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Recruiting NCT05276674

ZNN Bactiguard Retrograde Femoral Nails PMCF Study

Trial Parameters

Condition Femoral Fracture
Sponsor Zimmer Biomet
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-23
Completion 2027-12
Interventions
ZNN Bactiguard Retrograde Femoral Nail

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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 impossib

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