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

Primary Purpose

Lisfranc Injury, Foot Sprain

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Conservative treatment
Minimally invasive stabilization
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lisfranc Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oslo University Hospital, UllevålRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cohort 1 - Conservative

Cohort 2 - Surgical

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Manchester-Oxford Foot Questionnaire (MOxFQ)
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2023
Last Updated
April 18, 2023
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05799807
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
April 18, 2024 (Anticipated)
Study Completion Date
April 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lisfranc Injury, Foot Sprain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 - Conservative
Arm Type
Active Comparator
Arm Description
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
Arm Title
Cohort 2 - Surgical
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Conservative treatment
Intervention Description
Patients with negativ weight-bearing CT will be treated conservative
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive stabilization
Intervention Description
Patients with positive weight-bearing CT will be operated by minimally invasive stabilization (eg, isolated homerun screw)
Primary Outcome Measure Information:
Title
Manchester-Oxford Foot Questionnaire (MOxFQ)
Description
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
Description
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Time Frame
1 year
Title
Visual Analogue Scale (VAS) for pain
Description
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Time Frame
1 year
Title
Short-Form (SF) 36
Description
Patient reported score measuring quality of life and health status (0-100 with 100 representing the best possible outcome)
Time Frame
1 year
Title
Posttraumatic osteoarthritis
Description
The presence of osteoarthritis of the tarsometatarsal joints using the Kellgren & Lawrence classification system
Time Frame
1 year
Title
Incidence of complications
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magnus Poulsen, MD
Phone
+4797729404
Email
japoul@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Are Stødle, MD PhD
Phone
+4797174507
Email
arhauk@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Poulsen, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Ullevål
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Röhrl, MD, PhD
Phone
+4794424677
Email
UXRHST@ous-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

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

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