ClinicalTrials.Veeva

Menu

Implementation of the Low Risk Ankle Rule

T

The Hospital for Sick Children

Status

Completed

Conditions

Ankle Injury

Treatments

Other: LRAR Implementation

Study type

Interventional

Funder types

Other

Identifiers

NCT00785876
1000012792

Details and patient eligibility

About

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-rays of the injured ankle, even though only 12% of these x-rays show a break in the bone. Some excellent research has created some rules that doctors can use to help them decide which children really need x-rays. Unfortunately, even though these rules have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using these rules.

Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If we show that doctors can safely use this rule regularly and the number of ankle x-rays will be significantly less, this will lessen unnecessary potentially harmful radiation exposure in children, these children will spend less time in an ED, and the health care system will save money.

Enrollment

3,000 estimated patients

Sex

All

Ages

3 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  1. Children with ankle injuries who were referred from outside the hospital with radiographs.
  2. Children with ankle injuries who returned for reassessment of the same ankle injury.
  3. Children with open wounds on their ankle and/or foot
  4. 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.
  5. Congenital anomalies of the feet and/or ankles (eg club feet, tarsal coalition). These abnormalities may have features which may complicate clinical assessment.
  6. Patients with known coagulopathies. Underlying hemarthrosis may complicate clinical assessment.
  7. Patients with cognitive and/or developmental delay. These patients may not localize pain.
  8. 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.
  9. 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.
  10. 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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,000 participants in 2 patient groups

1
No Intervention group
Description:
Control Sites
2
Experimental group
Description:
Intervention Sites
Treatment:
Other: LRAR Implementation

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems