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

NCT07080450 | Recruiting

• 1 other identifier: MDRG2017-89MS-197SM
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Repairs

Outcome Measures

Primary Outcomes (1)

• Assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff)

  The investigator will clinically evaluate at 1 year follow-up visit if soft tissue to bone healing has occurred by the absence of device-related revisions and re-tears that were not previously reported. The following question will be asked to the investigator: "Did soft tissue to bone healing occur"? If "yes" is answered, then the soft tissue to bone healing is successful, if "no" is answered, then the soft tissue to bone healing is considered unsuccessful.

  From operation to study completion, 0-1 year

Secondary Outcomes (3)

• EQ-5D-5L Score

  From operation to study completion, 0-1 year

• The incidence and frequency of device and/or procedure related adverse events

  From operation to study completion, 0-1 year

• Oxford Shoulder Score

  From surgery until study completion, 0-1 year

Study Arms (1)

Patients who received the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding

No specific interventions will be administered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must have been treated with the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Clinique Mutualiste de Bretagne Occidentale

Quimper, 29000, France

RECRUITING

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Julie NICOUX

CONTACT

+33672613502; julie.nicoux@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

FR (1)