Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-04-23 @ 2:30 PM
Study NCT ID:
NCT02514993
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2015-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Unstable Thoracic Cage Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-08-03', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1 year after trauma', 'description': 'Patient survival after polytraumatization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sternal fracture', 'Thoracic spine fracture', 'Thoracic cage injury'], 'conditions': ['Thoracic Spine Fracture', 'Concomitant Sternal Fracture']}, 'descriptionModule': {'briefSummary': '* Analysis of patient data and computed tomography scan of polytraumatized patients thoracic spine fractures\n* A concomitant sternal fracture was identified an indicator for an unstable thoracic spine fracture', 'detailedDescription': 'Previous studies stated, that sternal fractures can be regarded as an indicator for thoracic spine fractures and described the combined injury pattern of thoracic spine fracture and sternal fracture as "upper thoracic cage injury". But literature research is lacking data that in patients with a thoracic cage injury a highly unstable thoracic spine fracture can be expected.\n\nIn a large cohort of 130 patients with a thoracic spine fracture and concomitant sternal fracture the investigators analyzed the injury pattern and evaluated associated injuries, trauma mechanism, and clinical outcome.\n\nThe investigators could prove that in patients with a thoracic cage injury the concomitant sternal fracture may be regarded as an indicator for an unstable thoracic spine fracture, which requires surgical stabilization. Furthermore the analysis revealed that even a highly rotationally unstable type C fracture has to be expected, if sternal and thoracic spine fractures are located in the same segment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering a thoracic spine fracture and a concomitant sternal fracture', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sternal fracture and concomitant thoracic spine fracture\n* Injury Severity Scale ≥ 16\n* Age under 50 years\n* Presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital\n\nExclusion Criteria:\n\n* Missing consent\n* Incomplete patient data'}, 'identificationModule': {'nctId': 'NCT02514993', 'briefTitle': 'The Unstable Thoracic Cage Injury', 'organization': {'class': 'OTHER', 'fullName': 'BG Unfallklinik Murnau'}, 'officialTitle': 'The Unstable Thoracic Cage Injury: The Concomitant Sternal Fracture Indicates a Severe Thoracic Spine Fracture', 'orgStudyIdInfo': {'id': '10-2004-2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Inclusion criteria for the study were (a) sternal fracture and concomitant thoracic spine fracture, (b) Injury Severity scale (ISS) ≥ 16, (c) age under 50 years, (d) presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital.'}, {'label': 'Control group', 'description': 'The inclusion criteria for the control group included: (a) Thoracic spine fracture without concomitant sternal fracture, (b) ISS ≥ 16, (c) age under 50 years, (d) presence of a whole body computed-tomography (CT-scan) performed at admission of the patient to the hospital.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mario Morgenstern, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trauma Center Murnau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BG Unfallklinik Murnau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Dr. Mario Morgenstern', 'investigatorAffiliation': 'BG Unfallklinik Murnau'}}}}