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Pediatric Femur Research Project

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ClinicalTrials.gov Identifier: NCT00943332
Recruitment Status : Unknown
Verified June 2015 by J. Eric Gordon, Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2009
Last Update Posted : June 11, 2015
Information provided by (Responsible Party):

July 17, 2009
July 22, 2009
June 11, 2015
June 2009
December 2014   (Final data collection date for primary outcome measure)
Impact on family [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00943332 on ClinicalTrials.gov Archive Site
  • post-operative functional level [ Time Frame: 1 year ]
  • pain management [ Time Frame: 6 weeks ]
  • complications [ Time Frame: 2 years ]
Same as current
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Pediatric Femur Research Project
Pediatric Femur Research Project
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.
Not Provided
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Non-Probability Sample
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.
Femur Fracture
Procedure: femur fracture repair
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
  • spica casting
    Intervention: Procedure: femur fracture repair
  • intramedullary nailing
    Intervention: Procedure: femur fracture repair
  • submuscualr plating
    Intervention: Procedure: femur fracture repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
June 2016
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Child diagnosed with femur fracture between the ages of 2-6 years old
  • Patient will undergo surgical intervention for a femur fracture (e.g., submuscular plating, Nancy nailing, casting )

Exclusion Criteria:

  • Parent refusal to participate for any reason
  • Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3
  • Pathologic fracture
Sexes Eligible for Study: All
2 Years to 6 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
J. Eric Gordon, Washington University School of Medicine
Washington University School of Medicine
  • University of Missouri-Columbia
  • Children's Mercy Hospital Kansas City
Principal Investigator: J. Eric Gordon, MD Washington Univeristy
Washington University School of Medicine
June 2015