Actively Recruiting
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Primary Revision Stems (Implants and Instrumentation) A Retrospective and Prospective Consecutive Series Study
Led by Zimmer Biomet · Updated on 2026-04-28
59
Participants Needed
2
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting long-term data to confirm the safety, performance, and clinical benefits of the Comprehensive Primary Revision Stems used in shoulder arthroplasty. This observational study includes both retrospective and prospective data from patients who have received these implants. The study focuses on conditions such as shoulder pain, injuries, fractures, disease, and arthritis. The study involves patients implanted with the Comprehensive Primary Revision Stem device, including both the implants and instrumentation, used during shoulder replacement surgery. The safety will be assessed by tracking implant survivorship over 10 years, noting any revisions, complications, or adverse events related to the implant or procedure. Performance will be evaluated through patient-reported outcome measures and radiographic assessments over the same period. Participants will be followed at intervals up to 10 years to monitor implant survival and safety outcomes. Clinical outcomes will be measured using tools like the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure. The study team will record any adverse events and analyze their relation to the implant, instrumentation, or procedure. This long-term monitoring aims to provide comprehensive data about the device's performance and safety.
CONDITIONS
Brief 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical procedure day
Participants receive the Comprehensive Primary Revision Stem implant during shoulder arthroplasty as part of routine care.
1 visit (in-person)
Duration - Up to 10 years
Participants are monitored for safety and performance of the implant through clinical outcome assessments and radiographic evaluations.
Follow-up visits scheduled over 10 years
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
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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