|
ISRCTN
|
ISRCTN37807450
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised controlled trial to estimate the clinical and cost-effectiveness of four different methods of mechanical support in severe ankle sprains
|
|
Scientific title
|
|
|
Acronym
|
CAST
|
|
Serial number at source
|
HTA 01/14/10
|
|
Study hypothesis
|
To estimate:
1. The clinical effectiveness of three different methods of ankle support (below knee plaster cast, Kendall ankle support, Bledsoe boot) in comparison to Tubigrip in the recovery of mobility and function after Grade II and III sprains of the ankle joint.
2. The cost-effectiveness of the three different methods of ankle support in comparison to Tubigrip only. The economic analysis will be conducted from a societal perspective.
Tubigrip has been chosen as the reference (status quo) treatment; it is the cheapest, but is likely to be least effective (ref 1). The Bledsoe boot is a factor of 30 times more expensive (US$50 usual, assuming no re-use), and its clinical effectiveness is yet to be proven. The below knee plaster cast will be Scotch Cast (cost £5). There are a range of ankle supports available. We have selected the Kendall Gel Brace (£19 per brace), which is the cheapest and, in our experience is as clinically effective as other brands. All treatments will be provided in the NHS, in a manner consistent with current national practice.
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Injury, occupational diseases, poisoning: Musculoskeletal injury
|
|
Participants - inclusion criteria
|
Patients with Grade II and III sprains of the ankle joint.
|
|
Participants - exclusion criteria
|
Not provided at time of registration.
|
|
Anticipated start date
|
18/11/2002
|
|
Anticipated end date
|
17/05/2006
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
650
|
|
Interventions
|
1. Below knee plaster cast
2. Kendall ankle support
3. Bledsoe boot
4. Tubigrip
|
|
Primary outcome measure(s)
|
Not provided at time of registration.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration.
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
|
|
Publications
|
Study protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15777484
|
|
Contact name
|
Dr
Matthew
Cooke
|
|
Address
|
School of Health & Social Studies
University of Warwick
|
|
City/town
|
Coventry
|
|
Zip/Postcode
|
CV4 7AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 024 76 575850
|
|
Fax
|
+44 024 76 574657
|
|
Email
|
m.w.cooke@warwick.ac.uk
|
|
Sponsor
|
Department of Health (UK)
|
|
Address
|
Quarry House
Quarry Hill
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 7UE
|
|
Country
|
United Kingdom
|
|
Email
|
Sheila.Greener@doh.gsi.gov.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/en/index.htm
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
14/01/2008
|
|
Date ISRCTN assigned
|
25/04/2003
|
