Status:
COMPLETED
Implementation of the Low Risk Ankle Rule
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Ankle Injury
Eligibility:
All Genders
3-16 years
Phase:
NA
Brief Summary
Ankle injuries are a very common injury in children. Each year approximately 35000 kids present to Ontario emergency departments (ED) with this problem. Right now, about 90% of these children get x-ra...
Eligibility Criteria
Inclusion
- All otherwise healthy children between the ages of 3 and 16 years of age that present to the participating EDs with an isolated acute (\< 72 hours) blunt ankle injury due to any mechanism of injury will be eligible for the study. The age criteria were chosen to match those ages in which the LRAR was validated.
Exclusion
- Children with ankle injuries who were referred from outside the hospital with radiographs.
- Children with ankle injuries who returned for reassessment of the same ankle injury.
- Children with open wounds on their ankle and/or foot
- All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease (Appendix I). Clinical presentation and risks in these cases may be altered.
- Congenital anomalies of the feet and/or ankles (eg club feet, tarsal coalition). These abnormalities may have features which may complicate clinical assessment.
- Patients with known coagulopathies. Underlying hemarthrosis may complicate clinical assessment.
- Patients with cognitive and/or developmental delay. These patients may not localize pain.
- Injuries greater than 72 hours old. The signs and symptoms of the most common fracture, the Salter-Harris I fracture of the distal fibula, may be diminished. Our ability to make this clinical diagnosis with confidence may thus be compromised.
- Recent history of surgery or closed reduction of the same ankle within the last 3 months. These prior events may confuse current presenting symptomatology and ability to weight-bear and recover normally.
- Patients with low risk injuries who do not have phone or electronic mail access and/or have an insurmountable language barrier. This will preclude follow up.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00785876
Start Date
November 1 2008
End Date
November 1 2011
Last Update
October 9 2017
Active Locations (4)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
2
North York General Hospital
Toronto, Ontario, Canada
3
The Hospital for Sick Children
Toronto, Ontario, Canada
4
Toronto East General Hospital
Toronto, Ontario, Canada