Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06182904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Pilon Fractures With Versus Without Fibula Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-03-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-24', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-12-24', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture healing and bone union', 'timeFrame': 'Baseline', 'description': 'by RUST score'}], 'secondaryOutcomes': [{'measure': 'Incidece and rate of complications', 'timeFrame': 'Baseline', 'description': 'Incidence and rate of complications (e.g. non-union, skin breakdown , infections and postraumatic malaligment) by AOFAS score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pilon Fracture']}, 'descriptionModule': {'briefSummary': 'Management of pilon fractures with versus without fibula fixation', 'detailedDescription': 'Comparing results with or without fibular fixation in :\n\n* Rate of bone union .\n* Functional return ( clinical outcomes)\n* Alignment of lower limb.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Management of pilon fractures with versus withot fibula fixation: prospective controlled study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with metaphyseal non rotational pilon or distal tibia : age ( 18 \\_ 65 )\n* No skin troubles\n* No infections\n* Non-dibetic patients.\n\nExclusion Criteria:\n\n* Patients who will not complete their follow up.\n* Skin troubles\n* Infections'}, 'identificationModule': {'nctId': 'NCT06182904', 'briefTitle': 'Management of Pilon Fractures With Versus Without Fibula Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Management of Pilon Fractures With Versus Without Fibula Fixation', 'orgStudyIdInfo': {'id': 'pilon fractures'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Management of pilon fractures with fibula fixation', 'interventionNames': ['Device: Dynamic compression plate']}, {'label': '2', 'description': 'Management of pilon fracture without fibula fixation'}], 'interventions': [{'name': 'Dynamic compression plate', 'type': 'DEVICE', 'description': 'Fixation of fibula in some cases with dynamic compression plate', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mina Mofdy', 'role': 'CONTACT', 'email': 'minamofdy55@gmail.com', 'phone': '01286998347'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Mina Mofdy Shafik kaeen', 'investigatorAffiliation': 'Assiut University'}}}}