Ankle Injuries Clinical Trial
Official title:
A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
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%.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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