Lok™ Suture Anchors Safety & Performance Trial

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.
• •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.