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Completed

NCT Number: NCT01293916

Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts

Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.

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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

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

Introduction

  • double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old.
  • Investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment.

Methods

  • Prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures
  • patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained
  • Radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation
  • After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • diaphyseal femur fracture
  • age between 2 and 6 years old

Exclusion criteria

  • underlying bone disorder
  • neuromuscular disease

Treatment and study plan

Spica casting

Other

single versus double leg spica casting

Primary outcomes

  1. Acceptable fracture healing

    Time frame: 8 weeks

    evaluation of shortening, angulation, and rotation radiographically at time of fracture healing

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2011
Registry last updated
Feb 5, 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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