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New shoulder anchor shows promise in healing torn rotator cuffs

NCT ID NCT05690776

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at 106 people who had surgery to fix a torn rotator cuff using a special anchor and tape. The goal was to see if the device helps the tendon heal back to the bone and improves shoulder function. Researchers checked healing and measured pain and daily activities one year after surgery. The study also tracked any side effects or problems related to the device or procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Quattro® X Suture Anchor with BroadBand™ Tape (a medical device used in shoulder surgery)
What this could lead to
If successful, this could confirm that the device helps torn shoulder tendons heal properly, giving surgeons a reliable option for rotator cuff repair.
What could go wrong
This is a small, non-randomized study without a comparison group, so results may not apply to all patients. The device could still fail to heal the tendon or cause complications like retears or infection.

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.

Participants

106 people

The number who actually took part.

Started

Jun 2022

Finished

Nov 2024

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.

Who is studied

Subjects treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair, according to the IFU and who meet all of the inclusion and none of exclusion criteria.

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: 1. Subject treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair; 2. Older than 18 years and skeletally mature; 3. Willing and able to comply with the study procedures; 4. Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program; 5. Subject is able to read and understand the ICF and has voluntarily provided written informed consent. Exclusion Criteria: 1. Presence of infection; 2. Insufficient or immature bone; 3. Insufficient blood supply or previous infections which may hinder the healing process; 4. Foreign body sensitivity; 5. Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant); 6. The subject is unwilling or unable to give consent or to comply with the follow-up program; 7. Subject meets any contraindications of the appropriate Instruction for Use.

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Clinical

    Soyaux, 16800, France

  • Ortheo

    Saint-Etienne, 42100, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.