NCT07448584 Lok™ Suture Anchors Safety & Performance Trial

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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).

Eligibility Criteria

Inclusion Criteria: * Consent to participate in the study: oral and written. * Man or woman over 18 years old with bone maturity finished. * Presented with one of the following indications: * Rotator cuff lesion (tear or calcific tendinopathy) associated to a pathology of the long head of the biceps, * Gleno-humeral instability, * partial articular-sided tendon avulsion \[PASTA\] lesion. * MRI or arthrogram proving the rotator cuff lesion and long head of the biceps tendon injury, or the labrum injury, or PASTA injury. Non inclusion Criteria: * Radiographic sign of fracture: glenoid or lesser tuberosity. * Major trauma to the shoulder joint. * Any active infection or avascular necrosis. * Inflammatory joint disease. * Moderate to severe degenerative glenohumeral arthropathy (Kellgren-Lawrence Grade 3 or 4). * Bone pathologies compromising anchorage (cystic changes, severe osteopenia). * Pathological conditions of soft tissues impairing suture fixation. * Known hypersensitivity to impla

Related Trials