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Shoulder surgery showdown: to repair or not to repair a key tendon?

NCT ID NCT04728282

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compares two versions of a shoulder replacement surgery for people with shoulder arthritis. In one version, surgeons repair a small but important tendon called the subscapularis; in the other, they leave it unrepaired. The goal is to see which approach gives better shoulder function and less pain over two years. About 284 participants will be randomly assigned to one of the two procedures.

What this could mean

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

Active substance
reverse total shoulder arthroplasty (a type of shoulder replacement surgery) with or without repair of the subscapularis tendon
What this could lead to
If successful, this could show that repairing the subscapularis tendon during shoulder replacement leads to better shoulder function and less pain for patients with arthritis.
What could go wrong
This is a relatively small, early-stage trial, and results may not apply to all patients. Surgery always carries risks like infection, nerve damage, or implant failure.

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 284 people

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

Started

Nov 2021

Expected to finish

Mar 2030

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: * Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA * First RTSA implantation * Absence of neoplastic diseases at the treated site * Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier \< Grade 3) based on pre-operative CT performed as standard of care in the patient group Exclusion Criteria: * Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA) * Avascular necrosis * Post-infectious arthritis * Proximal humerus fracture * Inflammatory arthritis * Inability to communicate in English * Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.) Intra-operative Exclusions: * Subscapularis with fatty infiltration (Goutallier ≥ 3) * Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site * Any anatomical or patient characteristic that warrants a non-lateralized implant

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Conditions

The condition(s) this trial relates to.

arthritic joint disease arthropathy rotator cuff syndrome

As listed by the trial registrant

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

Arthritis shoulder

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

  • Pan Am Clinic

    RECRUITING

    Winnipeg, Manitoba, R3M 3E4, Canada

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