Femoral fixation with intramedullary nails: Femoral fracture fixation Femoral Osteotomy
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 follow-up program (e.g. patient with no fixed address, long-distance, plans to move during the course of study)
* Patients not expected to survive the duration of the follow-up program
Primary outcome measure(s)
Performance of the study device — 12 months after fracture fixation Analyzed as fracture healing 12 months after fracture fixation. Fracture healing will be analyzed radiographically and clinically. Radiographic healing is considered achieved when two or more cortices reach a score of two (2) on a version of the Radiographic Union-Scale in Tibial fractures (RUST) tool adapted for the femur, in A/P and lateral views. Clinical fracture healing will be assessed via the FiX-IT score.
Trial sites (2)
Facility
City
Region
Status
Hospital Universitario Nuestra Señora de Candelaria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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