Femur Fracture: Functional Bracing vs. Hip Spica Cast

Pediatric Femur Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03948139
• Other study ID #: CHLA-18-00233
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: July 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Pediatric Femur Fracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Pediatric Orthopaedic Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.