Lisfranc InjuryNCT05799807
Weight-bearing Diagnostics in Acute Lisfranc Injury: CT vs X-ray
A study testing Conservative treatment and Minimally invasive stabilization in people with Lisfranc Injury and Foot Sprain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
A prospective, cohort study comparing weight-bearing computed tomography with weight-bearing radiography in patients with an acute Lisfranc injury. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lisfranc Injury, Foot Sprain
- What is being tested?
- Conservative treatment and Minimally invasive stabilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- 18 Apr 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight-bearing Diagnostics in Acute Lisfranc Injury: A Prospective Study Comparing Computed Tomography Versus Conventional Radiography
A prospective, cohort study comparing weight-bearing computed tomography with weight-bearing radiography in patients with an acute Lisfranc injury.
Read the 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
- Being tested
- Conservative treatment, Minimally invasive stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentProcedure or surgery
Patients with negativ weight-bearing CT will be treated conservative
Minimally invasive stabilizationProcedure or surgery
Patients with positive weight-bearing CT will be operated by minimally invasive stabilization (eg, isolated homerun screw)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Procedure: Minimally invasive stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manchester-Oxford Foot Questionnaire (MOxFQ)
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
Measured: 1 year
Secondary outcomes (5)
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Measured: 1 year
Visual Analogue Scale (VAS) for pain
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Measured: 1 year
Short-Form (SF) 36
Patient reported score measuring quality of life and health status (0-100 with 100 representing the best possible outcome)
Measured: 1 year
Posttraumatic osteoarthritis
The presence of osteoarthritis of the tarsometatarsal joints using the Kellgren \& Lawrence classification system
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start18 Apr 2023
- Primary completion30 Apr 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lisfranc InjuryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Poulsen, Oslo University Hospital
- Investigators
- Magnus Poulsen, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799807
- Sponsor's protocol ID
- 110364
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poulsen M, Rohrl SM, Schulz A, Stodle AH. Prospective Validation of a Weightbearing CT Stability Threshold for Subtle Lisfranc Injuries. Foot Ankle Int. 2025 Dec;46(12):1386-1394. doi: 10.1177/10711007251374674. Epub 2025 Oct 31.
PubMed 41170783
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-bearing Diagnostics in Acute Lisfranc Injury: A Prospective Study Comparing Computed Tomography Versus Conventional Radiography
- ClinicalTrials.gov ID
- NCT05799807
- Acronym / sponsor ID
- 110364
- Conditions
- Lisfranc Injury, Foot Sprain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Conservative | Active comparator | Procedure: Conservative treatmentNegative 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 |
| Cohort 2 - Surgical | Active comparator | Procedure: Minimally invasive stabilizationPositive weight-bearing CT (> 2mm between C1-M2, as opposed to the uninjured side) will be operated by minimally invasive stabilization (eg, isolated homerun screw) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatmentPatients with negativ weight-bearing CT will be treated conservative | Procedure or surgery | Cohort 1 - Conservative |
| Minimally invasive stabilizationPatients with positive weight-bearing CT will be operated by minimally invasive stabilization (eg, isolated homerun screw) | Procedure or surgery | Cohort 2 - Surgical |
Primary outcome
Manchester-Oxford Foot Questionnaire (MOxFQ)
Time frame: 1 year
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
5 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
Time frame: 1 year
Visual Analogue Scale (VAS) for pain
Time frame: 1 year
Short-Form (SF) 36
Time frame: 1 year
Posttraumatic osteoarthritis
Time frame: 1 year
Incidence of complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 41170783Poulsen M, Rohrl SM, Schulz A, Stodle AH. Prospective Validation of a Weightbearing CT Stability Threshold for Subtle Lisfranc Injuries. Foot Ankle Int. 2025 Dec;46(12):1386-1394. doi: 10.1177/10711007251374674. Epub 2025 Oct 31.
- Individual participant dataSharing planned: No
Related trials for Lisfranc Injury
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Active, not recruiting
Stability and Outcomes of Non-displaced Lisfranc Injuries
Lisfranc Injury, Sprain of Foot
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Poulsen, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment and Minimally invasive stabilization in people with Lisfranc Injury and Foot Sprain, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester-Oxford Foot Questionnaire (MOxFQ) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.