Lok™ suture anchors: safety and performance
Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical Trial
NA · Move Up SAS · NCT07448584
This will test whether Move‑Up's lok™ suture anchors are safe and help adults with rotator cuff or labrum injuries who need shoulder repair surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Move Up SAS (industry) |
| Locations | 1 site (Valence, Auvergne-Rhône-Alpes) |
| Trial ID | NCT07448584 on ClinicalTrials.gov |
What this trial studies
Adults with rotator cuff tears, labrum injuries or PASTA lesions who undergo surgical repair with the lok™ suture anchors will be followed after surgery. Clinical outcomes will be measured at about 3, 6 and 12 months using the Constant score, VAS pain score, and Subjective Shoulder Value. Tendon healing and recurrence of rupture will be evaluated at 6 and 12 months using the Sugaya score on ultrasound, and adverse events will be recorded at 1, 3, 6 and 12 months. The trial is conducted at a single participating center and includes predefined inclusion and exclusion criteria to select appropriate surgical candidates.
Who should consider this trial
Good fit: Adults (over 18) with MRI or arthrogram-confirmed rotator cuff lesions with biceps pathology, glenohumeral instability, or PASTA lesions who are scheduled for surgical repair and can consent are ideal candidates.
Not a fit: Patients with shoulder fractures, major trauma, active infection, avascular necrosis, severe degenerative arthropathy, significant bone loss or other conditions that impair suture fixation are unlikely to benefit or meet inclusion criteria.
Why it matters
Potential benefit: If successful, the lok™ anchors could offer a safe option that improves tendon healing and reduces repair failures after shoulder surgery.
How similar studies have performed: Other suture‑anchor systems are widely used and prior studies generally show acceptable safety and repair outcomes, but published data specific to the lok™ system are limited.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Valence, Auvergne-Rhône-Alpes
- Alixan — Valence, Auvergne-Rhône-Alpes, France (RECRUITING)
Study contacts
- Study coordinator: Manal OUBOUKHA, Clinical affairs manager
- Email: manal.ouboukha@move-ortho.com
- Phone: 33 677 096 697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tears of the Shoulder, Labrum Injury