NCT06287853

Tapestry Rotator Cuff Repair PMCF

A Multi-Center, Prospective Post Market Clinical Follow-Up Evaluating Arthroscopic Rotator Cuff Repair Augmented With TAPESTRY® Biointegrative Implant

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor.

Detailed description

The objectives of the study are to calculate the overall clinical success rate, the performance, and clinical benefits, and confirm the safety of the Tapestry RC Biointegrative Implant System. * The clinical success will be evaluated by absence of rotator cuff re-tear. * The performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Visual Analogue Scale (VAS), Constant-Murley Score (CMS), Single Assessment Numeric Evaluation (SANE), Return to Activity, Patient Satisfaction, EQ-5D-5L, and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration. * The safety of the Tapestry RC Biointegrative Implant System will be assessed by monitoring the frequency and incidence of adverse events. The primary endpoint of this study is defined by the rotator cuff re-tear rate post-operatively. This will be measured against the success criteria of the re-tear rate in 18.3% of cases at two years.

Conditions

• Rotator Cuff Tears
• Rotator Cuff Injuries

Interventions

Type	Name	Description
DEVICE	Tapestry Biointegrative Implant	The Tapestry RC Biointegrative Implant System is an arthroscopic delivery and fixation system intended for tendon augmentation with Tapestry Biointegrative Implant during arthroscopic rotator cuff (RC) repair. The system combines the biointegrative collagen-based implant (Tapestry Biointegrative Implant) with bioabsorbable fixation ( Bioabsorbable Anchors). Tapestry Biointegrative Implant is a collagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues.

Timeline

• Start date: 2026-12-28
• Primary completion: 2030-12-30
• Completion: 2030-12-30
• First posted: 2024-03-01
• Last updated: 2025-11-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study