<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/NCT03042546</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00002348</org_study_id>
    <nct_id>NCT03042546</nct_id>
  </id_info>
  <brief_title>Calcium Sulfate Spacer in Open Tibia Fractures</brief_title>
  <official_title>Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing&#xD;
      in these sub-segmental bone defects.&#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>Phase 4</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>Patients are blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With a Nonunion</measure>
    <time_frame>One Year</time_frame>
    <description>Radiographic healing at one year with no additional surgery</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Open tíbia Fracture With Sub-segmental Bone Loss</condition>
  <arm_group>
    <arm_group_label>Calcium Sulphate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PMMA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nothing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Sulfate</intervention_name>
    <description>Calcium Sulfate with abx will be used in the defect</description>
    <arm_group_label>Calcium Sulphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PMMA</intervention_name>
    <description>PMMA with abx will be used in the defect</description>
    <arm_group_label>PMMA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No treatment</intervention_name>
    <description>The defect will not be treated</description>
    <arm_group_label>Nothing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Open tibia shaft fracture treated with an IMN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>February 2023</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>
  <results_first_submitted>April 22, 2019</results_first_submitted>
  <results_first_submitted_qc>February 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2023</results_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>there is no plan to share individual data</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03042546/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Only enrolled patient was not randomized</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Calcium Sulphate</title>
          <description>Calcium Sulfate: Calcium Sulfate with abx will be used in the defect</description>
        </group>
        <group group_id="P2">
          <title>PMMA</title>
          <description>PMMA: PMMA with abx will be used in the defect</description>
        </group>
        <group group_id="P3">
          <title>Nothing</title>
          <description>No treatment: The defect will not be treated</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>project abandoned</population>
      <group_list>
        <group group_id="B1">
          <title>Calcium Sulphate</title>
          <description>Calcium Sulfate: Calcium Sulfate with abx will be used in the defect</description>
        </group>
        <group group_id="B2">
          <title>PMMA</title>
          <description>PMMA: PMMA with abx will be used in the defect</description>
        </group>
        <group group_id="B3">
          <title>Nothing</title>
          <description>No treatment: The defect will not be treated</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With a Nonunion</title>
        <description>Radiographic healing at one year with no additional surgery</description>
        <time_frame>One Year</time_frame>
        <population>project was abandoned as PI left institution</population>
        <group_list>
          <group group_id="O1">
            <title>Calcium Sulphate</title>
            <description>Calcium Sulfate: Calcium Sulfate with abx will be used in the defect</description>
          </group>
          <group group_id="O2">
            <title>PMMA</title>
            <description>PMMA: PMMA with abx will be used in the defect</description>
          </group>
          <group group_id="O3">
            <title>Nothing</title>
            <description>No treatment: The defect will not be treated</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With a Nonunion</title>
          <description>Radiographic healing at one year with no additional surgery</description>
          <population>project was abandoned as PI left institution</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>no one randomized or treated</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Calcium Sulphate</title>
          <description>Calcium Sulfate: Calcium Sulfate with abx will be used in the defect</description>
        </group>
        <group group_id="E2">
          <title>PMMA</title>
          <description>PMMA: PMMA with abx will be used in the defect</description>
        </group>
        <group group_id="E3">
          <title>Nothing</title>
          <description>No treatment: The defect will not be treated</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>research coordinator</name_or_title>
      <organization>Harboview</organization>
      <phone>206.744.4406</phone>
      <email>bagel@uw.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03042546
org study id: STUDY00002348
nct id: NCT03042546
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing
      in these sub-segmental bone defects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients are blinded
measure: Number of Patients With a Nonunion
time frame: One Year
description: Radiographic healing at one year with no additional surgery
arm group label: Calcium Sulphate
arm group type: Active Comparator
arm group label: PMMA
arm group type: Active Comparator
arm group label: Nothing
arm group type: Active Comparator
intervention type: Drug
intervention name: Calcium Sulfate
description: Calcium Sulfate with abx will be used in the defect
arm group label: Calcium Sulphate
intervention type: Drug
intervention name: PMMA
description: PMMA with abx will be used in the defect
arm group label: PMMA
intervention type: Other
intervention name: No treatment
description: The defect will not be treated
arm group label: Nothing
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
mesh term: Calcium
sharing ipd: No
ipd description: there is no plan to share individual data
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 