Study Synopsis
Study Title: The clinical and cost effectiveness of surgical repair of partial rotator cuff tears in patients with subacromial shoulder pain: A comparison of surgical repair versus surgery with no repair.
Short Title: Partial Rotator Cuff Tear Repair Trial (PRoCuRe)
Study Design: Multi-centre, parallel, patient blinded two arm randomised controlled trial, with integrated QuinteT Recruitment Intervention (QRI) to support recruitment
Sample Size: Approx. 386 recruits will be needed to achieve 270 randomised participants.
Recruitment Period: 24 months
Study Participants
Patients aged over 18 years with subacromial shoulder pain and a partial thickness rotator cuff tear, for whom their normal pathway management of physiotherapy, steroid injection over a six month period has failed, and have decided to pursue surgical treatment.
Study Treatments
- Arthroscopic Debridement Only (ADO)
- Arthroscopic Debridement with Arthoscopic Repair (ADAR)
Primary Outcome
Oxford Shoulder Score (OSS) at 24 months post-randomisation
Post-Randomisation Follow-up
- Questionnaire follow-up at 6, 12, 24 months and 5 years
- MRI scan at 24 months
- HES data follow-up at 5 years
- Are you a consultant orthopaedic surgeon based at an NHS Trust in England?
- Do you perform partial rotator cuff repair surgery?
- Are you interested in becoming a Principal Investigator (PI) for PRoCuRe?
Use the 'contact us page' to express your interest in becoming a recruiting centre