Cast vs Removable Boot for Toddler's Fracture
Trial Summary
What is the purpose of this trial?
A toddler's fracture is a fracture that occurs in the lower leg, oven the shin, of children 9 months to four years of age. It usually happens when a young child twists the leg while running or jumping. It is one of the most common injuries of the leg in this age group. In Canada and the United States there are about 80,000 cases per year that present to emergency departments. The good news is that these fractures are stable injuries and heal exceptionally well, without any reported concerns for problems in the future. Despite this, most children with this fracture are managed in a restrictive full circular cast, often including the entire leg, for three to six weeks. This cast management then also includes about two to three repeat visits to see a bone doctor, where the cast is often changed and new x-rays are taken with each visit. However, none of these things has ever been shown to change the way these young children's fractures heal. Further, casting can cause harm such as skin irritation or poor cast fit which may result in problems that are more distressing than the fracture itself. There are also costs to consider. The needless excess costs of the current management strategy in Canada alone can be estimated to be about 1.8 million dollars annually. And so, increasingly, some doctors are choosing to manage these stable fractures with a supportive device on the lower leg, a removable walking boot. This type of device can be taken off as needed by the parent and child and used only as long as the child needs it to manage the pain that results from this stable fracture. This makes caring for the child much easier and allows the child to return to activities when the child is ready. Further, families do not necessarily need to return to a bone doctor for cast changes or x-rays or reassessment. Since this fracture recovers so well, patients can see their family doctor to make sure their child is returning to activity as expected and have their questions about recovery answered. But, in order to be sure that the removable walking boot works as well as a cast in these fractures, we need to do a well-designed study to make sure we consider all the important aspects of making this change. As a result, in children with toddler's fractures, we will compare the traditional treatment of cast placement to a removable walking boot with respect to how each immobilization strategy controls pain and how quickly children return to their usual activities. We hope that children treated with a removable walking boot will still be able to achieve good pain control while their injury is healing. It is possible too those children will even return to their activities sooner and this newer strategy could save the health care system money.
Eligibility Criteria
This trial is for healthy, walking toddlers aged 9 months to 4 years who come to specific hospitals within five days of hurting their lower leg. They must be diagnosed with a toddler's fracture (a common shin injury from twisting the leg).Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a removable below knee device or a circumferential walking cast
Follow-up
Participants are monitored for pain control and recovery using the EVENDOL pain scale
Extended Follow-up
Participants are monitored for complications and weight-bearing ability
Treatment Details
Interventions
- Cast
- Removable Walking Boot
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Hospital for Sick Children
Lead Sponsor
Population Services International
Collaborator