Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 4:12 AM
Study NCT ID:
NCT02359656
Status:
COMPLETED
Last Update Posted:
2015-02-10
First Post:
2015-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recent and Non United Odontoid Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2015-01-31', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome (range of motion) and radiographic (bony fusion) long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions.', 'timeFrame': 'follow up of at least 5 years'}], 'secondaryOutcomes': [{'measure': 'Composite outcome measure consisting of multiple measures as late bony fusion, cervical spin, neurological sequalea', 'timeFrame': 'follow up of at least 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Odontoid Process']}, 'descriptionModule': {'briefSummary': "The purpose of this study was to determine the clinical and radiographic long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions, with particular regards to late bony fusion, cervical spine motion, neurological sequela, and patient's quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 65 years or older who had undergone surgical or non - operative management of odontoid non-unions were sorted and their dataset of follow - up monitoring was examined for completeness and accuracy. According to our inclusion criteria, patients with complete sets of collected data and a follow-up examination of at least five years after treatment of the non - union were finally enrolled in this study. Collected data included variables, such as age, gender, mechanism of injury, fracture type, associated injuries, presence and severity of primary neurological deficits, primary treatment, clinical and neurological outcome after primary treatment, methods of treatment, clinical and radiographic outcome after treatment of the non-union, as well as morbidity and mortality of the patients.\n\nExclusion Criteria:\n\nExclusion criteria for this study contain patients with previous or subsequent surgery at the cervical spine level, patients with incomplete data sets, as well as patients with penetrating mechanism of injury or congenital cervical spine anomalies. Incomplete data set was determined, if pertinent clinical or radiographic data of follow - up monitoring (e.g. documents of clinical findings or functional results, radiographs, CT-scanning, e.g.) were missing.'}, 'identificationModule': {'nctId': 'NCT02359656', 'briefTitle': 'Recent and Non United Odontoid Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Recent and Non United Odontoid Fractures: Clinical and Biomechanical Aspects', 'orgStudyIdInfo': {'id': '1127/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'non operative treatment', 'description': 'specif non operative treatment protocol', 'interventionNames': ['Other: non operative treatment for odontoid non unions']}, {'type': 'OTHER', 'label': 'operative treatment', 'description': 'dorsal atlanto-axial C1-C2 Arthrodesis', 'interventionNames': ['Procedure: surgical treatment']}], 'interventions': [{'name': 'surgical treatment', 'type': 'PROCEDURE', 'description': 'C1-C1 arthrodesis', 'armGroupLabels': ['operative treatment']}, {'name': 'non operative treatment for odontoid non unions', 'type': 'OTHER', 'description': 'specific non operative treatment protocol', 'armGroupLabels': ['non operative treatment']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Priv. Doz. Dr. Patrick Platzer, PhD, MBA', 'investigatorFullName': 'Julian Joestl', 'investigatorAffiliation': 'Medical University of Vienna'}}}}