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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
Sponsor:
Collaborators:
University of Missouri-Columbia
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
J. Eric Gordon, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Femur Fracture Procedure: femur fracture repair

Study Type : Observational
Estimated Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Femur Research Project
Study Start Date : June 2009
Primary Completion Date : December 2014
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
spica casting 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
intramedullary nailing 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
submuscualr plating 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



Primary Outcome Measures :
  1. Impact on family [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. post-operative functional level [ Time Frame: 1 year ]
  2. pain management [ Time Frame: 6 weeks ]
  3. complications [ Time Frame: 2 years ]


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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943332


Locations
United States, Missouri
Children's Hospital - University Missouri
Columbia, Missouri, United States, 65201
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
St. Louis Childrens Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
University of Missouri-Columbia
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: J. Eric Gordon, MD Washington Univeristy

Responsible Party: J. Eric Gordon, Director of Clinical Services, Pediatric Orthopedic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00943332     History of Changes
Other Study ID Numbers: 09-0819
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by J. Eric Gordon, Washington University School of Medicine:
Orthopedic Procedures
Fracture Fixation, Internal
Fracture Fixation, External
femur fracture
pediatrics

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries