Trials Sponsors Conditions Drugs Pricing

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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;

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

Clinique Mutualiste de Bretagne Occidentale

Quimper, 29000, France

RECRUITING

Alexandre SonnardCONTACT+332 57 23 05 05 a.sonnard@orange.fr

Alexandre SonnardPRINCIPAL INVESTIGATOR

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

Actual (reported)

Primary Completion

August 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

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

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

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

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations