Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Trial Parameters
Brief Summary
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
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 intramedullary (IM) nailing (standard or suprapatellar approach) and meets at least one of the following conditions: * 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). * Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s). * Closed fractures with severe tissue damage: Tscherne grade C2 and C3. * Patient: * will be treated with ZNN Bactiguard tibia for inclusion in investigational group (retrospective enrollment is allowed up to 1st follow-up visit); * was treated with u