ZNN Bactiguard Retrograde Femoral Nails PMCF Study
ConditionFemoral Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ZNN Bactiguard Retrograde Femoral Nail
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov