Published online June 1, 2007
PEDIATRICS Vol. 119 No. 6 June 2007, pp. e1256-e1263 (doi:10.1542/peds.2006-2958)

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ARTICLE

A Randomized, Controlled Trial of a Removable Brace Versus Casting in Children With Low-Risk Ankle Fractures

Kathy Boutis, MD^a,b, Andrew R. Willan, PhD^b, Paul Babyn, MD^c, Unni G. Narayanan, MD^b,d, Benjamin Alman, MD^d, Suzanne Schuh, MD^a,b

^a Division of Emergency Medicine
^b Population Health Sciences, Research Institute
^c Divisions of Diagnostic Imaging
^d Orthopedic Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada

OBJECTIVES. Isolated distal fibular ankle fractures in children are very common and at very low risk for future complications. Nevertheless, standard therapy for these fractures still consists of casting, a practice that carries risks, inconveniences, and use of subspecialty health care resources. Therefore, the main objective of this study was to determine whether children who have these low-risk ankle fractures that are treated with a removable ankle brace have at least as effective a recovery of physical function as those that are treated with a cast.

METHODS. This was a noninferiority, randomized, single-blind trial in which children who were 5 to 18 years of age and treated in a pediatric emergency department for low-risk ankle fractures were randomly assigned to a removable ankle brace or a below-knee walking cast. The primary outcome at 4 weeks was physical function, measured by using the modified Activities Scale for Kids. Additional outcomes included patient preferences and costs.

RESULTS. The mean activity score at 4 weeks was 91.3% in the brace group (n = 54), and this was significantly higher than the mean of 85.3% in the cast group (n = 50). Significantly more children who were treated with a brace had returned to baseline activities by 4 weeks compared with those who were casted (80.8% vs 59.5%). Fifty-four percent of the casted children would have preferred the brace, but only 5.7% of children who received the brace would have preferred the cast. The cost-effectiveness acceptability curve was always >80%; therefore, the brace was cost-effective compared with the cast.

CONCLUSIONS. The removable ankle brace is more effective than the cast with respect to recovery of physical function, is associated with a faster return to baseline activities, is superior with respect to patient preferences, and is also cost-effective.

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Key Words: children • fractures • treatment • ankle

Abbreviations: ED—emergency department • PEM—pediatric emergency medicine • ASKp—performance version of Activities Scale for Kids • H₀—null hypothesis

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Accepted Dec 12, 2006.

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