Categorization and recommendations for outcome measures for lower limb absence by an expert panel.

BACKGROUND: Understanding the psychometric strengths and limitations of outcome measures for use with people with lower limb absence (LLA) is important for selecting measures suited to evaluating patient outcomes, answering clinical and research questions, and informing health care policy. The aim of this project was to review the current psychometric evidence on outcome measures in people with LLA to determine which measures should be included in a stakeholder consensus process. METHODS: An expert panel was assembled, and a 3-stage review process was used to categorize outcome measures identified in a systematic literature review into 3 distinct categories (recommended for measures with better than adequate psychometric properties; recommended with qualification; and unable to recommend). Panelists were asked to individually categorize measures based on results of a systematic review of identified measures' psychometric properties. Each measure's final categorization was based on ≥70% agreement by all panelists. RESULTS: No outcome measure attained the ≥70% consensus threshold needed to achieve a rating of "recommend." Hence, panelists suggested combining "recommend" and "recommend with qualifications" into a single category of "recommend with qualifications." Using this approach, consensus was reached for 59 of 60 measures. Consensus could not be reached on 1 outcome measure (socket comfort score). Thirty-six outcome measures were categorized as "unable to recommend" based on available evidence; however, 23 (12 patient-reported measures and 11 performance-based measures) demonstrated adequate psychometric properties in LLA samples and were thus rated as "recommend with qualification" by the expert panel. The panel of experts were able to recommend 23 measures for inclusion in the subsequent stakeholder review. A key strength of this process was bringing together international researchers with extensive experience in developing and/or using LLA outcome measures who could assist in identifying psychometrically sound measures to include in a subsequent stakeholder consensus process. CONCLUSION: The above categorizations represent the current state of psychometric evidence on outcome measures for people with LLA and hence may change over time as additional research becomes available. The results will be used to achieve wider consensus from clinicians, health policymakers, health clinic managers, researchers, and end users (i.e., individuals with LLA) on outcome measures for the International Society of Prosthetics and Orthotics lower limb Consensus Outcome Measures for Prosthetic and Amputation ServiceS.

Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications.

Background: Osseointegrated implants for patients with transfemoral amputations (TFAs) are a novel treatment under development, and prospective long-term evidence is lacking. The objectives were to determine patient-reported outcomes (PROs) and complications after ten years compared to before treatment and to compare the first five-year period with the later five-year period with regard to the outcomes. Methods: In a nonrandomized, prospective cohort study, patients with TFAs treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system (n â€‹= â€‹51) (28 men/23 women; mean age at amputation: 32 years old; mean age at treatment: 44 years old in a single university hospital were followed for ten years. PROs included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA, four scores 0-100) and the Short Form 36 Health Survey (SF-36, ten scores 0-100) and were answered before treatment and until the ten-year follow-up after treatment. Analyses of differences in PRO scores were conducted using Wilcoxon's signed rank test. The implant survival and revision-free rates with respect to adverse events (implant revision, mechanical complications, and deep infections) were presented as Kaplan-Meier graphs with 95% confidence intervals (CIs). The incidences of events per ten and five person-years were calculated. Spearman's correlation analysis was used for analyses of associations between adverse events. Results: PROs showed statistically significant mean improvements between baseline and the ten-year follow-up with regard to all Q-TFA scores: the prosthetic use score (+36), prosthetic mobility score (+18), problem score (-28) and global score (+38) (all p â€‹< â€‹0.001), and the SF-36 physical functioning score (+26, p â€‹< â€‹0.001) and physical component score (+6, p â€‹< â€‹0.01). No PROs showed a statistically significant deterioration. Over the ten years, 12 patients were lost (one lost to follow-up, one dropped out of the study, two died, and eight had implants removed (four before five years and four between five and ten years). At ten years, the revision-free survival rates were 83% (CI: 69%-91%), 65% (CI: 49%-77%) and 17% (CI: 7%-29%) for implant revision, deep infection and mechanical complications, respectively. Mechanical complications, 3.9 per 10 person-years (CI: 2.2-5.1) constituted the most common serious adverse event and were more common during the last five years than during the first five years (p â€‹< â€‹0.001). No significant difference in the incidence of deep infections was observed between the earlier and the later five-year periods: 0.3 per 5 person-years (CI: 0.1-0.5) vs. 0.3 per person-years (CI: 0.1-0.5) (p â€‹= â€‹0.740). Correlation analyses between the earlier and later five years revealed a positive association between deep infections and implant removal (0.57, p â€‹< â€‹0.001) and between mechanical complications and adverse events (0.65, p â€‹< â€‹0.001). Conclusion: Improved PROs were demonstrated ten years after the introduction of a novel principle for bone anchorage of amputation prostheses. Nevertheless, an increasing rate of mechanical complications is of concern.

The Kenevo microprocessor-controlled prosthetic knee compared with non-microprocessor-controlled knees in individuals older than 65 years in Sweden: A cost-effectiveness and budget-impact analysis.

BACKGROUND: Growing evidence suggests that individuals with transfemoral amputation or knee disarticulation using a prosthesis equipped with a microprocessor-controlled knee (MPK) benefit from enhanced mobility and safety, including less falls. In elderly individuals, high mortality rates are assumed to reduce the expected useful life of MPKs, and this raises concerns regarding their economic effectiveness. OBJECTIVE: To investigate the cost-effectiveness and budget impact of the Kenevo/MPK (Ottobock, Germany) compared with non-microprocessor-controlled knees (NMPKs) in people older than 65 years at the time of transfemoral amputation/knee disarticulation, from a Swedish payer's perspective. METHODS: A decision-analytic model was developed to conduct the economic analysis of the Kenevo/MPK. Model parameters were derived from Swedish databases and published literature. Univariate and probabilistic sensitivity analyses were performed to explore parameter uncertainty. RESULTS: Compared with NMPKs, the Kenevo/MPK reduced the frequency of hospitalizations by 137 per 1,000 person years while the frequency of fatal falls was reduced by 19 per 1,000 person-years in the simulation. Over a 25-year time horizon, the incremental cost-effectiveness ratio was EUR11,369 per quality-adjusted life year. The probability of the MPK being cost-effective at a threshold of EUR40,000 per quality-adjusted life year was 99%. The 5-year budget impact model predicted an increase in payer expenditure of EUR1.76 million if all new patients received a Kenevo/MPK, and 50% of current NMPK users switched to the MPK. CONCLUSIONS: Results of the modeling suggest that the Kenevo/MPK is likely to be cost-effective for elderly individuals, primarily because of a reduction in falls.

Health-related quality of life in patients with lower limb amputation - an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry.

PURPOSE: To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). METHODS: This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. RESULTS: The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and -5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. CONCLUSION: The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.Implications for rehabilitationThe measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA)The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measuresThe five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLAIn the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities.

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation.

In research on lower limb prostheses, safety during testing and training is paramount. Lower limb prosthesis users risk unintentional loss of balance that can result in injury, fear of falling, and overall decreased confidence in their prosthetic leg. Here, we present a protocol for managing the risks during evaluation of active prosthetic legs with modifiable control systems. We propose graded safety levels, each of which must be achieved before advancing to the next one, from laboratory bench testing to independent ambulation in real-world environments.

Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products.

BACKGROUND: The medical community demands evidence for the benefits of medical devices such as bone-anchored prostheses (BAPs). MedTech20  is a novel instrument aiming to address general benefits of medical devices. OBJECTIVE: To describe general patient-reported benefits of BAPs measured with MedTech20. STUDY DESIGN: This is a cross-sectional descriptive survey. METHODS: Patients treated in Sweden who had used a BAP for >1 year were mailed the MedTech20  Questionnaire. Responses to each attribute were described, and the MedTech20   Index (0-1), in which a higher figure represents larger benefits from the product, was calculated. Index values were compared based on demographic variables (sex, unilateral or bilateral transfemoral amputation (TFA), and those having experienced any complication of implant parts or the prosthetic connection device). RESULTS: The response rate was 72%. The 62 participants (41 men and 21 women; mean age 57 years) had 11 ± 6.9 mean years of BAP experience. Single attributes stated as highly relevant and with high benefit for BAPs included perceived reliability, perceived safety, sense of control of the disability, facilitation of movement outside home, no discomfort at use, and ease of use. Attributes with less relevance included aid to remember tasks, reduction of barriers to a good sleep, and reduced sense of compromised integrity. The MedTech20  Index was 0.655 ± 0.188 and was not statistically significantly different based on any of the demographic variables. CONCLUSIONS: By using a general measure on attributes of medical devices, this study provides new insights strengthening the evidence regarding the benefits that BAPs provide for patients with TFA who had difficulties with socket-suspended prostheses.

Cortical brain activity in transfemoral or knee-disarticulation prosthesis users performing single- and dual-task walking activities.

INTRODUCTION: Walking with a prosthesis while performing secondary tasks increases demand on cognitive resources, compromising balance and gait. This study investigated effects of a secondary task on patterns of brain activity and temporospatial gait parameters in individuals using a prosthesis with or without a microprocessor-controlled prosthetic knee(MPK) and controls. METHODS: A cross-sectional study with repeated measures was performed. Twenty-nine individuals with amputations and 16 controls were recruited. Functional near-infrared spectroscopy was used to evaluate changes in oxygenated and de-oxygenated haemoglobin in the prefrontal cortex and temporospatial variables during single-and dual-task walking. RESULTS: Differences in brain activity were observed within the MPK-group and controls without changes in temporospatial parameters. The Trail-Walking test was associated with highest levels of brain activity in both groups. No differences were observed between single- and dual-task walking in the non-MPK-group (p > 0.05). The Non-MPK and the MPK-group recorded higher levels of brain activity than controls during single-task walking and poorer results on temporospatial variables compared to controls. CONCLUSIONS: For the MPK-group and controls, introduction of a secondary task led to an increase in brain activity. This was not seen in the Non-MPK-group. Significant differences in brain activity were observed in the absence of changes in temporospatial parameters.

SwedeAmp-the Swedish Amputation and Prosthetics Registry: 8-year data on 5762 patients with lower limb amputation show sex differences in amputation level and in patient-reported outcome.

Background and purpose - For want of national guidelines for lower limb amputation (LLA) the quality registry SwedeAmp was started in 2011 to increase knowledge around LLA and prosthetic rehabilitation. We now present data from the first 8 years of registration.Patients and methods - We present descriptive data from the first 8 years (2011-2018) of registration. Patient-reported outcome was collected at baseline and at follow-up 12 and 24 months after surgery for patients with prosthetic supply and included generic (EQ-5D-5L) and amputee-specific (e.g., LCI-5L and Prosthetic Use Score) measures. Sex differences were investigated.Results - As at December 31, 2018, 5,762 patients, 7,776 amputations, 2,658 prosthetic supplies, 1,848 baselines, and 2,006 follow-ups were registered. 61% of the patients were male, and mean age by the time of the first registered amputation was 74 years (SD 14). Women were older, more frequently had vascular disease without diabetes and more often underwent amputation at a higher level compared with men (p < 0.001). Time from amputation to fitting of first individual prosthesis was median 69 days (6-500) after transtibial amputation (TTA) and 97 days (19-484) after transfemoral amputation (TFA). The outcomes were lower after TFA than after TTA.Interpretation - SwedeAmp shows sex differences concerning amputation level, diagnosis, and age, leading to the conclusion that women have worse preconditions for successful prosthetic mobility after LLA. With increasing coverage, SwedeAmp can provide deeper knowledge with regard to patients undergoing LLA in Sweden.

A 15-year follow-up of transfemoral amputees with bone-anchored transcutaneous prostheses.

AIMS: The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis. METHODS: In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years' follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded. RESULTS: The Q-TFA scores at two, five, seven, and ten years showed significantly more prosthetic use, better mobility, fewer problems, and an improved global situation, compared with baseline. The survival rate of the osseointegrated implant part (the fixture) was 89% and 72% after seven and 15 years, respectively. A total of 61 patients (55%) had mechanical complications (mean 3.3 (SD 5.76)), resulting in exchange of the percutaneous implant parts. There was a positive relationship between a higher activity grade and the number of mechanical complications. CONCLUSION: Compared with before treatment, the patient-reported outcome was significantly better and remained so over time. Although osseointegration and the ability to transfer loads over a 15-year period have been demonstrated, a large number of mechanical failures in the external implant parts were found. Since these were related to higher activity, restrictions in activity and improvements to the mechanical properties of the implant system are required. Cite this article: Bone Joint J 2020;102-B(1):55-63.

Bone-anchored prostheses in patients with traumatic bilateral transfemoral amputations: rehabilitation description and outcome in 12 cases treated with the OPRA implant system.

PURPOSE: To describe the rehabilitation experience and outcome of treatment with bone-anchored prostheses in individuals with bilateral transfemoral amputations (TFAs) treated in Sweden over a period of 25 years. METHOD: Hospital records were reviewed for all patients with traumatic bilateral TFAs treated until 2015. The use of prostheses, walking aids and wheelchairs was noted. RESULTS: The cohort comprised 12 patients (nine men and three women with a mean age 35 years at treatment) and the median follow-up time was seven years (1-20). At baseline, 9/12 used prostheses and 3/12 did not. The main means of locomotion was in a wheelchair without wearing prostheses (n = 8/12) or in a wheelchair in combination with prosthetic walking supported by walking aids (n = 4/12). All prosthetic users had problems with sitting comfort. At follow-up, 11/12 patients used prostheses, while one did not. The means of locomotion was prosthetic walking in 3/12 cases, a combination of a wheelchair and prosthetic walking in 4/12, a wheelchair while wearing prostheses but not walking in 4/12 and a wheelchair without wearing prostheses in 1/12. Three patients walked unsupported by walking aids. Seven patients had no problem with prosthetic sitting comfort (n = 3 had small problems). CONCLUSIONS: Bone-anchored prostheses in patients with bilateral TFAs resulted in more prosthesis use during everyday locomotion, due hypothetically to improved comfort while wearing prostheses. The results further underline the importance of other assistive devices such as wheelchairs and walking aids used in combination with prostheses in this group of patients facing severe functional limitations. Implications for Rehabilitation This study provides an insight into the details of the rehabilitation and outcome in patients with traumatic bilateral transfemoral amputations treated with bone-anchored prostheses in Sweden. The treatment can lead to a large amount of prosthetic use, but most patients will also use a range of assistive devices including full-length prostheses, stubbies, walking aids and wheelchairs after treatment. The importance of sitting in comfort while wearing prostheses should not be underestimated in patients with bilateral transfemoral amputations.

Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Five-year Follow-up of Patient-reported Outcomes and Complications.

INTRODUCTION: Direct skeletal attachment of prostheses has previously been shown to improve patient-reported outcome (PRO) measures of individuals with transfemoral amputation (TFA) at 2-year follow-up. This prospective study reports the outcomes at 5-year follow-up. METHODS: A total of 51 patients (55 legs) with TFA were included in a prospective study. Complications, success rate, and PRO measures were followed for 5 years. RESULTS: The cumulative fixture survival rate at 5 years was 92%, and the revision-free survival rate was 45%. Thirty-four patients had 70 superficial infections. Eleven patients had 14 deep infections. Fifteen patients had mechanical complications. Four fixtures were removed (ie, one deep infection and three loosening). PRO measures showed significant improvements including more use of the prosthesis, better mobility, fewer issues, and improved physical health-related quality of life (all P < 0.0001) compared with baseline. CONCLUSION: Individuals with TFA at 5-year follow-up had significant improvement in PRO measures, but increases in deep infections and mechanical complications are concerning.

Reduced cortical brain activity with the use of microprocessor-controlled prosthetic knees during walking.

BACKGROUND: Individuals using a lower-limb prosthesis indicate that they need to concentrate on every step they take. Despite self-reports of increased cognitive demand, there is limited understanding of the link between cognitive processes and walking when using a lower-limb prosthesis. OBJECTIVE: The objective was to assess cortical brain activity during level walking in individuals using different prosthetic knee components and compare them to healthy controls. It was hypothesized that the least activity would be observed in the healthy control group, followed by individuals using a microprocessor-controlled prosthetic knee and finally individuals using a non-microprocessor-controlled prosthetic knee. STUDY DESIGN: Cross-sectional study. METHODS: An optical brain imaging system was used to measure relative changes in concentration of oxygenated and de-oxygenated haemoglobin in the frontal and motor cortices during level walking. The number of steps and time to walk 10 m was also recorded. The 6-min walk test was assessed as a measure of functional capacity. RESULTS: Individuals with a transfemoral or knee-disarticulation amputation, using non-microprocessor-controlled prosthetic knee ( n = 14) or microprocessor-controlled prosthetic knee ( n = 15) joints and healthy controls ( n = 16) participated in the study. A significant increase was observed in cortical brain activity of individuals walking with a non-microprocessor-controlled prosthetic knee when compared to healthy controls ( p < 0.05) and individuals walking with an microprocessor-controlled prosthetic knee joint ( p < 0.05). CONCLUSION: Individuals walking with a non-microprocessor-controlled prosthetic knee demonstrated an increase in cortical brain activity compared to healthy individuals. Use of a microprocessor-controlled prosthetic knee was associated with less cortical brain activity than use of a non-microprocessor-controlled prosthetic knee. CLINICAL RELEVANCE: Increased understanding of cognitive processes underlying walking when using different types of prosthetic knees can help to optimize selection of prosthetic components and provide an opportunity to enhance functioning with a prosthesis.

Perceived self-efficacy and specific self-reported outcomes in persons with lower-limb amputation using a non-microprocessor-controlled versus a microprocessor-controlled prosthetic knee.

PURPOSE: To measure self-efficacy in a group of individuals who have undergone a lower-limb amputation and investigate the relationship between self-efficacy and prosthetic-specific outcomes including prosthetic use, mobility, amputation-related problems and global health. A second purpose was to examine if differences exist in outcomes based upon the type of prosthetic knee unit being used. METHOD: Cross-sectional study using the General Self-Efficacy (GSE) Scale and the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA). Forty-two individuals participated in the study. Twenty-three used a non-microprocessor-controlled prosthetic knee joint (non-MPK) and 19 used a microprocessor-controlled prosthetic knee joint (MPK). RESULTS: The study sample had quite high GSE scores (32/40). GSE scores were significantly correlated to the Q-TFA prosthetic use, mobility and problem scores. High GSE scores were related to higher levels of prosthetic use, mobility, global scores and negatively related to problem score. No significant difference was observed between individuals using a non-MPK versus MPK joints. CONCLUSIONS: Individuals with high self-efficacy used their prosthesis to a higher degree and high self-efficacy was related to higher level of mobility, global scores and fewer problems related to the amputation in individuals who have undergone a lower-limb amputation and were using a non-MPK or MPK knee. Implications for rehabilitation Perceived self-efficacy has has been shown to be related to quality of life, prosthetic mobility and capability as well as social activities in daily life. Prosthetic rehabilitation is primary focusing on physical improvement rather than psychological interventions. More attention should be directed towards the relationship between self-efficacy and prosthetic related outcomes during prosthetic rehabilitation after a lower-limb amputation.

Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses.

BACKGROUND: Percutaneous anchoring of femoral amputation prostheses using osseointegrating titanium implants has been in use for more than 25 years. The method offers considerable advantages in daily life compared with conventional socket prostheses, however long-term success might be jeopardized by implant-associated infection, especially osteomyelitis, but the long-term risk of this complication is unknown. QUESTIONS/PURPOSES: (1) To quantify the risk of osteomyelitis, (2) to characterize the clinical effect of osteomyelitis (including risk of implant extraction and impairments to function), and (3) to determine whether common patient factors (age, sex, body weight, diabetes, and implant component replacements) are associated with osteomyelitis in patients with transfemoral amputations treated with osseointegrated titanium implants. METHODS: We retrospectively analyzed our first 96 patients receiving femoral implants (102 implants; mean implant time, 95 months) treated at our center between 1990 and 2010 for osteomyelitis. Six patients were lost to followup. The reason for amputation was tumor, trauma, or ischemia in 97 limbs and infection in five. All patients were referred from other orthopaedic centers owing to difficulty with use or to be fitted with socket prostheses. If found ineligible for this implant procedure no other treatment was offered at our center. Osteomyelitis was diagnosed by medical chart review of clinical signs, tissue culture results, and plain radiographic findings. Proportion of daily prosthetic use when osteomyelitis was diagnosed was semiquantitatively graded as 1 to 3. Survivorship free from implant- associated osteomyelitis and extraction attributable to osteomyelitis respectively was calculated using the Kaplan-Meier estimator. Indication for extraction was infection not responsive to conservative treatment with or without minor débridement or loosening of implant. RESULTS: Implant-associated osteomyelitis was diagnosed in 16 patients corresponding to a 10-year cumulative risk of 20% (95% CI 0.12-0.33). Ten implants were extracted owing to osteomyelitis, with a 10-year cumulative risk of 9% (95% CI 0.04-0.20). Prosthetic use was temporarily impaired in four of the six patients with infection who did not undergo implant extraction. With the numbers available, we did not identify any association between age, BMI, or diabetes with osteomyelitis; however, this study was underpowered on this endpoint. CONCLUSION: The increased risk of infection with time calls for numerous measures. First, patients should be made aware of the long-term risks, and the surgical team should have a heightened suspicion in patients with method-specific presentation of possible infection. Second, several research questions have been raised. Will the surgical procedure, rehabilitation, and general care standardization since the start of the program result in lower infection rates? Will improved diagnostics and early treatment resolve infection and prevent subsequent extraction? Although not supported in this study, it is important to know if most infections arise as continuous bacterial invasion from the skin and implant interface and if so, how this can be prevented? LEVEL OF EVIDENCE: Level IV, therapeutic study.

Static load bearing exercises of individuals with transfemoral amputation fitted with an osseointegrated implant: Loading compliance.

BACKGROUND: Load-bearing exercises are performed by transfemoral amputees fitted with an osseointegrated implant to facilitate bone remodelling. OBJECTIVE: This study presents the loading compliance comparing loads prescribed and applied on the three axes of the implant during static load-bearing exercises with a specific emphasis on axial and vectorial comparisons. STUDY DESIGN: Cohort study. METHODS: A total of 11 fully rehabilitated unilateral transfemoral amputees fitted with an osseointegrated implant performed five trials in four loading conditions using a static standing frame. The load prescribed was monitored using a vertical single-axis strain gauge connected to an electronic display. The tri-axial forces applied on the implant were measured directly with an instrumented pylon including a six-channel transducer. The analysis included 'axial' and 'vectorial' comparisons corresponding to the difference between the force applied on the long axis of the implant and the load prescribed as well as the resultant of the three components of the load applied and the load prescribed, respectively. RESULTS: The results demonstrated that axial and vectorial differences were significant in all conditions ( p < 0.05), except for the vectorial difference for the 40 kg condition ( p = 0.182). CONCLUSION: The significant lack of axial compliance led to systematic underloading of the long axis of the implant. Clinical relevance This study contributes to a better understanding of the load applied on an osseointegrated implant during the static load-bearing exercises that could contribute to improve the design of apparatus to monitor loading exercises as well as clinical guidelines for the loading progression during rehabilitation.

Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers.

OBJECTIVE: Foot deformities, neuropathy, and dysfunction in the lower extremities are known risk factors that increase plantar peak pressure (PP) and, as a result, the risk of developing foot ulcers in patients with diabetes. However, knowledge about the prevalence of these factors is still limited. The aim of the present study was to describe the prevalence of risk factors observed in patients with diabetes without foot ulcers and to explore possible connections between the risk factors and high plantar pressure. PATIENTS AND METHODS: Patients diagnosed with type 1 (n=27) or type 2 (n=47) diabetes (mean age 60.0±15.0 years) were included in this cross-sectional study. Assessments included the registration of foot deformities; test of gross function at the hip, knee, and ankle joints; a stratification of the risk of developing foot ulcers according to the Swedish National Diabetes Register; a walking test; and self-reported questionnaires including the SF-36 health survey. In-shoe PP was measured in seven regions of interests on the sole of the foot using F-Scan(®). An exploratory analysis of the association of risk factors with PP was performed. RESULTS: Neuropathy was present in 28 (38%), and 39 (53%) had callosities in the heel region. Low forefoot arch was present in 57 (77%). Gait-related parameters, such as the ability to walk on the forefoot or heel, were normal in all patients. Eighty percent had normal function at the hip and ankle joints. Gait velocity was 1.2±0.2 m/s. All patients were stratified to risk group 3. Hallux valgus and hallux rigidus were associated with an increase in the PP in the medial forefoot. A higher body mass index (BMI) was found to increase the PP at metatarsal heads 4 and 5. Pes planus was associated with a decrease in PP at metatarsal head 1. Neuropathy did not have a high association with PP. CONCLUSIONS: This study identified several potential risk factors for the onset of diabetic foot ulcers (DFU). Hallux valgus and hallux rigidus appeared to increase the PP under the medial forefoot and a high BMI appeared to increase the PP under the lateral forefoot. There is a need to construct a simple, valid, and reliable assessment routine to detect potential risk factors for the onset of DFU.

Static load bearing exercises of individuals with transfemoral amputation fitted with an osseointegrated implant: reliability of kinetic data.

This study aimed at presenting the intra-tester reliability of the static load bearing exercises (LBEs) performed by individuals with transfemoral amputation (TFA) fitted with an osseointegrated implant to stimulate the bone remodeling process. There is a need for a better understanding of the implementation of these exercises particularly the reliability. The intra-tester reliability is discussed with a particular emphasis on inter-load prescribed, inter-axis and inter-component reliabilities as well as the effect of body weight normalization. Eleven unilateral TFAs fitted with an OPRA implant performed five trials in four loading conditions. The forces and moments on the three axes of the implant were measured directly with an instrumented pylon including a six-channel transducer. Reliability of loading variables was assessed using intraclass correlation coefficients (ICCs) and percentage standard error of measurement values ( %SEMs ). The ICCs of all variables were above 0.9 and the %SEM values ranged between 0 and 87%. This study showed a high between-participants' variance highlighting the lack of loading consistency typical of symptomatic population as well as a high reliability between the loading sessions indicating a plausible correct repetition of the LBE by the participants. However, these outcomes must be understood within the framework of the proposed experimental protocol.

Outcome of percutaneous osseointegrated prostheses for patients with unilateral transfemoral amputation at two-year follow-up.

OBJECTIVE: To report outcomes regarding general and specific physical health-related quality of life of treatment with percutaneous osseointegrated prostheses. DESIGN: Prospective 2-year case-control study. SETTING: University hospital. PARTICIPANTS: Individuals (N=39; mean age, 44 ± 12.4 y) with unilateral transfemoral amputation as a result of trauma (n=23), tumor (n=11), or other cause (n=5). At baseline, 33 of the 39 participants used socket-suspended prostheses. INTERVENTION: Osseointegrated prosthesis. MAIN OUTCOME MEASURES: Questionnaire for Persons with Transfemoral Amputation (Q-TFA), Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical functioning (PF) and physical component summary (PCS), SF-6D, and Physiological Cost Index (PCI). RESULTS: At 2 years postimplantation, 6 of 7 Q-TFA scores improved (P<.0001) compared with baseline (prosthetic use, mobility, problem, global, capability, walking habits). The walking aid subscore did not improve (P=.327). Of the 39 participants, increased prosthesis use was reported by 26, same amount of use by 11, and less use by 2. Improvement was reported in 16 of the 30 separate problem items (P<.05). Unchanged items included problems regarding phantom limb pain and pain from the back, shoulders, and contralateral limb. The PF, PCS, and SF-6D improved a mean of 24.1 ± 21.4 (P<.0001), 8.5 ± 9.7 (P<.0001), and .039 ± .11 (P=.007) points, respectively. Walking energy cost decreased (mean PCI at baseline, .749; mean PCI at follow-up, .61; P<.0001). CONCLUSIONS: Two years after intervention, patients with a unilateral TFA treated with an OPRA implant showed important improvements in prosthetic function and physical quality of life. However, walking aids used and the presence of phantom limb pain and pain in other extremities were unchanged. This information is valuable when considering whether percutaneous osseointegrated prostheses are a relevant treatment option.

Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers - A two-year, randomized trial.

BACKGROUND: Special insoles and shoes designed to prevent foot ulcers caused by repetitive high pressures are recommended for patients with diabetes who have any of the following risk factors: neuropathy; peripheral vascular disease; foot deformities; previous ulcers; amputation; and skin pathologies. However, there is a need for increased knowledge regarding: a) differences in the peak pressure (PP) and pressure time integral (PTI) for different types of insoles; and b) the properties of the pressure distribution for insoles used over a period of several months. We present the results of a randomized trial to compare the plantar pressures of three commonly used insoles. OBJECTIVES: The primary objective was to compare the PP and PTI between three types of insoles. The secondary objective was to explore the long-term pattern of peak plantar pressure distribution and variations in specific regions of interest (ROI). The tertiary objective was to investigate the impacts of insole adjustments, how much the insoles were used, and the levels of patient satisfaction. METHODS: In a 2-year trial, 114 patients with type 1 (N = 31) or type 2 (N = 83) diabetes (62 men and 52 women; mean age, 57.7 ± 15.4 years; duration of diabetes, 12.3 ± 11.2 years; neuropathy, 38%), were randomized to be supplied with one of three different insoles. The ethylene vinyl acetate (EVA) insoles were used in outdoor walking shoes. The 35 EVA group (N = 39) received soft custom-made insoles composed of EVA of 35 shore A hardness, the 55 EVA group (N = 37) received custom-made insoles composed of EVA of 55 shore hardness, and the control group (N = 38) received prefabricated insoles composed of a hard core with a top layer of soft 12 shore hardness microfiber. Using F-Scan®, the in-shoe plantar pressures were measured at seven ROI (hallux, metatarsal head 1, metatarsal head 2, metatarsal head 4, metatarsal head 5, lateral aspect of the mid-foot, heel) on five occasions during the study period. The plantar-pressure variables used were PP (main outcome) and PTI. The plantar patterns of load were explored, satisfaction and usage of the insoles were rated by the participants, and insole adjustments were recorded. RESULTS: A mixed model analysis estimated lower PP values in the heel regions for the 35 EVA and 55 EVA insoles (171 ± 13 and 161 ± 13 kPa, respectively) than for the prefabricated insoles (234 ± 10 kPa) (p < 0.001). Also for some of the other six ROI indications of difference in PP or PTI could be observed. The redistribution of peak plantar pressure for all of the insoles, was stable at the mid-foot, while the proportion of load on the distal area changed during the study period According to the self-reported answers (scale, 0-100), the average usage of the insoles was rated as 79 and satisfaction was rated as 85 (N = 75). Thirty-two percent of the subjects had not received foot care. Fourteen adjustments to insoles were made during the study period, and 86 pairs of insoles were exchanged due to wear, with 49% being exchanged in the 35 EVA group. CONCLUSIONS: Custom-made insoles used in combination with stable walking shoes gave lower pressures at the heel region. The variation makes it difficult to detect a systematic difference in plantar pressure for the 6 ROI, if such a difference indeed exists. The levels of satisfaction and usage for all the insoles tested were high. The insoles maintained their pressure redistribution properties over long periods, and few adjustments were needed.