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OpenTrials
Completed

NCT Number: NCT00943332

Pediatric Femur Research Project

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.

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Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital - University Missouri, Columbia, Missouri, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Children's Mercy Hospital Kansas City
  • University of Missouri-Columbia

Registry information

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2009
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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