New shoulder implant put to the test against standard replacement
NCT ID NCT07812324
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
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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
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About 286 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561, United States
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Central Indiana Orthopedics
Fishers, Indiana, 46037, United States
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Cornell Med NY
New York, New York, 10021, United States
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Dartmouth Hitchcock
Lebanon, New Hampshire, 03756, United States
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Foundation for Orthopedic Research and Education
Tampa, Florida, 33607, United States
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Intermountain Health
St. George, Utah, 84790, United States
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Johns Hopkins - Washington
Columbia, Maryland, 21044, United States
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OrthoArizona
Gilbert, Arizona, 85297, United States
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Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
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Southern Oregon Orthopedics
Medford, Oregon, 97504, United States
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University of Utah Hospital
Salt Lake City, Utah, 84108, United States
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West Boca Medical Center
Boca Raton, Florida, 33428, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Standing x-rays may reveal what lying scans miss in shoulder replacement planning
- Could a weaker nerve block mean less pain after shoulder surgery?
- Can big data improve shoulder replacement success?
- Can a 48-Hour nerve block prevent the 'Rebound Pain' after shoulder surgery?
- Iodine-coated surgical drapes may cut infection risk in shoulder replacements