Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
Study NCT ID:
NCT06678568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-11-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'loss of reduction rate', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Angulation is more than 10 degree in coronal view or more than 20 degree in sagittal view'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'Number of Participants with malunion, nonunion, joint stiffness and cast problem'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metaphyseal forearm fracture', 'loss of reduction', 'follow-up protocol', 'wrist fracture'], 'conditions': ['Wrist Fracture']}, 'descriptionModule': {'briefSummary': 'The randomized controlled study which compare radiologic outcomes (loss of reduction rate) and complications in pediatric patients with displaced metaphyseal forearm fractures who underwent conservative treatment. The patients were assigned in two different follow-up protocols. In the control group, the patients will go to hospital for follow-up visit and film every week until 4th week after injury. In the intervention group, the patients will go to hospital for follow-up visit every week except in the 3rd week after injury they will be gotten telemedicine follow-up.', 'detailedDescription': "Randomization of patients for 2 different follow-up protocols\n\nObjective: to compare loss of reduction rate by angulation measurement and prevalence of complications in patients with displaced metaphyseal forearm fractures who underwent conservative treatment.\n\nMethod:\n\nPatients will be randomly assigned to one of two groups using various block computerized randomization. Randomization will be performed using STATA version 16.0, Statacorp, College Station, Texas, USA\n\nInterventions:\n\nGroup 1 (control group): The patients will go to hospital for follow-up visit and film every week until 4th week after injury.\n\nGroup 2 (intervention group): The patients will go to hospital for follow-up visit every week except in the 3rd week after injury they will be gotten telemedicine follow-up.\n\nTreatment Allocation and concealment:\n\nA randomization will prepare with sealed envelopes containing assigned follow-up protocols for each patient.\n\nThe envelopes will be labeled with the study ID.\n\nBlinding:\n\nBecause of the two different of follow-up protocol, we cannot blind the protocol from participants, physicians and assessors.\n\nOutcomes:\n\n1. Primary outcome is loss of reduction rate using angulation measurement. The definition of loss of reduction angulation is angulation which is more than 10 degree in coronal view or more than 20 degree in sagittal view. Angulation measurement will be measured in bisector between longitudinal axis and center of diaphysis. Angulation will be measured by two physicians and two times using PACS (Picture Archiving and Communication System) in Ramathibodi hospital.\n2. Secondary outcomes are other complications such as malunion, nonunion, joint stiffness and cast problem\n\nStatistical Analysis Plan:\n\nData will be recorded in Microsoft Excel and imported to STATA version 16.0 for re-check.\n\nFor continuous data, use mean and standard deviation (S.D.) For categorical data, use frequency and percentage For comparing non-normal distribution between group, use Mann-Whitney test and for continuous data, use Fisher's exact test Define the Statistical significant is p-value \\< 0.05 Data analysis will be performed with STATA version 16.0, Statacorp, College Station, Texas, USA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0-12 years\n* Patients with distal metaphyseal forearm fractures in Ramathibodi hospital and Chakri Naruebodindra Medical Institute\n* Presented to hospital within 72 hours of injury\n\nExclusion Criteria:\n\n* Open fracture\n* Operative treatment at 1st visit\n* Neurovascular injury\n* Polytraumatized patient\n* Ipsilateral fracture of upper limb\n* History of previous surgery in the affected arm\n* Metabolic bone disease'}, 'identificationModule': {'nctId': 'NCT06678568', 'briefTitle': 'The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'The Optimized Follow-up Protocol for Pediatric Metaphyseal Forearm Fractures', 'orgStudyIdInfo': {'id': 'MURA2024/689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'The standard follow-up protocol', 'description': 'follow-up and film every week at hospital'}, {'type': 'EXPERIMENTAL', 'label': 'The optimized follow-up protocol', 'description': 'follow-up and film every week at hospital except the 3rd week is telemedicine follow-up', 'interventionNames': ['Other: telemedicine follow-up in 3rd week']}], 'interventions': [{'name': 'telemedicine follow-up in 3rd week', 'type': 'OTHER', 'description': 'Intervention group will be appointed with telemedicine follow-up in 3rd week after injury, instead of hospital follow-up visit.', 'armGroupLabels': ['The optimized follow-up protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Ramathibodi Hospital, Mahidol University', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'centralContacts': [{'name': 'Nonticha Thanthong, Doctor of medicine', 'role': 'CONTACT', 'email': 'por-43@hotmail.co.th', 'phone': '(+66)898829505'}, {'name': 'Chanika Angsanuntsukh, Diploma of orthopaedics', 'role': 'CONTACT', 'email': 'achanika@gmail.com', 'phone': '(+66)917767879'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nonticha Thanthong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor Investigator', 'investigatorFullName': 'Nonticha Thanthong', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}