A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
NCT ID: NCT01205841
Last Updated: 2010-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1500 participants
INTERVENTIONAL
2010-09-30
2012-08-31
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Adults
Patients from 16 years of age onwards
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.
Bernese Ankle Rules
As previously published
Children
Patients aged 5 to 15 years
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Must be at least 5 years old
Exclusion Criteria
* 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
5 Years
ALL
No
Sponsors
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KU Leuven
OTHER
Responsible Party
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Emergency Department of the University Hospitals, Catholic University Leuven
Principal Investigators
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Dimitri Vandoninck, MD
Role: PRINCIPAL_INVESTIGATOR
Emergency Department of the University Hospitals, Catholic University Leuven
Marc Sabbe, MD, PhD
Role: STUDY_DIRECTOR
Emergency Department of the University Hospitals, Catholic University Leuven
Locations
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Emergency Department of the University Hospitals, Catholic University Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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S52510
Identifier Type: -
Identifier Source: org_study_id