Brace Versus Casting in Pediatric Low Risk Ankle Fractures
NCT00132964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111
Last updated 2021-09-30
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.
Conditions
- Ankle Fracture
Interventions
- DEVICE
-
Below knee walking cast
Not required
- DEVICE
-
Removable ankle brace
not required
Sponsors & Collaborators
-
The Physicians' Services Incorporated Foundation
collaborator OTHER -
The Hospital for Sick Children
lead OTHER
Principal Investigators
-
Kathy K Boutis, MD · The Hospital for Sick Children
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-07-31
- Primary Completion
- 2005-11-30
- Completion
- 2005-11-30
Countries
- Canada
Study Locations
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