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

Not Applicable

• Conditions: Ankle Injuries

• 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%.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Last Update Submitted: 2010-09-20
• Study First Posted: 2010-09-21
• Last Update Posted: 2010-09-21
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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