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

NCT06569199 | Not Yet Recruiting DMC

• 1 other identifier: REB24-0318
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Femur Fracture

Keywords

Functional Brace; Hip Spica Cast; Orthopedic Surgery; Pediatric

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Functional Bracing

EXPERIMENTAL

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.

Device: Functional Bracing

Hip Spica Cast

ACTIVE COMPARATOR

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.

Device: Hip Spica Cast

Interventions

Functional Bracing DEVICE

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).

Functional Bracing

Hip Spica Cast DEVICE

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.

Hip Spica Cast

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6mo-5 years
• Isolated closed diaphyseal femur fracture
• Parent or caregiver 18 years of age or older who are cognitively able to complete the parent/caregiver satisfaction survey.

You may not qualify if:

• Patients \<6 months or \>5 years of age
• Underlying neuromuscular disorders
• Open diaphyseal femur fracture
• Polytrauma
• Medical comorbidities impacting fracture healing
• \<6 week follow-up

Sponsors & Collaborators

• University of Calgary: lead
• OrthoPediatrics (2850 Frontier Drive Warsaw, IN, USA): collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3C 1N9, Canada

Location

Related Publications (5)

• Chen V, Sanders JS, Skaggs DL, Kay RM, Andras LM. (2022). Functional Bracing of Femur Fractures in Young Children Avoids Anesthesia and Spica Casting with Equivalent Outcomes: A Randomized Prospective Study: 2022 POSNA Annual Meeting. Journal of the Pediatric Orthopaedic Society of North America, 4(3).

  BACKGROUND

• Kramer AS, JS, Woon C, Speers D, (2016). Functional Bracing for Treatment of Pediatric Diaphyseal Femur Fractures: An Alternative to Spica Casting: 2016 POSNA Annual Meeting. Journal of the Pediatric Orthopaedic Society of North America.

  BACKGROUND

• Kocher, M., Ciarlo, M., Feroe, A., Dichtel, L., & Traver, J. (2022). Impact on Family Functioning of Immediate Spica Casting for Pediatric Femur Fractures: An Ecological Study: Original Research. Journal of the Pediatric Orthopaedic Society of North America, 4(1).

  BACKGROUND

• Rockwood C.A., Beaty J.H., Kasser J.R. Lippincott Williams & Wilkins; 2010. Rockwood and Wilkins' Fractures in Children.

  BACKGROUND

• Flynn JM, Luedtke LM, Ganley TJ, Dawson J, Davidson RS, Dormans JP, Ecker ML, Gregg JR, Horn BD, Drummond DS. Comparison of titanium elastic nails with traction and a spica cast to treat femoral fractures in children. J Bone Joint Surg Am. 2004 Apr;86(4):770-7. doi: 10.2106/00004623-200404000-00015.

  PMID: 15069142 BACKGROUND

Study Officials

• Lisa Phillips, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• David Parsons, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben Wajda, MD

CONTACT

4034651996; benjamin.wajda@ucalgary.ca

Devin White, LPN

CONTACT

403-955-7258; devin.white@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants and parents are blinded until after study has been explained and consent obtained. Participants then are randomized into either the spica cast or functional bracing group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 28, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)