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

• ClinicalTrials.gov Identifier: NCT05799807
• Recruitment Status: Recruiting
• First Posted: April 5, 2023
• Last Update Posted: April 20, 2023
• Sponsor: Oslo University Hospital
• Information provided by (Responsible Party): Magnus Poulsen, Oslo University Hospital

Tracking Information

• First Submitted Date: March 23, 2023
• First Posted Date: April 5, 2023
• Last Update Posted Date: April 20, 2023
• Actual Study Start Date: April 18, 2023
• Estimated Primary Completion Date: April 18, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2023)

Manchester-Oxford Foot Questionnaire (MOxFQ) [ Time Frame: 1 year ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 7, 2023)

• American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score [ Time Frame: 1 year ]
  Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
• Visual Analogue Scale (VAS) for pain [ Time Frame: 1 year ]
  Scores pain at rest and on activity (0-10 with 0 representing no pain)
• Short-Form (SF) 36 [ Time Frame: 1 year ]
  Patient reported score measuring quality of life and health status (0-100 with 100 representing the best possible outcome)
• Posttraumatic osteoarthritis [ Time Frame: 1 year ]
  The presence of osteoarthritis of the tarsometatarsal joints using the Kellgren & Lawrence classification system
• Incidence of complications [ Time Frame: 1 year ]
  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.

Original Secondary Outcome Measures (submitted: April 4, 2023)

• American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score [ Time Frame: 1 year ]
  Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
• Visual Analogue Scale (VAS) for pain [ Time Frame: 1 year ]
  Scores pain at rest and on activity (0-10 with 0 representing no pain)
• Short-Form (SF) 36 [ Time Frame: 1 year ]
  Patient reported score measuring quality of life and health status
• Posttraumatic osteoarthritis [ Time Frame: 1 year ]
  The presence of osteoarthritis of the tarsometatarsal joints using the Kellgren & Lawrence classification system
• Incidence of complications [ Time Frame: 1 year ]
  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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Weight-bearing Diagnostics in Acute Lisfranc Injury: CT vs X-ray
• Official Title: Weight-bearing Diagnostics in Acute Lisfranc Injury: A Prospective Study Comparing Computed Tomography Versus Conventional Radiography
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).

Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition

• Lisfranc Injury
• Foot Sprain

Intervention

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

Study Arms

• Active Comparator: 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
  Intervention: Procedure: Conservative treatment
• Active Comparator: 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)
  Intervention: Procedure: Minimally invasive stabilization

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 4, 2023): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 18, 2025
• Estimated Primary Completion Date: April 18, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Magnus Poulsen, MD; +4797729404; japoul@ous-hf.no

Contact: Are Stødle, MD PhD; +4797174507; arhauk@ous-hf.no

• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT05799807
• Other Study ID Numbers: 110364
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Magnus Poulsen, Oslo University Hospital
• Original Responsible Party: Magnus Poulsen, Oslo University Hospital, Dr
• Current Study Sponsor: Oslo University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Magnus Poulsen, MD; Oslo University Hospital

• PRS Account: Oslo University Hospital
• Verification Date: April 2023