<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/NCT03805698</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00053449</org_study_id>
    <nct_id>NCT03805698</nct_id>
  </id_info>
  <brief_title>Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears</brief_title>
  <official_title>Use of Platelet Rich Plasma After Arthroscopic Debridement for Triangular Fibrocartilage Complex Tears</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare outcomes and functionality measures of subjects&#xD;
      treated with platelet rich plasma (PRP) after arthroscopic debridement of triangular&#xD;
      fibrocartilage complex (TFCC) tears to subjects treated with arthroscopic debridement alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with triangular fibrocartilage complex (TFCC) tears will undergo treatment with&#xD;
      arthroscopic debridement, as is standard of care, followed by treatment with platelet rich&#xD;
      plasma (PRP) (24 subjects) versus no treatment with PRP (24 subjects). Outcome measures will&#xD;
      include Modified Mayo Wrist scores (pain scale scores, grip strength, wrist range of motion,&#xD;
      functional status) and Patient-rated Wrist Evaluation (PRWE) scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID stopped surgeries&#xD;
  </why_stopped>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">February 6, 2021</completion_date>
  <primary_completion_date type="Actual">February 6, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated with PRP (24 subjects) versus no treatment with Platelet-rich plasma (PRP) (24 subjects).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-rated Wrist Evaluation (PRWE) Scores</measure>
    <time_frame>change from pre to post-op</time_frame>
    <description>The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150.&#xD;
Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Mayo Wrist Score - Grip Strength Score</measure>
    <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.</time_frame>
    <description>Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.&#xD;
Compare mean (percentage of normal) Grip strength scores from pre-op to post-op.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Mayo Wrist Score - Pain Score</measure>
    <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1</time_frame>
    <description>Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Mayo Wrist Score - Range of Motion Score</measure>
    <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.</time_frame>
    <description>Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Mayo Wrist Score - Functional Status Score</measure>
    <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.</time_frame>
    <description>Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Arthroscopic Surgery</condition>
  <condition>Triangular Fibrocartilage Complex Injury</condition>
  <arm_group>
    <arm_group_label>Platelet-rich Plasma (PRP) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated intraoperatively with platelet-rich plasma (PRP) (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the platelet-rich plasma (PRP)is injected into the debrided wrist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will undergo treatment, as is standard of care, followed by no treatment with platelet-rich plasma (PRP)(24 subjects).&#xD;
Intervention: No platelet-rich plasma (PRP) injection into debrided wrist</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Platelet-rich Plasma (PRP)</intervention_name>
    <description>The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
    <arm_group_label>Platelet-rich Plasma (PRP) group</arm_group_label>
    <other_name>PRP group</other_name>
    <other_name>Treatment group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Arthroscopic Debridement</intervention_name>
    <description>Standard arthroscopic debridement. No PRP injection.</description>
    <arm_group_label>Standard Treatment group</arm_group_label>
    <other_name>Standard Treatment</other_name>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female &gt;18 years of age&#xD;
&#xD;
          -  triangular fibrocartilage complex (TFCC) tear requiring surgical intervention&#xD;
&#xD;
          -  Be willing to undergo arthroscopic debridement and injection with platelet-rich plasma&#xD;
             (PRP)&#xD;
&#xD;
          -  Be in good health other than the TFCC tear&#xD;
&#xD;
          -  Have realistic expectations of surgical results&#xD;
&#xD;
          -  Understand and be willing to follow all aspects of the study protocol and have signed&#xD;
             and dated the IRB-approved Informed Consent Form and the Authorization for Use and&#xD;
             Release of Health and Research Study Information (HIPAA) form prior to any&#xD;
             study-related procedures being performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have collagen-vascular, connective tissue, or bleeding disorders&#xD;
&#xD;
          -  Be a smoker or have smoked in last 2 months&#xD;
&#xD;
          -  Have any disease, including uncontrolled diabetes, which is clinically known to impact&#xD;
             wound healing ability&#xD;
&#xD;
          -  Have regional sympathetic dystrophy&#xD;
&#xD;
          -  Be pregnant, lactating or expecting to be within the next 24 months&#xD;
&#xD;
          -  Currently have an alcohol/substance abuse problem or have had a relapse within one&#xD;
             year to screening visit&#xD;
&#xD;
          -  Have an abscess or infection at the time of surgery&#xD;
&#xD;
          -  Have a condition or be in a situation that, in the Investigator's opinion, may put the&#xD;
             subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the subject's participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Kulber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Department of Hand Surgery</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>July 8, 2022</results_first_submitted>
  <results_first_submitted_qc>September 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2022</results_first_posted>
  <last_update_submitted>September 9, 2022</last_update_submitted>
  <last_update_submitted_qc>September 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>David Kulber, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Platelet-rich Plasma</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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>October 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03805698/Prot_SAP_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03805698/ICF_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>medical clinic from 07/22/19-02/02/2020</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Platelet-rich Plasma (PRP) Group</title>
          <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
        </group>
        <group group_id="P2">
          <title>Standard Treatment Group</title>
          <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects).&#xD;
Intervention: No PRP injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>study not completed due to COVID shutdown</population>
      <group_list>
        <group group_id="B1">
          <title>Platelet-rich Plasma (PRP) Group</title>
          <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
        </group>
        <group group_id="B2">
          <title>Standard Treatment Group</title>
          <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects).&#xD;
Intervention: No PRP injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.</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="10"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="10"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="9"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.9" lower_limit="30" upper_limit="76"/>
                    <measurement group_id="B3" value="54.9" lower_limit="30" upper_limit="76"/>
                  </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="10"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient-rated Wrist Evaluation (PRWE) Scores</title>
        <description>The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150.&#xD;
Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op.</description>
        <time_frame>change from pre to post-op</time_frame>
        <population>The intervention was incomplete due to COVID and questionnaires were not obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP) Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects).&#xD;
Intervention: No PRP injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-rated Wrist Evaluation (PRWE) Scores</title>
          <description>The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150.&#xD;
Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op.</description>
          <population>The intervention was incomplete due to COVID and questionnaires were not obtained.</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>Modified Mayo Wrist Score - Grip Strength Score</title>
        <description>Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.&#xD;
Compare mean (percentage of normal) Grip strength scores from pre-op to post-op.</description>
        <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.</time_frame>
        <population>The Grip strength score was not obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP) Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects).&#xD;
Intervention: No PRP injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Mayo Wrist Score - Grip Strength Score</title>
          <description>Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.&#xD;
Compare mean (percentage of normal) Grip strength scores from pre-op to post-op.</description>
          <population>The Grip strength score was not obtained.</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>Modified Mayo Wrist Score - Pain Score</title>
        <description>Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale</description>
        <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1</time_frame>
        <population>Measurement was not obtained for any subject.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP) Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects).&#xD;
Intervention: No PRP injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Mayo Wrist Score - Pain Score</title>
          <description>Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale</description>
          <population>Measurement was not obtained for any subject.</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>Modified Mayo Wrist Score - Range of Motion Score</title>
        <description>Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.</description>
        <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.</time_frame>
        <population>The wrist score was not obtained for any patient in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP) Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects).&#xD;
Intervention: No PRP injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Mayo Wrist Score - Range of Motion Score</title>
          <description>Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.</description>
          <population>The wrist score was not obtained for any patient in the study.</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>Modified Mayo Wrist Score - Functional Status Score</title>
        <description>Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment</description>
        <time_frame>Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.</time_frame>
        <population>Wrist score was not obtained for any subject.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Plasma (PRP) Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will be treated intraoperatively with PRP (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.</description>
          </group>
          <group group_id="O2">
            <title>Standard Treatment Group</title>
            <description>Twenty-four (24) subjects undergoing arthroscopic debridement for TFCC tears will undergo treatement, as is standard of care, followed by no treatment with PRP (24 subjects).&#xD;
Intervention: No PRP injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No PRP injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Mayo Wrist Score - Functional Status Score</title>
          <description>Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment</description>
          <population>Wrist score was not obtained for any subject.</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>2 years</time_frame>
      <desc>no additional adverse event collected</desc>
      <group_list>
        <group group_id="E1">
          <title>Platelet-rich Plasma (PRP) Group</title>
          <description>Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated intraoperatively with Platelet-rich Plasma (PRP) (24 subjects).&#xD;
Intervention: use of Cascade device; Autologous Fibrin &amp; Platelet System; once processed, the PRP is injected into the debrided wrist&#xD;
Platelet-rich Plasma (PRP): The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for Platelet-rich Plasma (PRP) processing. Once processed, the Platelet-rich Plasma (PRP) is injected into the debrided wrist.</description>
        </group>
        <group group_id="E2">
          <title>Standard Treatment Group</title>
          <description>Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will undergo treatment, as is standard of care, followed by no treatment with Platelet-rich Plasma (PRP) (24 subjects).&#xD;
Intervention: No Platelet-rich Plasma (PRP) injection into debrided wrist&#xD;
Standard Arthroscopic Debridement: Standard arthroscopic debridement. No Platelet-rich Plasma (PRP) injection.</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>David Kulber, MD, PI</name_or_title>
      <organization>Cedars-Sinai Medical Center</organization>
      <phone>3104235900</phone>
      <email>david.kulber@cshs.org</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/NCT03805698
org study id: Pro00053449
nct id: NCT03805698
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of this study is to compare outcomes and functionality measures of subjects
      treated with platelet rich plasma (PRP) after arthroscopic debridement of triangular
      fibrocartilage complex (TFCC) tears to subjects treated with arthroscopic debridement alone.
Patients with triangular fibrocartilage complex (TFCC) tears will undergo treatment with
      arthroscopic debridement, as is standard of care, followed by treatment with platelet rich
      plasma (PRP) (24 subjects) versus no treatment with PRP (24 subjects). Outcome measures will
      include Modified Mayo Wrist scores (pain scale scores, grip strength, wrist range of motion,
      functional status) and Patient-rated Wrist Evaluation (PRWE) scores.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated with PRP (24 subjects) versus no treatment with Platelet-rich plasma (PRP) (24 subjects).
primary purpose: Treatment
masking: None (Open Label)
measure: Patient-rated Wrist Evaluation (PRWE) Scores
time frame: change from pre to post-op
description: The Patient-rated Wrist Evaluation is a 15 item patient-reported questionnaire to assess change from pre to post-op that asks the patient to rate their pain and function on a 10-point scale. 0 (minimum) means no pain/did not experience functional difficulties and 10 (maximum) means the worst pain/difficulty to function. Total minimum is 0 and total maximum for this scale measure is 150.
Compare Mean patient-rated Wrist Evaluation outcome scores from pre-op to post-op.
measure: Modified Mayo Wrist Score - Grip Strength Score
time frame: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.
description: Modified Mayo Wrist score - Grip strength score: A change in grip strength from pre to post-op (percentage of normal) - on 0 (minimum/total)-100% (maximum/total) scale between patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.
Compare mean (percentage of normal) Grip strength scores from pre-op to post-op.
measure: Modified Mayo Wrist Score - Pain Score
time frame: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1
description: Modified Mayo Wrist score - Mean Pain score change assessment from pre to post-op: 0 (minimum/total; severe to intolerable)-25 (maximum/total; no pain) point scale
measure: Modified Mayo Wrist Score - Range of Motion Score
time frame: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.
description: Modified Mayo Wrist score - Range of motion score: Assessment of change from pre to post-op in patient's range of motion (percentage of normal) on a 0 (minimum/total)-100% (maximum/total) scale between mean patient score of patients treated with PRP vs. patients not treated with PRP after arthroscopic debridement.
measure: Modified Mayo Wrist Score - Functional Status Score
time frame: Up to 5 time points (change from pre to post-op): pre-op, post op: month 1, month 3, month 6 and year 1; Subjects will be followed for 12 months post arthroscopic debridement.
description: Modified Mayo Wrist score - Functional status score: An assessment to review mean change from pre to post-op) 0 (minimum)-25 (maximum) point scale; a score of 0 denotes patient's inability to work because of pain and 25 denotes patients ability to work/return to regular employment
arm group label: Platelet-rich Plasma (PRP) group
arm group type: Experimental
description: Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will be treated intraoperatively with platelet-rich plasma (PRP) (24 subjects).
Intervention: use of Cascade device; Autologous Fibrin & Platelet System; once processed, the platelet-rich plasma (PRP)is injected into the debrided wrist
arm group label: Standard Treatment group
arm group type: Active Comparator
description: Twenty-four (24) subjects undergoing arthroscopic debridement for triangular fibrocartilage complex (TFCC) tears will undergo treatment, as is standard of care, followed by no treatment with platelet-rich plasma (PRP)(24 subjects).
Intervention: No platelet-rich plasma (PRP) injection into debrided wrist
intervention type: Device
intervention name: Platelet-rich Plasma (PRP)
description: The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.
arm group label: Platelet-rich Plasma (PRP) group
other name: PRP group
other name: Treatment group
intervention type: Other
intervention name: Standard Arthroscopic Debridement
description: Standard arthroscopic debridement. No PRP injection.
arm group label: Standard Treatment group
other name: Standard Treatment
other name: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Kulber, MD
role: Principal Investigator
affiliation: Cedars-Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: David Kulber, MD
investigator title: Principal Investigator
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 