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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 ISSN 2055-5784.
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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 | ||||||
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| Subjects: | R Medicine > R Medicine (General) | ||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| 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: |
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| 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 (Creative Commons) | ||||||
| Date of first compliant deposit: | 28 March 2018 | ||||||
| Date of first compliant Open Access: | 28 March 2018 | ||||||
| RIOXX Funder/Project Grant: |
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