ZNN Bactiguard Antegrade Femoral Nails PMCF Study (NCT05339360) | Clinical Trial Compass
RecruitingNot Applicable
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Spain, United Kingdom100 participantsStarted 2024-01-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
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…