[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465333":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":68,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":10,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":10,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ZNN Bactiguard Antegrade Femoral Nail",null,"Subjects that have received or will receive the ZNN Bacitugard Antegrade Femoral Nail to treat femoral fractures or osteotomies according to the cleared\u002Fapproved indications.",[13],"Procedure: Femoral fixation with intramedullary nails",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Femoral fixation with intramedullary nails","Femoral fracture fixation Femoral Osteotomy",[9],[21],{"name":22,"affiliation":5,"role":23},"Emilie Rohmer","STUDY_DIRECTOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Gemma de Ramon Francàs","CONTACT","+41 79 377 11 96","gemma.deramonfrancas@zimmerbiomet.com",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Lisa To","+32 479 97 05 43","lisa.to@zimmerbiomet.com",[35,48],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Hospital Universitario Nuestra Señora de Candelaria","ACTIVE_NOT_RECRUITING","Santa Cruz de Tenerife","38010","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],-16.25462,28.46824,{"lat":46,"lon":45},{"facility":49,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Manchester Royal Infirmary","RECRUITING","Manchester","M13 9WL","United Kingdom","UK",{"type":43,"coordinates":56},[57,58],-2.23743,53.48095,{"lat":58,"lon":57},[61,65],{"name":62,"role":27,"phone":63,"phoneExt":10,"email":64},"Abigail Lamas, CTA","0161 291 4850","Abigail.Lomas@mft.nhs.uk",{"name":66,"role":67,"phone":10,"phoneExt":10,"email":10},"Joseph Alsousou, Mr","PRINCIPAL_INVESTIGATOR",{"type":69,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100465333","znn-bactiguard-antegrade-femoral-nails-pmcf-study-100465333",false,"NCT05339360","ZNN Bactiguard Antegrade Femoral Nails PMCF Study","Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series","Inclusion Criteria:\n\n* Patient must be 18 or older\n* Patient must have a signed EC-approved informed consent.\n* Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy 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 Antegrade Femoral Nail\n* Patient must be able and willing to complete the protocol required for follow-up\n* Patients capable of understanding the surgeon's explanations and following his instructions\n\nExclusion Criteria:\n\nSkeletally immature patients\n\n* 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 to give consent.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subjects with 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 the course of study)\n* Patients not expected to survive the duration of the follow-up program","ALL","18 Years",{"count":80,"type":81},100,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies.\n\nThis is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.",[85,86],"Femur Fracture","Osteotomy",[88,89],"Intramedullary antegrade femoral nail","Bactiguard","2025-11-19",{"date":92,"type":93},"2025-11-25","ACTUAL",{"date":95,"type":93},"2024-01-16",{"date":97,"type":81},"2027-12",{"name":5,"class":6},2]