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Pediatric Femur Research Project

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Missouri-Columbia
Children's Mercy Hospital-Kansas City, MO
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00943332
First received: July 17, 2009
Last updated: February 9, 2011
Last verified: February 2011
History of Changes

July 17, 2009
February 9, 2011
June 2009
June 2013   (final data collection date for primary outcome measure)
Impact on family [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00943332 on ClinicalTrials.gov Archive Site
  • post-operative functional level [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • pain management [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.
Femoral Fractures
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.
 
Enrolling by invitation
145
June 2013
June 2013   (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
Both
2 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943332
09-0819
No
J. Eric Gordon, MD, Washington University
Washington University School of Medicine
  • University of Missouri-Columbia
  • Children's Mercy Hospital-Kansas City, MO
Principal Investigator: J. Eric Gordon, MD Washington Univeristy
Washington University School of Medicine
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP