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/NCT06003296</url>
    </required_header>
    <id_info>
      <org_study_id>Calcaneocuboid arthrodesis</org_study_id>
      <nct_id>NCT06003296</nct_id>
    </id_info>
    <brief_title>Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial</brief_title>
    <official_title>Calcaneocuboid Arthrodesis in Triple Arthrodesis by Plate Versus Screw: Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Investigators aim to compare clinical and radiological outcome of use of plate versus screw&#xD;
        fixation for calcaneocuboid arthrodesis in adult population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The calcaneocuboid joint is stable, even although multiple conditions might affect the joint,&#xD;
        ranging from osteoarthritis to fracture, subluxation, and dislocation. Calcaneocuboid&#xD;
        arthrodesis is more commonly performed as an adjunct procedure with other rearfoot procedures&#xD;
        such as triple arthrodesis and is less used as isolated fusion.[1],[2],[3] What the most&#xD;
        effective and least cost method for calcaneocuboid arthrodesis?! Many conditions that may&#xD;
        affect foot that cause pain ; and there are many methods for relieve that pain , one of these&#xD;
        is arthrodesis , and calcaneocuboid joint one of the most affected joints , and commonly we&#xD;
        do calcaneocuboid arthrodesis as a part of triple arthrodesis ( subtalar , talonavicular ,&#xD;
        calcaneocuboid ); The traditional fixation for a calcaneocuboid (CC) arthrodesis in triple&#xD;
        arthrodesis is with a 6.5-mm cancellous screw. This procedure can be technically challenging.&#xD;
        Fixation with a locking compression plate (LCP) may be easier to perform while achieving&#xD;
        compression perpendicular to the fusion site. Investigators suppose that plate is more&#xD;
        powerful than screw in calcaneocuboid arthrodesis. The purpose of this study was to compare&#xD;
        the load to failure and the stiffness for each fixation method. [4],[5],[6] literature reveal&#xD;
        that: More stability to the fusion site can be applied by using plate fixation. Rationale of&#xD;
        the research that: calcaneocuboid arthrodesis with screw is effective and least cost compare&#xD;
        to plate fixation? [7]&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assess calcaneocuboid arthrodesis union</measure>
      <time_frame>One year</time_frame>
      <description>calcaneocuboid arthrodesis union by RUST score</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">3</enrollment>
    <condition>Calcaneocuboid Osteoarthritis Secondary to Trauma</condition>
    <arm_group>
      <arm_group_label>Screw fixation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Calcaneocuboid arthrodesis</intervention_name>
      <description>Calcaneocuboid arthrodesis in triple arthrodesis</description>
      <arm_group_label>Screw fixation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          all patients who will be operated by calcaneocuboid fusion for any indication age range&#xD;
          18-65 no paralytic patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt; 18 , &gt; 65 acute calcaneal fracture infection non union bone defect that need&#xD;
               bone graft refusing to participate in the study neuropathic patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abdelrazik Talaat</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abdelrazik Talaat</last_name>
      <phone>01015828696</phone>
      <email>Abdelraziktalaat@med.aun.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amr A. Elfadle</last_name>
      <phone>01007788699</phone>
      <email>Amr.a.mohamed@aun.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Assiut University</name>
        <address>
          <city>Assiut</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abdelrazik Talaat</last_name>
        <phone>01015828696</phone>
        <email>Abdelraziktalaat@med.aun.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Abdelrazik Talaat Abdelrazik Khalifa</investigator_full_name>
      <investigator_title>Assiut</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</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/NCT06003296
  org study id: Calcaneocuboid arthrodesis
  nct id: NCT06003296
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Investigators aim to compare clinical and radiological outcome of use of plate versus screw
        fixation for calcaneocuboid arthrodesis in adult population.
  The calcaneocuboid joint is stable, even although multiple conditions might affect the joint,
        ranging from osteoarthritis to fracture, subluxation, and dislocation. Calcaneocuboid
        arthrodesis is more commonly performed as an adjunct procedure with other rearfoot procedures
        such as triple arthrodesis and is less used as isolated fusion.[1],[2],[3] What the most
        effective and least cost method for calcaneocuboid arthrodesis?! Many conditions that may
        affect foot that cause pain ; and there are many methods for relieve that pain , one of these
        is arthrodesis , and calcaneocuboid joint one of the most affected joints , and commonly we
        do calcaneocuboid arthrodesis as a part of triple arthrodesis ( subtalar , talonavicular ,
        calcaneocuboid ); The traditional fixation for a calcaneocuboid (CC) arthrodesis in triple
        arthrodesis is with a 6.5-mm cancellous screw. This procedure can be technically challenging.
        Fixation with a locking compression plate (LCP) may be easier to perform while achieving
        compression perpendicular to the fusion site. Investigators suppose that plate is more
        powerful than screw in calcaneocuboid arthrodesis. The purpose of this study was to compare
        the load to failure and the stiffness for each fixation method. [4],[5],[6] literature reveal
        that: More stability to the fusion site can be applied by using plate fixation. Rationale of
        the research that: calcaneocuboid arthrodesis with screw is effective and least cost compare
        to plate fixation? [7]
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Assess calcaneocuboid arthrodesis union
  time frame: One year
  description: calcaneocuboid arthrodesis union by RUST score
  arm group label: Screw fixation
  arm group type: Other
  description: Calcaneocuboid arthrodesis in triple arthrodesis by Screw fixation
  intervention type: Procedure
  intervention name: Calcaneocuboid arthrodesis
  description: Calcaneocuboid arthrodesis in triple arthrodesis
  arm group label: Screw fixation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Abdelrazik Talaat
  role: Principal Investigator
  affiliation: Assiut University
  last name: Abdelrazik Talaat
  phone: 01015828696
  email: Abdelraziktalaat@med.aun.edu.eg
  last name: Amr A. Elfadle
  phone: 01007788699
  email: Amr.a.mohamed@aun.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Abdelrazik Talaat Abdelrazik Khalifa
  investigator title: Assiut
  mesh term: Osteoarthritis