Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 12:28 AM
Study NCT ID:
NCT07192250
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2025-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracolumbar Burst Fracture Management: Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '6 months', 'description': 'VAS score'}, {'measure': 'healing', 'timeFrame': '6 months', 'description': 'radiological union'}, {'measure': 'deformity', 'timeFrame': '1 year', 'description': 'Cobb angle'}], 'secondaryOutcomes': [{'measure': 'function', 'timeFrame': '1 year', 'description': 'ODI score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluation of the Validity of Thoracolumbar AO Spine Injury Score (TL AOSIS) in A3 and A4 Fractures']}, 'descriptionModule': {'briefSummary': 'Between December 2019 to December 2022, patients presenting to causalty department with TL fracture type A3 and A4 with a TL AOSIS scores of 4 and 5 were randomly managed either by conservative or operative management.', 'detailedDescription': 'Conservative management group was treated by bed rest and brace for 3 weeks followed by early mobilization. Operative management group received management through Short-segment fixation with one or two screws in fractured vertebra when applicable with posterior spinal fusion. Patients were evaluated both clinically regarding pain (VAS score), disability by Oswestry Disability Index (ODI score) and neurological status. Radiological evaluation included local sagittal spinal alignment, including pre- and post- management Cobb angle and local segment kyphosis. Bony fusion was also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '57 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletally mature patients (age 21-55 years old), TL spine fractures of types A3 and A4 with TL AOSIS score 4 or 5. These include different variables; A4N0, A3N1, A3N2 and A3M1N0.\n\nExclusion Criteria:\n\n* Osteoporotic fractures and skeletally immature patients, associated comorbidities (e.g. bleeding disorders, rheumatoid arthritis), or any fracture type other than A3 and A4, and significant neurological compromise.'}, 'identificationModule': {'nctId': 'NCT07192250', 'briefTitle': 'Thoracolumbar Burst Fracture Management: Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'The Thoracolumbar AOSpine Injury Score: Clinical And Radiological Outcomes Of Management Of Fractures Having Scores Of 4 And 5: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '585/9/444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'operative group', 'interventionNames': ['Procedure: short segment TPF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conservative group', 'interventionNames': ['Procedure: conservative management']}], 'interventions': [{'name': 'short segment TPF', 'type': 'PROCEDURE', 'description': 'short segment transpedicular screw fixation with one or two screws in fractured vertebra', 'armGroupLabels': ['operative group']}, {'name': 'conservative management', 'type': 'PROCEDURE', 'description': 'brace and bed rest with mobilization as tolerated', 'armGroupLabels': ['conservative group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82425', 'city': 'Sohag', 'state': 'Sohag Governorate', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'mohamed younis, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Hamed Kassem Abdelaal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed Hamed Kassem Abdelaal', 'investigatorAffiliation': 'Sohag University'}}}}