NCT06323980

INHANCE Stemless Reverse Shoulder IDE

Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arthroplasty
• Replacement
• Shoulder

Interventions

Type	Name	Description
DEVICE	Reverse Total Shoulder	Uncemented Reverse Total Shoulder

Timeline

• Start date: 2025-03-04
• Primary completion: 2027-11-10
• Completion: 2028-09-29
• First posted: 2024-03-21
• Last updated: 2026-04-13

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study