<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04430101</url>
  </required_header>
  <id_info>
    <org_study_id>20/00913</org_study_id>
    <nct_id>NCT04430101</nct_id>
  </id_info>
  <brief_title>Stability and Outcomes of Non-displaced Lisfranc Injuries</brief_title>
  <official_title>Stability and Outcomes of Non-displaced Lisfranc Injuries - A Prospective Multicenter Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostfold Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ostfold Hospital Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this multicenter cohort study, the stability of non-displaced Lisfranc injuries as well as&#xD;
      their outcomes will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Injuries to the tarsometatarsal joints (&quot;Lisfranc injuries&quot;) that are non-displaced on&#xD;
      non-weightbearing radiographs and CT are common injuries. To refer these injuries to the&#xD;
      right treatment, evaluating their stability is essential. For this purpose, both&#xD;
      weightbearing radiographs and stress fluoroscopy have been proposed. However, there is no&#xD;
      consensus concerning both the use and interpretation of weightbearing radiographs and no&#xD;
      standardized technique and interpretation of stress fluoroscopy in non-displaced Lisfranc&#xD;
      injuries.&#xD;
&#xD;
      In the current study, participants will be assigned to non-operative or operative treatment&#xD;
      based on Lisfranc joint stability evaluation by weightbearing radiographs.&#xD;
&#xD;
      All Patients with negative weightbearing radiographs will be treated conservatively. In&#xD;
      addition, their injured feet will be evaluated by manual stress fluoroscopy. Depending on the&#xD;
      result of the stress fluoroscopy (positive/negative), the conservatively treated patients&#xD;
      will be assigned to 2 cohorts, whose outcomes will be compared.&#xD;
&#xD;
      Patients with positive weightbearing radiographs will be treated operatively by minimally&#xD;
      invasive stabilization of the midfoot (eg. isolated &quot;homerun screw&quot;). The operatively treated&#xD;
      patients will be followed up as an independent cohort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2029</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.&#xD;
The study design is a non-inferiority study, proving to show that the outcomes of Cohort 2 are non-inferior compared to Cohort 1.&#xD;
Patients with positive weightbearing radiographs (interval between medial cuneiform and base of second metatarsal increased by &gt; 2 mm compared to the contralateral side) will be operated with minimally invasive stabilization (eg. isolated &quot;homerun screw&quot;) and followed up prospectively as a single cohort (Cohort 3).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The participants will be blinded for the result of the stress fluoroscopy.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Manchester-Oxford Foot Questionnaire (MOxFQ)</measure>
    <time_frame>5 years</time_frame>
    <description>Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score</measure>
    <time_frame>5 years</time_frame>
    <description>Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported foot and ankle score (SEFAS)</measure>
    <time_frame>5 years</time_frame>
    <description>Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS) for pain</measure>
    <time_frame>5 years</time_frame>
    <description>Scores pain at rest and on activity (0-10 with 0 representing no pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form (SF) 36</measure>
    <time_frame>5 years</time_frame>
    <description>Patient reported score measuring quality of life and health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posttraumatic osteoarthritis</measure>
    <time_frame>5 years</time_frame>
    <description>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 &amp; Lawrence classification system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications</measure>
    <time_frame>5 years</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Lisfranc Injury</condition>
  <condition>Sprain of Foot</condition>
  <arm_group>
    <arm_group_label>Negative WB radiographs and stress fluoroscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 1&#xD;
Negative weight bearing radiographs:&#xD;
Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side.&#xD;
Negative stress fluoroscopy: the midfoot is tested stable</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative WB radiographs / positive stress fluoroscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cohort 2&#xD;
Negative weight bearing radiographs:&#xD;
Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side.&#xD;
Positive stress fluoroscopy: manual testing reveals midfoot instability</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical cohort (Cohort 3)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minimally invasive stabilization of Lisfranc injuries</intervention_name>
    <description>Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)</description>
    <arm_group_label>Surgical cohort (Cohort 3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conservative treatment</intervention_name>
    <description>Patients with negative weightbearing radiographs will be treated conservatively</description>
    <arm_group_label>Negative WB radiographs / positive stress fluoroscopy</arm_group_label>
    <arm_group_label>Negative WB radiographs and stress fluoroscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Lisfranc injuries that are non-displaced (&lt; 2mm) on non-weightbearing&#xD;
             radiographs and CT&#xD;
&#xD;
          -  Patients between 18 and 70 years of age&#xD;
&#xD;
          -  Acute presentation at one of our departments, enabling evaluating the stability of the&#xD;
             injuries within 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fractures with an intraarticular step of &gt; 2mm on the initial non weight-bearing&#xD;
             radiographs and/or CT&#xD;
&#xD;
          -  Delayed presentation (weight-bearing radiographs taken &gt; 4 weeks after injury)&#xD;
&#xD;
          -  Bilateral injuries&#xD;
&#xD;
          -  Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation&#xD;
             process&#xD;
&#xD;
          -  Multitraumized patients&#xD;
&#xD;
          -  Previous injury or surgery of the mid foot&#xD;
&#xD;
          -  Charcot foot&#xD;
&#xD;
          -  Noncompliant patients&#xD;
&#xD;
          -  Insufficient Norwegian or English language skills&#xD;
&#xD;
          -  Patients not available for follow-up&#xD;
&#xD;
          -  Inability to conduct the rehabilitation protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marius Molund, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ostfold Hospital Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo university hospial</name>
      <address>
        <city>Oslo</city>
        <zip>0588</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Østfold Hospital Trust</name>
      <address>
        <city>Sarpsborg</city>
        <state>Østfold</state>
        <zip>1714</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lisfranc injury</keyword>
  <keyword>Weightbearing radiographs</keyword>
  <keyword>Stress fluoroscopy</keyword>
  <keyword>Homerun screw</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04430101
org study id: 20/00913
nct id: NCT04430101
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this multicenter cohort study, the stability of non-displaced Lisfranc injuries as well as
      their outcomes will be evaluated.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention 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).
primary purpose: Treatment
masking: Single (Participant)
masking description: The participants will be blinded for the result of the stress fluoroscopy.
measure: Manchester-Oxford Foot Questionnaire (MOxFQ)
time frame: 5 years
description: Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
time frame: 5 years
description: Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
measure: Self-reported foot and ankle score (SEFAS)
time frame: 5 years
description: Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
measure: Visual Analogue Scale (VAS) for pain
time frame: 5 years
description: Scores pain at rest and on activity (0-10 with 0 representing no pain)
measure: Short-Form (SF) 36
time frame: 5 years
description: Patient reported score measuring quality of life and health status
measure: Posttraumatic osteoarthritis
time frame: 5 years
description: 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.
measure: Incidence of complications
time frame: 5 years
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.
arm group label: Negative WB radiographs and stress fluoroscopy
arm group type: Active Comparator
description: 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
arm group label: Negative WB radiographs / positive stress fluoroscopy
arm group type: Active Comparator
description: 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
arm group label: Surgical cohort (Cohort 3)
arm group type: Other
description: Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort.
intervention type: Procedure
intervention name: Minimally invasive stabilization of Lisfranc injuries
description: Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)
arm group label: Surgical cohort (Cohort 3)
intervention type: Procedure
intervention name: Conservative treatment
description: Patients with negative weightbearing radiographs will be treated conservatively
arm group label: Negative WB radiographs / positive stress fluoroscopy
arm group label: Negative WB radiographs and stress fluoroscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Marius Molund, MD
role: Principal Investigator
affiliation: Ostfold Hospital Trust
facility: 
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No