Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts
- Conditions
- Femur Fracture
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- diaphyseal femur fracture
- age between 2 and 6 years old
- underlying bone disorder
- neuromuscular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Acceptable fracture healing 8 weeks evaluation of shortening, angulation, and rotation radiographically at time of fracture healing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital🇺🇸Baltimore, Maryland, United States