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

This study has been completed.
Sponsor:
Collaborators:
Dirk Leu MD
Gerkan Erkula MD
M Catherine Sargent MD
Michael C Ain MD
Arabella I Leet MD
John E Tis MD
Paul D Sponseller MD
Information provided by (Responsible Party):
Paul Sponseller, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01293916
First received: February 10, 2011
Last updated: April 3, 2013
Last verified: April 2013
History of Changes

February 10, 2011
April 3, 2013
June 2006
January 2009   (final data collection date for primary outcome measure)
Acceptable fracture healing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
evaluation of shortening, angulation, and rotation radiographically at time of fracture healing
Same as current
Complete list of historical versions of study NCT01293916 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts
Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs 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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Femur Fracture
Other: Spica casting
single versus double leg spica casting
  • Active Comparator: Double leg spica cast
    The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.
    Intervention: Other: Spica casting
  • Experimental: Single leg spica casts
    The study group is the single leg spica cast group
    Intervention: Other: Spica casting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • underlying bone disorder
  • neuromuscular disease
Both
2 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01293916
4109553136
Yes
Paul Sponseller, Johns Hopkins University
Johns Hopkins University
  • Dirk Leu MD
  • Gerkan Erkula MD
  • M Catherine Sargent MD
  • Michael C Ain MD
  • Arabella I Leet MD
  • John E Tis MD
  • Paul D Sponseller MD
Study Director: Dirk Leu, MD Johns Hopkins University
Principal Investigator: Paul D Sponseller, MD MPH Johns Hopkins University
Johns Hopkins University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP