Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-01 @ 6:36 PM
Study NCT ID:
NCT05206968
Status:
UNKNOWN
Last Update Posted:
2022-01-25
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intermodality agreement', 'timeFrame': '6 months', 'description': 'mesuring the intermodality agreement between two scoring system: the The Childhood Arthritis Radiographic Score of the Hip (CARSH) and the new radiographic scoring system for growth abnormalities and structural change in children with juvenile idiopathic arthritis of the hip'}], 'secondaryOutcomes': [{'measure': 'interreader agreement', 'timeFrame': '3 months', 'description': 'mesuring the interreader agreement between two experimented pediatric rheumatologist for the assessement of structurla damage in JIA hip'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis Hip']}, 'referencesModule': {'references': [{'pmid': '40224384', 'type': 'DERIVED', 'citation': 'Maatallah K, Lassoued Ferjani H, Ben Nessib D, Dghaies A, Kharrat L, Majdoub F, Kaffel D, Hamdi W. Can pediatric rheumatologists apply available hip scoring systems in daily practice for juvenile idiopathic arthritis? Front Pediatr. 2025 Mar 28;13:1436200. doi: 10.3389/fped.2025.1436200. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease in children affecting mobility and physical function. The hip involvement represents a frequent complication in JIA patients. The assessment of hip damage becomes a mandatory step in disease monitoring. However, radiological scoring was not standardized. This study aimed to compare the two scoring systems previously proposed, examine their repeatability and their intra and inter agreement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General data demographics , disease characteristics \\[symptom duration, disease presentation, JIA subtypes, Antigen(HLA) B27 positivity)\\], disease activity: Juvenile arthritis disease activity (JADAS), were collected.\n\nAll patients underwent a posteroanterior pelvic radiograph', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All included patient followed the ILAR criteria of JIA and have a hip involvement. This later was defined as the presence of rang motion limitation, and abnormal findings in pelvic radiographic, or ultrasound or MRI in the coxo-femoral joint.\n\nExclusion Criteria:\n\n* The presence of a contraindication to the performance of conventional radiography any disease affecting cognition Patients who have had surgery on the hip'}, 'identificationModule': {'nctId': 'NCT05206968', 'acronym': 'hip index', 'briefTitle': 'Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Scoring System of Structural Damage for the Hip in Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': '5981'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pelvic radiograph', 'type': 'RADIATION', 'description': 'Patients with hip involvement underwent a pelvic radiograph'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Manouba', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Hanène Lassoued Ferjani', 'role': 'CONTACT', 'email': 'lassouedferjanihanene@gmail.com', 'phone': '97950842'}], 'facility': 'Kassab institute of orthopedics', 'geoPoint': {'lat': 36.81006, 'lon': 10.09557}}], 'centralContacts': [{'name': 'Hanène Lassoued Ferjani, assistant professor', 'role': 'CONTACT', 'email': 'lassouedferjanihanene@gmail.com', 'phone': '97950842'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'lassoued ferjani Hanene', 'investigatorAffiliation': 'University Tunis El Manar'}}}}