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Lok™ Suture Anchors Safety & Performance Trial
Sponsor: Move Up SAS
Summary
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).
Official title: Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2026-02
Completion Date
2027-08
Last Updated
2026-03-04
Healthy Volunteers
No
Interventions
Rotator cuff lesions repair combined to a long head of biceps pathology
Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),
PASTA lesion
partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair
Shoulder instability repair
Gleno-humeral instabilities (Bankart lesion, SLAP lesion)
Locations (1)
Alixan
Valence, Auvergne-Rhône-Alpes, France