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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary:

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%.


Sponsor: Katholieke Universiteit Leuven

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Katholieke Universiteit Leuven

Dates:
Date Received: September 20, 2010
Date Started: September 2010
Date Completion: August 2012
Last Updated: September 20, 2010
Last Verified: September 2010