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NCT Number: NCT00785876

Implementation of the Low Risk Ankle Rule

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.

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Key information

Conditions

Ankle Injury Ankle Injuries Disease Attributes Emergencies Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

LRAR Implementation

Other

Pre-LRAR - no changes in the usual procedures for the first 26 weeks except for flagging of all paediatric charts with ankle injuries, ED documentation which will not refer to the LRAR and phone follow up.

Post-LRAR: At 27 weeks, in addition to the aforementioned ED collection sheet and phone follow up, the implementation strategy for the LRAR rule and related management will be introduced at the intervention hospitals.

Primary outcomes

  1. To assess the impact of a LRAR implementation strategy on paediatric ankle radiography rates in participating EDS.

    Time frame: three six month phases of implementation

Secondary outcomes

  1. Ankle x-ray rate changes at individual hospital from pre-LRAR to post-LRAR implementation phases.

    Time frame: duration of subjects participation in study

  2. Intervention and control sites will be compared individually and collectively, during the post-LRAR for: missed significant fractures, number of unscheduled x-rays following initial ED visit, total length of stay, patient and physician satisfaction

    Time frame: duration of subjects participation in study

  3. To determine the sustainability of the clinical impact of the LRAR strategy at intervention sites by comparing high and low intensity implementation phases with respect to weekly x-ray rates, missed fractures and physician and patient satisfaction

    Time frame: duration of subjects participation in study

  4. To evaluate the performance of the LRAR during the implementation period of the rule at intervention sites with respect to: sensitivity and specificity of the LRAR for detecting "high risk" fractures and physician compliance with use of the rule

    Time frame: duration of subjects participation in study

  5. To compare total costs of "low risk injuries" at intervention versus control sites during the post-LRAR implementation phase.

    Time frame: duration of subjects participation in study

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Controlled Radiography for Ankle Injury Cases in Kids in the Emergency Department: Implementation of the Low Risk Ankle Rule

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2008
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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