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NOT YET RECRUITING
NCT07448584
NA

Lok™ Suture Anchors Safety & Performance Trial

Sponsor: Move Up SAS

View on ClinicalTrials.gov

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

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)

Locations (1)

Alixan

Valence, Auvergne-Rhône-Alpes, France