Partial Rotator Cuff Tear Repair Trial (PRoCuRe)
Research type
Research Study
Full 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.
IRAS ID
283908
Contact name
Jonathan Rees
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN60983694
Duration of Study in the UK
7 years, 0 months, 31 days
Research summary
Rotator cuff tears are tendon tears in the shoulder that cause pain, weakness and loss of movement. These tears can be full tears through the whole tendon or only part way through - a partial tear. The PRoCuRe study aims to assess if surgical repair of partial tears, in patients with persistent pain despite physiotherapy, is effective.
The study is important because, even though rotator cuff problems are the most common cause of shoulder pain and disability, it remains unknown how best to treat them and whether surgical repair has any extra value. In particular, we don’t know if repairing partial tears prevents bigger full tears and worsening problems.
The main aim of this study is therefore to find out if repairing these partial tears is effective, provides lasting benefit and prevents bigger tears. We will do this by conducting a study called a randomised controlled trial to assess any benefit of tendon repair surgery. PRoCuRe will compare two similar procedures: Arthroscopic (keyhole) surgery to debride (shave away inflamed tissue, rough tear edges, and bone spurs) and repair the tear; compared to Arthroscopic surgery to debride only (shave away inflamed tissue, rough tear edges, and bone spurs) without any repair. Repairing the tear involves stitching some of the tendon back to bone. 270 patients with a partial thickness tear will have one of these two treatments options by random allocation.
Using questionnaires, participants will be monitored to assess how well they recover from their treatment, and how much benefit they have received. Patients will also undergo a shoulder scan at their local hospital 2 years after randomisation. Longer term follow up (5 years after surgery) to assess benefit of each surgery will be collected using routine information collected by the NHS, and a patient questionnaire.
REC name
London - Central Research Ethics Committee
REC reference
21/LO/0081
Date of REC Opinion
3 Feb 2021
REC opinion
Favourable Opinion