NCT05438914

Subscapularis Repair in Reverse Shoulder Arthroplasty

Subscapularis Repair in Reverse Shoulder Arthroplasty: a Randomized, Controlled, Multicenter, Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

Detailed description

The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative. Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.

Conditions

• Rotator Cuff Tear Arthropathy

Interventions

Type	Name	Description
DEVICE	Repair of the subscapularis	The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Timeline

• Start date: 2022-11-14
• Primary completion: 2025-09-14
• Completion: 2025-09-14
• First posted: 2022-06-30
• Last updated: 2024-01-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study