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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Contact Information
Primary
Octavia Gladden
octavia.gladden@zimmerbiomet.com
7044930178
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2040-12
Participants
Target number of participants: 59
Treatments
Treatment Group
The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.
Related Therapeutic Areas
Sponsors
Leads: Zimmer Biomet