Ankle InjuryNCT00785876
Implementation of the Low Risk Ankle Rule
A study testing LRAR Implementation in people with Ankle Injury, run by The Hospital for Sick Children at 4 sites in Canada.
Trial summary
Ankle injuries are a very common injury in children. Each year approximately 35000 kids present to Ontario emergency departments (ED) with this problem. Right now, about 90% of these children get x-rays of the injured ankle, even though only 12% of these x-rays show a break in the bone. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Ankle Injury
- What is being tested?
- LRAR Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2008to Nov 2011
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All otherwise healthy children between the ages of 3 and 16 years of age that present to the participating EDs with an isolated acute (< 72 hours) blunt ankle injury due to any mechanism of injury will be eligible for the study. The age criteria were chosen to match those ages in which the LRAR was validated.
Who cannot join
- Children with ankle injuries who were referred from outside the hospital with radiographs.
- Children with ankle injuries who returned for reassessment of the same ankle injury.
- Children with open wounds on their ankle and/or foot
- All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease (Appendix I). Clinical presentation and risks in these cases may be altered.
- Congenital anomalies of the feet and/or ankles (eg club feet, tarsal coalition). These abnormalities may have features which may complicate clinical assessment.
- Patients with known coagulopathies. Underlying hemarthrosis may complicate clinical assessment.
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- Patients with cognitive and/or developmental delay. These patients may not localize pain.
- Injuries greater than 72 hours old. The signs and symptoms of the most common fracture, the Salter-Harris I fracture of the distal fibula, may be diminished. Our ability to make this clinical diagnosis with confidence may thus be compromised.
- Recent history of surgery or closed reduction of the same ankle within the last 3 months. These prior events may confuse current presenting symptomatology and ability to weight-bear and recover normally.
- Patients with low risk injuries who do not have phone or electronic mail access and/or have an insurmountable language barrier. This will preclude follow up.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Children's Hospital of Eastern Ontario
Ottawa, Ontario
North York General Hospital
Toronto, Ontario
The Hospital for Sick Children
Toronto, Ontario
Toronto East General Hospital
Toronto, Ontario
About this study
Official title: Controlled Radiography for Ankle Injury Cases in Kids in the Emergency Department: Implementation of the Low Risk Ankle Rule
Ankle injuries are a very common injury in children. Each year approximately 35000 kids present to Ontario emergency departments (ED) with this problem. Right now, about 90% of these children get x-rays of the injured ankle, even though only 12% of these x-rays show a break in the bone. Some excellent research has created some rules that doctors can use to help them decide which children really need x-rays. Unfortunately, even though these rules have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using these rules.
Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If we show that doctors can safely use this rule regularly and the number of ankle x-rays will be significantly less, this will lessen unnecessary potentially harmful radiation exposure in children, these children will spend less time in an ED, and the health care system will save money.
- Conditions
- Ankle Injury
- Being tested
- LRAR Implementation
- Keywords
- Paediatric, Emergency Department, Ankle, Injury, Low risk ankle rule
- Medical subject headings
- Ankle Injuries, Emergencies, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LRAR ImplementationOther
Pre-LRAR - no changes in the usual procedures for the first 26 weeks except for flagging of all paediatric charts with ankle injuries, ED documentation which will not refer to the LRAR and phone follow up.
Post-LRAR: At 27 weeks, in addition to the aforementioned ED collection sheet and phone follow up, the implementation strategy for the LRAR rule and related management will be introduced at the intervention hospitals.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control Sites |
| 2 | Experimental | Intervention Sites Receives: Other: LRAR Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of a LRAR implementation strategy on paediatric ankle radiography rates in participating EDS.
Measured: three six month phases of implementation
Secondary outcomes (5)
Ankle x-ray rate changes at individual hospital from pre-LRAR to post-LRAR implementation phases.
Measured: duration of subjects participation in study
Intervention and control sites will be compared individually and collectively, during the post-LRAR for: missed significant fractures, number of unscheduled x-rays following initial ED visit, total length of stay, patient and physician satisfaction
Measured: duration of subjects participation in study
To determine the sustainability of the clinical impact of the LRAR strategy at intervention sites by comparing high and low intensity implementation phases with respect to weekly x-ray rates, missed fractures and physician and patient satisfaction
Measured: duration of subjects participation in study
To evaluate the performance of the LRAR during the implementation period of the rule at intervention sites with respect to: sensitivity and specificity of the LRAR for detecting "high risk" fractures and physician compliance with use of the rule
Measured: duration of subjects participation in study
To compare total costs of "low risk injuries" at intervention versus control sites during the post-LRAR implementation phase.
Measured: duration of subjects participation in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuryStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathy Boutis, The Hospital for Sick Children
- Investigators
- Kathy Boutis, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785876
- Sponsor's protocol ID
- 1000012792
- Status last verified
- Oct 2017
- First submitted
- 4 Nov 2008
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Boutis K, Grootendorst P, Willan A, Plint AC, Babyn P, Brison RJ, Sayal A, Parker M, Mamen N, Schuh S, Grimshaw J, Johnson D, Narayanan U. Effect of the Low Risk Ankle Rule on the frequency of radiography in children with ankle injuries. CMAJ. 2013 Oct 15;185(15):E731-8. doi: 10.1503/cmaj.122050. Epub 2013 Aug 12.
PubMed 23939215Boutis K, von Keyserlingk C, Willan A, Narayanan UG, Brison R, Grootendorst P, Plint AC, Parker M, Goeree R. Cost Consequence Analysis of Implementing the Low Risk Ankle Rule in Emergency Departments. Ann Emerg Med. 2015 Nov;66(5):455-463.e4. doi: 10.1016/j.annemergmed.2015.05.027. Epub 2015 Jul 14.
PubMed 26187612
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Radiography for Ankle Injury Cases in Kids in the Emergency Department: Implementation of the Low Risk Ankle Rule
- ClinicalTrials.gov ID
- NCT00785876
- Acronym / sponsor ID
- 1000012792
- Conditions
- Ankle Injury
- Keywords
- Paediatric, Emergency Department, Ankle, Injury, Low risk ankle rule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Nov 2008 (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.
Ankle injuries are a very common injury in children. Each year approximately 35000 kids present to Ontario emergency departments (ED) with this problem. Right now, about 90% of these children get x-rays of the injured ankle, even though only 12% of these x-rays show a break in the bone. Some excellent research has created some rules that doctors can use to help them decide which children really need x-rays. Unfortunately, even though these rules have been proven to safely reduce x-rays by as much as two-thirds, most doctors are not using these rules.
Therefore, this study will be the first to put the best paediatric ankle x-ray rule, the Low Rick Ankle Rule, into physician practice in EDs. Our main goal is to determine how much we can reduce ankle x-ray rates in EDs that use this rule regularly versus those that do not. If we show that doctors can safely use this rule regularly and the number of ankle x-rays will be significantly less, this will lessen unnecessary potentially harmful radiation exposure in children, these children will spend less time in an ED, and the health care system will save money.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control Sites |
| 2 | Experimental | Other: LRAR ImplementationIntervention Sites |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All otherwise healthy children between the ages of 3 and 16 years of age that present to the participating EDs with an isolated acute (< 72 hours) blunt ankle injury due to any mechanism of injury will be eligible for the study. The age criteria were chosen to match those ages in which the LRAR was validated.
Key exclusion criteria (10 listed)
- Children with ankle injuries who were referred from outside the hospital with radiographs.
- Children with ankle injuries who returned for reassessment of the same ankle injury.
- Children with open wounds on their ankle and/or foot
- All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease (Appendix I). Clinical presentation and risks in these cases may be altered.
- Congenital anomalies of the feet and/or ankles (eg club feet, tarsal coalition). These abnormalities may have features which may complicate clinical assessment.
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 |
|---|---|---|
| LRAR ImplementationPre-LRAR - no changes in the usual procedures for the first 26 weeks except for flagging of all paediatric charts with ankle injuries, ED documentation which will not refer to the LRAR and phone follow up. Post-LRAR: At 27 weeks, in addition to the aforementioned ED collection sheet and phone follow up, the implementation strategy for the LRAR rule and related management will be introduced at the intervention hospitals. | Other | 2 |
Primary outcome
To assess the impact of a LRAR implementation strategy on paediatric ankle radiography rates in participating EDS.
Time frame: three six month phases of implementation
5 secondary outcomes
Ankle x-ray rate changes at individual hospital from pre-LRAR to post-LRAR implementation phases.
Time frame: duration of subjects participation in study
Intervention and control sites will be compared individually and collectively, during the post-LRAR for: missed significant fractures, number of unscheduled x-rays following initial ED visit, total length of stay, patient and physician satisfaction
Time frame: duration of subjects participation in study
To determine the sustainability of the clinical impact of the LRAR strategy at intervention sites by comparing high and low intensity implementation phases with respect to weekly x-ray rates, missed fractures and physician and patient satisfaction
Time frame: duration of subjects participation in study
To evaluate the performance of the LRAR during the implementation period of the rule at intervention sites with respect to: sensitivity and specificity of the LRAR for detecting "high risk" fractures and physician compliance with use of the rule
Time frame: duration of subjects participation in study
To compare total costs of "low risk injuries" at intervention versus control sites during the post-LRAR implementation phase.
Time frame: duration of subjects participation in study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Results publication: PubMed 23939215Boutis K, Grootendorst P, Willan A, Plint AC, Babyn P, Brison RJ, Sayal A, Parker M, Mamen N, Schuh S, Grimshaw J, Johnson D, Narayanan U. Effect of the Low Risk Ankle Rule on the frequency of radiography in children with ankle injuries. CMAJ. 2013 Oct 15;185(15):E731-8. doi: 10.1503/cmaj.122050. Epub 2013 Aug 12.
- Results publication: PubMed 26187612Boutis K, von Keyserlingk C, Willan A, Narayanan UG, Brison R, Grootendorst P, Plint AC, Parker M, Goeree R. Cost Consequence Analysis of Implementing the Low Risk Ankle Rule in Emergency Departments. Ann Emerg Med. 2015 Nov;66(5):455-463.e4. doi: 10.1016/j.annemergmed.2015.05.027. Epub 2015 Jul 14.
- Link to Abstract: : Ann Emerg Med. 2015 Nov;66(5):455-Link provided by the sponsor.
- Link to Abstract: Effect of the Low Risk Ankle Rule on the frequency of radiography in children with ankle injuries.Link provided by the sponsor.
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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.
Kathy Boutis, MD principal investigator
The Hospital for Sick Children
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LRAR Implementation in people with Ankle Injury, run by The Hospital for Sick Children at 4 sites in Canada.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the impact of a LRAR implementation strategy on paediatric ankle radiography rates in participating EDS. (time frame: three six month phases of implementation). 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 NCT00785876, which also lists 2 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 9 Oct 2017.