Title: Partial Rotator Cuff Tear Repair Trial (PRO CURE Trial)
Funder: Department of Health and Social Care

Abstract: WHAT ARE PARTIAL ROTATOR CUFF TEARS?_x000D_ Rotator cuff tears are tendon tears in the shoulder that cause pain, weakness and loss of movement. People affected have problems with day to day activities, work, recreation and sleep. These tears can be full tears through the whole tendon or only part way through - a partial tear. Partial tears are treated in the NHS first with physiotherapy and a steroid injection. Patients who do not get better with these treatments may then choose to have surgery._x000D_ _x000D_ WHY IS THIS STUDY IMPORTANT?_x000D_ The aim of this study is 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 surgery has any extra value. In particular, we don’t know if repairing partial tears prevents bigger full tears and worsening problems. Surgery for full tears is one of the most common shoulder operations in the UK. Prevention of full tears was identified as important by patients and doctors in the 2015 James Lind Alliance Priority Setting Partnership (PSP) for Surgery for Common Shoulder Conditions (4 of the top 10 priorities were about rotator cuff problems)._x000D_ 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._x000D_ _x000D_ HOW WILL THE STUDY BE DESIGNED?_x000D_ We plan to conduct a study across 20 NHS hospitals in the UK, recruiting patients aged over 30 years. These patients will have persistent shoulder pain and partial tears of the rotator cuff tendon. They will only be recruited if they have chosen to have surgery after continuing to experience shoulder pain and disability after completing physiotherapy treatment and an injection._x000D_ We will conduct a study called a randomised controlled trial to make sure the effect of tendon repair surgery is assessed correctly and the other general effects of surgery are taken into account. The trial will compare the tendon repair procedure to similar surgery but with no repair: Arthroscopic (Keyhole) cleaning and tidying of the tear AND REPAIR; compared to Arthroscopic cleaning and tidying of the tear WITHOUT REPAIR. In each participant the type of surgery received will be chosen at random by a computer programme._x000D_ We will then monitor how well patients recover from their treatment using questionnaires about benefit and satisfaction. We will also carry out shoulder scans at 2 years to see whether larger full tears have been prevented. We will determine the costs of the two different surgeries and any further treatments over two years. We also plan a 5 year follow-up study using routine information collected by the NHS._x000D_ _x000D_ PATIENT INVOLVEMENT_x000D_ We have conducted patient focus groups and a surgeon survey. Patients and surgeons agreed this is the only feasible way to answer this research question. Patients have been central to developing this application and will continue to be involved in the study setup, implementation and dissemination plans. A patient from the 2015 JLA PSP is a co-applicant on this application._x000D_ We plan to publicise the results of the study widely and use the evidence to influence and improve patient care pathways, including provision of guidelines for primary care and hospital health workers who manage and treat patients with rotator cuff problems.

Lay abstract: AIM: To investigate the clinical & cost effectiveness of surgically repairing degenerative partial thickness rotator cuff tears (PTT) in symptomatic patients by conducting a multicentre blinded RCT using a 2 arm parallel design with 1:1 allocation; including a 5-year follow up using routinely collected NHS data in Hospital Episode Statistics (HES)_x000D_ SETTING/DATA SOURCES: 20 Secondary Care NHS Hospitals & HES_x000D_ POPULATION: Patients aged over 30 years_x000D_ INCLUSION CRITERIA: Patients with recalcitrant subacromial shoulder pain after 6 months of physiotherapy & at least 1 subacromial injection; who have chosen surgery; & Magnetic Resonance Imaging (MRI) or Ultrasound Scan (USS) suggests a PTT. USS & MRI are poor at diagnosing PTTs (1), & PTTs are only repaired when > 50% of the tendon thickness (or >50% PTT with a minor full thickness breach), & so their presence and suitability can only be confirmed intra-operatively. 30% of patients will become ineligible and so randomisation will therefore be done after PTT confirmation._x000D_ EXCLUSION CRITERIA: Patients found intra-operatively to have; no tear; PTT < 50% tendon thickness; or an established full tear thickness tear (FTT). Steroid injection if within 6 weeks of surgery, inflammatory arthritis, gleno-humeral arthritis, malignancy, tears with acute fractures, upper limb neuro deficit_x000D_ INTERVENTION: Arthroscopic Debridement & Repair. PTTs are either on the joint side or bursal side of the tendon. Surgeons need to debride tissue to fully inspect & confirm the presence & extent of any PTT. They then perform an arthroscopic in-situ repair (without converting to FTT), or a take-down repair (conversion to small FTT before repair)._x000D_ CONTROL: Arthroscopic Debridement Only (NO Repair). This procedure is the first half of the procedure above but with NO repair_x000D_ The post-op rehab will be the same in both groups_x000D_ OUTCOMES: The primary outcome measure will be the Oxford Shoulder Score (OSS) at 2 years (18-21). Secondary outcomes will be OSS at 6 & 12 months, EQ5D, patient satisfaction, resource-usage, complications, further surgery & MRI at 2 years._x000D_ SAMPLE SIZE: To detect an MCID of 4 OSS points, assuming a SD of 9 with 2-sided 5% significance level & 90% statistical power, 108 participants per group are needed. Allowing for 20% attrition, the final sample size is 135 per group (270 overall). Allowing for 30% ineligibility intra-operatively means 386 patients will be recruited_x000D_ STATISTICAL ANALYSIS: This will be according to randomised groups & at 5%, 2-sided, significance level for all analyses with 95% confidence intervals calculated; primary & secondary outcomes will be analysed using generalised linear models adjusted for randomisation variables_x000D_ MILESTONES: Full trial setup (0-8 months). Pilot (8-14 months). QuinteT Recruitment Intervention (0-24 months). The first 6 centres will recruit 30 patients during the pilot and then 1 patient/centre/month once all centres recruiting. Recruitment (8-32 months). Final follow up (56 months). Analysis & write up (56-62 months). 2nd stage HES data cut (92 months), HES analysis & write up (93-110 months)_x000D_ EXPERTISE: Multicentre Trials (Oxford, Keele); HES (Oxford, Keele); QuinteT (Bristol, Oxford); data analysis & interpretation (All); PPI & dissemination (All)

Research activity codes: 6.4 SURGERY
Health categories: MUSCULOSKELETAL