Zimmer Biomet Shoulder Arthroplasty PMCF
Condition(s) studied
Investigational drug(s) / intervention(s)
Alliance Glenoid: Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
Identity 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
Study 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
Primary outcome measure(s)
- Implant Survivorship at 10 years follow-up (Kaplan Meier) — 10 years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method. - Frequency and Incidence of Adverse Events (Safety) — 10 years
Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Hoag Orthopedic Institute | Irvine | California | Active Not Recruiting |
| Panorama Orthopaedic and Spine Center | Golden | Colorado | Recruiting |
| Northwestern University | Chicago | Illinois | Active Not Recruiting |
| Norton Healthcare, Inc | Louisville | Kentucky | Terminated |
| William Beaumont Hospital | Royal Oak | Michigan | Active Not Recruiting |
| TRIA Orthopaedic Center Research Institute | Bloomington | Minnesota | Active Not Recruiting |
| Mississippi Sports Medicine and Orthopaedic Center, PLLC | Jackson | Mississippi | Active Not Recruiting |
| Advance Bone and Joint | City of Saint Peters | Missouri | Active Not Recruiting |
| Washington University | St Louis | Missouri | Active Not Recruiting |
| University of Buffalo | Buffalo | New York | Active Not Recruiting |
| Rothman Institute | Philadelphia | Pennsylvania | Active Not Recruiting |
| Intermountain Health | Murray | Utah | Recruiting |
| Fukui General Hospital | Fukui | Japan | Active Not Recruiting |
| Iwaki City Medical Center | Fukushima | Japan | Active Not Recruiting |
| Yuuai Medical Center | Okinawa | Japan | Active Not Recruiting |
| Kichijoji Minami Hospital | Tokyo | Japan | Withdrawn |
| Kensington Private Hospital | Whangarei | New Zealand | Withdrawn |
More Zimmer Biomet trials in Japan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04984291 on ClinicalTrials.gov ↗ ← All trials in Japan