Overview

This trial is active, not recruiting.

Condition femur fracture
Treatment femur fracture repair
Sponsor Washington University School of Medicine
Collaborator University of Missouri-Columbia
Start date June 2009
End date December 2014
Trial size 145 participants
Trial identifier NCT00943332, 09-0819

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
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
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 Outcomes

Measure
Impact on family
time frame: 6 months

Secondary Outcomes

Measure
post-operative functional level
time frame: 1 year
pain management
time frame: 6 weeks
complications
time frame: 2 years

Eligibility Criteria

Male or female participants from 2 years up to 6 years old.

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

Additional Information

Official title Pediatric Femur Research Project
Principal investigator J. Eric Gordon, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.