Femur Fracture: Functional Bracing vs. Hip Spica Cast

September 21, 2023 updated by: Lindsay Andras, Children's Hospital Los Angeles

Prospective Randomized Study Comparing Functional Bracing vs. Hip Spica Cast in Pediatric Femur Fractures

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.

Study Overview

Status

Active, not recruiting

Detailed Description

Femur fractures are the most common orthopedic injury for which children are hospitalized in the United States. 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.

Functional bracing plays an established role in the non-operative management of other long bone fractures in pediatric patients, and offers numerous advantages, including being lightweight, simple to apply, and conducive to hygienic skin care. A study conducted by Kramer et al. suggests there are both clinical and financial benefits of functional bracing when compared to spica casting for femur fractures, including increased patient/parent satisfaction and better cost effectiveness. To date, there have been no prospective trials to confirm these initial findings.

While previous work by Kramer et al demonstrated the advantages of functional bracing when compared to traditional spica casting, the ability to generalize this to other pediatric practices has been limited due to the challenges of making braces in a timely fashion. The braces utilized by Kramer et al require a carver to create a brace with a foot plate that improves rotational control for femur fractures. The cost of a carver is approximately $125,000, and thus few orthotists have access to this piece of equipment. This limits the ability for many pediatric orthopaedists to incorporate functional bracing into their practice.

To make this treatment option more cost effective and accessible, the investigators propose to generate five standardized sized braces based on measurements from prior scans that will be stocked at each institution and modified by the local orthoptist 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.

The investigators hypothesize that functional bracing will demonstrate equivalent objective outcomes with respect to leg length, time to union, rate of malunion, number of radiographs, and number of clinic visits. The investigators also hypothesize that functional bracing will demonstrate superior economic costs with respect to operating room cost and work days lost for parents, as well as subjective outcomes with respect to Pediatric Outcome Data Collection Instrument, patient/parent satisfaction.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 5 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Functional Bracing Group
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.
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.
Other: Spica Cast Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Leg Length
Time Frame: Radiographs will be reviewed at the pre-op and clinical follow-ups up to 1 year.
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
Time Frame: Radiographs will be reviewed at the pre-op and clinical follow-ups up to 1 year.
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
Time Frame: This will be reviewed and counted for up to 1 year.
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)
Time Frame: This will be examined at the 1 day of intervention.
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
Time Frame: This will be surveyed at the 6 week post-intervention visit.
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
Time Frame: This will be surveyed at the 1 year post-intervention visit.
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)
Time Frame: This will be surveyed at the 6 week post-intervention visit.
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)
Time Frame: This will be surveyed at the 1 year post-intervention visit.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 13, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CHLA-18-00233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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