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
This trial does not accept healthy volunteersQualifiers
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 population
Consecutive series of patients aged 18 or older with femur fractures or osteotomies implanted with the ZNN Bactiguard Antegrade Femoral Nail according to the approved/cleared indications.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Femoral fixation with intramedullary nails
Procedure/SurgeryFemoral fracture fixation Femoral Osteotomy
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ZNN Bactiguard Antegrade Femoral Nail1 intervention
Trial outcomes
Primary outcomes
1
Performance of the study device
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.
Time frame
12 months after fracture fixationSecondary outcomes
1
Safety assesment
Recording and analyzing incidence and frequency of adverse events.
Time frame
6 weeks and 3, 6, and 12 months after fracture fixation2
Oxford Hip Score
Patient-Reported Outcome Measures (PROMs) that documents hip function and pain. It's used as a surrogate to assess function and pain of the operated limb.
Time frame
3, 6, and 12 months after fracture fixation3
EQ-5D Health Questionnaire
Patient-reported outcome completed by the patient. It assesses the general health status of the patient and it can be used to derive a quality of life index used for health economics considerations.
Time frame
3, 6, and 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
6 weeks and 3, 6, and 12 months after fracture fixationSponsors and contacts
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Source ClinicalTrials.gov