Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-01 @ 6:41 AM
Study NCT ID:
NCT06792305
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2024-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sequence of Fixation in Tile C1.2 and C1.3 Vertical Shear Pelvic Ring Injuries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2024-11-23', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological outcome scores', 'timeFrame': '12 months', 'description': 'Patients will be followed up at two weeks, six weeks, three months, six months and one year postoperatively. Matta \\& Tornetta radiological principles will be used to assess the radiological and clinical outcomes via plain X-ray of pelvis showing both hips through anteroposterior, inlet and outlet views. Evaluation of five criteria on X-ray films postoperatively: residual posterior displacement, vertical displacement, pubic symphyseal translation, sagittal rotation and gapping of the sacroiliac joint. According to the grading of Matta \\& Tornetta principles, results will be as follows; excellent (\\< 4 mm), good (4 - 10 mm), fair (10- 20 mm), and poor (\\> 20 mm).'}, {'measure': 'Clinical outcome score', 'timeFrame': '12 months', 'description': 'Clinical outcome assessment at final follow up using Majeed pelvic score. Five factors are assessed and scored: pain, standing, sitting, sexual intercourse and work performance. The total score is then given a clinical grade as excellent, good, fair or poor.'}], 'secondaryOutcomes': [{'measure': 'Operative time in minutes.', 'timeFrame': '3 hours', 'description': 'Operative time will be recorded in each group'}, {'measure': 'Implant failure rate', 'timeFrame': '12 months', 'description': 'Implant failure if any, will be recorded during follow up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic ring injuries', 'vertical shear pelvic fracture', 'tile classification'], 'conditions': ['Pelvic Ring Fractures', 'Pelvic Ring Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the sequence of fixation in Vertically Unstable Tile C1.2 and C1.3 pelvic ring injuries, as regards clinical, radiological outcomes and implant failure rates. Our hypothesis is that starting with anterior ring fixation will achieve superior results as regards easier reduction, less operation time, and finally better radiological and functional outcomes when compared with starting with posterior ring fixation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18 years - 60 years.\n2. Tile C1.2 and C1.3 pelvic ring injuries.\n3. Pure anterior ring ligamentous injuries.\n\nExclusion Criteria:\n\n1. Bony fracture of the pubic rami.\n2. Tile C2 and C3 pelvic ring injuries.\n3. Associated acetabular fracture that requires intervention.'}, 'identificationModule': {'nctId': 'NCT06792305', 'briefTitle': 'The Sequence of Fixation in Tile C1.2 and C1.3 Vertical Shear Pelvic Ring Injuries.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'SEQUENCE OF FIXATION IN VERTICALLY UNSTABLE TILE C1.2 AND C1.3 PELVIC RING INJURIES: A PROSPECTIVE COMPARATIVE STUDY', 'orgStudyIdInfo': {'id': 'FMASU R230/2024'}, 'secondaryIdInfos': [{'id': 'No funds recieved', 'type': 'OTHER', 'domain': 'Ainshams University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A will be fixed anteriorly first', 'description': 'Group A will consist of 15 patients and will be fixed anteriorly first.', 'interventionNames': ['Procedure: Starting by anterior ring fixation in vertical shear pelvic ring injuries']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B will be fixed posteriorly first', 'description': 'Group B: 15 cases, and will be fixed posteriorly first.', 'interventionNames': ['Procedure: Starting by posterior ring fixation in vertical shear pelvic ring injuries']}], 'interventions': [{'name': 'Starting by anterior ring fixation in vertical shear pelvic ring injuries', 'type': 'PROCEDURE', 'description': 'The procedure will involve addressing the pelvic ring anteriorly with open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate. The goal isto achieve anatomical reduction and stable fixation to restore the integrity of the pelvic ring. Fixation of the posterior ring will be achieved using a single sacroiliac screw in S1. The goal of posterior fixation is to achieve stability and alignment of the posterior pelvic structures.', 'armGroupLabels': ['Group A will be fixed anteriorly first']}, {'name': 'Starting by posterior ring fixation in vertical shear pelvic ring injuries', 'type': 'PROCEDURE', 'description': 'the procedure will involve fixation of the posterior ring which will be achieved by using a single sacroiliac screw in S1. Then open reduction and internal fixation (ORIF) of the pubic rami and symphysis pubis by using a single 3.5 mm recon plate.', 'armGroupLabels': ['Group B will be fixed posteriorly first']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Karim Salem, Master of Orthopedic surgery', 'role': 'CONTACT', 'email': 'karimatefsalem@gmail.com', 'phone': '1000017388', 'phoneExt': '+20'}, {'name': 'Karim Salem, Masters of Orthopedic surgery', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ainshams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Karim Salem, Masters of Orthopedic surgery', 'role': 'CONTACT', 'email': 'karimatefsalem@gmail.com', 'phone': '1000017388', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Karim Atef Salem', 'investigatorAffiliation': 'Ain Shams University'}}}}