<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/NCT03816124</url>
  </required_header>
  <id_info>
    <org_study_id>09.2018.663</org_study_id>
    <nct_id>NCT03816124</nct_id>
  </id_info>
  <brief_title>The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis</brief_title>
  <official_title>The Effect of Radiofrequency Ablation of Genicular Nerves on Postural Stability in Patients With Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</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>
      In advanced knee osteoarthritis, postural stability is also disturbed. There are some&#xD;
      concerns about performing radiofrequency ablation to genicular nerves since this may further&#xD;
      decrease the postural stability of the patient. The aim of this study is to see if&#xD;
      application of genicular radiofrequency causes a significant change in postural stability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Patients with knee osteoarthritis with Kellgren-Lawrance scale stage 3-4 will receive radiofrequency ablation to their genicular nerves and will be evaluated before treatment, 3 weeks and 3 months after treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue scale</measure>
    <time_frame>3 weeks and 3 months after the intervention</time_frame>
    <description>The change of pain will be evaluated with 10 cm visual analogue scale will be applied to the patients, 0 being no pain while 10 being intolerable pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postural stability</measure>
    <time_frame>3 weeks and 3 months after the treatment</time_frame>
    <description>The change of weight bearing indexes of both feet will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC</measure>
    <time_frame>3 weeks and 3 months after the treatment</time_frame>
    <description>Western Ontario &amp; McMaster Universities Osteoarthritis Index</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Genicular RF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who will receive genicular radiofrequency ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency ablation</intervention_name>
    <description>radiofrequency ablation of the genicular nerves</description>
    <arm_group_label>Genicular RF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage 3 and 4 knee osteoarthritis according to Kellgren-Lawrance scale&#xD;
&#xD;
          -  Knee pain more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological diseases such as polyneuropathies&#xD;
&#xD;
          -  Presence of severe psychiatric disorders&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  History of any surgery from the knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marmara University School of Medicine Department of Physical Medicine and Rehabilitation</name>
      <address>
        <city>Istanbul</city>
        <zip>34899</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ozge Kenis-Coskun, MD</last_name>
      <phone>5058294947</phone>
      <email>ozgekenis@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>radiofrequency ablation</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>
  <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/NCT03816124
org study id: 09.2018.663
nct id: NCT03816124
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In advanced knee osteoarthritis, postural stability is also disturbed. There are some
      concerns about performing radiofrequency ablation to genicular nerves since this may further
      decrease the postural stability of the patient. The aim of this study is to see if
      application of genicular radiofrequency causes a significant change in postural stability.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients with knee osteoarthritis with Kellgren-Lawrance scale stage 3-4 will receive radiofrequency ablation to their genicular nerves and will be evaluated before treatment, 3 weeks and 3 months after treatment.
primary purpose: Treatment
masking: None (Open Label)
measure: Visual analogue scale
time frame: 3 weeks and 3 months after the intervention
description: The change of pain will be evaluated with 10 cm visual analogue scale will be applied to the patients, 0 being no pain while 10 being intolerable pain
measure: Postural stability
time frame: 3 weeks and 3 months after the treatment
description: The change of weight bearing indexes of both feet will be measured
measure: WOMAC
time frame: 3 weeks and 3 months after the treatment
description: Western Ontario & McMaster Universities Osteoarthritis Index
arm group label: Genicular RF
arm group type: Experimental
description: Patients who will receive genicular radiofrequency ablation
intervention type: Procedure
intervention name: radiofrequency ablation
description: radiofrequency ablation of the genicular nerves
arm group label: Genicular RF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No