Femur Fracture: Functional Bracing vs. Hip Spica Cast

NCT03948139 | Completed

• 1 other identifier: CHLA-18-00233
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pediatric; Fracture; Functional Brace; Hip Spica Cast

Outcome Measures

Primary Outcomes (8)

• Changes in Leg Length

  After treatment, leg length will be measured using clinical radiographs to determine if there are any changes to leg length and determine if there are discrepancies.

  Radiographs will be reviewed at the pre-op and clinical follow-ups up to 1 year.

• Changes in union/rate of malunion

  This will be measuring the length of time and changes in union of bone, and to see if the bone has not healed properly.

  Radiographs will be reviewed at the pre-op and clinical follow-ups up to 1 year.

• Number of radiographs and clinic visits

  This will be used to determine which arm had less radiation from radiographs and less visits with the surgeon.

  This will be reviewed and counted for up to 1 year.

• Economic costs (operating room cost)

  This will be to compare the economic costs between the administration of a spica cast vs. a functional brace.

  This will be examined at the 1 day of intervention.

• Work days lost for parents

  This will be collected from a parent reported outcome survey which will help determine the amount of days a parent lost to work due to their child's condition.

  This will be surveyed at the 6 week post-intervention visit.

• Work days lost for parents

  This will be collected from a parent reported outcome survey which will help determine the amount of days a parent lost to work due to their child's condition.

  This will be surveyed at the 1 year post-intervention visit.

• Pediatric Outcome Data Collection Instrument (PODCI)

  The PODCI is a validated quality of life and outcome questionnaire used for various pediatric orthopaedic studies. It will allow the study team to determine the subjective outcomes of the subject.This will also be completed by the parent.

  This will be surveyed at the 6 week post-intervention visit.

• Pediatric Outcome Data Collection Instrument (PODCI)

  The PODCI is a validated quality of life and outcome questionnaire used for various pediatric orthopaedic studies. It will allow the study team to determine the subjective outcomes of the subject.This will also be completed by the parent.

  This will be surveyed at the 1 year post-intervention visit.

Study Arms (2)

Functional Bracing Group

OTHER

In a presented abstract, the functional brace group has been to shown equivalent outcomes to the hip spica cast. Subject will be administered the functional brace without going to the operating room to be put under full anesthesia. Most cases will not require any sedation in this group (in some cases, light sedation may be needed). Brace will be used for up to 8 weeks post-administration, until adequate callous formation is confirmed.

Device: Functional Brace

Spica Cast Group

OTHER

If subject is randomized into the hip spica cast group, subject will proceed to the operating room and be given general anesthesia to administer the spica cast. Cast will be used for up to 8 weeks, until adequate callous formation is confirmed.

Device: Hip Spica Cast

Interventions

Functional Brace DEVICE

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.

Functional Bracing Group

Hip Spica Cast DEVICE

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.

Spica Cast Group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients ages 0-5 years with an isolated diaphyseal femur fracture. Parents =18 years of age who are cognitively able to take a survey.

You may not qualify if:

• Patients \>5 years of age without a diagnosis of an isolated diaphyseal femur fracture or polytrauma and those with medical co-morbidities that may affect fracture healing. Parents \<18 year of age and unable to take a survey.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• Pediatric Orthopaedic Society of North America: collaborator

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Lindsay Andras, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects and parents are blinded until after consent to the study in which they are randomized into the functional brace group or spica cast group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: October 16, 2018
• Primary Completion: June 19, 2023
• Study Completion: February 11, 2025
• Last Updated: March 5, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)