MDR - Comprehensive Primary Revision Stems PMCF
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
Zimmer Biomet
59 participants
Jun 19, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria6
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06788717