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Shoulder surgery boost: biceps patch may help torn rotator cuffs heal better

NCT ID NCT07568392

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether using a piece of the patient's own biceps tendon as a patch during rotator cuff repair helps the torn tendon heal better. 80 adults with medium to large tears will be randomly assigned to standard repair or repair with the patch. Researchers will measure shoulder function and healing on MRI up to 2 years 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
biceps tendon autograft patch augmentation
What this could lead to
If successful, this technique could improve tendon healing and shoulder function after rotator cuff repair, offering a cost-effective option.
What could go wrong
This is a small, early-stage trial with only 80 participants. The procedure may not improve outcomes over standard repair, and risks include surgical complications or poor healing.

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 80 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

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 to 99 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: * Patients \> 18 years of age who speak English, indicated for arthroscopic rotator cuff repair and open subpectoral biceps tenodesis. * Supraspinatus (+/- anterior infraspinatus tendon) full thickness tears. * Medium (1-3cm) and large (3-5) cm tears. Classification according to anterior to posterior dimensions: small \<1cm, medium 1-3 cm, large 3-5 cm, massive \>5cm or 2 tendons. * Patte Grade 1 and 2. Patte Classification: grade 1, tear at insertion; grade 2, retracted to humeral head; grade 3, retracted to glenoid or medial to glenoid. * Goutallier grade 0-2 fatty infiltration on pre-operative MRI. * Repairable upper border subscapularis tendon tear. * Patients undergoing concomitant biceps tenodesis. Exclusion Criteria: * Pregnant women, non-English speakers and prisoners. * Patients with prior surgery on the ipsilateral shoulder. * Worker's compensation status. * Adhesive capsulitis. * Patient with glenohumeral osteoarthritis, as graded by the modified Samilson and Prieto Classification (grades 1-3). * Partial thickness rotator cuff tears. * Any cuff tears requiring medialization of the footprint * Patients undergoing concomitant distal clavicle resection.

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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 tears

How to take part

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  1. 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 ↗

  2. A doctor treating you

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