The Library
A protocol for a feasibility randomised controlled trial to assess the difference between functional bracing and plaster cast for the treatment of ankle fractures
Tools
Tools
Tools
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
|
PDF
WRAP-protocol-feasibility-randomised-controlled-trial-assess-difference-between-functional-bracing-plaster-cast-Kearney-2017.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (731Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s40814-017-0125-z
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: |
|
||||||
| Date of first compliant deposit: | 28 March 2018 | ||||||
| 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: |
|
Request changes or add full text files to a record
Repository staff actions (login required)
 |
View Item |
Downloads
Downloads per month over past year
