Title: UK Study of tendo Achilles Rehabilitation – multicentre randomised clinical trial (UK STAR)
Funder: Department of Health and Social Care

Abstract: 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 of living 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 strategy for patients with a rupture of the Achilles. In operatively treated patients, current evidence suggests that functional bracing provides better functional outcomes compared with rehabilitation in plaster casts. However the role of functional bracing in non-operatively managed patients is unclear. We therefore propose to perform a multi-centre randomised trial of plaster cast immobilisation versus functional bracing for patients with a rupture of the Achilles tendon managed non-operatively. 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 randomised controlled trial in a minimum of 22 trauma centres across the UK. All adult patients presenting at the trial centres with a primary 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, they will be eligible to take part in the trial. A computer generated randomisation sequence, stratified by centre, will be produced and administered independently by a secure web-based service. Randomisation will be on a 1:1 basis to either functional bracing or plaster cast. Both of these rehabilitation strategies are widely used for various indications within the NHS, and all of the clinical teams in the chosen centres will be familiar with both techniques. Research sites will be instructed to follow a standardised protocol for both treatments, but the details of the plaster material and brace will be left to the discretion of the treating clinician, as per their usual practice. A total of 330 patients will be randomised to obtain 90% power to detect a difference of 8 points in Achilles Tendon Rupture Score (ATRS) at 9 months at the 5% level. The ATRS is a 10-question, patient reported, outcome measure designed for patients with an Achilles tendon rupture. Baseline demographic data and pre-injury functional data using the ATRS will be collected. The patients will also be asked to fill out the EuroQol EQ-5D-5L health-related quality of life questionnaire to indicate their typical pre-injury and current health status. A research associate will perform a clinical assessment and make a record of any early complications at 8 weeks. Functional outcome, health-related quality of life and resource use questionnaires will be collected at 3, 6 and 9 months post-injury. The main analysis will investigate differences in the primary outcome measure, the ATRS at 9 months after the injury, between the two treatment groups on an intention-to-treat basis. The differences between treatment groups will be assessed using a Student t-test, based on a Normal approximation for the ATRS score at 9 months, and at other occasions.

Lay abstract: 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 total of 330 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.

Research activity codes: 6.3 MEDICAL DEVICES;7.1 INDIVIDUAL CARE NEEDS
Health categories: MUSCULOSKELETAL