MedTrace Logo

ZNN Bactiguard Cephalomedullary Nails PMCF Study

NCT05362864 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 149

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary 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 trochanteric, sub-trochanteric or shaft 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

  • Osteotomy
  • Trochanteric Fractures
  • Sub-trochanteric Fractures
  • Femoral Shaft Fracture

Interventions

PROCEDURE

Fracture fixation via Intramedullary Nailing

Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.

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
2023-01-23
Primary Completion
2025-12-17
Completion
2025-12-17

Countries

  • France
  • Spain

Study Locations

More Related Trials

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 NCT05362864 on ClinicalTrials.gov