[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586027":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":49,"collaborators":7,"id":51,"slug":7,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":7,"maxAge":7,"enrollmentInfo":59,"targetDuration":7,"studyType":62,"phases":7,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":68,"whyStopped":7,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"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",[20,35],{"facility":21,"status":7,"city":22,"state":7,"zip":7,"country":23,"cosmosGeoPoint":24,"geoPoint":29,"contacts":30},"Rigshospitalet","Copenhagen","Denmark",{"type":25,"coordinates":26},"Point",[27,28],12.56553,55.67594,{"lat":28,"lon":27},[31],{"name":32,"role":16,"phone":33,"phoneExt":7,"email":34},"Dr. Thomas Kofod","+45 35 45 20 02","tand-mund.rigshospitalet@regionh.dk",{"facility":36,"status":7,"city":37,"state":7,"zip":7,"country":38,"cosmosGeoPoint":39,"geoPoint":43,"contacts":44},"Hôpital Pitié-Salpêtrière","Paris","France",{"type":25,"coordinates":40},[41,42],2.3488,48.85341,{"lat":42,"lon":41},[45],{"name":46,"role":16,"phone":47,"phoneExt":7,"email":48},"Prof. Thomas Schouman","+33 (0)1 42 17 82 91","odile.pomet@aphp.fr",{"type":50,"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":60,"type":61},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.",[65],"Craniofacial Defects",[65,67],"Implants","NOT_YET_RECRUITING","2025-09-26",{"date":71,"type":72},"2025-09-29","ACTUAL",{"date":74,"type":61},"2025-11",{"date":76,"type":61},"2026-11",{"name":5,"class":6},2]