Clinical Trial: Brace Versus Casting in Pediatric Low Risk Ankle Fractures
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Control Trial of Casting Versus Ankle Bracing in Children With Low-risk Ankle Fractures
Brief 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 Summary:
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
Sponsor: The Hospital for Sick Children
Current Primary Outcome: Functional outcome as measured by the Activities Scale for Kids at 4 weeks from the time of the initial injury [ Time Frame: 4 weeks ]
Original Primary Outcome: Functional outcome as measured by the Activities Scale for Kids at 4 weeks from the time of the initial injury
Current Secondary Outcome:
- Pain at 4 weeks [ Time Frame: 4 weeks ]
- Range of motion at 4 weeks [ Time Frame: 4 weeks ]
- Health economic outcomes [ Time Frame: 12 weeks ]
Original Secondary Outcome:
- Pain at 4 weeks
- Range of motion at 4 weeks
- Health economic outcomes
Information By: The Hospital for Sick Children
Dates:
Date Received: August 19, 2005
Date Started: July 2003
Date Completion:
Last Updated: June 5, 2012
Last Verified: January 2007
