Actively Recruiting
MDR - Comprehensive Primary Revision Stems PMCF
Led by Zimmer Biomet · Updated on 2026-04-28
59
Participants Needed
2
Research Sites
806 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.
CONDITIONS
Official Title
MDR - Comprehensive Primary Revision Stems PMCF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older.
- Patient must be willing and able to follow directions.
- Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem
You will not qualify if you...
- Off-label use.
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
- Patient is unwilling to sign informed consent.
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 900033
Actively Recruiting
2
Aalborg University Hospital
Aalborg, Denmark, DK-9000
Actively Recruiting
Research Team
O
Octavia Gladden
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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