Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Zimmer Biomet
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.
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 Su…
Eligibility
- Age range
- 20+ years
- Sex
- All
- Healthy volunteers
- No
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 su…
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 InstituteIrvine, California
- Panorama Orthopaedic and Spine CenterGolden, Colorado
- Northwestern UniversityChicago, Illinois
- Norton Healthcare, IncLouisville, Kentucky
- William Beaumont HospitalRoyal Oak, Michigan
- TRIA Orthopaedic Center Research InstituteBloomington, Minnesota