STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations.

OBJECTIVES: To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot. DESIGN: Multicentre parallel group feasibility RCT. SETTING: Five prosthetics centres in England recruiting from July 2018 to August 2019. PARTICIPANTS: Adults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having 'limited community mobility' and using a non-self-aligning ankle-foot. INTERVENTION: Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. OUTCOMES: Feasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire. RESULTS: Fifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%-94%, and clinical assessments were 92%-95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively. CONCLUSIONS: This feasibility trial recruited and retained participants who were categorised as having 'limited community mobility' following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery. TRIAL REGISTRATION NUMBER: ISRCTN15043643.

Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study).

INTRODUCTION: The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis. METHODS AND ANALYSIS: This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT. ETHICS AND DISSEMINATION: Ethical approval was granted by Yorkshire and the Humber-Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group. TRIAL REGISTRATION NUMBER: ISRCTN15043643.

Multimodality imaging review of the post-amputation stump pain.

Limb amputation is one of the oldest known surgical procedures performed for a variety of indications. Little surgical technical improvements have been made since the first procedure, but perioperative and post-operative refinements have occurred over time. Post-amputation pain (PAP) of the stump is a common complication but is an extremely challenging condition to treat. Imaging allows early diagnosis of the underlying cause so that timely intervention is possible to minimize physical disability with its possible psychological and socioeconomic implications. A multidisciplinary approach should be taken involving the rehabilitation medicine team, surgeon, prosthetist, occupational therapist and social workers. Conventional radiographs demonstrate the osseous origin of PAP while high-resolution ultrasound is preferred to assess soft-tissue abnormalities. These are often the first-line investigations. MRI remains as a problem-solving tool when clinical and imaging findings are equivocal. This article aimed to raise a clear understanding of common pathologies expected in the assessment of PAP. A selection of multimodality images from our Specialist Mobility and Rehabilitation Unit are presented so that radiologists are aware of and recognize the spectrum of pathological conditions involving the amputation stump. These include but are not limited to aggressive bone spurs, heterotopic ossification, soft-tissue inflammation (stump bursitis), collection, nervosas, osteomyelitis etc. The role of the radiologist in reaching the diagnosis early is vital so that appropriate treatment can be instituted to limit long-term disability. The panel of authors hopes this article helps readers identify the spectrum of pathological conditions involving the post-amputation stump by recognizing the imaging features of the abnormalities in different imaging modalities.

Phantom limb pain after amputation in diabetic patients does not differ from that after amputation in nondiabetic patients.

There is a commonly held belief that diabetic amputees experience less phantom limb pain than nondiabetic amputees because of the effects of diabetic peripheral neuropathy; however, evidence to verify this claim is scarce. In this study, a customised postal questionnaire was used to examine the effects of diabetes on the prevalence, characteristics, and intensity of phantom limb pain (PLP) and phantom sensations (PS) in a representative group of lower-limb amputees. Participants were divided into those who had self-reported diabetes (DM group) and those who did not (ND group). Participants with diabetes were further divided into those with long-duration diabetes (>10years) and those with short-duration diabetes. Two hundred questionnaires were sent, from which 102 responses were received. The overall prevalence of PLP was 85.6% and there was no significant difference between the DM group (82.0%) and the ND group (89.4%) (P=0.391). There was also no difference in the prevalence of PS: DM group (66.0%), ND group (70.2%) (P=0.665). The characteristics of the pain were very similar in both groups, with sharp/stabbing pain being most common. Using a 0-10 visual analogue scale, the average intensity of PLP was 3.89 (±0.40) for the DM group and 4.38 (±0.41) for the ND group, which was not a statistically significant difference (P=0.402). Length of time since diagnosis of diabetes showed no correlation with average PLP intensity. Our findings suggest that there is no large difference in the prevalence, characteristics, or intensity of PLP when comparing diabetic and nondiabetic amputees, though a larger adjusted comparison would be valuable.