NCT05720286

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

Verification of the Performance and Safety of the First Row Resorbable Threaded Anchor FIXIT® in Arthroscopic Rotator Cuff Repair as Part of the Post-marketing Follow-up of Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Science and biomaterials · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

the main objective of this study was to verify the safety of the resorbable threaded anchor FIXIT®, used in arthroscopic rotator cuff repair. This objective was to be imaging assessed (echography, MRI) for the presence or absence of a rotator cuff re-tear and its degree of retractation. The second objective was to verify the performance of the FIXIT® anchor with 4 scoring criteria : Constant score, pain score EVA, Quick DASH score and Bernageau classification

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-12
• Primary completion: 2020-09-14
• Completion: 2022-07-31
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated device study