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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Rotator Cuff Injuries

Intervention / Treatment
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* Device: Arthroscopic rotator cuff repair


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>There was only one group as the study was a non-comparative study | Device: Arthroscopic rotator cuff repair<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sugaya classification | Radiological evaluation to assess the absence of rotator cuff re-tears with the Sugaya classification and the retraction's degree of the cuff. | 1 year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score | Functional score | 45 days, 5months and 1 year postoperative | 
| Pain score | EVA pain scale | 45 days, 5months and 1 year postoperative | 
| Quick DASH score | Capacity of shoulder score | 45 days, 5months and 1 year postoperative | 
| Fatty degeneration | Bernageau classification | preoperative |