<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/NCT04441112</url>
  </required_header>
  <id_info>
    <org_study_id>SaintAlphonsusRMC</org_study_id>
    <nct_id>NCT04441112</nct_id>
  </id_info>
  <brief_title>Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial</brief_title>
  <official_title>Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Alphonsus Regional Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint Alphonsus Regional Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis.&#xD;
      Steroid injections are common yet have immune-modulating effects and can alter gene&#xD;
      expression which may delay definitive arthroplasty and further damage cartilage.&#xD;
      Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their&#xD;
      differing mechanism of action; however, there is a relative dearth of information regarding&#xD;
      their efficacy. This non-inferiority study compares the effectiveness of triamcinolone versus&#xD;
      ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and&#xD;
      knee.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2018</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">August 20, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (Baseline to One Week Post-injection)</measure>
    <time_frame>Comparing baseline to one week post-injection</time_frame>
    <description>Pain Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (Baseline to One Month Post-injection)</measure>
    <time_frame>Comparing baseline to one month post-injection</time_frame>
    <description>Pain Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Visual Analogue Scale (Baseline to Three Months Post-injection)</measure>
    <time_frame>Comparing baseline to three months post-injection</time_frame>
    <description>Pain Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)</measure>
    <time_frame>Comparing baseline to one week post-injection</time_frame>
    <description>Overall patient wellbeing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)</measure>
    <time_frame>Comparing baseline to one month post-injection</time_frame>
    <description>Overall patient wellbeing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)</measure>
    <time_frame>Comparing baseline to three months post-injection</time_frame>
    <description>Overall patient wellbeing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)</measure>
    <time_frame>Comparing baseline to one week post-injection</time_frame>
    <description>Functionality and pain of affected knee</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)</measure>
    <time_frame>Comparing baseline to one month post-injection</time_frame>
    <description>Functionality and pain of affected knee</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)</measure>
    <time_frame>Comparing baseline to three months post-injection</time_frame>
    <description>Functionality and pain of affected knee</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)</measure>
    <time_frame>Comparing baseline to one week post-injection</time_frame>
    <description>Functionality and pain of affected hip</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)</measure>
    <time_frame>Comparing baseline to one month post-injection</time_frame>
    <description>Functionality and pain of affected hip</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)</measure>
    <time_frame>Comparing baseline to three months post-injection</time_frame>
    <description>Functionality and pain of affected hip</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Arthritis Knee</condition>
  <condition>Arthritis of Hip</condition>
  <arm_group>
    <arm_group_label>Ketorolac Intraarticular Hip Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an intraarticular hip injection with ketorolac.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triamcinolone Intraarticular Hip Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an intraarticular hip injection with triamcinolone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketorolac Intraarticular Knee Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an intraarticular knee injection with ketorolac.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triamcinolone Intraarticular Knee Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an intraarticular knee injection with triamcinolone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac Intraarticular Injection</intervention_name>
    <description>Injections will be given under ultrasound guidance with one of two possible medications.</description>
    <arm_group_label>Ketorolac Intraarticular Hip Injection</arm_group_label>
    <arm_group_label>Ketorolac Intraarticular Knee Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Intraarticular Injection</intervention_name>
    <description>Injections will be given under ultrasound guidance with one of two possible medications.</description>
    <arm_group_label>Triamcinolone Intraarticular Hip Injection</arm_group_label>
    <arm_group_label>Triamcinolone Intraarticular Knee Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic, radiographically proven degenerative joint disease in the hip or knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent injection in the hip or knee within the previous 3 months&#xD;
&#xD;
          -  history of traumatic osteoarthritis or ligamentous reconstruction&#xD;
&#xD;
          -  chronic narcotic use&#xD;
&#xD;
          -  history of inflammatory or neuropathic arthropathy&#xD;
&#xD;
          -  pregnant and/or nursing women&#xD;
&#xD;
          -  allergy or strong reaction to study medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Jurgensmeier, BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Student Investigator at Saint Alphonsus Regional Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven B Daines, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Surgeon at Saint Alphonsus Regional Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Alphonsus Regional Medical Center</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Alphonsus Regional Medical Center</investigator_affiliation>
    <investigator_full_name>Kevin Jurgensmeier</investigator_full_name>
    <investigator_title>Medical Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Ketorolac</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>No plan currently decided.</ipd_description>
  </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/NCT04441112
org study id: SaintAlphonsusRMC
nct id: NCT04441112
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis.
      Steroid injections are common yet have immune-modulating effects and can alter gene
      expression which may delay definitive arthroplasty and further damage cartilage.
      Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their
      differing mechanism of action; however, there is a relative dearth of information regarding
      their efficacy. This non-inferiority study compares the effectiveness of triamcinolone versus
      ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and
      knee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Visual Analogue Scale (Baseline to One Week Post-injection)
time frame: Comparing baseline to one week post-injection
description: Pain Score
measure: Change in Visual Analogue Scale (Baseline to One Month Post-injection)
time frame: Comparing baseline to one month post-injection
description: Pain Score
measure: Change in Visual Analogue Scale (Baseline to Three Months Post-injection)
time frame: Comparing baseline to three months post-injection
description: Pain Score
measure: Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)
time frame: Comparing baseline to one week post-injection
description: Overall patient wellbeing
measure: Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)
time frame: Comparing baseline to one month post-injection
description: Overall patient wellbeing
measure: Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)
time frame: Comparing baseline to three months post-injection
description: Overall patient wellbeing
measure: Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
time frame: Comparing baseline to one week post-injection
description: Functionality and pain of affected knee
measure: Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
time frame: Comparing baseline to one month post-injection
description: Functionality and pain of affected knee
measure: Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
time frame: Comparing baseline to three months post-injection
description: Functionality and pain of affected knee
measure: Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)
time frame: Comparing baseline to one week post-injection
description: Functionality and pain of affected hip
measure: Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)
time frame: Comparing baseline to one month post-injection
description: Functionality and pain of affected hip
measure: Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)
time frame: Comparing baseline to three months post-injection
description: Functionality and pain of affected hip
arm group label: Ketorolac Intraarticular Hip Injection
arm group type: Experimental
description: Patients will receive an intraarticular hip injection with ketorolac.
arm group label: Triamcinolone Intraarticular Hip Injection
arm group type: Active Comparator
description: Patients will receive an intraarticular hip injection with triamcinolone.
arm group label: Ketorolac Intraarticular Knee Injection
arm group type: Experimental
description: Patients will receive an intraarticular knee injection with ketorolac.
arm group label: Triamcinolone Intraarticular Knee Injection
arm group type: Active Comparator
description: Patients will receive an intraarticular knee injection with triamcinolone.
intervention type: Drug
intervention name: Ketorolac Intraarticular Injection
description: Injections will be given under ultrasound guidance with one of two possible medications.
arm group label: Ketorolac Intraarticular Hip Injection
arm group label: Ketorolac Intraarticular Knee Injection
intervention type: Drug
intervention name: Triamcinolone Intraarticular Injection
description: Injections will be given under ultrasound guidance with one of two possible medications.
arm group label: Triamcinolone Intraarticular Hip Injection
arm group label: Triamcinolone Intraarticular Knee Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Jurgensmeier, BS
role: Principal Investigator
affiliation: Student Investigator at Saint Alphonsus Regional Medical Center
last name: Steven B Daines, MD
role: Study Chair
affiliation: Surgeon at Saint Alphonsus Regional Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Saint Alphonsus Regional Medical Center
investigator full name: Kevin Jurgensmeier
investigator title: Medical Student
mesh term: Arthritis
mesh term: Triamcinolone
mesh term: Ketorolac
sharing ipd: Undecided
ipd description: No plan currently decided.