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

NCT05799807 | Active Not Recruiting

• 1 other identifier: 110364
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lisfranc Injury; Foot Sprain

Outcome Measures

Primary Outcomes (1)

• Manchester-Oxford Foot Questionnaire (MOxFQ)

  Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)

  1 year

Secondary Outcomes (5)

• American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score

  1 year

• Visual Analogue Scale (VAS) for pain

  1 year

• Short-Form (SF) 36

  1 year

• Posttraumatic osteoarthritis

  1 year

• Incidence of complications

  1 year

Study Arms (2)

Cohort 1 - Conservative

ACTIVE COMPARATOR

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

Procedure: Conservative treatment

Cohort 2 - Surgical

ACTIVE COMPARATOR

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)

Procedure: Minimally invasive stabilization

Interventions

Conservative treatment PROCEDURE

Patients with negativ weight-bearing CT will be treated conservative

Cohort 1 - Conservative

Minimally invasive stabilization PROCEDURE

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

Cohort 2 - Surgical

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, 0450, Norway

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Magnus Poulsen, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Acute Lisfranc injuries are investigated with weight-bearing diagnostics to determine the degree of TMT stability. Patients are examined using both CT and conventional radiography during full weight and non-weight-bearing sequences. 3 foot- and ankle surgeons will examine the scans independently, starting with the conventional radiographs. Distance between the medial cuneiform and second metatarsal bone (C1-M2) is measured. For the CT images, measuring method previously described by Y. Sripanich et al. (DOI: 10.1007/s00402-020-03477-5) will be used. CT findings will determine the treatment outcome. If the C1-M2 diastasis is \>2mm, as opposed to the uninjured side, the injury will be determined unstable and surgical fixation will be recommended (Cohort 2). All other patients (≤ 2mm) are considered stable and treated conservatively (Cohort 1).

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 18, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)