[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586027":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":51,"collaborators":7,"id":53,"slug":7,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":7,"maxAge":7,"enrollmentInfo":61,"targetDuration":7,"studyType":64,"phases":7,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":7,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Materialise","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Craniomaxillofacial (CMF) porous titanium implant","All patients were treated, between 2016 and 2023, with patient-specific CMF Porous Titanium Implants for facial and\u002For cranial reconstruction or restoration of bone defects.",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Dorien Haesen, PhD","CONTACT","+32 11 28 69 48","dorien.haesen@archerresearch.eu",[20,36],{"facility":21,"status":7,"city":22,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"Rigshospitalet","Copenhagen","Denmark","DK",{"type":26,"coordinates":27},"Point",[28,29],12.56553,55.67594,{"lat":29,"lon":28},[32],{"name":33,"role":16,"phone":34,"phoneExt":7,"email":35},"Dr. Thomas Kofod","+45 35 45 20 02","tand-mund.rigshospitalet@regionh.dk",{"facility":37,"status":7,"city":38,"state":7,"zip":7,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":45,"contacts":46},"Hôpital Pitié-Salpêtrière","Paris","France","FR",{"type":26,"coordinates":42},[43,44],2.3488,48.85341,{"lat":44,"lon":43},[47],{"name":48,"role":16,"phone":49,"phoneExt":7,"email":50},"Prof. Thomas Schouman","+33 (0)1 42 17 82 91","odile.pomet@aphp.fr",{"type":52,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100586027",false,"NCT06910033","Long-term Safety and Performance of CMF Porous Titanium Implants","CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants","CMF SafeTi Fit","Inclusion Criteria:\n\n* Age: Patients of any age are eligible for this study.\n* Patients treated with Materialise patient-specific CMF Porous Titanium Implants for facial and\u002For cranial reconstruction.\n* Patients who have followed Standard of Care, as determined in each case by the treating surgeon.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Titanium at the time of surgery.\n* Patients who had or will receive the TMJ Total Arthroplasty System.\n* Pregnancy at the time of surgery.","ALL",{"count":62,"type":63},200,"ESTIMATED","OBSERVATIONAL","The goal of this retrospective study is to evaluate the clinical characteristics, efficiency, safety, and long-term performance of craniomaxillofacial (CMF) Porous Titanium Implants within the standard of care across children (0 - \\\u003C12 years old), adolescent (12 - \\\u003C22 years old), and adult (≥ 22 years old) populations.",[67],"Craniofacial Defects",[67,69],"Implants","NOT_YET_RECRUITING","2025-09-26",{"date":73,"type":74},"2025-09-29","ACTUAL",{"date":76,"type":63},"2025-11",{"date":78,"type":63},"2026-11",{"name":5,"class":6},2]