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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Katholieke Universiteit Leuven.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205841
First Posted: September 21, 2010
Last Update Posted: September 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Katholieke Universiteit Leuven
September 20, 2010
September 21, 2010
September 21, 2010
September 2010
August 2012   (Final data collection date for primary outcome measure)
  • Sensitivity for detection of significant fractures [ Time Frame: 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 [ Time Frame: 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.
Same as current
No Changes Posted
  • Prevalence of proximal fibula fractures in ankle trauma [ Time Frame: 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 [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
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
Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.

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%.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Ankle Injuries
  • 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
  • Experimental: Adults
    Patients from 16 years of age onwards
    Interventions:
    • 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: Bernese Ankle Rules
  • Experimental: Children
    Patients aged 5 to 15 years
    Interventions:
    • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1500
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01205841
S52510
No
Not Provided
Not Provided
Dimitri Vandoninck MD, Emergency Department of the University Hospitals, Catholic University Leuven
Katholieke Universiteit Leuven
Not Provided
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
Katholieke Universiteit Leuven
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP