Clinical Trials Directory

Trials / Completed

CompletedNCT01293916

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
2 Years – 6 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERSpica castingsingle versus double leg spica casting

Timeline

Start date
2006-06-01
Primary completion
2009-01-01
Completion
2009-01-01
First posted
2011-02-11
Last updated
2019-02-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01293916. Inclusion in this directory is not an endorsement.