<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/NCT04472702</url>
  </required_header>
  <id_info>
    <org_study_id>1868999</org_study_id>
    <secondary_id>STUDY00005460</secondary_id>
    <nct_id>NCT04472702</nct_id>
  </id_info>
  <brief_title>Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial</brief_title>
  <official_title>Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Medical Society for Sports Medicine Collaborative Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment&#xD;
      option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical&#xD;
      guidance of choice, but uses bony landmarks to target these nerves which have variable&#xD;
      positions around the knee. Alternatively, ultrasound allows for targeting based on&#xD;
      visualization of bony landmarks, the nerves, and their accompanying vascular structures, and&#xD;
      thus may offer greater accuracy. However, there are few studies which directly compare the&#xD;
      clinical efficacy of these two guidance options. This study will compare these two options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a&#xD;
      promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is&#xD;
      the typical guidance of choice, but uses bony landmarks to target these nerves which have&#xD;
      variable positions around the knee. Alternatively, ultrasound allows for targeting based on&#xD;
      visualization of bony landmarks, the nerves, and their accompanying vascular structures, and&#xD;
      thus may offer greater accuracy. However, there are few studies which directly compare the&#xD;
      clinical efficacy of these two guidance options. Objective: To compare the effectiveness of&#xD;
      geniculate nerve cRFA on knee osteoarthritis outcomes when using either ultrasound or&#xD;
      fluoroscopic guidance. The primary outcome measures will be patient pain levels and&#xD;
      patient-reported function. The secondary outcome measures will be objective performance-based&#xD;
      functional outcomes. The exploratory outcome measures will be blood biomarkers of&#xD;
      inflammation, extracellular matrix turnover, and cartilage degradation. Methods: Knee&#xD;
      osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to&#xD;
      conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve&#xD;
      blocks will be enrolled and randomized to fluoroscopic (N=45) or ultrasound (N=45) cRFA&#xD;
      treatment arms. Baseline assessments will include 1) Numeric Pain Rating Scale, Western&#xD;
      Ontario and McMaster Universities Osteoarthritis Index, and PROMIS depression and pain&#xD;
      interference measures; 2) the Osteoarthritis Research Society International recommended&#xD;
      physical performance assessments including the 30-Second Chair Stand Test, Stair Climb Test,&#xD;
      40m Fast Paced Walk Test, Timed Up and Go Test, and Six Minute Walk Test; and 3) in a subset&#xD;
      of patients (N=24), blood biomarkers including MMP-3, IL-1β, TNF-α, COMP, and CTX-II. These&#xD;
      measures will be re-assessed at one month (pain and patient-reported function only, via phone&#xD;
      contact), three months, and 6 months after the cRFA procedure. Study endpoints will be&#xD;
      assessed using a mixed model repeated measures analysis of variance using an alpha level of&#xD;
      0.05. Statement of Relevance: Knee osteoarthritis patients are commonly treated by sports&#xD;
      medicine providers, who are typically well-trained in the use of ultrasound. Should&#xD;
      ultrasound be demonstrated as effective for cRFA, sports medicine providers would be&#xD;
      well-positioned to use relatively low-cost and accessible imaging technology to significantly&#xD;
      improve patient pain and function using cRFA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 2, 2022</start_date>
  <completion_date type="Anticipated">October 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>
    <intervention_model_description>Participants (N=90; 45 at each site) will be randomized with equal probability to either treatment group, restricted by equal enrollment and equal distribution at each site. Patients will be enrolled for the exploratory aim separately at the University of Florida site only. After enrollment into the main study (primary and secondary aims), subjects at the UF site will be offered enrollment into the exploratory aim (N=24) on a consecutive basis restricted by equal enrollment into each treatment arm. A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>The objective is to rate patient's reported pain. The NPRS asks for a number between zero and ten that fits best to the subject's pain intensity, with zero as &quot;no pain at all&quot; and ten representing &quot;the worst pain ever possible&quot;. It has a similar minimal clinically significant difference (20%) as the visual analog scale and can be administered via a phone interview.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>The objective is to measure the patient's reported functional status.The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).&#xD;
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS - Depression</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>The objective is to measure items relevant to the subject's mood, views of self, and engagement. The test version 8b has good responsiveness with a minimally important difference range of 3-3.1 in adults with knee OA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS - Pain Interference</measure>
    <time_frame>Baseline up to 24 months</time_frame>
    <description>The objective is to measure the consequences of pain on the subject's life with a minimally important difference range of 2.35 to 2.4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-Second Chair Stand Test</measure>
    <time_frame>The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.</time_frame>
    <description>The objective is to determine the maximum number of chair stand repetitions possible in a 30 second period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stair Climb Test</measure>
    <time_frame>The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.</time_frame>
    <description>The objective is to determine the time (seconds) it takes to ascend and descend a flight of stairs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>40m Fast Paced Walk Test</measure>
    <time_frame>The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.</time_frame>
    <description>The objective is to determine the time (seconds) it takes to complete a fast-paced walking task over 4x10m (total 40m).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go Test48</measure>
    <time_frame>The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.</time_frame>
    <description>The objective is to determine the time (seconds) to rise from a chair, walk 3m, turn, walk back to the chair, and then sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minute Walk Test</measure>
    <time_frame>The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.</time_frame>
    <description>The objective is to determine the maximal distance covered in a 6min period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Subjects with knee OA using ultrasound for cRFA intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to ultrasound (N=45) cRFA treatment arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with knee OA using fluoroscopy for cRFA intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) cRFA treatment arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cRFA</intervention_name>
    <description>cRFA intervention will occur under sterile conditions, the patient will be placed in a supine position on a table and a bolster to provide flexion in the treated knee joint. Skin and soft tissues will be anaesthetized with 2 mL 1% lidocaine at each of the three anatomic sites for cRFA, and a introducer needle will then be placed under ultrasound or fluoroscopic guidance to the SLG, SMG, and IMG nerves. Adjustments at these positions will be made when using ultrasound guidance in order to capture the geniculate nerve if the nerve and/or its accompanying vasculature can be directly visualized using greyscale or Doppler modes. When using ultrasound, the physician will note and record whether their positioning of the needle is based on bony landmarks, direct visualization of the nerve, and/or vascularity accompanying the nerve. Once the introducer needle is placed, the cRFA will be placed into the introducer needle.</description>
    <arm_group_label>Subjects with knee OA using fluoroscopy for cRFA intervention</arm_group_label>
    <arm_group_label>Subjects with knee OA using ultrasound for cRFA intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) patients of either gender with primary knee OA of one or both knees fulfilling the&#xD;
             diagnostic criteria for knee OA by the American College of Rheumatology,&#xD;
&#xD;
          -  2) Kellgren-Lawrence score of two to four,&#xD;
&#xD;
          -  3) reported NPRS pain intensity of at least four on most or all days of the past week&#xD;
&#xD;
          -  4) pain resistant to conventional treatments which may include but is not limited to&#xD;
             medications (e.g. acetaminophen, oral or topical non-steroidal anti-inflammatory&#xD;
             drugs, opioids), physical therapy, and intra-articular injections (e.g.&#xD;
             corticosteroids, hyaluronic acid, platelet-rich-plasma) for at least 3 months. In the&#xD;
             case of bilateral knee OA, the most symptomatic knee will be treated and studied.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) age &lt;35 years,&#xD;
&#xD;
          -  2) non-English speaking patients,&#xD;
&#xD;
          -  3) body mass index greater than 40,&#xD;
&#xD;
          -  4) previous radiofrequency ablation procedure for the knee,&#xD;
&#xD;
          -  5) active systemic or local infections at the site of needle/cRFA probe placement,&#xD;
&#xD;
          -  6) previous knee joint replacement surgery,&#xD;
&#xD;
          -  7) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic&#xD;
             arthritis,&#xD;
&#xD;
          -  8) non-ambulatory patients,&#xD;
&#xD;
          -  9) patients who are unable to provide their own consent (e.g. dementia),&#xD;
&#xD;
          -  10) unstable medical or psychiatric illness,&#xD;
&#xD;
          -  11) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or&#xD;
             similar devices,&#xD;
&#xD;
          -  12) patients seeking care as a part of workman's compensation or have litigation&#xD;
             pending&#xD;
&#xD;
          -  13) a negative response to diagnostic geniculate nerve lidocaine injections.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Herman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Herman, MD</last_name>
    <phone>916-734-6805</phone>
    <email>dcherman@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katherine Rizzone, MD</last_name>
    <phone>585-341-9407</phone>
    <email>katherine_rizzone@urmc.rochester.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UC Davis Health</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Daniel Herman, MD</last_name>
      <phone>916-734-6805</phone>
      <email>dcherman@ucdavis.edu</email>
    </contact>
    <investigator>
      <last_name>Daniel Herman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14627</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katherine Rizzone, MD</last_name>
      <phone>585-341-9407</phone>
      <email>katherine_rizzone@urmc.rochester.edu</email>
    </contact>
    <investigator>
      <last_name>Katherine Rizzone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04472702
org study id: 1868999
secondary id: STUDY00005460
nct id: NCT04472702
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment
      option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical
      guidance of choice, but uses bony landmarks to target these nerves which have variable
      positions around the knee. Alternatively, ultrasound allows for targeting based on
      visualization of bony landmarks, the nerves, and their accompanying vascular structures, and
      thus may offer greater accuracy. However, there are few studies which directly compare the
      clinical efficacy of these two guidance options. This study will compare these two options.
Background: Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a
      promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is
      the typical guidance of choice, but uses bony landmarks to target these nerves which have
      variable positions around the knee. Alternatively, ultrasound allows for targeting based on
      visualization of bony landmarks, the nerves, and their accompanying vascular structures, and
      thus may offer greater accuracy. However, there are few studies which directly compare the
      clinical efficacy of these two guidance options. Objective: To compare the effectiveness of
      geniculate nerve cRFA on knee osteoarthritis outcomes when using either ultrasound or
      fluoroscopic guidance. The primary outcome measures will be patient pain levels and
      patient-reported function. The secondary outcome measures will be objective performance-based
      functional outcomes. The exploratory outcome measures will be blood biomarkers of
      inflammation, extracellular matrix turnover, and cartilage degradation. Methods: Knee
      osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to
      conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve
      blocks will be enrolled and randomized to fluoroscopic (N=45) or ultrasound (N=45) cRFA
      treatment arms. Baseline assessments will include 1) Numeric Pain Rating Scale, Western
      Ontario and McMaster Universities Osteoarthritis Index, and PROMIS depression and pain
      interference measures; 2) the Osteoarthritis Research Society International recommended
      physical performance assessments including the 30-Second Chair Stand Test, Stair Climb Test,
      40m Fast Paced Walk Test, Timed Up and Go Test, and Six Minute Walk Test; and 3) in a subset
      of patients (N=24), blood biomarkers including MMP-3, IL-1β, TNF-α, COMP, and CTX-II. These
      measures will be re-assessed at one month (pain and patient-reported function only, via phone
      contact), three months, and 6 months after the cRFA procedure. Study endpoints will be
      assessed using a mixed model repeated measures analysis of variance using an alpha level of
      0.05. Statement of Relevance: Knee osteoarthritis patients are commonly treated by sports
      medicine providers, who are typically well-trained in the use of ultrasound. Should
      ultrasound be demonstrated as effective for cRFA, sports medicine providers would be
      well-positioned to use relatively low-cost and accessible imaging technology to significantly
      improve patient pain and function using cRFA.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants (N=90; 45 at each site) will be randomized with equal probability to either treatment group, restricted by equal enrollment and equal distribution at each site. Patients will be enrolled for the exploratory aim separately at the University of Florida site only. After enrollment into the main study (primary and secondary aims), subjects at the UF site will be offered enrollment into the exploratory aim (N=24) on a consecutive basis restricted by equal enrollment into each treatment arm. A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.
primary purpose: Treatment
masking: Single (Investigator)
masking description: A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.
measure: Numeric Pain Rating Scale
time frame: Baseline up to 24 months
description: The objective is to rate patient's reported pain. The NPRS asks for a number between zero and ten that fits best to the subject's pain intensity, with zero as "no pain at all" and ten representing "the worst pain ever possible". It has a similar minimal clinically significant difference (20%) as the visual analog scale and can be administered via a phone interview.
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: Baseline up to 24 months
description: The objective is to measure the patient's reported functional status.The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores
measure: PROMIS - Depression
time frame: Baseline up to 24 months
description: The objective is to measure items relevant to the subject's mood, views of self, and engagement. The test version 8b has good responsiveness with a minimally important difference range of 3-3.1 in adults with knee OA.
measure: PROMIS - Pain Interference
time frame: Baseline up to 24 months
description: The objective is to measure the consequences of pain on the subject's life with a minimally important difference range of 2.35 to 2.4
measure: 30-Second Chair Stand Test
time frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
description: The objective is to determine the maximum number of chair stand repetitions possible in a 30 second period.
measure: Stair Climb Test
time frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
description: The objective is to determine the time (seconds) it takes to ascend and descend a flight of stairs.
measure: 40m Fast Paced Walk Test
time frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
description: The objective is to determine the time (seconds) it takes to complete a fast-paced walking task over 4x10m (total 40m).
measure: Timed Up and Go Test48
time frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
description: The objective is to determine the time (seconds) to rise from a chair, walk 3m, turn, walk back to the chair, and then sit down.
measure: Six Minute Walk Test
time frame: The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.
description: The objective is to determine the maximal distance covered in a 6min period.
arm group label: Subjects with knee OA using ultrasound for cRFA intervention
arm group type: Experimental
description: Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to ultrasound (N=45) cRFA treatment arm.
arm group label: Subjects with knee OA using fluoroscopy for cRFA intervention
arm group type: Experimental
description: Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) cRFA treatment arm.
intervention type: Procedure
intervention name: cRFA
description: cRFA intervention will occur under sterile conditions, the patient will be placed in a supine position on a table and a bolster to provide flexion in the treated knee joint. Skin and soft tissues will be anaesthetized with 2 mL 1% lidocaine at each of the three anatomic sites for cRFA, and a introducer needle will then be placed under ultrasound or fluoroscopic guidance to the SLG, SMG, and IMG nerves. Adjustments at these positions will be made when using ultrasound guidance in order to capture the geniculate nerve if the nerve and/or its accompanying vasculature can be directly visualized using greyscale or Doppler modes. When using ultrasound, the physician will note and record whether their positioning of the needle is based on bony landmarks, direct visualization of the nerve, and/or vascularity accompanying the nerve. Once the introducer needle is placed, the cRFA will be placed into the introducer needle.
arm group label: Subjects with knee OA using fluoroscopy for cRFA intervention
arm group label: Subjects with knee OA using ultrasound for cRFA intervention
criteria: 
gender: All
minimum age: 35 Years
maximum age: 99 Years
healthy volunteers: No
last name: Daniel Herman, MD
role: Principal Investigator
affiliation: University of California, Davis
last name: Daniel Herman, MD
phone: 916-734-6805
email: dcherman@ucdavis.edu
last name: Katherine Rizzone, MD
phone: 585-341-9407
email: katherine_rizzone@urmc.rochester.edu
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No