A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
- Conditions
- Ankle Injuries
- Interventions
- Procedure: Ottawa Ankle and Foot RulesProcedure: Buffalo RuleProcedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibiaProcedure: Thompson TestProcedure: Palpation of the fibulaProcedure: Bernese Ankle RulesProcedure: Ottawa Ankle and Foot Rules + palpation of the cuboid boneProcedure: Ottawa Ankle and Foot Rules + palpation over the deltoid ligamentProcedure: Malleolar Zone AlgorithmProcedure: Low Risk ExamProcedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula
- Registration Number
- NCT01205841
- Lead Sponsor
- KU Leuven
- Brief Summary
Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.
- Detailed Description
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%.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- Pain due to blunt trauma to the ankle
- Must be at least 5 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Children Thompson Test Patients aged 5 to 15 years Adults Ottawa Ankle and Foot Rules Patients from 16 years of age onwards Children Palpation of the fibula Patients aged 5 to 15 years Adults Buffalo Rule Patients from 16 years of age onwards Adults Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia Patients from 16 years of age onwards Adults Thompson Test Patients from 16 years of age onwards Adults Palpation of the fibula Patients from 16 years of age onwards Adults Bernese Ankle Rules Patients from 16 years of age onwards Children Ottawa Ankle and Foot Rules Patients aged 5 to 15 years Children Buffalo Rule Patients aged 5 to 15 years Children Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia Patients aged 5 to 15 years Children Ottawa Ankle and Foot Rules + palpation of the cuboid bone Patients aged 5 to 15 years Children Ottawa Ankle and Foot Rules + palpation over the deltoid ligament Patients aged 5 to 15 years Children Malleolar Zone Algorithm Patients aged 5 to 15 years Children Low Risk Exam Patients aged 5 to 15 years Children Bernese Ankle Rules Patients aged 5 to 15 years Children Ottawa Ankle and Foot Rules + swelling of the distal fibula Patients aged 5 to 15 years
- Primary Outcome Measures
Name Time Method Sensitivity for detection of significant fractures At the first visit to the emergency department * 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.Specificity for detection of significant fractures At the first visit to the emergency department * 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.
- Secondary Outcome Measures
Name Time Method Prevalence of proximal fibula fractures in ankle trauma At the first visit to the emergency department The prevalence of proximal fibula fractures in ankle trauma has, to the best of our knowledge, not yet been quantified.
Prevalence of gastrocnemius tendon rupture in ankle trauma At the first visit to the emergency department The prevalence of gastrocnemius tendon rupture in ankle trauma has, to the best of our knowledge, not yet been quantified.
Trial Locations
- Locations (1)
Emergency Department of the University Hospitals, Catholic University Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium