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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: an economic evaluation

The feasibility of point-of-care ultrasound conducted by physiotherapists for the diagnosis of ankle syndesmosis injuries in the acute care setting: an economic evaluation

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001434583
Acronym
FOCUS
Enrollment
268
Registered
2024-12-09
Start date
2025-02-01
Completion date
2026-12-31
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 aims to assess the quality of life and patient health care resource utilisation of a POCUS pathway (POCUS group/ intervention) compared to usual care (usual care group/ control). This will enable a budget-impact analysis of the proposed syndesmosis injury management pathway to be performed. It is hypothesised that early detection of syndesmosis injuries will minimise management delays, enhance patient outcomes, at no additional cost, compared to usual care. 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 either the point of care ultrasound (POCUS) group or usual care group. Participant recruitment will be non-randomised, with convenience sampling based on the availability of a POCUS trained Emergency Physiotherapy Practitioner (EPP). If a POCUS trained EPP is available and if a musculoskeletal so

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 either the point of care ultrasound (POCUS) group or usual care group. Participant recruitment will be non-randomised, with convenience sampling based on the availability of a POCUS trained Emergency Physiotherapy Practitioner (EPP). If a POCUS trained EPP is available and if a musculoskeletal sonographer is available on the day or the following day, the participant will be assigned to the POCUS group. A POCUS trained 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. If a POCUS trained EPP is unavailable (e.g. not rostered, out of hours) and a musculoskeletal sonographer is unavailable on the day or the following day, they will be assigned to the usual care group. Participants in the usual care group can be seen by any treating clinician (i.e. doctor, nurse practitioner, EPP not POCUS trained). 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). The EPP POCUS assessment and sonography ultrasound will happen within their 4 hours of their presentation to the emergency department. 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
Parallel
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