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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014