The aim of this study is to evaluate the performance and safety of Move-Up's lokâ„¢ system (lokâ„¢ 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 lokâ„¢ 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
Constant score
Timeframe: From enrollment to the final follow up at 12 months