Zimmer Biomet Shoulder Arthroplasty PMCF

Recruiting now · Not applicable

Conditions studied: Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Deformity, Shoulder Injuries, Shoulder Pain

In brief

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.

Key facts

Study ID

NCT04984291

Run by

Zimmer Biomet

People needed

584

Starts

2021-07-28

Expected to finish

2033-08-15

Last updated by the study team

2026-04-28

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Intermountain Health — Murray, Utah, United States (enrolling)
• Panorama Orthopaedic and Spine Center — Golden, Colorado, United States (enrolling)
• Norton Healthcare, Inc — Louisville, Kentucky, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• TRIA Orthopaedic Center Research Institute — Bloomington, Minnesota, United States
• Mississippi Sports Medicine and Orthopaedic Center, PLLC — Jackson, Mississippi, United States
• Advance Bone and Joint — City of Saint Peters, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of Buffalo — Buffalo, New York, United States
• Rothman Institute — Philadelphia, Pennsylvania, United States
• Fukui General Hospital — Fukui, Japan
• Iwaki City Medical Center — Fukushima, Japan
• Yuuai Medical Center — Okinawa, Japan
• Kichijoji Minami Hospital — Tokyo, Japan
• Hoag Orthopedic Institute — Irvine, California, United States
• Kensington Private Hospital — Whangarei, New Zealand
• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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