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

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Ankle Injuries

Treatments: Procedure: Malleolar Zone Algorithm; Procedure: Thompson Test; Procedure: Ottawa Ankle and Foot Rules + palpation of the cuboid bone; Procedure: Low Risk Exam; Procedure: Bernese Ankle Rules; Procedure: Ottawa Ankle and Foot Rules; Procedure: Ottawa Ankle and Foot Rules + palpation over the deltoid ligament; Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia; Procedure: Buffalo Rule; Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula; Procedure: Palpation of the fibula

Study type: Interventional

Funder types: Other

Identifiers

NCT01205841

S52510

Details and patient eligibility

About

Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.

Full 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%.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Adults

Experimental group

Description:

Patients from 16 years of age onwards

Treatment:

Procedure: Thompson Test

Procedure: Bernese Ankle Rules

Procedure: Buffalo Rule

Procedure: Palpation of the fibula

Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia

Procedure: Ottawa Ankle and Foot Rules

Children

Experimental group

Description:

Patients aged 5 to 15 years

Treatment:

Procedure: Malleolar Zone Algorithm

Procedure: Thompson Test

Procedure: Low Risk Exam

Procedure: Bernese Ankle Rules

Procedure: Ottawa Ankle and Foot Rules + palpation over the deltoid ligament

Procedure: Buffalo Rule

Procedure: Ottawa Ankle and Foot Rules + palpation of the cuboid bone

Procedure: Palpation of the fibula

Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia

Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula

Procedure: Ottawa Ankle and Foot Rules