Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT00583856
Status:
COMPLETED
Last Update Posted:
2010-12-20
First Post:
2007-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computer Modeling With Reconstruction of Maxillofacial Skeleton
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008446', 'term': 'Maxillofacial Injuries'}], 'ancestors': [{'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-16', 'studyFirstSubmitDate': '2007-12-22', 'studyFirstSubmitQcDate': '2007-12-22', 'lastUpdatePostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['computer aided design', 'maxillofacial fracture', 'orbital design'], 'conditions': ['Maxillofacial Injury']}, 'descriptionModule': {'briefSummary': 'Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.', 'detailedDescription': 'The concept of open reduction and internal fixation of facial fractures is well accepted. However, there are situations in which an accurate reduction and restoration of facial symmetry is challenging. In these more difficult cases, the PI uses computer aided design/modeling software as well as intra-operative computer aided surgical navigation systems to assist with repair of these complex injuries. A retrospective review of these cases has not previously been performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '11 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'UCDMC Patients with specific complex fractures', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* specific complex maxillofacial trauma\n\nExclusion Criteria:\n\n* must meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00583856', 'briefTitle': 'Computer Modeling With Reconstruction of Maxillofacial Skeleton', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Is Computer Modeling and Intra-Operative Navigation Helpful With Reconstruction of the Maxillofacial Skeleton?', 'orgStudyIdInfo': {'id': '200614968-1'}}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Edward B Strong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Edward B. Strong, MD', 'oldOrganization': 'University of California Davis'}}}}