INHANCE Stemless Reverse Shoulder IDE Study
This study is testing a new type of shoulder replacement called the INHANCE Stemless Reverse Cementless Total Shoulder. It's for people who need a reverse total shoulder replacement because of severe pain and arthritis (osteoarthritis, post-traumatic arthritis, or rotator cuff arthropathy). You might be able to join if you are at least 22 years old, are a good candidate for the implant, and have a working deltoid muscle. The study will be considered successful if the new shoulder replacement works at least as well as existing treatments and doesn't cause more safety issues. The current recruitment status is unclear.
- Study design
- This is a multi-center study that will randomly assign participants to different groups in a 2:1 ratio. It plans to enroll 168 people.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your shoulder function will be checked before surgery and again at 2 years. Researchers will also look for any need to remove or revise the implant at 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
INHANCE Stemless Reverse Shoulder IDE
At a glance
Conditions
Where it's being run
15 sites across 11 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Constant Murley Score (CMS)Pre-op, 2 years
Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative. The CMS is a 100 point scale, the higher the score, the higher the quality of the function. ACM will be obtained by dividing the raw score by the relative score.
- Removal of any system component2 year
No removal of any system component
- Revision of any system component2 year
No revision of any system component
- Reoperation of any system component2 year
No reoperation of any system component
- Supplemental Fixation of any system component2 year
No supplemental fixation of any system component
- Radiolucent Lines (Humeral & Glenoid)2 year
No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
- Migration and Tilt (Humeral & Glenoid)2 year
No conclusive evidence of migration and tilt (greater than 5mm migration and greater than 10 degrees tilt) of the humeral or glenoid component