Trial Status - Under Analysis
UK STAR is funded by the NIHR Health Technology Assessment programme.
HTA Project Reference: 13/115/62
UK Study of Tendo Achilles Rehabilitation
The Achilles tendon is the largest tendon in the human body and transmits the powerful contractions of the calf muscles that are required for walking and running. Consequently, when the tendon ruptures it has a serious detrimental impact on daily activities and results in prolonged periods off work and away from sporting activity. Achilles rupture affects over 11,000 people each year in the UK, and the incidence is increasing as the population remains more active into older age. Controversy remains with regards the best rehabilitation plan for patients with a rupture of the Achilles. Traditionally, patients have been treated in a series of plaster casts; the casts extend from below the knee and around the ankle. The position of the cast is changed until the patient can put their weight through the foot. However, there is some evidence that a functional brace or walking boot , gives as much support and may speed recovery in the first year after the injury. We therefore propose to perform a multi-centre randomised trial of plaster casts versus functional bracing for patients with a rupture of the Achilles tendon.
The proposed project is a two-phased study. Phase 1 will confirm how many patients are willing to take part in a large-scale multi-centre randomised controlled trial. Phase 2 will be the proposed randomised controlled trial in a minimum of 22 hospitals across the UK. All adult patients attending one of trial centres with a rupture of the Achilles tendon will be screened. The patient, together with their surgeon, will decide if they have surgery or not. If they decide not to have surgery, they will be eligible to take part in the trial. Patients will be allocated to either functional bracing or plaster cast, with an equal chance of getting either treatment. Both plaster casts and functional braces are widely used within the NHS, for both broken bones and sprains, and all of the clinical teams in the trial centres will be familiar with both techniques. A minimum of 330, maximum of 550 patients will be entered into the study. Baseline data and pre-injury function will be assessed using a questionnaire. The patients will also be asked to fill out a quality of life questionnaire. A research associate will perform a clinical assessment and make a record of any early complications at 8 weeks. Functional outcome, quality of life and questionnaires of out-of-pocket expenses will be collected at 3, 6 and 9 months post-injury. The main question we will investigate is whether there is a difference in the Achilles tendon Rupture Score at 9 months after the injury, between the two treatment groups.