Lok™ Suture Anchors Safety & Performance Trial

Move Up SAS

Status: Not yet enrolling

Conditions: Labrum Injury; Rotator Cuff Tears of the Shoulder

Treatments: Procedure: Shoulder instability repair; Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology; Procedure: PASTA lesion

Study type: Interventional

Funder types: Industry

Identifiers

NCT07448584

lok01

Details and patient eligibility

About

The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ 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 lok™ 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).

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

216 participants in 2 patient groups

Move-Up arm

Experimental group

Description:

lok™ suture anchors range and associated instrumentation

Treatment:

Procedure: PASTA lesion

Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology

Procedure: Shoulder instability repair

Routine care

Active Comparator group

Description:

Anchors and Ancillairies already CE marked (control arm) and used in routine care

Treatment:

Procedure: PASTA lesion

Procedure: Rotator cuff lesions repair combined to a long head of biceps pathology

Procedure: Shoulder instability repair