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Can a collagen suture help torn shoulder tendons heal better?

NCT ID NCT06971497

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Last updated Aug 28, 2026

Summary

Researchers at the Cleveland Clinic are testing a new type of suture called ActivBraid for repairing torn rotator cuff tendons in the shoulder. The suture is coated with collagen, a protein that makes up tendons and bones, which may help the tendon heal more firmly to the bone. The study will enroll up to 65 people aged 18 to 75 with a full-thickness tear of the supraspinatus or infraspinatus tendon. Participants will undergo arthroscopic repair with ActivBraid, and researchers will track healing using MRI and CT scans, as well as shoulder strength and patient-reported outcomes, over two years.

What this could mean

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

Active substance
ActivBraid™ Collagen Co-Braid suture, a device made of polyethylene and cow-skin collagen, used during rotator cuff repair surgery
What this could lead to
If it works, this suture could improve tendon healing after rotator cuff repair, potentially leading to better shoulder function and fewer re-tears.
What could go wrong
This is a small, early-stage study, and the collagen coating may not improve healing over standard sutures. There is also a risk of allergic reaction to cow-derived collagen.

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

About 65 people

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

Started

Aug 2025

Expected to finish

Aug 2029

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.

Who is studied

Patients undergoing primary arthroscopic rotator cuff repair

Ages

18 to 75 years

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: * 18-75 years * acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons Exclusion Criteria: * prior ipsilateral shoulder surgery * outstanding worker's compensation claim * symptomatic cervical spine disease * a frozen shoulder * advanced glenohumeral arthritis * isolated subscapularis tear * significant radiation exposure for other medical reasons. * known is advance to be claustrophobic * known history of hypersensitivity to bovine-derived materials.

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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.

Rotator cuff repair of the shoulder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

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