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10-Year checkup: do these shoulder implants hold up?

NCT ID NCT04984291

Disease control Sponsor: Zimmer Biomet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is following 584 people who received Zimmer Biomet shoulder implants to see how well the devices work over 10 years. Participants have shoulder arthritis, fractures, or deformities. Researchers will track implant survival, pain, function, and any side effects. The goal is to confirm the implants are safe and effective for long-term use.

What this could mean

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

Active substance
Shoulder implant devices (Alliance Glenoid and Identity Stem)
What this could lead to
If successful, this study could confirm that these shoulder implants are safe and effective for long-term use, helping people with shoulder problems regain function and reduce pain.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove the implants are better than other options. Risks include implant failure, infection, or need for revision surgery.

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 584 people

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

Started

Jul 2021

Expected to finish

Aug 2033

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

20 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: * Patient must be 20 years of age or older. * Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants. * Patient is a candidate for shoulder arthroplasty due to one or more of the following: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * Rheumatoid arthritis. * Correction of functional deformity. * Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. * Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate. * Patient must be able and willing to complete the protocol required follow-up. * Patient must be able and willing to sign the IRB/EC approved informed consent. * Patient has grossly deficient rotator, (for reverse application) * With severe arthropathy and/or * Previously failed shoulder joint replacement * Patient must have functional deltoid muscle (for reverse application) Exclusion Criteria: * Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study. * Patient is known to be pregnant or breastfeeding. * Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant). * Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions. * Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. * Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram. * Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable. * Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device. * Patient has osteomalacia. * Patient has a metabolic disorder that may impair bone formation. * Patient has deficient rotator cuff. * Patient presents with significant injury to the upper brachial plexus. * Patient has paralysis of the axillary nerve. * Patient has non-functional deltoid or external rotator muscles.

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Conditions

The condition(s) this trial relates to.

arthropathy avascular necrosis humerus fracture osteoarthritis rheumatoid arthritis Shoulder Fractures Shoulder Injuries Shoulder Pain

As listed by the trial registrant

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

Shoulder arthritis Shoulder deformity Shoulder fractures Shoulder injuries Shoulder osteoarthritis Shoulder pain

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Advance Bone and Joint

    ACTIVE_NOT_RECRUITING

    City of Saint Peters, Missouri, 63376, United States

  • Fukui General Hospital

    ACTIVE_NOT_RECRUITING

    Fukui, 910-3113, Japan

  • Hoag Orthopedic Institute

    ACTIVE_NOT_RECRUITING

    Irvine, California, 92618, United States

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

  • Iwaki City Medical Center

    ACTIVE_NOT_RECRUITING

    Fukushima, 973-8555, Japan

  • Kensington Private Hospital

    WITHDRAWN

    Whangarei, 0112, New Zealand

  • Kichijoji Minami Hospital

    WITHDRAWN

    Tokyo, 180-0003, Japan

  • Mississippi Sports Medicine and Orthopaedic Center, PLLC

    ACTIVE_NOT_RECRUITING

    Jackson, Mississippi, 39202, United States

  • Northwestern University

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60208, United States

  • Norton Healthcare, Inc

    TERMINATED

    Louisville, Kentucky, 40202, United States

  • Panorama Orthopaedic and Spine Center

    RECRUITING

    Golden, Colorado, 80401, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Rothman Institute

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • TRIA Orthopaedic Center Research Institute

    ACTIVE_NOT_RECRUITING

    Bloomington, Minnesota, 55431, United States

  • University of Buffalo

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14215, United States

  • Washington University

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63130, United States

  • William Beaumont Hospital

    ACTIVE_NOT_RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Yuuai Medical Center

    ACTIVE_NOT_RECRUITING

    Okinawa, 901-0224, Japan

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