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Zimmer Biomet Shoulder Arthroplasty PMCF

Zimmer Biomet · NCT04984291

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 20+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
584
US sites recruiting
2
Study start
July 28, 2021
Record last updated
April 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Being studied: Alliance Glenoid; Identity Stem

Conditions: Shoulder Fractures; Shoulder Arthritis; Shoulder Osteoarthritis; Shoulder Deformity; Shoulder Injuries; Shoulder Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Panorama Orthopaedic and Spine Center

    Golden, CO 80401

    Site contact: Paul Lee, PA · 720-497-6697 · ResearchCoordinators@panoramaortho.com

  • Intermountain Health

    Murray, UT 84107

    Site contact: Maha Maleki, BS · 801-507-8095 · Maha.Maleki@imail.org

Study contacts (from the official record)

  • Cayla Lafollette, BS · 574 268-8610 · Cayla.lafollette@zimmerbiomet.com
  • Ryan Boylan, MBA · ryan.boylan@zimmerbiomet.com
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Zimmer Biomet Shoulder Arthroplasty PMCF (NCT04984291) | Bored Studies