<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/NCT04482582</url>
  </required_header>
  <id_info>
    <org_study_id>57099</org_study_id>
    <nct_id>NCT04482582</nct_id>
  </id_info>
  <brief_title>Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients</brief_title>
  <official_title>Early Percutaneous Cryoablation for Pain Control After Rib Fractures Among Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to provide long-term pain control for elderly patients with rib&#xD;
      fractures in order to minimize their risk of complications and return them to baseline&#xD;
      functional capacity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to provide long-term pain control for elderly patients with rib&#xD;
      fractures in order to minimize their risk of complications and return them to baseline&#xD;
      functional capacity. In order to do this, we would offer a minimally invasive solution known&#xD;
      as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy&#xD;
      nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting&#xD;
      epineural or perineurial tissue. The application of cryoneurolysis will help reduce the&#xD;
      amount of narcotics the patient would need, and potentially lead to a better post-injury&#xD;
      quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2024</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>We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons &gt;=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Pain Assessed by Numeric Pain Score</measure>
    <time_frame>12 months</time_frame>
    <description>The patient will be asked to verbalize their numeric pain score daily after discharge and at follow-up visits. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to 1 month</time_frame>
    <description>The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>1 month</time_frame>
    <description>Will be obtained from chart review after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants requiring ICU admission</measure>
    <time_frame>1 month</time_frame>
    <description>Will be obtained from chart review after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Narcotic Equivalents</measure>
    <time_frame>12 months</time_frame>
    <description>Oral narcotic equivalents on day of discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day rib-specific readmission</measure>
    <time_frame>1 month</time_frame>
    <description>Incidence of readmission. The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score</measure>
    <time_frame>12 months</time_frame>
    <description>The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/ clinical staff upon discharge. The scoring system yields a pain rating index (PRI) score between 0 and 50 used to temporally track pain, higher scores correspond to higher pain levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Glasgow Outcome Scale Extended (GOS-E) Score</measure>
    <time_frame>12 months</time_frame>
    <description>The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category:&#xD;
Death (D)&#xD;
Vegetative state (VS)&#xD;
Lower severe disability (SD -)&#xD;
Upper severe disability (SD +)&#xD;
Lower moderate disability ( MD -)&#xD;
Upper moderate disability ( MD +)&#xD;
Lower good recovery (GR -)&#xD;
Upper good recovery (GR +)&#xD;
The questionnaire will be administered to the patient by study/clinical staff upon discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form (SF-12) Health Survey Scale Score</measure>
    <time_frame>12 months</time_frame>
    <description>The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff upon discharge.&#xD;
Score ranges from 1 (Excellent) to 5 (Poor) , 1 (Yes, limited a lot) to 3 (No, not limited at all), 1 (Yes) 2 (No), 1 (Not at all) to 5 (Extremely), 1 (All of the time) to 6 (None of the time) and 1 (All of the time) to 5 (None of the time).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Rib Fractures</condition>
  <arm_group>
    <arm_group_label>Image-guided percutaneous ICN (pICN): Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who were admitted after a traumatic injury, with rib fractures identified, who are &gt;= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard-of Care : Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who were admitted after a traumatic injury, with rib fractures identified, who are &gt;= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Cryoneurolysis</intervention_name>
    <description>Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.</description>
    <arm_group_label>Image-guided percutaneous ICN (pICN): Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.</description>
    <arm_group_label>Standard-of Care : Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        i) Patients greater than 65 years with any acute rib fracture&#xD;
&#xD;
        ii) Pain score equal to or greater than 5 with deep inspiration.&#xD;
&#xD;
        iii) Presenting and admitted to Stanford Emergency Department&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        i) Radiographic evidence of metastasis to ribs&#xD;
&#xD;
        ii) Glasgow Coma Scale (GCS) score &lt;13&#xD;
&#xD;
        iii) Patients undergoing SSRF&#xD;
&#xD;
        iv) Rib fractures located &lt; 3cm from spinous process&#xD;
&#xD;
        v) Coagulopathy (INR &gt;1.5, Pat &lt; 100)&#xD;
&#xD;
        vi) Other factors precluding cryoablation at IR attending's discretion&#xD;
&#xD;
        vii) If only ribs broken are 1,2 or 10,11, 12&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph D Forrester, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nishita Kothary, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sydney Guthrie-Baker, BS</last_name>
    <phone>6507248445</phone>
    <email>sydneygb@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford Hospital and Clinics</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Joseph Forrester</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Rib 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/NCT04482582
org study id: 57099
nct id: NCT04482582
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to provide long-term pain control for elderly patients with rib
      fractures in order to minimize their risk of complications and return them to baseline
      functional capacity
The purpose of this study is to provide long-term pain control for elderly patients with rib
      fractures in order to minimize their risk of complications and return them to baseline
      functional capacity. In order to do this, we would offer a minimally invasive solution known
      as Cryoneurolysis. By directly applying cold Cryoneurolysis to the nerves, this can destroy
      nerve axons, resulting in Wallerian degeneration of the distal nerve without distorting
      epineural or perineurial tissue. The application of cryoneurolysis will help reduce the
      amount of narcotics the patient would need, and potentially lead to a better post-injury
      quality of life.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We are proposing a prospective, randomized trial evaluating efficacy of image-guided percutaneous intercostal cryoneurolysis (pICN) for pain control after traumatic rib fractures in persons >=65 years. Eligible patients would be enrolled by the trauma service after consent or assent is obtained. Patients will be randomized to either pICN within 72 hours of presentation or existing standard-of-care.
primary purpose: Treatment
masking: None (Open Label)
measure: Acute Pain Assessed by Numeric Pain Score
time frame: 12 months
description: The patient will be asked to verbalize their numeric pain score daily after discharge and at follow-up visits. Pain measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain.
measure: Length of hospital stay
time frame: Up to 1 month
description: The Length of Stay will be obtained from the patient's chart after discharge and will depend on the level of care required for recovery from their injuries.
measure: 30-day mortality
time frame: 1 month
description: Will be obtained from chart review after discharge
measure: Number of participants requiring ICU admission
time frame: 1 month
description: Will be obtained from chart review after discharge
measure: Use of Narcotic Equivalents
time frame: 12 months
description: Oral narcotic equivalents on day of discharge.
measure: 30-day rib-specific readmission
time frame: 1 month
description: Incidence of readmission. The patient will be admitted back to the hospital if pain level relates to rib-specific injuries such as hemothorax and pneumonia.
measure: The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
time frame: 12 months
description: The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/ clinical staff upon discharge. The scoring system yields a pain rating index (PRI) score between 0 and 50 used to temporally track pain, higher scores correspond to higher pain levels.
measure: The Glasgow Outcome Scale Extended (GOS-E) Score
time frame: 12 months
description: The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category:
Death (D)
Vegetative state (VS)
Lower severe disability (SD -)
Upper severe disability (SD +)
Lower moderate disability ( MD -)
Upper moderate disability ( MD +)
Lower good recovery (GR -)
Upper good recovery (GR +)
The questionnaire will be administered to the patient by study/clinical staff upon discharge.
measure: Short Form (SF-12) Health Survey Scale Score
time frame: 12 months
description: The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff upon discharge.
Score ranges from 1 (Excellent) to 5 (Poor) , 1 (Yes, limited a lot) to 3 (No, not limited at all), 1 (Yes) 2 (No), 1 (Not at all) to 5 (Extremely), 1 (All of the time) to 6 (None of the time) and 1 (All of the time) to 5 (None of the time).
arm group label: Image-guided percutaneous ICN (pICN): Group A
arm group type: Experimental
description: Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
arm group label: Standard-of Care : Group B
arm group type: Active Comparator
description: Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
intervention type: Radiation
intervention name: Cryoneurolysis
description: Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.
arm group label: Image-guided percutaneous ICN (pICN): Group A
intervention type: Other
intervention name: Standard of Care
description: Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
arm group label: Standard-of Care : Group B
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph D Forrester, MD
role: Principal Investigator
affiliation: Stanford University
last name: Nishita Kothary, MD
role: Principal Investigator
affiliation: Stanford University
last name: Sydney Guthrie-Baker, BS
phone: 6507248445
email: sydneygb@stanford.edu
facility: 
status: Recruiting
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Joseph Forrester
investigator title: Assistant Professor of Surgery
mesh term: Fractures, Bone
mesh term: Rib Fractures
sharing ipd: No