Trials / Recruiting
RecruitingNCT04984291
Zimmer Biomet Shoulder Arthroplasty PMCF
Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 584 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Shoulder Fractures
- Shoulder Arthritis
- Shoulder Osteoarthritis
- Shoulder Deformity
- Shoulder Injuries
- Shoulder Pain
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Alliance Glenoid | Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty |
| DEVICE | 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 |
Timeline
- Start date
- 2021-07-28
- Primary completion
- 2033-08-15
- Completion
- 2033-08-15
- First posted
- 2021-07-30
- Last updated
- 2025-10-29
Locations
17 sites across 3 countries: United States, Japan, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04984291. Inclusion in this directory is not an endorsement.