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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01205841
Acronym
LEFO
Enrollment
1500
Registered
2010-09-21
Start date
2010-09-30
Completion date
2012-08-31
Last updated
2010-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries

Keywords

Ottawa Ankle and Foot Rules, Buffalo Rule, Bernese Ankle Rules, Low Risk Exam, Malleolar Zone Algorithm, Clinical decision rule, Ankle injury, Ankle sprain, Inversion trauma

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%.

Interventions

PROCEDUREOttawa Ankle and Foot Rules

As previously published

PROCEDUREBuffalo Rule

As previously published

PROCEDUREOttawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia

As previously published

PROCEDUREThompson Test

As previously published

PROCEDUREPalpation of the fibula

Palpation of the fibula over its entire length.

PROCEDUREOttawa Ankle and Foot Rules + palpation of the cuboid bone

As previously published

PROCEDUREOttawa Ankle and Foot Rules + palpation over the deltoid ligament

As previously published

PROCEDUREMalleolar Zone Algorithm

As previously published

PROCEDURELow Risk Exam

As previously published

PROCEDUREBernese Ankle Rules

As previously published

PROCEDUREOttawa Ankle and Foot Rules + swelling of the distal fibula

As previously published

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity for detection of significant fracturesAt 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 fracturesAt 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

MeasureTime frameDescription
Prevalence of proximal fibula fractures in ankle traumaAt the first visit to the emergency departmentThe 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 traumaAt the first visit to the emergency departmentThe prevalence of gastrocnemius tendon rupture in ankle trauma has, to the best of our knowledge, not yet been quantified.

Countries

Belgium

Contacts

Primary ContactDimitri Vandoninck, MD
dimitri_vandoninck@yahoo.com+32 479 744 845
Backup ContactMarc Sabbe, MD, PhD
marc.sabbe@uzleuven.be+32 16 343927

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026