Rotator Cuff Injuries
Conditions
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
Interventions
DEVICEArthroscopic 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.
Sponsors
Science and biomaterials
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Constant score | 45 days, 5months and 1 year postoperative | Functional score |
| Pain score | 45 days, 5months and 1 year postoperative | EVA pain scale |
| Quick DASH score | 45 days, 5months and 1 year postoperative | Capacity of shoulder score |
| Fatty degeneration | preoperative | Bernageau classification |
Countries
France
Outcome results
None listed