<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/NCT03042533</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001680</org_study_id>
    <nct_id>NCT03042533</nct_id>
  </id_info>
  <brief_title>Union Rate of Transverse Tibia Fracture</brief_title>
  <official_title>Union Rates of Transverse Tibia Fractures Managed With Internal Fracture Compression Through an Intramedullary Rod Compared to Standard Backslapping or Backslapping With Dynamic Locking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare the three methods of seating a tibial nail - Backslapping or&#xD;
      Backslapping with Dynamic Locking or Internal Compression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study halted prematurely and will not resume; participants are no longer being examined or&#xD;
    receiving intervention. Low enrollment and PI leaving institution&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">May 29, 2018</completion_date>
  <primary_completion_date type="Actual">May 29, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant Blinding</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Healing of Tibia Fracture by radiographic exam</measure>
    <time_frame>One Year</time_frame>
    <description>Healing of Tibia Fracture by radiographic exam</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Closed Transverse Fracture of Shaft of Tibia</condition>
  <arm_group>
    <arm_group_label>Conventional Compression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nail will be seated using conventional compression technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Backslapping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nail will be seated using standard backslapping technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dynamic Locking with Backslapping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nail will be seated using backslapping with dynamic locking</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional Compression</intervention_name>
    <description>Method of Nail fitting</description>
    <arm_group_label>Conventional Compression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Backslapping</intervention_name>
    <description>Method of Nail fitting</description>
    <arm_group_label>Standard Backslapping</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic Locking with Backslapping</intervention_name>
    <description>Method of Nail fitting</description>
    <arm_group_label>Dynamic Locking with Backslapping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Closed Tibia Shaft Fracture Treated with an IMN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to consent due to language&#xD;
&#xD;
          -  Unlikely to follow-up for one year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claude Sagi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>May 29, 2018</last_update_submitted>
  <last_update_submitted_qc>May 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Claude Sagi</investigator_full_name>
    <investigator_title>Professor, Orthopedics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Tibial Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Currently there is no plan</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>October 28, 2019</submitted>
    <returned>November 15, 2019</returned>
    <submitted>October 20, 2022</submitted>
    <returned>August 25, 2023</returned>
    <submitted>September 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03042533
org study id: STUDY00001680
nct id: NCT03042533
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The investigators will compare the three methods of seating a tibial nail - Backslapping or
      Backslapping with Dynamic Locking or Internal Compression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Participant Blinding
measure: Healing of Tibia Fracture by radiographic exam
time frame: One Year
description: Healing of Tibia Fracture by radiographic exam
arm group label: Conventional Compression
arm group type: Active Comparator
description: Nail will be seated using conventional compression technique
arm group label: Standard Backslapping
arm group type: Active Comparator
description: Nail will be seated using standard backslapping technique
arm group label: Dynamic Locking with Backslapping
arm group type: Active Comparator
description: Nail will be seated using backslapping with dynamic locking
intervention type: Device
intervention name: Conventional Compression
description: Method of Nail fitting
arm group label: Conventional Compression
intervention type: Device
intervention name: Standard Backslapping
description: Method of Nail fitting
arm group label: Standard Backslapping
intervention type: Device
intervention name: Dynamic Locking with Backslapping
description: Method of Nail fitting
arm group label: Dynamic Locking with Backslapping
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Claude Sagi
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Claude Sagi
investigator title: Professor, Orthopedics
mesh term: Fractures, Bone
mesh term: Tibial Fractures
sharing ipd: No
ipd description: Currently there is no plan
submitted: October 28, 2019
returned: November 15, 2019
submitted: October 20, 2022
returned: August 25, 2023
submitted: September 5, 2023