Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-31 @ 9:23 PM
Study NCT ID:
NCT06933004
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.'}, {'measure': 'Fusion Rate', 'timeFrame': 'Preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'National Taiwan University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT06933004', 'briefTitle': 'Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.', 'orgStudyIdInfo': {'id': '202402029DIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'interventionNames': ['Device: Posterior Spinal Fixation System']}], 'interventions': [{'name': 'Posterior Spinal Fixation System', 'type': 'DEVICE', 'description': 'Using spine implants SmartMIS Spinal Fixation System or ASA Spinal Fixation System.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100225', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Dr. Xiao Furen', 'role': 'CONTACT', 'email': 'fxiao@ntu.edu.tw', 'phone': '+886 2-23123456', 'phoneExt': '63110'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Dr. Xiao Furen', 'role': 'CONTACT', 'email': 'fxiao@ntu.edu.tw', 'phone': '+886 2-23123456', 'phoneExt': '63110'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}