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Femur Fracture: Functional Bracing vs. Hip Spica Cast

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ClinicalTrials.gov Identifier: NCT03948139
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Pediatric Orthopaedic Society of North America
Information provided by (Responsible Party):
Lindsay Andras, Children's Hospital Los Angeles

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.

Condition or disease Intervention/treatment Phase
Pediatric Femur Fracture Device: Functional Brace Device: Hip Spica Cast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Functional Bracing vs. Hip Spica Cast in Pediatric Femur Fractures
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948139


Contacts
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Contact: Joshua Yang 323-361-5139 josyang@chla.usc.edu

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Joshua Yang    323-361-5139    josyang@chla.usc.edu   
Principal Investigator: Lindsay M Andras, MD         
United States, Colorado
Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Eun Bi Kim    720-777-8026    Eun.Kim@childrenscolorado.org   
Principal Investigator: Julia Sanders, MD         
Sponsors and Collaborators
Children's Hospital Los Angeles
Pediatric Orthopaedic Society of North America
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Responsible Party: Lindsay Andras, Assistant Professor of Orthopaedic Surgery, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03948139    
Other Study ID Numbers: CHLA-18-00233
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Lindsay Andras, Children's Hospital Los Angeles:
Pediatric
Fracture
Functional Brace
Hip Spica Cast
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries