This prospective, multicenter, randomized controlled clinical study is designed to enroll 112 subjects with irreparable rotator cuff tear and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with rotator cuff restoration balloon, and the control group was treated with rotator cuff partial repair. The main end point of the study was improvement of the Constant Score at 6 months after the surgery. All subjects were followed up clinically at 1 day, 6 weeks, 3 months, 6 months and 1 year after the surgery, and were followed up with imaging examination at 3 months, 6 months and 1 year after the surgery.
This study is a prospective, multicenter, randomized, controlled clinical study aiming to evaluate the safety and efficacy of the rotator cuff function restoration balloon in patients with irreparable rotator cuff tear compared to partial repair of the rotator cuff.