Weight-bearing Diagnostics in Acute Lisfranc Injury: CT vs X-ray

Lisfranc Injury Clinical Trial

Official title:

Weight-bearing Diagnostics in Acute Lisfranc Injury: A Prospective Study Comparing Computed Tomography Versus Conventional Radiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799807
• Other study ID #: 110364
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: April 18, 2025

Study information

• Verified date: April 2023
• Source: Oslo University Hospital
• Contact: Magnus Poulsen, MD
• Phone: +4797729404
• Email: japoul[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, cohort study comparing weight-bearing computed tomography with weight-bearing radiography in patients with an acute Lisfranc injury.

Description:

Injury to the tarsometatarsal (TMT) joint complex in the midfoot is referred to as a Lisfranc injury. The broad spectrum of these injuries includes simple sprains to severe fracture-dislocations. Variable clinical presentations and radiographic findings make Lisfranc injuries notoriously difficult to detect, especially in the case of subtle ligament injuries. Nowadays, up to 30% of unstable Lisfranc injuries are overlooked or misdiagnosed. This can potentially lead to severe sequelae such as post-traumatic osteoarthritis and foot deformities.

For obvious injuries involving diastasis, subluxation, or dislocation, the diagnosis is relatively easy to establish using any imaging modality. However, for subtle injuries without gross bone separation, a dynamic imaging modality facilitating weight-bearing are to be preferred. Many consider weight-bearing conventional radiography as the current gold standard in acute Lisfranc injury diagnostics. However, conventional radiography is a 2D technique that can neither display nor measure the true dimensions of a detailed 3D object, such as the tarsal bones in the foot. Computed tomography (CT) provides greater accuracy in visualizing bone microarchitecture. In combination with weight-bearing, it can be ideal for detecting minor fractures and occult instability caused by load/stress.

To this day, there are no prospective studies comparing weight-bearing CT and weight-bearing radiography for acute Lisfranc injuries. In the current study, participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by the initial weight-bearing CT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 18, 2025
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Acute trauma to the midfoot

• Intraarticular fracture and/or avulsion fracture in the TMT joint line (detected on a non-weight-bearing CT)

• Suspicion of a purely ligamentous Lisfranc injury (no radiological fractures but substantial clinical findings in the midfoot region, or evidence of ligamentous damage on a MRI)

• Consent-competent patient

Exclusion Criteria:

• Obvious acute unstable Lisfranc injuries (>2mm dislocation between the medial cuneiform and second metatarsal)

• Injury older than four weeks

• Other major foot/ankle/leg injuries

• Previous foot infection or foot pathology on the affected side

• Previous surgery to the TMT joints, and sequelae after a previous foot injury

• Open injury

• Bilateral injury

• Patients with co-morbidities such as neuropathy and peripheral vascular disease

Related Conditions & MeSH terms

• Lisfranc Injury
• Wounds and Injuries

Intervention

Procedure:
• Conservative treatment
Patients with negativ weight-bearing CT will be treated conservative
• Minimally invasive stabilization
Patients with positive weight-bearing CT will be operated by minimally invasive stabilization (eg, isolated homerun screw)

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevål	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manchester-Oxford Foot Questionnaire (MOxFQ)	Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)	1 year
Secondary	American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score	Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)	1 year
Secondary	Visual Analogue Scale (VAS) for pain	Scores pain at rest and on activity (0-10 with 0 representing no pain)	1 year
Secondary	Short-Form (SF) 36	Patient reported score measuring quality of life and health status (0-100 with 100 representing the best possible outcome)	1 year
Secondary	Posttraumatic osteoarthritis	The presence of osteoarthritis of the tarsometatarsal joints using the Kellgren & Lawrence classification system	1 year
Secondary	Incidence of complications	Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery. Regards the patients that have undergone surgical treatment.	1 year