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
  Purpose

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.


Condition Intervention
Femur Fracture
Other: Spica casting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Acceptable fracture healing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    evaluation of shortening, angulation, and rotation radiographically at time of fracture healing


Enrollment: 52
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Double leg spica cast
The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.
Other: Spica casting
single versus double leg spica casting
Experimental: Single leg spica casts
The study group is the single leg spica cast group
Other: Spica casting
single versus double leg spica casting

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • underlying bone disorder
  • neuromuscular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293916

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
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
Investigators
Study Director: Dirk Leu, MD Johns Hopkins University
Principal Investigator: Paul D Sponseller, MD MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Paul Sponseller, Vice Chairman, Department of Orthopedic Surgery, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01293916     History of Changes
Other Study ID Numbers: 4109553136
Study First Received: February 10, 2011
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
pediatric
femur
femoral
fracture
spica
cast
diaphyseal
single
double
patient age 2 to 6 years old

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 17, 2014