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

NCT ID: NCT07080450

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

The ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants are intended for use in rotator cuff repairs. They are intended for for the reattachment of soft tissue to bone.

Up to two sites will be involved in this study. The aim is to include a total of 43 consecutive series cases who received the device. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.

Conditions

Rotator Cuff Repairs

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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

No specific interventions will be administered.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Rohmer

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Clinique Mutualiste de Bretagne Occidentale

Quimper, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julie NICOUX

Role: CONTACT

julie.nicoux@zimmerbiomet.com

+33672613502

Facility Contacts

Alexandre Sonnard

Role: primary

a.sonnard@orange.fr

+332 57 23 05 05

Other Identifiers

MDRG2017-89MS-197SM

Identifier Type: -

Identifier Source: org_study_id