Lok™ Suture Anchors Safety & Performance Trial

Inclusion Criteria27

• 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.
• 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.