NCT07448584

Lok™ Suture Anchors Safety & Performance Trial

Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Move Up SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Rotator Cuff Tears of the Shoulder
• Labrum Injury

Interventions

Type	Name	Description
PROCEDURE	Rotator cuff lesions repair combined to a long head of biceps pathology	Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),
PROCEDURE	PASTA lesion	partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair
PROCEDURE	Shoulder instability repair	Gleno-humeral instabilities (Bankart lesion, SLAP lesion)

Timeline

• Start date: 2026-03-05
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2026-03-04
• Last updated: 2026-04-15

Locations

1 site across 1 country: France