RecruitingNCT05276674

ZNN Bactiguard Retrograde Femoral Nails PMCF Study

Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)

Sponsor

Zimmer Biomet

Enrollment

100 participants

Start Date

Oct 23, 2023

Study Type

OBSERVATIONAL

Conditions

Femoral Fracture

Summary

Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Patients must be 18 years or older.
Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention 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 Retrograde Femoral Nail.
Patient must be able and willing to complete the protocol required follow-up.
Patient must have a signed EC approved consent.
Patients capable of understanding the surgeon's explanations and following his instructions.

Exclusion Criteria11

Skeletally immature patients
A 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 or unable to give consent.
Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, 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 course of study).
Not expected to survive the duration of the follow-up program