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

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

Study Overview

• Status: Unknown
• Conditions: Ankle Injuries
• Intervention / Treatment: 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; 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: Ottawa Ankle and Foot Rules + swelling of the distal fibula

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%.

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Emergency Department of the University Hospitals, Catholic University Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Bernese Ankle Rules; As previously published; 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: Ottawa Ankle and Foot Rules + swelling of the distal fibula; As previously published

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for detection of significant fractures	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.	At the first visit to the emergency department
Specificity for detection of significant fractures	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.	At the first visit to the emergency department

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of proximal fibula fractures in ankle trauma	The prevalence of proximal fibula fractures in ankle trauma has, to the best of our knowledge, not yet been quantified.	At the first visit to the emergency department
Prevalence of gastrocnemius tendon rupture in ankle trauma	The prevalence of gastrocnemius tendon rupture in ankle trauma has, to the best of our knowledge, not yet been quantified.	At the first visit to the emergency department

Collaborators and Investigators

• Sponsor: KU 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

Publications and helpful links

General Publications

• Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Worthington JR. A study to develop clinical decision rules for the use of radiography in acute ankle injuries. Ann Emerg Med. 1992 Apr;21(4):384-90. doi: 10.1016/s0196-0644(05)82656-3.
• Eggli S, Sclabas GM, Eggli S, Zimmermann H, Exadaktylos AK. The Bernese ankle rules: a fast, reliable test after low-energy, supination-type malleolar and midfoot trauma. J Trauma. 2005 Nov;59(5):1268-71. doi: 10.1097/01.ta.0000196436.95569.a3.
• Dissmann PD, Han KH. The tuning fork test--a useful tool for improving specificity in "Ottawa positive" patients after ankle inversion injury. Emerg Med J. 2006 Oct;23(10):788-90. doi: 10.1136/emj.2006.035519.
• Leddy JJ, Kesari A, Smolinski RJ. Implementation of the Ottawa ankle rule in a university sports medicine center. Med Sci Sports Exerc. 2002 Jan;34(1):57-62. doi: 10.1097/00005768-200201000-00010.
• Dayan PS, Vitale M, Langsam DJ, Ruzal-Shapiro C, Novick MK, Kuppermann N, Miller SZ. Derivation of clinical prediction rules to identify children with fractures after twisting injuries of the ankle. Acad Emerg Med. 2004 Jul;11(7):736-43. doi: 10.1197/j.aem.2004.02.517.
• Boutis K, Komar L, Jaramillo D, Babyn P, Alman B, Snyder B, Mandl KD, Schuh S. Sensitivity of a clinical examination to predict need for radiography in children with ankle injuries: a prospective study. Lancet. 2001 Dec 22-29;358(9299):2118-21. doi: 10.1016/S0140-6736(01)07218-X.
• Clark KD, Tanner S. Evaluation of the Ottawa ankle rules in children. Pediatr Emerg Care. 2003 Apr;19(2):73-8. doi: 10.1097/00006565-200304000-00003.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: September 20, 2010
• First Submitted That Met QC Criteria: September 20, 2010
• First Posted (Estimate): September 21, 2010

Study Record Updates

• Last Update Posted (Estimate): September 21, 2010
• Last Update Submitted That Met QC Criteria: September 20, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Ankle sprain; Clinical decision rule; Ottawa Ankle and Foot Rules; Buffalo Rule; Bernese Ankle Rules; Low Risk Exam; Malleolar Zone Algorithm; Ankle injury; Inversion trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: S52510