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

Johns Hopkins University

Status: Completed

Conditions: Femur Fracture

Treatments: Other: Spica casting

Study type: Interventional

Funder types: Other

Identifiers

NCT01293916

NA_00005452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• underlying bone disorder
• neuromuscular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Double leg spica cast

Active Comparator group

Description:

The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.

Treatment:

Other: Spica casting

Single leg spica casts

Experimental group

Description:

The study group is the single leg spica cast group

Treatment:

Other: Spica casting