NCT01293916CompletedNot Applicable
Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Acceptable fracture healing
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
Study Sites (2)
Loading locations...
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