Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 4:25 AM
Study NCT ID:
NCT06245993
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'absence of lower limb overgrowth', 'timeFrame': '3 years', 'description': 'Leg Length Discrepancy in EOS imaging'}], 'secondaryOutcomes': [{'measure': 'Measurement of the angle on the lower limb sagittal axis', 'timeFrame': '3 years', 'description': 'Measurement of the angle on the sagittal axis of the lower limb 3 years after the end of treatment'}, {'measure': 'Measurement of the angle on the lower limb on the frontal axis', 'timeFrame': '3 years', 'description': 'Measurement of the angle on the frontal axis of the lower limb 3 years after the end of treatment'}, {'measure': 'Measurement of the angle on the lower limb on the frontal axis', 'timeFrame': '3 years', 'description': 'Measurement of the angle on the femoral torsion of the lower limb 3 years after the end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EOS', 'skin traction', 'femoral fracture', 'remodeling', 'leg length'], 'conditions': ['EOS']}, 'descriptionModule': {'briefSummary': 'Diaphyseal femoral fracture in children \\<6 years old are treated by the skin traction technique. As demonstrated by numerous studies, given the significant potential for bone remodeling in young children, remodeling (excluding rotational disorder) allows anatomical correction. The aim of this study is to confirm, via EOS imaging, the absence of residual deformities 3 years after the end of treatment in children treated in Amiens hospital department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diaphyseal femoral fracture in children \\<6 years old are treated by the skin traction.\n\nThe children have a Clinical examination and EOS imaging 3 years after skin traction treatment for femoral shaft fracture.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<6 years old at the time of the fracture\n* treatment by skin zenith traction\n* femoral shaft fracture, traumatic, unilateral\n\nExclusion Criteria:\n\n* Multiple fracture\n* pathological fracture\n* history of lower limb fracture\n* contraindication to zenith traction'}, 'identificationModule': {'nctId': 'NCT06245993', 'acronym': 'FRAFEMKID', 'briefTitle': 'Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction', 'orgStudyIdInfo': {'id': 'PI2023_843_0060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diaphyseal femoral fracture treated children', 'interventionNames': ['Other: EOS imaging']}], 'interventions': [{'name': 'EOS imaging', 'type': 'OTHER', 'description': 'EOS imaging 3 years after skin traction treatment for femoral shaft fracture.', 'armGroupLabels': ['Diaphyseal femoral fracture treated children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Céline Klein, MD', 'role': 'CONTACT', 'email': 'klein.celine@chu-emaine.fr', 'phone': '(33)322087571'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'celine Klein, Pr', 'role': 'CONTACT', 'email': 'klein.celine@chu-picardie.fr', 'phone': '(33)322087571'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}