Clinical Trial

Lok™ Suture Anchors Safety & Performance Trial

Recruiting
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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).
Protocol Amendment History 2 changes
critical Recruitment opened 2026-04-16
notable Primary completion pushed: 2027-06 -> 2027-07 2026-04-16
Trial Details
NCT Number NCT07448584
Lead Sponsor Move Up SAS
Conditions Rotator Cuff Tears of the Shoulder, Labrum Injury
Enrollment 216 participants
Start Date 2026-03-05
Primary Completion 2027-07 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-15