QSVI of CAM Boot vs Walking Cast for Treatment of Low Risk Ankle Injuries
Grant Recipient: Jennifer Beck, MD
- Orthopaedic Institute for Children
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The aim of our study, QSVI Study of CAM Boot vs Walking Cast for Treatment of Low Risk Ankle Injury In Pediatric Patients, is to investigate the clinical efficacy of two standard care procedures historically used to treat low-risk ankle fractures: CAM walker boot, and fiberglass casting. The study will include a total of sixty patients that are skeletally immature, aged 5-16 years, with a “low-risk ankle fracture” (defined as: inability to bear weight, tenderness over the lateral ankle on physical exam, no evidence of growth plate fracture on x-ray or a fibular avulsion fracture distal to the fibular growth plate) who are seen within the first 7 days after injury. These patients are being randomized to two groups: Group 1- CAM walker boot, who are also given range of motion exercises to complete daily, and Group 2- non-waterproof fiberglass short leg walking cast with a cast shoe. The study design is as follows: eligible patient participants present for initial visit, participants return to clinic for a 3-4 week follow-up visit, and participants are contacted via phone call roughly 8 weeks following initial presentation.
This study will determine if the “low-risk ankle fractures” have differences in clinical efficacy and time to return to activities based on treatment with either a CAM walker boot or with fiberglass casting. This study will explore quality of treatment, which we are measuring by: 1. Time to return to full activities 2. Patient satisfaction recorded as a 1-5 scale (strongly agree, agree, neutral, disagree, strongly disagree) with immobilization, ease of use, preference of the other treatment 3. Self-reported pain scores using validated pain measurement Wong-Baker FACES scale 4. Range of Motion assessed by ROM measurements in clinic at CAM/Cast removal 5. Ankle function as measured by Oxford ankle foot questionnaire for children, (OxAFQ-C) which is validated between ages of 5-16 years. If any patient experiences complications with treatment application, utilization, and removal it will be recorded. We will examine reported cast saw injuries, pressure sores, skin infections, any skin lesions, need for revision cast application from both casts and CAM boots, as well as return visits for wet/broken casts or CAM walkers if any of these should occur. We are also documenting the number of patients who report subacute re-injury, which for purposes of this study, are injuries occurred by an 8 week follow-up phone call.
Given previous literature review, we hypothesize that the CAM boots will prove to be the more efficient treatment option, with regards to patient satisfaction, ankle range of motion and muscle strength, and time to return to full activities.
Was the primary outcome measure of success reached?
With the grant, we were able to purchase 30 CAM walker boots of varying sizes, and an equal number of patients are to be treated with the fiberglass casting for a total of 60 patients. Due to the prospective nature of the study, it took 9 months to receive IRB approval, and then added time to coordinate beginning enrollment with our new Urgent Care center that was just opening. Given this delay, we are still enrolling patients to achieve our desired number of participants. Currently, 10 patients are enrolled. Given that data collection is still underway, our primary outcome measure of success has yet to be reached. Once we have a completed data set, it will be sent to our statistician to analyze the difference in treatment outcomes between the two groups and determine any significance.
Future plans, presentations or publications as a result of this grant.
This study will be used as pilot data for a larger study prepared based on the study results. We will eventually submit the study abstract for the PRiSM, AAOS, AAP, and POSNA 2021 conferences, as well as submit a final manuscript for publication to the Journal of Pediatric Orthopedics.
Thank you for the support with this study. Once completed, the researchers will happily provide POSNA an updated report with study findings. We look forward to these study results as they will improve care of a common pediatric orthopedic condition.
Jennifer J Beck MD
Pediatric, Sports Medicine
Orthopaedic Institute for Children
UCLA, Los Angeles, CA