Femur Fracture: Functional Bracing vs. Hip Spica Cast

NACompletedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

October 16, 2018

Primary Completion Date

June 19, 2023

Study Completion Date

February 11, 2025

Conditions
Pediatric Femur Fracture
Interventions
DEVICE

Functional Brace

The study will generate five standardized sized braces based on measurements from prior scans that will be stocked at each institution and modified by the local orthotist to fit the needs of each patient. This will facilitate expedited care while obtaining the same clinical and radiographic results as the fully customized braces. This idea has the potential to be extrapolated to the wider clinical community, creating a true shift in pediatric orthopaedic clinical practice throughout the country.

DEVICE

Hip Spica Cast

Traditional spica casts, the current standard of care for diaphyseal femoral shaft fractures with minimal shortening in children age 0-5 years old. Although spica cast immobilization is standard of care for femur fractures in young children, caring for a child in a spica cast presents a significant socioeconomic burden on families and the healthcare system. Basic hygiene and transportation for a child in a spica cast requires burdensome adjustments for caretakers, as well as the added expenses of specialized car seats or transportation services. Improper spica cast care can lead to skin complications, additional visits for cast adjustments, or even revision casting in the operating room.

Trial Locations (2)

80045

Children's Hospital Colorado, Aurora

90027

Children's Hospital Los Angeles, Los Angeles

All Listed Sponsors
collaborator

Pediatric Orthopaedic Society of North America

OTHER

lead

Children's Hospital Los Angeles

OTHER

NCT03948139 - Femur Fracture: Functional Bracing vs. Hip Spica Cast | Biotech Hunter | Biotech Hunter