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New patch could help shoulder tendons heal stronger after surgery

NCT ID NCT05439850

Disease control Sponsor: Henry Ford Health System 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares standard rotator cuff surgery to surgery plus a bioinductive patch that aims to help the tendon heal better. About 78 adults with full-thickness tears will be randomly assigned to one of the two groups. The main goal is to see if the patch leads to fewer tendon defects on ultrasound one year after surgery.

What this could mean

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

Active substance
Bioinductive implant (a patch placed on the tendon during surgery to promote healing)
What this could lead to
If it works, this could mean fewer repeat tears and better shoulder function after rotator cuff surgery.
What could go wrong
This is a relatively small, early-phase study. The patch may not improve healing rates, and surgery always carries risks like infection or stiffness.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 78 people

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

Started

Aug 2022

Expected to finish

Jul 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.

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: * Indicated and scheduled for arthroscopic rotator cuff repair. * Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging. * Chronic, degenerative rotator cuff tears. * Ability to read and understand English. * Age ≥18 years * Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy Exclusion Criteria: * Patient scheduled for open or mini-open rotator cuff repair * Prior surgery of affected shoulder (except diagnostic arthroscopy) * Partial-thickness rotator cuff tears * Small (\<1 cm) rotator cuff tears * Rotator cuff tears involving the subscapularis tendon * Acute and traumatic rotator cuff tears * Active infection * Cancer * Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome Rotator Cuff Tear Arthropathy

As listed by the trial registrant

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

Rotator cuff tear arthropathy Rotator cuff tears

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

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

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