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ZNN Bactiguard Antegrade Femoral Nails PMCF Study

NCT05339360 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Femur Fracture
  • Osteotomy

Interventions

PROCEDURE

Femoral fixation with intramedullary nails

Femoral fracture fixation Femoral Osteotomy

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Emilie Rohmer · Zimmer Biomet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2027-01-31
Completion
2027-12-31

Countries

  • Spain
  • 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 NCT05339360 on ClinicalTrials.gov