Pediatric Femur Fractures: Functional Bracing vs Spica Casting - Outcomes and Cost Analysis
NCT Number: NCT06569199
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Femur Fracture
Interventions: DEVICE: Functional Bracing|DEVICE: Hip Spica Cast
Sponsor: University of Calgary
Collaborators: OrthoPediatrics (2850 Frontier Drive Warsaw, IN, USA)
Sex: ALL
Age: CHILD
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-01-01
Locations: Alberta Children's Hospital, Calgary, Alberta, T3C 1N9, Canada

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.

Primary Outcome Measures: Time to union/rate of non-union, 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., Post-intervention clinical follow-ups up to 1 year|Rates of malunion, 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., Post-intervention clinical follow-ups up to 1 year|Changes in Leg Length, 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., Post-intervention clinical follow-ups up to 1 year|Flynn Score, 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., 6 weeks post intervention and at 1 year post-intervention|Number of radiographs and cast clinic visits, This will be used to determine which arm had less radiation from radiographs and less visits with the surgeon., Post-intervention clinical follow-ups up to 1 year|Pediatric Outcome Data Collection Instrument (PODCI), 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., Post-intervention clinical follow-ups up to 1 year|Complications, Includes skin break down issues, pressure sores, repeat operative intervention, cast or brace related issues., Post-intervention clinical follow-ups up to 1 year|Parent Satisfaction Survey, 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., At 6 week and 1 year follow-up.|Economic costs, Direct costs associated with treatment, including materials, equipment, and hospital stays, OR costs, emergency room visit costs will be compared between the two groups., Initial presentation to hospital up to 1 year