Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT03402269
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-11', 'size': 223275, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-24T09:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Strength Measurements', 'timeFrame': '6 months and 12 months', 'description': 'Upper extremity strength measurements, measured by dynamometer (forward flexion, abduction, and external rotation'}], 'primaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': 'at 1 year post injury', 'description': 'Range of motion measured by goniometer'}, {'measure': 'Radiographic healing', 'timeFrame': 'at 1 year post injury', 'description': 'Radiographic evidence of healing on 3 of 4 cortices'}], 'secondaryOutcomes': [{'measure': 'QuickDash', 'timeFrame': 'at 3 months, 6 months and 12 months', 'description': 'QuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand'}, {'measure': 'PODCI', 'timeFrame': 'at 3 months, 6 months and 12 months', 'description': 'Adolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clavicle Fracture', 'Adolescent']}, 'descriptionModule': {'briefSummary': 'Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '11-17 years old with displaced fractures of the middle third of the clavicle', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 11-17 years old with fractures of the middle third of the clavicle\n* Displaced 100% the width of the clavicle or shortened 1 centimeter\n* Operative and non-operative treated clavicles will be eligible for enrollment\n\nExclusion Criteria:\n\n* Open clavicle fractures\n* Ipsilateral shoulder injuries\n* Fractures involving the lateral ligaments or the sternoclavicular joint\n* Bilateral clavicle fractures\n* Pathologic fractures\n* Refractures\n* Fractures with neurovascular compromise\n* Displaced fractures with impending skin compromise\n* If there has been more than 21 days between injury and enrollment\n* Patients with cognitive disabilities that inhibit the completion of the questionnaires'}, 'identificationModule': {'nctId': 'NCT03402269', 'briefTitle': 'Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'Pro00066019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adolescents with displaced clavicle fractures', 'description': 'Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study.', 'interventionNames': ['Other: Clavicle fracture injury- observation']}], 'interventions': [{'name': 'Clavicle fracture injury- observation', 'type': 'OTHER', 'description': 'The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing', 'armGroupLabels': ['Adolescents with displaced clavicle fractures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Christopher C Bray, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prisma Health-Upstate'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}