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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)

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001435572
Acronym
FOCUS
Enrollment
214
Registered
2024-12-09
Start date
2025-02-01
Completion date
2026-12-02
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Syndesmosis injuries are relatively uncommon but difficult to diagnose, especially in the acute phase. The long term sequalae of undiagnosed syndesmosis injuries include chronic pain, instability and osteoarthritis. In some cases, surgical fixation is required. Point of care ultrasound (POCUS), which is ultrasound performed on patients at the bedside, provides a novel investigative method to accurately diagnose potential syndesmosis injuries, but its feasibility in the acute care setting remains unclear. This study will determine the feasibility and accuracy of Emergency Physiotherapy Practitioners (EPPs) using POCUS to diagnose anterior inferior tibiofibular ligament (AITFL) injuries, which is a surrogate marker for syndesmosis injuries, compared with the reference standard of radiology ultrasound. Patients found to have a syndesmosis injury on radiology ultrasound will be initiated on a novel pathway, of an MRI and orthopaedic follow up. This will also allow comparison of positive ultrasound findings compared with MRI results. It is hypothesised that physiotherapists will be accurate at identifying an injury to the AITFL when compared to a radiologist report. The results of this study could inform the development of a diagnostic pathway that could be implemented in EDs and Minor Injury Clinics throughout Australia.

Interventions

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 P

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.

Sponsors

Metro South
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026