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Zimmer Biomet Shoulder Arthroplasty Systems for Shoulder Conditions

This study is looking at the safety and effectiveness of Zimmer Biomet's Alliance Glenoid and Identity Stem devices, used in shoulder replacement surgery (arthroplasty). It aims to confirm how well these devices work and how safe they are for people with shoulder fractures, arthritis, osteoarthritis, deformity, or injuries. To join, you must be at least 20 years old and a candidate for shoulder replacement surgery. The study will track how long the implants last and any problems that occur over 10 years. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 584 participants. It will assess the safety and performance of two specific shoulder implant devices.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years to assess implant survival and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04984291

Zimmer Biomet Shoulder Arthroplasty PMCF

Recruiting
NAAges 20+InterventionalTreatment
Zimmer Biomet
~584 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Alliance GlenoidIdentity Stem

At a glance

Recruiting sites
2 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Measured over 10 years
+1 more outcome measured

Conditions

Shoulder Fractures
Shoulder Arthritis
Shoulder Osteoarthritis
Shoulder Deformity
Shoulder Injuries
Shoulder Pain

Explore related trials

OsteoarthritisRheumatoid ArthritisShoulder FractureShoulder joint deformity

NCT04984291

Where you'd take part

This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Intermountain Health

    Murray, Utahstudy coordinator listed

    Recruiting

  • Panorama Orthopaedic and Spine Center

    Golden, Coloradostudy coordinator listed

    Recruiting

  • Advance Bone and Joint

    City of Saint Peters, Missourino site contact published

    Active, not recruiting

  • Fukui General Hospital

    Fukui, Japanno site contact published

    Active, not recruiting

  • Hoag Orthopedic Institute

    Irvine, Californiano site contact published

    Active, not recruiting

  • Iwaki City Medical Center

    Fukushima, Japanno site contact published

    Active, not recruiting

  • Kensington Private Hospital

    Whangarei, New Zealandno site contact published

    Withdrawn

  • Kichijoji Minami Hospital

    Tokyo, Japanno site contact published

    Withdrawn

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ryan Boylan · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

Cayla Lafollette, BS
[email protected]
574 268-8610
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Implant Survivorship at 10 years follow-up (Kaplan Meier)10 years

    Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

  • Frequency and Incidence of Adverse Events (Safety)10 years

    Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.