<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/NCT02984228</url>
  </required_header>
  <id_info>
    <org_study_id>2015-188</org_study_id>
    <nct_id>NCT02984228</nct_id>
  </id_info>
  <brief_title>Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis</brief_title>
  <official_title>The Efficacy of Ultrasound Guided Glenohumeral Joint Injections of Platelet Rich Plasma (PRP) Versus Hyaluronic Acid (HA) in the Treatment of Glenohumeral Osteoarthritis: a Randomized, Double-blind Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <brief_summary>
    <textblock>
      This study seeks to expand the current literature in demonstrating potentially efficacious,&#xD;
      conservative treatments in the management of glenohumeral osteoarthritis (OA) and will&#xD;
      compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to&#xD;
      obtain information measuring potential benefits of these interventions and to observe for any&#xD;
      adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be&#xD;
      classified into primary and secondary forms. Primary glenohumeral OA is caused by&#xD;
      degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary&#xD;
      to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative&#xD;
      changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in&#xD;
      synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory&#xD;
      properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains&#xD;
      growth factors that have been shown to promote tissue regeneration. The aim of this study is&#xD;
      to determine whether injections of hyaluronic acid or platelet-rich plasma can be used&#xD;
      reliably to decrease pain, restore function, and improve quality of life in patients&#xD;
      suffering from glenohumeral OA. Patients will be randomized to receive either an injection of&#xD;
      hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via&#xD;
      questionnaires for up to 52 weeks post-procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">November 2020</completion_date>
  <primary_completion_date type="Actual">November 2020</primary_completion_date>
  <phase>Phase 4</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI) Score</measure>
    <time_frame>Up to 52 weeks post-procedure</time_frame>
    <description>Score ranges from 0-100, with a higher score representing higher disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder Function</measure>
    <time_frame>Up to 52 weeks post-procedure</time_frame>
    <description>Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Were Satisfied After Treatment</measure>
    <time_frame>Up to 52 weeks post-procedure</time_frame>
    <description>Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: &quot;The procedure met my expectations&quot;; &quot;The procedure improved my condition enough so that I would go through it again for the same outcome&quot;; &quot;The procedure helped me, but I would not go through it again for the same outcome&quot;; or &quot;I am the same or worse compared to before the procedure&quot;. Responses of &quot;The procedure met my expectations&quot; and &quot;The procedure improved my condition enough so that I would go through it again for the same outcome&quot; were considered to be &quot;satisfied&quot;. The other two responses were considered to be &quot;not satisfied&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Complication Events After the Procedure</measure>
    <time_frame>Up to 52 weeks post-procedure</time_frame>
    <description>Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Platelet-rich plasma (PRP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an injection of PRP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyaluronic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an injection of hyaluronic acid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRP</intervention_name>
    <arm_group_label>Platelet-rich plasma (PRP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyaluronic Acid</intervention_name>
    <arm_group_label>Hyaluronic Acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Hyaluronic Acid</arm_group_label>
    <arm_group_label>Platelet-rich plasma (PRP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking/literate&#xD;
&#xD;
          -  Age 18-100 years&#xD;
&#xD;
          -  Visual analog score pain &gt;= 5&#xD;
&#xD;
          -  Greater than or equal to 3 months of pain after onset of symptoms that has failed&#xD;
             conservative treatments&#xD;
&#xD;
          -  Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and&#xD;
             within the past year)&#xD;
&#xD;
          -  Transient relief of symptoms after diagnostic intra-articular injection into the&#xD;
             glenohumeral joint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking/illiterate&#xD;
&#xD;
          -  Painful active, concurrent cervical spine conditions&#xD;
&#xD;
          -  Current non-steroidal anti-inflammatory drug (NSAID) use&#xD;
&#xD;
          -  History of taking coumadin or similar anticoagulant, have a known coagulopathy,&#xD;
             bleeding dyscrasia, or platelet count &lt; 150,000/cubic mm&#xD;
&#xD;
          -  Allergic reaction to poultry or previous viscosupplementation&#xD;
&#xD;
          -  Involved in workers' compensation or active litigation involving affected shoulder&#xD;
&#xD;
          -  Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection&#xD;
&#xD;
          -  History of corticosteroid injection to affected shoulder within the last 3 months&#xD;
&#xD;
          -  History of viscosupplementation or platelet-rich plasma to affected shoulder within&#xD;
             the last 6 months&#xD;
&#xD;
          -  Presence of acute fracture&#xD;
&#xD;
          -  History of shoulder tumor&#xD;
&#xD;
          -  Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency&#xD;
             virus, vasculitis, autoimmune/inflammatory disease)&#xD;
&#xD;
          -  Psychiatric and somatoform disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Kirschner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>March 29, 2022</results_first_submitted>
  <results_first_submitted_qc>August 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2022</results_first_posted>
  <last_update_submitted>August 5, 2022</last_update_submitted>
  <last_update_submitted_qc>August 5, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <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>October 28, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02984228/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Platelet-rich Plasma (PRP)</title>
          <description>Patients will receive an injection of PRP.&#xD;
PRP&#xD;
Ultrasound</description>
        </group>
        <group group_id="P2">
          <title>Hyaluronic Acid</title>
          <description>Patients will receive an injection of hyaluronic acid.&#xD;
Hyaluronic Acid&#xD;
Ultrasound</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Platelet-rich Plasma (PRP)</title>
          <description>Patients will receive an injection of PRP.&#xD;
PRP&#xD;
Ultrasound</description>
        </group>
        <group group_id="B2">
          <title>Hyaluronic Acid</title>
          <description>Patients will receive an injection of hyaluronic acid.&#xD;
Hyaluronic Acid&#xD;
Ultrasound</description>
        </group>
        <group group_id="B3">
          <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="34"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.1" spread="11.5"/>
                    <measurement group_id="B2" value="68.4" spread="11.9"/>
                    <measurement group_id="B3" value="68.7" spread="11.6"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Severe osteoarthritis</title>
          <description>Severity of osteoarthritis was determined from radiographs, magnetic resonance imaging, or computed tomography scans by a fellowship-trained musculoskeletal radiologist. Severe osteoarthritis was defined as severe joint space loss with formation of osteophytes (bone spurs).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Shoulder Pain and Disability Index (SPADI) Score</title>
        <description>Score ranges from 0-100, with a higher score representing higher disability.</description>
        <time_frame>Up to 52 weeks post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP)</title>
            <description>Patients will receive an injection of PRP.&#xD;
PRP&#xD;
Ultrasound</description>
          </group>
          <group group_id="O2">
            <title>Hyaluronic Acid</title>
            <description>Patients will receive an injection of hyaluronic acid.&#xD;
Hyaluronic Acid&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Shoulder Pain and Disability Index (SPADI) Score</title>
          <description>Score ranges from 0-100, with a higher score representing higher disability.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.3" lower_limit="38.7" upper_limit="62"/>
                    <measurement group_id="O2" value="49" lower_limit="38" upper_limit="60.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shoulder Function</title>
        <description>Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.</description>
        <time_frame>Up to 52 weeks post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP)</title>
            <description>Patients will receive an injection of PRP.&#xD;
PRP&#xD;
Ultrasound</description>
          </group>
          <group group_id="O2">
            <title>Hyaluronic Acid</title>
            <description>Patients will receive an injection of hyaluronic acid.&#xD;
Hyaluronic Acid&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Shoulder Function</title>
          <description>Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.8" lower_limit="47.9" upper_limit="68"/>
                    <measurement group_id="O2" value="59" lower_limit="46.3" upper_limit="68.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Were Satisfied After Treatment</title>
        <description>Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: &quot;The procedure met my expectations&quot;; &quot;The procedure improved my condition enough so that I would go through it again for the same outcome&quot;; &quot;The procedure helped me, but I would not go through it again for the same outcome&quot;; or &quot;I am the same or worse compared to before the procedure&quot;. Responses of &quot;The procedure met my expectations&quot; and &quot;The procedure improved my condition enough so that I would go through it again for the same outcome&quot; were considered to be &quot;satisfied&quot;. The other two responses were considered to be &quot;not satisfied&quot;.</description>
        <time_frame>Up to 52 weeks post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP)</title>
            <description>Patients will receive an injection of PRP.&#xD;
PRP&#xD;
Ultrasound</description>
          </group>
          <group group_id="O2">
            <title>Hyaluronic Acid</title>
            <description>Patients will receive an injection of hyaluronic acid.&#xD;
Hyaluronic Acid&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Were Satisfied After Treatment</title>
          <description>Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: &quot;The procedure met my expectations&quot;; &quot;The procedure improved my condition enough so that I would go through it again for the same outcome&quot;; &quot;The procedure helped me, but I would not go through it again for the same outcome&quot;; or &quot;I am the same or worse compared to before the procedure&quot;. Responses of &quot;The procedure met my expectations&quot; and &quot;The procedure improved my condition enough so that I would go through it again for the same outcome&quot; were considered to be &quot;satisfied&quot;. The other two responses were considered to be &quot;not satisfied&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Complication Events After the Procedure</title>
        <description>Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.</description>
        <time_frame>Up to 52 weeks post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP)</title>
            <description>Patients will receive an injection of PRP.&#xD;
PRP&#xD;
Ultrasound</description>
          </group>
          <group group_id="O2">
            <title>Hyaluronic Acid</title>
            <description>Patients will receive an injection of hyaluronic acid.&#xD;
Hyaluronic Acid&#xD;
Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Complication Events After the Procedure</title>
          <description>Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over 1 year.</time_frame>
      <desc>Adverse events included bleeding from the injection site, swelling, infection, allergic reactions, weakness of the muscle surrounding the infected joint. The adverse event percentages noted in this section do not match the ones reported under Outcome Measures, as the Outcome Measures represent the percentage of adverse event cases among all events available (e.g., number of patients * number of follow-up time points).</desc>
      <group_list>
        <group group_id="E1">
          <title>Platelet-rich Plasma (PRP)</title>
          <description>Patients will receive an injection of PRP.&#xD;
PRP&#xD;
Ultrasound</description>
        </group>
        <group group_id="E2">
          <title>Hyaluronic Acid</title>
          <description>Patients will receive an injection of hyaluronic acid.&#xD;
Hyaluronic Acid&#xD;
Ultrasound</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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction with itchiness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Weakness of muscle surrounding injection site</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Difficulty moving affected shoulder joint</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Jennifer Cheng</name_or_title>
      <organization>Hospital for Special Surgery</organization>
      <phone>6467146870</phone>
      <email>chengj@hss.edu</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/NCT02984228
org study id: 2015-188
nct id: NCT02984228
lead sponsor: 
This study seeks to expand the current literature in demonstrating potentially efficacious,
      conservative treatments in the management of glenohumeral osteoarthritis (OA) and will
      compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to
      obtain information measuring potential benefits of these interventions and to observe for any
      adverse events.
Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be
      classified into primary and secondary forms. Primary glenohumeral OA is caused by
      degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary
      to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative
      changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in
      synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory
      properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains
      growth factors that have been shown to promote tissue regeneration. The aim of this study is
      to determine whether injections of hyaluronic acid or platelet-rich plasma can be used
      reliably to decrease pain, restore function, and improve quality of life in patients
      suffering from glenohumeral OA. Patients will be randomized to receive either an injection of
      hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via
      questionnaires for up to 52 weeks post-procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Shoulder Pain and Disability Index (SPADI) Score
time frame: Up to 52 weeks post-procedure
description: Score ranges from 0-100, with a higher score representing higher disability.
measure: Shoulder Function
time frame: Up to 52 weeks post-procedure
description: Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.
measure: Number of Patients Who Were Satisfied After Treatment
time frame: Up to 52 weeks post-procedure
description: Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: "The procedure met my expectations"; "The procedure improved my condition enough so that I would go through it again for the same outcome"; "The procedure helped me, but I would not go through it again for the same outcome"; or "I am the same or worse compared to before the procedure". Responses of "The procedure met my expectations" and "The procedure improved my condition enough so that I would go through it again for the same outcome" were considered to be "satisfied". The other two responses were considered to be "not satisfied".
measure: Number of Patients With Complication Events After the Procedure
time frame: Up to 52 weeks post-procedure
description: Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.
arm group label: Platelet-rich plasma (PRP)
arm group type: Active Comparator
description: Patients will receive an injection of PRP.
arm group label: Hyaluronic Acid
arm group type: Active Comparator
description: Patients will receive an injection of hyaluronic acid.
intervention type: Biological
intervention name: PRP
arm group label: Platelet-rich plasma (PRP)
intervention type: Drug
intervention name: Hyaluronic Acid
arm group label: Hyaluronic Acid
intervention type: Device
intervention name: Ultrasound
arm group label: Hyaluronic Acid
arm group label: Platelet-rich plasma (PRP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Jonathan Kirschner, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Shoulder Pain
mesh term: Hyaluronic Acid
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 