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

NCT ID: NCT01293916

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-01-31

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.

Conditions

Femur Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Double leg spica cast

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

Group Type: ACTIVE_COMPARATOR

Spica casting

Intervention Type: OTHER

single versus double leg spica casting

Single leg spica casts

The study group is the single leg spica cast group

Group Type: EXPERIMENTAL

Spica casting

Intervention Type: OTHER

single versus double leg spica casting

Interventions

Spica casting

single versus double leg spica casting

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• underlying bone disorder
• neuromuscular disease

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk Leu, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Paul D Sponseller, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00005452

Identifier Type: -

Identifier Source: org_study_id