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Open Access Study protocol

Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450]

SE Lamb12*, RA Nakash1, EJ Withers1, M Clark1, JL Marsh3, S Wilson4, JL Hutton3, A Szczepura1, JR Dale1, MW Cooke1 and the Collaborative Ankle Support Trial research team (CAST)

Author Affiliations

1 Centre for Primary Health Care Studies, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK

2 Kadoorie Critical Care Research Centre, John Radcliffe Hospital, Oxford, OX3 9DU, UK

3 Department of Statistics, University of Warwick, Coventry, CV4 7AL, UK

4 Department of Primary Care and General Practice, Medical School, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

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BMC Musculoskeletal Disorders 2005, 6:1  doi:10.1186/1471-2474-6-1

Published: 13 January 2005

Abstract

Background

The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast® brace and Bledsoe® boot) in comparison to Tubigrip®, and (2) to compare the cost of each strategy, including subsequent health care costs.

Methods/design

Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions.

Discussion

This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.