NCT01205841

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Ankle Injuries

Interventions

Type	Name	Description
PROCEDURE	Ottawa Ankle and Foot Rules	As previously published
PROCEDURE	Buffalo Rule	As previously published
PROCEDURE	Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia	As previously published
PROCEDURE	Thompson Test	As previously published
PROCEDURE	Palpation of the fibula	Palpation of the fibula over its entire length.
PROCEDURE	Ottawa Ankle and Foot Rules + palpation of the cuboid bone	As previously published
PROCEDURE	Ottawa Ankle and Foot Rules + palpation over the deltoid ligament	As previously published
PROCEDURE	Malleolar Zone Algorithm	As previously published
PROCEDURE	Low Risk Exam	As previously published
PROCEDURE	Bernese Ankle Rules	As previously published
PROCEDURE	Ottawa Ankle and Foot Rules + swelling of the distal fibula	As previously published

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-09-21
• Last updated: 2010-09-21

Locations

1 site across 1 country: Belgium