Clinical Trial

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-04-20; most recent amendment 2025-11-19.
Status change: Active, Not Recruiting → Recruiting 2024-05-31
Status change: Not Yet Recruiting → Active, Not Recruiting 2024-01-22
Trial Details
NCT Number NCT05339360
Lead Sponsor Zimmer Biomet
Conditions Femur Fracture, Osteotomy
Enrollment 100 participants
Start Date 2024-01-16
Primary Completion 2027-01 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-25