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New shoulder implant under Long-Term watch: will it hold up?
NCT ID NCT06920459
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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 2037
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.
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
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20 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: * 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites in 2 countries. 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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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ARCUS Kliniken Pforzheim
RECRUITINGPforzheim, 75179, Germany
Contact Email: •••••@•••••
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Meander Medisch Centrum
RECRUITINGAmersfoort, TZ, 3813, Netherlands
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