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

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Lamb, S. E. (Sallie E.), Nakash, Rachel Anne, Withers, Emma J., Clark, M. D. (Michael D.), Marsh, J. L., Wilson, Sue, Dr, Hutton, Jane (Statistician), Szczepura, Ala, Dale, Jeremy, 1958- and Cooke, Matthew (Professor of clinical systems design). (2005) Clinical and cost effectiveness of mechanical support for severe ankle sprains : design of a randomised controlled trial in the emergency department [ISRCTN 37807450]. BMC Musculoskeletal Disorders, Vol.6 (No.1). ISSN 1471-2474

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Official URL: http://dx.doi.org/10.1186/1471-2474-6-1

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.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Sprains, Ankle -- Wounds and injuries, Joints -- Wounds and injuries
Journal or Publication Title:	BMC Musculoskeletal Disorders
Publisher:	BioMed Central Ltd.
ISSN:	1471-2474
Official Date:	January 2005
Volume:	Vol.6
Number:	No.1
Identification Number:	10.1186/1471-2474-6-1
Status:	Peer Reviewed
Access rights to Published version:	Open Access
Funder:	NHS R & D HTA Programme (Great Britain) (HTA)
Grant number:	01/14/10 (HTA)
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URI:	http://wrap.warwick.ac.uk/id/eprint/576