Pediatric Femur Research Project

NCT00943332 | Completed

• 1 other identifier: 09-0819-201105030
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Femur Fracture

Keywords

Orthopedic Procedures; Fracture Fixation, Internal; Fracture Fixation, External; femur fracture; pediatrics

Outcome Measures

Primary Outcomes (1)

• Impact on family

  6 months

Secondary Outcomes (3)

• post-operative functional level

  1 year

• pain management

  6 weeks

• complications

  2 years

Study Arms (3)

spica casting

Procedure: femur fracture repair

intramedullary nailing

Procedure: femur fracture repair

submuscualr plating

Procedure: femur fracture repair

Interventions

femur fracture repair PROCEDURE

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; spica casting; submuscualr plating

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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 )

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Missouri-Columbia: collaborator
• Children's Mercy Hospital Kansas City: collaborator

Study Sites (3)

Children's Hospital - University Missouri

Columbia, Missouri, 65201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

St. Louis Childrens Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• J. Eric Gordon, MD

  Washington Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 22, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

US (3)