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. Partial Rotator Cuff Repair Trial (PRoCuRe Trial)
Rees J., Carr A., Cook J., Rangan A., Millar J., van der Windt D., Keele A., Prieto-Alhambra D., Pinedo-Villanueva R., Jaggi A., Cooper C., Jepson M., Lamb S., Lorenc A., Merritt N., Chester-Jones M., Appleton L., Fletcher H., Davies L., Beard D.
Aims and objectives: To assess if surgical repair of partial rotator cuff tears is effective in patients with persistent shoulder pain despite physiotherapy and steroid injection. Background: Rotator cuff tears are shoulder tendon tears causing pain, weakness and loss of movement, leading to problems with daily activities, work, recreation and sleep. Tears can be full thickness (whole tendon) or partial. Patients who do not get better with non-operative treatments may choose surgery. Although rotator cuff tears cause pain and disability, it is not known which surgery is best or if repairing partial tears prevents full tears and worsening problems. Methods: We planned a randomised controlled trial across 20 UK NHS hospitals . Between July 2021 and August 2022 we aimed to recruit 376 patients over 18 years of age suffering persistent shoulder pain and partial rotator cuff tears . Eligible patients received arthroscopic (keyhole) surgery to either debride (shave away inflamed tissue, rough tear edges and bone spurs) and repair the tear, or debride only without repair. Patients were followed up using questionnaires. Key findings: This study of an elective surgical procedure was severely impacted by the COVID-19 pandemic, especially staff shortages, sickness and redeployment. Changes post pandemic to the patient pathway and national surgical prioritisation processes had a major impact on identifying eligible patients with partial tears. All these factors effected site set-up and patient recruitment. The study closed early due to slow recruitment. Only 10 patients from 9 NHS Trusts were randomised, precluding any meaningful analysis . Patient and public involvement: Patients were involved in the study design, set up and monitoring. Conclusions and future plans: The impact of the pandemic prevented trial progression and this research question is now likely to remain unanswered. Detailed post-pandemic feasibility work is needed before attempting a similar study.