Title: UK study of ankle fracture rehabilitation – multicentre randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Background Ankle fractures are common, with an annual incidence of 184 per 100,000 annually.This figure is expected to increase three-fold by 2030. Patients requiring surgical fixation of their fracture usually have their ankle immobilised with a plaster cast. This provides maximum support for the healing ankle but is associated with stiffness and muscle wasting. A Cochrane review (2012) concluded that functional bracing may reduce muscle wasting and speed recovery of ankle movement. However no definitive evidence currently exists regarding the optimal rehabilitation strategy for patients with an ankle fracture. Research Question Does use of a functional ankle brace improve functional and clinical outcomes six months after injury following an ankle fracture when compared to immobilisation in a cast? Aims and Objectives The aim of this project is to improve functional outcomes by determining the best rehabilitation strategy for ankle fractures. The primary objective is to quantify and draw inferences on observed differences in the Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ) at six months after injury between adults with an ankle fracture followed by functional bracing versus standard plaster cast care. The secondary objectives are:To quantify and draw inferences on observed differences between the functional status (MOXFQ) of the trial treatment groups at three, 12 and 24 months.To quantify and draw inferences on observed differences between health related quality of life (EQ5D-5L) of the trial treatment groups at three, six, 12 and 24 months.To quantify and draw inferences on observed differences in the radiological outcomes: joint congruence, fracture angulation, fibular shortening, subluxation and non-union at 6 weeks and 6 months.To estimate comparative cost-utility of the two trial treatment groups.To determine the difference in complication rate between the trial treatment groups.Plan of Investigation: The proposed project will be randomised controlled trial across a minimum of 19 hospitals across the UK. All patients with a fractured ankle under the care of an orthopaedic consultant are potentially eligible. The trial will employ a 1:1 randomisation sequence, stratified by age, centre and whether or not the patient receives surgical fixation. It will be implemented using a remote, independent telephone randomisation service at Warwick Clinical Trials Unit. All patients will follow a standardised protocol for both rehabilitation methods that are routinely used across the UK centres. A total of 476 patients will be randomised. Baseline pre and post injury functional data using the MOXFQ alongside the EuroQol EQ-5D-5L health related quality of life questionnaire will be collected. A research associate will perform clinical assessment at six weeks and six months to record any early and late complications and collect routine x-rays at these time points. Functional outcome, health related quality of life and resource use questionnaires will be collected at three, six, 12 and 24 months post injury. The main analysis will investigate the primary outcome measure, the MOXFQ, at six months. Benefits to patients and the NHS: This large multi-centre trial will provide authoritative high quality evidence determining the best rehabilitation strategy for ankle fractures.

Lay abstract: Background In the UK, there are 184 per 100,000 persons sustaining an ankle fracture annually. This figure is expected to increase three fold by 2030 due to a greater population of older adults. Immediate impact on the patient includes difficulty walking and pain. Longer term impact includes inability to participate in recreational/work activities and development of arthritis in the ankle. Current Treatment Regardless of whether or not a patient has surgery to fix the ankle fracture, standard care involves immobilisation of the ankle in a plaster cast. The cast provides maximum support, but immobilises the ankle completely which causes muscle wastage, joint stiffness and other complications. An alternative rehabilitation plan uses a functional brace, which is a type of walking-boot that can be removed. This does not provide as much support for the ankle, but it can be removed to allow early movement of the ankle which may overcome the problems associated with rigid plaster casts. Currently there is no definitive study comparing these two approaches. Research Plan Following on from my current feasibility to answer the question Can this study be done?' I will now proceed to a full trial comparing plaster cast versus functional bracing for patients with a broken ankle to answer the question Which rehabilitation method is best?'. Patient and public members have been consulted throughout the planning stages for this research project and will continue to lead the development of its implementation and dissemination of its results through an ongoing active collaboration. To answer this important question the study will be conducted across a minimum of 19 hospitals across the UK. Hospital sites will be recruited using as a phased roll out process to ensure scalability of trial process. Throughout, patient/public representatives will be part of the research team to ensure that the study is designed to meet the needs of the patients taking part. Adult patients with a broken ankle that a doctor would consider plaster cast to be a reasonable management option will be screened. All participants who consent to take part in the research will be allocated to either a functional brace or a plaster cast, with an equal chance of getting either treatment. Both treatments are widely used, and clinical teams across the UK will be familiar with both. A total of 476 patients will be entered into the study. The effect of the injury and the patients' recovery will be assessed using a questionnaire. The questionnaire will collect information about any complications that have occurred since being treated, what physical activities the patient can complete, alongside information on their general health and wellbeing and any out of pocket expenses. This information will be collected during routine hospital follow up appointments at 6 and 24 weeks and through postal collection at 6, 12 and 24 months. The main question I will investigate is whether at six months after injury, is there a difference in foot/ankle function between the two treatment groups.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS