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
|
---|---|
Published in |
Pilot and Feasibility Studies, March 2017
|
DOI | 10.1186/s40814-017-0125-z |
Pubmed ID | |
Authors |
Rebecca S. Kearney, Nick Parsons, Dipesh Mistry, Jonathan Young, Jaclyn Brown, Joanne O’Beirne-Elliman, Matthew Costa |
Abstract |
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. 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. 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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 22 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Other | 4 | 18% |
Student > Ph. D. Student | 4 | 18% |
Student > Master | 3 | 14% |
Student > Bachelor | 2 | 9% |
Student > Doctoral Student | 2 | 9% |
Other | 2 | 9% |
Unknown | 5 | 23% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 9 | 41% |
Nursing and Health Professions | 5 | 23% |
Psychology | 1 | 5% |
Social Sciences | 1 | 5% |
Neuroscience | 1 | 5% |
Other | 0 | 0% |
Unknown | 5 | 23% |