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.

NCT06323980

INHANCE Stemless Reverse Shoulder IDE

Recruiting
NAAges 22+InterventionalTreatment
DePuy Orthopaedics
~168 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Reverse Total Shoulder

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Constant Murley Score (CMS)
Measured over Pre-op, 2 years
+6 more outcomes measured
Arthroplasty
Replacement
Shoulder
15 sites across 11 states
Ohio3
North Carolina2
Pennsylvania2
Florida1
Massachusetts1
Michigan1
Missouri1
Oregon1

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  • 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