xml: <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/NCT06005090</url>
    </required_header>
    <id_info>
      <org_study_id>2012-KAEK-15/2103</org_study_id>
      <nct_id>NCT06005090</nct_id>
    </id_info>
    <brief_title>Is Far Cortical Locking More Effective Than Bicortical Locking in Treating AO 43A1-3 Fractures?</brief_title>
    <official_title>A Comparison of the Effects of Bicortical Locking and Far Cortical Locking Techniques on Clinical, Functional and Radiological Results During Minimally Invasive Plate Osteosynthesis of Tibial Distal Metaphyseal Fracture</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi</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>
        Delayed union or nonunion, which is a common complication of periarticular fractures repaired&#xD;
        with angled locking plate systems, may be due to the unintentionally rigid formation of this&#xD;
        system. This study aimed to compare the results of the treatment of distal tibial fractures&#xD;
        made more flexible using the far cortical locking (FCL) technique with the classical&#xD;
        bicortical locking screw (BL) technique.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Extra-articular distal tibia fractures are uncommon; it constitutes less than 10% of all&#xD;
        lower extremity fractures, but even if the fracture is closed, contusion and fracture&#xD;
        blisters may accompany these fractures, which can be very effective in deciding the type of&#xD;
        treatment because the soft tissue envelope surrounding the tibia is very thin. Discussions on&#xD;
        the method of fixation of these fractures continue and seem to never end. Since comparative&#xD;
        studies with two popular methods, intra-medullary nailing (IMN) and minimally invasive plate&#xD;
        osteosynthesis (MIPO), eventually yielded similar results, the choice based on experience and&#xD;
        patient-specific characteristics, described as surgeon comfort, has been more accepted.&#xD;
  &#xD;
        Malunion after IMN is a common problem and may be caused by the gradual enlargement of the&#xD;
        canal after the isthmus or the incomplete centering of the proximal insertion site of the&#xD;
        nail. On the contrary, the most common complications reported after MIPO are delayed union,&#xD;
        nonunion and infection. In the MIPO technique, angle-stable locked plates are used, which can&#xD;
        prevent shear displacement and provide more than 0.2 mm of axial interfragmentary movement,&#xD;
        allowing the formation of natural callus tissue. Different methods can be applied to make the&#xD;
        partially rigid mechanical environment created by these plates more flexible. These can be&#xD;
        diaphyseal fixation with conventional non-locking screws or far cortical locking (FCL),&#xD;
        lengthening the bridging plate, or dynamizing the plate with active plates. The FCL method,&#xD;
        which changes the axial load with the more parallel interfragmentary method and provides&#xD;
        progressive symmetrical mineralization of the callus tissue, is based on the principle that a&#xD;
        system that works like an external fixator but works as an internal fixator.&#xD;
  &#xD;
        It is thought that this method, which can be defined biomechanically in this way, can prevent&#xD;
        the formation of insufficient callus, which may occur especially between plate and bone, in&#xD;
        the treatment of periarticular fractures. However, studies on this subject are insufficient&#xD;
        in number. Therefore, we aimed to compare the radiological and clinical results of two&#xD;
        different diaphyseal fixation models that we performed in the treatment of extra-articular&#xD;
        distal tibial metaphyseal fractures with the MIPO method. Our hypothesis is that fixation&#xD;
        with the FCL method will provide faster complete union compared to the classical locking&#xD;
        plate technique, where the diaphyseal fixation is fixed at all three points with locking&#xD;
        screws.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2020</start_date>
    <completion_date type="Actual">March 6, 2023</completion_date>
    <primary_completion_date type="Actual">May 30, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>RUST score</measure>
      <time_frame>between 1.5, 6, 9th month and 12th month control</time_frame>
      <description>Radiological Union Score of Tibia with a maximum of 12 points which means full union of all cortices</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>AOFAS scores</measure>
      <time_frame>between 1.5, 6, 9th month and 12th month control</time_frame>
      <description>American Orthopedic Foot and Ankle Society scores range from 0 to 100, with healthy ankles receiving 100 points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Johner and Wruhs' Criteria</measure>
      <time_frame>at 12th month control</time_frame>
      <description>final functional evaluation of the ankle that includes the conditions of union and infection, as well as deformity and mobility, categorizes patients as excellent, good, fair, and poor.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">26</enrollment>
    <condition>Tibia Distal Fracture</condition>
    <condition>Nonunion of Fracture of Tibia</condition>
    <arm_group>
      <arm_group_label>FCL group</arm_group_label>
      <description>Plate fixation performed with the use of far cortical locking (2 point screw fixation into the plate and far cortex of the diaphysis)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BL group</arm_group_label>
      <description>Traditional 3 point fixation of the screw into two cortices of the diaphysis and into the plate</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Far Cortical Locking Technique</intervention_name>
      <description>Apart from the traditional 3 point fixation of the locking screw this technique compromises two point fixation of the screw where one into the plate and the other is into the far cortex of the diaphysis. The near cortex was widened by 3.2 mm of dirll bit to eliminate the fixation of the screw into the near cortex</description>
      <arm_group_label>FCL group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Skeletally mature patients with closed extra articular AO 43A1-3 distal tibial fractures&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  closed extra articular AO 43A1-3 distal tibial fractures&#xD;
  &#xD;
            -  Skeletally mature patients&#xD;
  &#xD;
            -  giving informed consent&#xD;
  &#xD;
            -  competent neurological and vascular status&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  open fractures&#xD;
  &#xD;
            -  intraarticular extension,&#xD;
  &#xD;
            -  pathological fractures&#xD;
  &#xD;
            -  with poor medical health&#xD;
  &#xD;
            -  patients with deep abrasion or extensive skin contusion and crush injury preventing&#xD;
               one-satge MIPPO&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Keçiören SUAM</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
      <investigator_full_name>İsmail Demirkale</investigator_full_name>
      <investigator_title>Clinical professor</investigator_title>
    </responsible_party>
    <keyword>Extra-articular</keyword>
    <keyword>distal tibia</keyword>
    <keyword>MIPO</keyword>
    <keyword>far cortical locking</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Fractures, Ununited</mesh_term>
      <mesh_term>Tibial Fractures</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005090
  org study id: 2012-KAEK-15/2103
  nct id: NCT06005090
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Delayed union or nonunion, which is a common complication of periarticular fractures repaired
        with angled locking plate systems, may be due to the unintentionally rigid formation of this
        system. This study aimed to compare the results of the treatment of distal tibial fractures
        made more flexible using the far cortical locking (FCL) technique with the classical
        bicortical locking screw (BL) technique.
  Extra-articular distal tibia fractures are uncommon; it constitutes less than 10% of all
        lower extremity fractures, but even if the fracture is closed, contusion and fracture
        blisters may accompany these fractures, which can be very effective in deciding the type of
        treatment because the soft tissue envelope surrounding the tibia is very thin. Discussions on
        the method of fixation of these fractures continue and seem to never end. Since comparative
        studies with two popular methods, intra-medullary nailing (IMN) and minimally invasive plate
        osteosynthesis (MIPO), eventually yielded similar results, the choice based on experience and
        patient-specific characteristics, described as surgeon comfort, has been more accepted.
  
        Malunion after IMN is a common problem and may be caused by the gradual enlargement of the
        canal after the isthmus or the incomplete centering of the proximal insertion site of the
        nail. On the contrary, the most common complications reported after MIPO are delayed union,
        nonunion and infection. In the MIPO technique, angle-stable locked plates are used, which can
        prevent shear displacement and provide more than 0.2 mm of axial interfragmentary movement,
        allowing the formation of natural callus tissue. Different methods can be applied to make the
        partially rigid mechanical environment created by these plates more flexible. These can be
        diaphyseal fixation with conventional non-locking screws or far cortical locking (FCL),
        lengthening the bridging plate, or dynamizing the plate with active plates. The FCL method,
        which changes the axial load with the more parallel interfragmentary method and provides
        progressive symmetrical mineralization of the callus tissue, is based on the principle that a
        system that works like an external fixator but works as an internal fixator.
  
        It is thought that this method, which can be defined biomechanically in this way, can prevent
        the formation of insufficient callus, which may occur especially between plate and bone, in
        the treatment of periarticular fractures. However, studies on this subject are insufficient
        in number. Therefore, we aimed to compare the radiological and clinical results of two
        different diaphyseal fixation models that we performed in the treatment of extra-articular
        distal tibial metaphyseal fractures with the MIPO method. Our hypothesis is that fixation
        with the FCL method will provide faster complete union compared to the classical locking
        plate technique, where the diaphyseal fixation is fixed at all three points with locking
        screws.
  observational model: Case-Control
  time perspective: Retrospective
  measure: RUST score
  time frame: between 1.5, 6, 9th month and 12th month control
  description: Radiological Union Score of Tibia with a maximum of 12 points which means full union of all cortices
  measure: AOFAS scores
  time frame: between 1.5, 6, 9th month and 12th month control
  description: American Orthopedic Foot and Ankle Society scores range from 0 to 100, with healthy ankles receiving 100 points
  measure: Johner and Wruhs' Criteria
  time frame: at 12th month control
  description: final functional evaluation of the ankle that includes the conditions of union and infection, as well as deformity and mobility, categorizes patients as excellent, good, fair, and poor.
  arm group label: FCL group
  description: Plate fixation performed with the use of far cortical locking (2 point screw fixation into the plate and far cortex of the diaphysis)
  arm group label: BL group
  description: Traditional 3 point fixation of the screw into two cortices of the diaphysis and into the plate
  intervention type: Procedure
  intervention name: Far Cortical Locking Technique
  description: Apart from the traditional 3 point fixation of the locking screw this technique compromises two point fixation of the screw where one into the plate and the other is into the far cortex of the diaphysis. The near cortex was widened by 3.2 mm of dirll bit to eliminate the fixation of the screw into the near cortex
  arm group label: FCL group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi
  investigator full name: İsmail Demirkale
  investigator title: Clinical professor
  mesh term: Fractures, Bone
  mesh term: Fractures, Ununited
  mesh term: Tibial Fractures