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Tests treatment safety and results for Rotator Cuff Tears of the Shoulder
Official title Lok™ Suture Anchors Safety & Performance Trial
ClinicalTrials.gov ID: NCT07448584
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Valence, Auvergne-Rhône-Alpes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valence, Auvergne-Rhône-Alpes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.