Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT06138912
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thoracolumbar Junction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013121', 'term': 'Spinal Curvatures'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction', 'timeFrame': '2year', 'description': 'The present study measured the normal functional Local Alignment and Segmental Motion at the Thoracolumbar junction based on the age and sex of healthy subjects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracolumbar spine', 'Alignment', 'Range of motion'], 'conditions': ['Spinal Curvatures']}, 'descriptionModule': {'briefSummary': 'Several studies have investigated the mechanical behavior of the thoracolumbar spine. However, an accurate reference for normal functional local alignment and segmental motion at the thoracolumbar junction is still illusive. Therefore, we conducted a cross-sectional cohort study with a balanced distribution of age and sex of healthy subjects to examine the normal alignment and segmental motion at the thoracolumbar junction using dynamic plain radiography. This study aimed to provide data that can be used when planning surgery or performing rehabilitation in pathological situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints were included if they successfully met the study's exclusion criteria\n\nExclusion Criteria:\n\n* (1) coronal deformity (Cobb angle \\> 10°); (2) a history of prior spine surgery; (3) a history of hip or knee arthroplasty or any other realignment surgery of the lower extremities (osteotomy, trauma, etc.); (4) complaints of back or neck pain that resulted in missed work, affected daily living activities, participation in recreational activities or required narcotic pain medication; (5) degenerative or pathologic conditions of the spine that necessitated physician intervention (i.e., physician appointment or epidural steroid injections); (6) non-ambulatory patients; (7) a history of neuromuscular disorders, inflammatory arthritis, or congenital anomalies; and (8) pregnancy"}, 'identificationModule': {'nctId': 'NCT06138912', 'briefTitle': 'Thoracolumbar Junction', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction: A Cross-Sectional Study of Healthy Subjects', 'orgStudyIdInfo': {'id': 'ChonnamNUH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Age', 'description': '20-29, 30-39, 40-49, 50-59, 60-69, and 70-79', 'interventionNames': ['Radiation: plain radiography (x-ray)']}, {'label': 'sex', 'description': 'each group included 10 subjects', 'interventionNames': ['Radiation: plain radiography (x-ray)']}], 'interventions': [{'name': 'plain radiography (x-ray)', 'type': 'RADIATION', 'description': 'Radiographic imaging of the subjects was performed, and anteroposterior, lateral, flexion-extension, and right-left lateral bending radiograph views were obtained', 'armGroupLabels': ['Age', 'sex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61469', 'city': 'Gwangju', 'state': 'Dong-gu', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Neurosurgery', 'investigatorFullName': 'Han Moon-Soo', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}