New shoulder anchors aim to fix torn tendons
NCT ID NCT07448584
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new medical device called the lok™ suture anchor system for repairing torn tendons and labrum in the shoulder. About 216 adults with rotator cuff tears, shoulder instability, or partial tendon avulsions will receive the anchors during surgery. Researchers will track their pain, shoulder function, and tendon healing for 12 months to see if the device is safe and works well.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lok™ suture anchors (medical device for shoulder repair)
- What this could lead to
- If successful, this could provide a safe and effective option for repairing torn shoulder tendons and labrum, improving function and reducing pain.
- What could go wrong
- This is a relatively small, early-stage device trial. The anchors might fail to hold, cause complications, or not improve outcomes over existing methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Calcific tendinopathy of the rotator cuff are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Alixan
RECRUITINGValence, Auvergne-Rhône-Alpes, 26300, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New shoulder implant aims to fix common rotator cuff tears
- Distract your brain, heal your shoulder? new study tests Attention-Shift exercise
- Shoulder patch passes safety check in ongoing study
- New patch could help shoulder tears heal stronger
- Could acne wash prevent shoulder surgery infections?
- New shoulder implant aims to stop rotator cuff tears from returning