Pediatric Femur Research Project

Completed

• Conditions: Femur Fracture
• Interventions: Procedure: femur fracture repair

• Registration Number: NCT00943332
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intramedullary nailing	femur fracture repair	-
spica casting	femur fracture repair	-
submuscualr plating	femur fracture repair	-

Primary Outcome Measures

Name	Time	Method
Impact on family	6 months

Secondary Outcome Measures

Name	Time	Method
pain management	6 weeks
post-operative functional level	1 year
complications	2 years

Trial Locations

Locations (3)

St. Louis Childrens Hospital; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital - University Missouri; 🇺🇸 Columbia, Missouri, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States