Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
DePuy Orthopaedics
Summary
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Description
There is one primary effectiveness endpoint and there are three primary safety endpoints: 1. Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative 2. Primary safety endpoint(s): 1. No revision, removal, reoperation, supplemental fixation, or other intervention for any system component 2. No humeral or glenoid radiolucent line \>2 mm is present in 50% or more zones at 2 years 3. No conclusive evidence of migration and tilt (\>5mm migration and \>10° tilt) of the humeral or glenoid component at 2 years The study will be suc…
Eligibility
- Age range