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Surgery or exercise? landmark trial tests best treatment for Worn-Out shoulders

NCT ID NCT04864158

Disease control Sponsor: University of Aarhus 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Jul 02, 2026

Summary

This trial compares two approaches for people with rotator cuff arthropathy, a condition where the shoulder joint wears down due to a torn rotator cuff. One group receives reverse total shoulder replacement surgery followed by standard rehab, while the other group completes a 12-week supervised exercise program. The study aims to see if surgery leads to better pain relief and function than exercise alone. Participants are between 60 and 85 years old and are eligible for shoulder replacement.

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 and a 12-week exercise program
What this could lead to
If surgery proves superior, it could confirm reverse shoulder replacement as the best option for severe rotator cuff arthropathy. If exercise works as well, it may offer a non-surgical alternative.
What could go wrong
This is a relatively small trial (102 participants) and results may not apply to all patients. Surgery carries risks like infection or implant failure, while exercise may not provide enough relief for severe cases.

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 102 people

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

Started

May 2021

Expected to finish

Jan 2037

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

60 to 85 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 60-85 years * Eligible for RSA * Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33) Exclusion Criteria: * Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture) * Planned other upper extremity surgery within six months * Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA * Cancer diagnosis and receiving chemo-, immuno- or radiotherapy * Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease) * Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test. * Unable to communicate in the participating countries respective languages

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Conditions

The condition(s) this trial relates to.

arthropathy rotator cuff syndrome Rotator Cuff Tear Arthropathy

As listed by the trial registrant

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

Rotator cuff arthropathy

How to take part

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

  1. The places running it

    8 sites in 4 countries. 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

  • Aalborg University Hospital

    RECRUITING

    Farsø, 9640, Denmark

  • Aarhus University Hospital

    RECRUITING

    Aarhus N, Denmark

  • Esbjerg Hospital

    RECRUITING

    Esbjerg, 6700, Denmark

  • Oslo University Hospital

    RECRUITING

    Oslo, 4956, Norway

  • Silkeborg Regional Hospital

    RECRUITING

    Silkeborg, 8600, Denmark

  • Tampere University Hospital

    RECRUITING

    Tampere, 33521, Finland

  • Tartu University Hospital

    RECRUITING

    Tartu, Estonia

  • Viborg Regional Hospital

    RECRUITING

    Viborg, 8800, Denmark

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