Lok™ suture anchors: safety and performance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.