Clinical trial NCT03948139: Femur Fracture: Functional Bracing vs. Hip Spica Cast
Official title: Prospective Randomized Study Comparing Functional Bracing vs. Hip Spica Cast in Pediatric Femur Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Femur Fracture
Keywords: Pediatric
Fracture
Functional Brace
Hip Spica Cast
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Pediatric Orthopaedic Society of North America
First posted: 2019-05-13
Enrollment: 92
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Leg Length
timeFrame: Radiographs will be reviewed at the pre-op and clinical follow-ups up to 1 year.
measure: Changes in union/rate of malunion
timeFrame: Radiographs will be reviewed at the pre-op and clinical follow-ups up to 1 year.
measure: Number of radiographs and clinic visits
timeFrame: This will be reviewed and counted for up to 1 year.
measure: Economic costs (operating room cost)
timeFrame: This will be examined at the 1 day of intervention.
measure: Work days lost for parents
timeFrame: This will be surveyed at the 6 week post-intervention visit.
measure: Work days lost for parents
timeFrame: This will be surveyed at the 1 year post-intervention visit.
measure: Pediatric Outcome Data Collection Instrument (PODCI)
timeFrame: This will be surveyed at the 6 week post-intervention visit.
measure: Pediatric Outcome Data Collection Instrument (PODCI)
timeFrame: This will be surveyed at the 1 year post-intervention visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Los Angeles
name: Lindsay Andras, MD
role: PRINCIPAL_INVESTIGATOR
References: