<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/NCT03293238</url>
  </required_header>
  <id_info>
    <org_study_id>PRISMM-Knee</org_study_id>
    <nct_id>NCT03293238</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Knee Injections in Musculoskeletal Medicine</brief_title>
  <acronym>PRISMM</acronym>
  <official_title>Practical Indications for Sonography in Musculoskeletal Medicine-Knee Joint Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrews Research &amp; Education Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Medical Society for Sports Medicine (AMSSM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Andrews Research &amp; Education Foundation</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the accuracy and patient reported outcomes between four different&#xD;
      techniques used to perform a knee injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will compare the accuracy and patient-oriented outcomes between various techniques&#xD;
      for intra-articular knee injections. Historically, a joint line (intercondylar) technique of&#xD;
      injection at the medial or lateral joint line, reliant solely upon clinical palpation, has&#xD;
      been the most popular approach among primary care and orthopedic providers. Newer approaches,&#xD;
      making use of ultrasound visualization to accomplish access to the intercondylar recess and&#xD;
      the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain&#xD;
      accuracy with the traditional approach, this study is designed to determine if sonographic&#xD;
      visualization combined with either of these two newer techniques improves accuracy and&#xD;
      affects patient-oriented outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2011</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>Patients will be randomized into one of four intervention arms for the purpose of obtaining patient reported outcomes as it relates to the accuracy of injections into the knee joint with or without ultrasound guidance.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients will be blindfolded for the duration of their procedure. Investigator will always place ultrasound probe on patient's knee regardless of group assignment to eliminate bias. To further enhance blinding, the ultrasound screen will placed on freeze for the patients randomized into the groups without ultrasound guidance. Radiologist will be blinded to patient's group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Successful Knee Injection</measure>
    <time_frame>Procedure visit 3 (3-4 weeks after 1st injection)</time_frame>
    <description>To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural Satisfaction Score at 3 Months Post Injection</measure>
    <time_frame>3 month follow-up appointment following 3rd injection</time_frame>
    <description>Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score</measure>
    <time_frame>Pre-Injection and 3 month follow-up appointment following 3rd injection</time_frame>
    <description>Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Joint Line Ultrasound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Joint Line Landmark</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suprapatellar Ultrasound Guided</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suprapatellar Landmark</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Joint line ultrasound</intervention_name>
    <description>Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance.</description>
    <arm_group_label>Joint Line Ultrasound</arm_group_label>
    <other_name>JLUS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Joint line landmark</intervention_name>
    <description>Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.</description>
    <arm_group_label>Joint Line Landmark</arm_group_label>
    <other_name>JLL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suprapatellar ultrasound guided</intervention_name>
    <description>Patients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch.</description>
    <arm_group_label>Suprapatellar Ultrasound Guided</arm_group_label>
    <other_name>SPUS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suprapatellar Landmark</intervention_name>
    <description>Patients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch.</description>
    <arm_group_label>Suprapatellar Landmark</arm_group_label>
    <other_name>SPL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 18 to 90&#xD;
&#xD;
          -  Clinician determined need for intra-articular knee injection&#xD;
&#xD;
          -  Radiograph confirmed grade 1-4 Kellgren Lawrence osteoarthritis scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to contrast dye, shellfish&#xD;
&#xD;
          -  Allergy to egg product or hyaluronate&#xD;
&#xD;
          -  Allergy to lidocaine&#xD;
&#xD;
          -  Localized skin infection at planned site of injection&#xD;
&#xD;
          -  Inability to complete follow-up phone call three months following the injection&#xD;
&#xD;
          -  Viscosupplementation injection within 6 months of the current evaluation&#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_official>
    <last_name>Joshua Hackel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Andrews Institute for Orthopaedic &amp; Sports Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andrews Research &amp; Education Foundation</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.</citation>
    <PMID>11156538</PMID>
  </reference>
  <reference>
    <citation>Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone Joint Surg Am. 2002 Sep;84(9):1522-7. doi: 10.2106/00004623-200209000-00003.</citation>
    <PMID>12208907</PMID>
  </reference>
  <reference>
    <citation>Wiler JL, Costantino TG, Filippone L, Satz W. Comparison of ultrasound-guided and standard landmark techniques for knee arthrocentesis. J Emerg Med. 2010 Jul;39(1):76-82. doi: 10.1016/j.jemermed.2008.05.012. Epub 2008 Dec 5.</citation>
    <PMID>19062223</PMID>
  </reference>
  <reference>
    <citation>Esenyel C, Demirhan M, Esenyel M, Sonmez M, Kahraman S, Senel B, Ozdes T. Comparison of four different intra-articular injection sites in the knee: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):573-7. doi: 10.1007/s00167-006-0231-6. Epub 2006 Dec 6.</citation>
    <PMID>17149645</PMID>
  </reference>
  <reference>
    <citation>Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.</citation>
    <PMID>14760802</PMID>
  </reference>
  <reference>
    <citation>Berkoff DJ, Miller LE, Block JE. Clinical utility of ultrasound guidance for intra-articular knee injections: a review. Clin Interv Aging. 2012;7:89-95. doi: 10.2147/CIA.S29265. Epub 2012 Mar 20.</citation>
    <PMID>22500117</PMID>
  </reference>
  <reference>
    <citation>Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D. A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis. Arthritis Rheum. 2010 Jul;62(7):1862-9. doi: 10.1002/art.27448.</citation>
    <PMID>20222114</PMID>
  </reference>
  <reference>
    <citation>Im SH, Lee SC, Park YB, Cho SR, Kim JC. Feasibility of sonography for intra-articular injections in the knee through a medial patellar portal. J Ultrasound Med. 2009 Nov;28(11):1465-70. doi: 10.7863/jum.2009.28.11.1465.</citation>
    <PMID>19854960</PMID>
  </reference>
  <reference>
    <citation>Hong BY, Lim SH, Cho YR, Kim HW, Ko YJ, Han SH, Lee JI. Detection of knee effusion by ultrasonography. Am J Phys Med Rehabil. 2010 Sep;89(9):715-21. doi: 10.1097/PHM.0b013e3181e29c55.</citation>
    <PMID>20531157</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>January 8, 2019</results_first_submitted>
  <results_first_submitted_qc>October 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2019</results_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>ultrasound</keyword>
  <keyword>sonography</keyword>
  <keyword>injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2011</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03293238/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited through individual physician practices.</recruitment_details>
      <pre_assignment_details>Sixty-three patients were enrolled and randomized into four groups: Group 1: Joint Line Ultrasound Guided (n= 19), Group 2: Joint Line Landmark Based (sham Ultrasound) (n= 16), Group 3: Suprapatellar Ultrasound Guided (n= 14), Group 4: Suprapatellar Landmark Based (sham Ultrasound) (n= 14). One patient's radiographic imaging was lost.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Joint Line Ultrasound</title>
          <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.&#xD;
Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance.</description>
        </group>
        <group group_id="P2">
          <title>Joint Line Landmark</title>
          <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.&#xD;
Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.</description>
        </group>
        <group group_id="P3">
          <title>Suprapatellar Ultrasound Guided</title>
          <description>Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.&#xD;
Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch.</description>
        </group>
        <group group_id="P4">
          <title>Suprapatellar Landmark</title>
          <description>Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.&#xD;
Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Joint Line Ultrasound</title>
          <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.&#xD;
Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance.</description>
        </group>
        <group group_id="B2">
          <title>Joint Line Landmark</title>
          <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.&#xD;
Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.</description>
        </group>
        <group group_id="B3">
          <title>Suprapatellar Ultrasound Guided</title>
          <description>Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.&#xD;
Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch.</description>
        </group>
        <group group_id="B4">
          <title>Suprapatellar Landmark</title>
          <description>Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.&#xD;
Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="14"/>
            <count group_id="B4" value="14"/>
            <count group_id="B5" value="63"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="14"/>
                    <count group_id="B4" value="14"/>
                    <count group_id="B5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.7" spread="12.2"/>
                    <measurement group_id="B2" value="65.3" spread="12.1"/>
                    <measurement group_id="B3" value="71.4" spread="9.6"/>
                    <measurement group_id="B4" value="68.8" spread="9.5"/>
                    <measurement group_id="B5" value="67.6" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="14"/>
                    <count group_id="B4" value="14"/>
                    <count group_id="B5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="16"/>
                    <count group_id="B3" value="14"/>
                    <count group_id="B4" value="14"/>
                    <count group_id="B5" value="63"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Successful Knee Injection</title>
        <description>To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.</description>
        <time_frame>Procedure visit 3 (3-4 weeks after 1st injection)</time_frame>
        <population>Number of patients in each group with successful injections into the knee joint.</population>
        <group_list>
          <group group_id="O1">
            <title>Joint Line Ultrasound</title>
            <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.&#xD;
Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance.</description>
          </group>
          <group group_id="O2">
            <title>Joint Line Landmark</title>
            <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.&#xD;
Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.</description>
          </group>
          <group group_id="O3">
            <title>Suprapatellar Ultrasound Guided</title>
            <description>Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.&#xD;
Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch.</description>
          </group>
          <group group_id="O4">
            <title>Suprapatellar Landmark</title>
            <description>Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.&#xD;
Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Knee Injection</title>
          <description>To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.</description>
          <population>Number of patients in each group with successful injections into the knee joint.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedural Satisfaction Score at 3 Months Post Injection</title>
        <description>Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.</description>
        <time_frame>3 month follow-up appointment following 3rd injection</time_frame>
        <population>ANOVA</population>
        <group_list>
          <group group_id="O1">
            <title>Joint Line Ultrasound</title>
            <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.&#xD;
Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance.</description>
          </group>
          <group group_id="O2">
            <title>Joint Line Landmark</title>
            <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.&#xD;
Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.</description>
          </group>
          <group group_id="O3">
            <title>Suprapatellar Ultrasound Guided</title>
            <description>Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.&#xD;
Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch.</description>
          </group>
          <group group_id="O4">
            <title>Suprapatellar Landmark</title>
            <description>Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.&#xD;
Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedural Satisfaction Score at 3 Months Post Injection</title>
          <description>Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.</description>
          <population>ANOVA</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.84" spread="3.13"/>
                    <measurement group_id="O2" value="8.71" spread="2.20"/>
                    <measurement group_id="O3" value="7.14" spread="3.33"/>
                    <measurement group_id="O4" value="8.29" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.527</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score</title>
        <description>Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.</description>
        <time_frame>Pre-Injection and 3 month follow-up appointment following 3rd injection</time_frame>
        <population>Mean WOMAC score Pre-Injection and at 3-months post injection.</population>
        <group_list>
          <group group_id="O1">
            <title>Joint Line Ultrasound</title>
            <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.&#xD;
Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance.</description>
          </group>
          <group group_id="O2">
            <title>Joint Line Landmark</title>
            <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.&#xD;
Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.</description>
          </group>
          <group group_id="O3">
            <title>Suprapatellar Ultrasound Guided</title>
            <description>Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.&#xD;
Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch.</description>
          </group>
          <group group_id="O4">
            <title>Suprapatellar Landmark</title>
            <description>Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.&#xD;
Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch.</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score</title>
          <description>Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.</description>
          <population>Mean WOMAC score Pre-Injection and at 3-months post injection.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.05" spread="30.92"/>
                    <measurement group_id="O2" value="43.75" spread="27.53"/>
                    <measurement group_id="O3" value="53.15" spread="25.25"/>
                    <measurement group_id="O4" value="47.61" spread="30.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.42" spread="25.88"/>
                    <measurement group_id="O2" value="31.07" spread="28.63"/>
                    <measurement group_id="O3" value="32.5" spread="27.02"/>
                    <measurement group_id="O4" value="28.57" spread="20.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.749</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Joint Line Ultrasound</title>
          <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.&#xD;
Joint line ultrasound: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was aided by real time visualization utilizing ultrasound guidance.</description>
        </group>
        <group group_id="E2">
          <title>Joint Line Landmark</title>
          <description>Patients assigned to this group received a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.&#xD;
Joint line landmark: Patients were sitting with knee bent at 90 degrees. Clinician palpated the extremity to determine if a medial or lateral approach would be made for the injection of Euflexxa into the joint space. The procedure was not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.</description>
        </group>
        <group group_id="E3">
          <title>Suprapatellar Ultrasound Guided</title>
          <description>Patients assigned to this group received an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.&#xD;
Suprapatellar ultrasound guided: Patients were lying supine on exam table. Ultrasound was used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa was made within the suprapatellar pouch.</description>
        </group>
        <group group_id="E4">
          <title>Suprapatellar Landmark</title>
          <description>Patients assigned to this group received an injection of Euflexxa while lying down into the supratpatellar pouch without ultrasound guidance.&#xD;
Suprapatellar Landmark: Patients were lying supine on exam table. Injecting physician inserted a needle lateral to the vastus lateralis toward the suprapatellar pouch, and injected of Euflexxa once it is believed that the needle tip is in the pouch.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Joshua Hackel</name_or_title>
      <organization>Andrews Research &amp; Education Foundation</organization>
      <phone>850-916-8796</phone>
      <email>jghackelmd@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03293238
org study id: PRISMM-Knee
nct id: NCT03293238
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will compare the accuracy and patient reported outcomes between four different
      techniques used to perform a knee injection.
This study will compare the accuracy and patient-oriented outcomes between various techniques
      for intra-articular knee injections. Historically, a joint line (intercondylar) technique of
      injection at the medial or lateral joint line, reliant solely upon clinical palpation, has
      been the most popular approach among primary care and orthopedic providers. Newer approaches,
      making use of ultrasound visualization to accomplish access to the intercondylar recess and
      the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain
      accuracy with the traditional approach, this study is designed to determine if sonographic
      visualization combined with either of these two newer techniques improves accuracy and
      affects patient-oriented outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized into one of four intervention arms for the purpose of obtaining patient reported outcomes as it relates to the accuracy of injections into the knee joint with or without ultrasound guidance.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients will be blindfolded for the duration of their procedure. Investigator will always place ultrasound probe on patient's knee regardless of group assignment to eliminate bias. To further enhance blinding, the ultrasound screen will placed on freeze for the patients randomized into the groups without ultrasound guidance. Radiologist will be blinded to patient's group assignment.
measure: Number of Participants With Successful Knee Injection
time frame: Procedure visit 3 (3-4 weeks after 1st injection)
description: To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.
measure: Procedural Satisfaction Score at 3 Months Post Injection
time frame: 3 month follow-up appointment following 3rd injection
description: Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
time frame: Pre-Injection and 3 month follow-up appointment following 3rd injection
description: Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
arm group label: Joint Line Ultrasound
arm group type: Active Comparator
description: Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa aided by ultrasound guidance while sitting up.
arm group label: Joint Line Landmark
arm group type: Sham Comparator
description: Patients assigned to this group receive a standard medial or lateral joint line injection of Euflexxa without ultrasound guidance while sitting up.
arm group label: Suprapatellar Ultrasound Guided
arm group type: Active Comparator
description: Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch aided by ultrasound guidance.
arm group label: Suprapatellar Landmark
arm group type: Sham Comparator
description: Patients assigned to this group receive an injection of Euflexxa while lying down into the suprapatellar pouch without ultrasound guidance.
intervention type: Procedure
intervention name: Joint line ultrasound
description: Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance.
arm group label: Joint Line Ultrasound
other name: JLUS
intervention type: Procedure
intervention name: Joint line landmark
description: Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.
arm group label: Joint Line Landmark
other name: JLL
intervention type: Procedure
intervention name: Suprapatellar ultrasound guided
description: Patients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch.
arm group label: Suprapatellar Ultrasound Guided
other name: SPUS
intervention type: Procedure
intervention name: Suprapatellar Landmark
description: Patients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch.
arm group label: Suprapatellar Landmark
other name: SPL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Joshua Hackel, MD
role: Principal Investigator
affiliation: Andrews Institute for Orthopaedic & Sports Medicine
facility: 
country: United States
citation: Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
PMID: 11156538
citation: Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone Joint Surg Am. 2002 Sep;84(9):1522-7. doi: 10.2106/00004623-200209000-00003.
PMID: 12208907
citation: Wiler JL, Costantino TG, Filippone L, Satz W. Comparison of ultrasound-guided and standard landmark techniques for knee arthrocentesis. J Emerg Med. 2010 Jul;39(1):76-82. doi: 10.1016/j.jemermed.2008.05.012. Epub 2008 Dec 5.
PMID: 19062223
citation: Esenyel C, Demirhan M, Esenyel M, Sonmez M, Kahraman S, Senel B, Ozdes T. Comparison of four different intra-articular injection sites in the knee: a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):573-7. doi: 10.1007/s00167-006-0231-6. Epub 2006 Dec 6.
PMID: 17149645
citation: Naredo E, Cabero F, Beneyto P, Cruz A, Mondejar B, Uson J, Palop MJ, Crespo M. A randomized comparative study of short term response to blind injection versus sonographic-guided injection of local corticosteroids in patients with painful shoulder. J Rheumatol. 2004 Feb;31(2):308-14.
PMID: 14760802
citation: Berkoff DJ, Miller LE, Block JE. Clinical utility of ultrasound guidance for intra-articular knee injections: a review. Clin Interv Aging. 2012;7:89-95. doi: 10.2147/CIA.S29265. Epub 2012 Mar 20.
PMID: 22500117
citation: Cunnington J, Marshall N, Hide G, Bracewell C, Isaacs J, Platt P, Kane D. A randomized, double-blind, controlled study of ultrasound-guided corticosteroid injection into the joint of patients with inflammatory arthritis. Arthritis Rheum. 2010 Jul;62(7):1862-9. doi: 10.1002/art.27448.
PMID: 20222114
citation: Im SH, Lee SC, Park YB, Cho SR, Kim JC. Feasibility of sonography for intra-articular injections in the knee through a medial patellar portal. J Ultrasound Med. 2009 Nov;28(11):1465-70. doi: 10.7863/jum.2009.28.11.1465.
PMID: 19854960
citation: Hong BY, Lim SH, Cho YR, Kim HW, Ko YJ, Han SH, Lee JI. Detection of knee effusion by ultrasonography. Am J Phys Med Rehabil. 2010 Sep;89(9):715-21. doi: 10.1097/PHM.0b013e3181e29c55.
PMID: 20531157
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 