Brace Versus Casting in Pediatric Low Risk Ankle Fractures
Condition: Ankle Fracture
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      Acute ankle fractures are common in children. Most of these are stable and have a low risk of
      problems in the future. Even though these fractures are benign, these injuries are often
      casted for a fixed time period, which is inconvenient, expensive, and does not appear to be a
      practice that has been proven to be scientifically correct.

      Therefore, in this study, in healthy children with low-risk ankle fractures, we, the
      investigators at the Hospital for Sick Children, will examine if a removable ankle brace is
      at least as good as casting with respect to how well and how fast children return to their
      usual activities. In addition, we will compare the costs of each method for the patient and
      the health care system.

      Successful management of low-risk fractures with an ankle brace will allow for several
      advantages over the use of the cast. These advantages include the possibility of returning to
      normal activities faster, fewer visits to specialty hospital clinics, and significant cost
      savings.
    

Detailed description: 
      Objective: To determine if a removable ankle brace is at least as effective as casting in
      children between 5 and 18 years old with low-risk ankle fractures.

      Rationale: Ankle injuries are very common among children. The Canadian Health Injury
      Reporting and Prevention Program reports approximately 5500 ankle injuries per year in
      children presenting to the 16 participating emergency departments, 35% of which are
      fractures. The majority of ankle injuries in children, including ankle fractures, have an
      excellent prognosis with a very low risk for any complications. We have recently shown that a
      predefined structured 'low-risk' clinical exam reliably identifies these low risk injuries,
      while simultaneously excluding 100% of high-risk fractures. This clinical rule reduces the
      need for radiography in children with ankle injuries by 63%. However, all low-risk injuries
      are currently not managed uniformly. Low-risk ankle fractures are often treated with a cast
      while soft tissue injuries are treated in a brace. Due to this distinction in management,
      many physicians still feel compelled to do radiographs in children with low risk ankle
      injuries in order to identify the fractures. We will now expand our previous work to show
      that all low risk ankle fractures can be safely treated in the same way as soft tissue
      injuries of the ankle. The current treatment of low risk fractures is casting which is
      inconvenient, necessitates orthopedic referral, and may be associated with soft tissue
      complications. Furthermore, casting is not an evidence-based practice. Preliminary evidence
      in adults with stable ankle fractures suggests that an ankle brace may offer a safe
      alternative to casting, while allowing comparable resumption of usual activities and less
      reliance on sub-specialty care. Therefore, the primary purpose of this study is to compare
      the functional outcomes that result from ankle bracing with those from casting in children
      with low-risk ankle fractures.

      Design: In this randomized, outcomes assessor blinded, single center trial, children
      diagnosed with low-risk ankle fractures will receive either an ankle brace or a below-knee
      walking cast.

      Outcome Measures: The primary outcome measure will be an assessment of functional daily
      activities as measured by the modified performance Activities Scale for Kids (ASKp) at four
      weeks post injury. Secondary outcomes will include an assessment of pain scores, ankle range
      of motion and return to baseline function. A concurrent health economic evaluation will be
      conducted using both patient and health care sector costs.

      Sample Size and Analysis: The null hypothesis for the primary analysis is that the brace is
      less effective than casting by at least five percentage points on the ASKp scale. Assuming a
      standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size
      of 112 patients. Secondary analyses will include Fisher's Exact test to compare proportions
      of children with full range of motion of the injured ankle at four weeks and with full
      baseline activity level at four months, and the area under the curve of a pain-time profile
      curve will be compared using a Student's t-test. An economic analysis will assess the
      incremental net benefit of bracing versus casting from a health care perspective.

      Significance: If the removable brace is found to be at least as effective as the cast, this
      study has the potential to standardize the treatment of all low risk ankle injuries. Since
      these injuries can be reliably detected by physical examination, routine radiography of these
      injuries can be eliminated. These injuries could therefore be safely treated by primary
      physicians, thereby reducing the number of emergency department visits, obviating the need
      for orthopedic referral, or a return visit for cast removal. As a result, this study will
      provide critical information about the optimal treatment for the majority of ankle injuries
      in children from the perspective of clinical efficacy and health economics.
    

Intervention name(s): Below knee walking cast; Removable ankle brace
Intervention type(s): Device; Device
Intervention description(s): Not required; not required
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; ankle fractures; randomized controlled trial; management