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/NCT06032299</url>
    </required_header>
    <id_info>
      <org_study_id>22-004415</org_study_id>
      <nct_id>NCT06032299</nct_id>
    </id_info>
    <brief_title>Dual Implant Versus Single Implant Distal End of Femur</brief_title>
    <official_title>Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
        This research study is being conducted to examine the effect of two versus one fixation&#xD;
        device for fixation of distal femur fractures.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of study-eligible subjects</measure>
      <time_frame>Baseline</time_frame>
      <description>Total number of subjects to be enrolled in the study</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Operative times</measure>
      <time_frame>Duration of surgery, approximately 2-4 hours</time_frame>
      <description>Total recorded amount of time in minutes to complete the surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood loss</measure>
      <time_frame>Duration of surgery, approximately 2-4 hours</time_frame>
      <description>Total amount of surgical blood loss, reported in mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization days</measure>
      <time_frame>approximately 2-3 days</time_frame>
      <description>Total number of days a subject requires hospitalization after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early post-surgical complications</measure>
      <time_frame>2 weeks post-surgery</time_frame>
      <description>Number of subjects to experience VTE, cardiopulmonary, and/or infectious complications after surgery</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Femur Fracture</condition>
    <arm_group>
      <arm_group_label>Single Distal Femur Implant Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dual Distal Femur Implant Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Single Distal Femur Implant</intervention_name>
      <description>Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.</description>
      <arm_group_label>Single Distal Femur Implant Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dual Distal Femur Implant</intervention_name>
      <description>Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.</description>
      <arm_group_label>Dual Distal Femur Implant Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Femur fracture distal to the femoral diaphysis.&#xD;
  &#xD;
            -  Operative treatment within 72 hours of presenting to the treating hospital.&#xD;
  &#xD;
            -  Patient was previously ambulatory.&#xD;
  &#xD;
            -  Fracture amendable to either single or dual implant fixation.&#xD;
  &#xD;
            -  Informed consent can be obtained from the patient, family member, or power of&#xD;
               attorney.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Associated major lower extremity fracture.&#xD;
  &#xD;
            -  Ongoing infection.&#xD;
  &#xD;
            -  History of metabolic bone disease (Paget's, etc).&#xD;
  &#xD;
            -  Pathologic fracture.&#xD;
  &#xD;
            -  Open fracture.&#xD;
  &#xD;
            -  Severe cognitive impairment (Six Item Screener with 3 or more errors).&#xD;
  &#xD;
            -  Stage 5 Parkinson's disease.&#xD;
  &#xD;
            -  Significant femoral bone loss requiring planned staged bone grafting.&#xD;
  &#xD;
            -  Vascular injury.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brandon Yuan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Clinic Minnesota</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Brandon James Yuan</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Femoral Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06032299
  org study id: 22-004415
  nct id: NCT06032299
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research study is being conducted to examine the effect of two versus one fixation
        device for fixation of distal femur fractures.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of study-eligible subjects
  time frame: Baseline
  description: Total number of subjects to be enrolled in the study
  measure: Operative times
  time frame: Duration of surgery, approximately 2-4 hours
  description: Total recorded amount of time in minutes to complete the surgery
  measure: Blood loss
  time frame: Duration of surgery, approximately 2-4 hours
  description: Total amount of surgical blood loss, reported in mL.
  measure: Hospitalization days
  time frame: approximately 2-3 days
  description: Total number of days a subject requires hospitalization after surgery
  measure: Early post-surgical complications
  time frame: 2 weeks post-surgery
  description: Number of subjects to experience VTE, cardiopulmonary, and/or infectious complications after surgery
  arm group label: Single Distal Femur Implant Group
  arm group type: Active Comparator
  description: Subjects will receive one of two types of implants for the distal femur fracture. The single implant will be either a plate and screws or a rod. The type of single implant used will be determined by the surgeon based on the characteristics of the fracture.
  arm group label: Dual Distal Femur Implant Group
  arm group type: Experimental
  description: Subjects will receive two implants for fixation of the distal femur fracture. The dual implant will be either 2 plates with screws or a plate with screws and a rod. The type of dual implant used will be determined by the surgeon based on the characteristics of the fracture.
  intervention type: Procedure
  intervention name: Single Distal Femur Implant
  description: Single implant constructs will be either a retrograde intramedullary nail with interlocking screws or a single plate and screw construct.
  arm group label: Single Distal Femur Implant Group
  intervention type: Procedure
  intervention name: Dual Distal Femur Implant
  description: Dual implant constructs will either be an intramedullary nail with an additional plate and screw construct or dual (two plates in any orientation) plate and screw construct.
  arm group label: Dual Distal Femur Implant Group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brandon Yuan, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  facility: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Brandon James Yuan
  investigator title: Principal Investigator
  mesh term: Femoral Fractures
  sharing ipd: No