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

Ankle Injuries Clinical Trial

— LEFO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01205841
• Other study ID #: S52510
• Status: Not yet recruiting
• Phase: N/A
• First received: September 20, 2010
• Last updated: September 20, 2010
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2010
• Source: Katholieke Universiteit Leuven
• Contact: Dimitri Vandoninck, MD
• Phone: +32 479 744 845
• Email: dimitri_vandoninck[@]yahoo.com
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ankle Injuries

Intervention

Procedure:
• Ottawa Ankle and Foot Rules
As previously published
• Buffalo Rule
As previously published
• Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia
As previously published
• Thompson Test
As previously published
• Palpation of the fibula
Palpation of the fibula over its entire length.
• Ottawa Ankle and Foot Rules + palpation of the cuboid bone
As previously published
• Ottawa Ankle and Foot Rules + palpation over the deltoid ligament
As previously published
• Malleolar Zone Algorithm
As previously published
• Low Risk Exam
As previously published
• Bernese Ankle Rules
As previously published
• Ottawa Ankle and Foot Rules + swelling of the distal fibula
As previously published

Locations

Country	Name	City	State
Belgium	Emergency Department of the University Hospitals, Catholic University Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

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. — View Citation

Clark KD, Tanner S. Evaluation of the Ottawa ankle rules in children. Pediatr Emerg Care. 2003 Apr;19(2):73-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	No
Secondary	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	No