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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Publications

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: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:BackgroundCommercially available osseointegrated devices for transfemoral amputees are limited in size and thus fail to meet the significant anatomical variability in the femoral medullary canal. This study aimed to develop a customized osseointegrated stem to better accommodate a variety of femoral anatomies in transfemoral amputees than off-the-shelf stems. Customization is expected to enhance cortical bone preservation and increase the stem-bone contact area, which are critical for the long-term stability and success of implants.MethodsA customized stem (OsteoCustom) was designed based on the statistical shape variability of the medullary canal. The implantability of the OsteoCustom stem was tested via 70 computed tomography (CT) images of human femurs and compared to that of a commercial device (OFI-C) for two different resection levels. The evaluations included the volume of cortical bone removed and the percentage of stem-bone contact area for both resection levels. Statistical significance was analyzed using paired and unpaired t tests.ResultsThe OsteoCustom stem could be virtually implanted in all 70 femurs, while the OFI-C was unsuitable in 19 cases due to insufficient cortical thickness after implantation, further emphasizing its adaptability to varying anatomical conditions. The OsteoCustom stem preserved a greater volume of cortical bone than did the OFI-C. In fact, 42% less bone was removed at the proximal resection level (3.15 cm³ vs. 5.42 cm³, p ≤ 0.0001), and 33% less at the distal resection level (2.25 cm³ vs. 3.39 cm³, p = 0.003). The stem-bone contact area was also greater for the OsteoCustom stem, particularly at the distal resection level, showing a 20% increase in contact area (52.3% vs. 32.2%, p = 0.002) compared to that of the OFI-C.ConclusionsThe OsteoCustom stem performed better than the commercial stem by preserving more cortical bone and achieving a greater stem-bone contact area, especially at distal resection levels where the shape of the medullary canal exhibits more inter-subject variability. Optimal fit in the distal region is of paramount importance for ensuring the stability of osseointegrated implants. This study highlights the potential benefits of customized osseointegrated stems in accommodating a broader range of femoral anatomies, with enhanced fit in the medullary canal.

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.

Dataset Information

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

Background

Methods

Findings

Interpretation

Publications

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

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