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CompletedNCT00943332Updated Apr 26, 2019

Pediatric Femur Research Project

An observational study in Femur Fracture, sponsored by Washington University School of Medicine. Completed at 3 sites in United States. Open to participants aged 2 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
2 Years to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Femur Fracture

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Keywords

  • Orthopedic Procedures
  • Fracture Fixation, Internal
  • Fracture Fixation, External
  • femur fracture
  • pediatrics
03

In context

Femoral Fractures

293 studies on the registry are indexed under Femoral Fractures; 47 are open to participants now.

This study's enrollment of 48 is below the median of 100 across 96 observational studies indexed under Femoral Fractures.

Browse Femoral Fractures studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 6 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • Parent refusal to participate for any reason
  • Children with neuromuscular disorders having a Gross Motor Function Classification greater than 3
  • Pathologic fracture
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)

Groups and cohorts

  • spica casting

    Procedure: femur fracture repair

  • intramedullary nailing

    Procedure: femur fracture repair

  • submuscualr plating

    Procedure: femur fracture repair

Interventions

  • Procedurefemur 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

06

What researchers measure

Primary outcomes

  1. Impact on family

    Time frame: 6 months

Secondary outcomes

  1. post-operative functional level

    Time frame: 1 year

  2. pain management

    Time frame: 6 weeks

  3. complications

    Time frame: 2 years

07

Study locations

3 sites
  • Children's Hospital - University Missouri
    Columbia, Missouri 65201, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
  • St. Louis Childrens Hospital
    Saint Louis, Missouri 63110, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00943332
Lead sponsor
Washington University School of Medicine
Collaborators
University of Missouri-Columbia, Children's Mercy Hospital Kansas City
Responsible party
Sponsor
First posted
Jul 22, 2009
Start date
Jun 2009
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Apr 26, 2019

Study contacts

J. Eric Gordon, MD
principal investigator · Washington Univeristy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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