A randomised controlled trial to estimate the clinical and cost-effectiveness of four different methods of mechanical support in severe ankle sprains

ISRCTN ISRCTN37807450
DOI https://doi.org/10.1186/ISRCTN37807450
Secondary identifying numbers HTA 01/14/10
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
16/01/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Matthew Cooke
Scientific

School of Health & Social Studies
University of Warwick
Coventry
CV4 7AL
United Kingdom

Phone +44 024 76 575850
Email m.w.cooke@warwick.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleA randomised controlled trial to estimate the clinical and cost-effectiveness of four different methods of mechanical support in severe ankle sprains
Study acronymCAST
Study objectivesTo 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedInjury, occupational diseases, poisoning: Musculoskeletal injury
Intervention1. Below knee plaster cast
2. Kendall ankle support
3. Bledsoe boot
4. Tubigrip
Intervention typeOther
Primary outcome measureNot provided at time of registration.
Secondary outcome measuresNot provided at time of registration.
Overall study start date18/11/2002
Completion date17/05/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants650
Key inclusion criteriaPatients with Grade II and III sprains of the ankle joint.
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment18/11/2002
Date of final enrolment17/05/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Health & Social Studies
Coventry
CV4 7AL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 13/01/2005 Yes No
Results article results 14/02/2009 Yes No
Results article results 01/08/2010 Yes No
Results article case study results 14/01/2020 16/01/2020 Yes No

Editorial Notes

16/01/2020: Publication reference added.