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Pediatric Femur Research Project

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The Washington University

Status

Completed

Conditions

Femur Fracture

Treatments

Procedure: femur fracture repair

Study type

Observational

Funder types

Other

Identifiers

NCT00943332
09-0819-201105030

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

2 to 6 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

48 participants in 3 patient groups

spica casting
Treatment:
Procedure: femur fracture repair
intramedullary nailing
Treatment:
Procedure: femur fracture repair
submuscualr plating
Treatment:
Procedure: femur fracture repair

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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