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Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair

NCT05720286 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-02-09

No results posted yet for this study

Summary

Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices

Conditions

  • Rotator Cuff Injuries

Interventions

DEVICE

Arthroscopic rotator cuff repair

Arthroscopic transosseous reinsertion of the rotator cuff is the most widely used arthroscopic technique. The tendons are repositioned on the greater and lesser tuberosities of the humerus with specific anchors. These anchors, placed in the humeral bone, are attached to sutures which are in turn tied to the tendon.

Sponsors & Collaborators

  • Science and biomaterials

    lead INDUSTRY

Principal Investigators

  • Nicolas BONNEVIALLE, Pr

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2020-09-14
Completion
2022-07-31
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720286 on ClinicalTrials.gov