<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/NCT03000972</url>
  </required_header>
  <id_info>
    <org_study_id>PFNA</org_study_id>
    <nct_id>NCT03000972</nct_id>
  </id_info>
  <brief_title>PFN-A Augmentation for Intertrochanteric Femoral Fractures</brief_title>
  <official_title>PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the potential negative effect of cement augmentation in the femoral head&#xD;
      on viability of the head. Half of the participants will have the standard intramedullary nail&#xD;
      (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail&#xD;
      plus cement augmentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cement augmentation is believed to increase the bone implant interface and therefore decrease&#xD;
      the risk of implant cut-out of the femoral head. The cement used in previous studies has&#xD;
      produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+)&#xD;
      is manufactured specially for this implant and for the augmentation of this implant.&#xD;
      TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat&#xD;
      necrosis. The volume effect of the cement could theoretically also damage the blood flow in&#xD;
      the femoral head. There have been no negative effects in big series of patients operated with&#xD;
      this technique.&#xD;
&#xD;
      The aim of this study is to quantify the viability of the femoral head with the use PET-CT&#xD;
      (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive&#xD;
      isotope (Fluorine-18) and the use of threedimensional computed tomography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</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>Viability of the femoral head as assessed by fluoride uptake using PET-CT</measure>
    <time_frame>4 months postoperatively</time_frame>
    <description>The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viability of the femoral head as assessed by fluoride uptake using PET-CT</measure>
    <time_frame>Within 1 week postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viability of the femoral head as assessed by fluoride uptake using PET-CT</measure>
    <time_frame>1 year postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Intertrochanteric Fracture</condition>
  <arm_group>
    <arm_group_label>Standard Nail</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Augmented Nail</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cement augmentation</intervention_name>
    <arm_group_label>Augmented Nail</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PFN-A Nail</intervention_name>
    <arm_group_label>Augmented Nail</arm_group_label>
    <arm_group_label>Standard Nail</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1&#xD;
             or AO 31-A2&#xD;
&#xD;
          -  Healthy contralateral hip&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologists) Physical Status Class I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olof Wolf, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <state>Uppsala Lan</state>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Augmentation</keyword>
  <keyword>PET-CT</keyword>
  <keyword>Positron Emission Tomography</keyword>
  <keyword>Fluorine-18</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip 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>


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/NCT03000972
org study id: PFNA
nct id: NCT03000972
lead sponsor: 
has dmc: No
This study evaluates the potential negative effect of cement augmentation in the femoral head
      on viability of the head. Half of the participants will have the standard intramedullary nail
      (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail
      plus cement augmentation.
Cement augmentation is believed to increase the bone implant interface and therefore decrease
      the risk of implant cut-out of the femoral head. The cement used in previous studies has
      produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+)
      is manufactured specially for this implant and for the augmentation of this implant.
      TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat
      necrosis. The volume effect of the cement could theoretically also damage the blood flow in
      the femoral head. There have been no negative effects in big series of patients operated with
      this technique.

      The aim of this study is to quantify the viability of the femoral head with the use PET-CT
      (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive
      isotope (Fluorine-18) and the use of threedimensional computed tomography.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Viability of the femoral head as assessed by fluoride uptake using PET-CT
time frame: 4 months postoperatively
description: The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.
measure: Viability of the femoral head as assessed by fluoride uptake using PET-CT
time frame: Within 1 week postoperatively
measure: Viability of the femoral head as assessed by fluoride uptake using PET-CT
time frame: 1 year postoperatively
measure: Harris Hip Score
time frame: 4 months
measure: Harris Hip Score
time frame: 1 year
arm group label: Standard Nail
arm group type: Active Comparator
description: Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).
arm group label: Augmented Nail
arm group type: Experimental
description: Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+
intervention type: Procedure
intervention name: Cement augmentation
arm group label: Augmented Nail
intervention type: Procedure
intervention name: PFN-A Nail
arm group label: Augmented Nail
arm group label: Standard Nail
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: No
last name: Olof Wolf, MD PhD
role: Principal Investigator
affiliation: Uppsala University Hospital
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: No