<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/NCT02978833</url>
  </required_header>
  <id_info>
    <org_study_id>2015-184</org_study_id>
    <nct_id>NCT02978833</nct_id>
  </id_info>
  <brief_title>Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy</brief_title>
  <official_title>Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study</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>
      Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain&#xD;
      Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by&#xD;
      side lying, stair climbing, and walking. Treatment is currently limited to lifestyle&#xD;
      modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical&#xD;
      repair. Platelet rich plasma (PRP) injections contain important growth factors that are&#xD;
      essential in the healing and tissue formation processes. However, the extent to which PRP is&#xD;
      more efficacious than whole blood in tendinopathy remains unclear. In this double-blind&#xD;
      randomized trial, patients will be allocated to receive either a PRP or whole-blood&#xD;
      injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months,&#xD;
      and 1 year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow enrollment, lack of patients&#xD;
  </why_stopped>
  <start_date>October 1, 2013</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Pain</measure>
    <time_frame>Up to 1 year post-injection</time_frame>
    <description>The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Function</measure>
    <time_frame>Up to 1 year post-injection</time_frame>
    <description>The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Up to 1 year post-injection</time_frame>
    <description>The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from &quot;very dissatisfied&quot; to &quot;extremely satisfied&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Movement During the Forward Step-down Test</measure>
    <time_frame>Up to 1 year post-injection</time_frame>
    <description>The quality of movement will be assessed on a scale of 0-4+, where 4+=&quot;good&quot;, 2-3=&quot;moderate&quot;, and 0-1=&quot;poor&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain During Side-lying Hip Abduction</measure>
    <time_frame>Up to 1 year post-injection</time_frame>
    <description>Pain will be assessed using the 10-cm Visual Analog Scale, which will range from &quot;no pain&quot; to &quot;worst possible pain&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain During Forward Step-down Test</measure>
    <time_frame>Up to 1 year post-injection</time_frame>
    <description>Pain will be assessed using the 10-cm Visual Analog Scale, which will range from &quot;no pain&quot; to &quot;worst possible pain&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Tendinopathy</condition>
  <condition>Hip Pain</condition>
  <arm_group>
    <arm_group_label>PRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole Blood</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRP</intervention_name>
    <arm_group_label>PRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Whole Blood</intervention_name>
    <arm_group_label>Whole Blood</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>PRP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate to severe lateral hip pain for greater than 3 months&#xD;
&#xD;
          -  Symptoms are refractory to conservative treatment, including at least 8 weeks of&#xD;
             traditional physical therapy for this condition&#xD;
&#xD;
          -  Moderate to severe gluteus medius tendinosis with or without partial tear &lt;1 cm&#xD;
&#xD;
          -  Normal neurologic exam except for hip abductor weakness on the affected side&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe (Tonnis grade &gt;1) hip osteoarthritis with active synovitis or bone edema&#xD;
&#xD;
          -  Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal&#xD;
             distribution&#xD;
&#xD;
          -  No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on&#xD;
             MRI&#xD;
&#xD;
          -  Any condition that requires anti-platelet or anti-coagulation therapy, including&#xD;
             aspirin therapy for cardiac conditions&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Moley, M.D.</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 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>June 4, 2018</results_first_submitted>
  <results_first_submitted_qc>August 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 7, 2018</results_first_posted>
  <last_update_submitted>August 6, 2018</last_update_submitted>
  <last_update_submitted_qc>August 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gluteus Medius Tendinosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02978833/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02978833/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Platelet-rich Plasma</title>
          <description>PRP&#xD;
Ultrasound</description>
        </group>
        <group group_id="P2">
          <title>Whole Blood</title>
          <description>Whole Blood</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study terminated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Platelet-rich Plasma</title>
          <description>PRP&#xD;
Ultrasound</description>
        </group>
        <group group_id="B2">
          <title>Whole Blood</title>
          <description>Whole Blood</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="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</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>&gt;=65 years</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>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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</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>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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Improvement in Pain</title>
        <description>The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.</description>
        <time_frame>Up to 1 year post-injection</time_frame>
        <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma</title>
            <description>PRP&#xD;
Ultrasound</description>
          </group>
          <group group_id="O2">
            <title>Whole Blood</title>
            <description>Whole Blood</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Pain</title>
          <description>The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.</description>
          <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Improvement in Function</title>
        <description>The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.</description>
        <time_frame>Up to 1 year post-injection</time_frame>
        <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma</title>
            <description>PRP</description>
          </group>
          <group group_id="O2">
            <title>Whole Blood</title>
            <description>Whole Blood</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Function</title>
          <description>The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.</description>
          <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction</title>
        <description>The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from &quot;very dissatisfied&quot; to &quot;extremely satisfied&quot;.</description>
        <time_frame>Up to 1 year post-injection</time_frame>
        <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma</title>
            <description>PRP</description>
          </group>
          <group group_id="O2">
            <title>Whole Blood</title>
            <description>Whole Blood</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from &quot;very dissatisfied&quot; to &quot;extremely satisfied&quot;.</description>
          <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Movement During the Forward Step-down Test</title>
        <description>The quality of movement will be assessed on a scale of 0-4+, where 4+=&quot;good&quot;, 2-3=&quot;moderate&quot;, and 0-1=&quot;poor&quot;.</description>
        <time_frame>Up to 1 year post-injection</time_frame>
        <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma</title>
            <description>PRP</description>
          </group>
          <group group_id="O2">
            <title>Whole Blood</title>
            <description>Whole Blood</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Movement During the Forward Step-down Test</title>
          <description>The quality of movement will be assessed on a scale of 0-4+, where 4+=&quot;good&quot;, 2-3=&quot;moderate&quot;, and 0-1=&quot;poor&quot;.</description>
          <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain During Side-lying Hip Abduction</title>
        <description>Pain will be assessed using the 10-cm Visual Analog Scale, which will range from &quot;no pain&quot; to &quot;worst possible pain&quot;.</description>
        <time_frame>Up to 1 year post-injection</time_frame>
        <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma</title>
            <description>PRP</description>
          </group>
          <group group_id="O2">
            <title>Whole Blood</title>
            <description>Whole Blood</description>
          </group>
        </group_list>
        <measure>
          <title>Pain During Side-lying Hip Abduction</title>
          <description>Pain will be assessed using the 10-cm Visual Analog Scale, which will range from &quot;no pain&quot; to &quot;worst possible pain&quot;.</description>
          <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain During Forward Step-down Test</title>
        <description>Pain will be assessed using the 10-cm Visual Analog Scale, which will range from &quot;no pain&quot; to &quot;worst possible pain&quot;.</description>
        <time_frame>Up to 1 year post-injection</time_frame>
        <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma</title>
            <description>PRP</description>
          </group>
          <group group_id="O2">
            <title>Whole Blood</title>
            <description>Whole Blood</description>
          </group>
        </group_list>
        <measure>
          <title>Pain During Forward Step-down Test</title>
          <description>Pain will be assessed using the 10-cm Visual Analog Scale, which will range from &quot;no pain&quot; to &quot;worst possible pain&quot;.</description>
          <population>This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>This study was terminated early. Adverse event data were not collected to completion for each of the patients.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Platelet-rich Plasma</title>
          <description>PRP&#xD;
Ultrasound</description>
        </group>
        <group group_id="E2">
          <title>Whole Blood</title>
          <description>Whole Blood</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </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/NCT02978833
org study id: 2015-184
nct id: NCT02978833
lead sponsor: 
Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain
      Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by
      side lying, stair climbing, and walking. Treatment is currently limited to lifestyle
      modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical
      repair. Platelet rich plasma (PRP) injections contain important growth factors that are
      essential in the healing and tissue formation processes. However, the extent to which PRP is
      more efficacious than whole blood in tendinopathy remains unclear. In this double-blind
      randomized trial, patients will be allocated to receive either a PRP or whole-blood
      injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months,
      and 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Improvement in Pain
time frame: Up to 1 year post-injection
description: The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.
measure: Improvement in Function
time frame: Up to 1 year post-injection
description: The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
measure: Patient Satisfaction
time frame: Up to 1 year post-injection
description: The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".
measure: Quality of Movement During the Forward Step-down Test
time frame: Up to 1 year post-injection
description: The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".
measure: Pain During Side-lying Hip Abduction
time frame: Up to 1 year post-injection
description: Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
measure: Pain During Forward Step-down Test
time frame: Up to 1 year post-injection
description: Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
arm group label: PRP
arm group type: Experimental
arm group label: Whole Blood
arm group type: Active Comparator
intervention type: Biological
intervention name: PRP
arm group label: PRP
intervention type: Biological
intervention name: Whole Blood
arm group label: Whole Blood
intervention type: Device
intervention name: Ultrasound
arm group label: PRP
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Peter Moley, M.D.
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 