Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-27 @ 1:16 PM
Study NCT ID:
NCT05987150
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2023-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional anisotropy (FA) values', 'timeFrame': 'preoperative', 'description': 'Raw DTI data were postprocessed on FuncTool (GE) software. After an initial correction of geometric distortions, the color-coded FA maps were generated.'}], 'secondaryOutcomes': [{'measure': 'Global kyphosis (GK) in degrees', 'timeFrame': 'preoperative', 'description': 'Measured on anteroposterior and lateral radiographs and defined as the angle from upper to lower most tilted end vertebrae.'}, {'measure': 'Sagittal deformity angular ratio (SDAR)', 'timeFrame': 'preoperative', 'description': 'Divided GK by the number of levels spanning the curve.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperkyphosis']}, 'descriptionModule': {'briefSummary': 'Spinal cord compression is commonly seen in patients with severe kyphosis. However, conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in microstructural integrity of the spinal cord around the apical vertebrae in these patients. The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).', 'detailedDescription': 'Spinal cord compression is commonly seen in patients with severe kyphosis. However, conventional morphologic magnetic resonance imaging (MRI) was unable to detect the damage in microstructural integrity of the spinal cord around the apical vertebrae in these patients. The aim of the study was to evaluate the neuronal metrics/microstructure of the spinal cord around apical region in patients with hyperkyphosis using diffusion tensor imaging (DTI).\n\nTwenty-four patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T MRI examination with DTI sequence were prospectively enrolled from July 2022 to January 2023. Patients were divided into three groups according to spinal cord/cerebrospinal fluid architecture (CSF) on sagittal-T2 MRI of the thoracic apex: Type A-circular cord with visible CSF, Type B-circular cord but no visible CSF at apical dorsal, and Type C-spinal cord deformed without intervening CSF. The Fractional Anisotropy (FA) values acquired from DTI were compared among different groups. Correlations between DTI parameters and global kyphosis (GK)/sagittal deformity angular ratio (SDAR) were evaluated using Pearson correlation coefficients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '24 patients with hyperkyphosis aged 46.1±22.8 years who underwent 3.0T magnetic resonance imaging (MRI) examination with DTI sequence were prospectively enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of hyperkyphosis;\n* the apex located at the thoracal region (T1-T12);\n* full DTI data;\n* records of detailed and systematic neurological physical examination.\n\nExclusion Criteria:\n\n* any case with active infection, tumor, or trauma;\n* any cases of comorbidity of neurofibromatosis type I;\n* any cases combined with spinal syringomyelia, split cord malformations or diastematomyelia, tethered cord syndrome;\n* previous spinal surgery.'}, 'identificationModule': {'nctId': 'NCT05987150', 'briefTitle': 'Variation in Anisotropy of the Spinal Cord in Patients With Hyperkyphosis', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Variation in Anisotropy of the Spinal Cord Around Apical Region in Patients With Hyperkyphosis: A Pilot Study Using Diffusion Tensor Imaging', 'orgStudyIdInfo': {'id': '2021-398-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type A', 'description': 'Type A was defined as a round/oval spinal cord shape with visible cerebrospinal fluid (CSF) between the cord and the apical vertebrae.', 'interventionNames': ['Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging']}, {'label': 'Type B', 'description': 'Type B was defined as a round/oval spinal cord shape with no CSF between the apical vertebrae and spinal cord.', 'interventionNames': ['Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging']}, {'label': 'Type C', 'description': 'Type C cord was defined as a spinal cord that is fattened/deformed by the vertebral body, with no visible CSF between the apex and the cord.', 'interventionNames': ['Radiation: Variation in anisotropy of the Spinal Cord using diffusion tensor imaging']}], 'interventions': [{'name': 'Variation in anisotropy of the Spinal Cord using diffusion tensor imaging', 'type': 'RADIATION', 'description': 'All examinations were performed on a 3.0-T MRI machine with a 12-channel spine special coil (Ingenia CX, Philips Healthcare, Best, the Netherlands). The multi-sequence MRI protocol included conventional T1-weighted (sag \\& tra), T2-weighted (sag \\& tra), and DTI sequence.', 'armGroupLabels': ['Type A', 'Type B', 'Type C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}