From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial Comparing Mechanical Implant Stability of MIO-RSA and BIO-RSA Using CT-based Motion Analysis

What this Trial Is About

This research aims to compare two methods of lateralization in reverse shoulder arthroplasty, a surgery often performed for patients with shoulder osteoarthritis and related conditions. The study evaluates whether metallic lateralization (MIO-RSA) is as stable as bony lateralization (BIO-RSA) during the first two years after surgery, using CT-based motion analysis to measure implant stability. This is important because lateralization may reduce complications such as limited shoulder movement and scapular notching. Participants will be randomly assigned to receive either the BIO-RSA procedure, which uses a bone transplant for lateralization, or the MIO-RSA procedure, which uses a metallic component for lateralization. Both procedures involve reverse shoulder arthroplasty, and the study will track the 3-dimensional movement of the glenoid components over two years to assess their stability. During the study, participants will undergo CT scans at baseline and at 3, 6, 12, and 24 months after surgery to measure implant migration. Additional assessments include evaluations of shoulder function, pain, quality of life, and range of motion using established scoring systems before surgery and at multiple follow-up points. The primary outcome is implant migration at 24 months. The total participation duration includes these follow-ups to monitor the stability and function of the shoulder implants.

Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?