Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Recruiting Observational Study
Tibial Fractures Fracture Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Zimmer Biomet · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient must be 18 or older. * Patient has signed IRB/EC-approved informed consent (if applicable for retrospective controls, based on local requirements). * Patient suffered primary tibia fracture (monolateral or bilateral) at high risk of infection, eligible for fixation by …
Contacts

Gemma de Ramon Francas

+41 79 377 11 96

gemma.deramonfrancas@zimmerbiomet.com

CONTACT

Lisa To

+32 2 456 12 70

Lisa.To@zimmerbiomet.com

CONTACT