Title: Patient acceptability of a novel prosthetic device: A randomised feasibility study in older patients with vascular-related amputations and multimorbidities
Funder: Department of Health and Social Care

Abstract: Background:The majority of amputations in the UK are transtibial (below-knee), as a result of diabetes and/or vascular disease and occur in patients over 50 years. Therefore, individuals with a lower-limb amputation (LLA) must deal with concomitant factors related to their age, their new physical constraints, and overall worsening health and well-being. Many older patients with a transtibial amputation routinely receive a standard (rigid) prosthesis, designed for walking on level ground, and does not accommodate to everyday activities such as stairs and slopes. Consequently, patients become more sedentary, report more pain and are overall dissatisfied with their healthcare provision. A self-aligning prosthesis specifically designed for everyday environments for patients with a LLA and limited mobility is available on the NHS, but seldom prescribed to older adults with other health comorbidities. Research into the effectiveness of this self-aligning prosthesis to ease daily walking is warranted, and an evaluation of the cost-effectiveness is necessary to inform clinical practice. Aim:The aim of this two-year study is to assess the feasibility of conducting an RCT about the effectiveness and cost-effectiveness of a novel prosthesis for older patients with vascular-related amputations and multimorbidities. The study will determine the patient recruitment rates from multiple prosthetics centres in England; determine acceptability to patients of randomisation to trial arms and of study processes; measure NHS resource use related to the novel prosthesis; identify a primary outcome measure(s) for future research and assess the feasibility of collecting patient-reported outcome measures, including adherence to the self-aligning prosthesis. Plan:Patients with a transtibial amputation of vascular and/or diabetic aetiology, over the age of 50 years and currently prescribed a standard functioning prosthesis will be recruited from three prosthetics centres across England. Following baseline measurements, psychometric measures, functional performance measures, resource use and daily activity monitoring with wearable technologies, patients will be randomised into a standard treatment (rigid) or novel (self-aligning) prosthesis group. Patients in the novel group will be asked to wear the new prosthesis for 12 weeks; patients in the standard group will keep their normal prosthesis. Follow-up measurements will be conducted mid-way through the intervention at 6 weeks and 12 weeks for all patients. A subset of patients (from different recruitment centres) will also be invited to attend a one-to-one interview to discuss their experience of participating in the study. The costs of providing the self-aligning prosthesis will be estimated and the potential resource implications versus the standard prosthesis explored. The data collected from all elements of the study will be used to determine the feasibility of a future trial. Potential benefits:Patients report a &ldquo;vicious circle&rdquo; in their treatment, whereby they are prescribed a low-functioning (standard) prosthesis, which they describe as &ldquo;not fit for purpose&rdquo;, as it limits their movement. Subsequently, with reduced usage, their prosthetic socket fit becomes painful, and their function deteriorates. Patients may become confined to a wheelchair, and their physical and mental health decline. They are not offered an alternative prosthesis and there is a lack of evidence to support provision of a more functional but expensive prosthesis. This research will help us determine if we can conduct a large scale RCT looking at whether the prescription of a more functional prosthesis leads to better outcomes for patients and is cost-effective. The long-term potential benefits to patients include improving current clinical practice and informing NHS policy regarding the most effective and cost-effective prosthesis for this group of patients. The main RCT will provide high-quality evidence that will inform the level of care offered to patients by NHS prosthetics services. The benefits also extend to ensuring a more integrated approach to prosthetic prescription. .

Lay abstract: Background:Annually, 6,000 people in the UK are referred for fitting of an artificial lower leg (known as a prosthesis) following the surgical removal of their limb (lower-limb amputation). These are mostly patients over 50 years and usually with diabetes and/or blood vessel (vascular) problems. Older patients are generally prescribed standard foot-ankle prostheses which are rigid at the &ldquo;ankle&rdquo;, unlike those often given to younger people which can adjust to slopes and stairs. It is unknown which is the best prosthesis for older patients. Aim:To see if it is possible to do a large randomised controlled trial comparing the standard foot-ankle prosthesis to a new version. We will first carry out a smaller study. Methods:We will look at the randomisation process, recruitment and whether patients found the study processes acceptable. Over two years, we want to recruit 90 older people with a below-knee amputation because of vascular problems and who find walking difficult. We will invite patients from three prosthetics centres across England to participate who will be placed randomly into one of two groups by a computer: wearing 1) their existing prosthesis; or 2) a new prosthesis for 12 weeks. We will hold interviews to ask how patients felt about the study. We will measure how far patients can walk, how long they wear their prosthesis daily, and ask them to score their pain, health and well-being. We will do this with questionnaires, simple exercise tests and wearable activity monitors. Public involvement:We have already spoken to patients with a lower-limb amputation and their input has been valuable in developing the research questions around what is important to them, including walking ability, managing daily activities and measuring pain. Members of that group will be invited to the steering committee and help share the findings with fellow patients.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: METABOLIC AND ENDOCRINE;CARDIOVASCULAR