<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/NCT02199249</url>
  </required_header>
  <id_info>
    <org_study_id>105500</org_study_id>
    <nct_id>NCT02199249</nct_id>
  </id_info>
  <brief_title>Open Reduction Syndesmosis Tightrope Versus Screw Fixation</brief_title>
  <official_title>A Prospective Randomized Multi Center Study to Compare Open Reduction, TightRope Fixation (OT) Versus Open Reduction Screw Fixation (OS) of the Tibia - Fibular Syndesmosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orthopaedic Trauma Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is&#xD;
      assumed to disrupt the syndesmotic ligaments.&#xD;
&#xD;
      The goal of operative treatment is to reduce the ankle mortise to restore normal joint&#xD;
      kinematics. Syndesmosis repair can be performed using either open or closed reduction,&#xD;
      combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated&#xD;
      high rates of non anatomic reductions greater than 40%; therefore, open reduction will be&#xD;
      performed in this study. Screw fixation is stable but concerns exist regarding potential&#xD;
      excess rigidity.&#xD;
&#xD;
      Recently, flexible fixation techniques combined with anatomic reduction have demonstrated&#xD;
      improvements in functional outcomes and reduction quality. Both open reduction and flexible&#xD;
      TightRope fixation have considerable support in the literature in cohort studies but have not&#xD;
      been compared to open screw fixation in a randomized controlled trial.&#xD;
&#xD;
      In this multi centre randomized study, radiographic, economic and functional outcomes are&#xD;
      compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open&#xD;
      reduction screw fixation (OS)] of the syndesmosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is&#xD;
      assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce&#xD;
      the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed&#xD;
      using either open or closed reduction, combined with fixation between the distal tibia and&#xD;
      fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than&#xD;
      40%; therefore, open reduction will be performed in this study. Screw fixation is stable but&#xD;
      concerns exist regarding potential excess rigidity.&#xD;
&#xD;
      Recently, flexible fixation techniques combined with anatomic reduction have demonstrated&#xD;
      improvements in functional outcomes and reduction quality. Both open reduction and flexible&#xD;
      TightRope fixation have considerable support in the literature in cohort studies but have not&#xD;
      been compared to open screw fixation in a randomized controlled trial.&#xD;
&#xD;
      This study is a multi centre randomized controlled trial comparing clinical, economic and&#xD;
      functional outcomes between open reduction, flexible Tightrope syndesmosis fixation (OT) to&#xD;
      open reduction rigid screw fixation (OS) for syndesmotic injuries in high ankle fractures,&#xD;
      involving the fibula 1 cm above the level of the syndesmosis (Weber C (OTA 44.C1, 44.C2,&#xD;
      44C3)).&#xD;
&#xD;
      We anticipate recruiting 72 patients (36 in each arm) from up to 20 clinical sites across&#xD;
      North America. Post operative follow up will occur at 2 and 6 weeks, 3, 6, and 12 months. At&#xD;
      each follow up, radiographic and functional outcomes will be assessed as well as&#xD;
      documentation of costs associated with treatment and rehabilitation.&#xD;
&#xD;
      The research questions that this study will answer include the following:&#xD;
&#xD;
        1. Does open reduction and repair with TightRope syndesmosis fixation (OT) provide better&#xD;
           reduction compared to open reduction and syndesmosis screw fixation (OS)?&#xD;
&#xD;
        2. Which surgical technique provides better functional outcomes?&#xD;
&#xD;
        3. Are complications and costs associated with repair comparable between surgical&#xD;
           techniques?&#xD;
&#xD;
      The null hypothesis is that there will be no difference between the treatment groups in terms&#xD;
      of reduction and functional testing.&#xD;
&#xD;
      The scientific aims of this study are to compare:&#xD;
&#xD;
        1. anatomic (open) reduction between the two groups using CT scan and plain radiographs.&#xD;
&#xD;
        2. post-operative pain and functional performance in each group.&#xD;
&#xD;
        3. rates of complications and costs for each method of fixation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>anatomic reduction between the two groups using CT scan and plain radiographs.</measure>
    <time_frame>3 months</time_frame>
    <description>anatomic reduction between the two groups using CT scan and plain radiographs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post-operative pain</measure>
    <time_frame>6 weeks, 3, 6, 12 months</time_frame>
    <description>evaluated by means of patient completed visual analogue scale and questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional performance</measure>
    <time_frame>6 weeks, 3,6 12 months</time_frame>
    <description>patients will complete validated self administered functional outcome, pain and quality of life questionnaires at the time of study enrolment and at 6 weeks, 3, 6 and 12 months following enrolment. Questionnaires will include a generic health status measurement instrument (EQ-5D) and a disease specific outcome measure (Foot and Ankle Disability Index (FADI)). The EQ5D is widely used to describe the extent to which patients are having a problem in each of 5 dimensions of health (mobility, ability to self care, usual activities, pain, and anxiety/depression). The FADI is designed to assess functional limitations related to foot and ankle conditions. It captures activities of daily living and more difficult tasks essential to sport activity (FADI Sport).&#xD;
In addition, the AAOS Hindfoot Score will be completed by the surgeon. This score assesses pain, function, alignment, stability and motion. Patients will be asked if they have returned to work with modified duties etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Ankle Fractures</condition>
  <arm_group>
    <arm_group_label>Open Reduction Tightrope fixation (OT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Reduction screw fixation (OS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Open reduction Tightrope fixation</intervention_name>
    <description>Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)</description>
    <arm_group_label>Open Reduction Tightrope fixation (OT)</arm_group_label>
    <other_name>Athrex tightrope</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>open reduction screw fixation</intervention_name>
    <description>Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)</description>
    <arm_group_label>Open Reduction screw fixation (OS)</arm_group_label>
    <other_name>syndesmosis screw fixation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female 18yrs with a diagnosis of a closed Weber C ankle (OTA 44.C1, 44.C2,&#xD;
             44.C3) fracture.&#xD;
&#xD;
          2. Randomization and treatment of syndesmosis injury within 14 days of the date of&#xD;
             injury.&#xD;
&#xD;
          3. Demonstrates lateral subluxation of talus on x-ray or stress views. Talar shift &gt; 1mm&#xD;
             or medial clear space widening ≥ 5mm (unstable)&#xD;
&#xD;
          4. No history of previous severe ankle injury, pathologic fracture, ligamentous laxity,&#xD;
             no prior diagnosis or current treatment of osteoporosis or metabolic bone disease.&#xD;
&#xD;
          5. No concurrent injury that is deemed by the treating surgeon to delay or alter the&#xD;
             rehabilitation protocol for the ankle injury.&#xD;
&#xD;
          6. No neuromuscular or sensory deficiency.&#xD;
&#xD;
          7. Able to understand and complete assessments&#xD;
&#xD;
          8. Provision of Informed Consent&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Age &lt; 18 years&#xD;
&#xD;
          2. Open fracture or pathological fracture.&#xD;
&#xD;
          3. Talar shift &lt; 1mm or medial clear space widening &lt; 5mm (stable)&#xD;
&#xD;
          4. Prior diagnosis or current treatment for osteoporosis or metabolic bone disease.&#xD;
&#xD;
          5. Concurrent injury that is deemed by the treating surgeon to delay or alter the&#xD;
             rehabilitation protocol for the ankle injury.&#xD;
&#xD;
          6. Prior diagnosis or treatment for neuromuscular disease or sensory deficiency (i.e.&#xD;
             diabetic neuropathy).&#xD;
&#xD;
          7. Likely problems, in the judgment of the investigator, with maintaining follow-up (i.e.&#xD;
             patients with no fixed address, patients incapable of providing informed consent,&#xD;
             prisoners etc.).&#xD;
&#xD;
          8. Patients who are currently pregnant or planning to become pregnant during the study&#xD;
             duration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Sanders, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>February 7, 2018</last_update_submitted>
  <last_update_submitted_qc>February 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>David Sanders</investigator_full_name>
    <investigator_title>Md, FRCSC</investigator_title>
  </responsible_party>
  <keyword>open anatomic reduction</keyword>
  <keyword>syndesmosis screw fixation, syndesmosis Tightrope fixation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ankle Fractures</mesh_term>
  </condition_browse>
  <!-- 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/NCT02199249
org study id: 105500
nct id: NCT02199249
lead sponsor: 
collaborator: 
has dmc: No
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is
      assumed to disrupt the syndesmotic ligaments.

      The goal of operative treatment is to reduce the ankle mortise to restore normal joint
      kinematics. Syndesmosis repair can be performed using either open or closed reduction,
      combined with fixation between the distal tibia and fibula. Closed fixation has demonstrated
      high rates of non anatomic reductions greater than 40%; therefore, open reduction will be
      performed in this study. Screw fixation is stable but concerns exist regarding potential
      excess rigidity.

      Recently, flexible fixation techniques combined with anatomic reduction have demonstrated
      improvements in functional outcomes and reduction quality. Both open reduction and flexible
      TightRope fixation have considerable support in the literature in cohort studies but have not
      been compared to open screw fixation in a randomized controlled trial.

      In this multi centre randomized study, radiographic, economic and functional outcomes are
      compared between [open reduction, flexible Tightrope syndesmosis fixation (OT)] and [open
      reduction screw fixation (OS)] of the syndesmosis.
Tibia-fibular syndesmosis injury occurs in a significant proportion of ankle injuries and is
      assumed to disrupt the syndesmotic ligaments. The goal of operative treatment is to reduce
      the ankle mortise to restore normal joint kinematics. Syndesmosis repair can be performed
      using either open or closed reduction, combined with fixation between the distal tibia and
      fibula. Closed fixation has demonstrated high rates of non anatomic reductions greater than
      40%; therefore, open reduction will be performed in this study. Screw fixation is stable but
      concerns exist regarding potential excess rigidity.

      Recently, flexible fixation techniques combined with anatomic reduction have demonstrated
      improvements in functional outcomes and reduction quality. Both open reduction and flexible
      TightRope fixation have considerable support in the literature in cohort studies but have not
      been compared to open screw fixation in a randomized controlled trial.

      This study is a multi centre randomized controlled trial comparing clinical, economic and
      functional outcomes between open reduction, flexible Tightrope syndesmosis fixation (OT) to
      open reduction rigid screw fixation (OS) for syndesmotic injuries in high ankle fractures,
      involving the fibula 1 cm above the level of the syndesmosis (Weber C (OTA 44.C1, 44.C2,
      44C3)).

      We anticipate recruiting 72 patients (36 in each arm) from up to 20 clinical sites across
      North America. Post operative follow up will occur at 2 and 6 weeks, 3, 6, and 12 months. At
      each follow up, radiographic and functional outcomes will be assessed as well as
      documentation of costs associated with treatment and rehabilitation.

      The research questions that this study will answer include the following:

        1. Does open reduction and repair with TightRope syndesmosis fixation (OT) provide better
           reduction compared to open reduction and syndesmosis screw fixation (OS)?

        2. Which surgical technique provides better functional outcomes?

        3. Are complications and costs associated with repair comparable between surgical
           techniques?

      The null hypothesis is that there will be no difference between the treatment groups in terms
      of reduction and functional testing.

      The scientific aims of this study are to compare:

        1. anatomic (open) reduction between the two groups using CT scan and plain radiographs.

        2. post-operative pain and functional performance in each group.

        3. rates of complications and costs for each method of fixation.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: anatomic reduction between the two groups using CT scan and plain radiographs.
time frame: 3 months
description: anatomic reduction between the two groups using CT scan and plain radiographs
measure: post-operative pain
time frame: 6 weeks, 3, 6, 12 months
description: evaluated by means of patient completed visual analogue scale and questionnaires
measure: functional performance
time frame: 6 weeks, 3,6 12 months
description: patients will complete validated self administered functional outcome, pain and quality of life questionnaires at the time of study enrolment and at 6 weeks, 3, 6 and 12 months following enrolment. Questionnaires will include a generic health status measurement instrument (EQ-5D) and a disease specific outcome measure (Foot and Ankle Disability Index (FADI)). The EQ5D is widely used to describe the extent to which patients are having a problem in each of 5 dimensions of health (mobility, ability to self care, usual activities, pain, and anxiety/depression). The FADI is designed to assess functional limitations related to foot and ankle conditions. It captures activities of daily living and more difficult tasks essential to sport activity (FADI Sport).
In addition, the AAOS Hindfoot Score will be completed by the surgeon. This score assesses pain, function, alignment, stability and motion. Patients will be asked if they have returned to work with modified duties etc.
arm group label: Open Reduction Tightrope fixation (OT)
arm group type: Active Comparator
description: Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)
arm group label: Open Reduction screw fixation (OS)
arm group type: Active Comparator
description: Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)
intervention type: Device
intervention name: Open reduction Tightrope fixation
description: Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)
arm group label: Open Reduction Tightrope fixation (OT)
other name: Athrex tightrope
intervention type: Device
intervention name: open reduction screw fixation
description: Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)
arm group label: Open Reduction screw fixation (OS)
other name: syndesmosis screw fixation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Sanders, MD
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: David Sanders
investigator title: Md, FRCSC
mesh term: Ankle Fractures