<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/NCT02262988</url>
  </required_header>
  <id_info>
    <org_study_id>FOG-TOH175</org_study_id>
    <nct_id>NCT02262988</nct_id>
  </id_info>
  <brief_title>Thigh Pain After Total Knee Arthroplasty (TKA)</brief_title>
  <official_title>Thigh Pain After Total Knee Arthroplasty (TKA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondren Orthopedic Group L.L.P.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>InGeneron, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondren Orthopedic Group L.L.P.</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>
      The purpose of this research study is to evaluate the cause of thigh pain after knee&#xD;
      replacement. Different surgical techniques will be used to help determine the cause of thigh&#xD;
      pain, and all surgical techniques are accepted and produce good clinical results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study will be a randomized study in which patients volunteer participate.&#xD;
      &quot;Randomized&quot; means the patients who received the new treatment are chosen at random, similar&#xD;
      to flipping a coin. Several factors have been identified as possible sources of thigh pain&#xD;
      after surgery: use of a tourniquet around the thigh to control bleeding during surgery; use&#xD;
      of an intramedullary rod during surgery or quadriceps muscle strain. Participants will be&#xD;
      randomized into surgical groups that use/do not use a tourniquet and use/do not use&#xD;
      intramedullary rod during surgery. A subset of participants in all surgical groups will have&#xD;
      a MRI to look for quadriceps muscle strain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcomes Survey (KOOS)</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scores on Numerical Rating Scale</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Pain scale from 0-10 with 0 representing no pain and 10 representing maximum pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Physician evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Range of Motion</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Goniometer measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients with Adverse Events as a Measure of Safety</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Adverse events</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Tourniquet used with intramedullary rod</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo a total knee replacement with a tourniquet and intramedullary rod.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No tourniquet with intramedullary rod</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo a total knee replacement without a tourniquet and with an intramedullary rod.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tourniquet without intramedullary rod</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo a total knee replacement with a tourniquet and without an intramedullary rod.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No tourniquet without intramedullary rod</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo a total knee replacement without a tourniquet nor an intramedullary rod.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total knee replacement</intervention_name>
    <description>Total knee replacement (TKA)</description>
    <arm_group_label>No tourniquet with intramedullary rod</arm_group_label>
    <arm_group_label>No tourniquet without intramedullary rod</arm_group_label>
    <arm_group_label>Tourniquet used with intramedullary rod</arm_group_label>
    <arm_group_label>Tourniquet without intramedullary rod</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects undergoing total knee arthroplasty for osteoarthritis&#xD;
&#xD;
          -  Adult patients (age 18 years or older)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Ability to speak, read and write English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak, read and write English or Spanish&#xD;
&#xD;
          -  Evidence of malignant disorder/neoplasm in past 60 months&#xD;
&#xD;
          -  Contraindication for removal of infrapatellar fat pad&#xD;
&#xD;
          -  History of smoking and not committed to give up&#xD;
&#xD;
          -  Chronic skin conditions&#xD;
&#xD;
          -  Connective, metabolic or skin disease&#xD;
&#xD;
          -  Evidence of active infection&#xD;
&#xD;
          -  Pregnancy or lactating for female subjects&#xD;
&#xD;
          -  Current corticosteroid use&#xD;
&#xD;
          -  Immunosuppressive medication&#xD;
&#xD;
          -  Renal failure (creatine &gt; 1.8 mg/dL)&#xD;
&#xD;
          -  Hepatic failure (AST, ALT &gt; 2x normal values; bilirubin &gt; 2 mg/dL)&#xD;
&#xD;
          -  Inflammatory joint diseases of the knee that indicate additional, conflating therapies&#xD;
&#xD;
          -  Joint infection within the past 6 months&#xD;
&#xD;
          -  No prisoners or mentally disabled persons&#xD;
&#xD;
          -  No Workers' Compensation cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory W Stocks, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondren Orthopedic Group L.L.P.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondren Orthopedic Group, L.L.P.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>joint replacement</keyword>
  <keyword>total knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- 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/NCT02262988
org study id: FOG-TOH175
nct id: NCT02262988
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to evaluate the cause of thigh pain after knee
      replacement. Different surgical techniques will be used to help determine the cause of thigh
      pain, and all surgical techniques are accepted and produce good clinical results.
This research study will be a randomized study in which patients volunteer participate.
      "Randomized" means the patients who received the new treatment are chosen at random, similar
      to flipping a coin. Several factors have been identified as possible sources of thigh pain
      after surgery: use of a tourniquet around the thigh to control bleeding during surgery; use
      of an intramedullary rod during surgery or quadriceps muscle strain. Participants will be
      randomized into surgical groups that use/do not use a tourniquet and use/do not use
      intramedullary rod during surgery. A subset of participants in all surgical groups will have
      a MRI to look for quadriceps muscle strain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
time frame: up to 3 months
description: Survey
measure: Pain Scores on Numerical Rating Scale
time frame: up to 3 months
description: Pain scale from 0-10 with 0 representing no pain and 10 representing maximum pain.
measure: Knee swelling
time frame: up to 3 months
description: Physician evaluation
measure: Knee Range of Motion
time frame: up to 3 months
description: Goniometer measurement
measure: Number of Patients with Adverse Events as a Measure of Safety
time frame: up to 3 months
description: Adverse events
arm group label: Tourniquet used with intramedullary rod
arm group type: Experimental
description: Patients will undergo a total knee replacement with a tourniquet and intramedullary rod.
arm group label: No tourniquet with intramedullary rod
arm group type: Experimental
description: Patients will undergo a total knee replacement without a tourniquet and with an intramedullary rod.
arm group label: Tourniquet without intramedullary rod
arm group type: Experimental
description: Patients will undergo a total knee replacement with a tourniquet and without an intramedullary rod.
arm group label: No tourniquet without intramedullary rod
arm group type: Experimental
description: Patients will undergo a total knee replacement without a tourniquet nor an intramedullary rod.
intervention type: Procedure
intervention name: Total knee replacement
description: Total knee replacement (TKA)
arm group label: No tourniquet with intramedullary rod
arm group label: No tourniquet without intramedullary rod
arm group label: Tourniquet used with intramedullary rod
arm group label: Tourniquet without intramedullary rod
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory W Stocks, MD
role: Principal Investigator
affiliation: Fondren Orthopedic Group L.L.P.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee