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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | There was only one group as the study was a non-comparative study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic rotator cuff repair | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 30 patients, aged between 45 to 78 and operated for a rotator cuff repair were selected in this study. Initially, 31 patients were included but 1 withdrew from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas BONNEVIALLE, Pr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique de l'Ormeau | Tarbes | France | ||||
| CH Purpan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 11, 2024 | |
| Reset | Jun 28, 2024 | |
| Release | Jul 25, 2024 | |
| Reset | Oct 17, 2024 | |
| Release | Nov 6, 2024 | |
| Reset | Dec 13, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 11, 2024 | Jun 28, 2024 | |||
| Jul 25, 2024 |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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|
| Quick DASH score | Capacity of shoulder score | 45 days, 5months and 1 year postoperative |
| Fatty degeneration | Bernageau classification | preoperative |
| Toulouse |
| 31000 |
| France |
| Oct 17, 2024 |
| Nov 6, 2024 | Dec 13, 2024 |