Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 8:53 AM
Study NCT ID:
NCT04218058
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2019-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-01', 'studyFirstSubmitDate': '2019-12-30', 'studyFirstSubmitQcDate': '2020-01-01', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'zygomatic arch reduction', 'timeFrame': 'immediate post operative CT scan', 'description': 'to measure the amount of zygomatic arch reduction on postoperative ct scan and compare it with the normal side'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Zygomatic Arch Reduction']}, 'descriptionModule': {'briefSummary': 'To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture.\n\nTo evaluate the role of intra-operative ultrasound during zygomatic arch reduction.\n\nTo compare between esthetic appearance, orbital movement, wound healing, scaring, and postoperative ocular complications in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with ZMC fractures that require reduction and fixation\n* Patients between 20 to 50 years old with no gender predilections\n\nExclusion Criteria:\n\n* Existence of infection at the fracture line\n* Chronic systemic diseases such as metabolic bone disease, immunocompromised status'}, 'identificationModule': {'nctId': 'NCT04218058', 'briefTitle': 'Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Ultrasound Guided Closed Reduction Versus Open Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures', 'orgStudyIdInfo': {'id': '0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study (ultrasound guided closed reduction of zygomatic arch))', 'description': 'reduction of zygomatic arch guided by ultrasound', 'interventionNames': ['Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control (open reduction of zygomatic arch)', 'description': 'open reduction of zygomatic arch through coronal incision', 'interventionNames': ['Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture']}], 'interventions': [{'name': 'reduction of zygomatic arch in zygomaticomaxillary complex fracture', 'type': 'PROCEDURE', 'otherNames': ['open reduction of zygomatic arch in zygomaticomaxillary complex fracture'], 'description': 'ultrasound guided reduction of zygomatic arch', 'armGroupLabels': ['control (open reduction of zygomatic arch)', 'study (ultrasound guided closed reduction of zygomatic arch))']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21500', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Tasneem Ahmed Mabrouk Amer', 'investigatorAffiliation': 'Alexandria University'}}}}