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

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

This project will see if ComposiTCP suture anchors help rotator cuff repairs heal and are safe for adults who received them.

Quick facts

• Study type: Observational
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zimmer Biomet (Industry-sponsored)
• Locations: 1 site (Quimper)
• Trial ID: NCT07080450 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) who received the ComposiTCP double‑loaded suture anchors for rotator cuff repair and can provide informed consent and attend the one‑year follow‑up are ideal candidates.

Not a fit: Patients who did not receive this specific implant, who have contraindications per the device instructions, who are unable to consent or comply with follow‑up, or who are considered vulnerable may not receive benefit from participation.

Why it matters

Potential benefit: If successful, the device could improve tendon‑to‑bone healing and shoulder function after rotator cuff repair, potentially lowering re‑tear rates and improving recovery.

How similar studies have performed: Other studies of suture anchors and broad‑tape fixation constructs have reported favorable healing and functional outcomes, but post‑market data specific to the ComposiTCP implant remain limited and are being collected here.

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.

Where this trial is running

Quimper

• Clinique Mutualiste de Bretagne Occidentale — Quimper, France (Recruiting)

Study contacts

• Study coordinator: Julie NICOUX

Conditions Rotator Cuff Repairs