[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589189":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":15,"locations":21,"responsibleParty":39,"collaborators":7,"id":41,"slug":7,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":7,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":7,"maxAge":7,"enrollmentInfo":48,"targetDuration":7,"studyType":51,"phases":7,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":57,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Materialise","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","TMJ Total Arthroplasty System (TMJ System)","All patients treated or to be treated with the TMJ Total Arthroplasty System for TMJ reconstruction. The TMJ Total Arthroplasty System (TMJ System) is a medical device intended to restore the TMJ. It comprises two articulating components: a temporal component and a mandibular component. The TMJ System is patient-specific based on the patient's anatomy and surgical treatment. Different shape designs are possible depending on the patient's anatomy and the type of surgery performed.",[14],"Temporomandibular joint reconstruction",[16],{"name":17,"role":18,"phone":19,"phoneExt":7,"email":20},"Dorien Haesen, PhD","CONTACT","+32 11 28 69 48","dorien.haesen@archerresearch.eu",[22],{"facility":23,"status":7,"city":24,"state":25,"zip":26,"country":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Rigshospitalet","Copenhagen","Capital Region of Denmark","2100","Denmark",{"type":29,"coordinates":30},"Point",[31,32],12.56553,55.67594,{"lat":32,"lon":31},[35],{"name":36,"role":18,"phone":37,"phoneExt":7,"email":38},"Thomas Kofod, Dr.","+45 35 45 20 0","tand-mund.rigshospitalet@regionh.dk",{"type":40,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100589189",false,"NCT06951178","Long-term Safety and Performance of Materialise's Patient-specific TMJ System.","Unlocking TMJs Clinical Study: Safety and Performance of Materialise's Patient-specific TMJ System","Inclusion Criteria:\n\n* Patients prescribed with Materialise TMJ Total Arthroplasty System for TMJ reconstruction\n* Patient who has received and understood the study information leaflet and has agreed to participate in the study and signed the informed consent form (ICF) (adult or legal guardian(s) if minor).\n\nExclusion Criteria:\n\n* Known hypersensitivity to Titanium, Nickel, or Cobalt-Chrome alloys.\n* Patient conditions where there is not enough bone quality or quantity to support the components.\n* Active infection in the anatomical area or the vicinity of the site to be implanted, preventing the implantation of the device.\n* Patients with marked hyperfunctional habits (e.g., tooth clenching, bruxism).\n* Pregnant woman.\n* Patient is known to be or suspected of being unable to comply with the study protocol or proposed follow-up visits by the investigator.","ALL",{"count":49,"type":50},30,"ESTIMATED","OBSERVATIONAL","This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement. The study will evaluate the efficiency, safety, clinical performance, accuracy, benefits, and risks associated with long-term use and the impact on life quality and diet of the TMJ system, its fixation devices, TMJ Implant trial, and guides in the adolescent and adult populations.",[54],"Temporomandibular Joint Disorders",[54,56],"Implant","NOT_YET_RECRUITING","2025-04-22",{"date":60,"type":61},"2025-04-30","ACTUAL",{"date":63,"type":50},"2025-06",{"date":65,"type":50},"2037-06",{"name":5,"class":6},1]