Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study with retrospective controls. The study will enroll patients that will be implanted with the Zimmer Natural Nail Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails. 500 tibias will be recruited at maximum 15 sites and allocated on a 1:1 ratio into an: * investigational group (prospective/consecutive series of 250 tibias treated with ZNN Bactiguard tibia) * a control group (retrospective series of 250 tibias treated with uncoated titanium-alloy tibia nail - data collection will be retrospective, these subjects will not have to undergo any study-related procedure). The primary endpoint is the Fracture Related Infection (FRI) rate in the study population 12 months after fracture fixation. The secondary endpoint is the confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation through the following measure systems: * Radiologic (RUST) \& clinical (FIX-IT) fracture healing 12 months after fracture fixation (performance). * Patients' outcomes assessed by the Oxford Knee Score 12 months after fracture fixation (clinical benefits). * EQ5D-5L (patients' quality of life). * Incidence and frequency of adverse events (safety). Data will be collected at 2 weeks, 3 months, 6 months and 1 year after fracture fixation.
Study Type
OBSERVATIONAL
Enrollment
500
Tibia fracture fixation
Tirolkliniken Innsbruck
Innsbruck, Austria
RECRUITINGHôpital Ambroise-Paré
Boulogne-Billancourt, France
Fracture related infection (FRI) rate in investigational and control group
FRI diagnosed according to the updated diagnostic algorithm drafted by the Fracture-Related Infection Consensus Group (Definition and diagnosis of fracture-related infection, M McNally,G Govaert, M Dudareva, M Morgenstern, W J Metsemakers, EFORT Open Rev 2020;5:614-619.)
Time frame: 12 months after fracture fixation
Tibia fracture healing assessed radiologically through Radiographic Union Scale in Tibial fractures (RUST) score
The RUST score assigns each tibial cortex (anterior, posterior, medial and lateral) a score from 1 to 3, based on the appearance on the X-ray. The scores of all cortices combined will give a minimum score of 4 (definitely not healed) up to a maximum of 12 (completely healed).
Time frame: 12 months after fracture fixation
Tibia fracture healing assessed clinically through the Function IndeX for Trauma (FIX-IT) score
The FIX-IT score assesses the subject's pain and ability to bear weight on lower extremity fractures. It ranges from 0 to 12 points, with 12 points representing the highest level of limb function.
Time frame: 12 months after fracture fixation
Limb functionality measured through the Oxford Knee Score
The Oxford Knee Score consists of twelve questions regarding knee functionality and pain. The score ranges from 12 to 60 points, with 12 points indicating the best outcome.
Time frame: 12 months after fracture fixation
Quality of life of study participants assessed through the EQ-5D-5L questionnaire
The EQ-5D is a self-reported descriptive questionnaire about the patient's quality of life composed of 5 questions referring to mobility, self-care, daily activities, pain and anxiety/depression. Each question has 3 possible answers, which define the level of perceived problems (none, moderate,extreme problem)
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Hôpitaux Universitaires de Marseille Nord
Marseille, France
RECRUITINGUniversitätsklinikum Marburg
Marburg, Hesse, Germany
RECRUITINGUniversitätsklinikum Leipzig
Leipzig, Germany
RECRUITINGUniversitätsklinikum Regensburg
Regensburg, Germany
RECRUITINGAOU Policlinico di Bari
Bari, Italy
RECRUITINGAzienda Ospedaliero-Universitaria Careggi
Florence, Italy
RECRUITINGTygerberg Hospital
Cape Town, South Africa
RECRUITINGGroote Schuur Hospital
Cape Town, South Africa
RECRUITING...and 6 more locations
Time frame: 12 months after fracture fixation
Incidence and frequency of adverse events
Frequency and incidence of recorded AEs will be calculated
Time frame: 12 months after fracture fixation