Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-02 @ 1:55 AM
Study NCT ID:
NCT06931366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Column Fractures of Tibial Plateau
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092463', 'term': 'Tibial Plateau Fractures'}], 'ancestors': [{'id': 'D000092443', 'term': 'Knee Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013978', 'term': 'Tibial Fractures'}, {'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}, {'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical reduction of articular surface of tibial plateau by Rasmussen score', 'timeFrame': 'From the enrollment to the end of treatment of 1 year', 'description': 'This score measures the articular depression, condylar widening and angulation. Each result has a value which is summed all together where 18 is excellent, 12-17 is good, 6-10 is fair, less than 6 is poor'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tibial Plateau Fractures']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the long-term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept. The main question it aims to answer is:\n\nDoes the internal fixation of posterior column fractures of tibial plateau according to three column concept has a good radiological and clinical outcomes in follow up for 1 year? Participants already having internal fixation for their posterior column fractures will do X ray in their follow up visit and answer survey questions about their joint pain, ROM for 1 year.', 'detailedDescription': 'The goal of this observational study is to measure the radiological and clinical long term effects of internal fixation methods in patients with posterior column fractures of tibial plateau according to three column concept by using Rasmussen score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any public patient with posterior column tibial plateau fracture', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletally mature patients (18 - 60 years old).\n* Tibial plateau fracture with posterior column involvement classified by X-ray and CT scan\n* Fractures within 3 weeks of trauma\n\nExclusion Criteria:\n\n* Open fracture grade 3 Gustilo Anderson Classification but not managed by internal fixation within 3 weeks of trauma\n* Paediatric fractures.\n* Pathological fractures'}, 'identificationModule': {'nctId': 'NCT06931366', 'briefTitle': 'Posterior Column Fractures of Tibial Plateau', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Outcomes of Internal Fixation of Tibial Plateau Fractures Involving Posterior Column According to Three Column Concept: Prospective Case Series', 'orgStudyIdInfo': {'id': '214117'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Open reduction and internal fixation', 'type': 'PROCEDURE', 'description': 'plates and screws'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Islam A Mahmoud Atia, Resident', 'role': 'CONTACT', 'email': 'Islam.16266328@med.aun.edu.eg', 'phone': '+20 01129198914'}, {'name': 'Ali F, lecturer', 'role': 'CONTACT', 'email': 'Ali.fergany.83@med.aun.edu.eg', 'phone': '+20 01027339300'}], 'facility': 'Assiut university trauma hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Islam A Mahmoud Atia, Resident', 'role': 'CONTACT', 'email': 'Islam.16266328@med.aun.edu.eg', 'phone': '+20 01129198914'}, {'name': 'Ali F Abdelrahem, Lecturer', 'role': 'CONTACT', 'email': 'Ali.fergany.83@med.aun.edu.eg', 'phone': '+20 01027339300'}], 'overallOfficials': [{'name': 'Ali F Abdelrahem, lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Orthopedic Surgery and Traumatology, Assiut University'}, {'name': 'Aly M Mohamed, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Orthopedic Surgery and Traumatology, Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Islam Abodeef Mahmoud Atia', 'investigatorAffiliation': 'Assiut University'}}}}