Clinical trial NCT06569199: Pediatric Femur Fractures: Functional Bracing vs Spica Casting - Outcomes and Cost Analysis
Official title: Functional Bracing Versus Spica Casting for the Treatment of Pediatric Diaphyseal Femur Fractures: A Randomized Prospective Study and Cost-effectiveness Analysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Femur Fracture
Keywords: Functional Brace
Hip Spica Cast
Orthopedic Surgery
Pediatric
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: OrthoPediatrics (2850 Frontier Drive Warsaw, IN, USA)
First posted: 2024-08-23
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to union/rate of non-union
timeFrame: Post-intervention clinical follow-ups up to 1 year
measure: Rates of malunion
timeFrame: Post-intervention clinical follow-ups up to 1 year
measure: Changes in Leg Length
timeFrame: Post-intervention clinical follow-ups up to 1 year
measure: Flynn Score
timeFrame: 6 weeks post intervention and at 1 year post-intervention
measure: Number of radiographs and cast clinic visits
timeFrame: Post-intervention clinical follow-ups up to 1 year
measure: Pediatric Outcome Data Collection Instrument (PODCI)
timeFrame: Post-intervention clinical follow-ups up to 1 year
measure: Complications
timeFrame: Post-intervention clinical follow-ups up to 1 year
measure: Parent Satisfaction Survey
timeFrame: At 6 week and 1 year follow-up.
measure: Economic costs
timeFrame: Initial presentation to hospital up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Lisa Phillips, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: David Parsons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).
citation: 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.
citation: 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).
citation: Rockwood C.A., Beaty J.H., Kasser J.R. Lippincott Williams & Wilkins; 2010. Rockwood and Wilkins' Fractures in Children.
citation: 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.