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

Primary Purpose

Ankle Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ottawa Ankle and Foot Rules
Buffalo Rule
Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia
Thompson Test
Palpation of the fibula
Ottawa Ankle and Foot Rules + palpation of the cuboid bone
Ottawa Ankle and Foot Rules + palpation over the deltoid ligament
Malleolar Zone Algorithm
Low Risk Exam
Bernese Ankle Rules
Ottawa Ankle and Foot Rules + swelling of the distal fibula
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankle Injuries focused on measuring 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

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emergency Department of the University Hospitals, Catholic University Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adults

Children

Arm Description

Patients from 16 years of age onwards

Patients aged 5 to 15 years

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 20, 2010
Last Updated
September 20, 2010
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01205841
Brief Title
A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
Acronym
LEFO
Official Title
A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults
Arm Type
Experimental
Arm Description
Patients from 16 years of age onwards
Arm Title
Children
Arm Type
Experimental
Arm Description
Patients aged 5 to 15 years
Intervention Type
Procedure
Intervention Name(s)
Ottawa Ankle and Foot Rules
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Buffalo Rule
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Thompson Test
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Palpation of the fibula
Intervention Description
Palpation of the fibula over its entire length.
Intervention Type
Procedure
Intervention Name(s)
Ottawa Ankle and Foot Rules + palpation of the cuboid bone
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Ottawa Ankle and Foot Rules + palpation over the deltoid ligament
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Malleolar Zone Algorithm
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Low Risk Exam
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Bernese Ankle Rules
Intervention Description
As previously published
Intervention Type
Procedure
Intervention Name(s)
Ottawa Ankle and Foot Rules + swelling of the distal fibula
Intervention Description
As previously published
Primary Outcome Measure Information:
Title
Sensitivity for detection of significant fractures
Description
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.
Time Frame
At the first visit to the emergency department
Title
Specificity for detection of significant fractures
Description
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.
Time Frame
At the first visit to the emergency department
Secondary Outcome Measure Information:
Title
Prevalence of proximal fibula fractures in ankle trauma
Description
The prevalence of proximal fibula fractures in ankle trauma has, to the best of our knowledge, not yet been quantified.
Time Frame
At the first visit to the emergency department
Title
Prevalence of gastrocnemius tendon rupture in ankle trauma
Description
The prevalence of gastrocnemius tendon rupture in ankle trauma has, to the best of our knowledge, not yet been quantified.
Time Frame
At the first visit to the emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitri Vandoninck, MD
Phone
+32 479 744 845
Email
dimitri_vandoninck@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Sabbe, MD, PhD
Phone
+32 16 343927
Email
marc.sabbe@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Vandoninck, MD
Organizational Affiliation
Emergency Department of the University Hospitals, Catholic University Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Sabbe, MD, PhD
Organizational Affiliation
Emergency Department of the University Hospitals, Catholic University Leuven
Official's Role
Study Director
Facility Information:
Facility Name
Emergency Department of the University Hospitals, Catholic University Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Sabbe, MD, PhD
Phone
+32 16 343927
Email
marc.sabbe@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Lea Van Roelen
Phone
+32 16 343927
Email
lea.vanroelen@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Marc Sabbe, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dimitri Vandoninck, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16385314
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.
Results Reference
background
PubMed Identifier
16988308
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.
Results Reference
background
PubMed Identifier
11782648
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.
Results Reference
background
PubMed Identifier
1554175
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.
Results Reference
background
PubMed Identifier
15231460
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.
Results Reference
background
PubMed Identifier
11784626
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.
Results Reference
background
PubMed Identifier
12698029
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.
Results Reference
background

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

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