A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma

Study Overview
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Brief Summary
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Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.

Detailed Description
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Patients with ankle trauma frequently present in the emergency department. In many institutions radiographies of the ankle and foot are obtained in most of these patients, although significant fractures occur only in 15%. Therefore clinical decision rules were developed to clinically rule out significant ankle fractures, thereby reducing the number of radiographies resulting in significant time and cost savings. Up until now the Ottawa Ankle and Foot Rules are the only clinical decision rules for ankle trauma that are widely accepted. They have a high sensitivity for the detection of fractures but a relatively low specificity. This led to the development of alternative clinical decision rules claiming equally high sensitivity but improved specificity. These alternatives have mostly not been replicated nor have they been directly compared. This is what the researchers want to do in this study: compare different clinical decision rules regarding sensitivity and specificity. Radiographies of ankle and foot made for every patient are used as the gold standard for the detection of fractures. Different clinical decision rules will be compared in a pediatric (5-15 years) and an adult population (from 16 years onwards). The researchers consider a clinical decision rule acceptable of it has a sensitivity of at least 95% and a specificity of at least 25%.

Official Title
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A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma

Conditions
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Ankle Injuries

Intervention / Treatment
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* Procedure: Ottawa Ankle and Foot Rules
* Procedure: Buffalo Rule
* Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia
* Procedure: Thompson Test
* Procedure: Palpation of the fibula
* Procedure: Ottawa Ankle and Foot Rules + palpation of the cuboid bone
* Procedure: Ottawa Ankle and Foot Rules + palpation over the deltoid ligament
* Procedure: Malleolar Zone Algorithm
* Procedure: Low Risk Exam
* Procedure: Bernese Ankle Rules
* Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain due to blunt trauma to the ankle Must be at least 5 years old Exclusion Criteria: Skin defects in the injured area Time of trauma > 72 hours before presentation Multiple significant injuries making clinical examination impossible Clinically obvious fracture Re-evaluation Referred with radiography Result of radiography already known to investigator Glasgow Coma Scale < 15

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults<br>Patients from 16 years of age onwards | Procedure: Ottawa Ankle and Foot Rules<br>* As previously published<br>Procedure: Buffalo Rule<br>* As previously published<br>Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia<br>* As previously published<br>Procedure: Thompson Test<br>* As previously published<br>Procedure: Palpation of the fibula<br>* Palpation of the fibula over its entire length.<br>Procedure: Bernese Ankle Rules<br>* As previously published<br>|
| Experimental: Children<br>Patients aged 5 to 15 years | Procedure: Ottawa Ankle and Foot Rules<br>* As previously published<br>Procedure: Buffalo Rule<br>* As previously published<br>Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia<br>* As previously published<br>Procedure: Thompson Test<br>* As previously published<br>Procedure: Palpation of the fibula<br>* Palpation of the fibula over its entire length.<br>Procedure: Ottawa Ankle and Foot Rules + palpation of the cuboid bone<br>* As previously published<br>Procedure: Ottawa Ankle and Foot Rules + palpation over the deltoid ligament<br>* As previously published<br>Procedure: Malleolar Zone Algorithm<br>* As previously published<br>Procedure: Low Risk Exam<br>* As previously published<br>Procedure: Bernese Ankle Rules<br>* As previously published<br>Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula<br>* As previously published<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for detection of significant fractures | In the adult population: fractures of the ankle, midfoot or fibula with a fragment measuring > 3mm detected by radiography In the pediatric population: fractures of the ankle, midfoot or fibula with a fragment measuring > 3mm detected by radiography. Salter-Harris I and II are not considered to be significant fractures. Due to considerable controversy in the literature sensitivity and specificity of the clinical decision rules will be calculated separately for different definitions of significant fractures. | At the first visit to the emergency department | 
| Specificity for detection of significant fractures | In the adult population: fractures of the ankle, midfoot or fibula with a fragment measuring > 3mm detected by radiography In the pediatric population: fractures of the ankle, midfoot or fibula with a fragment measuring > 3mm detected by radiography. Salter-Harris I and II are not considered to be significant fractures. Due to considerable controversy in the literature sensitivity and specificity of the clinical decision rules will be calculated separately for different definitions of significant fractures. | At the first visit to the emergency department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of proximal fibula fractures in ankle trauma | The prevalence of proximal fibula fractures in ankle trauma has, to the best of our knowledge, not yet been quantified. | At the first visit to the emergency department | 
| Prevalence of gastrocnemius tendon rupture in ankle trauma | The prevalence of gastrocnemius tendon rupture in ankle trauma has, to the best of our knowledge, not yet been quantified. | At the first visit to the emergency department | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ottawa Ankle and Foot Rules, Buffalo Rule, Bernese Ankle Rules, Low Risk Exam, Malleolar Zone Algorithm, Clinical decision rule, Ankle injury, Ankle sprain, Inversion trauma