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Affixus Natural Nail System Humeral Nail PMCF
Sponsor: Zimmer Biomet
Summary
A commercially available product clinical study which aims to confirm the safety, performance and clinical benefits to the patient of the Affixus Natural Nail upper arm (humerus) bone nail system for both the implant itself and the instrumentation used during surgery.
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Affixus Natural Nail System Humeral Nail (Implants and Instrumentation)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2022-08-29
Completion Date
2027-08
Last Updated
2025-11-12
Healthy Volunteers
No
Interventions
humeral fracture
Patient with either a proximal humeral fracture or humeral shaft fracture requiring surgical intervention and be eligible for fixation by intramedullary nailing.
Locations (5)
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
UZ Leuven - Traumatology Department
Leuven, Belgium
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
General Foundation of the University of Valladolid
Valladolid, Spain
Kantonsspital Frauenfeld
Frauenfeld, Thurgau, Switzerland