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
Protocol serial number	HTA 01/14/10
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Not provided at time of registration.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	17/05/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

School of Health & Social Studies

Coventry
CV4 7AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	13/01/2005		Yes	No

Editorial Notes

16/01/2020: Publication reference added.