RecruitingNCT05339360

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

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

Sponsor

Zimmer Biomet

Enrollment

100 participants

Start Date

Jan 16, 2024

Study Type

OBSERVATIONAL

Conditions

femur fracture Osteotomy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Patient must be 18 or older
Patient must have a signed EC-approved informed consent.
Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling/ high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
Patient has been or is scheduled to be treated with the ZNN Bactiguard System Antegrade Femoral Nail
Patient must be able and willing to complete the protocol required for follow-up
Patients capable of understanding the surgeon's explanations and following his instructions

Exclusion Criteria11

Skeletally immature patients
Medullary canal obliterated by a previous fracture or tumor
Bone shaft having excessive bow or a deformity
Lack of bone substance or bone quality, which makes stable seating of the implant impossible
All concomitant diseases that can impair the operation, functioning or the success of the implant
Insufficient blood circulation
Infection
Patient is unwilling to give consent.
Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subjects with alcohol/drug addiction, known to be pregnant or breast feeding)
Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long-distance, plans to move during the course of study)
Patients not expected to survive the duration of the follow-up program