Osseointegrated reconstruction and rehabilitation of transtibial amputees: the Osseointegration Group of Australia surgical technique and protocol for a prospective cohort study.
ABSTRACT: INTRODUCTION:Lower 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 ANALYSIS:This 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 DISSEMINATION:The 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:Osseointegrated implants are an alternative for prosthetic attachment in individuals with amputation who are unable to wear a socket. However, the load transmitted through the osseointegrated fixation to the residual tibia and knee joint can be unbearable for those with transtibial amputation and knee arthritis. We report on the feasibility of combining total knee replacement (TKR) with an osseointegrated implant for prosthetic attachment.We retrospectively reviewed all 4 cases (aged 38-77 years) of transtibial amputations managed with osseointegration and TKR in 2012-2014. The below-the-knee prosthesis was connected to the tibial base plate of a TKR, enabling the tibial residuum and knee joint to act as weight-sharing structures. A 2-stage procedure involved connecting a standard hinged TKR to custom-made implants and creation of a skin-implant interface. Clinical outcomes were assessed at baseline and after 1-3 years of follow-up using standard measures of health-related quality of life, ambulation, and activity level including the questionnaire for transfemoral amputees (Q-TFA) and the 6-minute walk test.There were no major complications, and there was 1 case of superficial infection. All patients showed improved clinical outcomes, with a Q-TFA improvement range of 29-52 and a 6-minute walk test improvement range of 37-84 meters.It is possible to combine TKR with osseointegrated implants.
Project description:OBJECTIVES:The objectives are to determine neural dynamics during gait using electro-encephalography and source localization, and to investigate the attentional demand during walking in able-bodied individuals, and individuals with an amputation. MATERIALS & METHODS:Six able-bodied individuals conducted one experimental trial, and 6 unilateral transtibial and 6 unilateral transfemoral amputees performed 2 experimental trials; the first with the prosthesis currently used by the subjects and the second with a novel powered transtibial prosthesis, i.e. the Ankle Mimicking Prosthetic foot 4.0. Each experimental trial comprised 2 walking tasks; 6 and 2 minutes treadmill walking at normal speed interspersed by 5 minutes of rest. During 6 minutes walking the Sustained Attention to Response (go-no go) Task, which measures reaction time and accuracy, was performed. Electro-encephalographic data were gathered when subjects walked 2 minutes. Motor-related cortical potentials and brain source activity during gait were examined. Normality and (non-) parametric tests were conducted (p<0.05). RESULTS AND DISCUSSION:In contrast to transtibial amputees, transfemoral amputees required more attentional demands during walking with Ankle Mimicking Prosthetic foot 4.0 compared to the current passive prosthetic device and able-bodied individuals (reaction time and accuracy: p?0.028). Since risk of falling is associated with altered attentional demands, propulsive forces of the novel device need to be better controlled for transfemoral amputees. No motor-related cortical potentials at Cz were observed in transfemoral amputees walking with the novel prosthesis, whereas motor-related cortical potentials between transtibial amputees and able-bodied individuals during walking at normal speed did not differ. The first positive electro-physiological peak deflection appeared during toe-off phase and showed higher activity within the underlying brain sources in transtibial amputees walking with Ankle Mimicking Prosthetic foot 4.0 compared to able-bodied individuals. The required higher neural input to accomplish the same physical activity compared to able-bodied individuals is possibly due to the limited acclimation period to the novel device and consequently increased afferent sensory feedback for postural control.
Project description:<h4>Objectives:</h4>(1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events.<h4>Design:</h4>Prospective cohort study.<h4>Setting:</h4>University medical centre.<h4>Subjects:</h4>A total of 40 consecutive persons (median age: 56?years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016.<h4>Intervention:</h4>Osseointegration implant surgery followed by a predefined rehabilitation programme.<h4>Main measures:</h4>Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6?minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events.<h4>Results:</h4>Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline ( P ? 0.002). The TUG showed no change at 6-month follow-up ( P = 0.420) but improved significantly at 12-month follow-up compared to baseline ( P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT ( P ? 0.038) and back pain ( P ? 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users.<h4>Conclusion:</h4>Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.
Project description: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.
Project description:OBJECTIVE:For individuals with lower-limb loss, functional mobility (ie, K-level) classification can be subjective. Performance-based outcome measures improve the objectivity of K-level assignment; therefore, this study aimed to determine differences in functional strength- and dynamic balance-based outcome measures performance between K3- and K4-classified adults with lower-limb loss. DESIGN:Prosthetists used subjective information and prosthetic componentry to determine K-levels before outcome measures testing for adults with a unilateral transtibial (n = 50) or transfemoral amputation (n = 17). Outcome measures (ie, 5-Times Sit-to-Stand Test, Figure-of-8 Walk Test, 360-degree Turn Test, and modified Four-Square Step Test) were administered by a blinded examiner. Univariate analyses of variance were used to evaluate between-subgroup differences. RESULTS:K4-classified participants with a unilateral transfemoral amputation performed better on all outcome measures when compared with K3-classified peers, whereas K4-classified individuals with a transtibial amputation performed better on the modified Four-Square Step Test compared with K3-classified peers (P < 0.050). CONCLUSIONS:K4-classified individuals demonstrated greater lower-limb functional strength and better dynamic balance compared with K3-classified peers. To assist with K-level classification, clinicians should consider selecting outcome measures that objectively differentiate between K-levels (ie, modified Four-Square Step Test for those with a unilateral transtibial or transfemoral amputation; 5-Times Sit-to-Stand Test, Figure-of-8 Walk Test, and 360-degree Turn Test for those with a transfemoral amputation).
Project description:Knowledge of joint moments will provide greater insight into the manner in which lower-extremity amputees wearing running-specific prostheses regain running capacity and compensate for replacement of an active leg with a passive prosthetic implement. Thus, the purpose of this study was to investigate three-dimensional joint moments during sprinting for unilateral transfemoral amputees wearing running-specific prostheses. Ten sprinters with unilateral transfemoral amputation performed maximal sprinting at the 22 m mark while wearing running-specific prostheses. Joint moments were calculated through an inverse dynamics approach. All peak flexion and extension moments in the prosthetic leg were found to be lower than those of the intact leg, except for the peak plantar flexion moment. In the frontal plane, the peak adduction and abduction moments in the prosthetic leg were generally lower than those of the intact leg. The peak internal rotation moments differed significantly between the legs, but the peak external rotation moments did not. The results of the present study suggest that asymmetric joint moment adaptations occur for unilateral transfemoral amputees to compensate for replacement of the biological leg with a passive prosthetic knee joint and running-specific prosthesis.
Project description:OBJECTIVES:To evaluate the feasibility of the Nintendo WiiFit™ as an adjunct to usual therapy in individuals with a lower limb amputation. METHODS:The study was a Multiple Baseline (AB) Single Subject Research Design. Subjects were ?19 years old, had their first unilateral transtibial or transfemoral amputation ??12 months ago, and were participating in prosthetic training. WiiFit training was provided for 30 min, 5 times a week, for a minimum of 2 and a maximum of 6 weeks in addition to usual therapy. Feasibility indicators were safety, post-intervention fatigue and pain levels, adherence, and subject's acceptability of the program as measured by the Short Feedback Questionnaire-modified (SFQ-M). The primary clinical outcome was walking capacity assessed by the 2 Minute Walk Test (2MWT). The secondary clinical outcomes were the Short Physical Performance Battery, L-test, and Activities-Specific Balance Confidence. RESULTS:Subjects (4 transtibial; 2 transfemoral) had a median age of 48.5 years (range = 45-59 years). No adverse events associated with the intervention occurred. Median pain and fatigue levels were 1.3 (range = 0.5-3.5) and 3.1 (range = 1.4-4.1), respectively. Median adherence was 80%. Subjects found the WiiFit enjoyable and acceptable (median SFQ-M = 35). Five subjects showed statistical improvement on the 2MWT and four on the secondary outcomes (p < 0.05). CONCLUSION:The WiiFit intervention was found to be feasible in individuals with unilateral lower limb amputation. This research provides the foundation for future clinical research investigating the use of the WiiFit as a viable adjunctive therapy to improve outcomes in individuals with unilateral lower limb amputation who are participating in prosthetic training.
Project description:In recent years, numerous prosthetic ankle-foot devices have been developed to address the demands of sloped walking for individuals with lower-limb amputation. The goal of this study was to compare the performance of a passive, hydraulic ankle-foot prosthesis to two related, non-hydraulic ankles based on their ability to minimize the socket reaction moments of individuals with transtibial amputation during a range of sloped walking tasks. After a two-week accommodation period, kinematic data were collected on seven subjects with a transtibial amputation walking on an instrumented treadmill set at various slopes. Overall, this study was unable to find significant differences in the torque at the distal end of the prosthetic socket between an ankle-foot prosthesis with a hydraulic range-of-motion and other related ankle-foot prosthesis designs (rigid ankle, multiaxial ankle) during the single-support phase of walking. In addition, socket comfort and perceived exertion were not significantly different for any of the ankle-foot prostheses tested in this study. These results suggest the need for further work to determine if more advanced designs (e.g., those with microprocessor control of hydraulic features, powered ankle-foot designs) can provide more biomimetic function to prosthesis users.
Project description:BACKGROUND:In our clinic, a substantial number of patients present with transtibial residual limb pain of no specific somatic origin. Silicone liner induced tissue compression may reduce blood flow, possibly causing residual limb pain. Thus, as a first step we investigated if the liner itself has an effect on transcutaneous oxygen pressure (TcPO2). METHODS:Persons with unilateral transtibial amputation and residual limb pain of unknown origin were included. Medical history, including residual limb pain, was recorded, and the SF-36 administered. Resting TcPO2 levels were measured in the supine position and without a liner at 0, 10, 20 and 30 minutes using two sensors: one placed in the Transverse plane over the tip of the Tibia End (= TTE), the other placed in the Sagittal plane, distally over the Peroneal Compartment (= SPC). Measurements were repeated with specially prepared liners avoiding additional pressure due to sensor placement. Statistical analyses were performed using SPSS. RESULTS:Twenty persons (9 women, 11 men) with a mean age of 68.65 years (range 47-86 years) participated. The transtibial amputation occurred on average 43 months prior to study entry (range 3-119 months). With liner wear, both sensors measured TcPO2 levels that were significantly lower than those measured without a liner (TTE: p < 0.001; SPC: p = 0.002) after 10, 20 and 30 minutes. No significant differences were found between TcPO2 levels over time between the sensors. There were no significant associations between TcPO2 levels and pain, smoking status, age, duration of daily liner use, mobility level, and revision history. CONCLUSION:Resting TcPO2 levels decreased significantly while wearing a liner alone, without a prosthetic socket. Further studies are required to investigate the effect of liner wear on exercise TcPO2 levels.
Project description:Management of residual limb volume affects decisions regarding timing of fit of the first prosthesis, when a new prosthetic socket is needed, design of a prosthetic socket, and prescription of accommodation strategies for daily volume fluctuations. This systematic review assesses what is known about measurement and management of residual limb volume change in persons with lower-limb amputation. Publications that met inclusion criteria were grouped into three categories: group I: descriptions of residual limb volume measurement techniques; group II: studies investigating the effect of residual limb volume change on clinical care in people with lower-limb amputation; and group III: studies of residual limb volume management techniques or descriptions of techniques for accommodating or controlling residual limb volume. We found that many techniques for the measurement of residual limb volume have been described but clinical use is limited largely because current techniques lack adequate resolution and in-socket measurement capability. Overall, limited evidence exists regarding the management of residual limb volume, and the evidence available focuses primarily on adults with transtibial amputation in the early postoperative phase. While we can draw some insights from the available research about residual limb volume measurement and management, further research is required.