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Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair — FIXIT®2018  

Rotator Cuff Injuries Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05720286
Study type Observational
Source Science and biomaterials
Contact
Status Completed
Phase
Start date December 12, 2018
Completion date July 31, 2022
View Details
See also
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