New shoulder implant put to the test against standard replacement

NCT ID NCT07812324

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

Researchers are comparing a new anatomic total shoulder replacement system with currently marketed shoulder implants in adults with osteoarthritis or post-traumatic arthritis. The trial enrolls about 286 people who need total shoulder replacement. The goal is to see whether the new implant is as safe and effective as standard devices, based on shoulder function scores, X-ray appearance, and the need for revision surgery over two years.

What this could mean

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

Active substance
Mirror Anatomic Total Shoulder Prosthesis, a shoulder replacement implant
What this could lead to
If the new implant performs as well as standard shoulder replacements, it could offer another option for people with severe shoulder arthritis who need surgery to ease pain and restore movement.
What could go wrong
The trial may show the new implant is no better than standard devices, or it could reveal unexpected problems such as loosening or the need for repeat surgery. Results take two years to gather, and individual outcomes vary.

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 286 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 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: * Adult subject 22 years or older * Clinical indication for total shoulder replacement due to osteoarthritis, and/or post-traumatic arthritis. * Scapula and proximal humerus must have reached skeletal maturity * Willing and able to comply with the protocol * Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject) Exclusion Criteria: * Lack of sufficient bone quality that in the Investigator's medical judgment could compromise implant fixation or bone healing, including conditions such as: * Rapid joint destruction, marked bone loss or bone resorption; * Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and * Osteomalacia * osteoporosis * rheumatoid arthritis * Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene * Patient presents with a malunion or non-union of the tuberosities of the proximal humerus. * Infection at or near the site of implantation, including: * Glenohumeral joint infection * Osteomyelitis * Distant or systemic infection * Medical conditions or balance impairments that could lead to falls * Prior Total, or Reverse Total Shoulder arthroplasty in the affected shoulder. * Prior failed rotator cuff surgery, but excluding successful shoulder arthroscopy * Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff * Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery * Metabolic disorders which may impair bone function * Nonfunctional deltoid muscle * Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint) * Patients diagnosed with severe shoulder instability * Patients diagnosed with subscapularis incompetence * Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease * Currently, or within the last 6 months, or planning to be on chemotherapy or radiation * Currently taking \> 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery or patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery) * Female subjects who are pregnant or planning to become pregnant within the study period * In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice * History of any cognitive or mental health status that would interfere with study participation * Substance Use Disorder (alcohol and/or drug) * Engages in manual labor or sports activities that could affect shoulder outcome * Patients who have a work-related injury leading to shoulder OA * Currently enrolled in any clinical research study that might interfere with the current study endpoints * Patients with a life expectancy of less than three years * Medical condition or balance impairment that could lead to falls * Weight bearing shoulder due to wheelchair, crutches, rollator at the time of operation * Individuals who are incarcerated or detained in a correctional facility or under any form of legal supervision that limits their ability to voluntarily consent to participate in the trial. * Previous randomization of the subject in the current study.

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

    12 sites. 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

  • Andrews Research & Education Foundation

    Gulf Breeze, Florida, 32561, United States

  • Central Indiana Orthopedics

    Fishers, Indiana, 46037, United States

  • Cornell Med NY

    New York, New York, 10021, United States

  • Dartmouth Hitchcock

    Lebanon, New Hampshire, 03756, United States

  • Foundation for Orthopedic Research and Education

    Tampa, Florida, 33607, United States

  • Intermountain Health

    St. George, Utah, 84790, United States

  • Johns Hopkins - Washington

    Columbia, Maryland, 21044, United States

  • OrthoArizona

    Gilbert, Arizona, 85297, United States

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Southern Oregon Orthopedics

    Medford, Oregon, 97504, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84108, United States

  • West Boca Medical Center

    Boca Raton, Florida, 33428, United States

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