Pediatric Femur Fractures: Functional Bracing vs Spica Casting - Outcomes and Cost Analysis

Condition(s) studied

Investigational drug(s) / intervention(s)

Functional Bracing: 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. Braces will be applied to participants in the emergency department. As these braces are designed to allow for positional adjustments, if deemed necessary adjustments will be made by the attending orthopaedic surgeon at subsequent follow-up visit(s).

Hip Spica Cast: The current standard of care for diaphyseal pediatric hip fractures in children aged 6 months to 5 years old is hip spica casting. A hip spica is a hard cast that covers a child's body from the chest down to their knees or ankles allowing for fracture immobilization to promote healing. Application of the spica cast occurs in the operating room and requires a general anaesthetic. Caring for a child in a hip spica cast presents significant challenges for caregivers due to the cast's cumbersome size and restricted mobility which makes routine caregiver activities like daily hygiene, toileting, transportation and skin surveillance difficult. Inadequate maintenance of the spica cast may result in skin complications, necessitating extra visits for cast adjustments, or potentially requiring revision casting in the operating room.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Time to union/rate of non-union — Post-intervention clinical follow-ups up to 1 year
  Assessed by radiographic evidence at clinic follow-up visits. This will be measuring the length of time and changes in union of bone, and to see if the bone has not healed properly.
• Rates of malunion — Post-intervention clinical follow-ups up to 1 year
  Assessed by radiographic evidence at clinic follow-up visits. Malunion defined as 6 months-2years: \> 30 degrees varus/valgus; \>30 degrees procurvatum; or \>15 mm shortening. 2 years-5 years: \> 15 degrees varus/valgus; \> 20 degrees procurvatum; or \>20 mm shortening.
• Changes in Leg Length — Post-intervention clinical follow-ups up to 1 year
  Assessed by radiographic evidence at clinic follow-up visits. Leg length will be measured using radiographs to determine if there any changes to leg length or discrepancies compared to the contralateral side.
• Flynn Score — 6 weeks post intervention and at 1 year post-intervention
  Flynn Scoring system will be used to determine final functional results. The Flynn scoring system classifies functional results as: excellent, satisfactory or poor. An excellent result is defined as leg-length discrepancy \<1.0cm, femoral malalignment \<5 degrees, no pain and no complications. Satisfactory result is defined as leg-length discrepancy \<2.0cm, femoral malalignment 5-10 degrees, no pain as well as minor and resolved complications. A poor result is defined as leg-length discrepancy \>2.0cm, femoral malalignment \>10 degrees, presence of pain and major and lasting complications. Flynn score will be calculated at the 6 week mark and 1 year mark.
• Number of radiographs and cast clinic visits — Post-intervention clinical follow-ups up to 1 year
  This will be used to determine which arm had less radiation from radiographs and less visits with the surgeon.
• Pediatric Outcome Data Collection Instrument (PODCI) — Post-intervention clinical follow-ups up to 1 year
  a validated patient-reported quality of life and outcome measure primarily used to assess motor function following orthopedic surgical intervention. Will be completed by the parent at the 6-week and 1-year post-intervention visit and will allow for us to determine subjective outcomes.
• Complications — Post-intervention clinical follow-ups up to 1 year
  Includes skin break down issues, pressure sores, repeat operative intervention, cast or brace related issues.
• Parent Satisfaction Survey — At 6 week and 1 year follow-up.
  The caregiver will complete both the Impact on Family Scales (IFS) and EQ-5D questionnaires. The IFS is a validated 27-item score with Likert-scaling that measures the impact of children's health conditions on his/her family life that addresses four domains: economic impact on family, social impact, familial impact and personal strain/coping. The EQ-5D questionnaire is a brief validated questionnaire designed to evaluate mobility, self-care, usual activities, pain and discomfort as well as anxiety and depression.
• Economic costs — Initial presentation to hospital up to 1 year
  Direct costs associated with treatment, including materials, equipment, and hospital stays, OR costs, emergency room visit costs will be compared between the two groups.

Trial sites (1)

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