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Femur Fracture: Functional Bracing vs. Hip Spica Cast

NCT03948139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-03-05

No results posted yet for this study

Summary

Spica casting is the current standard of care when treating pediatric diaphyseal femur fractures in the 0-5 year age group. A study conducted by Kramer et al. suggests there are both clinical and financial benefits of functional bracing when compared to spica casting. To this date there have been no prospective trials to evaluate these two treatment options. The investigators plan to conduct a multi-center randomized-control trial that will compare the subjective, objective and financial aspects of functional bracing and spica casting for pediatric femur fractures.

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.

Sponsors & Collaborators

Principal Investigators

  • Lindsay Andras, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2023-06-19
Completion
2025-02-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948139 on ClinicalTrials.gov