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

Functional Bracing Versus Spica Casting for the Treatment of Pediatric Diaphyseal Femur Fractures: A Randomized Prospective Study and Cost-effectiveness Analysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Femur Fracture
• Intervention / Treatment: Device: Functional Bracing; Device: Hip Spica Cast

Detailed Description

Pediatric diaphyseal femur fractures are a common orthopedic injury in children, with about one-third occurring in patients under the age of five. These fractures require effective management to promote optimal healing and functional recovery. In the 6-month to 5-year-old age group, diaphyseal femur fractures have traditionally been treated with a hip spica cast. Application of a hip spica cast typically occurs in the operating room (OR) under general anesthesia given that patients must undergo prolonged sedation for cast application. Caring for a child with a hip spica cast presents significant challenges for caregivers due to the cast's cumbersome size and restricted mobility. This makes routine activities such as daily hygiene, toileting and skin surveillance difficult for caregivers. An ecological study performed by Kocher et al. found that spica casting places a greater burden on family functioning than medical treatment in children with serious chronic medical conditions including diabetes, renal failure, and juvenile rheumatoid arthritis.1

Kramer et al. have recently proposed the use of functional bracing as an equally effective alternative to traditional hip spica casting for the treatment of pediatric diaphyseal femur fractures. In their study, they found no differences in the correction and maintenance of fracture alignment, time to union and functional outcomes2. The use of a prefabricated and adjustable functional brace was suggested to be better tolerated by patients and their parents as the open design allows for improved hygiene, ease of cleaning, toileting, skin surveillance and improved positional movement.

From a cost-effectiveness analysis perspective, it has been inferred that the overall cost of functional bracing compared to spica casting is lower as it can be applied in the emergency department without the need for a general anesthetic or operating room time. Furthermore, we hypothesize that functional bracing will also decrease visits to orthopedic clinics for cast-related issues which will further decrease the overall costs associated with the treatment of pediatric diaphyseal fractures with a functional brace when compared to a hip spica cast. Having said this, no comprehensive cost-effectiveness analysis studies have been performed to our knowledge and there is minimal literature comparing functional bracing versus spica casting for the treatment of pediatric diaphyseal femur fractures.

This proposed study aims to address this gap by conducting a randomized prospective study comparing functional bracing and spica casting for the treatment of pediatric diaphyseal femur fractures by evaluating maintenance of fracture reduction, time to union, leg-length, functional outcomes, complications, parent/caregiver satisfaction with the treatment as well as performing a supplemental comprehensive cost-effectiveness analysis.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ben Wajda, MD; Phone Number: 4034651996; Email: benjamin.wajda@ucalgary.ca
• Study Contact Backup: Name: Devin White, LPN; Phone Number: 403-955-7258; Email: devin.white@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3C 1N9
      • Alberta Children's Hospital
      • Contact: Ben Wajda, MD; Phone Number: 4034651996; Email: benjamin.wajda@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. 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; 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).
Active Comparator: Hip Spica Cast; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: OrthoPediatrics (2850 Frontier Drive Warsaw, IN, USA)
• Investigators: Principal Investigator: Lisa Phillips, MD, University of Calgary; Principal Investigator: David Parsons, MD, University of Calgary

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Functional Brace; Hip Spica Cast; Orthopedic Surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: REB24-0318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No