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

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ClinicalTrials.gov Identifier: NCT01293916
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : April 5, 2013
Sponsor:
Collaborators:
Dirk Leu MD
Gerkan Erkula MD
Sargent, M. Catherine, M.D.
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

Brief Summary:
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 or disease Intervention/treatment Phase
Femur Fracture Other: Spica casting Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Acceptable fracture healing [ Time Frame: 8 weeks ]
    evaluation of shortening, angulation, and rotation radiographically at time of fracture healing



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • underlying bone disorder
  • neuromuscular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sargent, M. Catherine, M.D.
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

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
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

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

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