Status:
COMPLETED
Brace Versus Casting in Pediatric Low Risk Ankle Fractures
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Ankle Fracture
Eligibility:
All Genders
5-18 years
Phase:
NA
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 fixe...
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 ...
Eligibility Criteria
Inclusion
- 5 to 18 years of age with one of the following fractures:
- Undisplaced Salter-Harris types I and II fractures of the distal fibula;
- Avulsion fractures of the distal fibula or distal fibular epiphysis;
- Metaphyseal buckle fractures of the distal fibula;
- Lateral talus fractures.
Exclusion
- The diagnosis of ankle sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates.
- All open fractures which require surgical debridement.
- All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease.
- Congenital anomalies of the feet and/or ankles.
- Patients with coagulopathies.
- Multisystem trauma and multiple fractures of the same or opposite limb.
- Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level.
- Injuries greater than 72 hours old.
- Past history of surgery or closed reduction of the same ankle within the last 6 months or ankle trauma of the same ankle within 3 months.
- Patients who do not have phone or electronic mail access.
- Patients living outside the Greater Toronto area (GTA) and who are unwilling to meet the physiotherapist at Hospital for Sick Children (HSC) for the four week assessment.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00132964
Start Date
July 1 2003
End Date
November 1 2005
Last Update
September 30 2021
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8