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ACTIVE NOT RECRUITING
NCT05362864

ZNN Bactiguard Cephalomedullary 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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2023-01-23

Completion Date

2026-02-01

Last Updated

2025-08-17

Healthy Volunteers

No

Interventions

PROCEDURE

Fracture fixation via Intramedullary Nailing

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

Locations (3)

Centre Hospitalier de Douai

Douai, France, France

Hospital Rio Hortega

Valladolid, Castille-La Mancha, Spain

Hospital Clinico de Valencia

Valencia, Valencia, Spain