Functional Bracing vs Spica Casting for Broken Bones

Overseen By Devin White, LPN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Neuromuscular disorders, Polytrauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for broken thigh bones (femur fractures) in young children: functional bracing and hip spica casting. Researchers aim to determine which method promotes better bone healing, is more convenient for caregivers, and is more cost-effective. The trial will monitor bone healing quality and speed, as well as caregiver satisfaction with the treatment. Eligible children have an isolated femur fracture and are between 6 months and 5 years old. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance treatment options for young children with femur fractures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these treatment methods are safe for pediatric femur fractures?

Previous studies have shown that young children tolerate functional braces for broken bones well. Research indicates that functional braces yield results similar to traditional spica casts, with most patients experiencing excellent or satisfactory outcomes. Functional braces can help prevent stiffness and muscle loss, but there is a slightly higher risk of wound infection after some surgeries. Overall, both functional braces and spica casts are considered safe options for treating broken thigh bones in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring functional bracing for broken bones in young children because it offers a potentially more convenient and comfortable alternative to the traditional hip spica cast. Unlike the spica cast, which requires general anesthesia and is applied in an operating room, the functional brace can be fitted in the emergency department under light sedation, making the process less invasive. Additionally, the brace is premade in various sizes, which could lead to quicker application and adjustments. Overall, if proven effective, functional bracing could simplify treatment for both kids and their caregivers, offering greater ease of movement and potentially improving the overall recovery experience.

What evidence suggests that this trial's treatments could be effective for pediatric femur fractures?

This trial will compare the effectiveness of functional bracing and hip spica casting for treating broken thigh bones in children. Studies have shown that a functional brace is as effective as a spica cast for bone healing and recovery. Participants using functional bracing may benefit from earlier mobility and reduced immobility time, helping maintain normal knee movement. Additionally, functional braces can be more convenient for caregivers, often eliminating the need for surgery and hospital stays. ^{2 3 4 6 7}

Who Is on the Research Team?

Lisa Phillips, MD

Principal Investigator

University of Calgary

David Parsons, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for children aged 6 months to 5 years who have a specific type of thigh bone break called diaphyseal femur fractures. The study is looking for participants who traditionally would be treated with hip spica casting.

Inclusion Criteria

I am between 6 months and 5 years old.

I have a single, closed fracture in the middle section of my thigh bone.

I am over 18 and can fill out a satisfaction survey.

Exclusion Criteria

Less than 6-week follow-up

I am either younger than 6 months or older than 5 years.

Underlying neuromuscular disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either functional bracing or hip spica casting for up to 8 weeks

8 weeks

Initial visit for treatment application, followed by regular follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic assessments and functional evaluations

1 year

Regular follow-up visits up to 1 year post-intervention

Cost-effectiveness Analysis

Comprehensive analysis of the economic costs associated with each treatment method

Concurrent with follow-up phase

What Are the Treatments Tested in This Trial?

Interventions

• Functional Bracing
• Hip Spica Cast

Trial Overview The study compares two treatments: functional bracing and hip spica casting, to see which one is better in terms of healing, functionality, caregiver satisfaction, and cost-effectiveness. It's a randomized trial where kids will be put into groups by chance.

How Is the Trial Designed?

Group I: Functional Bracing Experimental Treatment 1 Intervention

Premade fabricated braces in three sizes (small, medium and large) that have been designed for the pediatric age group between 0-5 years old will be stocked at the Alberta Children's Hospital. Participants who are randomized to the functional bracing group will be administered the functional brace within the emergency department under light procedural sedation. Brace will be used for up to 8 weeks administration until adequate callous formation confirmed with X-ray imaging.

Group II: Hip Spica Cast Active Control 1 Intervention

Participants who are randomized to the spica casting group will undergo casting in the operating room and be given general anesthesia to apply the hip spica cast. Cast will be used for up to 8 weeks administration until adequate callous formation confirmed with X-ray imaging.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

OrthoPediatrics (2850 Frontier Drive Warsaw, IN, USA)

Collaborator

Trials

1

Recruited

70+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40570075/

A Prospective, Randomized Comparison of Functional ... In this prospective randomized trial, patients who were treated with functional bracing had equivalent outcomes to those who were treated with spica casting.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06569199

Pediatric Femur Fractures: Functional Bracing vs Spica ... The study will evaluate fracture reduction, time to union, functional outcomes, and caregiver satisfaction. Additionally, a comprehensive cost-effectiveness ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2768276525000471

Dynamic Femur Fracture Brace vs Hip Spica Cast for ... This study compares short-term outcomes and complications between the DF2 brace and spica casting in the management of pediatric femoral shaft fractures.

4. withpower.com withpower.com/trial/phase-femoral-fractures-9-2024-5fd6c

Functional Bracing vs Spica Casting for Broken Bones Research shows that functional bracing allows for earlier movement and walking, reducing the time a child is immobilized and helping maintain normal knee motion ...

5. ota.org ota.org/sites/files/legacy_abstracts/ota16/OTA%20AM16%20Paper%20089.pdf

Functional Bracing for Treatment of Pediatric Diaphyseal ... Conclusion: FFB is equally effective to SC in correction and maintenance of fracture alignment, time to union, and functional outcomes but is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12088119/

Functional Bracing for Pediatric Femoral Shaft Fractures Functional femur bracing is an alternative to spica casting in toddlers and preschool-aged patients with femoral shaft fractures.

7. ijoro.org ijoro.org/index.php/ijoro/article/download/3203/1860/18104

Functional outcome of femoral shaft fracture in pediatric ... Functional outcomes at 12 weeks post-operation were mostly excellent (60.87%) or satisfactory (30.43%), with one poor result (8.70%).