Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial.

OBJECTIVE: To compare comfort and functional performance of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket with the ischial containment (IC) socket in persons with unilateral transfemoral amputation. DESIGN: Randomized crossover trial with two 7-week periods. SETTING: Private prosthetic clinics and university research laboratory. PARTICIPANTS: A total of 30 enrolled (N=30); 25 participants completed the study with full (n=18) or partial data (n=7). INTERVENTIONS: Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery. MAIN OUTCOME MEASURES: The primary outcome was change in Socket Comfort Score (SCS) at 7 weeks. Secondary outcomes at 7 weeks included the Orthotic and Prosthetic Users' Survey (OPUS) to assess lower extremity functional status, health-related quality of life, and satisfaction with device, as well as the 5-Times Rapid Sit-to-Stand Test, Four Square Step Test, and T-Test of Agility to assess functional performance. RESULTS: At 7 weeks, the mean SCS for IC (7.0±1.7) and NU-FlexSIV (8.4±1.1) Sockets were significantly different (P<.001; 95% confidence interval, 0.8-2.3). Results from a linear mixed-effects model, accounting for data from all time points, indicated that the SCS was 1.7 (SE=0.45) points higher for the NU-FlexSIV Socket (P<.001). For the secondary outcomes, only OPUS satisfaction with device was significantly better in the NU-FlexSIV Socket after accounting for all data points. CONCLUSIONS: The results suggest that after 7 weeks' accommodation, the NU-FlexSIV Socket was more comfortable and led to greater satisfaction with device than the IC socket in persons with unilateral transfemoral amputation and K3/K4 mobility. Other patient-reported outcomes and function were no different between sockets.

[The necessity for treatment paths for lower limb prosthetics : All that glitters is not gold!] / Behandlungspfade in der exoskelettalen prothetischen Versorgung der unteren Extremitäten : Es ist nicht alles Gold, was glänzt!

BACKGROUND: Frequently occurring problems in the fitting of leg prostheses are either, for a prosthetic fitting, insufficiently resilient leg stumps or insufficiently adapted prostheses. For this reason, there has been a demand at the political level to establish treatment pathways and a quality standard for the care of people after leg amputations. QUESTION: How can a joint, interdisciplinary approach to the provision of aids be developed? Does interdisciplinary care of amputees lead to an improvement in the quality of care? MATERIAL AND METHOD: A compendium "Quality standard in the field of lower extremity prostheses" was compiled and presented at the OT World in Leipzig in 2018. The basic principle is treatment pathways for the interdisciplinary care of all amputation levels of the lower extremities. RESULTS: The result is a compendium that represents the current "gold standard" in orthopaedic care after lower limb amputations. The compendium not only describes the treatment paths in detail but also makes demands on the quality of the result of the surgical amputation, as well as the goals of residual limb conditioning and the demands on the quality of the fitting of the prosthesis. A traffic light system is used to make recommendations, restrictions and rejections, thus defining the gold standard. CONCLUSIONS: If all the professions involved (doctors, CPOs, physiotherapists) do not work separately but rather together with the necessary expertise and routine, the quality of care for amputees will improve, and at the same time, the health care system will become more cost efficient.

[Transcutaneous osseointegrated prosthetic systems after major amputation of the lower extremity : A retrospective 3-year analysis]. / Transkutane osseointegrierte Prothesensysteme (TOPS) nach Majoramputation der unteren Extremität : Eine retrospektive 3-Jahres-Analyse.

INTRODUCTION: Transcutaneous osseointegrated prosthetic systems (TOPS) are an established optional procedure for the prosthetic treatment of amputations. Under the term endo-exo-prosthesis (EEP), the endosteal adapted exo-prosthesis (Dr. Grundei®) is currently used as the only standard prosthesis for clinical application in Germany. The prosthetic treatment with EEP involves a two-stage surgical procedure. In a first surgical step, the endo-fixed stem is implanted into the bone; in a second operation, approx. 2-6 weeks later, the skin/soft tissue stoma is created, through which the exoprosthetic components can be coupled transcutaneously. AIM: The aim of this manuscript was to retrospectively collect descriptive 3­year statistics (2017-2019) from clinical follow-ups and to analyze them with regard to possible effects of TOPS on the mobility level measured by k­levels. In addition, a brief description of the current standard of care in Germany regarding TOPS will be given. METHODS: All patients who underwent EEP after major amputation from February 2017 to December 2019 (n = 72, with 76 implants) were included in this study. The data of the EEP patients were collected in standardized follow-ups. K­levels were compared preoperatively to 6 months postoperatively. RESULTS: A total of N = 72 patients (N = 76 implantations) was analyzed in the described period. The main cause of amputations was trauma (68.9%). Main complications were myofascial complaints. Implant loosening and deep infections were observed in two cases (2.7%) during this period. Stoma problems occurred with a 3-year average of 25.7%. In terms of K­levels, there was a high significant increase from preoperative 1.8 ± 0.8 to 3.0 ± 0.4 after a 6-month period. CONCLUSION: TOPS is an established optional procedure for the treatment of limb loss. In Germany, only one implant is currently regularly implanted (endo-exo prosthesis), and the restoration is currently focused on the lower limb. The restoration of patients with major amputation of the lower extremity by means of TOPS can lead to an increase in mobility and, thus, to an increase in daily activities and participation in daily living.

Gülhane lower extremity amputee rehabilitation protocol: A nationwide, 123-year experience.

Amputation, one of the oldest known surgical procedures, causes many physical, mental and sociological problems. With its 123 years of experience, Gülhane has a special knowledge and experience, particularly in amputation. The main purpose of this protocol is to reveal the steps to be followed in individuals with lower extremity amputation. In this way, it is aimed to create a resource which can be used by our colleagues who have difficulties in using an appropriate approach due to the lack of experience.

Exploring the role of transtibial prosthetic use in deep tissue injury development: a scoping review.

BACKGROUND: The soft tissue of the residual limb in transtibial prosthetic users encounters unique biomechanical challenges. Although not intended to tolerate high loads and deformation, it becomes a weight-bearing structure within the residuum-prosthesis-complex. Consequently, deep soft tissue layers may be damaged, resulting in Deep Tissue Injury (DTI). Whilst considerable effort has gone into DTI research on immobilised individuals, only little is known about the aetiology and population-specific risk factors in amputees. This scoping review maps out and critically appraises existing research on DTI in lower-limb prosthetic users according to (1) the population-specific aetiology, (2) risk factors, and (3) methodologies to investigate both. RESULTS: A systematic search within the databases Pubmed, Ovid Excerpta Medica, and Scopus identified 16 English-language studies. The results indicate that prosthetic users may be at risk for DTI during various loading scenarios. This is influenced by individual surgical, morphological, and physiological determinants, as well as the choice of prosthetic componentry. However, methodological limitations, high inter-patient variability, and small sample sizes complicate the interpretation of outcome measures. Additionally, fundamental research on cell and tissue reactions to dynamic loading and on prosthesis-induced alterations of the vascular and lymphatic supply is missing. CONCLUSION: We therefore recommend increased interdisciplinary research endeavours with a focus on prosthesis-related experimental design to widen our understanding of DTI. The results have the potential to initiate much-needed clinical advances in surgical and prosthetic practice and inform future pressure ulcer classifications and guidelines.

[Expert assessment of lower extremity prosthetics]. / Begutachtung von Prothesenversorgungen der unteren Extremität.

Although the number of major amputations is declining throughout Germany, more than 57,000 surgical procedures for amputation still take place. As a consequence of high prosthetic care costs, these often lead to disputes before the social court in which expert medical opinions are required. With knowledge of the legal norms, the remit of the expert opinion can be fulfilled. The expert begins with evaluation of the patient's file and a search of the contested parts. The investigation includes a medical history, in addition to a physical examination, in order to be able to comment on the disputed beneficial use of the therapeutic appliance and respond to questions of proof. Questionnaires may be helpful.

Sensitivity to change and minimal clinically important difference of the Locomotor Capabilities Index-5 in people with lower limb amputation undergoing prosthetic training.

OBJECTIVE: To determine the sensitivity to change and minimal clinically important difference (MCID) for the self-administered Locomotor Capabilities Index-5 (LCI-5) in people with lower limb amputation undergoing prosthetic training. DESIGN: Prospective single-group observational study. METHODS: The LCI-5 was administered to 110 patients (69 males [63%]; median [interquartile range] age, 60 [48-69] years) before and after prosthetic training. The external anchor administered after the program was a 7-point Global Rating of Change Scale (GRCS) designed to quantify the effect (improvement or deterioration) of the intervention. RESULTS: Test-retest reliability of the LCI-5 (n=30) was high (intraclass correlation coefficient [ICC2,1]=0.92). The minimum detectable change at the 95% confidence level was 5.66 points. After triangulating these results with those of the mean-change approach and receiver operating characteristic (ROC) curve analysis (area under the ROC curve≥0.90), based on a different GRCS score splitting, we identified 2 cutoffs for the LCI-5: a change of 7 points, indicating the MCID, and 12 points, indicating "large improvement" in locomotor capabilities (12.5% and 21.4% of the maximum possible score, respectively). CONCLUSIONS: The LCI-5 showed a high ability to detect change over time (responsiveness). The 2 proposed values (MCID of 7 points and large improvement of 12 points), based on a mix of distribution- and anchor-based approaches, represent cutoffs that can accurately identify 2 different levels of true change (as perceived by the patient) in locomotor capability after prosthetic training.

Osseointegrated Prosthetic Limb for the treatment of lower limb amputations : Experience and outcomes.

BACKGROUND: Osseointegration has emerged over the past two decades as a dramatically different approach for the treatment of lower limb amputations, which involves direct attachment of the prosthesis to the skeletal residuum. This approach can address many of the socket-interface issues associated with socket prostheses which represent the current standard of care for amputees. The Osseointegrated Prosthetic Limb (OPL) is an osseointegration implant with a new design and improved features compared to other available implant systems. OBJECTIVES: To report on the experience and outcomes of using the OPL for osseointegrated reconstruction of lower limb amputations. MATERIALS AND METHODS: This is a retrospective study of 22 patients who received the OPL implant between December 2013 and November 2014. Clinical outcomes were obtained pre- and post-operatively, with results reported at the 1­year follow-up. Outcome measures included the Questionnaire for persons with a Trans-Femoral Amputation (Q-TFA), Short Form Health Survey 36 (SF-36), Six-Minute Walk Test (6MWT), and Timed Up and Go (TUG). Adverse events were also recorded. RESULTS: Compared to the mean pre-operative values obtained while patients were using socket prostheses or were wheelchair-bound, the mean post-operative values for all four validated outcome measures were significantly improved. There were 15 episodes of minor infections in 12 patients, all of which responded to antibiotics. Soft tissue refashioning was performed electively on 6 patients. No other adverse events were recorded. CONCLUSIONS: The results demonstrate that osseointegration surgery using the OPL is a relatively safe and effective procedure for the reconstruction and rehabilitation of lower limb amputees.

Fifteen years of experience with Integral-Leg-Prosthesis: Cohort study of artificial limb attachment system.

Integral-Leg-Prosthesis (ILP) is a comparatively new attachment system that allows direct skeletal docking of artificial limbs. Between January 1999 and December 2013, 69 patients with transfemoral amputation were fitted with ILPs by a single German surgeon. Device design iterations and surgical techniques evolved during these years. For the purposes of comparison, patients receiving the first two designs and procedure iterations were placed in group 1 and the patients fitted with the final design were placed in group 2. Infection rate and planned and unplanned surgical interventions were statistically compared using Fisher exact test. Data demonstrated that the high rate of stoma-associated infections seen in group 1 was dramatically reduced in group 2. Of the 39 patients with 42 implants in group 2, none had operative interventions secondary to infection. All group 2 patients remained infection-free without the use of antibiotics by following a simple but defined wound-hygiene protocol. We concluded that the final iteration of the osseointegrated intramedullary device with a low energy surface at the soft tissue and prosthesis interface allowed a biologically stable skin stoma that remained infection-free without chronic use of antibiotics. The reduction in the infection rate was attributed to the clinically based, empirically driven changes in design and surgical techniques.

Predictors of non-use of prostheses by people with lower limb amputation after discharge from rehabilitation: development and validation of clinical prediction rules.

QUESTIONS: Can rules be developed to predict the risk of non-use of prostheses by people with lower limb amputation following discharge from rehabilitation? Are these clinical prediction rules valid? DESIGN: Retrospective and prospective cohort study designs. PARTICIPANTS: Consecutive tertiary rehabilitation patients: 135 retrospective (103 males, mean age = 56 years, SD 15) and 66 prospective (58 males, mean age = 54 years, SD 16). METHOD: Medical records were audited for potential predictor variables. Retrospective participants were interviewed at a median of 1.9 years after discharge (IQR 1.4 to 2.5) and prospective participants at a median of 1.3 years (IQR 1.1 to 1.4). RESULTS: Clinical prediction rules were identified at 4, 8 and 12 months after discharge, and validated. Amputation levels above transtibial and mobility-aid use were common predictors for all three time frames. At 4 months, if four out of five predictor variables were present (LR+ = 43.9, 95% CI 2.73 to 999+), the probability of non-use increased from 12 to 86% (p<0.001). At 8 months, if all three predictor variables were present (LR+ = 33.9, 95% CI 2.1 to 999+), the probability of non-use increased from 15 to 86% (p<0.001). At 12 months, if two out of three predictor variables were present (LR+=2.8, 95% CI 0.9 to 6.6), the probability of non-use increased from 17 to 36% (p<0.031). CONCLUSIONS: These validated clinical prediction rules have implications for rehabilitation and service model development. [Roffman CE, Buchanan J, Allison GT (2014) Predictors of non-use of prostheses by people with lower limb amputation after discharge from rehabilitation: development and validation of clinical prediction rules.Journal of Physiotherapy60: 224-231].

The Role and Significance of a Mobile Unit Providing Prostheses in Thailand / 国際保健医療

<b>Introduction</b><br> Developing countries have many urgent issues to cope with, such as infectious diseases, and therefore people with disabilities have not had enough opportunities to receive rehabilitation services. A mobile unit as an outreach approach seems to be valuable in countries or areas lacking in adequate health care facilities. In Thailand, there are about 56 thousand people with lower extremity amputations. There are very few workshops and technicians in health care facilities producing prostheses. We studied a working mobile unit to clarify its effectiveness.<br><b>Method</b><br> We conducted participatory observations of the mobile unit in Chiang Rai, Thailand in October, 2006 run by the Prostheses Foundation, and hearings from the staff and the amputees to collect the information such as outlines of the foundation and the unit, and the number of participants. We collected data on those amputees from the reception note, such as their occupations, causes of amputations, kinds of prostheses, and their experiences of using prostheses.<br><b>Results</b><br> The mobile unit was a huge scale activity including 75 staff members, who visited the field with all necessary equipments. Fifty-four technicians produced 204 prostheses for 177 amputees in 4 days. Eighty percent of those amputees were unstable in income, such as farmers and those unemployed. Landmines were the cause of amputation for 20 percent of those seen. Thirty percent experienced their prostheses initially, 20 percent of whom had waited for 6 years or more to receive them. Therefore, it was found to be an effective activity to provide prostheses for poor people with amputations in rural areas. Also, technicians in rural areas learnt skills regarding prostheses from specialists in cities.<br><b>Conclusions</b><br> A mobile unit seems to be effective in Thailand to provide amputees with prostheses, and Prosthetics and Orthotics technicians in rural areas with opportunities for education.