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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 because the information has not been verified recently.
Verified September 2010 by Katholieke Universiteit Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01205841
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205841

Contacts
Contact: Dimitri Vandoninck, MD +32 479 744 845 dimitri_vandoninck@yahoo.com
Contact: Marc Sabbe, MD, PhD +32 16 343927 marc.sabbe@uzleuven.be

Locations
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         
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
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
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 21, 2014