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PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP

NCT07080450 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2026-02-03

No results posted yet for this study

Summary

The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants when used in rotator cuff repair.

The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient.

The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Oxford Shoulder Score and EQ-5D-5L) at 1 year post-operative.

The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.

Conditions

  • Rotator Cuff Repairs

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Emilie Rohmer · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • France

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 NCT07080450 on ClinicalTrials.gov