Clinical Trial

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Recruiting
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Record status
This record was last updated November 25, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-08-20; most recent amendment 2025-11-20.
Status change: Not Yet Recruiting → Recruiting 2022-04-29
Trial Details
NCT Number NCT05022485
Lead Sponsor Zimmer Biomet
Conditions Tibial Fractures, Fracture Infection
Enrollment 500 participants
Start Date 2022-04-11
Primary Completion 2026-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-11-25