Pediatric Femur Research Project

Femur Fracture Clinical Trial

Official title:

Pediatric Femur Research Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943332
• Other study ID #: 09-0819-201105030
• Status: Completed
• Start date: June 2009
• Est. completion date: January 2018

Study information

• Verified date: April 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital - University Missouri	Columbia	Missouri
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	St. Louis Childrens Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Children's Mercy Hospital Kansas City, University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on family		6 months
Secondary	post-operative functional level		1 year
Secondary	pain management		6 weeks
Secondary	complications		2 years