Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT04214405
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2019-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-14', 'studyFirstSubmitDate': '2019-12-28', 'studyFirstSubmitQcDate': '2019-12-28', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'union of fractures', 'timeFrame': '2 months', 'description': 'assessment of proper union of fractures'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Assessment of Proper Union of Fractures']}, 'referencesModule': {'availIpds': [{'url': 'https://www.ncbi.nlm.nih.gov', 'type': 'Clinical Study Report', 'comment': 'Birgfeld CB, Mundinger GS, Gruss JS. Evidence-based medicine: Evaluation and treatment of zygoma fractures. Plast Reconstr Surg 2017;139(1): 168e-80e.\\[http://dx.doi.org/10.1097/PRS.0000000000002852\\] \\[PMID: 28027253\\]'}]}, 'descriptionModule': {'briefSummary': 'The zygomatic bone defines the anterior and lateral projection of the face and articulates with the frontal, sphenoid,temporal, and maxillary bones. The zygomatic complex is responsible for the protection of the orbital contents and the mid-facial contour. Fracture of the zygomatic complex is one of the most common facial injuries in maxillofacial trauma and predominately appears in young adult males. The etiology of zygomatic complex fractures primarily includes road traffic accidents, violent assaults, falls and sports injuries. The main clinical features of zygomatic complex fractures include diplopia, enophthalmos, subconjunctival ecchymosis, extraocular muscle entrapment, cosmetic deformity with depression of the malar eminence, malocclusion and neurosensory disturbances of the infraorbital nerve. Diagnosis of zygomatic complex fractures is usually clinical with confirmation by computed tomography (CT) scan. Zygomatic complex fractures with no or minimal displacement are often treated without surgical intervention, whereas fractures with functional or esthetic impairments often necessitate surgical intervention. Various surgical approaches and treatment strategies have been proposed to obtain successful treatment outcome, including the Gilles temporal approach, eyebrow, upper eyelid, transconjunctival, infraciliary lower eyelid, and intraoral vestibular approaches. The surgical approach for adequate reduction of zygomatic complex fractures must ensure a good functional and cosmetic result. Surgical reduction of zygomatic fractures by an intraoral surgical approach was first described in1909 by Keen, and several studies have subsequently documented the treatment outcome after open reduction of zygomatic complex fractures by an intraoral surgical approach.', 'detailedDescription': 'This study is a prospective clinical intervention study where the admitted patients do lab investigation as CBC, coagulation profile ,Kidney function test and Imaging as CT maxillofacial with axial and coronal cuts. Patients will be assigned randomly into either one of the two groups under the study using concealed envelope. Under general anaesthesia with oral or naso-tracheal intubation, open reduction and internal fixation of tripod zygomatic fractures will be done using miniplates and screws at one point (zygomaticomaxillary area) or at two points (zygomaticomaxillary and frontozygomatic areas).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (a) Adult patients with maxillofacial fractures including tripodal zygomatic fractures as determined on clinical and radiological finding (b) Isolated tripodal fracture zygoma\n\nExclusion Criteria:\n\n* patients with Le Fort I/II/III fractures'}, 'identificationModule': {'nctId': 'NCT04214405', 'briefTitle': 'One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures', 'orgStudyIdInfo': {'id': 'Mohamed Gamal Thabet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'union of fractures', 'description': 'proper union of zygomatic fractures', 'interventionNames': ['Procedure: fixation of tripodal zygomatic fractures']}], 'interventions': [{'name': 'fixation of tripodal zygomatic fractures', 'type': 'PROCEDURE', 'description': 'One point versus two point fixation of tripodal zygomatic fractures', 'armGroupLabels': ['union of fractures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'AssiutU', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohamed Gamal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Gamal Thabet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohamed Gamal Thabet', 'investigatorAffiliation': 'Assiut University'}}}}