Zimmer Biomet Shoulder Arthroplasty PMCF
Start Date
7/28/2021
Completion Date
8/15/2033
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.
Detailed Description
The primary endpoint is defined as survival of the implant at 10 years, which is based on removal or intended removal of at least 1-study implant component and will be determined by using the Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Separate analysis will be done for each arm of the study. The secondary endpoint is represented by the performance and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation after 2 years, which will be assessed by the American Shoulder and Elbow Surgeons (ASES) shoulder score. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.
Eligibility Criteria
Age Range: 20 years to No maximum
Interventions
Alliance Glenoid
Identity Stem
Conditions
Locations
Hoag Orthopedic Institute
Irvine, California 92618
United States
Panorama Orthopaedic and Spine Center
Golden, Colorado 80401
United States
Northwestern University
Chicago, Illinois 60208
United States
Norton Healthcare, Inc
Louisville, Kentucky 40202
United States
William Beaumont Hospital
Royal Oak, Michigan 48073
United States
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota 55431
United States
Mississippi Sports Medicine and Orthopaedic Center, PLLC
Jackson, Mississippi 39202
United States
Advance Bone and Joint
City of Saint Peters, Missouri 63376
United States
Washington University
St Louis, Missouri 63130
United States
University of Buffalo
Buffalo, New York 14215
United States
Rothman Institute
Philadelphia, Pennsylvania 19107
United States
Intermountain Health
Murray, Utah 84107
United States
Fukui General Hospital
Fukui, 910-3113
Japan
Iwaki City Medical Center
Fukushima, 973-8555
Japan
Yuuai Medical Center
Okinawa, 901-0224
Japan
Kichijoji Minami Hospital
Tokyo, 180-0003
Japan
Kensington Private Hospital
Whangarei, 0112
New Zealand