Clinical Study Comparing SINEFIX Implant and Conventional Surgery for Repairing Rotator Cuff Tears up to 2 cm in Adults

What this Trial Is About

Shoulder pain is a common problem that affects daily activities, work, sports, and independence. Rotator cuff disease is the main cause of shoulder pain and accounts for up to 70% of shoulder-related doctor visits. This condition includes various issues like tendinopathy, bursal problems, and rotator cuff tears RCTs, which often happen due to trauma or degenerative changes, especially in middle-aged or older adults. The study focuses on adult patients with rotator cuff tears up to 2 cm in size to better understand and treat these injuries. The trial compares two surgical methods for repairing rotator cuff tears using the SINEFIX implant and instruments versus a conventional surgical technique. The SINEFIX system was previously tested in a pilot study and is now being evaluated in a larger group. Participants will be randomly assigned to receive one of these two repair methods. Both treatments involve arthroscopic surgery aimed at reconstructing the rotator cuff. Participants will be followed for up to two years after surgery, with evaluations at multiple time points including 10 weeks, 6 months, 1 year, and 2 years. Researchers will assess shoulder function through physical exams and patient questionnaires, monitor healing and implant status using imaging, and record complications, re-tear rates, and patient satisfaction. The main outcome measured is the functional and clinical improvement one year after surgery compared to before the operation.

SINEFIX-2022 Comparative Phase