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New shoulder anchors aim to fix torn tendons

NCT ID NCT07448584

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Valence, Auvergne-Rhône-Alpes, 26300, France

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