Clinical trial NCT01205841: A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
Official title: A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Injuries
Keywords: 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
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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 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

Primary outcomes:
measure: Sensitivity for detection of significant fractures
timeFrame: At the first visit to the emergency department
measure: Specificity for detection of significant fractures
timeFrame: At the first visit to the emergency department
Secondary outcomes:
measure: Prevalence of proximal fibula fractures in ankle trauma
timeFrame: At the first visit to the emergency department
measure: Prevalence of gastrocnemius tendon rupture in ankle trauma
timeFrame: At the first visit to the emergency department
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Emergency Department of the University Hospitals, Catholic University Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Emergency Department of the University Hospitals, Catholic University Leuven
name: Dimitri Vandoninck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department of the University Hospitals, Catholic University Leuven
name: Marc Sabbe, MD, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1097/01.ta.0000196436.95569.a3.
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. doi: 10.1136/emj.2006.035519.
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. doi: 10.1097/00005768-200201000-00010.
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. doi: 10.1016/s0196-0644(05)82656-3.
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. doi: 10.1197/j.aem.2004.02.517.
citation: 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.
citation: 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.