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Can a collagen patch make torn shoulder tendons heal stronger?

NCT ID NCT06269965

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether adding a collagen membrane called Regeneten during arthroscopic rotator cuff repair improves tendon healing and quality compared to standard surgery alone. Adults with a torn supraspinatus tendon, sometimes with other small tears, are randomly assigned to receive the implant or not. One year later, MRI scans assess how well the tendon has healed and whether the repair holds up.

What this could mean

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

Active substance
Regeneten, a bioinductive collagen implant added during arthroscopic rotator cuff repair
What this could lead to
If successful, this could improve tendon healing and quality after rotator cuff surgery, potentially reducing re-tear rates and improving shoulder function.
What could go wrong
The trial is early and results may not confirm the hoped-for benefit. Surgery plus the implant carries standard risks like infection or stiffness, and the implant may not improve outcomes for everyone.

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 204 people

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

Started

Apr 2024

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: * Patient, male or female, aged ≥ 18 years * Patient candidate for rotator cuff repair affecting supraspinatus tendon (distal lesion) +/- infraspinatus on a non-pseudo-paralytic shoulder +/- proximal lesion of subscapularis * Patient with GI ≤ 2 for each muscle * Non-smoking patient * Patient who is not involved in a work accident * Patient candidate for total rotator cuff repair completely covering the footprint during surgery Exclusion Criteria: * Patient with contraindication to MRI * Patient operated for cuff revision

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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.

Cuff rotator syndrome

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

  • Hôpital Privé Jean Mermoz

    RECRUITING

    Lyon, 69008, France