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