Condition: Rotator Cuff Tears of the Shoulder · Labrum Injury · Sponsor: Move Up SAS
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation). These devices will be evaluated at approximately 3, 6 and 12 months with 3 scoring criteria: Constant score, VAS pain score, and subjective shoulder value score (SSV). At the 6-month and 12-month post-operative visit, tendon healing, and the absence of recurrence of rupture or failure to heal in patients treated with lok™ anchors will also be analyzed. The Sugaya score on ultrasound imaging will be used for this assessment. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be assessed after the surgery and at each follow-up (1, 3, 6 and 12 months after the surgery).
This description comes directly from the study's public registry record.
Manal OUBOUKHA, Clinical affairs manager · 33 677 096 697 · manal.ouboukha@move-ortho.com
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| Alixan | Valence, Auvergne-Rhône-Alpes, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07448584