Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-02 @ 8:38 AM
Study NCT ID:
NCT06503718
Status:
RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D005596', 'term': 'Fractures, Closed'}], 'ancestors': [{'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': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the result of orthopedic treatment and osteosynthesis from the outset', 'timeFrame': 'Up to 6 months', 'description': 'Use of the functional score for this assessment :\n\nScores :\n\n* 95-100 : Excellent\n* 75-94 : Good\n* 51-74 : Fair\n* 0-50 : Poor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tibial Fractures', 'Osteosynthesis, Fracture', 'Closed Fracture'], 'conditions': ['Tibial Fractures']}, 'descriptionModule': {'briefSummary': 'Most displaced tibial shaft fractures in pediatric patients have traditionally been treated after reduction by cast immobilization with good long-term results. Recently, there has been a growing trend towards surgical intervention by osteosynthesis from the outset. This study aims to describe the results of orthopedic treatment and osteosynthesis from the outset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minor subject (under 18 years old) treated at the HUS, between June 1, 2004 and April 31, 2024, for a fracture of the displaced diaphysis of the tibia treated orthopedically or by osteosynthesis reviewed after more than 6 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minor subject (under 18 years old)\n* Subject treated at the HUS, between June 1, 2004 and April 31, 2024, for a fracture of the displaced diaphysis of the tibia treated orthopedically or by osteosynthesis reviewed after more than 6 months\n* Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.\n\nExclusion criteria:\n\n* Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.\n* Non-displaced and/or displaced fracture not located at the level of the tibial diaphysis\n* Open fracture\n* Incomplete or unusable file'}, 'identificationModule': {'nctId': 'NCT06503718', 'acronym': 'FFD', 'briefTitle': 'Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Management of Closed Diaphyseal Displaced Leg Fractures in Children and Adolescents: Should Osteosynthesis Be Favored From the Start?', 'orgStudyIdInfo': {'id': '9244'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe GICQUEL, MD, PhD', 'role': 'CONTACT', 'email': 'Philippe.Gicquel@chru-strasbourg.fr', 'phone': '33 3 88 12 82 65'}, {'name': 'Philippe GICQUEL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Grah Franck LOHOUROU, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Chirurgie Pédiatrique - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Philippe GICQUEL, MD', 'role': 'CONTACT', 'email': 'Philippe.Gicquel@chru-strasbourg.fr', 'phone': '33 3 88 12 82 65'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}