Lok™ Suture Anchors Safety & Performance Trial

Move Up SAS216 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

216

Conditions

Rotator Cuff Tears of the Shoulder Labrum Injury

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Constant score

The functional improvement related to the implantation of these devices will be at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days with the primary endpoint being the Constant score.

Time frame: From enrollment to the final follow up at 12 months

Secondary Outcomes

Visual Analog Scale (VAS)

Evaluate the evolution of pain: This will be assessed using the Visual Analog Scale (VAS) for pain at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days.

Time frame: From enrollment to the end of follow up at 12 months

Adverse Events (AEs)

Evaluate the safety of the lok™ system: Adverse Events (AEs) related to the devices will be collected at any time from the start of inclusion until 12 months after surgery.

Time frame: from enrollment to the final follow up at 12 months

Subjective Shoulder Value (SSV)

Evaluation of the patient's subjective value with the Subjective Shoulder Value (SSV) at 3 months ± 7 days, 6 months ± 15 days and 12 months ± 15 days.