Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-30 @ 10:29 AM
Study NCT ID:
NCT05425758
Status:
UNKNOWN
Last Update Posted:
2022-06-21
First Post:
2022-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Index for Pediatric Distal Forearm Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-30', 'releaseDate': '2025-06-15'}], 'estimatedResultsFirstSubmitDate': '2025-06-15'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2022-06-11', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cast index', 'timeFrame': '4 weeks observation after reduction and applying cast.', 'description': 'formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.'}, {'measure': 'The gap index', 'timeFrame': '4 weeks observation after reduction and applying cast.', 'description': 'formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.'}, {'measure': 'The padding index', 'timeFrame': '4 weeks observation after reduction and applying cast.', 'description': 'formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.'}, {'measure': 'The Canterbury index', 'timeFrame': '4 weeks observation after reduction and applying cast.', 'description': 'formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.'}, {'measure': 'The three-point index', 'timeFrame': '4 weeks observation after reduction and applying cast.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optimal index for Pediatric distal forearm fractures'], 'conditions': ['Pediatric Distal Forearm Fractures']}, 'descriptionModule': {'briefSummary': "This is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children 3-12 years of age with displaced distal forearm fractures requiring manipulation for and will be treated with casting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females 3 to 12 years old.\n2. Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting.\n\nExclusion Criteria:\n\n1. Children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with Kirschner wires.\n2. Children whose casts is split will be excluded.'}, 'identificationModule': {'nctId': 'NCT05425758', 'briefTitle': 'Optimal Index for Pediatric Distal Forearm Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'What is the Optimal Index for Assessment of Plaster Cast Quality in Pediatric Distal Forearm Fractures', 'orgStudyIdInfo': {'id': 'Soh-Med-22-05-07'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator of orthopedic surgery', 'investigatorFullName': 'Meena Mikhael Rizk', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-15', 'type': 'RELEASE'}, {'date': '2025-06-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Meena Mikhael Rizk, Principal Investigator of orthopedic surgery, Sohag University'}}}}