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
Scientific
School of Health & Social Studies
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 024 76 575850 |
|---|---|
| m.w.cooke@warwick.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | A randomised controlled trial to estimate the clinical and cost-effectiveness of four different methods of mechanical support in severe ankle sprains |
| Study acronym | CAST |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Injury, occupational diseases, poisoning: Musculoskeletal injury |
| Intervention | 1. Below knee plaster cast 2. Kendall ankle support 3. Bledsoe boot 4. Tubigrip |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 18/11/2002 |
| Completion date | 17/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 650 |
| Key inclusion criteria | Patients with Grade II and III sprains of the ankle joint. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 18/11/2002 |
| Date of final enrolment | 17/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Health & Social Studies
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
