Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 9:00 PM
Study NCT ID:
NCT07067333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixation of Shaft Femure Fracrture by Ender Versus Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005594', 'term': 'Fracture Fixation, Intramedullary'}, {'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture Femure fixation by intramedullary nails versus plates', 'timeFrame': '6 months', 'description': 'limb length discrepancy by planning X rays.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shaft Femure Fracture in Adolescents']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the\n\n* functional outcomes, fracture healing time, rate of complications, and long-term growth outcomes between intramedullary nail and plating in adolescent.\n* Assess radiographic outcomes (e.g., alignment, limb length discrepancy, and growth plate disturbance).\n* Evaluate complications such as infection, nonunion, malunion, refractures, and need for reoperation (e.g., hardware removal).', 'detailedDescription': 'Elastic Nails (EN) are flexible intramedullary devices, usually made of titanium or stainless steel, that allow for dynamic stabilization. They are typically used for fractures in children and adolescents. The intramedullary nails offer the advantage of minimally invasive insertion, less disruption of the periosteum, and potential for less disruption of the growth plate.The nails bend and allow for some motion at the fracture site, which promotes healing through the formation of callus.\n\nPlate fixation typically involves a compression or neutralization plate, usually a dynamic compression plate (DCP) or a locking plate. This method provides rigid stabilization but often requires more extensive dissection and can interfere with growth if the plate is applied too close to the physis (growth plate).While plating can be very effective in providing stability, there is a higher risk of complications such as hardware-related issues (e.g., plate prominence, need for removal) and potential growth disturbances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 10-16 years (skeletally immature, based on radiographic evidence of growth plates).\n* Diagnosis: Closed or open (Grade I) diaphyseal femoral fractures.\n* Fracture type: Simple transverse, short oblique, or spiral fractures (classified by the AO/OTA system or by the Müller classification).\n\nExclusion Criteria:\n\n* • Fractures with significant comminution or open fractures (Grade II or III).\n\n * Pathological fractures (e.g., secondary to bone disease).\n * Severe systemic conditions that may affect bone healing or postoperative recovery (e.g., metabolic bone diseases).\n * Patients with previous ipsilateral femur fractures or those requiring re-operation for non-union or malunion.'}, 'identificationModule': {'nctId': 'NCT07067333', 'briefTitle': 'Fixation of Shaft Femure Fracrture by Ender Versus Plate', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Elastic Intramedullary Nails Versus Plate Fixation in Treatment of Diaphyseal Femoral Fracture in Adolescent', 'orgStudyIdInfo': {'id': 'Soh-Med--25-5-4MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A for intramadullary nail', 'description': 'fixation of the femure in group A by intramedullary nails', 'interventionNames': ['Device: intramedullary nails for group A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B for plating', 'description': 'fixation of the shaft femure fracture in group B by plates', 'interventionNames': ['Device: plate for group B']}], 'interventions': [{'name': 'intramedullary nails for group A', 'type': 'DEVICE', 'description': 'fixation of the shaft femure fracture in this group by intramedullary nails', 'armGroupLabels': ['group A for intramadullary nail']}, {'name': 'plate for group B', 'type': 'DEVICE', 'description': 'fixation of the shaft femure fracture in the group b by plates', 'armGroupLabels': ['group B for plating']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}, {'name': 'Mohamed Hashem Ahmed, master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed Hashem Ahmed, master', 'role': 'CONTACT', 'email': 'mohammed.hashem@med.sohag.edu.eg', 'phone': '+2001097500949'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Mohamed Hashem Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}