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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., Nakash, Rachel Anne, Withers, Emma J., Clark, M. D., Marsh, J. L., Wilson, Sue, Hutton, Jane, Szczepura, Ala, Dale, Jeremy and Cooke, Matthew. (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

Dates:

Date	Event
January 2005	Published

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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