Study Comparing INHANCE Stemless and Stemmed Reverse Total Shoulder Systems for Shoulder Replacement

What this Trial Is About

This clinical trial evaluates the INHANCE Stemless Reverse Cementless Total Shoulder device compared to the INHANCE Stemmed Reverse Total Shoulder for people needing reverse total shoulder replacement due to painful, disabling arthritis or rotator cuff arthropathy. The study aims to assess effectiveness and safety by comparing shoulder function and implant stability over two years after surgery. Participants will be randomly assigned to receive either the stemless or stemmed reverse total shoulder device. The study focuses on measuring shoulder function using the Constant-Murley Score and monitoring for any implant revisions, removals, reoperations, or fixation issues. Safety endpoints include checking for bone radiolucency and implant migration or tilt at two years post-operation. Throughout the study, participants will undergo evaluations before surgery and at multiple follow-up points up to two years, including shoulder function tests and questionnaires about their health and shoulder performance. Researchers will track complications and implant survivorship while ensuring participants complete patient-reported outcome measures. The total study duration extends up to the final two-year assessment after surgery.

INHANCE Stemless Reverse Shoulder IDE