Comparing Outcomes of Two Reverse Shoulder Replacement Types BIO-RSA Versus Conventional RSA in Patients Aged 45 to 80

What this Trial Is About

Researchers are comparing two types of reverse shoulder replacements to see which provides better shoulder function after two years. This study focuses on patients who need shoulder replacement due to conditions like osteoarthritis or rotator cuff issues. The study aims to find out if a bone transplant method, called BIO-RSA, improves outcomes compared to the conventional reverse shoulder arthroplasty RSA. The trial involves 130 patients randomly assigned to receive either the BIO-RSA or the conventional RSA procedure. BIO-RSA includes placing a bone graft under the shoulder implant to increase joint stability and range of motion, potentially reducing complications like scapular notching. The study is blinded and conducted across multiple hospitals to compare these two surgical methods over a two-year period. Participants will have their shoulder function evaluated before surgery and at 3, 12, and 24 months afterward using patient questionnaires, physical exams by physiotherapists, and CT scans reviewed by radiologists. The main measure is the change in the Western Ontario Osteoarthritis Shoulder WOOS score after 24 months. Other assessments include quality of life, shoulder motion, and pain. The study will monitor participants for two years to gather comprehensive data on outcomes and complications.

Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?