Dataset Information

Initial stability of a percutaneous osseointegrated endoprosthesis with proximal interlocking screws for transhumeral amputees.

ABSTRACT: BACKGROUND:Percutaneous osseointegrated devices for skeletal fixation of prosthetic limbs have the potential to improve clinical outcomes in the transhumeral amputee population. Initial endoprosthesis stability is paramount for long-term osseointegration and safe clinical introduction of this technology. We evaluated an endoprosthetic design featuring a distally porous coated titanium stem with proximal slots for placement of bicortical interlocking screws. METHODS:Yield load, ultimate failure load, and construct stiffness were measured in 18 pairs of fresh-frozen and thawed cadaver humeri, at distal and proximal amputation levels, without and with screws, under axial pull-out, torsion, and bending loads. Paired statistical comparisons were performed without screws at the two resection levels, and at distal and proximal levels with and without screws. FINDINGS:Without screws, the location of the amputation influenced the stability only in torsional yield (p = 0.032) and torsional ultimate failure (p = 0.033). Proximally, the torsional yield and the torsional ultimate failure were 44% and 47% of that distally. Screws improved stability. In axial pull-out, screws increased the distal ultimate failure 3.2 times (p = 0.003). In torsion, screws increased the yield at the proximal level 1.9 times (p = 0.035), distal ultimate failure load 3.3 times (p = 0.016) and proximal ultimate failure 6.4 times (p = 0.013). In bending, screws increased ultimate failure at the proximal level 1.6 times (p = 0.026). INTERPRETATION:Proximal slots and bicortical interlocking screws may find application in percutaneous osseointegrated devices for patients with amputations, especially in the less stable proximal bone of a short residual limb.

SUBMITTER: Drew AJ

PROVIDER: S-EPMC7414792 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Initial stability of a percutaneous osseointegrated endoprosthesis with proximal interlocking screws for transhumeral amputees.

Drew Alex J AJ Taylor Carolyn E CE Tashjian Robert Z RZ Chalmers Peter N PN Henninger Heath B HB Bachus Kent N KN

Clinical biomechanics (Bristol, Avon) 20191206

<h4>Background</h4>Percutaneous osseointegrated devices for skeletal fixation of prosthetic limbs have the potential to improve clinical outcomes in the transhumeral amputee population. Initial endoprosthesis stability is paramount for long-term osseointegration and safe clinical introduction of this technology. We evaluated an endoprosthetic design featuring a distally porous coated titanium stem with proximal slots for placement of bicortical interlocking screws.<h4>Methods</h4>Yield load, ult ...[more]

PMID: 31862604

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Project description:Percutaneous osseointegrated (OI) implants are increasingly viable as an alternative to socket suspension of prosthetic limbs. Upper extremity prostheses have also become more complex to better replicate hand and arm function and attempt to recreate pre-amputation functional levels. With more functionality comes heavier devices that put more stress on the bone-implant interface, which could be an issue for implant stability. This study quantified transhumeral loading at defined amputation levels using four simulated prosthetic limb-types: (1) body powered hook, (2) myoelectric hook, (3) myoelectric hand, and (4) advanced prosthetic limb. Computational models were constructed to replicate the weight distribution of each prosthesis type, then applied to motion capture data collected during Advanced Activities of Daily Living (AADLs). For activities that did not include a handheld weight, the body powered prosthesis bending moments were 13-33% (range of means for each activity across amputation levels) of the intact arm moments (reference 100%), torsional moments were 12-15%, and axial pullout forces were 30-40% of the intact case (p≤0.001). The myoelectric hook and hand bending moments were 60-99%, torsional moments were 44-97%, and axial pullout forces were 62-101% of the intact case. The advanced prosthesis bending moments were 177-201%, torsional moments were 164-326%, and axial pullout forces were 133-185% of the intact case (p≤0.001). The addition of a handheld weight for briefcase carry and jug lift activities reduced the overall impact of the prosthetic model itself, where the body powered forces and moments were much closer to those of the intact model, and more complex prostheses further increased forces and moments beyond the intact arm levels. These results reveal a ranked order in loading magnitude according to complexity of the prosthetic device, and highlight the importance of considering the patient's desired terminal device when planning post-operative percutaneous OI rehabilitation and training.

Project description:BackgroundPercutaneous osseointegrated (OI) docking of prosthetic limbs returns loading directly to the residual bone of individuals with amputations. Lower limb diaphyseal biomechanics have not been studied during the wide range of daily activities performed by individuals with lower extremity amputations; therefore, little is known about the loads experienced at the bone-endoprosthetic interface of a percutaneous OI device.Research questionDoes residual limb length and/or gender influence loading magnitudes in the diaphysis of the femur or tibia during daily activities?MethodsThis observational study used motion capture data from 40 non-amputee volunteers performing nine activities ranging from low to high demand, to virtually simulate residual limbs of amputees. To simulate diaphyseal bone loading in individuals with lower limb amputations, virtual joints were defined during post-processing at 25, 50, and 75 % of residual limb length of both the femur and the tibia, representing six clinically relevant residual limb lengths for OI device placement. Peak axial distractive and compressive forces, torsional moments, and bending moments were calculated for each activity. Comparisons were made between genders and between different levels of the simulated residual limb.ResultsFor simulated above and below knee amputations, short residual limbs showed the highest average bending, torsion, and axial distractive loads, while axial compressive loads were highest for long residual limbs. Absolute maxima for all subjects showed this same trend, except in below knee torsion, where 75 % residual tibia length showed the maximum. The highest demand activities yielding peaks in all directions were cutting with right leg planted, jump, run, and fall.SignificanceOverall, individuals with shorter residual limbs experienced higher diaphyseal forces. This should be taken into consideration during surgical implantation of percutaneous OI devices where residual limb length can potentially be shortened, and during rehabilitation of percutaneous OI patients.

Project description:IntroductionLower extremity amputation uniformly impairs a person's vocational, social and recreational capacity. Rehabilitation in traditional socket prostheses (TSP) is associated with a spectrum of complications involving the socket-residuum interface which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel concept to overcome these complications by eliminating this interface and anchoring the prosthesis directly to bone. Though the complications of TSPs affect both transfemoral and transtibial amputees, Osseointegration has been predominantly performed in transfemoral ones assuming a greater benefit/risk ratio. However, as the safety of the procedure has been established, we intend to extend the concept to transtibial amputees and document the outcomes.Methods and analysisThis is protocol for a prospective cohort study, with patient enrolment started in 2014 and expected to be completed by 2022. The inclusion criteria are age over 18 years, unilateral, bilateral and mixed transtibial amputation and experiencing socket-related problems. All patients receive osseointegrated implants, the type of which depend on the length of the residuum and quality of bone, which are press-fitted into the residual bone. Objective functional outcomes comprising 6-Minute Walk Test, Timed Up-and-Go test and K-level, subjective patient-reported-quality-of-life outcomes (Short Form Health Survey 36, daily prosthetic wear hours, prosthetic wear satisfaction) and adverse events are recorded preoperatively and at postoperative follow-up intervals of 3, 6, 12 months and yearly, and compared with the preoperative values using appropriate statistical tests. Multivariable multilevel logistic regression will be performed with a focus to identify factors associated with outcomes and adverse events, specifically infection, periprosthetic fracture, implant fracture and aseptic loosening.Ethics and disseminationThe Ethics approval for the study has been received from the University of Notre Dame, Sydney, Australia (014153S). The outcomes of this study will be disseminated by publications in peer-reviewed academic journals and scientific presentations at relevant orthopaedic conferences.

Project description:BackgroundA bone-anchored prosthesis (BAP) eliminates the need for a conventional socket by attaching a prosthesis directly to the user's skeleton. Currently, limited research addresses changes in gait mechanics post BAP implantation.ObjectiveExamine changes in frontal plane movement patterns after BAP implantation.MethodsParticipants were individuals with unilateral transfemoral amputation (TFA) enrolled in the US Food and Drug Administration (FDA) Early Feasibility Study examining the Percutaneous Osseointegrated Prosthesis (POP). The participants completed overground gait assessments using their conventional socket and at 6-weeks, 12-weeks, 6-months, and 12-months following POP implantation. Statistical parameter mapping techniques were used in examining changes in frontal plane kinematics over the 12-months and differences with reference values for individuals without limb loss.ResultsStatistically significant deviations were found pre-implantation compared to reference values for hip and trunk angles during prosthetic limb stance phase, and for pelvis and trunk relative to the pelvis angles during prosthetic limb swing. At 6-weeks post-implantation, only the trunk angle demonstrated a statistically significant reduction in the percent of gait cycle with deviations relative to reference values. At 12-months post-implantation, results revealed frontal plane movements were no longer statistically different across the gait cycle for the trunk angle compared to reference values, and less of the gait cycle was statistically different compared to reference values for all other frontal plane patterns analyzed. No statistically significant within-participant differences were found for frontal plane movement patterns between pre-implantation and 6-weeks or 12-months post-implantation.ConclusionsDeviations from reference values displayed prior to device implantation were reduced or eliminated 12-months post-implantation in all frontal plane patterns analyzed, while within-participant changes over the 12-month period did not reach statistical significance. Overall, the results suggest the transition to a BAP aided in normalizing gait patterns in a sample of relatively high functioning individuals with TFA.

Dataset Information

Initial stability of a percutaneous osseointegrated endoprosthesis with proximal interlocking screws for transhumeral amputees.

Publications

Initial stability of a percutaneous osseointegrated endoprosthesis with proximal interlocking screws for transhumeral amputees.

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