ComposiTCP suture anchors for rotator cuff repair — safety, healing and recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter post‑market program collects both retrospective and prospective consecutive cases of adults treated with ComposiTCP double‑loaded suture anchors with BroadBand Tape for rotator cuff repair. Up to two sites will include about 43 patients, using existing medical records for baseline pre-, intra-, and immediate post‑op data and scheduling a one‑year follow‑up visit for questionnaires and clinical assessment. Performance will be judged by soft‑tissue‑to‑bone healing using patient‑reported outcome measures and clinical exams, functional benefit will be measured with scores such as the Oxford Shoulder Score and EQ‑5D‑5L at one year, and safety will be monitored through device‑ or procedure‑related adverse events. The study is non‑randomized, non‑controlled, and aims to gather real‑world evidence on safety, performance and clinical benefit after market release.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinique Mutualiste de Bretagne Occidentale
  Quimper, France Recruiting

Study contacts

• Study coordinator: Julie NICOUX
• Email: julie.nicoux@zimmerbiomet.com
• Phone: +33672613502

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.