Actively Recruiting
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP
Led by Zimmer Biomet · Updated on 2026-02-03
43
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Treated with ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair
- At least 18 years old and skeletally mature
- Willing and able to comply with study procedures
- Able to understand doctor's instructions and participate in follow-up
- Able to read and understand informed consent and voluntarily provided consent
You will not qualify if you...
- Unable to fully understand the study or vulnerable to manipulation
- Unwilling or unable to give consent or comply with follow-up
- Meets any contraindications listed in the device's instructions for use
- Use of the device off-label
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinique Mutualiste de Bretagne Occidentale
Quimper, France, 29000
Actively Recruiting
Research Team
J
Julie NICOUX
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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