Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:58 PM
Study NCT ID:
NCT01926795
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2013-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days to Ambulation', 'timeFrame': '12 weeks', 'description': 'Recorded in parent journal, date of first ambulation without assistance.'}], 'secondaryOutcomes': [{'measure': 'Fracture displacement', 'timeFrame': '12 weeks', 'description': 'Displacement of the fracture greater than 2 mm in any direction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["toddler's fracture", 'tibial fracture', 'children'], 'conditions': ['Tibial Fractures']}, 'descriptionModule': {'briefSummary': "Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing \\& bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis.\n\nExclusion Criteria:\n\n* • Children with clinical suspicion but lack of radiographic evidence for toddler's fracture\n\n * Fractures displaced \\>2mm\n * Open fractures\n * Pathologic fracture\n * Fractures involving the physis\n * Previous fracture of the ipsilateral extremity\n * Concomitant fracture involving the ipsilateral or contralateral leg\n * Concomitant head injury\n * Non-ambulatory children (i.e., those who have not yet begun to walk)\n * Children with bone-metabolism disorders (i.e., osteogenesis imperfect, rickets)\n * Children who are geographically prohibited from following up in our system\n * Children whose caregivers are not proficient in English\n * Presentation \\>7 days from injury\n * Cases considered to be non-accidental trauma"}, 'identificationModule': {'nctId': 'NCT01926795', 'briefTitle': "Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial", 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': "Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'Pro00025178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short Leg Cast', 'description': 'Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union', 'interventionNames': ['Procedure: Short leg cast']}, {'type': 'EXPERIMENTAL', 'label': 'No immobilization', 'description': 'No cast or splint will be applied to the injured extremity', 'interventionNames': ['Procedure: No Immobilization']}, {'type': 'OTHER', 'label': 'Observational', 'description': 'Patient will be treated based on the parents comfort. This arm will consist of individuals in which the parent/guardian did not agree to randomization, but did consent for observational follow-up regardless of treatment.', 'interventionNames': ['Procedure: Short leg cast', 'Procedure: No Immobilization']}], 'interventions': [{'name': 'Short leg cast', 'type': 'PROCEDURE', 'armGroupLabels': ['Observational', 'Short Leg Cast']}, {'name': 'No Immobilization', 'type': 'PROCEDURE', 'armGroupLabels': ['No immobilization', 'Observational']}]}, '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': 'Michael L Beckish, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Greenville Hospital System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}