Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-29 @ 12:05 PM
Study NCT ID:
NCT01544933
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2012-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}, {'id': 'D007738', 'term': 'Kyphosis'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2012-02-22', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'residual kyphosis', 'timeFrame': '3 years', 'description': 'measurement of residual kyphosis by x-ray'}], 'secondaryOutcomes': [{'measure': 'vertebral canal narrowing', 'timeFrame': '3 years', 'description': 'vertebral canal narrowing in CT'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['spinal fractures', 'Thoracic vertebrae', 'spinal canal', 'kyphosis'], 'conditions': ['Burst Thoracic Spine Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures.', 'detailedDescription': 'To analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures, with the measurements of kyphosis, vertebral collapse and vertebral canal narrowing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with burst fractures of the thoracic spine treated by the Hospital Ortopedico de Passo Fundo', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* burst fractures in thoracic spine\n\nExclusion Criteria:\n\n* fractures that were not burst fractures in thoracic spine'}, 'identificationModule': {'nctId': 'NCT01544933', 'briefTitle': 'The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Universidade de Passo Fundo'}, 'officialTitle': 'The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures', 'orgStudyIdInfo': {'id': 'rtisot01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'burst fractures in vertebrae with true ribs', 'description': 'between T1 and T10'}, {'label': 'burst fractures in vertebrae with floating ribs', 'description': 'between T11 and T12'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99010-121', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Rodrigo Tisot', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}], 'overallOfficials': [{'name': 'Rodrigo A Tisot, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Ortopedico de Passo Fundo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade de Passo Fundo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rodrigo Arnold Tisot', 'investigatorAffiliation': 'Universidade de Passo Fundo'}}}}