Lisfranc InjuryNCT04430101
Stability and Outcomes of Non-displaced Lisfranc Injuries
A study testing Minimally invasive stabilization of Lisfranc injuries and Conservative treatment in people with Lisfranc Injury and Sprain of Foot, run by Ostfold Hospital Trust at 2 sites in Norway.
Trial summary
In this multicenter cohort study, the stability of non-displaced Lisfranc injuries as well as their outcomes will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lisfranc Injury, Sprain of Foot
- What is being tested?
- Minimally invasive stabilization of Lisfranc injuries and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 2 sitesNorway
- Study dates
- 9 Jun 2020to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Lisfranc injuries that are non-displaced (< 2mm) on non-weightbearing radiographs and CT
- Patients between 18 and 70 years of age
- Acute presentation at one of our departments, enabling evaluating the stability of the injuries within 4 weeks
Who cannot join
- Fractures with an intraarticular step of > 2mm on the initial non weight-bearing radiographs and/or CT
- Delayed presentation (weight-bearing radiographs taken > 4 weeks after injury)
- Bilateral injuries
- Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process
- Multitraumized patients
- Previous injury or surgery of the mid foot
Show all 11Show fewer
- Charcot foot
- Noncompliant patients
- Insufficient Norwegian or English language skills
- Patients not available for follow-up
- Inability to conduct the rehabilitation protocol
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo university hospial
Oslo, 0588
Østfold Hospital Trust
Sarpsborg, Østfold fylke, 1714
About this study
Official title: Stability and Outcomes of Non-displaced Lisfranc Injuries - A Prospective Multicenter Cohort Study
In this multicenter cohort study, the stability of non-displaced Lisfranc injuries as well as their outcomes will be evaluated.
Read the detailed description
Injuries to the tarsometatarsal joints ("Lisfranc injuries") that are non-displaced on non-weightbearing radiographs and CT are common injuries. To refer these injuries to the right treatment, evaluating their stability is essential. For this purpose, both weightbearing radiographs and stress fluoroscopy have been proposed. However, there is no consensus concerning both the use and interpretation of weightbearing radiographs and no standardized technique and interpretation of stress fluoroscopy in non-displaced Lisfranc injuries.
In the current study, participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by weightbearing radiographs.
All Patients with negative weightbearing radiographs will be treated conservatively. In addition, their injured feet will be evaluated by manual stress fluoroscopy. Depending on the result of the stress fluoroscopy (positive/negative), the conservatively treated patients will be assigned to 2 cohorts, whose outcomes will be compared.
Patients with positive weightbearing radiographs will be treated operatively by minimally invasive stabilization of the midfoot (eg. isolated "homerun screw"). The operatively treated patients will be followed up as an independent cohort.
- Conditions
- Lisfranc Injury, Sprain of Foot
- Being tested
- Minimally invasive stabilization of Lisfranc injuries, Conservative treatment
- Keywords
- Lisfranc injury, Weightbearing radiographs, Stress fluoroscopy, Homerun screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive stabilization of Lisfranc injuriesProcedure or surgery
Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)
Conservative treatmentProcedure or surgery
Patients with negative weightbearing radiographs will be treated conservatively
| Study group | Role | What they receive |
|---|---|---|
| Negative WB radiographs and stress fluoroscopy | Active comparator | Cohort 1
Negative weight bearing radiographs:
Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side.
Negative stress fluoroscopy: the midfoot is tested stable Receives: Procedure: Conservative treatment |
| Negative WB radiographs / positive stress fluoroscopy | Active comparator | Cohort 2
Negative weight bearing radiographs:
Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side.
Positive stress fluoroscopy: manual testing reveals midfoot instability Receives: Procedure: Conservative treatment |
| Surgical cohort (Cohort 3) | Other | Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort. Receives: Procedure: Minimally invasive stabilization of Lisfranc injuries |
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: 5 years
Secondary outcomes (6)
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Measured: 5 years
Self-reported foot and ankle score (SEFAS)
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Measured: 5 years
Visual Analogue Scale (VAS) for pain
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Measured: 5 years
Short-Form (SF) 36
Patient reported score measuring quality of life and health status
Measured: 5 years
Posttraumatic osteoarthritis
The presence of osteoarthritis of the tarsometatarsal joints is graded based on the Brodén radiographs taken at 1 year, 2 year and 5 year follow-up using the Kellgren \& Lawrence classification system.
Measured: 5 years
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: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start9 Jun 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lisfranc InjuryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are evaluated by weightbearing radiographs. Patients with no signs of dislocation on the weightbearing radiographs will undergo stress fluoroscopy. Patients with negative stress fluoroscopy are allocated to Cohort 1, patients with positive stress fluoroscopy are allocated to Cohort 2. The study design is a non-inferiority study, proving to show that the outcomes of Cohort 2 are non-inferior compared to Cohort 1. Patients with positive weightbearing radiographs (interval between medial cuneiform and base of second metatarsal increased by \> 2 mm compared to the contralateral side) will be operated with minimally invasive stabilization (eg. isolated "homerun screw") and followed up prospectively as a single cohort (Cohort 3).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Marius Molund, MD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430101
- Sponsor's protocol ID
- 20/00913
- Status last verified
- Apr 2023
- First submitted
- 10 Jun 2020
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability and Outcomes of Non-displaced Lisfranc Injuries - A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT04430101
- Acronym / sponsor ID
- 20/00913
- Conditions
- Lisfranc Injury, Sprain of Foot
- Keywords
- Lisfranc injury, Weightbearing radiographs, Stress fluoroscopy, Homerun screw
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jun 2020 (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.
In this multicenter cohort study, the stability of non-displaced Lisfranc injuries as well as their outcomes will be evaluated.
Detailed description
Injuries to the tarsometatarsal joints ("Lisfranc injuries") that are non-displaced on non-weightbearing radiographs and CT are common injuries. To refer these injuries to the right treatment, evaluating their stability is essential. For this purpose, both weightbearing radiographs and stress fluoroscopy have been proposed. However, there is no consensus concerning both the use and interpretation of weightbearing radiographs and no standardized technique and interpretation of stress fluoroscopy in non-displaced Lisfranc injuries.
In the current study, participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by weightbearing radiographs.
All Patients with negative weightbearing radiographs will be treated conservatively. In addition, their injured feet will be evaluated by manual stress fluoroscopy. Depending on the result of the stress fluoroscopy (positive/negative), the conservatively treated patients will be assigned to 2 cohorts, whose outcomes will be compared.
Patients with positive weightbearing radiographs will be treated operatively by minimally invasive stabilization of the midfoot (eg. isolated "homerun screw"). The operatively treated patients will be followed up as an independent cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are evaluated by weightbearing radiographs. Patients with no signs of dislocation on the weightbearing radiographs will undergo stress fluoroscopy. Patients with negative stress fluoroscopy are allocated to Cohort 1, patients with positive stress fluoroscopy are allocated to Cohort 2. The study design is a non-inferiority study, proving to show that the outcomes of Cohort 2 are non-inferior compared to Cohort 1. Patients with positive weightbearing radiographs (interval between medial cuneiform and base of second metatarsal increased by > 2 mm compared to the contralateral side) will be operated with minimally invasive stabilization (eg. isolated "homerun screw") and followed up prospectively as a single cohort (Cohort 3).
| Arm | Type | Receives |
|---|---|---|
| Negative WB radiographs and stress fluoroscopy | Active comparator | Procedure: Conservative treatmentCohort 1 Negative weight bearing radiographs: Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side. Negative stress fluoroscopy: the midfoot is tested stable |
| Negative WB radiographs / positive stress fluoroscopy | Active comparator | Procedure: Conservative treatmentCohort 2 Negative weight bearing radiographs: Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side. Positive stress fluoroscopy: manual testing reveals midfoot instability |
| Surgical cohort (Cohort 3) | Other | Procedure: Minimally invasive stabilization of Lisfranc injuriesPatients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute Lisfranc injuries that are non-displaced (< 2mm) on non-weightbearing radiographs and CT
- Patients between 18 and 70 years of age
- Acute presentation at one of our departments, enabling evaluating the stability of the injuries within 4 weeks
Key exclusion criteria (11 listed)
- Fractures with an intraarticular step of > 2mm on the initial non weight-bearing radiographs and/or CT
- Delayed presentation (weight-bearing radiographs taken > 4 weeks after injury)
- Bilateral injuries
- Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process
- Multitraumized patients
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 |
|---|---|---|
| Minimally invasive stabilization of Lisfranc injuriesPatients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw) | Procedure or surgery | Surgical cohort (Cohort 3) |
| Conservative treatmentPatients with negative weightbearing radiographs will be treated conservatively | Procedure or surgery | Negative WB radiographs / positive stress fluoroscopy, Negative WB radiographs and stress fluoroscopy |
Primary outcome
Manchester-Oxford Foot Questionnaire (MOxFQ)
Time frame: 5 years
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
6 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
Time frame: 5 years
Self-reported foot and ankle score (SEFAS)
Time frame: 5 years
Visual Analogue Scale (VAS) for pain
Time frame: 5 years
Short-Form (SF) 36
Time frame: 5 years
Posttraumatic osteoarthritis
Time frame: 5 years
Incidence of complications
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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Recruiting
Opioid-Free Pain Treatment in Trauma Patients
Femoral Neck Fractures, Intertrochanteric Fractures
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.
Marius Molund, MD principal investigator
Ostfold Hospital Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive stabilization of Lisfranc injuries and Conservative treatment in people with Lisfranc Injury and Sprain of Foot, run by Ostfold Hospital Trust at 2 sites 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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.