PROCURE

AIM

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).

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.

STUDY DESIGN

We plan to conduct a study across 20 NHS hospitals in the UK, recruiting patients aged over 18 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.
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.

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.

PATIENT INVOLVEMENT

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.

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.