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Clinical Trials/NCT01293916
NCT01293916CompletedNot Applicable

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

Johns Hopkins University2 sites in 1 country52 target enrollmentStarted: June 2006Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
52
Locations
2
Primary Endpoint
Acceptable fracture healing
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •underlying bone disorder
  • •neuromuscular disease

Arms & Interventions

Double leg spica cast

Active Comparator

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

Intervention: Spica casting (Other)

Single leg spica casts

Experimental

The study group is the single leg spica cast group

Intervention: Spica casting (Other)

Outcomes

Primary Outcomes

Acceptable fracture healing

Time Frame: 8 weeks

evaluation of shortening, angulation, and rotation radiographically at time of fracture healing

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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