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

NCT ID: NCT05799807

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2025-06-30

Brief Summary

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

Detailed 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.

Conditions

Lisfranc Injury; Foot Sprain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1 - Conservative

Negative weight-bearing CT (≤ 2mm between C1-M2, as opposed to the uninjured side) will be considered stable and treated conservatively with a prefabricated walker with weight-bearing as tolerated for six weeks. These patients will undergo bilateral radiographs after six weeks and combined CT and radiographs after twelve weeks to monitor the degree of stability

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: PROCEDURE

Patients with negativ weight-bearing CT will be treated conservative

Cohort 2 - Surgical

Positive weight-bearing CT (\> 2mm between C1-M2, as opposed to the uninjured side) will be operated by minimally invasive stabilization (eg, isolated homerun screw)

Group Type: ACTIVE_COMPARATOR

Minimally invasive stabilization

Intervention Type: PROCEDURE

Patients with positive weight-bearing CT will be operated by minimally invasive stabilization (eg, isolated homerun screw)

Interventions

Conservative treatment

Patients with negativ weight-bearing CT will be treated conservative

Intervention Type: PROCEDURE

Minimally invasive stabilization

Patients with positive weight-bearing CT will be operated by minimally invasive stabilization (eg, isolated homerun screw)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Magnus Poulsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magnus Poulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital, Ullevål

Oslo, , Norway

Countries

Norway

Other Identifiers

110364

Identifier Type: -

Identifier Source: org_study_id