[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460518":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":29,"responsibleParty":87,"collaborators":10,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":10,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":10,"enrollmentInfo":98,"targetDuration":10,"studyType":101,"phases":10,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ZNN Bactiguard Retrograde Femoral Nail",null,"Patients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture.",[13],"Device: ZNN Bactiguard Retrograde Femoral Nail",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Femoral fracture internal fixation.",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Gemma de Ramon Francàs","CONTACT","+41 79 377 11 96","gemma.deramonfrancas@zimmerbiomet.com",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Emilie Rohmer","+41 79 368 91 28","emilie.rohmer@zimmerbiomet.com",[30,44,65,79],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"Hospital Universitario Ntra. Sra. de Candelaria","ACTIVE_NOT_RECRUITING","Santa Cruz de Tenerife","Tenerife","38010","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-16.25462,28.46824,{"lat":42,"lon":41},{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Leeds General Infirmary","RECRUITING","Leeds","LEEDS","LS1 3EX","United Kingdom","UK",{"type":39,"coordinates":53},[54,55],-1.54785,53.79648,{"lat":55,"lon":54},[58,62],{"name":59,"role":22,"phone":60,"phoneExt":10,"email":61},"Fiazia Ahmed","0113 34 30096","F.S.Ahmed@leeds.ac.uk",{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},"Nikolaos K Kanakaris, Dr","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":46,"city":67,"state":10,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Manchester Royal Infirmary","Manchester",{"type":39,"coordinates":69},[70,71],-2.23743,53.48095,{"lat":71,"lon":70},[74,77],{"name":75,"role":22,"phone":10,"phoneExt":10,"email":76},"Abigail Lamas","abigail.lomas@mft.nhs.uk",{"name":78,"role":64,"phone":10,"phoneExt":10,"email":10},"Joseph Alsousou",{"facility":80,"status":32,"city":81,"state":10,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":82,"geoPoint":86,"contacts":10},"Stepping Hill Hospital","Stockport",{"type":39,"coordinates":83},[84,85],-2.15761,53.40979,{"lat":85,"lon":84},{"type":88,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100460518","znn-bactiguard-retrograde-femoral-nails-pmcf-study-100460518",false,"NCT05276674","ZNN Bactiguard Retrograde Femoral Nails PMCF Study","Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)","Inclusion Criteria:\n\n* Patients must be 18 years or older.\n* Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling \u002F high energy trauma followed by definitive treatment by intramedullary nail) can also be included.\n* Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail.\n* Patient must be able and willing to complete the protocol required follow-up.\n* Patient must have a signed EC approved consent.\n* Patients capable of understanding the surgeon's explanations and following his instructions.\n\nExclusion Criteria:\n\n* Skeletally immature patients\n* A medullary canal obliterated by a previous fracture or tumor\n* Bone shaft having excessive bow or a deformity\n* Lack of bone substance or bone quality, which makes stable seating of the implant impossible\n* All concomitant diseases that can impair the operation, functioning or the success of the implant\n* Insufficient blood circulation\n* Infection\n* Patient is unwilling or unable to give consent.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol\u002Fdrug addiction, known to be pregnant or breast feeding).\n* Patient anticipated to be non-compliant and\u002For likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).\n* Not expected to survive the duration of the follow-up program","ALL","18 Years",{"count":99,"type":100},100,"ESTIMATED","OBSERVATIONAL","Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.",[104],"Femoral Fracture",[106,107,108,109],"Bactiguard","Femur fracture","Intramedullary nailing","Infection control","2026-02-02",{"date":112,"type":113},"2026-02-03","ACTUAL",{"date":115,"type":113},"2023-10-23",{"date":117,"type":100},"2027-12",{"name":5,"class":6},4]