title: A protocol for a feasibility randomised controlled trial to assess the difference between functional bracing and plaster cast for the treatment of ankle fractures.
abstract: BACKGROUND
  UK Hospital Episode Statistics 2013-2014 recorded 57,286 fractures of the lower limb including the ankle. This figure is expected to continue to increase due to a greater population of older adults. Following an ankle fracture, patients 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 has concluded that functional bracing may reduce muscle wasting and speed recovery of ankle movement. The aim of this study is to determine the feasibility of conducting a full randomised controlled trial in adults with an ankle fracture followed by functional bracing and exercises versus standard plaster cast care.
  
  
  METHODS
  This is a single-centre feasibility randomised controlled trial. All patients with a fractured ankle are potentially eligible. The trial will employ 1:1 random allocation, stratified by age and non-operative/operative management. Baseline demographic and pre-injury functional data, the Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ) and Olerud and Molander Ankle Score (OMAS) will be collected alongside the EuroQol EQ-5D-5 L health-related quality of life questionnaire. A research associate will perform a clinical assessment and obtain X-rays in 6 weeks and 6 months post randomisation to record complications. Functional outcome and health-related quality of life will be collected in 6 weeks, 3 and 6 months post randomisation.
  
  
  CONCLUSIONS
  This feasibility trial will provide authoritative high-quality evidence to inform the design of a definitive trial in this important area.
  This study is registered with the ISRCTN (ISRCTN17809322), assigned 5 November 2015 and approved by the NRES Committee (The Black Country, 15/WM/0340), protocol version 2.0 (17 November 2015). It is co-sponsored by the University Hospitals Coventry and Warwickshire NHS Trust and University of Warwick and funded by the NIHR Research for Patient Benefit (PB-PG-0614-34009). The trial sponsors have no direct involvement in any aspects of study design, conduct or decision to submit the report for publication.
authors.affiliation: Clinical Trials Unit, University of Warwick, CV4 7AL Gibbet Hill Road, Coventry, England.
authors.forename: Rebecca S
authors.initials: RS
authors.lastname: Kearney
authors.affiliation: Warwick Medical School, University of Warwick, CV4 7AL Gibbet Hill Road, Coventry, England.
authors.forename: Nick
authors.initials: N
authors.lastname: Parsons
authors.affiliation: Clinical Trials Unit, University of Warwick, CV4 7AL Gibbet Hill Road, Coventry, England.
authors.forename: Dipesh
authors.initials: D
authors.lastname: Mistry
authors.affiliation: University Hospitals Coventry and Warwickshire NHS Trust, CV2 2DX Clifford Bridge Rd, Coventry, England.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Young
authors.affiliation: Clinical Trials Unit, University of Warwick, CV4 7AL Gibbet Hill Road, Coventry, England.
authors.forename: Jaclyn
authors.initials: J
authors.lastname: Brown
authors.affiliation: Clinical Trials Unit, University of Warwick, CV4 7AL Gibbet Hill Road, Coventry, England.
authors.forename: Joanne
authors.initials: J
authors.lastname: O'Beirne-Elliman
authors.affiliation: Trauma Unit, Kadoorie Centre, Level 3, John Radcliffe Hospital, OX3 9DU Oxford, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Costa
keywords: Ankle fracture; Orthopaedic procedures; Rehabilitation