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Zimmer Biomet Shoulder Arthroplasty PMCF

Recruiting

Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study

Who can join

Ages 20 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Zimmer Biomet · Participants: 584 · Started: Jul 28, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04984291

Locations in the U.S.

ColoradoPanorama Orthopaedic and Spine Center, Golden
UtahIntermountain Health, Murray

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.