INHANCE Stemless Reverse Shoulder IDE

Status Not yet recruiting

Clinical Trial Summary

2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

Clinical Trial 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 successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant difference is seen on any of the 3 primary safety endpoints. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06323980
Study type	Interventional
Source	DePuy Orthopaedics
Contact	Study Contact
Phone	574-404-7996
Email	dfawley1@its.jnj.com
Status	Not yet recruiting
Phase	N/A
Start date	September 30, 2024
Completion date	April 27, 2028

View Details

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