An interventional study of Ottawa Ankle and Foot Rules and Buffalo Rule in Ankle Injuries, sponsored by KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2010-09-21.
Sponsored by KU Leuven · Not applicable, Interventional, and Diagnostic
Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.
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%.
352 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 56 across 273 interventional studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →KU Leuven is the lead sponsor of 359 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients from 16 years of age onwards
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: Bernese Ankle Rules
Patients aged 5 to 15 years
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
As previously published
As previously published
As previously published
As previously published
Palpation of the fibula over its entire length.
As previously published
As previously published
As previously published
As previously published
As previously published
As previously published
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.
Time frame: 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.
Time frame: At the first visit to the emergency department
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.
Time frame: 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.
Time frame: At the first visit to the emergency department
This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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