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

NCT05022485 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Tibial Fractures
  • Fracture Infection

Interventions

DEVICE

ZNN Bactiguard tibia

Tibia fracture fixation

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Emilie Rohmer · Clin Ops Director

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • Austria
  • France
  • Germany
  • Italy
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022485 on ClinicalTrials.gov