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RECRUITING
NCT05339360

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

Sponsor: Zimmer Biomet

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.

Official title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-01-16

Completion Date

2027-12

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

PROCEDURE

Femoral fixation with intramedullary nails

Femoral fracture fixation Femoral Osteotomy

Locations (2)

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Manchester Royal Infirmary

Manchester, Manchester, United Kingdom