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Pyrocarbon Clinical Follow-up Study
Sponsor: Stryker Trauma and Extremities
Summary
The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
76
Start Date
2021-10-27
Completion Date
2027-12-31
Last Updated
2026-02-10
Healthy Volunteers
No
Interventions
Aequalis Pyrocarbon Humeral Head
Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head
Locations (8)
HCA HealthONE, LLC
Denver, Colorado, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Tulane University
New Orleans, Louisiana, United States
Southern Maryland Orthopedics
Waldorf, Maryland, United States
Allina Health Orthopedics
Minneapolis, Minnesota, United States
Missouri Orthopaedic Institute
Columbia, Missouri, United States
Duke University
Durham, North Carolina, United States
Southern Oregon Orthopedics
Medford, Oregon, United States