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

Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293916
• Other study ID #: NA_00005452
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Est. completion date: January 2009

Study information

• Verified date: February 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• diaphyseal femur fracture

• age between 2 and 6 years old

Exclusion Criteria:

• underlying bone disorder

• neuromuscular disease

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Other:
• Spica casting
single versus double leg spica casting

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptable fracture healing	evaluation of shortening, angulation, and rotation radiographically at time of fracture healing	8 weeks