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ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Sponsor: Zimmer Biomet
Summary
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies. This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.
Official title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-01-16
Completion Date
2027-12
Last Updated
2025-11-25
Healthy Volunteers
No
Conditions
Interventions
Femoral fixation with intramedullary nails
Femoral fracture fixation Femoral Osteotomy
Locations (2)
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Manchester Royal Infirmary
Manchester, Manchester, United Kingdom