Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06294535
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2024-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009917', 'term': 'Orbital Fractures'}], 'ancestors': [{'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'patient select randomly from closed label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'restoring the accurate position of eye', 'timeFrame': 'one month- six months', 'description': 'using exophthalmometer to measure enophthalmous'}, {'measure': 'motility of eye', 'timeFrame': 'one month', 'description': 'using 9 gaze test to evaluate motility of eye'}, {'measure': 'volume of orbit', 'timeFrame': 'one to six months', 'description': 'using CT scan to measure orbital volume pre and postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orbital wall reconstruction', 'prebent titanium mesh', 'patient specific implant', 'PEEK'], 'conditions': ['Orbital Fractures']}, 'descriptionModule': {'briefSummary': 'under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.', 'detailedDescription': 'under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia\n\nExclusion Criteria:\n\n* systemic disease interfere with bone healing enophthamous less than 2 mm'}, 'identificationModule': {'nctId': 'NCT06294535', 'briefTitle': 'The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study', 'orgStudyIdInfo': {'id': '2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prebent titanium mesh', 'description': 'reconstruction of fractured orbital walls with perbent titanium mesh', 'interventionNames': ['Device: reconstruction of orbital walls']}, {'type': 'EXPERIMENTAL', 'label': 'customized titanium implant (patient specific implant)', 'description': 'econstruction of fractured orbital walls with patient specific implant (customized titanium implant)', 'interventionNames': ['Device: reconstruction of orbital walls']}], 'interventions': [{'name': 'reconstruction of orbital walls', 'type': 'DEVICE', 'description': 'under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.', 'armGroupLabels': ['customized titanium implant (patient specific implant)', 'prebent titanium mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'mona s sheta, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of oral and maxillofacial surgery department', 'investigatorFullName': 'mona samy sheta', 'investigatorAffiliation': 'Tanta University'}}}}