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Which shoulder surgery works best for seniors with arthritis? a Head-to-Head trial

NCT ID NCT05395819

Disease control Sponsor: University of Alberta 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study compares two types of shoulder replacement surgery—Total Shoulder Arthroplasty (TSA) and Reverse Total Shoulder Arthroplasty (RTSA)—in people aged 65 and older with advanced shoulder osteoarthritis. Participants are randomly assigned to one of the two procedures. The goal is to see which surgery leads to better shoulder function, quality of life, and fewer complications within the first year after surgery. This pilot study will also help determine if a larger trial is feasible.

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 (RTSA) and Total Shoulder Arthroplasty (TSA) surgical procedures
What this could lead to
If one procedure proves clearly better, surgeons may have clearer guidance on which shoulder replacement to use for older patients with osteoarthritis, potentially improving outcomes and reducing complications.
What could go wrong
This is a small pilot study with only 40 participants, so results may not apply to everyone. The trial is early-stage and designed mainly to test feasibility, not to provide definitive answers.

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 40 people

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

Started

May 2022

Expected to finish

May 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

65 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. Patients who have failed standard non-surgical management of their shoulder osteoarthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as: 1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs 2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.) 3. Activity modification 2. Imaging, and intra-operative findings confirming advanced gleno-humeral cartilage loss 3. Patients may present with a glenoid deficiency and \>15 degrees of retroversion 4. 65 years of age and older Exclusion Criteria: 1. Active joint or systemic infection 2. Rotator cuff arthropathy 3. Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral 4. Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique 5. Significant muscle paralysis 6. Charcot's arthropathy 7. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk) 8. Active Workers Compensation Board (WCB) claim 9. Unable to understand the consent form/process 10. Psychiatric illness that precludes informed consent 11. Unwilling to be followed for the duration of the study 12. History of previous shoulder surgery on affected side

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Conditions

The condition(s) this trial relates to.

osteoarthritis

As listed by the trial registrant

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

Shoulder osteoarthritis

Contacts and locations

Locations

  • Collaborative Orthopaedic Research (CORe), Clinical Sciences Building

    Edmonton, Alberta, T6G 2B7, Canada

  • Glen Sather Sports Medicine Clinic (University of Alberta)

    Edmonton, Alberta, T6G 1Z1, Canada

  • Grey Nuns Community Hospital

    Edmonton, Alberta, T6L 5X8, Canada

  • Kaye Edmonton Clinic

    Edmonton, Alberta, T6G 1Z1, Canada

  • Royal Alexandra Hospital (Orthopaedic Surgical Centre)

    Edmonton, Alberta, T5H 3V9, Canada

  • Sturgeon Community Hospital

    St. Albert, Alberta, T8N 6C4, Canada

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7, Canada

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