Ankle InjuriesLEFONCT01205841
A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
A study testing Ottawa Ankle and Foot Rules, Buffalo Rule and Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia in people with Ankle Injuries, run by KU Leuven at 1 site in Belgium.
Trial summary
Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Ottawa Ankle and Foot Rules, Buffalo Rule and Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pain due to blunt trauma to the ankle
- Must be at least 5 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Emergency Department of the University Hospitals, Catholic University Leuven
Leuven, Vlaams-Brabant, 3000
Marc Sabbe, MD, PhD, +32 16 343927, marc.sabbe@uzleuven.be
Lea Van Roelen, +32 16 343927, lea.vanroelen@uzleuven.be
About this study
Comparison of the reliability of different examination techniques to detect fractures in patients with ankle trauma.
Read the 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%.
- Conditions
- Ankle Injuries
- Being tested
- 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
- 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
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ottawa Ankle and Foot RulesProcedure or surgery
As previously published
Buffalo RuleProcedure or surgery
As previously published
Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibiaProcedure or surgery
As previously published
Thompson TestProcedure or surgery
As previously published
Palpation of the fibulaProcedure or surgery
Palpation of the fibula over its entire length.
Ottawa Ankle and Foot Rules + palpation of the cuboid boneProcedure or surgery
As previously published
Ottawa Ankle and Foot Rules + palpation over the deltoid ligamentProcedure or surgery
As previously published
Malleolar Zone AlgorithmProcedure or surgery
As previously published
Low Risk ExamProcedure or surgery
As previously published
Bernese Ankle RulesProcedure or surgery
As previously published
Ottawa Ankle and Foot Rules + swelling of the distal fibulaProcedure or surgery
As previously published
| Study group | Role | What they receive |
|---|---|---|
| Adults | Experimental | Patients from 16 years of age onwards Receives: 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 |
| Children | Experimental | Patients aged 5 to 15 years Receives: 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: 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: Bernese Ankle Rules; Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the first visit to the emergency department
Secondary outcomes (2)
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.
Measured: 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.
Measured: At the first visit to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Dimitri Vandoninck, MD, Principal investigator, Emergency Department of the University Hospitals, Catholic University LeuvenMarc Sabbe, MD, PhD, Study director, Emergency Department of the University Hospitals, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205841
- Sponsor's protocol ID
- S52510
- Acronym
- LEFO
- Status last verified
- Sep 2010
- First submitted
- 20 Sep 2010
- Last updated
- 21 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16385314Dissmann 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.
PubMed 16988308Leddy 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.
PubMed 11782648Stiell 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.
PubMed 1554175Dayan 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.
PubMed 15231460Boutis 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.
PubMed 11784626Clark 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.
PubMed 12698029
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Different Clinical Decision Rules in Adult and Pediatric Ankle Trauma
- ClinicalTrials.gov ID
- NCT01205841
- Acronym / sponsor ID
- LEFO / S52510
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | Experimental | 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 RulesPatients from 16 years of age onwards |
| Children | Experimental | 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: 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: Bernese Ankle Rules, Procedure: Ottawa Ankle and Foot Rules + swelling of the distal fibulaPatients aged 5 to 15 years |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pain due to blunt trauma to the ankle
- Must be at least 5 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ottawa Ankle and Foot RulesAs previously published | Procedure or surgery | Adults, Children |
| Buffalo RuleAs previously published | Procedure or surgery | Adults, Children |
| Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibiaAs previously published | Procedure or surgery | Adults, Children |
| Thompson TestAs previously published | Procedure or surgery | Adults, Children |
| Palpation of the fibulaPalpation of the fibula over its entire length. | Procedure or surgery | Adults, Children |
| Ottawa Ankle and Foot Rules + palpation of the cuboid boneAs previously published | Procedure or surgery | Children |
| Ottawa Ankle and Foot Rules + palpation over the deltoid ligamentAs previously published | Procedure or surgery | Children |
| Malleolar Zone AlgorithmAs previously published | Procedure or surgery | Children |
| Low Risk ExamAs previously published | Procedure or surgery | Children |
| Bernese Ankle RulesAs previously published | Procedure or surgery | Adults, Children |
| Ottawa Ankle and Foot Rules + swelling of the distal fibulaAs previously published | Procedure or surgery | Children |
Primary outcome
Sensitivity for detection of significant fractures
Time frame: At the first visit to the emergency department
* 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
Time frame: At the first visit to the emergency department
* 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.
2 secondary outcomes
Prevalence of proximal fibula fractures in ankle trauma
Time frame: At the first visit to the emergency department
Prevalence of gastrocnemius tendon rupture in ankle trauma
Time frame: At the first visit to the emergency department
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
- Background: PubMed 16385314Eggli 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.
- Background: PubMed 16988308Dissmann 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.
- Background: PubMed 11782648Leddy 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.
- Background: PubMed 1554175Stiell 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.
- Background: PubMed 15231460Dayan 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.
- Background: PubMed 11784626Boutis 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.
- Background: PubMed 12698029Clark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Vandoninck, MD principal investigator
Emergency Department of the University Hospitals, Catholic University Leuven
Marc Sabbe, MD, PhD study director
Emergency Department of the University Hospitals, Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ottawa Ankle and Foot Rules, Buffalo Rule and Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia in people with Ankle Injuries, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitri Vandoninck, MD (+32 479 744 845, dimitri_vandoninck@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for detection of significant fractures (time frame: At the first visit to the emergency department). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205841, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2010.