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

Not Applicable

Completed

• Conditions: Femur Fracture
• Interventions: Other: Spica casting

• Registration Number: NCT01293916
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-06
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

• underlying bone disorder
• neuromuscular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double leg spica cast	Spica casting	The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.
Single leg spica casts	Spica casting	The study group is the single leg spica cast group

Primary Outcome Measures

Name	Time	Method
Acceptable fracture healing	8 weeks	evaluation of shortening, angulation, and rotation radiographically at time of fracture healing

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States