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Shoulder surgery showdown: which fix works best for torn rotator cuffs?

NCT ID NCT04742452

Disease control Sponsor: University Hospitals Cleveland Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study compares two surgical options for people with large, irreparable rotator cuff tears: partial repair alone versus partial repair plus a tissue graft to rebuild the shoulder capsule. Researchers will track pain, function, and quality of life in 105 participants over two years. The goal is to see if adding the graft provides extra benefit or if partial repair alone is enough.

What this could mean

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

Active substance
surgery (partial rotator cuff repair with or without superior capsule reconstruction)
What this could lead to
If this trial succeeds, it could show that one surgical method provides better pain relief and shoulder function for people with severe, untreatable rotator cuff tears.
What could go wrong
This is a relatively small, early-stage trial comparing two surgical techniques. The results may not apply to all patients, and there is a risk of surgical complications or that neither method proves clearly better.

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

41 people

The number who actually took part.

Started

Nov 2020

Finished

Apr 2026

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 89 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age range: ≥18 years * Irreparable rotator cuff tear suspected on pre-operative MRI Exclusion Criteria: * Pregnant, illiterate, or non-English speaking individuals * Rotator cuff pathology amenable to a complete repair intraoperatively * Moderate to severe rotator cuff arthropathy (Hamada grade ≥3) * Presence of glenohumeral arthritis on radiographs * Irreparable subscapularis muscle intraoperatively * Active infection within the ipsilateral glenohumeral joint * Neurologic pathology limiting shoulder function * Current smoker * Workers' compensation claim

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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

Contacts and locations

Locations

  • Lake Health

    Willoughby, Ohio, 44094, United States

  • Midwest Orthopaedics at Rush

    Chicago, Illinois, 60612, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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