Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT01293916
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2011-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'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': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2011-02-10', 'studyFirstSubmitQcDate': '2011-02-10', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptable fracture healing', 'timeFrame': '8 weeks', 'description': 'evaluation of shortening, angulation, and rotation radiographically at time of fracture healing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatric', 'femur', 'femoral', 'fracture', 'spica', 'cast', 'diaphyseal', 'single', 'double', 'patient age 2 to 6 years old'], 'conditions': ['Femur Fracture']}, 'descriptionModule': {'briefSummary': 'Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.', 'detailedDescription': 'Introduction\n\n* double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old.\n* Investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment.\n\nMethods\n\n* Prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures\n* patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained\n* Radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation\n* After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diaphyseal femur fracture\n* age between 2 and 6 years old\n\nExclusion Criteria:\n\n* underlying bone disorder\n* neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT01293916', 'briefTitle': 'Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts', 'orgStudyIdInfo': {'id': 'NA_00005452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double leg spica cast', 'description': 'The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.', 'interventionNames': ['Other: Spica casting']}, {'type': 'EXPERIMENTAL', 'label': 'Single leg spica casts', 'description': 'The study group is the single leg spica cast group', 'interventionNames': ['Other: Spica casting']}], 'interventions': [{'name': 'Spica casting', 'type': 'OTHER', 'description': 'single versus double leg spica casting', 'armGroupLabels': ['Double leg spica cast', 'Single leg spica casts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Dirk Leu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Paul D Sponseller, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}