NCT07080450 PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP
| NCT ID | NCT07080450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Rotator Cuff Repairs |
| Study Type | OBSERVATIONAL |
| Enrollment | 43 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 43 participants in total. It began in 2025-07-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Subject was treated with the 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 the study procedures; * Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program; * Subject is able to read and understand the ICF and has voluntarily provided written informed consent or non-opposition. Exclusion Criteria: * Subject is vulnerable (is unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response); * The subject is unwilling or unable to give consent or to comply with the follow-up program; * Subject meets any contraindications of the appropriate Instruction for Use; * Off-Label Use.
Contact & Investigator
Emilie Rohmer
STUDY DIRECTOR
Zimmer Biomet
Frequently Asked Questions
Who can join the NCT07080450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rotator Cuff Repairs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07080450 currently recruiting?
Yes, NCT07080450 is actively recruiting participants. Contact the research team at julie.nicoux@zimmerbiomet.com for enrollment information.
Where is the NCT07080450 trial being conducted?
This trial is being conducted at Quimper, France.
Who is sponsoring the NCT07080450 clinical trial?
NCT07080450 is sponsored by Zimmer Biomet. The principal investigator is Emilie Rohmer at Zimmer Biomet. The trial plans to enroll 43 participants.