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Tapestry Rotator Cuff Repair PMCF

NCT06287853 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears
  • Rotator Cuff Injuries

Interventions

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-28
Primary Completion
2030-12-30
Completion
2030-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06287853 on ClinicalTrials.gov