[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587793":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":19,"locations":26,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Study Group",null,[12],"Device: Posterior Spinal Fixation System",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Posterior Spinal Fixation System","Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Dr. Xiao Furen","CONTACT","+886 2-23123456","63110","fxiao@ntu.edu.tw",[27],{"facility":5,"status":28,"city":29,"state":10,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Taipei","100225","Taiwan","TW",{"type":34,"coordinates":35},"Point",[36,37],121.52639,25.05306,{"lat":37,"lon":36},[40],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100587793","long-term-clinical-follow-up-analysis-of-patients-with-lumbar-disease-100587793",false,"NCT06933004","Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.","Inclusion Criteria:\n\n1. Aged between 20 and 80 years.\n2. Patients with lumbar spine disorders requiring surgical treatment.\n3. Able to understand the study content after explanation, capable of expressing their experiences, and willing to sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with impaired decision-making capacity or from vulnerable populations.\n2. Individuals who are unable or unwilling to return for follow-up assessments.","ALL","20 Years","80 Years",{"count":53,"type":54},120,"ESTIMATED","OBSERVATIONAL","This study is a long-term follow-up of postoperative clinical outcomes in patients with lumbar spine disorders, monitoring spine implants SmartMIS Spinal Fixation System and ASA Spinal Fixation System.\n\nPatients will be selected based on inclusion and exclusion criteria. The informed consent process will be initiated by the physician. A questionnaire-based survey will be conducted, which includes the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Fusion Rate. Subjects will complete the same questionnaire assessments preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.\n\nThe total number of subjects to be enrolled is 120. The total duration of the study is expected to be 4 years.",[58],"Lumbar Disease","2025-04-10",{"date":61,"type":62},"2025-04-17","ACTUAL",{"date":64,"type":54},"2025-05",{"date":66,"type":54},"2028-03-31",{"name":5,"class":6},1]