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

N/ACompletedNCT05720286

Science and biomaterials30 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rotator Cuff Injuries

Interventions

Arthroscopic rotator cuff repairDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Polyclinique de l'Ormeau

Tarbes, France

CH Purpan

Toulouse, France

Outcomes

Primary Outcomes

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.

Time frame: 1 year postoperative

Secondary Outcomes

Constant score

Functional score

Time frame: 45 days, 5months and 1 year postoperative

Pain score

EVA pain scale

Time frame: 45 days, 5months and 1 year postoperative

Quick DASH score

Capacity of shoulder score

Time frame: 45 days, 5months and 1 year postoperative

Fatty degeneration

Bernageau classification

Time frame: preoperative

Data from ClinicalTrials.gov

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