<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/NCT03818022</url>
  </required_header>
  <id_info>
    <org_study_id>TOH180</org_study_id>
    <nct_id>NCT03818022</nct_id>
  </id_info>
  <brief_title>Pain Control With Pre-operative Cryoneurolysis Following TKA</brief_title>
  <official_title>Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondren Orthopedic Group L.L.P.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 study is to assess the potential benefit of preoperative cryoneurolysis&#xD;
      in postoperative pain management of total knee arthroplasty patients over current pain&#xD;
      management protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cryoneurolysis, is a novel technique that can yield temporary blockade of superficial sensory&#xD;
      nerves, generating immediate and meaningful relief of pain.The technique generates an&#xD;
      axonotmesis of the targeted peripheral nerves by percutaneously applying low temperatures&#xD;
      (-100 °C to -20 °C). Wallerian degeneration is produced whereby the axons and the myelin&#xD;
      sheath are damaged but the endoneurium, perineurium and epineurium remain intact. Therefore,&#xD;
      permanent damage to the nerve is avoided as it retains its regenerative properties. With&#xD;
      regards to the knee, the infrapatellar branch of the saphenous nerve (IPBSN), a sensory&#xD;
      branch serving both the inferior and anterior portion of the knee capsule and the&#xD;
      antero-medial skin of the knee is the prime target for the procedure.&#xD;
&#xD;
      Your participation in this study requires that you allow the radiology department of Texas&#xD;
      Orthopedic Hospital to administer Cryoneurolysis using the Iovera device with the functional&#xD;
      smart tip approximately 1 week prior to total knee arthroplasty surgery. A highly localized&#xD;
      cold zone is created via the Joule-Thompson effect as nitrous oxide enters the needles.&#xD;
      Nothing is injected into the body and the nitrous oxide gas is vented safely out of the&#xD;
      handpiece. Cryoneurolysis is administered following local anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Veterans Rand-12 (VR-12)</measure>
    <time_frame>up to 3 months</time_frame>
    <description>VR-12 is a 12 item questionnaire that measures health related quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)</measure>
    <time_frame>up to 3 months</time_frame>
    <description>KOOS Jr. is a short questionnaire that evaluates knee pain and function. Scores range from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subject with an adverse effect from treatment</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Any complication during treatment will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>up to 3 months</time_frame>
    <description>During clinical office visits, your ability to bend and straighten your knee will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee function</measure>
    <time_frame>up to 3 months</time_frame>
    <description>During clinical office visits, your ability to perform daily activities with regards to your knee will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee swelling</measure>
    <time_frame>up to 3 months</time_frame>
    <description>The amount of swelling in your knee will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Osteo Arthritis Knee</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving Cryoneurolysis (Iovera) prior to total knee arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryoneurolysis (Iovera)</intervention_name>
    <description>Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient scheduled for primary total knee arthroplasty(TKA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral TKA (patients routinely receive spinal anesthesia)&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Patients reporting a history of Raynaud's disease&#xD;
&#xD;
          -  Patients with an open and/or infected wound on surgical knee&#xD;
&#xD;
          -  Patients who are taking opioids during the pre-operative period due to knee pain&#xD;
&#xD;
          -  Patients who cannot return for the cryoneurolysis treatment 7 days prior to surgery or&#xD;
             post-operative clinical visits&#xD;
&#xD;
          -  Patients whose insurance would deny payment for the cryoneurolysis treatment&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients unable to speak and read English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mitzi S Laughlin, PHD</last_name>
    <phone>713-799-2300</phone>
    <email>Mitzi.Laughlin@fondren.com</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</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>
  <keyword>cryoneurolysis</keyword>
  <keyword>Iovera</keyword>
  <keyword>TKA</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <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/NCT03818022
org study id: TOH180
nct id: NCT03818022
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the potential benefit of preoperative cryoneurolysis
      in postoperative pain management of total knee arthroplasty patients over current pain
      management protocol.
Cryoneurolysis, is a novel technique that can yield temporary blockade of superficial sensory
      nerves, generating immediate and meaningful relief of pain.The technique generates an
      axonotmesis of the targeted peripheral nerves by percutaneously applying low temperatures
      (-100 °C to -20 °C). Wallerian degeneration is produced whereby the axons and the myelin
      sheath are damaged but the endoneurium, perineurium and epineurium remain intact. Therefore,
      permanent damage to the nerve is avoided as it retains its regenerative properties. With
      regards to the knee, the infrapatellar branch of the saphenous nerve (IPBSN), a sensory
      branch serving both the inferior and anterior portion of the knee capsule and the
      antero-medial skin of the knee is the prime target for the procedure.

      Your participation in this study requires that you allow the radiology department of Texas
      Orthopedic Hospital to administer Cryoneurolysis using the Iovera device with the functional
      smart tip approximately 1 week prior to total knee arthroplasty surgery. A highly localized
      cold zone is created via the Joule-Thompson effect as nitrous oxide enters the needles.
      Nothing is injected into the body and the nitrous oxide gas is vented safely out of the
      handpiece. Cryoneurolysis is administered following local anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Veterans Rand-12 (VR-12)
time frame: up to 3 months
description: VR-12 is a 12 item questionnaire that measures health related quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.
measure: Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)
time frame: up to 3 months
description: KOOS Jr. is a short questionnaire that evaluates knee pain and function. Scores range from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
measure: Number of subject with an adverse effect from treatment
time frame: up to 3 months
description: Any complication during treatment will be recorded.
measure: Range of motion
time frame: up to 3 months
description: During clinical office visits, your ability to bend and straighten your knee will be recorded.
measure: Knee function
time frame: up to 3 months
description: During clinical office visits, your ability to perform daily activities with regards to your knee will be recorded.
measure: Knee swelling
time frame: up to 3 months
description: The amount of swelling in your knee will be recorded.
arm group label: Experimental
arm group type: Experimental
description: Patients receiving Cryoneurolysis (Iovera) prior to total knee arthroplasty
arm group label: Control
arm group type: No Intervention
intervention type: Procedure
intervention name: Cryoneurolysis (Iovera)
description: Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mitzi S Laughlin, PHD
phone: 713-799-2300
email: Mitzi.Laughlin@fondren.com
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee