Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT06102603
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2023-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The clinical trial was approved by the research ethics review committee of the author's hospital (Number XXX) and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I9 supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of patients with fracture union', 'timeFrame': 'one month after intervention', 'description': 'clinical outcome'}, {'measure': 'the number of complications', 'timeFrame': 'one month after intervention', 'description': 'clinical outcome'}, {'measure': 'patient satisfaction questionnaire', 'timeFrame': 'one month after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric upper limb fracture', 'casting', 'Bioabased polyester', 'Synthetic cast'], 'conditions': ['Upper Limb Fracture']}, 'referencesModule': {'references': [{'pmid': '38166834', 'type': 'DERIVED', 'citation': 'Lan TY, Chen CW, Huang YH, Lin SM, Liang CT, Chang CH, Rwei SP. Biobased polyester versus synthetic fiberglass casts for treating stable upper limb fractures in children: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Jan 2;25(1):23. doi: 10.1186/s12891-023-07138-7.'}]}, 'descriptionModule': {'briefSummary': 'From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3-4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.', 'detailedDescription': "The clinical trial was approved by the research ethics review committee of the author's hospital and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) \\[9\\] diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital\n\nExclusion Criteria:\n\n* displaced or unstable fractures indicated for close or open reduction and fixation\n* previous surgeries to the affected upper limb\n* history of any chronic skin pathology (e.g., atopic dermatitis)\n* known allergy to cast materials'}, 'identificationModule': {'nctId': 'NCT06102603', 'briefTitle': 'Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '110245-F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the biobased polyester cast group', 'description': 'biobased polyester cast was applied', 'interventionNames': ['Other: the biobased polyester cast']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the synthetic fiberglass cast group', 'description': 'synthetic fiberglass cast was applied', 'interventionNames': ['Other: the synthetic fiberglass cast']}], 'interventions': [{'name': 'the biobased polyester cast', 'type': 'OTHER', 'description': 'long arm casting', 'armGroupLabels': ['the biobased polyester cast group']}, {'name': 'the synthetic fiberglass cast', 'type': 'OTHER', 'description': 'long arm casting', 'armGroupLabels': ['the synthetic fiberglass cast group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'Tsungyu Lan', 'role': 'STUDY_CHAIR', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'one year', 'ipdSharing': 'YES', 'description': 'the study protocol could be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}