Actively Recruiting
Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation in Shoulder Surgery Randomized Clinical Trial
Led by Move Up SAS · Updated on 2026-04-15
216
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the performance and safety of Move-Up's lok™ suture anchors and associated tools used in shoulder surgeries. The study focuses on patients with rotator cuff tears, labrum injury, or related shoulder conditions. Researchers will assess the devices by measuring shoulder function, pain, and patient-reported outcomes, along with healing status and device-related complications. This is a randomized, single-blind clinical trial sponsored by Move Up SAS. Participants will be randomly assigned to receive either the lok™ suture anchors and instruments or standard anchors and tools already approved and used in routine care. The study will monitor outcomes at about 1, 3, 6, and 12 months after surgery. Ultrasound imaging will be used at 6 and 12 months to check tendon healing and detect any rupture or failure to heal, using the Sugaya score. During the study, participants will undergo evaluations including the Constant score for shoulder function, Visual Analog Scale (VAS) for pain, and Subjective Shoulder Value (SSV). Researchers will also track adverse events and serious adverse events throughout the 12-month follow-up. Participants will be evaluated regularly after their surgery to monitor the treatment effects and safety of the devices used.
CONDITIONS
Brief Title
Lok™ Suture Anchors Safety & Performance Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consent to participate in the study: oral and written.
- Man or woman over 18 years old with finished bone maturity.
- Diagnosed with one of the following: rotator cuff lesion (tear or calcific tendinopathy) with long head of the biceps pathology, gleno-humeral instability, or partial articular-sided tendon avulsion (PASTA) lesion.
- MRI or arthrogram confirming the rotator cuff lesion, long head of the biceps tendon injury, labrum injury, or PASTA injury.
You will not qualify if you...
- Radiographic signs 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 diseases affecting anchorage (cystic changes, severe osteopenia).
- Soft tissue conditions impairing suture fixation.
- Known hypersensitivity to implant materials (PEEK, carbon, or polyethylene).
- Previous anterior ipsilateral shoulder surgeries.
- Physical conditions impairing anchoring support or healing.
- Contraindications from medical device instructions.
- Conditions limiting ability or willingness to follow activity restrictions during healing.
- Inability to complete questionnaires due to language barriers.
- Pregnant or breastfeeding women.
- Persons deprived of liberty or under guardianship.
- Unable to undergo medical monitoring for the trial.
- Psychiatric or cognitive disorders preventing informed consent.
- Participation in another clinical trial.
- Life expectancy less than 12 months.
- No health insurance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 weeks or until discharge
Participants undergo shoulder surgery to repair rotator cuff lesions, shoulder instability, or PASTA lesions using Lok™ suture anchors or routine care anchors.
1 surgery visit and several immediate post-operative visits
Duration - 12 months
Participants are monitored for recovery and assessed for safety and performance of the shoulder repair over time.
Regular follow-up visits during 12 months
Trial Site Locations
Total: 1 location
1
Alixan
Valence, Auvergne-Rhône-Alpes, France, 26300
Actively Recruiting
Research Team
M
Manal OUBOUKHA, Clinical affairs manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here