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1919","aaronsaini@nhs.net",{"name":285,"role":57,"phone":10,"phoneExt":10,"email":10},{"type":290,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100440989","zimmer-natural-nail-znn-bactiguard-tibia-post-market-clinical-follow-up-study-100440989",false,"NCT05022485","Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study","Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control","Inclusion Criteria:\n\n* Patient must be 18 or older.\n* Patient has signed IRB\u002FEC-approved informed consent (if applicable for retrospective controls, based on local requirements).\n* 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:\n\n  * Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.\n  * Delayed treatment (initial treatment by external fixation due to swelling\u002F high energy trauma followed by definitive treatment by intramedullary nail).\n  * Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s).\n  * Closed fractures with severe tissue damage: Tscherne grade C2 and C3.\n* Patient:\n\n  * will be treated with ZNN Bactiguard tibia for inclusion in investigational group (retrospective enrollment is allowed up to 1st follow-up visit);\n  * was treated with uncoated (conventional) titanium-alloy intramedullary tibia nail for inclusion in control group;\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent.\n* Patient is not expected to survive follow-up schedule.\n* Patient is anticipated to be non-compliant to the study protocol.\n* Patient has a mental or neurological condition or alcohol\u002Fdrug addiction that will not allow for proper informed consent and\u002For participation in follow-up program.\n* Patient is a prisoner.\n* Patient is known to be pregnant and\u002For breastfeeding.\n* Patient suffered tibia fracture that meets any of the following conditions:\n\n  * Pathologic fracture.\n  * Gustilo Type IIIC open fracture.\n  * Patient has multisegmented fracture NOT eligible for fixation by intramedullary nailing.\n  * Patients with wound closure more than 10 days after injury.\n  * Besides IM nail, patient requires additional tibia fixation by plate (additional tibia fixation by screw(s) and\u002For fibula plate fixation are allowed).\n  * Concomitant with fracture, patient suffered head injury with Abbreviated Injury Score (AIS) ≥ 3.\n* For control group:\n\n  * patient doesn't have all the minimum required data available:\n\n    1. demographic information\n    2. injury classification\n    3. FRI information\n    4. operative report and device information\n    5. radiographic analyses (until fracture healing or confirmation of non-union leading to reoperation)\n* Tibia medullary canal is obliterated by a previous fracture or tumor\\*\n* Tibia bone shaft having excessive bow or a deformity\\*\n* Lack of bone substance or bone quality, which makes stable seating of the nail implant impossible\\*\n* All concomitant diseases that can impair the operation, functioning or the success of the nail implant\\*\n* Insufficient blood circulation\\*\n* Skeletally immature patients\\*\n* Infection\\*\n\n  * ZNN Bactiguard tibia contraindication","ALL","18 Years",{"count":301,"type":302},500,"ESTIMATED","OBSERVATIONAL","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.\n\nThe secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.",[306,307],"Tibial Fractures","Fracture Infection",[309,310],"intramedullary tibia nail","Bactiguard","2025-11-20",{"date":313,"type":314},"2025-11-25","ACTUAL",{"date":316,"type":314},"2022-04-11",{"date":318,"type":302},"2027-07",{"name":5,"class":6},16]