RecruitingNot ApplicableNCT04984291

Zimmer Biomet Shoulder Arthroplasty PMCF

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


Sponsor

Zimmer Biomet

Enrollment

584 participants

Start Date

Jul 28, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This post-market clinical study collects follow-up data on patients who have received a Zimmer Biomet shoulder replacement (arthroplasty) to track long-term safety, performance, and patient satisfaction. No new experimental treatment is being tested — it tracks how well already-approved shoulder implants work over time. You may be eligible if... - You are 20 years or older - You are anatomically suitable for shoulder replacement surgery - You have a qualifying condition such as osteoarthritis, avascular necrosis, rheumatoid arthritis, a proximal humerus fracture, or a failed prior shoulder replacement - You have a grossly deficient rotator cuff (for reverse shoulder replacement) - You are willing and able to attend follow-up visits You may NOT be eligible if... - You are unwilling or unable to give consent or comply with follow-up - You are pregnant or breastfeeding - You have a current infection near the shoulder joint - You have significant bone loss or bone resorption - You have neuromuscular disease affecting the limb, osteoporosis, osteomalacia, or a metabolic bone disorder - You have a non-functional deltoid or external rotator muscles, or paralysis of the axillary nerve Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAlliance Glenoid

Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty

DEVICEIdentity Stem

Identity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty


Locations(17)

Hoag Orthopedic Institute

Irvine, California, United States

Panorama Orthopaedic and Spine Center

Golden, Colorado, United States

Northwestern University

Chicago, Illinois, United States

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

Intermountain Health

Murray, Utah, United States

Fukui General Hospital

Fukui, Japan

Iwaki City Medical Center

Fukushima, Japan

Yuuai Medical Center

Okinawa, Japan

Kichijoji Minami Hospital

Tokyo, Japan

Kensington Private Hospital

Whangarei, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04984291


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