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
This trial does not accept healthy volunteersQualifiers
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 population
Consecutive series of 18-year-old patients or older with femur fractures implanted with a ZNN Bactiguard Retrograde Femoral Nail according to the approved/cleared indications.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ZNN Bactiguard Retrograde Femoral Nail
DeviceFemoral fracture internal fixation.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ZNN Bactiguard Retrograde Femoral Nail1 intervention
Trial outcomes
Primary outcomes
1
Rate of fracture healing 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.
Time frame
3, 6, and 12 months after fracture fixationSecondary outcomes
1
Oxford Knee Score (limb function)
Range: 0 - 48, higher scores indicate better function. Patient-reported outcome to evaluate the function of the limb treated with ZNN Bactiguard Femur Retrograde.
Time frame
3, 6, and 12 months after fracture fixation2
EQ-5D-5L score (patient's quality of life)
Range: 0 - 100, higher scores indicate better quality of life. Patient-reported outcome to evaluate quality of life.
Time frame
pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation3
Adverse events frequency
The incidence and frequency of adverse events occurring during the study will be reported.
Time frame
12 months after fracture fixation4
Rate of fracture-related infections
Fracture-related infections are diagnosed in accordance with the algorithm described in M McNally,G Govaert, M Dudareva, M Morgenstern, W J Metsemakers, EFORT Open Rev 2020;5:614-619.
Time frame
12 months after fracture fixationSponsors and contacts
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Source ClinicalTrials.gov