Clinical Research Directory

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

Sponsor: Zimmer Biomet

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.

Official title: Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Benefits of the ComposiTCP™ Suture Anchors Double Loaded With BroadBand Tape, Sliding

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Locations (1)