Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-31 @ 10:39 PM
Study NCT ID:
NCT05754905
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-resolution CE-MRA of Children's Hip Joint
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The medial circumflex femoral artery (MCFA) and lateral circumflex femoral artery (LCFA) of the bilateral hip joint', 'timeFrame': '1 day (Magnetic resonance examination end time)', 'description': 'Morphology of the MCFA and LCFA of the bilateral hip joint'}, {'measure': 'The branches of the MCFA and/or LCFA around the bilateral femoral neck', 'timeFrame': '1 day (Magnetic resonance examination end time)', 'description': 'Morphology of MCFA and/or LCFA branches around the bilateral femoral neck'}, {'measure': 'The vessels of secondary ossification center and/or cartilaginous vascular canal in bilateral femoral head', 'timeFrame': '1 day (Magnetic resonance examination end time)', 'description': 'Morphology of the vessels and cartilaginous vascular canal in bilateral femoral head'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip', 'Vessels; Anomaly', 'Magnetic Resonance', 'Three-dimensional Water-selective Cartilage (3D-WATSc)']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about the feasibility of enhanced three-dimensional water-selective cartilage (3D-WATSc) sequence in displaying the vessels of children's hip by magnetic resonance. The main questions it aims to answer are:\n\n* Could the images of enhanced 3D-WATSc sequence show the healthy side hip joint vessels in children?\n* Could the images of enhanced 3D-WATSc sequence show the vascular disease of the suffering side hip joint in children?\n\nParticipants with unilateral hip disease will undergo the magnetic resonance examination including enhanced 3D-WATSc sequence. The pelvic plain film and magnetic resonance images will be collected and analysed.\n\nResearchers will compare the images of of the normal side with the images of the abnormal side to see if the enhanced 3D-WATSc sequence images could show the vascular disease of the suffering side hip joint in children?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children with hip disease from 2021-2022 in Children's Hospital of Chongqing Medical University", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children aged 6 months-14 years who are diagnosed as hip disease after screening by pediatric orthopedic surgeon in Children's Hospital of Chongqing Medical University during the study period. The hip disease contain developmental dysplasia of the hip, Perthes disease, infection of the hip, inflammation of the hip, fracture of the hip, and Meyer's dysplasia.\n\nExclusion Criteria:\n\n* patients with bilateral hip joint disease; patients with claustrophobia;Patients with metal implants (such as pacemaker implantation)"}, 'identificationModule': {'nctId': 'NCT05754905', 'briefTitle': "High-resolution CE-MRA of Children's Hip Joint", 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Chongqing Medical University"}, 'officialTitle': "High-resolution Contrast-enhanced Magnetic Mesonance Angiography of Children's Hip Joint", 'orgStudyIdInfo': {'id': 'CQMU-2023-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal hip joint', 'description': 'The normal side of patients with hip joint disease', 'interventionNames': ['Other: Magnetic resonance examination']}, {'label': 'Abnormal hip joint', 'description': 'The abnormal side of patients with hip joint disease', 'interventionNames': ['Other: Magnetic resonance examination']}], 'interventions': [{'name': 'Magnetic resonance examination', 'type': 'OTHER', 'description': 'the two groups are underwent magnetic resonance examination including enhanced 3D-WATSc sequence', 'armGroupLabels': ['Abnormal hip joint', 'Normal hip joint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400014', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': "Children's Hospital of Chongqing Medical University", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Yuxi Su, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital of Chongqing Medical University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Department', 'investigatorFullName': 'Yuxi Su', 'investigatorAffiliation': "Children's Hospital of Chongqing Medical University"}}}}