A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma (LEFO)
Recruitment status was Not yet recruiting
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Purpose
Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.
| Condition | Intervention |
|---|---|
|
Ankle Injuries |
Procedure: Ottawa Ankle and Foot Rules Procedure: Buffalo Rule Procedure: Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia Procedure: Thompson Test Procedure: Palpation of the fibula Procedure: Ottawa Ankle and Foot Rules + palpation of the cuboid bone Procedure: Ottawa Ankle and Foot Rules + palpation over the deltoid ligament Procedure: Malleolar Zone Algorithm Procedure: Low Risk Exam Procedure: Bernese Ankle Rules Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma |
- Sensitivity for detection of significant fractures [ Time Frame: At the first visit to the emergency department ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: At the first visit to the emergency department ] [ Designated as safety issue: No ]
- 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.
- Prevalence of proximal fibula fractures in ankle trauma [ Time Frame: At the first visit to the emergency department ] [ Designated as safety issue: No ]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 [ Time Frame: At the first visit to the emergency department ] [ Designated as safety issue: No ]The prevalence of gastrocnemius tendon rupture in ankle trauma has, to the best of our knowledge, not yet been quantified.
| Estimated Enrollment: | 1500 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Adults
Patients from 16 years of age onwards
|
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: Bernese Ankle Rules
As previously published
|
|
Experimental: Children
Patients aged 5 to 15 years
|
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
|
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%.
Eligibility| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Dimitri Vandoninck, MD | +32 479 744 845 | dimitri_vandoninck@yahoo.com |
| Contact: Marc Sabbe, MD, PhD | +32 16 343927 | marc.sabbe@uzleuven.be |
| Belgium | |
| Emergency Department of the University Hospitals, Catholic University Leuven | Not yet recruiting |
| Leuven, Vlaams-Brabant, Belgium, 3000 | |
| Contact: Marc Sabbe, MD, PhD +32 16 343927 marc.sabbe@uzleuven.be | |
| Contact: Lea Van Roelen +32 16 343927 lea.vanroelen@uzleuven.be | |
| Principal Investigator: Marc Sabbe, MD, PhD | |
| Sub-Investigator: Dimitri Vandoninck, MD | |
| Principal Investigator: | Dimitri Vandoninck, MD | Emergency Department of the University Hospitals, Catholic University Leuven |
| Study Director: | Marc Sabbe, MD, PhD | Emergency Department of the University Hospitals, Catholic University Leuven |
More Information
Publications:
| Responsible Party: | Dimitri Vandoninck MD, Emergency Department of the University Hospitals, Catholic University Leuven |
| ClinicalTrials.gov Identifier: | NCT01205841 History of Changes |
| Other Study ID Numbers: | S52510 |
| Study First Received: | September 20, 2010 |
| Last Updated: | September 20, 2010 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Katholieke Universiteit Leuven:
|
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 |
Additional relevant MeSH terms:
|
Ankle Injuries Leg Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013