Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT02432495
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Screw Fixation Versus Halo Immobilization of Type II Odontoid Fractures in Geriatric Patients With Increased Anesthesia Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2015-04-20', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurological deficits', 'timeFrame': 'at least 60 months follow up', 'description': 'Neurologic deficits measured including the CSOQ (Cervical Spine Outcome Questionnaire) before and after surgery as well as compared in both procedure groups'}, {'measure': 'radiographic outcome (documentation of boney union)', 'timeFrame': 'at least 60 months follow up', 'description': 'documentation of boney union compared in both procedure groups'}]}, 'conditionsModule': {'conditions': ['Spinal Fractures']}, 'descriptionModule': {'briefSummary': 'The management of type II odontoid fractures in geriatric trauma victims remains a source of substantial controversy. The purpose of this study was to compare anterior screw fixation with halo-vest-immobilization in patients with type II odontoid fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged 65 years or older with an ASA score of 2 or higher who had undergone either anterior screw fixation or halo immobilization of type II odontoid fractures', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 65 years or older with an ASA (= American society of anesthesiologists) score of 2 or higher\n* complete sets of collected data and a follow-up monitoring of at least five years\n\nExclusion Criteria:\n\n* type III odontoid fractures\n* patients with incomplete data sets\n* patients with penetrating mechanism of injury or congenital cervical spine anomalies'}, 'identificationModule': {'nctId': 'NCT02432495', 'briefTitle': 'Anterior Screw Fixation Versus Halo Immobilization of Type II Odontoid Fractures in Geriatric Patients With Increased Anesthesia Risk', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'orgStudyIdInfo': {'id': '2008/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anterior screw fixation', 'description': 'Patients aged 65 years or older with an ASA score of 2 or higher who had undergone anterior screw fixation of type II odontoid fractures', 'interventionNames': ['Other: ANTERIOR SCREW FIXATION']}, {'label': 'Halo immobilization', 'description': 'Patients aged 65 years or older with an ASA score of 2 or higher who had undergone of halo immobilization of type II odontoid fractures', 'interventionNames': ['Other: HALOV VEST IMMOBILIZATION']}], 'interventions': [{'name': 'ANTERIOR SCREW FIXATION', 'type': 'OTHER', 'description': 'Patients aged 65 years or older with an ASA score of 2 or higher who had undergone anterior screw fixation of type II odontoid fractures', 'armGroupLabels': ['Anterior screw fixation']}, {'name': 'HALOV VEST IMMOBILIZATION', 'type': 'OTHER', 'description': 'Patients aged 65 years or older with an ASA score of 2 or higher who had undergone halo immobilization of type II odontoid fractures', 'armGroupLabels': ['Halo immobilization']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Julian Joestl', 'investigatorAffiliation': 'Medical University of Vienna'}}}}