Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-09 @ 11:55 PM
Study NCT ID:
NCT03360318
Status:
UNKNOWN
Last Update Posted:
2017-12-04
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brace Versus Casting in Pediatric Radial Head Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D000092482', 'term': 'Elbow Fractures'}], 'ancestors': [{'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mayo score', 'timeFrame': '1 month', 'description': 'Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury'}], 'secondaryOutcomes': [{'measure': 'pain', 'timeFrame': '1 month', 'description': 'VAS score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'elbow fractures', 'management'], 'conditions': ['Radial Fracture']}, 'descriptionModule': {'briefSummary': 'Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month', 'detailedDescription': "Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included.\n\nOutcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS.\n\nSample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head\n\nExclusion Criteria:\n\nThe diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.\n\nAll open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.\n\nCongenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.\n\nInjuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.'}, 'identificationModule': {'nctId': 'NCT03360318', 'briefTitle': 'Brace Versus Casting in Pediatric Radial Head Fractures', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Brace Versus Casting in Pediatric Radial Head Fractures', 'orgStudyIdInfo': {'id': 'CSG-03qtd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Elbow cast', 'description': 'Device: Elbow cast', 'interventionNames': ['Device: elbow cast']}, {'type': 'EXPERIMENTAL', 'label': 'Removable elbow brace', 'description': 'Device: Removable elbow brace', 'interventionNames': ['Device: Removable elbow brace']}], 'interventions': [{'name': 'elbow cast', 'type': 'DEVICE', 'description': 'elbow cast', 'armGroupLabels': ['Elbow cast']}, {'name': 'Removable elbow brace', 'type': 'DEVICE', 'description': 'Removable elbow brace', 'armGroupLabels': ['Removable elbow brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Peixun Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangpeixun@163.com', 'phone': '08613611237628'}, {'name': 'Yichong Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangyichong@163.com', 'phone': '08601088326550'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'peng zhang, MD', 'role': 'CONTACT', 'email': 'hcooh@163.com', 'phone': '13010029908'}], 'overallOfficials': [{'name': 'peng zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of orthopaedics and trauma', 'investigatorFullName': 'pengzhang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}