Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-26 @ 10:47 PM
Study NCT ID:
NCT00943332
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2009-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Femur Research Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2009-07-17', 'studyFirstSubmitQcDate': '2009-07-21', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on family', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'post-operative functional level', 'timeFrame': '1 year'}, {'measure': 'pain management', 'timeFrame': '6 weeks'}, {'measure': 'complications', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Orthopedic Procedures', 'Fracture Fixation, Internal', 'Fracture Fixation, External', 'femur fracture', 'pediatrics'], 'conditions': ['Femur Fracture']}, 'descriptionModule': {'briefSummary': 'Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting for patients 6 years and younger and for patients over 6 years and older is percutaneous or open placement of titanium elastic intramedullary nails. The investigators would like to evaluate the current treatment protocol by comparing those patients 6 years and younger treated with closed reduction and spica casting to those 6 years and younger treated with percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The investigators will be comparing their post-operative functional level, pain management, impact on family and complications through chart and x-ray reviews. The goal is to improve patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6 years old and younger and increase the knowledge of those residents/physicians who care for this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will have undergone of the following interventions for the treatment of the femur fracture: spica casting, nancy nailing, or submuscular plating, by a participating physician in the trial. All of these treatments are considered standard of care for this pediatric population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child diagnosed with femur fracture between the ages of 2-6 years old\n* Patient will undergo surgical intervention for a femur fracture (e.g., submuscular plating, Nancy nailing, casting )\n\nExclusion Criteria:\n\n* Parent refusal to participate for any reason\n* Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3\n* Pathologic fracture'}, 'identificationModule': {'nctId': 'NCT00943332', 'briefTitle': 'Pediatric Femur Research Project', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pediatric Femur Research Project', 'orgStudyIdInfo': {'id': '09-0819-201105030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'spica casting', 'interventionNames': ['Procedure: femur fracture repair']}, {'label': 'intramedullary nailing', 'interventionNames': ['Procedure: femur fracture repair']}, {'label': 'submuscualr plating', 'interventionNames': ['Procedure: femur fracture repair']}], 'interventions': [{'name': 'femur fracture repair', 'type': 'PROCEDURE', 'description': 'all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure', 'armGroupLabels': ['intramedullary nailing', 'spica casting', 'submuscualr plating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Hospital - University Missouri", 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Childrens Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'J. Eric Gordon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington Univeristy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}