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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 impossible
* All concomitant diseases that can impair the operation, functioning or the success of the implant
* Insufficient blood circulation
* Infection
* Patient is unwilling or unable to give consent.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, 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 course of study).
* Not expected to survive the duration of the follow-up program
Primary outcome measure(s)
Rate of fracture healing 12 months after fracture fixation — 3, 6, and 12 months after fracture fixation Fracture healing is assessed with x-ray imaging and clinical examination.
Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6.
Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function.
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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