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A protocol for a feasibility randomised controlled trial to assess the difference between functional bracing and plaster cast for the treatment of ankle fractures

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Kearney, Rebecca S., Parsons, Nicholas R., Mistry, Dipesh, Young, Jonathan, Brown, Jaclyn, O’Beirne-Elliman, Joanne and Costa, Matthew L. (2017) A protocol for a feasibility randomised controlled trial to assess the difference between functional bracing and plaster cast for the treatment of ankle fractures. Pilot and Feasibility Studies, 3 (1). 11. doi:10.1186/s40814-017-0125-z

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Official URL: http://dx.doi.org/10.1186/s40814-017-0125-z

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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.

Discussion:
This feasibility trial will provide authoritative high-quality evidence to inform the design of a definitive trial in this important area.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Ankle -- Fractures -- Treatment, Clinical trials -- Design, Surgical plaster casts
Journal or Publication Title: Pilot and Feasibility Studies
Publisher: BioMed Central Ltd.
ISSN: 2055-5784
Official Date: 1 March 2017
Dates:
DateEvent
1 March 2017Published
28 January 2017Accepted
Volume: 3
Number: 1
Article Number: 11
DOI: 10.1186/s40814-017-0125-z
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
PB-PG-0614-34009National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272

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