Ankle InjuriesOttawaNCT07912476
Electronic Decision Support for Ankle Injury X-Ray Assessment
A study testing Electronic Clinical Decision Support Alert in people with Ankle Injuries and Ankle Sprains, run by SPECHBACH Hervé at 1 site in Switzerland.
Trial summary
Ankle injuries are a common reason for emergency department visits. Although fractures are relatively uncommon, ankle and foot X-rays are frequently ordered to exclude them. The Ottawa Ankle Rules are clinical decision rules designed to help healthcare professionals identify patients who require radiographic imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Injuries, Ankle Sprains, Ankle Fractures
- What is being tested?
- Electronic Clinical Decision Support Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to 30 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Presentation to the Emergency Department of Geneva University Hospitals with ankle trauma.
- Presentation during the study period from 1 November 2021 to 30 April 2022.
Who cannot join
- Deep or superficial wounds.
- Burns.
- Nerve injury.
- Vascular injury.
- Presence of foreign bodies.
- Animal or insect bites.
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- Gross deformity or dislocation of the foot or ankle.
- Polytrauma.
- Unconscious patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Clinical Decision Support for the Radiological Assessment of Ankle Injuries Based on the Ottawa Ankle Rules: a Before-and-after Study
Ankle injuries are a common reason for emergency department visits. Although fractures are relatively uncommon, ankle and foot X-rays are frequently ordered to exclude them. The Ottawa Ankle Rules are clinical decision rules designed to help healthcare professionals identify patients who require radiographic imaging. This study evaluated whether an electronic pop-up reminder of the Ottawa Ankle Rules could reduce the number of ankle and foot X-rays prescribed in the emergency department. The study also assessed adherence to the Ottawa Ankle Rules and evaluated their diagnostic performance for identifying fractures.
Read the detailed description
Ankle injuries are a frequent cause of emergency department consultations and often result in radiographic examinations. Despite the low prevalence of fractures, many patients undergo ankle or foot X-rays, leading to unnecessary radiation exposure, increased waiting times, and additional healthcare costs. The Ottawa Ankle Rules (OAR) were developed as a clinical decision aid to safely reduce unnecessary imaging while maintaining a high sensitivity for fracture detection.
This before-and-after study evaluated the impact of an electronic clinical decision support intervention consisting of a pop-up alert reminding physicians of the Ottawa Ankle Rules when ordering imaging for ankle injuries in the emergency department. During the pre-intervention period, physicians followed standard clinical practice. During the intervention period, the electronic reminder was available during the imaging ordering process.
The primary objective was to assess the proportion of patients presenting to the emergency department with ankle trauma who underwent radiographic examination before and after implementation of the electronic alert. Secondary objectives included assessing and comparing the proportion of prescribed X-rays that met Ottawa Ankle Rules criteria before and after implementation of the intervention. The diagnostic performance of the Ottawa Ankle Rules was also evaluated by calculating sensitivity, specificity, and negative predictive value for fracture identification.
- Conditions
- Ankle Injuries, Ankle Sprains, Ankle Fractures
- Being tested
- Electronic Clinical Decision Support Alert
- Keywords
- Ottawa Ankle Rules, Clinical Decision Support, Electronic Alert, Emergency Department, Radiography
- Medical subject headings
- Ankle Injuries, Ankle Fractures, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Clinical Decision Support AlertBehavioural
An electronic clinical decision support pop-up alert integrated into the emergency department workflow. The alert reminded physicians to apply the Ottawa Ankle Rules when evaluating patients with ankle trauma and when considering ankle or foot radiography. The intervention was implemented during the post-intervention period (1 February 2022 to 30 April 2022) and was intended to reduce unnecessary imaging while maintaining appropriate fracture detection
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice (Pre-Intervention) | No intervention | Patients presenting with ankle trauma to the Emergency Department between 1 November 2021 and 31 January 2022. Physicians followed standard routine practice without an electronic clinical decision support alert based on the Ottawa Ankle Rules. |
| Electronic Alert Intervention (Post-Intervention) | Experimental | Patients presenting with ankle trauma to the Emergency Department between 1 February 2022 and 30 April 2022. Physicians were exposed to an electronic clinical decision support pop-up alert reminding them to apply the Ottawa Ankle Rules when assessing ankle injuries and ordering imaging. Receives: Behavioral: Electronic Clinical Decision Support Alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Receiving Ankle or Foot Radiography
Assessment of the proportion of patients presenting to the emergency department with ankle trauma who underwent ankle or foot radiography before and after implementation of the electronic clinical decision support alert based on the Ottawa Ankle Rules.
Measured: During the emergency department visit (up to 1 day)
Secondary outcomes (3)
Proportion of Radiographs Meeting Ottawa Ankle Rules Criteria
Proportion of prescribed ankle and foot radiographs that met Ottawa Ankle Rules criteria before and after implementation of the electronic clinical decision support alert.
Measured: During the emergency department visit (up to 1 day)
Sensitivity of the Ottawa Ankle Rules for Fracture Detection
Diagnostic sensitivity of the Ottawa Ankle Rules for identifying fractures among patients presenting with ankle trauma.
Measured: Up to 2 weeks after the emergency department visit
Specificity and Negative Predictive Value of the Ottawa Ankle Rules
Diagnostic specificity and negative predictive value of the Ottawa Ankle Rules for excluding fractures among patients presenting with ankle trauma.
Measured: Up to 2 weeks after the emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPECHBACH Hervé
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, SPECHBACH Hervé, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912476
- Sponsor's protocol ID
- 2021-01629
- Acronym
- Ottawa
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Clinical Decision Support for the Radiological Assessment of Ankle Injuries Based on the Ottawa Ankle Rules: a Before-and-after Study
- ClinicalTrials.gov ID
- NCT07912476
- Acronym / sponsor ID
- Ottawa / 2021-01629
- Conditions
- Ankle Injuries, Ankle Sprains, Ankle Fractures
- Keywords
- Ottawa Ankle Rules, Clinical Decision Support, Electronic Alert, Emergency Department, Radiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- SPECHBACH HervéUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 3 Nov 2026 (actual)
- 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 common reason for emergency department visits. Although fractures are relatively uncommon, ankle and foot X-rays are frequently ordered to exclude them. The Ottawa Ankle Rules are clinical decision rules designed to help healthcare professionals identify patients who require radiographic imaging. This study evaluated whether an electronic pop-up reminder of the Ottawa Ankle Rules could reduce the number of ankle and foot X-rays prescribed in the emergency department. The study also assessed adherence to the Ottawa Ankle Rules and evaluated their diagnostic performance for identifying fractures.
Detailed description
Ankle injuries are a frequent cause of emergency department consultations and often result in radiographic examinations. Despite the low prevalence of fractures, many patients undergo ankle or foot X-rays, leading to unnecessary radiation exposure, increased waiting times, and additional healthcare costs. The Ottawa Ankle Rules (OAR) were developed as a clinical decision aid to safely reduce unnecessary imaging while maintaining a high sensitivity for fracture detection.
This before-and-after study evaluated the impact of an electronic clinical decision support intervention consisting of a pop-up alert reminding physicians of the Ottawa Ankle Rules when ordering imaging for ankle injuries in the emergency department. During the pre-intervention period, physicians followed standard clinical practice. During the intervention period, the electronic reminder was available during the imaging ordering process.
The primary objective was to assess the proportion of patients presenting to the emergency department with ankle trauma who underwent radiographic examination before and after implementation of the electronic alert. Secondary objectives included assessing and comparing the proportion of prescribed X-rays that met Ottawa Ankle Rules criteria before and after implementation of the intervention. The diagnostic performance of the Ottawa Ankle Rules was also evaluated by calculating sensitivity, specificity, and negative predictive value for fracture identification.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Practice (Pre-Intervention) | No intervention | –Patients presenting with ankle trauma to the Emergency Department between 1 November 2021 and 31 January 2022. Physicians followed standard routine practice without an electronic clinical decision support alert based on the Ottawa Ankle Rules. |
| Electronic Alert Intervention (Post-Intervention) | Experimental | Behavioral: Electronic Clinical Decision Support AlertPatients presenting with ankle trauma to the Emergency Department between 1 February 2022 and 30 April 2022. Physicians were exposed to an electronic clinical decision support pop-up alert reminding them to apply the Ottawa Ankle Rules when assessing ankle injuries and ordering imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older.
- Presentation to the Emergency Department of Geneva University Hospitals with ankle trauma.
- Presentation during the study period from 1 November 2021 to 30 April 2022.
Key exclusion criteria (9 listed)
- Deep or superficial wounds.
- Burns.
- Nerve injury.
- Vascular injury.
- Presence of foreign bodies.
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 |
|---|---|---|
| Electronic Clinical Decision Support AlertAn electronic clinical decision support pop-up alert integrated into the emergency department workflow. The alert reminded physicians to apply the Ottawa Ankle Rules when evaluating patients with ankle trauma and when considering ankle or foot radiography. The intervention was implemented during the post-intervention period (1 February 2022 to 30 April 2022) and was intended to reduce unnecessary imaging while maintaining appropriate fracture detection | Behavioural | Electronic Alert Intervention (Post-Intervention) |
Primary outcome
Proportion of Patients Receiving Ankle or Foot Radiography
Time frame: During the emergency department visit (up to 1 day)
Assessment of the proportion of patients presenting to the emergency department with ankle trauma who underwent ankle or foot radiography before and after implementation of the electronic clinical decision support alert based on the Ottawa Ankle Rules.
3 secondary outcomes
Proportion of Radiographs Meeting Ottawa Ankle Rules Criteria
Time frame: During the emergency department visit (up to 1 day)
Sensitivity of the Ottawa Ankle Rules for Fracture Detection
Time frame: Up to 2 weeks after the emergency department visit
Specificity and Negative Predictive Value of the Ottawa Ankle Rules
Time frame: Up to 2 weeks after the emergency department visit
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Clinical Decision Support Alert in people with Ankle Injuries and Ankle Sprains, run by SPECHBACH Hervé at 1 site in Switzerland.
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 3 inclusion and 9 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 3 Nov 2026. 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 Switzerland. 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?
Proportion of Patients Receiving Ankle or Foot Radiography (time frame: During the emergency department visit (up to 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.