Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001435572
Ethics application status
Approved
Date submitted
11/09/2024
Date registered
9/12/2024
Date last updated
9/12/2024
Date data sharing statement initially provided
9/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Feasibility Of point-of-Care UltraSound conducted by physiotherapists for the diagnosis of ankle syndesmosis injuries in the acute care setting: A diagnostic study (FOCUS)
Scientific title
The feasibility of point-of-care ultrasound conducted by physiotherapists for the diagnosis of ankle syndesmosis injuries in the acute care setting: A diagnostic study.
Secondary ID [1] 312894 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FOCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syndesmosis ankle injuries 335047 0
Condition category
Condition code
Musculoskeletal 331557 331557 0 0
Other muscular and skeletal disorders
Public Health 332290 332290 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients that have sustained an acute ankle injury (within seven days of their presentation) and meet the eligibility criteria will be recruited to the study. Consenting participants will be assigned to point of care ultrasound (POCUS) group based on the availability of a POCUS trained Emergency Physiotherapy Practitioner (EPP) and sonographer. A POCUS training EPP will be available on 92% of rostered shifts between the hours 0800 to 1800, therefore we expect no difficulties recruiting to the POCUS intervention. The EPP POCUS assessment and sonography ultrasound will happen within 4 hours of their presentation to the emergency department.

All participants in the POCUS group will receive both POCUS by the EPP and a focused radiology ultrasound by a musculoskeletal sonographer. The EPP POCUS scan will be performed on a GE Venue (or equivalent ultrasound machine) and the sonographers will perform the same scan on their standard machine (Philips Epic Elite). Patient’s are enrolled when they present to ED and provide written consent. Baseline measurements include the EPP POCUS scan, and the sonography ultrasound scan with the formal radiologist report based on this scan . The radiology report will be the reference standard, which the EPP POCUS scan is being compared to.

Patients that have an anterior inferior tibiofibular ligament (AITFL) injury on radiology ultrasound will be referred for Magnetic Resonance Imaging (MRI) and will be referred to orthopaedic fracture clinic for follow up. The MRI will be completed as an outpatient scan at the Wynnum or Cleveland Queensland xray clinics. These scans will take 15 minutes to 1 hour. The MRI scan will be performed by a radiographer and reported by a radiologist. This scan will be recommended to be performed within 1 week of leaving the emergency department. The patients will be seen at the fracture clinic within 2 weeks of their emergency department presentation. Patients that do not have an AITFL injury on radiology ultrasound will be seen in a physiotherapy soft tissue clinic at two weeks.

Adherence to the interventions will be monitored by the principal investigator or research assistant via their electronic medical record, which displays their appointments and scans they have attended. Patients that have not attended their MRI scan, fracture clinic appointment or soft tissue clinic will receive a call from the principal investigator or research assistant to determine the reason. If patients have not attended their fracture clinic or physiotherapy soft tissue clinic appointments they will be offered another appointment as per the hospital fail to attend policy. Patient's will be discharged from the service if they fail to attend two appointments.
Intervention code [1] 329430 0
Treatment: Other
Intervention code [2] 329947 0
Diagnosis / Prognosis
Comparator / control treatment
Following POCUS examination by the EPP, a musculoskeletal trained sonographer will perform a focused radiology ultrasound to evaluate the AITFL as per the same scanning protocol. The sonographer will document their findings on a standardised sonographer worksheet and will be blinded to the EPPs worksheet results. The reference standard for the primary outcome is the radiologist reported ultrasound (injury versus no injury). The formal radiologist ultrasound report will be available within 5 days. The POCUS findings and radiology ultrasound will be compared to a final diagnosis based on the MRI, or the orthopaedic expert review which involves a combination of MRI findings and/or expert opinion. The results of the MRI will be known within 1 week of the MRI being performed. The final orthopaedic diagnosis will be known within 1 month of the MRI being performed.
Control group
Active

Outcomes
Primary outcome [1] 339292 0
Agreement of an anterior inferior tibiofibular ligaments (AITFL) injury (injury versus no injury) between Emergency Physiotherapy Practitioner (EPP) point of care ultrasound (POCUS) and the radiology ultrasound report.
Timepoint [1] 339292 0
PABAK will be calculated at baseline once a member of the research team has compared the EPP POCUS findings to the radiology ultrasound report. The EPP POCUS results are documented on a worksheet immediately following the patient’s POCUS and the radiologist ultrasound report is available within 5 days of the sonographer's formal ultrasound scan being completed.
Secondary outcome [1] 442406 0
Agreement of AITFL oedema (ultrasound measurement) between EPP POCUS worksheet and radiology ultrasound report
Timepoint [1] 442406 0
This will be assessed at baseline, which is when the EPP’s POCUS worksheet is completed (immediately following the POCUS ) and when the radiology ultrasound report is available (within 5 days of the sonographer’s ultrasound scan being completed).
Secondary outcome [2] 439383 0
The secondary outcome measure will be the agreement regarding the degree of the anterior inferior tibiofibular ligament injury between the EPP POCUS compared to the radiology ultrasound report. The degree of the injury will be classified as sprain, partial tear or complete rupture,
Timepoint [2] 439383 0
PABAK will be calculated at baseline by comparing the EPP POCUS results versus the radiology report. The EPP’s worksheet is completed immediately following the patient’s POCUS and the radiologist ultrasound report is available within 5 days of the sonographer's ultrasound scan being completed.
Secondary outcome [3] 442404 0
Agreement of AITFL hypoechogenicity (ultrasound measurement) between EPP POCUS worksheet and radiology ultrasound report.
Timepoint [3] 442404 0
This will be assessed at baseline, which is when the EPP’s POCUS worksheet is completed (immediately following the POCUS) and when the radiology ultrasound report is available (within 5 days of the sonographer’s ultrasound scan being completed)
Secondary outcome [4] 442403 0
Agreement of AITFL irregularity (ultrasound measurement) between EPP POCUS and radiology ultrasound report
Timepoint [4] 442403 0
This will be assessed at baseline, which is when the EPP’s POCUS worksheet is completed (immediately following the POCUS) and when the radiology ultrasound report is available (within 5 days of the sonographer’s ultrasound scan being completed)
Secondary outcome [5] 442409 0
EPP POCUS and radiology ultrasound results that were positive for AITFL injuries will be compared to MRI (or orthopaedic expert review) to determine their agreement for sprain versus partial tear versus complete rupture.
Timepoint [5] 442409 0
This will be assessed once both the EPP’s worksheet is completed (immediately following the POCUS scan), once the radiology ultrasound report is completed (within 5 days of sonographer's ultrasound) and then once the MRI report is known (MRI results will be known within 1 week of the MRI being performed). The MRI is completed within 1 week of the patient’s initial presentation.
Secondary outcome [6] 441693 0
Comparison of EPP POCUS and radiology ultrasound report against the final diagnosis reference standard (clinical course, orthopaedic diagnosis and MRI findings)
Timepoint [6] 441693 0
This will be assessed when the final orthopaedic diagnosis is known, which is usually within 1 month following the MRI results.
Secondary outcome [7] 442408 0
Agreement of the size of the AITFL (ultrasound measurement) between EPP POCUS worksheet and radiology ultrasound report
Timepoint [7] 442408 0
This will be assessed at baseline, which is when the EPP’s POCUS worksheet is completed (immediately following the POCUS scan) and when the radiology ultrasound report is available (within 5 days of the sonographer's ultrasound scan being completed).
Secondary outcome [8] 442407 0
Agreement of cortical irregularity (ultrasound measurement) between EPP POCUS worksheet and radiology ultrasound report
Timepoint [8] 442407 0
This will be assessed at baseline, which is when the EPP’s POCUS worksheet is completed (immediately following the POCUS) and when the radiology ultrasound report is available (within 5 days of the sonographer’sl ultrasound scan being completed). These results will be compared by a member of the research team.
Secondary outcome [9] 442405 0
Agreement of AITFL thickness (ultrasound measurement) between EPP POCUS worksheet and radiology ultrasound report
Timepoint [9] 442405 0
This will be assessed at baseline, which is when the EPP’s POCUS worksheet is completed (immediately following the POCUS) and when the radiology ultrasound report is available (within 5 days of the sonographer’s ultrasound scan being completed)

Eligibility
Key inclusion criteria
• Adults greater than or equal to 18 years presenting to the Redlands Emergency Department or Redland Satellite Hospital Minor Injury Illness Clinic
• Symptomatic acute (within 7 days) traumatic ankle injury with clinical examination suggestive of syndesmosis injury
- Positive anterior inferior tibiofibular ligament palpation test, and/or
- Positive dorsiflexion lunge test
• No other major injuries that require inpatient management or urgent surgical intervention
• No fracture identified on x-ray (except for avulsion fractures around the ankle joint)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Clinical examination shows negative AITFL palpation test and dorsiflexion lunge test
• Open injury (i.e. open wound)
• Ankle fracture or dislocations (except for avulsion fracture)
• Previous surgery to the ankle
• Neurovascular compromise
• Osteoarthritis of ankle
• Diabetic neuropathy
• Active rheumatological joint disease
• Non-English speaking patients without an available translator (e.g. phone interpreter or family member / friend)
• Ultrasound or MRI has already been completed in the community
• Patients with contraindication to MRI (e.g. pacemaker)
• unable to provide informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of agreement between the EPPs and radiology ultrasound assessment to the AITFL (no injury vs injury) will be assessed using prevalence adjusted and bias adjusted kappa (PABAK). This will be further divided into normal, sprain, partial tear and complete rupture, and agreement between EPP and radiology ultrasound will also be examined using PABAK. Agreement for other AITFL ultrasound measures including irregularity, hypoechogenicity, presence of thickening, oedema and cortical irregularity will also be assessed via frequencies (percentages). Agreement between EPPs and sonographers on the size of the AITFL will be examined using the calculated mean (standard deviation). In addition, the sensitivity and specificity with 95% confidence intervals to assess the performance of the test for diagnosing AITFL tears (complete or partial tear) compared to final diagnosis (MRI or orthopaedic/expert opinion) will be performed, on both POCUS and radiology ultrasound. Data generated from ultrasound measurements will be summarised as frequencies (percentage) for categorical variables and as mean (standard deviation) or median (interquartile range) for continuous variables. Statistical analysis will be performed using SPSS (version 26 or above).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
2/12/2026
Actual
Date of last data collection
Anticipated
2/03/2027
Actual
Sample size
Target
214
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27068 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 43135 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 317329 0
Charities/Societies/Foundations
Name [1] 317329 0
Emergency Medicine Foundation
Country [1] 317329 0
Australia
Primary sponsor type
Government body
Name
Metro South
Address
Country
Australia
Secondary sponsor category [1] 319614 0
None
Name [1] 319614 0
Address [1] 319614 0
Country [1] 319614 0
Other collaborator category [1] 283179 0
University
Name [1] 283179 0
University of Queensland
Address [1] 283179 0
Country [1] 283179 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316060 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316060 0
Ethics committee country [1] 316060 0
Australia
Date submitted for ethics approval [1] 316060 0
12/09/2024
Approval date [1] 316060 0
11/11/2024
Ethics approval number [1] 316060 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136646 0
Mrs Laura Hayes
Address 136646 0
Redland Hospital, 21 Weippin Street, Cleveland, QLD, 4163
Country 136646 0
Australia
Phone 136646 0
+61 7 3488 4046
Fax 136646 0
Email 136646 0
[email protected]
Contact person for public queries
Name 136647 0
Laura Hayes
Address 136647 0
Redland Hospital, 21 Weippin Street, Cleveland, QLD, 4163
Country 136647 0
Australia
Phone 136647 0
+61 7 3488 3111
Fax 136647 0
Email 136647 0
[email protected]
Contact person for scientific queries
Name 136648 0
Laura Hayes
Address 136648 0
Redland Hospital, 21 Weippin Street, Cleveland, QLD, 4163
Country 136648 0
Australia
Phone 136648 0
+61 7 3488 4046
Fax 136648 0
Email 136648 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The data can be made available to researchers upon reasonable request and this will be on a case-by-case basis at discretion.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial, after de-identification, may be shared upon reasonable request.


What types of analyses could be done with individual participant data?
• The data will be available for any research with methodologically sound proposal.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately after publication and ending at 15 years following main results publication, as recommended by the NHMRC.


To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access to the data will be subject to approval by the principal investigator and Metro South Research. Please contact the principal investigator at [email protected].

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.