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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Pediatric diaphyseal femur fractures that occur in children aged 6 months to 5 years old are traditionally treated with hip spica casting. However, recent studies suggest that functional bracing may offer clinical and financial benefits, yet there's a lack of prospective trials comparing these two treatment methods. This single-center randomized-control trial aims to assess subjective and objective clinical outcomes as well as financial aspects of functional bracing versus spica casting. Functional bracing, proposed as a potentially superior alternative, may address caregiver challenges and reduce costs by avoiding operating room time and hospital admissions. The study will evaluate fracture reduction, time to union, functional outcomes, and caregiver satisfaction. Additionally, a comprehensive cost-effectiveness analysis will be conducted. Ultimately, this research aims to inform clinical decision-making regarding the optimal management of pediatric femur fractures, considering both clinical effectiveness and economic implications.

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 data supports the effectiveness of the treatment 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. In contrast, spica casting is a standard treatment but can limit mobility and complicate transportation. ^{1 2 3 4 5}

Is functional bracing or spica casting generally safe for humans?

Functional bracing may help avoid stiffness and muscle loss compared to casting, but it can increase the risk of wound infection after certain surgeries. Hip spica casts can make it difficult to safely transport children in car seats, especially in crashes, due to their fixed position. ^{2 3 6 7 8}

How does the treatment of functional bracing differ from spica casting for broken bones?

Functional bracing allows for early movement and can help patients return to daily activities sooner, while spica casting provides more rigid support but limits mobility. Functional bracing may reduce the risk of complications like blood clots, but it requires patient compliance and carries a higher risk of wound infection if used after surgery. ^{2 4 6 9 10}

Research Team

David Parsons, MD

Principal Investigator

University of Calgary

Lisa Phillips, MD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Less than 6-week follow-up

Underlying neuromuscular disorders

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Italy pubmed.ncbi.nlm.nih.gov

Treatment of fracture of the femur in children by a "cast-brace". [2009]

2. France pubmed.ncbi.nlm.nih.gov

Hip hinge thigh brace for early mobilization of proximal femoral shaft fractures. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Casting technique and restraint choice influence child safety during transport of body casted children subjected to a simulated frontal MVA. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of three treatments for fractures of the diaphysis of the femur. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Immediate spica casting of pediatric femoral fractures in the operating room versus the emergency department: comparison of reduction, complications, and hospital charges. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Bracing versus casting in ankle fractures. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Safe transport of spica casted infants: Reducing the risk of traumatic injury in side impact collisions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Abduction Bracing Following Anterior Open Reduction for Developmental Dysplasia of the Hip Does Not Improve Residual Dysplasia or Reduce Secondary Surgery. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Reinforcing a spica cast with a fiberglass bar. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Four Weeks in a Single-Leg Weight-Bearing Hip Spica Cast is Sufficient Treatment for Isolated Femoral Shaft Fractures in Children Aged 1 to 3 Years. [2022]