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New scaffold may help older patients heal torn shoulder tendons

NCT ID NCT04325789

Disease control Sponsor: Atreon Orthopedics 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a nanofiber scaffold during rotator cuff surgery helps the tendon heal better in people over 55. 91 patients were randomly assigned to get either standard repair or repair with the scaffold. The main goal was to see if the scaffold reduces the chance of the repair failing after surgery.

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

91 people

The number who actually took part.

Started

Jun 2020

Finished

Dec 2025

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.

Ages

55 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. Age 55 and older 2. Able to provide informed consent 3. Primary diagnosis of rotator cuff tear Exclusion Criteria: 1. Revision rotator cuff surgery 2. Partial thickness rotator cuff tears 3. Massive (greater than 5cm) rotator cuff tears 4. Patients with current tobacco history

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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.

Full-thickness rotator cuff tears Rotator cuff tears

Contacts and locations

Locations

  • Associated Orthopedists of Detroit

    Saint Clair Shores, Michigan, 48080, United States

  • Central Indiana Orthopedics

    Fishers, Indiana, 46037, United States

  • Steadman Hawkins Clinic of the Carolinas - Patewood

    Greenville, South Carolina, 29615, United States

  • The Christ Hospital & The Lindner Reseach Center at The Christ Hospital

    Cincinnati, Ohio, 45219, United States

More trials for these conditions

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