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

Completed

• Conditions: Rotator Cuff Injuries
• Interventions: Device: Arthroscopic rotator cuff repair

• Registration Number: NCT05720286
• Lead Sponsor: Science and biomaterials

Brief 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

Study Timeline

• Study Start: 2018-12-12
• Primary Completion: 2020-09-14
• Study Completion: 2022-07-31
• Study First Submitted: 2023-01-27
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient with broken tendinopathy of the rotator cuff
• Patient over 18 years old
• Patient who has received complete medical information and not objecting to participate in research
• Social insured patient

Exclusion Criteria

• Pregnant or likely to be pregnant, or breastfeeding
• Patient under guardianship
• Non-cooperative patient, who does not want or is unable to follow the post-operative instructions (drug addict or alcoholic patient in particular)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Arthroscopic rotator cuff repair	There was only one group as the study was a non-comparative study

Primary Outcome Measures

Name	Time	Method
Sugaya classification	1 year postoperative	Radiological evaluation to assess the absence of rotator cuff re-tears with the Sugaya classification and the retraction's degree of the cuff.

Secondary Outcome Measures

Name	Time	Method
Quick DASH score	45 days, 5months and 1 year postoperative	Capacity of shoulder score
Pain score	45 days, 5months and 1 year postoperative	EVA pain scale
Constant score	45 days, 5months and 1 year postoperative	Functional score
Fatty degeneration	preoperative	Bernageau classification

Trial Locations

Locations (2)

CH Purpan; 🇫🇷 Toulouse, France

Polyclinique de l'Ormeau; 🇫🇷 Tarbes, France