Actively Recruiting
Lok™ Suture Anchors Safety & Performance Trial
Led by Move Up SAS · Updated on 2026-04-15
216
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 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, or 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.
You will not qualify if you...
- 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 implant material (PEEK and carbon or Polyethylene).
- Anterior ipsilateral surgeries performed on the joint space.
- Physical conditions that would eliminate, or tend to eliminate, adequate anchoring support or delay healing.
- Contraindications from the instructions for use of the medical devices used.
- Conditions that would limit the subject's ability or willingness to restrict activities or follow instructions during the healing period.
- Inability to complete questionnaires: language problems, who do not speak/read/understand French.
- Pregnant or breastfeeding women.
- Persons deprived of liberty or under guardianship.
- Patients unable to undergo medical monitoring of the trial.
- Psychiatric illnesses, cognitive disorders, or health problems that prevent informed consent.
- Participation in another clinical trial.
- Life expectancy of less than 12 months.
- No health insurance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Alixan
Valence, Auvergne-Rhône-Alpes, France, 26300
Actively Recruiting
Research Team
M
Manal OUBOUKHA, Clinical affairs manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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