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


CONCLUSIONS
This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.
Lamb
S E
SE
Centre for Primary Health Care Studies, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK. s.lamb@warwick.ac.uk
Nakash
R A
RA
Withers
E J
EJ
Clark
M
M
Marsh
J L
JL
Wilson
S
S
Hutton
J L
JL
Szczepura
A
A
Dale
J R
JR
Cooke
M W
MW
D016512:Ankle Injuries / Q000628:therapy*; D004636:Emergency Service, Hospital; D017048:Health Care Costs; D006801:Humans; D009989:Orthotic Devices / Q000191:economics*; D012107:Research Design; D013180:Sprains and Strains / Q000628:therapy*; D016896:Treatment Outcome