compare to conventional prostheses?

PubMed

Resnik, Linda J; Borgia, Matthew L; Acluche, Frantzy; Cancio, Jill M; Latlief, Gail; Sasson, Nicole

2018-01-01

Objectives were to 1) compare self-reported function, dexterity, activity performance, quality of life and community integration of the DEKA Arm to conventional prostheses; and 2) examine differences in outcomes by conventional prosthesis type, terminal device type and by DEKA Arm configuration level. This was a two-part study; Part A consisted of in-laboratory training. Part B consisted of home use. Study participants were 23 prosthesis users (mean age = 45 ± 16; 87% male) who completed Part A, and 15 (mean age = 45 ± 18; 87% male) who completed Parts A and B. Outcomes including self-report and performance measures, were collected at Baseline using participants' personal prostheses and at the End of Parts A and B. Scores were compared using paired t-tests. Wilcoxon signed-rank tests were used to compare outcomes for the full sample, and for the sample stratified by device and terminal device type. Analysis of outcomes by configuration level was performed graphically. At the End of Part A activity performance using the DEKA Arm and conventional prosthesis was equivalent, but slower with the DEKA Arm. After Part B, performance using the DEKA Arm surpassed conventional prosthesis scores, and speed of activity completion was equivalent. Participants reported using the DEKA Arm to perform more activities, had less perceived disability, and less difficulty in activities at the End of A and B as compared to Baseline. No differences were observed in dexterity, prosthetic skill, spontaneity, pain, community integration or quality of life. Comparisons stratified by device type revealed similar patterns. Graphic comparisons revealed variations by configuration level. Participants using the DEKA Arm had less perceived disability and more engagement of the prosthesis in everyday tasks, although activity performance was slower. After home use experience, activity performance was improved and activity speed equivalent to using conventional prostheses.

[Preferred sites of accumulation of microbial plaque as shown by the color of the exterior surface of complete dentures].

PubMed

Merdes, L; Soueidan, A; Le Bars, P; Tabbi-Aneni, N

2009-03-01

The observation of the denture plaque for complete dentures caused many clinical works and researches, since 30 years. Most of the studies were interested, by the prosthetic under-surface. New data show that the polished (exterior) surface on the denture palate is colonized more than hard palate. The aim of our study is to locate the favorite zones of the accumulation of the denture plaque on the level of the suction polished faces of the acrylic resin. We proceeded by immersion during 24 hours of 62 used full dentures belongs to 33 patients, with mucous membranes of various clinical aspects in a plaque disclosing solution of erythrosine type. The suction faces were divided into several zones of marking. We record 100% of coloring of the interdental zones on the maxillary and mandibular prosthesis. On maxillary prosthesis: 100% of the former and posterior vestibular zones are colored. The bottom of the palate is colored to 67.74%, a rate equivalent to the zones of fractures. On mandibular prosthesis: retromolar and sublingual zones, are colored to 96.77%. The former hall is colored with a rate of 90.32%. The posterior vestibular zone seems the least colored with a rate of 80.64%. The former area of the hall carved in an aesthetic objective is generally colored as well on the maxillary and mandibular prosthesis. We point out that this zone should not be much carved on the level of the area simulating the attached gum. Patients should be always incited to practice a mechanical hygiene, which takes part largely in the evacuation of the denture plaque on prosthetic surfaces. This revealing plaque use should integrate a clinical attitude of good practice, to motivate a patient with prosthetic hygiene or to detect zones of cracks objectifying a mechanical weakness of a prosthesis to be taken again, as well as the checking of the quality of repair joint during a routine control.

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...

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

PubMed

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

2004-02-01

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

CKS knee prosthesis: biomechanics and clinical results in 42 cases.

PubMed

Martucci, E; Verni, E; Del Prete, G; Stulberg, S D

1996-01-01

From 1991 to 1993 a total of 42 CKS prostheses were implanted for the following reasons: osteoarthrosis (34 cases), rheumatoid arthritis (7 cases) tibial necrosis (1 case). At follow-up obtained after 17 to 41 months the results were: excellent or good: 41; the only poor result was probably related to excessive tension of the posterior cruciate ligament. 94% of the patients reported complete regression of pain, 85% was capable of going up and down stairs without support. Mean joint flexion was 105 degrees. Radiologically the anatomical axis of the knee had a mean valgus of anatomical axis of the knee had a mean valgus of 6 degrees. The prosthetic components were always cemented. The posterior cruciate ligament was removed in 7 knees, so that the prosthesis with "posterior stability" was used. The patella was never prosthetized. One patient complained of peri-patellar pain two months after surgery which then regressed completely.

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.

[Tripolar arthroplasty for recurrent total hip prosthesis dislocation].

PubMed

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

2003-05-01

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

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...

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

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

PubMed

Podevin, G; Larroquet, M; Camby, C; Audry, G; Plattner, V; Heloury, Y

2001-09-01

Pneumonectomy in children can be complicated by a severe mediastinal shift, which leads to bronchial stretching resulting in severe respiratory failure. This postpneumonectomy syndrome can be corrected by inserting a prosthesis in the empty side of the chest. Forty-two children, from 6 months to 15 years old, underwent a pneumonectomy. Seven of these patients were treated surgically for severe manifestations of postpneumonectomy syndrome. First insertion of an expandable prosthesis was followed up in 5 cases by its replacement with a breast prosthesis in adolescence. The expandable prosthesis was injected periodically with saline solution to maintain the mediastinum in a midline position as the children grew. The mean delay between pneumonectomy and first prosthesis implantation was 5 years (range, 11 months to 8 years). Pulmonary function tests showed a substantial improvement in the obstructive syndrome in all patients except one, in whom the functional improvement was moderate. The mean follow-up after the expandable prosthesis implantation was 6 years (range, 6 months to 10 years) and all patients are doing well. The insertion of an intrathoracic prosthesis can dramatically improve the clinical symptoms and reduce the functional obstructive syndrome. The expandable prosthesis allowed for progressive, well-tolerated recentering of the mediastinum and adjustment for growth. Copyright 2001 by W.B. Saunders Company.

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.

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.

Contrast Sensitivity With a Subretinal Prosthesis and Implications for Efficient Delivery of Visual Information

PubMed Central

Goetz, Georges; Smith, Richard; Lei, Xin; Galambos, Ludwig; Kamins, Theodore; Mathieson, Keith; Sher, Alexander; Palanker, Daniel

2015-01-01

Purpose To evaluate the contrast sensitivity of a degenerate retina stimulated by a photovoltaic subretinal prosthesis, and assess the impact of low contrast sensitivity on transmission of visual information. Methods We measure ex vivo the full-field contrast sensitivity of healthy rat retina stimulated with white light, and the contrast sensitivity of degenerate rat retina stimulated with a subretinal prosthesis at frequencies exceeding flicker fusion (>20 Hz). Effects of eye movements on retinal ganglion cell (RGC) activity are simulated using a linear–nonlinear model of the retina. Results Retinal ganglion cells adapt to high frequency stimulation of constant intensity, and respond transiently to changes in illumination of the implant, exhibiting responses to ON-sets, OFF-sets, and both ON- and OFF-sets of light. The percentage of cells with an OFF response decreases with progression of the degeneration, indicating that OFF responses are likely mediated by photoreceptors. Prosthetic vision exhibits reduced contrast sensitivity and dynamic range, with 65% contrast changes required to elicit responses, as compared to the 3% (OFF) to 7% (ON) changes with visible light. The maximum number of action potentials elicited with prosthetic stimulation is at most half of its natural counterpart for the ON pathway. Our model predicts that for most visual scenes, contrast sensitivity of prosthetic vision is insufficient for triggering RGC activity by fixational eye movements. Conclusions Contrast sensitivity of prosthetic vision is 10 times lower than normal, and dynamic range is two times below natural. Low contrast sensitivity and lack of OFF responses hamper delivery of visual information via a subretinal prosthesis. PMID:26540657

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.

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.

Computational Evaluation of the Effects of Bone Ingrowth on Bone Resorptive Remodeling after a Cementless Total Hip Arthroplasty

NASA Astrophysics Data System (ADS)

Jung, Duk-Young; Kang, Yu-Bong; Tsutsumi, Sadami; Nakai, Ryusuke; Ikeuchi, Ken; Sekel, Ron

In this study, we simulated a wide cortex separation from a cementless hip prosthesis using the bone resorption remodeling method that is based on the generation of high compressive stress around the distal cortical bone. Thereafter, we estimated the effect on late migration quantities of the hip prosthesis produced by the interface state arising from bone ingrowth. This was accomplished using cortical bone remodeling over a long period of time. Two-dimensional natural hip and implanted hip FEM models were constructed with each of the following interface statements between the bone and prosthesis: (1) non-fixation, (2) proximal 1/3, (3) proximal 2/3 and (4) full-fixation. The fixation interfaces in the fully and partially porous coated regions were rigidly fixed by bony ingrowth. The non-fixation model was constructed as a critical situation, with the fibrous or bony tissue not integrated at all into the implant surface. The daily load history was generated using the three loading cases of a one-legged stance as well as abduction and adduction motions. With the natural hip and one-legged stance, the peak compressive principal stresses were found to be under the criteria value for causing bone resorption, while no implant movement occurred. The migration magnitude of the stem of the proximal 1/3 fixation model with adduction motion was much higher, reaching 6%, 11%and 21%greater than those of the non-fixation, proximal 2/3 fixation and all-fixation models, respectively. The full-fixation model showed the lowest compressive principal stress and implant movement. Thus, we concluded that the late loosening and subsequent movement of the stem in the long term could be estimated with the cortical bone remodeling method based on a high compressive stress at the bone-implant interface. The change caused at the bone-prosthesis interface by bony or fibrous tissue ingrowth constituted the major factor in determining the extent of cortical bone resorption occurring with clinical loosening and subsequent implant movement.

Modeling and stress analyses of a normal foot-ankle and a prosthetic foot-ankle complex.

PubMed

Ozen, Mustafa; Sayman, Onur; Havitcioglu, Hasan

2013-01-01

Total ankle replacement (TAR) is a relatively new concept and is becoming more popular for treatment of ankle arthritis and fractures. Because of the high costs and difficulties of experimental studies, the developments of TAR prostheses are progressing very slowly. For this reason, the medical imaging techniques such as CT, and MR have become more and more useful. The finite element method (FEM) is a widely used technique to estimate the mechanical behaviors of materials and structures in engineering applications. FEM has also been increasingly applied to biomechanical analyses of human bones, tissues and organs, thanks to the development of both the computing capabilities and the medical imaging techniques. 3-D finite element models of the human foot and ankle from reconstruction of MR and CT images have been investigated by some authors. In this study, data of geometries (used in modeling) of a normal and a prosthetic foot and ankle were obtained from a 3D reconstruction of CT images. The segmentation software, MIMICS was used to generate the 3D images of the bony structures, soft tissues and components of prosthesis of normal and prosthetic ankle-foot complex. Except the spaces between the adjacent surface of the phalanges fused, metatarsals, cuneiforms, cuboid, navicular, talus and calcaneus bones, soft tissues and components of prosthesis were independently developed to form foot and ankle complex. SOLIDWORKS program was used to form the boundary surfaces of all model components and then the solid models were obtained from these boundary surfaces. Finite element analyses software, ABAQUS was used to perform the numerical stress analyses of these models for balanced standing position. Plantar pressure and von Mises stress distributions of the normal and prosthetic ankles were compared with each other. There was a peak pressure increase at the 4th metatarsal, first metatarsal and talus bones and a decrease at the intermediate cuneiform and calcaneus bones, in prosthetic ankle-foot complex compared to normal one. The predicted plantar pressures and von Misses stress distributions for a normal foot were consistent with other FE models given in the literature. The present study is aimed to open new approaches for the development of ankle prosthesis.

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

The accuracy and precision of radiostereometric analysis in upper limb arthroplasty.

PubMed

Ten Brinke, Bart; Beumer, Annechien; Koenraadt, Koen L M; Eygendaal, Denise; Kraan, Gerald A; Mathijssen, Nina M C

2017-06-01

Background and purpose - Radiostereometric analysis (RSA) is an accurate method for measurement of early migration of implants. Since a relation has been shown between early migration and future loosening of total knee and hip prostheses, RSA plays an important role in the development and evaluation of prostheses. However, there have been few RSA studies of the upper limb, and the value of RSA of the upper limb is not yet clear. We therefore performed a systematic review to investigate the accuracy and precision of RSA of the upper limb. Patients and methods - PRISMA guidelines were followed and the protocol for this review was published online at PROSPERO under registration number CRD42016042014. A systematic search of the literature was performed in the databases Embase, Medline, Cochrane, Web of Science, Scopus, Cinahl, and Google Scholar on April 25, 2015 based on the keywords radiostereometric analysis, shoulder prosthesis, elbow prosthesis, wrist prosthesis, trapeziometacarpal joint prosthesis, humerus, ulna, radius, carpus. Articles concerning RSA for the analysis of early migration of prostheses of the upper limb were included. Quality assessment was performed using the MINORS score, Downs and Black checklist, and the ISO RSA Results - 23 studies were included. Precision values were in the 0.06-0.88 mm and 0.05-10.7° range for the shoulder, the 0.05-0.34 mm and 0.16-0.76° range for the elbow, and the 0.16-1.83 mm and 11-124° range for the TMC joint. Accuracy data from marker- and model-based RSA were not reported in the studies included. Interpretation - RSA is a highly precise method for measurement of early migration of orthopedic implants in the upper limb. However, the precision of rotation measurement is poor in some components. Challenges with RSA in the upper limb include the symmetrical shape of prostheses and the limited size of surrounding bone, leading to over-projection of the markers by the prosthesis. We recommend higher adherence to RSA guidelines and encourage investigators to publish long-term follow-up RSA studies.

Comparison of fixed-bearing and mobile-bearing total knee arthroplasty after high tibial osteotomy.

PubMed

Hernigou, Philippe; Huys, Maxime; Pariat, Jacques; Roubineau, François; Flouzat Lachaniette, Charles Henri; Dubory, Arnaud

2018-02-01

There is no information comparing the results of fixed-bearing total knee replacement and mobile-bearing total knee replacement in the same patients previously treated by high tibial osteotomy. The purpose was therefore to compare fixed-bearing and mobile-bearing total knee replacements in patients treated with previous high tibial osteotomy. We compared the results of 57 patients with osteoarthritis who had received a fixed-bearing prosthesis after high tibial osteotomy with the results of 41 matched patients who had received a rotating platform after high tibial osteotomy. The match was made for length of follow-up period. The mean follow-up was 17 years (range, 15-20 years). The patients were assessed clinically and radiographically. The pre-operative knee scores had no statistically significant differences between the two groups. So was the case with the intra-operative releases, blood loss, thromboembolic complications and infection rates in either group. There was significant improvement in both groups of knees, and no significant difference was observed between the groups (i.e., fixed-bearing and mobile-bearing knees) for the mean Knee Society knee clinical score (95 and 92 points, respectively), or the Knee Society knee functional score (82 and 83 points, respectively) at the latest follow-up. However, the mean post-operative knee motion was higher for the fixed-bearing group (117° versus 110°). In the fixed-bearing group, one knee was revised because of periprosthetic fracture. In the rotating platform mobile-bearing group, one knee was revised because of aseptic loosening of the tibial component. The Kaplan-Meier survivorship for revision at ten years of follow-up was 95.2% for the fixed bearing prosthesis and 91.1% for the rotating platform mobile-bearing prosthesis. Although we did manage to detect significant differences mainly in clinical and radiographic results between the two groups, we found no superiority or inferiority of the mobile-bearing total knee prosthesis over the fixed-bearing total knee prosthesis for patients previously operated by high tibial osteotomy.

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.

2-year follow-up report on micromotion of a short tibia stem. A prospective, randomized RSA study of 59 patients.

PubMed

Molt, Mats; Toksvig-Larsen, Sören

2015-01-01

A shortened tibial stem could influence the early prosthetic fixation. We therefore compared the short stem to the standard-length stem using radiostereometric analysis (RSA) as primary outcome measure. 60 patients were randomized to receive a cemented Triathlon total knee arthroplasty (TKA) with a tibial tray of either standard or short stem length. The patients were blinded regarding treatment allocation. The micromotion of the tibial component was measured by RSA postoperatively, at 3 months, and after 1 and 2 years; clinical outcome was measured with the American Knee Society score (AKSS) and the knee osteoarthritis and injury outcome score (KOOS). The maximum total point motion (MTPM) for the standard stem was 0.36 (SD 0.16) mm at 3 months, 0.51 (SD 0.27) mm at 1 year, and 0.54 (SD 0.28) mm at 2 years. For the short stem, it was 0.42 (0.24) mm, 0.59 (0.43) mm, and 0.61 (0.39) mm. 4 short-stemmed components and 2 standard-stemmed components had more than 0.2 mm of migration between the first- and second-year follow-up, and were classified as continuously migrating. The short-stemmed cemented tibial prosthesis showed an early prosthetic migratory pattern similar to that of the standard-stemmed cemented Triathlon knee prosthesis. The number of continuously migrating tibial plates in each group is predictive of a lower revision rate than 5% at 10 years.

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

Influence of glenoid component design and humeral component retroversion on internal and external rotation in reverse shoulder arthroplasty: a cadaver study.

PubMed

Berhouet, J; Garaud, P; Favard, L

2013-12-01

A common disadvantage of reverse shoulder arthroplasty is limitation of the range of arm rotation. Several changes to the prosthesis design and implantation technique have been suggested to improve rotation range of motion (ROM). Glenoid component design and degree of humeral component retroversion influence rotation ROM after reverse shoulder arthroplasty. The Aequalis Reversed™ shoulder prosthesis (Tornier Inc., Edina, MN, USA) was implanted into 40 cadaver shoulders. Eight glenoid component combinations were tested, five with the 36-mm sphere (centred seating, eccentric seating, inferior tilt, centred with a 5-mm thick lateralised spacer, and centred with a 7-mm thick lateralised spacer) and three with the 42-mm sphere (centred with no spacer or with a 7-mm or 10-mm spacer). Humeral component position was evaluated with 0°, 10°, 20°, 30°, and 40° of retroversion. External and internal rotation ROMs to posterior and anterior impingement on the scapular neck were measured with the arm in 20° of abduction. The large glenosphere (42 mm) was associated with significantly (P<0.05) greater rotation ROMs, particularly when combined with a lateralised spacer (46° internal and 66° external rotation). Rotation ROMs were smallest with the 36-mm sphere. Greater humeral component retroversion was associated with a decrease in internal rotation and a significant increase (P<0.05) in external rotation. The best balance between rotation ROMs was obtained with the native retroversion, which was estimated at 17.5° on average in this study. Our anatomic study in a large number of cadavers involved a detailed and reproducible experimental protocol. However, we did not evaluate the variability in scapular anatomy. Earlier studies of the influence of technical parameters did not take humeral component retroversion into account. In addition, no previous studies assessed rotation ROMs. Rotation ROM should be improved by the use of a large-diameter glenosphere with a spacer to lateralise the centre of rotation of the gleno-humeral joint, as well as by positioning the humeral component at the patient's native retroversion value. Copyright © 2013 Elsevier Masson SAS. 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.

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average... titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high...

JPRS Report, Science & Technology USSR: Life Sciences.

DTIC Science & Technology

1988-07-01

practical problems must be actively expanded. The restructuring and the improvements must touch every component of the pharmacy service. Accomplishing...Ministry of Health touched on that. The situation today has gotten rather complex. Over the past 20 years, the number of physicians in the country...Prosthetics and Prosthesis Building [TsNIIPP]; A. P. Kuzhckin, deputy science director of TsNIIPP; M. V. Davydov, general director of the Mos- cow

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.

Analyzing at-home prosthesis use in unilateral upper-limb amputees to inform treatment & device design.

PubMed

Spiers, Adam J; Resnik, Linda; Dollar, Aaron M

2017-07-01

New upper limb prosthetic devices are continuously being developed by a variety of industrial, academic, and hobbyist groups. Yet, little research has evaluated the long term use of currently available prostheses in daily life activities, beyond laboratory or survey studies. We seek to objectively measure how experienced unilateral upper limb prosthesis-users employ their prosthetic devices and unaffected limb for manipulation during everyday activities. In particular, our goal is to create a method for evaluating all types of amputee manipulation, including non-prehensile actions beyond conventional grasp functions, as well as to examine the relative use of both limbs in unilateral and bilateral cases. This study employs a head-mounted video camera to record participant's hands and arms as they complete unstructured domestic tasks within their own homes. A new 'Unilateral Prosthesis-User Manipulation Taxonomy' is presented based observations from 10 hours of recorded videos. The taxonomy addresses manipulation actions of the intact hand, prostheses, bilateral activities, and environmental feature-use (aiïordances). Our preliminary results involved tagging 23 minute segments of the full videos from 3 amputee participants using the taxonomy. This resulted in over 2,300 tag instances. Observations included that non-prehensile interactions outnumbered prehensile interactions in the affected limb for users with more distal amputation that allowed arm mobility.

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

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.

Influence of post-cam design of posterior stabilized knee prosthesis on tibiofemoral motion during high knee flexion.

PubMed

Lin, Kun-Jhih; Huang, Chang-Hung; Liu, Yu-Liang; Chen, Wen-Chuan; Chang, Tsung-Wei; Yang, Chan-Tsung; Lai, Yu-Shu; Cheng, Cheng-Kung

2011-10-01

The post-cam design of contemporary posterior stabilized knee prosthesis can be categorized into flat-on-flat or curve-on-curve contact surfaces. The curve-on-curve design has been demonstrated its advantage of reducing stress concentration when the knee sustained an anteroposterior force with tibial rotation. How the post-cam design affects knee kinematics is still unknown, particularly, to compare the difference between the two design features. Analyzing knee kinematics of posterior stabilized knee prosthesis with various post-cam designs should provide certain instructions to the modification of prosthesis design. A dynamic knee model was utilized to investigate tibiofemoral motion of various post-cam designs during high knee flexion. Two posterior stabilized knee models were constructed with flat-on-flat and curve-on-curve contact surfaces of post-cam. Dynamic data of axial tibial rotation and femoral translation were measured from full-extension to 135°. Internal tibial rotation increased with knee flexion in both designs. Before post-cam engagement, the magnitude of internal tibial rotation was close in the two designs. However, tibial rotation angle decreased beyond femoral cam engaged with tibial post. The rate of reduction of tibial rotation was relatively lower in the curve-on-curve design. From post-cam engagement to extreme flexion, the curve-on-curve design had greater internal tibial rotation. Motion constraint was generated by medial impingement of femoral cam on tibial post. It would interfere with the axial motion of the femur relative to the tibia, resulting in decrease of internal tibial rotation. Elimination of rotational constraint should be necessary for achieving better tibial rotation during high knee flexion. Copyright © 2011 Elsevier Ltd. 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.

High rate of osteolytic lesions in medium-term followup after the AES total ankle replacement.

PubMed

Kokkonen, Ari; Ikävalko, Mikko; Tiihonen, Raine; Kautiainen, Hannu; Belt, Eero A

2011-02-01

Some previous studies have shown a high percentage of early-onset and rapidly progressing osteolysis associated with total ankle arthroplasty (TAA) by the Ankle Evolutive System (AES). The purpose of our study was to analyze medium-term results at our institution. Altogether 38 TAAs using AES prostheses were carried out between 2003 and 2007. Diagnoses were rheumatoid arthritis (71%), post-traumatic and idiopathic osteoarthritis (29%). The mean age was 54 years, followup 28 months. Tibial and talar components had hydroxyapatite coating on metal (Co-Cr) components (HA-coated). Since 2005 the design was changed and components were porous coated with titanium and hydroxyapatite (dual-coated). Two-year survival was 79% (95% CI: 56 to 98). At followup 34 (89%) primary tibial and talar components were preserved. In 19 (50%) TAAs osteolysis (more than or equal to 2 mm) occurred in the periprosthetic bone area and in nine (24%) comprised large "cyst-like osteolysis''. In HA-coated prostheses radiolucent lines (less than or equal to 2 mm) or osteolysis (more than or equal to 2 mm) were detected in 11 (100%) cases and in dual-coated prostheses in 19 (74%) (p = 0.08). On the other hand there was more large "cyst-like osteolysis'' around the dual-coated prosthesis and lesions were larger (p = 0.017). In rheumatoid arthritis osteolysis was detected in 14 (52%) and large "cyst-like osteolysis'' in seven (26%) prostheses and in the group of traumatic and idiopathic osteoarthritis in six (55%) and two (18%), respectively. This study showed a high frequency of osteolysis in medium-term followup after the AES ankle replacement. The outcome was not sufficiently beneficial and we have discontinued use of this prosthesis.

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.

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

PubMed

La Verde, Luca; Fenga, Domenico; Spinelli, Maria Silvia; Campo, Francesco Rosario; Florio, Michela; Rosa, Michele Attilio

2017-01-01

Metallosis is a condition characterized by an infiltration of periprosthetic soft tissues and bone by metallic debris resulting from wear or failure of joint arthroplasties. Authors describe a case of a 45-year-old man treated for an osteosarcoma of the distal femur with a modular prosthesis when he was 18 years old, he developed massive metallosis with skin dyspigmentation after 17 years. His medical\\surgical history was remarkable for a left tumoral knee prosthesis implanted 21 years ago. Two years before revision, the patient had a car accident with a two-points prosthesis breakage and despite the surgeon's advice, the patient refused surgery. In two years, prosthesis malfunction caused a progressive catastrophic soft tissues infiltration of metallic debris. Authors suggest that if prosthesis fracture is detected, revision surgery should be attempted as earlier as possible. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

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.

[Quantitative and qualitative analysis of oral microbiota by orthopedic rehabilitation with full and partial removable dentures].

PubMed

Stafeev, A A; Chesnokova, M G; Chesnokov, V A

2015-01-01

Microbiological analysis of biomaterial surface in dental prosthesis showed the most common colonizing gram-positive species to be S. aureus, Micrococcus spp., S. haemolyticus, E. faecalis, mainly massive colonization with S. aureus was seen. The highest concentration of C. albicans colonization was found in removable dentures and may have a destructive effect on prosthetic material.

Full-mouth rehabilitation with immediate loading of implants inserted with computer-guided flap-less surgery: a 3-year multicenter clinical evaluation with oral health impact profile.

PubMed

Marra, Roberto; Acocella, Alessandro; Rispoli, Alessandra; Sacco, Roberto; Ganz, Scott D; Blasi, Andrea

2013-10-01

The purpose of this report is to present the clinical outcomes and patients' satisfaction of full-mouth rehabilitation using computer-aided flapless implant placement and immediate loading of a prefabricated prosthesis. The study included 30 consecutive fully edentulous patients who received 312 implants. Mandible and maxilla were treated in the same surgical session with computer-guided flapless approach using the NobelGuide protocol. Prefabricated screw-retained fixed prostheses were inserted at the end of surgery. Clinical and radiographic evaluations were assessed at 6, 12, and 36 months. At baseline and 6 months after surgery, patients answered Oral Health Impact Profile in Edentulous Adults questionnaire to assess satisfaction. The implant survival rate was 97.9%, whereas the average marginal bone loss was 1.9 ± 1.3 mm after 3 years. At 6 months, patients showed significantly greater satisfaction with their fixed rehabilitation when compared with conventional dentures. The results of this study confirm that rehabilitation with a prefabricated fixed prosthesis supported by implants placed with NobelGuide protocol is a viable and predictable treatment and increases patients' satisfaction and improves oral health-related quality of life.

[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.

Review of the socket design and interface pressure measurement for transtibial prosthesis.

PubMed

Pirouzi, Gh; Abu Osman, N A; Eshraghi, A; Ali, S; Gholizadeh, H; Wan Abas, W A B

2014-01-01

Socket is an important part of every prosthetic limb as an interface between the residual limb and prosthetic components. Biomechanics of socket-residual limb interface, especially the pressure and force distribution, have effect on patient satisfaction and function. This paper aimed to review and evaluate studies conducted in the last decades on the design of socket, in-socket interface pressure measurement, and socket biomechanics. Literature was searched to find related keywords with transtibial amputation, socket-residual limb interface, socket measurement, socket design, modeling, computational modeling, and suspension system. In accordance with the selection criteria, 19 articles were selected for further analysis. It was revealed that pressure and stress have been studied in the last decaeds, but quantitative evaluations remain inapplicable in clinical settings. This study also illustrates prevailing systems, which may facilitate improvements in socket design for improved quality of life for individuals ambulating with transtibial prosthesis. It is hoped that the review will better facilitate the understanding and determine the clinical relevance of quantitative evaluations.

Review of the Socket Design and Interface Pressure Measurement for Transtibial Prosthesis

PubMed Central

Pirouzi, Gh.; Abu Osman, N. A.; Eshraghi, A.; Ali, S.; Gholizadeh, H.; Wan Abas, W. A. B.

2014-01-01

Socket is an important part of every prosthetic limb as an interface between the residual limb and prosthetic components. Biomechanics of socket-residual limb interface, especially the pressure and force distribution, have effect on patient satisfaction and function. This paper aimed to review and evaluate studies conducted in the last decades on the design of socket, in-socket interface pressure measurement, and socket biomechanics. Literature was searched to find related keywords with transtibial amputation, socket-residual limb interface, socket measurement, socket design, modeling, computational modeling, and suspension system. In accordance with the selection criteria, 19 articles were selected for further analysis. It was revealed that pressure and stress have been studied in the last decaeds, but quantitative evaluations remain inapplicable in clinical settings. This study also illustrates prevailing systems, which may facilitate improvements in socket design for improved quality of life for individuals ambulating with transtibial prosthesis. It is hoped that the review will better facilitate the understanding and determine the clinical relevance of quantitative evaluations. PMID:25197716

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

[Endoprosthetic replacement with lifting of abdominal wall in treatment of umbilical and postoperative ventral hernias].

PubMed

Sukhovatykh, B S; Valuyskaya, N M; Gerasimchuk, E V

2015-01-01

The results of complex clinical and ultrasonic investigation of abdominal wall and following surgical treatment in 60 women with umbilical and postoperative large ventral hernias combined with abdomen ptosis were analyzed. Patients were divided into 2 groups with 30 people per group. Endoprosthetic replacement of abdominal wall defect using standard polypropylene prosthesis was applied in the 1st group, endoprosthetic replacement with musculoaponeurotic tissues lifting in hypogastric area using original super lightweight polypropylenepolyvinylidenefluoride prosthesis--in the 2nd group. Polypropylene endoprosthesisconsist of main flap 15×15 cm with roundish edges and additional flap 5×40 cm in the form of wide stripe placed at the lower edge of main flap transversely to its direction. It was revealed increased physical health component in 1.8 times, psychic--in 2.5 times in the 2nd group. Thus number of excellent results increased on 33.3% and amount of satisfactory outcomes reduced on 30%.

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.

Hip Squeaking after Ceramic-on-ceramic Total Hip Arthroplasty

PubMed Central

Wu, Guo-Liang; Zhu, Wei; Zhao, Yan; Ma, Qi; Weng, Xi-Sheng

2016-01-01

Objective: The present study aimed to review the characteristics and influencing factors of squeaking after ceramic-on-ceramic (CoC) total hip arthroplasty (THA) and to analyze the possible mechanisms of the audible noise. Data Sources: The data analyzed in this review were based on articles from PubMed and Web of Science. Study Selection: The articles selected for review were original articles and reviews found based on the following search terms: “total hip arthroplasty”, “ceramic-on-ceramic”, “hip squeaking”, and “hip noise.” Results: The mechanism of the squeaking remains unknown. The possible explanations included stripe wear, edge loading, a third body, fracture of the ceramic liner, and resonance of the prosthesis components. Squeaking occurrence is influenced by patient, surgical, and implant factors. Conclusions: Most studies indicated that squeaking after CoC THA was the consequence of increasing wear or impingement, caused by prosthesis design, patient characteristics, or surgical factors. However, as conflicts exist among different articles, the major reasons for the squeaking remain to be identified. PMID:27453238

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.

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.

[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.

"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

Three-component hydraulic penile prosthesis malfunction due to penile fibrolipoma secondary to augmentative phalloplasty: A case report.

PubMed

Antonini, Gabriele; Vicini, Patrizio; De Berardinis, Ettore; Pacchiarotti, Arianna; Gentile, Vincenzo; Perito, Paul

2016-01-14

Fibrolipomas are an infrequent type of lipomas. We describe a case of a man suffering from subcutaneous penile fibrolipoma, who twelve months earlier has been submitted to augmentative phalloplasty due to aesthetic dysmorphophobia. The same patient three years earlier has been submitted to three-component hydraulic penile prostheses implantation due to erectile dysfunction. After six months from removing of the mass, the penile elongation and penile enlargement were stable, the prostheses were correctly functioning and the patient was satisfied with his sexual intercourse and life. The diagnostics and surgical characteristics of this case are reported.

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.

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.

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.

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.

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.

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.

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

Retention System and Splinting on Morse Taper Implants in the Posterior Maxilla by 3D Finite Element Analysis.

PubMed

Lemos, Cleidiel Aparecido Araujo; Verri, Fellippo Ramos; Santiago, Joel Ferreira; Almeida, Daniel Augusto de Faria; Batista, Victor Eduardo de Souza; Noritomi, Pedro Yoshito; Pellizzer, Duardo Piza

2018-01-01

The purpose of this study was to evaluate different retention systems (cement- or screw-retained) and crown designs (non-splinted or splinted) of fixed implant-supported restorations, in terms of stress distributions in implants/components and bone tissue, by 3-dimensional (3D) finite element analysis. Four 3D models were simulated with the InVesalius, Rhinoceros 3D, and SolidWorks programs. Models were made of type III bone from the posterior maxillary area. Models included three 4.0-mm-diameter Morse taper (MT) implants with different lengths, which supported metal-ceramic crowns. Models were processed by the Femap and NeiNastran programs, using an axial force of 400 N and oblique force of 200 N. Results were visualized as the von Mises stress and maximum principal stress (σmax). Under axial loading, there was no difference in the distribution of stress in implants/components between retention systems and splinted crowns; however, in oblique loading, cemented prostheses showed better stress distribution than screwed prostheses, whereas splinted crowns tended to reduce stress in the implant of the first molar. In the bone tissue cemented prostheses showed better stress distribution in bone tissue than screwed prostheses under axial and oblique loading. The splinted design only had an effect in the screwed prosthesis, with no influence in the cemented prosthesis. Cemented prostheses on MT implants showed more favorable stress distributions in implants/components and bone tissue. Splinting was favorable for stress distribution only for screwed prostheses under oblique loading.

Clinical Study of 3D Imaging and 3D Printing Technique for Patient-Specific Instrumentation in Total Knee Arthroplasty.

PubMed

Qiu, Bing; Liu, Fei; Tang, Bensen; Deng, Biyong; Liu, Fang; Zhu, Weimin; Zhen, Dong; Xue, Mingyuan; Zhang, Mingjiao

2017-10-01

Patient-specific instrumentation (PSI) was designed to improve the accuracy of preoperative planning and postoperative prosthesis positioning in total knee arthroplasty (TKA). However, better understanding needs to be achieved due to the subtle nature of the PSI systems. In this study, 3D printing technique based on the image data of computed tomography (CT) has been utilized for optimal controlling of the surgical parameters. Two groups of TKA cases have been randomly selected as PSI group and control group with no significant difference of age and sex ( p  > 0.05). The PSI group is treated with 3D printed cutting guides whereas the control group is treated with conventional instrumentation (CI). By evaluating the proximal osteotomy amount, distal osteotomy amount, valgus angle, external rotation angle, and tibial posterior slope angle of patients, it can be found that the preoperative quantitative assessment and intraoperative changes can be controlled with PSI whereas CI is relied on experience. In terms of postoperative parameters, such as hip-knee-ankle (HKA), frontal femoral component (FFC), frontal tibial component (FTC), and lateral tibial component (LTC) angles, there is a significant improvement in achieving the desired implant position ( p  < 0.05). Assigned from the morphology of patients' knees, the PSI represents the convergence of congruent designs with current personalized treatment tools. The PSI can achieve less extremity alignment and greater accuracy of prosthesis implantation compared against control method, which indicates potential for optimal HKA, FFC, and FTC angles. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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.

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.

Influence of malalignment on socket reaction moments during gait in amputees with transtibial prostheses.

PubMed

Boone, David A; Kobayashi, Toshiki; Chou, Teri G; Arabian, Adam K; Coleman, Kim L; Orendurff, Michael S; Zhang, Ming

2013-04-01

Alignment - the process and measured orientation of the prosthetic socket relative to the foot - is important for proper function of a transtibial prosthesis. Prosthetic alignment is performed by prosthetists using visual gait observation and amputees' feedback. The aim of this study was to investigate the effect of transtibial prosthesis malalignment on the moments measured at the base of the socket: the socket reaction moments. Eleven subjects with transtibial amputation were recruited from the community. An instrumented prosthesis alignment component was used to measure socket reaction moments during ambulation under 17 alignment conditions, including nominally aligned using conventional clinical methods, and angle perturbations of 3° and 6° (flexion, extension, abduction, and adduction) and translation perturbations of 5mm and 10mm (anterior, posterior, lateral, and medial) referenced from the nominal alignment. Coronal alignment perturbations caused systematic changes in the coronal socket reaction moments. All angle and translation perturbations revealed statistically significant differences on coronal socket reaction moments compared to the nominal alignment at 30% and 75% of stance phase (P<0.05). The effect of sagittal alignment perturbations on sagittal socket reaction moments was not as responsive as that of the coronal perturbations. The sagittal angle and translation perturbations of the socket led to statistically significant changes in minimum moment, maximum moment, and moments at 45% of stance phase in the sagittal plane. Therefore, malalignment affected the socket reaction moments in amputees with transtibial prostheses. Copyright © 2012 Elsevier B.V. All rights reserved.

Cobalt, chromium and molybdenum ions kinetics in the human body: data gained from a total hip replacement with massive third body wear of the head and neuropathy by cobalt intoxication.

PubMed

Pazzaglia, U E; Apostoli, P; Congiu, T; Catalani, S; Marchese, M; Zarattini, G

2011-09-01

A patient with a total hip replacement developed optic, acoustic and peripheral neuropathy from metal ions intoxication, due to the wear products released from the prosthesis. Subsequently the kinetics of the metal ions was studied. Massive wear and acute intoxication allowed a study of the metal ions kinetics and of EDTA treatment. Plasma and other organic fluids were saturated by each of the metal ions released from the exposed surface according to the solubility of each ion; a larger fraction of Co ions was bound within red cells, while the plasmatic fraction appeared more movable. In a patient with a prosthesis subjected to wear, the ions released are from the prosthetic and from the debris surface (spread in the body). The latter is a function of the number and size of particles. Revision of the prosthesis from the point of view of the metal ions kinetics corresponded to a reduction of the releasing surface because of debris washed out by irrigation and tissue excision; however, the metal particles spread by lymphatic circulation continued to release ions even though the source of wear had been removed. Early diagnosis of high metal wear can be ascertained with mass spectrometry and after revision high levels of metal ions can only be reduced with repeated chelating treatment. It is preferable not to revise fractured ceramic components with a polyethylene-metal articulation.

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

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...

[Guided and computer-assisted implant surgery and prosthetic: The continuous digital workflow].

PubMed

Pascual, D; Vaysse, J

2016-02-01

New continuous digital workflow protocols of guided and computer-assisted implant surgery improve accuracy of implant positioning. The design of the future prosthesis is based on the available prosthetic space, gingival height and occlusal relationship with the opposing and adjacent teeth. The implant position and length depend on volume, density and bone quality, gingival height, tooth-implant and implant-implant distances, implant parallelism, axis and type of the future prosthesis. The crown modeled on the software will therefore serve as a guide to the future implant axis and not the reverse. The guide is made by 3D printing. The software determines surgical protocol with the drilling sequences. The unitary or plural prosthesis, modeled on the software and built before surgery, is loaded directly after implant placing, if needed. These protocols allow for a full continuity of the digital workflow. The software provides the surgeon and the dental technician a total freedom for the prosthetic-surgery guide design and the position of the implants. The prosthetic project, occlusal and aesthetic, taking the bony and surgical constraints into account, is optimized. The implant surgery is simplified and becomes less "stressful" for the patient and the surgeon. Guided and computer-assisted surgery with continuous digital workflow is becoming the technique of choice to improve the accuracy and quality of implant rehabilitation. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

A training platform for many-dimensional prosthetic devices using a virtual reality environment

PubMed Central

Putrino, David; Wong, Yan T.; Weiss, Adam; Pesaran, Bijan

2014-01-01

Brain machine interfaces (BMIs) have the potential to assist in the rehabilitation of millions of patients worldwide. Despite recent advancements in BMI technology for the restoration of lost motor function, a training environment to restore full control of the anatomical segments of an upper limb extremity has not yet been presented. Here, we develop a virtual upper limb prosthesis with 27 independent dimensions, the anatomical dimensions of the human arm and hand, and deploy the virtual prosthesis as an avatar in a virtual reality environment (VRE) that can be controlled in real-time. The prosthesis avatar accepts kinematic control inputs that can be captured from movements of the arm and hand as well as neural control inputs derived from processed neural signals. We characterize the system performance under kinematic control using a commercially available motion capture system. We also present the performance under kinematic control achieved by two non-human primates (Macaca Mulatta) trained to use the prosthetic avatar to perform reaching and grasping tasks. This is the first virtual prosthetic device that is capable of emulating all the anatomical movements of a healthy upper limb in real-time. Since the system accepts both neural and kinematic inputs for a variety of many-dimensional skeletons, we propose it provides a customizable training platform for the acquisition of many-dimensional neural prosthetic control. PMID:24726625

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 888.3690 - 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 888.3690 - 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 888.3690 - 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 888.3690 - 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

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

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.

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.

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.

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...