Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT03269851
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parameters of Neurological Deficit After Thoracolumbar Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Measure spinal canal stenosis by cubic cm', 'timeFrame': 'one year', 'description': 'CT-Radiological parameters measured in patients with or without thoracolumbar fractures .'}, {'measure': 'To measure sagittal alignment of vertebral column by cobb angle', 'timeFrame': 'one year', 'description': 'CT-Radiological parameters measured in patients with or without thoracolumbar fractures'}, {'measure': 'To measure vertebral body compression by cm', 'timeFrame': 'one year', 'description': 'CT-Radiological parameters measured in patients with or without thoracolumbar fractures'}, {'measure': 'To measure type of fracture according to AO classification', 'timeFrame': 'one year', 'description': 'CT-Radiological parameters measured in patients with or without thoracolumbar fractures'}], 'secondaryOutcomes': [{'measure': 'Proportion of Neurological deficit among patients with thoracolumbar spine fractures.', 'timeFrame': 'one year', 'description': 'Number of patients with neurological deficit to the total number of patients with thoracolumbar spine fractures.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurological deficit'], 'conditions': ['SPINAL Fracture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1097/00007632-200102150-00013', 'label': 'The significance of thoracolumbar spinal canal size in spinal cord injury patients.'}, {'url': 'http://bjj.boneandjoint.org.uk/content/74-B/5/683.short', 'label': 'CT scan prediction of neurological deficit in thoracolumbar burst fractures.'}, {'url': 'https://doi.org/10.1097/00007632-198811000-00011', 'label': 'Relationship between traumatic spinal canal stenosis and neurologic deficits in thoracolumbar burst fractures.'}, {'url': 'https://doi.org/10.1097/00007632-199902010-00020', 'label': 'Neurologic injury and recovery in patients with burst fracture of the thoracolumbar spine.'}, {'url': 'https://doi.org/10.1097/01.brs.0000231730.34754.9e', 'label': 'Correlation among canal compromise, neurologic deficit, and injury severity in thoracolumbar burst fractures.'}]}, 'descriptionModule': {'briefSummary': 'To detect Radiological parameters affecting neurological injury after thoracolumbar spinal fractures.', 'detailedDescription': 'Thoracolumbar spine fractures are the most common spinal column fractures. High activity and lack of stability make it more prone to fractures.\n\nMany studies have attempted to determine whether the neurological deficit in such fractures is related to spinal canal stenosis or other parameters observed on axial computed tomography (CT). However, this relationship remains controversial.\n\nFew reports shed light on the relation between different imaging parameters like sagittal alignment, vertebral body compression, canal stenosis, and type of fracture according to AO classification with the severity of nerve damage.\n\nThese four radiographic parameters will be tested as expected risk factors for the neurological deficit in thoracolumbar fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years old with or without neurological deficit in orthopaedics and trauma department of Assiut university hospital from 1st of November 2018 to 31 st of October 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years old with or without neurological deficit\n2. In orthopaedics and trauma department of Assiut university hospital from 1st of November 2018 to 31 st of October 2019.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.\n* Patients suffering from preoperative neurological diseases that hinder our examination like peripheral neuropathy or previous strokes.\n* Obtuned patients who cannot be properly examined like those with low GCS score.\n* Patients with old thoracolumbar fractures more than one month duration.\n* Patients with pathological spine fractures like those with osteoporosis and cancer metastasis.\n* Patients with fracture type A0 according to AO classification.'}, 'identificationModule': {'nctId': 'NCT03269851', 'briefTitle': 'Parameters of Neurological Deficit After Thoracolumbar Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Radiological Parameters Predicting Neurological Injury After Thoracolumbar Spinal Fractures', 'orgStudyIdInfo': {'id': 'Neurological deficit'}, 'secondaryIdInfos': [{'id': 'Thoracolumbar fractures', 'type': 'OTHER', 'domain': 'Assiut University Hospital'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'computed tomography', 'type': 'RADIATION', 'description': 'ct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohammed G. Hassan', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Zamboo Safwat', 'investigatorAffiliation': 'Assiut University'}}}}