Toddlers Fractures - Cast Versus Removable Boot

Background: Toddler's fractures (TF) are characterized as stable, spiral or oblique fractures of the tibial diaphysis or distal metaphysis that mainly occur in children between nine months and four years of age. Despite its inherent stability, the most frequent treatment option remains an above/below knee casting for three to six weeks, without clear and strong evidence to do so. Casting and orthopedic follow‐up results in further burden including unnecessary visits to an orthopedic surgeon, additional sets of lower extremity radiographs and day‐to‐day inconveniences/complications (e.g. bathing/showering, problems of fit, breakage, and skin related complications). Commercially available removable immobilization devices have been applied successfully to low‐risk stable extremity pediatric fractures, and have numerous advantages over conventional immobilization with casts (e.g. easy care, comfort and application/removal convenience) but have not properly been studied in the management of TF. Study Aims: To compare the recovery of children with TF when treated with a commercial, removable immobilization device versus an above‐knee walking fiberglass cast. Hypothesis: The removable pediatric walking boot will be at least as effective as the walking above‐knee cast with respect to pain with ambulation as measured by the EVENDOL scale at four weeks after injury. Research Design: This is a multi‐centre, two‐arm, non‐inferiority randomized control trial. All independently weight‐bearing children age 9 months to 4 years who present to the ED within five days of a lower extremity injury/complaint and diagnosed clinically and radiolographically with an accidental TF will be eligible for enrolment. Study participants will be randomly assigned to receive either a removable below knee device or a circumferential walking cast. The main outcome will be pain with ambulation as measured by the EVENDOL pain scale at four weeks. Complications, day‐to‐day burdens, unscheduled visits will be ascertained, as the impact and satisfaction with the treatment device. Accounting to a maximal 20% drop‐off rate, a sample size of 160 participants was calculated to have a power of 90% to identify a difference of 2 with an alpha value of 0.025. About one‐third of participants will be recruited at CHU Sainte‐Justine (n=54). Relevance: Current practice patterns predominately include treatment with a circumferential cast for several weeks. This type of rigid immobilization is likely unnecessary for such a stable injury. However, the research to date comparing casting with removable devices in children with TF has significant limitations and has not been of sufficient quality to change the immobilization and follow‐up practice of TF. Specifically, retrospective design and analyses of data collected for a different purpose is subject to methodological limitations such as bias, missing data, and inconsistent measurement of outcomes. Further, these data have typically been limited to a single site, limiting generalizability. Other research has gathered data using surveys, which is limited by the fact that what physicians say they do does not necessarily represent what they actually do, and hence does not necessarily accurately represent clinical practice or outcomes. Finally, no research to date has considered the perspectives of families who need to care for these injured toddlers at home. Therefore, to secure the confidence of all relevant stakeholders, we need to provide high quality evidence to determine the most effective and convenient management strategy for this common childhood injury. If we can demonstrate that a removable device is at least as safe and effective as a circumferential cast in the treatment of TF, there are likely to be similar benefits for these fractures as it has been found with other minor pediatric fractures (e.g. comfort/convenience, safety, recovery, and cost‐effectiveness advantages). As this is a common injury in childhood, the use of a removable device to manage this injury is highly likely to result in lower morbidity and save costs for the health care system and population, and these advantages will also generalize nationally and internationally.