Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must be 18 or older.
Patient has signed IRB/EC-approved informed consent (if applicable for retrospective controls, based on local requirements).
Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.
Delayed treatment (initial treatment by external fixation due to swelling/ high energy trauma followed by definitive treatment by intramedullary nail).
Disqualifiers
Patient is unwilling or unable to give consent.
Patient is not expected to survive follow-up schedule.
Patient is anticipated to be non-compliant to the study protocol.
Patient has a mental or neurological condition or alcohol/drug addiction that will not allow for proper informed consent and/or participation in follow-up program.
Trial population
18-year-old patients or older with tibia fractures at high risk for infection (as defined in the inclusion criteria) treated with a titanium-alloy intramedullary nail.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
ZNN Bactiguard tibia
DeviceTibia fracture fixation
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Investigational group1 intervention
Group B: Control group0 interventions
Trial outcomes
Primary outcomes
1
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 fixationSecondary outcomes
1
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 fixation2
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 fixation3
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 fixation4
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)
Time frame
12 months after fracture fixationSponsors and contacts
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Source ClinicalTrials.gov