Details of HTA project
Last updated: 1 July 2008 - Next update due: 8 July 2008
Research type: |
Primary Research (e.g. trial) |
Project title: |
A randomised controlled trial to estimate the clinical and cost-effectiveness of four different methods of mechanical support in severe ankle sprains (CAST) |
Project ref: |
01/14/10 |
Cost: |
£388,142 |
Chief Investigator : |
Professor Matthew W Cooke, Professor of Emergency Care, Warwick Emergency Care and Rehabilitation, Warwick Medical School & Heart of England NHS Foundation NHS Trust |
Start Date: |
November 2002. |
Publication date: |
March 2009. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed. |
Plain English Summary |
This study aims to determine the best treatment for severe ankle injuries. Various splints have been developed to help early movement whilst also supporting the ankle but it is not known which, if any, of these is the best treatment . The four different treatments are being compared: An elastic bandage worn during the day A plaster of Paris cast, like used when people break a bone A plastic splint that supports the side of the ankle A boot that looks like a ski boot that supports the ankle but has a hinge to allow movement The study is looking at the most severe ankle sprains, where patients cannot manage to put any weight through that leg. People attending accident and emergency departments at seven hospitals are being invited to participate. They are then assigned to one of the treatments at random. They can still have other treatments as usual. Anybody taking part is asked to complete a series of questionnaires over the next nine months. These questionnaires determine how quickly recovery has occurred and any problems that persist. A key way of deciding recovery is the person's ability to walk and undertake usual activities such as sport and work. More information on the trial is available at www.warwick.ac.uk/go/ankle |
Abstract: |
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. |
MeSH* index primary terms: |
ANKLE-INJURIES Q-therapy; SPRAINS-AND-STRAINS Q-therapy; SPLINTS; BRACES |
MeSH* index secondary terms: |
HUMAN; PROSPECTIVE-STUDIES; RANDOMIZED-CONTROLLED-TRIAL; CLINICAL-TRIAL; EVALUATION-STUDIES; QUALITY-OF-LIFE; QUESTIONNAIRES |
NRR* number, if applicable: |
N0484128006 (*National Research Register) |
ISRCTN* number: | ISRCTN 37807450 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN37807450 |
Project Protocol: |
Project protocol not available |
URL of this page: |
http://www.hta.ac.uk/1309 |
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