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Recruiting NCT07448584

Lok™ Suture Anchors Safety & Performance Trial

No phase Interventional Rotator Cuff Tears of the Shoulder Labrum Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion, Shoulder instability repair.
Who it may be relevant to
Registry conditions: Rotator Cuff Tears of the Shoulder, Labrum Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of the Safety and Performance of the Lok™ Suture Anchors Range and Associated Instrumentation - Multicenter Interventional and Single Blind Randomized Clinical Trial

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).

Interventions

  • Procedure Rotator cuff lesions repair combined to a long head of biceps pathology
    Shoulder Gleno-humeral instability (Bankart lesion, SLAP lesion),
  • Procedure PASTA lesion
    partial articular-sided supraspinatus tendon avulsion (PASTA) lesions, treated with anchors specifically indicated for this repair
  • Procedure Shoulder instability repair
    Gleno-humeral instabilities (Bankart lesion, SLAP lesion)

Primary outcome measures

  • Constant score [Time frame: From enrollment to the final follow up at 12 months]
Secondary outcome measures (3)
  • Visual Analog Scale (VAS) [Time frame: From enrollment to the end of follow up at 12 months]
  • Adverse Events (AEs) [Time frame: from enrollment to the final follow up at 12 months]
  • Subjective Shoulder Value (SSV) [Time frame: From enrollment to the final follow up at 12 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Alixan — Valence

Identifiers

NCT: NCT07448584 · lok01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗