NCT05981833

Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).

Detailed description

The primary objective is to evaluate postoperative healing of rotator cuff repair with and without DAA. Primary: The primary outcome measure is healing evaluation in MRI . MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) Secondary: The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems, including: American Shoulder and Elbow Surgeons Score (ASES) Single Assessment Numeric Evaluation score (SANE) Visual Analog Scale (VAS) for pain Veterans RAND Health Survey (VR-12) Population: Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears Description of Treatment: Rotator cuff repair with or without augmentation using decellularized human dermal allograft.

Conditions

• Full-thickness Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	Repair with DAA (dermal allograft augmentation)	Patients undergo rotator cuff repair with dermal allograft augmentation.

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-09-15
• Completion: 2026-09-15
• First posted: 2023-08-08
• Last updated: 2025-02-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study