UK STAR
Research type
Research Study
Full title
UK Study of tendo Achilles Rehabilitation – multicentre randomised clinical trial
IRAS ID
163094
Contact name
Matthew Costa
Contact email
ISRCTN Number
ISRCTN62639639
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
The proposed project is a two-phased study. Phase 1 (Internal Pilot) will confirm the expected rate of recruitment in a large-scale multi-centre randomised controlled trial. Phase 2 (Main phase) will be the proposed RCT in a minimum of 22 trauma centres across the UK.
Internal Pilot summary
The pilot will take place in 6 centres over a period of 6 months. The aim of this initial phase will be to determine the number of eligible and recruited patients in the trauma centres. The pilot will also be used as a basis for testing the systems for collecting outcomes, including measures required for the economic evaluation. The trial will be stopped if the target recruitment during the internal pilot is not achieved.
Main RCT summary
All adult patients presenting at the trial centres with a primary (first-time) rupture of the Achilles tendon will be screened. The patient, in conjunction with their surgeon, will decide if they have surgery or not. If they decide not to have surgery (non-operative treatment), they will be eligible to take part in the trial. The broad eligibility criteria will ensure that the results of the study can readily be generalised to the wider patient population.Randomisation will be on a 1:1 basis to either functional bracing or plaster cast. Both of these rehabilitation strategies are widely used within the NHS and all of the clinical teams in the chosen centres will be familiar with both techniques.
Baseline pre-injury demographic, health-related quality of life (EQ-5D-5L) and functional data using the validated Achilles Tendon Rupture Score (ATRS) will be collected.
A record will be made of any early complications at 8 weeks when the cast/brace is removed and patients will be asked to complete the ATRS. Functional outcome, health-related quality of life, complications and resource use questionnaires will be collected at 3, 6 and 9 months post-injury.REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0109
Date of REC Opinion
18 Mar 2016
REC opinion
Favourable Opinion