Socket Prosthesis Research Articles

Biomechanical characteristics of transfemoral bone-anchored prostheses during gait: A review of literature.

Osseointegration (OI) is an emerging technique that allows a direct connection between the bone and a titanium metal implant, allowing the direct attachment of bone-anchored prostheses (BAP) to address the problems associated with socket prostheses. This review article aims to compare the biomechanical features of gait when using a transfemoral BAP in comparison to healthy gait, and in comparison to the gait of traditional transfemoral socket prosthesis users. A computer-based literature search of electronic databases since inception (ranging from 1967 to 2004 depending on the database) to June 14, 2022, identified peer-reviewed articles focusing on the temporal-spatial, kinematic, kinetic, and electromyography data related to transfemoral BAP gait. Eight articles were included that focused on these biomechanical features of gait in adults with BAP and were compared with socket prosthesis users or healthy gait. Compared with healthy participants, prosthesis users after OI surgery have slower speed and cadence, lower symmetry, longer duration of swing phase, increased pelvic and trunk motion, more hip extension, larger moments on the intact limb, and lower forces on the prosthetic side. Compared with transfemoral socket prosthesis gait, BAP gait shows faster cadence and longer duration of support phase. There are limited and inconsistent data on changes in trunk, pelvic, and hip motion with OI. Based on this review, transfemoral BAP improve spatial-temporal parameters closer to normal gait when compared to socket gait, but there are persisting deficits compared with healthy gait. Additional studies are needed to confirm the changes in kinematics and kinetics when walking with a BAP.

Approach for Non-Intrusive Detection of the Fit of Orthopaedic Devices Based on Vibrational Data.

The soft tissues of residual limb amputees are subject to large volume fluctuations over the course of a day. Volume fluctuations in residual limbs can lead to local pressure marks, causing discomfort, pain and rejection of prostheses. Existing methods for measuring interface stress encounter several limitations. A major problem is that the measurement instrumentation is applied in the sensitive interface between the prosthesis and residual limb. This paper presents the principle investigation of a non-intrusive technique to evaluate the fit of orthopaedic prosthesis sockets in transfemoral amputees based on experimentally obtained vibrational data. The proposed approach is based on changes in the dynamical behaviour detectable at the outer surface of prostheses; thus, the described interface is not affected. Based on the experimental investigations shown and the derived results, it can be concluded that structural dynamic measurements are a promising non-intrusive technique to evaluate the fit of orthopaedic prosthesis sockets in transfemoral amputee patients. The obtained resonance frequency changes of 2% are a good indicator of successful applicabilityas these changes can be detected without the need for complex measurement devices.

Enhancing the quasi-static strength of prosthetic socket made from composite laminates via hybridisation: Experimental and numerical study

This study aims to develop composite laminates for the manufacture of prosthesis socket with enhanced mechanical performance. Layered hybridisation of fabrics (i.e. glass, carbon, and Kevlar fabrics) is used to manufacture hybrid composite laminates by resin infusion via vacuum bagging method. The response of these materials to compression loading is investigated by using compression-loading testes and the load-bearing ability was examined by tensile strength tests. Moreover, finite element analysis has been carried out by using the Abaqus software to predict the compressive failure load and damage failure modes for all sockets samples. Experimental results revealed that the hybrid laminates exhibited more stability and higher absorbing energy compared to non-hybrid laminates during compressive loading tests. Furthermore, the hybridisation of fabrics layers can play key role for improving the tensile strength properties of hybrid composite laminates compared to composite laminates without hybridisation. The numerical simulation results of compressive failure load and damage failure modes are in accordance with experimental results qualitatively as well as quantitatively.

Prospective evaluation of canine partial limb amputation with socket prostheses.

Canine prostheses have been commercially available for many years but are still in early stages of research, development, and clinical application. To prospectively investigate mid-term clinical outcomes of partial limb amputation with a socket prosthesis (PLASP) in canine patients via a descriptive prospective clinical case series and to describe a clinical protocol for PLASP. Client-owned dogs (n = 12) with distal limb pathology for which total limb amputation was recommended were enrolled. Partial limb amputation was performed and a socket prosthesis was moulded and fitted to the limb. Complications, clinical follow-up, and objective gait analysis (OGA) were recorded for at least 6 months. An online survey was completed by owners after study completion. Ten dogs with thoracic limb pathology and two with pelvic limb pathology were included. The most common site of amputation was mid-radius (n = 5). Eleven of 12 dogs demonstrated quadrupedal gait on OGA with mean per cent body weight distribution (%BWD) of 26% on thoracic limb prostheses and a %BWD of 16% for the one pelvic limb prosthesis that OGA data were available for. Complications included prosthesis suspension difficulties (n = 5), pressure sores (4), bursitis (4), postoperative infection (3), prosthesis aversion (2), dermatitis (1), and owner noncompliance (1). Two owners elected to discontinue prosthesis use. PLASP allowed restoration of quadrupedal gait patterns in most patients. Owners reported overall positive satisfaction, though a high complication rate was observed. PLASP should be considered in select cases as an alternative to total limb amputation for dogs with distal limb pathology.

MEDIUM-TERM OUTCOMES OF TRANSTIBIAL OSSEOINTEGRATION IN ASSOCIATION WITH TOTAL KNEE ARTHROPLASTY

IntroductionTranstibial osseointegration (TFOI) for amputees has limited but clear literature identifying superior quality of life and mobility versus a socketed prosthesis. Some amputees have knee arthritis that would be relieved by a total knee replacement (TKR). No other group has reported performing a TKR in association with TTOI (TKR+TTOI). We report the outcomes of nine patients who had TKR+TTOI, followed for an average 6.5 years.Materials & MethodsOur osseointegration registry was retrospectively reviewed to identify all patients who had TTOI and who also had TKR, performed at least two years prior. Four patients had TKR first the TTOI, four patients had simultaneous TKR+TTOI, and one patient had 1 OI first then TKR. All constructs were in continuity from hinged TKR to the prosthetic limb. Outcomes were: complications prompting surgical intervention, and changes in daily prosthesis wear hours, Questionnaire for Persons with a Transfemoral Amputation (QTFA), and Short Form 36 (SF36). All patients had clinical follow-up, but two patients did not have complete survey and mobility tests at both time periods.ResultsSix (67%) were male, average age 51.2±14.7 years. All primary amputations were performed to manage traumatic injury or its sequelae. No patients died. Five patients (56%) developed infection leading to eventual transfemoral amputation 36.0±15.3 months later, and 1 patient had a single debridement six years after TTOI with no additional surgery in the subsequent two years. All patients who had transfemoral amputation elected for and received transfemoral osseointegration, and no infections occurred, although one patient sustained a periprosthetic fracture which was managed with internal fixation and implant retention and walks independently. The proportion of patients who wore their prosthesis at least 8 hours daily was 5/9=56%, versus 7/9=78% (p=.620). Even after proximal level amputation, the QTFA scores improved versus prior to TKR+TTOI, although not significantly: Global (45.2±20.3 vs 66.7±27.6, p=.179), Problem (39.8±19.8 vs 21.5±16.8, p=.205), Mobility (54.8±28.1 vs 67.7±25.0, p=.356). SF36 changes were also non-significant: Mental (58.6±7.0 vs 46.1±11.0, p=.068), Physical (34.3±6.1 vs 35.2±13.7, p=.904).ConclusionsTKR+TTOI presents a high risk for eventual infection prompting subsequent transfemoral amputation. Although none of these patients died, in general, TKR infection can lead to patient mortality. Given the exceptional benefit to preserving the knee joint to preserve amputee mobility and quality of life, it would be devastating to flatly force transtibial amputees with severe degenerative knee joint pain and unable to use a socket prosthesis to choose between TTOI but a painful knee, or preemptive transfemoral amputation for transfemoral osseointegration. Therefore, TTOI for patients who also request TKR must be considered cautiously. Given that this frequency of infection does not occur in patients who have total hip replacement in association with transfemoral osseointegration, the underlying issue may not be that linked joint replacement with osseointegrated limb replacement is incompatible, but may require further consideration of biological barriers to ascending infection and/or significant changes to implant design, surgical technique, or other yet-uncertain factors.

OSSEOINTEGRATION OUTCOMES FOLLOWING AMPUTEE LENGTHENING

IntroductionPercutaneous EndoProsthetic Osseointegration for Limbs (PEPOL) facilitates improved quality of life (QOL) and objective mobility for most amputees discontent with their traditional socket prosthesis (TSP) experience. Some amputees desiring PEPOL have residual bone much shorter than the currently marketed press-fit implant lengths of 14–16 cm, potentially a risk for failure to integrate. We report on the techniques used, complications experienced, the management of those complications, and the overall mobility outcomes of seven patients who had femur distraction osteogenesis (DO) with a Freedom nail followed by PEPOL.Materials & MethodsRetrospective evaluation of a prospectively maintained database identified nine patients (5 females) who had transfemoral DO in preparation for PEPOL with two years of follow-up after PEPOL. Six patients had traumatic causes of amputation, one had perinatal complications, one was performed to manage necrotizing fasciitis and one was performed as a result of osteosarcoma.ResultsThe average age at which DO commenced was 39.4±15.9 years, and seven patients had their amputation more than ten years prior (average 25.5±18.8 years). The residual femurs on average started at 102.2±39.7 mm and were lengthened 58.1±20.7 mm, 98±45% of goal (99±161% of the original bone length). Five patients (56%) had a complication requiring additional surgery: four events of inadequate regenerate were managed with continued lengthening to desired goal followed by autograft placement harvested from contralateral femur reaming; one patient had the cerclage wires break which required operative replacement. All patients had osseointegration performed, at 355±123 days after the initial lengthening nail surgery. One patient had K-level >2 before DO, at a mean of 3.4±0.6 (2.6–4.4) years following osseointegration six patients had K-level >2. The 6 Minute Walk Test remained unchanged (267±56 vs 308 ± 117 meters). Patient self-rating of prosthesis function, problems, and amputee situation did not significantly change from before DO to after osseointegration. Six patients required additional surgery following osseointegration: six to remove fixation plates placed to maintain distraction osteogenesis length at osseointegration; two required irritation and debridement for infection.ConclusionsExtremely short residual femurs which make TSP use troublesome can be lengthening with externally controlled telescoping nails, and successfully achieve osseointegration. However, it is imperative to counsel patients that additional surgery to address inadequate regenerate or to remove painful hardware used to maintain fixation may be necessary. This may improve the amputee's expectations before beginning on a potentially arduous process.

Experimental, Theoretical, and Numerical Analysis of Laminated Composite Prosthetic Socket Reinforced with Flax and Cotton Fibers

A lot of work has been done to enhance the mechanical properties of natural fiber composites to increase their strength and applicability. This research aims to investigate the utilization of natural fibers for below-knee prosthesis socket manufacture using the vacuum bagging technique experimentally, theoretically, and numerically. Lamination groups of different layering arrangements were evaluated by tensile tests. The finite element methodology (FEM) was utilized by noting the dispersion of safety factors, equivalent Von-Mises stress, and total deformation, while the theoretical part estimated Poisson's ratio, volume fraction, failure index, and theoretical safety factor. The study found that the number and type of fibers affected mechanical properties, in addition, that combining natural and artificial reinforcements permits the creation of high-performance bio-composites. FEM results coincided with both the theoretical and experimental results, with lamination 9 having the highest modulus of elasticity (5.6 GPa) and tensile strength (423 MPa). This work uncovered the properties of the proposed hybrid fiber-reinforced composites that haven't been exasperated up to the present and showed that sockets can be assembled from sustainable, low-risk materials without sacrificing the composite materials' strength. The study found that bio-composites with better performance could be created by combining synthetic with natural reinforcements.

Tensile Strength of Coconut Coir Fiber Composite as an Alternative Material to Replace Fiberglass in Hard Socket

Physically disabled is someone who has a movement system disorder or has physical abnormalities such as amputation, withering, stiffness, and others. The self-confidence of someone who has an amputee can be improved by having a prosthesis made, because it can replace the anatomical and functional functions of the body. The socket on the prosthesis is the most important component, because the use of the socket on the prosthesis is directly related to the patient's stump. One of the materials for making socket prosthesis is fiberglass. However, the use of fiberglass has a negative effect, namely it produces gas and dust emissions that can irritate stumps, is not a local product, and is difficult to recycle. Alternative fiber materials are using fibers from nature, coco fiber is an option as an alternative to fiberglass. The tensile strength test is the most basic test. The tensile strength test was carried out to determine the stress, strain, and elastic modulus of the fibrous polymer composites. The purpose of this study was to analyze and compare the tensile strength between fiberglass and coconut coir fiber, so as to find out which fiber material is suitable as an alternative to fiberglass in the manufacture of socket prosthesis. Using experimental quantitative methods. The composite material uses coconut coir fiber which was previously treated with 5% NaOH for 1 hour and then dried for 2-3 days. In the fabrication process using the vacuum bag method. Standard specimen refers to ASTM D3039/3039M. Tensile testing showed that the average tensile strength value of the coco fiber composite was 16.2 MPa and the average tensile strength value of the fiberglass composite was 30.2 MPa. This means that the value of the tensile strength of coco fiber is still below fiberglass and cannot be used as a substitute for fiberglass. However, coconut coir fiber can be used as an alternative to fiberglass, judging from the average maximum force that the coco fiber composite can withstand, which is 2630 N or equivalent to a load of 263 kg, this value is sufficient for the average adult weight in Indonesia with an average weight of 60 kg body

Bone density changes after five or more years of unilateral lower extremity osseointegration: Observational cohort study

ContextRehabilitation following lower extremity amputation presents multiple challenges, many related to the traditional prosthesis (TP) socket. Without skeletal loading, bone density also rapidly decreases. Transcutaneous osseointegration for amputees (TOFA) surgically implants a metal prosthesis attachment directly into the residual bone, facilitating direct skeletal loading. Quality of life and mobility are consistently reported to be significantly superior with TOFA than TP. ObjectiveTo investigate how femoral neck bone mineral density (BMD, g/cm2) changes for unilateral transfemoral and transtibial amputees at least five years following single-stage press-fit osseointegration. MethodsRegistry review was performed of five transfemoral and four transtibial unilateral amputees who had dual x-ray absorptiometry (DXA) performed preoperatively and after at least five years. The average BMD was compared using Student's t-test (significance p < .05). First, all nine Amputated versus Intact limbs. Second, the five patients with local disuse osteoporosis (ipsilateral femoral neck T-score < −2.5) versus the four whose T-score was greater than −2.5. ResultsThe average Amputated Limb BMD was significantly less than the Intact Limb, both Before Osseointegration (0.658 ± 0.150 vs 0.929 ± 0.089, p < .001) and After Osseointegration (0.720 ± 0.096 vs 0.853 ± 0.116, p = .018). The Intact Limb BMD decreased significantly during the study period (0.929 ± 0.089 to 0.853 ± 0.116, p = .020), while the Amputated Limb BMD increased a not statistically significant amount (0.658 ± 0.150 to 0.720 ± 0.096, p = .347). By coincidence, all transfemoral amputees had local disuse osteoporosis (BMD 0.545 ± 0.066), and all transtibial patients did not (BMD 0.800 ± 0.081, p = .003). The local disuse osteoporosis cohort eventually had a greater average BMD (not statistically significant) than the cohort without local disuse osteoporosis (0.739 ± 0.100 vs 0.697 ± 0.101, p = .556). ConclusionsSingle-stage press-fit TOFA may facilitate significant BMD improvement to unilateral lower extremity amputees with local disuse osteoporosis.

Daily steps and stepping cadence increase one-year following prosthesis osseointegration in people with lower-limb amputation

Purpose People with lower-limb loss participate in less physical activity than able-bodied individuals, which increases the mortality risk and incidence of metabolic syndromes. This study evaluated the effect of lower-limb prosthesis osseointegration on physical activity, including daily steps and stepping cadence. Methods Free-living walking activity was assessed from 14 patients scheduled to undergo prosthesis osseointegration at two time points (within 2 weeks prior to osseointegration surgery and 12-months following). Daily step count, stepping time, number of walking bouts, average step cadence per bout, maximum step cadence per bout, and time spent in bands of step cadence were compared before and after osseointegration. Results Twelve months after prosthesis osseointegration, participants increased daily steps, daily stepping time, average step cadence, and maximum cadence per walking bout compared to pre-osseointegration. Conclusions Participants engaged in more daily steps, higher stepping cadence, and longer bouts at higher cadence one year following osseointegration compared to when using a socket prosthesis. As a novel intervention that is becoming more common, it is important to understand walking activity outcomes as these are critical for long-term health.

Numerical Analysis of a Transtibial Prosthesis Socket Using 3D-Printed Bio-Based PLA

Lower-limb prosthesis design and manufacturing still rely mostly on the workshop process of trial-and-error using expensive unrecyclable composite materials, resulting in time-consuming, material-wasting, and, ultimately, expensive prostheses. Therefore, we investigated the possibility of utilizing Fused Deposition Modeling 3D-printing technology with inexpensive bio-based and bio-degradable Polylactic Acid (PLA) material for prosthesis socket development and manufacturing. The safety and stability of the proposed 3D-printed PLA socket were analyzed using a recently developed generic transtibial numeric model, with boundary conditions of donning and newly developed realistic gait cycle phases of a heel strike and forefoot loading according to ISO 10328. The material properties of the 3D-printed PLA were determined using uniaxial tensile and compression tests on transverse and longitudinal samples. Numerical simulations with all boundary conditions were performed for the 3D-printed PLA and traditional polystyrene check and definitive composite socket. The results showed that the 3D-printed PLA socket withstands the occurring von-Mises stresses of 5.4 MPa and 10.8 MPa under heel strike and push-off gait conditions, respectively. Furthermore, the maximum deformations observed in the 3D-printed PLA socket of 0.74 mm and 2.66 mm were similar to the check socket deformations of 0.67 mm and 2.52 mm during heel strike and push-off, respectively, hence providing the same stability for the amputees. We have shown that an inexpensive, bio-based, and bio-degradable PLA material can be considered for manufacturing the lower-limb prosthesis, resulting in an environmentally friendly and inexpensive solution.

Development of a Hip Joint Socket by Finite-Element-Based Analysis for Mechanical Assessment.

This article evaluates a hip joint socket design by finite element method (FEM). The study was based on the needs and characteristics of a patient with an oncological amputation; however, the solution and the presented method may be generalized for patients with similar conditions. The research aimed to solve a generalized problem, taking a typical case from the study area as a reference. Data were collected on the use of the current improving prosthesis-specifically in interaction with its socket-to obtain information on the new approach design: this step constituted the work's starting point, where the problems to be solved in conventional designs were revealed. Currently, the development of this type of support does not consider the functionality and comfort of the patient. Research has reported that 58% of patients with sockets have rejected their use, because they do not fit comfortably and functionally; therefore, patients' low acceptance or rejection of the use of the prosthesis socket has been documented. In this study, different designs were evaluated, based on the FEM as scientific support for the results obtained, for the development of a new ergonomic fit with a 60% increase in patient compliance, that had correct gait performance when correcting postures, improved fit-user interaction, and that presented an esthetic fit that met the usability factor. The validation of the results was carried out through the physical construction of the prototype. The research showed how the finite element method improved the design, analyzing the structural behavioral, and that it could reduce cost and time instead of generating several prototypes.

Surface profile analysis of laminated transfemoral prosthetic socket fabricated with different ratios of epoxy resin and acrylic resin

Acrylic and epoxy are common types of resin used in fabricating sockets. Different types of resin will affect the internal surface of a laminated socket. This paper is to determine the best combination of ratio for epoxy and acrylic resin for a laminated prosthesis socket and to evaluate the surface profile analysis of different combinations of laminated prosthetic sockets for surface roughness. Transfemoral sockets were created using various resin-to-hardener ratios of 2:1, 3:1, 3:2, 2:3, and 1:3 for epoxy resin and 100:1, 100:2, 100:3, 100:4, and 100:5 for acrylic resin. Eight layers of stockinette consisting of four elastic stockinette and four Perlon stockinette were used. A sample with a size of 4 cm × 6 cm was cut out from the socket on the lateral side below the Greater Trochanter area. The Mitutoyo Sj-210 Surface Tester stylus was run through the sample and gave the Average Surface Roughness value (Ra), Root Mean Square Roughness value (Rq), and Ten-Point Mean Roughness value (Rz). Epoxy resin shows a smoother surface compared to acrylic resin with Ra values of is 0.766 µm, 0.9716 µm, 0.9847 µm and 1.5461 µm with 3:2, 3:1, 2:1 and 2:3 ratio respectively. However, for epoxy resin with ratio 1:3, the resin does not cure with the hardener. As for acrylic resin the Ra values are 1.0086 µm, 2.362 µm, 3.372 µm, 4.762 µm and 6.074 µm with 100: 1, 100:2, 100:5, 100:4 and 100:3 ratios, respectively. Epoxy resin is a better choice in fabricating a laminated socket considering the surface produced is smoother.

OSSEOINTEGRATION OUTCOMES FOLLOWING AMPUTEE LENGTHENING

Percutaneous EndoProsthetic Osseointegration for Limbs (PEPOL) facilitates improved quality of life (QOL) and objective mobility for most amputee's discontent with their traditional socket prosthesis (TSP) experience. Some amputees desiring PEPOL have residual bone much shorter than the currently marketed press-fit implant lengths of 14-16 cm, potentially a risk for failure to integrate. We report on the techniques used, complications experienced, the management of those complications, and the overall mobility outcomes of seven patients who had femur distraction osteogenesis (DO) with a Freedom nail followed by PEPOL.Retrospective evaluation of a prospectively maintained database identified nine patients (5 females) who had transfemoral DO in preparation for PEPOL with two years of follow-up after PEPOL. Six patients had traumatic causes of amputation, one had perinatal complications, one was performed to manage necrotizing fasciitis and one was performed as a result of osteosarcoma.The residual femurs on average started at 102.2±39.7 mm and were lengthened 58.1±20.7 mm, 98±45% of goal (99±161% of the original bone length). Five patients (56%) had a complication requiring additional surgery. At a mean of 3.4±0.6 (2.6-4.4) years following osseointegration six patients had K-level &gt;2. The 6 Minute Walk Test remained unchanged (267±56 vs 308 ± 117 meters). Patient self-rating of prosthesis function, problems, and amputee situation did not significantly change from before DO to after osseointegration. Six patients required additional surgery following osseointegration: six to remove fixation plates placed to maintain distraction osteogenesis length at osseointegration; two required irritation and debridement for infection.Extremely short residual femurs which make TSP use troublesome can be lengthening with externally controlled telescoping nails, and successfully achieve osseointegration. However, it is imperative to counsel patients that additional surgery to address inadequate regenerate or to remove painful hardware used to maintain fixation may be necessary. This may improve the amputee's expectations before beginning on a potentially arduous process.

TRANSCUTANEOUS OSSEOINTEGRATION RECONSTRUCTION FOR WHEELCHAIR-BOUND TRANSFEMORAL AMPUTEES (K0 LEVEL)

Traditional socket prosthesis (TSP) rehabilitation for amputees is associated with substantial dissatisfaction due to poor mobility and pain from soft tissue squeezing. Osseointegration (OI), eliminates skin compression and prosthesis fit issues, providing superior mobility and quality of life (QOL) for most amputees. The potential for OI to benefit patients with exceptionally poor mobility is understudied. To address this knowledge gap, this project investigated the mobility and QOL changes.A retrospective review was performed to identify transfemoral amputees who presented with wheelchair-bound mobility (K0) and had at least five years of post-osseointegration follow-up. Outcome measures included changes in mobility (K-level, daily prosthesis wear hours, Timed Up and Go (TUG), 6 minute walk test (6MWT)) and QOL (Questionnaire for persons with a Transfemoral Amputation (QTFA); Short Form Health Survey 36 (SF36). Adverse events recorded included debridement for infection, implant revision surgery, fractures, and implant failures.9 patients with mean age 48.2±7.7 (range 34-59) years were included. The proportion of patients achieving K-level &gt;2 improved from 0/9=0% to [9/9=100%], p&lt;0.001. The 6MWT improved from 0±0 to 320.65±57 meters (p&lt;0.001). The TUG improved from incapable to 10.68±2.7 seconds (p&lt;0.001). Statistically significant QOL metrics included QTFA global score (33.33±31 vs 68.52±21, p=0.039), SF36 physical component score (30.03±6.3 vs 42.34±12, p=0.023) and the SF36 mental component score (47.89±8.8 vs 51.95±10.4, p=0.332). Six patients required operative intervention to address complications. Five developed infections: three had debridement, and 2 required implant removal and reimplantation.Osseointegration does confer significant sustained mobility and quality of life improvement for wheelchair bound transfemoral amputees. All 9 K0 patients had statistically improved mobility and QOL after osseointegrated reconstruction. This supports osseointegration as an effective rapid and long-term rehabilitation alternative for patients who have the neurologic and muscular capacity to walk but are unable due to issues related to their TSP.

Comparison of prosthetic mobility and balance in transfemoral amputees with bone-anchored prosthesis vs. socket prosthesis.

The literature comparing bone-anchored prosthesis (BAP) with socket prosthesis (SP) consistently reports improvement in physical health and quality of life using primarily patient-reported outcome measures (PROMs). To determine the differences in mobility and balance using performance-based outcome measures and PROMs in people with transfemoral amputations (TFAs) fitted with BAP vs. SP. Causal comparative. Two groups of people with TFAs were recruited: one using a BAP (N = 11; mean age ± standard deviation, 44 ± 14.9 years; mean residual limb length as a percentage of the intact femur, 68% ± 15.9) and another group using a SP (N = 11; mean age ± standard deviation, 49.6 ± 16.0 years; mean residual limb length as a percentage of the intact femur, 81% ± 13.9), and completed the 10-meter walk test, component timed-up-and-go, Prosthetic Limb Users Survey of Mobility™ 12-item, and Activities-specific Balance Confidence Scale. There were no statistically significant differences between the BAP and SP groups in temporal spatial gait parameters and prosthetic mobility as measured by the 10-meter walk test and component timed-up-and-go, yet large effect sizes were found for several variables. In addition, Activities-specific Balance Confidence Scale and Prosthetic Limb Users Survey of Mobility™ scores were not statistically different between the BAP and SP groups, yet a large effect sizes were found for both variables. This study found that people with TFA who use a BAP can demonstrate similar temporal spatial gait parameters and prosthetic mobility, as well as self-perceived balance confidence and prosthetic mobility as SP users. Therefore, suggesting that the osseointegration reconstruction surgical procedure provides an alternative option for a specific population with TFA who cannot wear nor have limitations with a SP. Future research with a larger sample and other performance-based outcome measures and PROMs of prosthetic mobility and balance would further determine the differences between the prosthetic options.

Improvements in disability and function in people with lower-limb amputation one year after prosthesis osseointegration.

People with lower-limb amputation (LLA) are routinely prescribed a socket prosthesis; however, many socket prosthesis users experience severe complications with the fit of their prosthesis including residual limb wounds and pain. Osseointegration is a procedure that creates a direct connection between the bone and prosthetic limb through a bone-anchored prosthesis, eliminating the need for a socket interface. It is offered as a secondary procedure to people with LLA who experience significant complications with socket prostheses. To evaluate change in disability and function 1 year postosseointegration compared with preosseointegration in people with LLA. Single group, pretest, and post-test. Twelve participants (9 transfemoral and 3 transtibial amputations, age: 44 ± 10 years, 7 female participants, 14 ± 12 years since amputation) with unilateral LLA underwent osseointegration with press-fit implants. Disability was measured with the World Health Organization Disability Assessment Schedule 2.0, and function was measured with both Prosthetic Limb Users Mobility Survey and the Activities-Specific Balance Confidence Scale. Questionnaires were administered preosseointegration and 1 year postosseointegration. Paired t tests assessed change in outcomes between time points. Postosseointegration, participants demonstrated reduced disability measured with World Health Organization Disability Assessment Schedule 2.0 (%Δ = -52.6, p = 0.01), improved mobility measured with Prosthetic Limb Users Mobility Survey (%Δ = 21.8, P < 0.01), and improved balance confidence measured with the Activities-Specific Balance Confidence Scale (%Δ = 28.4, P < 0.01). Participants report less disability and greater function in their prosthesis postosseointegration. Osseointegration is a novel procedure for people experiencing complications with their socket prosthesis, and this study is the first to show improvements in disability postosseointegration.

Osseointegrated prostheses improve balance and balance confidence in individuals with unilateral transfemoral limb loss

BackgroundMore than half of patients with lower-limb amputation who use socket prostheses experience at least one fall annually. These falls are primarily attributed to reduced proprioception which negatively affects balance. A promising alternative to socket prostheses are osseointegrated prostheses that involve direct fixation of the prosthetic limb to the residual limb through a bone-anchored implant, yet its effect on balance remains unknown. Research questionDo osseointegrated prostheses change static and dynamic balance, as well as patient reported measures of balance confidence, compared to a socket prosthesis? MethodsA sample of 10 patients with unilateral transfemoral amputation scheduled to undergo prosthesis osseointegration were enrolled (6 F/4 M, BMI: 26.7 ± 2.9 kg/m2, Age: 46.1 ± 6.3 years). Motion capture data during quiet standing (eyes opened and eyes closed) and overground walking at a self-selected speed, and the Activities-Specific Balance Confidence (ABC) scale, were collected before (with socket prosthesis) and 12-months following osseointegration. Postural sway via the center of pressure (COP), variability of spatiotemporal parameters, and ABC scores were compared using a repeated measures design before and after osseointegration. ResultsFollowing prosthesis osseointegration, COP path length and 95 % confidence ellipse area were reduced during quiet standing (d = 0.75, P = 0.09; d = 0.52, P = 0.29, respectively) and the variability of step width and length were reduced during overground walking (d = 0.50, P = 0.06; d = 0.72, P = 0.06, respectively). Furthermore, patients reported significantly improved ABC scores with an osseointegrated prosthesis compared to a socket prosthesis (d = −1.36, P = 0.01). SignificanceImprovements in postural sway, reductions in gait variability, and greater balance confidence indicate that osseointegrated prostheses improve balance for people with unilateral transfemoral amputation.

Rehabilitation system of human micromotor capabilities: concept and design

Nowadays many modern prostheses hand are available on the market today, but they are still far from being able to completely replace the human hand. In addition, there are many factors that limit the ability to fully use the prostheses by individuals with hand disability caused by amputation or nerve damage. This article presents a new concept of hand disability rehabilitation means, which allows precise manipulation of the instrument and, thus, a system to facilitate the reintegration in the labour market. The operation of tool manipulation is divided into initial rough and final fine movement phases. At the initial phase, the prosthesis is freely transferred in the workspace of the user stump. the precise movement of the instrument at the final phase is performed by a micromanipulator built into the prosthesis and resting on a table or other environmental objects. An inverted system is possible, in which the manipulator is installed on the desktop, where then the prosthesis can rest or the targeted object is fixed on it, for example, assembly process. The manipulator is controlled either by the prosthesis socket or by an external device. In the latter case, the user carries out the control actions by various parts of the body or by voice. As an example of a possible implementation of this concept, the design of a prosthesis with an integrated three-degree manipulator carried on adaptive support is described. The support naturally adjusts to the comfortable height and orientation of the tool, then its braked. A computer model of speed-position control of the rehabilitation system is presented.

Association Between Osseointegration of Lower Extremity Amputation and Mortality Among Adults

Transcutaneous osseointegration post amputation (TOPA) creates a direct linkage between residual bone and an external prosthetic limb, providing superior mobility and quality of life compared with a socket prosthesis. The causes and potential risks of mortality after TOPA have not been investigated. To investigate the association between TOPA and mortality and assess the potential risk factors. This observational cohort study included all patients with amputation of a lower extremity who underwent TOPA between November 1, 2010, and October 31, 2021, at a specialty orthopedic practice and tertiary referral hospital in a major urban center. Patients lived on several continents and were followed up as long as 10 years. Transcutaneous osseointegration post amputation, consisting of a permanent intramedullary implant passed transcutaneously through a stoma and connected to an external prosthetic limb. Death due to any cause. The hypotheses tested-that patient variables (sex, age, level of amputation, postosseointegration infection, and amputation etiology) may be associated with subsequent mortality-were formulated after initial data collection identifying which patients had died. A total of 485 patients were included in the analysis (345 men [71.1%] and 140 women [28.9%]), with a mean (SD) age at osseointegration of 49.1 (14.6) years among living patients or 61.2 (12.4) years among patients who had died. Nineteen patients (3.9%) died a mean (SD) of 2.2 (1.7) years (range, 58 days to 5 years) after osseointegration, including 17 (3.5%) who died of causes unrelated to osseointegration (most commonly cardiac issues) and 2 (0.4%) who died of direct osseointegration-related complications (infectious complications), of which 1 (0.2%) was coclassified as a preexisting health problem exacerbated by osseointegration (myocardial infarction after subsequent surgery to manage infection). No deaths occurred intraoperatively or during inpatient recuperation or acute recovery after index osseointegration (eg, cardiopulmonary events). Kaplan-Meier survival analysis with log-rank comparison and Cox proportional hazards regression modeling identified increased age (hazard ratio, 1.06 [95% CI, 1.02-1.09]) and vascular (odds ratio [OR], 4.73 [95% CI, 1.35-16.56]) or infectious (OR, 3.87 [95% CI, 1.31-11.40]) amputation etiology as risk factors. Notable factors not associated with mortality risk included postosseointegration infection and male sex. These findings suggest that patients who have undergone TOPA rarely die of problems associated with the procedure but instead usually die of unrelated causes.