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Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

NCT06971497 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2025-08-17

No results posted yet for this study

Summary

We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y.

Conditions

  • Rotator Cuff Repair of the Shoulder

Interventions

DEVICE

ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)

ActivBraid™ is a suture made from approximately half ultra-high molecular weight polyethylene and and half collagen derived from cow skin. Collagen is the most abundant protein in our bodies and serves as the building block for tendons and bones. The collagen in ActivBraid™ is intended to enhance cell attachment and tissue integration which may improve the healing of a rotator cuff repair. ActivBraid™ suture has been shown to have equivalent strength as other high strength sutures used in orthopaedic procedures and has been approved by the Food and Drug Administration (FDA) for repairing tendons. ActivBraid™ is a commercially available product that has been and is used in humans. This is the first post-market clinical study with ActivBraid™.

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Kathleen Derwin, PhD · The Cleveland Clinic

  • Eric Ricchetti, MD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2029-08-31
Completion
2029-08-31
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 NCT06971497 on ClinicalTrials.gov