Randomized Study of Arthroscopic Surgery for Massive Rotator Cuff Tears Comparing Debridement with or without a Biodegradable Balloon Spacer for Patients Aged 60 to 85 Years

What this Trial Is About

Massive rotator cuff tears affect about 12% of adults aged 60 or older, with 40% of these injuries classified as massive. These tears cause significant pain and have limited treatment options. This research investigates a new surgical treatment involving a biodegradable balloon spacer for patients with massive rotator cuff tears. The study is a randomized controlled trial comparing the new treatment with standard arthroscopic surgery. Participants undergo arthroscopic debridement and biceps tenotomy, then are randomly assigned to either receive the biodegradable subacromial spacer or not. Before randomization, the surgeon assesses if the patient is a candidate for partial suture to balance the groups. Post-surgery, patients follow a rehabilitation plan including immobilization, gradual shoulder mobilization, and progressive weight lifting over 12 weeks. During the study, participants are evaluated using the Constant score before surgery and repeatedly up to 10 years after. Additional assessments include shoulder X-rays, pain scales VAS, quality of life questionnaires Eq-5D, and the WORC index at various intervals. The study uses double-blinding for patients and physiotherapists, with the surgeon aware of group assignment but not involved in testing. Follow-up visits and functional tests will monitor outcomes and safety over time.

Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.