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New shoulder implant under Long-Term watch: will it hold up?

NCT ID NCT06920459

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 50 people who receive a Zimmer Biomet shoulder replacement implant to see if it safely improves pain, movement, and quality of life over two years. Participants have shoulder arthritis, fractures, or other joint damage. The main goal is to measure a meaningful improvement in shoulder function using a standard score. Researchers will also track any side effects or device problems.

What this could mean

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

Active substance
Alliance™ Glenoid shoulder implant
What this could lead to
If successful, this study will confirm that the shoulder implant reliably reduces pain and improves function for people with arthritis or fractures.
What could go wrong
This is a small, non-controlled study (50 patients) with no comparison group, so results may not apply to everyone. Implant risks include infection, loosening, 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.

Participants

About 50 people

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

Started

Apr 2025

Expected to finish

Jun 2037

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.

Who is studied

The Alliance Glenoid is intended to be used as part of an anatomic total shoulder arthroplasty to reduce shoulder pain an improve shoulder function. The Alliance Glenoid is intended to be used as a component of a total shoulder replacement system for primary arthroplasty. It provides the surface on the glenoid side that articulates with the modular head component and stem component on the humeral side. Patients must meet all inclusion and none on the exclusion criteria.

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. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. Difficult clinical management problems, where other method 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. 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 a metabolic disorder that may impair bone formation. * Patient has osteomalacia.

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Conditions

The condition(s) this trial relates to.

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 study's own enquiry address

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

  2. The places running it

    2 sites in 2 countries. 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

  • ARCUS Kliniken Pforzheim

    RECRUITING

    Pforzheim, 75179, Germany

    Contact Email: •••••@•••••

  • Meander Medisch Centrum

    RECRUITING

    Amersfoort, TZ, 3813, Netherlands

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