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Which shoulder repair works best for massive tears? a trial pits two techniques Head-to-Head

NCT ID NCT03617562

Disease control Sponsor: Sunnybrook Health Sciences Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This pilot trial compares two surgical options for people with massive, irreparable rotator cuff tears that haven't improved with non-surgical treatment. One group receives a partial repair, leaving some of the tear unrepaired, while the other gets a newer procedure called superior capsular reconstruction, which uses a donated tissue graft to cover the defect. The study aims to see which approach leads to better shoulder function and less pain, helping to design a larger, more definitive trial.

What this could mean

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

Active substance
two surgical procedures: arthroscopic partial rotator cuff repair and superior capsular reconstruction using a dermal allograft
What this could lead to
If one technique proves superior, it could establish a standard surgical approach for massive irreparable rotator cuff tears, improving shoulder function and pain relief.
What could go wrong
This is a small pilot study, so results may not be definitive. Both procedures carry surgical risks like infection, stiffness, or graft failure, and the new SCR technique lacks long-term safety data.

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 70 people

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

Started

Jul 2018

Expected to finish

Jul 2028

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 65 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: * Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis) * Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus. * Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications * Irreparable tear determined intra-operatively using standard arthroscopic techniques * Informed consent obtained Exclusion Criteria: * Absence of subscapularis muscle insertion, or irreparable subscapularis tear * Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+) * Acute tears (within 6 months) * Neurologic injury causing paralysis of affected shoulder / arm * Any previous surgery to the affected shoulder * Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher) * Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.) * Are there any non-orthopedic comorbidities that put the patient at significant risk?

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Conditions

The condition(s) this trial relates to.

Rotator Cuff Injuries rotator cuff syndrome Shoulder Injuries

As listed by the trial registrant

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

Rotator cuff tear

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Sunnybrook Holland Orthopaedic & Arthritic Centre

    RECRUITING

    Toronto, Ontario, M4Y 1H1, Canada

  • Women's College Hospital

    RECRUITING

    Toronto, Ontario, M5S 1B2, Canada

    Contact Email: •••••@•••••

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