Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 5:32 PM
Study NCT ID:
NCT05620394
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2022-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2022-11-09', 'studyFirstSubmitQcDate': '2022-11-09', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years', 'timeFrame': 'Files analysed retrospectively from January 01, 2015 to February 29, 2020 will be examined', 'description': 'To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years with the aim of later developing a numerical model to study fracture mechanisms for forensic applications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Femur Fracture, Childhood'], 'conditions': ['Femur Fracture, Childhood']}, 'descriptionModule': {'briefSummary': 'Childhood fractures are the second most common presentation of abuse. The target population for screening for these injuries is children under the age of three who are unable to express themselves about the circumstances of the trauma, hence the need to develop a validated model to predict the outcome of trauma as well as the origin of a fracture.\n\nFew morphological data are available in the literature for the femur concerning the period of rapid growth between 0 and 3 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minor patient who died before the age of 3 years', 'eligibilityCriteria': "Inclusion criteria:\n\n* Minor patient who died before the age of 3 years\n* Whole body CT imaging performed post mortem on judicial requisition in the framework of a forensic procedure\n* Absence of refusal in the medical file by the holders of parental authority concerning the re-use of their child's data for the purposes of this research\n\nExclusion criteria:\n\n* Refusal manifested in the medical record by parental authority holders regarding the reuse of their child's data for the purpose of this research,\n* Femur not fully assessable on imaging acquisition"}, 'identificationModule': {'nctId': 'NCT05620394', 'acronym': 'GFI', 'briefTitle': 'Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan', 'orgStudyIdInfo': {'id': '7714'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Sébastien RAUL, MD, PhD', 'role': 'CONTACT', 'email': 'jean-sebastien.raul@chru-strasbourg.fr', 'phone': '33 3 69 55 10 34'}, {'name': 'Jean-Sébastien RAUL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexis WALCH, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Médecine Légale et Toxicologie - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Jean-Sébastien RAUL, MD, PhD', 'role': 'CONTACT', 'email': 'jean-sebastien.raul@chru-strasbourg.fr', 'phone': '33 3 69 55 10 34'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}