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Pediatric Femur Fractures: Functional Bracing vs Spica Casting - Outcomes and Cost Analysis
Sponsor: University of Calgary
Summary
Pediatric diaphyseal femur fractures that occur in children aged 6 months to 5 years old are traditionally treated with hip spica casting. However, recent studies suggest that functional bracing may offer clinical and financial benefits, yet there's a lack of prospective trials comparing these two treatment methods. This single-center randomized-control trial aims to assess subjective and objective clinical outcomes as well as financial aspects of functional bracing versus spica casting. Functional bracing, proposed as a potentially superior alternative, may address caregiver challenges and reduce costs by avoiding operating room time and hospital admissions. The study will evaluate fracture reduction, time to union, functional outcomes, and caregiver satisfaction. Additionally, a comprehensive cost-effectiveness analysis will be conducted. Ultimately, this research aims to inform clinical decision-making regarding the optimal management of pediatric femur fractures, considering both clinical effectiveness and economic implications.
Official title: Functional Bracing Versus Spica Casting for the Treatment of Pediatric Diaphyseal Femur Fractures: A Randomized Prospective Study and Cost-effectiveness Analysis
Key Details
Gender
All
Age Range
6 Months - 5 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2024-10-01
Completion Date
2028-01-01
Last Updated
2024-08-28
Healthy Volunteers
No
Conditions
Interventions
Functional Bracing
Premade fabricated braces in three sizes (small, medium and large) that have been designed for the pediatric age group between 0-5 years old will be stocked at the Alberta Children's Hospital. Braces will be applied to participants in the emergency department. As these braces are designed to allow for positional adjustments, if deemed necessary adjustments will be made by the attending orthopaedic surgeon at subsequent follow-up visit(s).
Hip Spica Cast
The current standard of care for diaphyseal pediatric hip fractures in children aged 6 months to 5 years old is hip spica casting. A hip spica is a hard cast that covers a child's body from the chest down to their knees or ankles allowing for fracture immobilization to promote healing. Application of the spica cast occurs in the operating room and requires a general anaesthetic. Caring for a child in a hip spica cast presents significant challenges for caregivers due to the cast's cumbersome size and restricted mobility which makes routine caregiver activities like daily hygiene, toileting, transportation and skin surveillance difficult. Inadequate maintenance of the spica cast may result in skin complications, necessitating extra visits for cast adjustments, or potentially requiring revision casting in the operating room.
Locations (1)
Alberta Children's Hospital
Calgary, Alberta, Canada