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Knotless suture technique aims to hold rotator cuff repairs together like a hot air balloon

NCT ID NCT07828366

Symptom relief Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are studying a surgical method for repairing rotator cuff tears that uses two rows of anchors and sutures without knots, called the Montgolfier technique. The sutures spread tension evenly around the repair, similar to the cables of a hot air balloon. Adults scheduled for this type of shoulder repair receive the surgery and then complete questionnaires and ultrasound scans at 6 and 12 months. The study tracks whether patients improve enough on a standard shoulder function score to notice a real difference in daily life.

What this could mean

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

Active substance
Montgolfier double-row knotless rotator cuff repair, a surgical technique using anchors and sutures without knots
What this could lead to
If the technique works well, it could offer surgeons a reliable, adjustable way to repair rotator cuff tears and inform larger studies comparing repair methods.
What could go wrong
This is a small pilot study with no comparison group, so any good outcomes could reflect the surgeons' skill or natural healing rather than the technique itself. Shoulder surgery carries risks of infection, stiffness, and retear.

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 78 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Male or female patient aged over 18, * Patient scheduled for rotator cuff repair using the Montgolfier double-row technique, * Patient affiliated with or a beneficiary of a social security scheme, * Patient who has been informed and has provided free, informed, and written consent. Exclusion Criteria: * Patient who has previously undergone shoulder surgery * Patient with a shoulder condition resulting from a workplace accident or suffering from an occupational disease * Patients lacking the intellectual or physical capacity to provide consent * Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision; or under judicial protection * Pregnant, breastfeeding, or recently delivered woman * Patient hospitalized without consent.

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Conditions

The condition(s) this trial relates to.

rotator cuff syndrome

As listed by the trial registrant

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

Double raw repair Rotator cuff

How to take part

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  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

  • Hôpital privé Jean Mermoz

    Lyon, 69008, France

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