<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/NCT02249377</url>
  </required_header>
  <id_info>
    <org_study_id>14-00457</org_study_id>
    <nct_id>NCT02249377</nct_id>
  </id_info>
  <brief_title>PRP vs Corticosteroid in Baker's Cyst</brief_title>
  <official_title>Clinical Outcomes of Platelet Rich Plasma Injection Versus Corticosteroid Injection for Baker's Cyst</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Prospective study with Randomized patients into either Ultrasound-guided&#xD;
      Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3 months&#xD;
      and 6 months follow ups after aspiration at our institution. There will be 25 patients in&#xD;
      each group, including any patient with symptomatic baker's cyst.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of Baker's Cysts are based on its presentation, asymptomatic cysts are&#xD;
      currently managed conservatively, symptomatic cysts are treated with joint aspiration and&#xD;
      Corticosteroid injection, which have shown according to literature a decrease of the cyst&#xD;
      size in approximately two-thirds of patients within 2-7 days but only complete disappearance&#xD;
      in approximately 7 %. Ultrasound guided cyst aspiration and Corticosteroid injection are also&#xD;
      used with reduction of cyst's size with recurrence in 6 months of 19%. Surgical options to&#xD;
      remove the cyst include, Open Resection with a recurrence of 50%, 25% of patients have motion&#xD;
      limitation recurrence, 37% have wound healing problems or tense swelling of the calf and 75%&#xD;
      of patients have joint pain lasting more than 2 days. Arthroscopic resection, with no&#xD;
      recurrence in ultrasound performed 6 and 12 months after procedure, pain lasting more than 3&#xD;
      days in 28% of patients, mild hematoma in 7% of patients and 7% where converted into an open&#xD;
      procedure&#xD;
&#xD;
      There is no study using ultrasound guided aspiration with platelet-rich-plasma injection&#xD;
      (PRP). The rationale for the use of PRP is the belief that the additional platelets will&#xD;
      exponentially increase the concentration and release of multiple growth and differentiation&#xD;
      factors at the injury site to augment the natural healing process9. PRP does not have any&#xD;
      described negative side effect due to the fact that is being prepared from subject's own&#xD;
      blood, with no risk of allergy or cross infection, relatively easy for a practiced clinician,&#xD;
      and reproducible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Outcome of Baker's Cysts With the Use of Platelets-Rich-Plasma Versus Corticosteroid</measure>
    <time_frame>6 Months</time_frame>
    <description>Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Baker's Cysts Treated on Each Group</measure>
    <time_frame>6 Months</time_frame>
    <description>Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>6 Months</time_frame>
    <description>All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>6 Months</time_frame>
    <description>All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Baker's Cyst</condition>
  <arm_group>
    <arm_group_label>Platelets-Rich-Plasma Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corticosteroid group:</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Platelets-Rich-Plasma</intervention_name>
    <description>Platelet-Rich Plasma</description>
    <arm_group_label>Platelets-Rich-Plasma Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <description>Corticosteroid</description>
    <arm_group_label>Corticosteroid group:</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at least 18 years old.&#xD;
&#xD;
          -  Patients with baker's cyst who also present with at least one of the following:&#xD;
             swelling, local pain or discomfort, limited range of motion or any other symptom&#xD;
             directly caused by the baker's cyst.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years old&#xD;
&#xD;
          -  Local or Systemic active infection&#xD;
&#xD;
          -  Active cancer treatment&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Hypersensitivity or allergy to Corticosteroid or Lidocaine&#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>Eric J Strauss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Hospital for Joint Diseases - Center for Musculoskeletal Care</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Handy JR. Popliteal cysts in adults: a review. Semin Arthritis Rheum. 2001 Oct;31(2):108-18. doi: 10.1053/sarh.2001.27659.</citation>
    <PMID>11590580</PMID>
  </reference>
  <reference>
    <citation>Johnson LL, van Dyk GE, Johnson CA, Bays BM, Gully SM. The popliteal bursa (Baker's cyst): an arthroscopic perspective and the epidemiology. Arthroscopy. 1997 Feb;13(1):66-72. doi: 10.1016/s0749-8063(97)90211-5.</citation>
    <PMID>9043606</PMID>
  </reference>
  <reference>
    <citation>Koroglu M, Callioglu M, Eris HN, Kayan M, Cetin M, Yener M, Gurses C, Erol B, Turkbey B, Parlak AE, Akhan O. Ultrasound guided percutaneous treatment and follow-up of Baker's cyst in knee osteoarthritis. Eur J Radiol. 2012 Nov;81(11):3466-71. doi: 10.1016/j.ejrad.2012.05.015. Epub 2012 Jun 20.</citation>
    <PMID>22726355</PMID>
  </reference>
  <reference>
    <citation>Ko S, Ahn J. Popliteal cystoscopic excisional debridement and removal of capsular fold of valvular mechanism of large recurrent popliteal cyst. Arthroscopy. 2004 Jan;20(1):37-44. doi: 10.1016/j.arthro.2003.10.017.</citation>
    <PMID>14716277</PMID>
  </reference>
  <reference>
    <citation>Acebes JC, Sanchez-Pernaute O, Diaz-Oca A, Herrero-Beaumont G. Ultrasonographic assessment of Baker's cysts after intra-articular corticosteroid injection in knee osteoarthritis. J Clin Ultrasound. 2006 Mar-Apr;34(3):113-7. doi: 10.1002/jcu.20210.</citation>
    <PMID>16547992</PMID>
  </reference>
  <reference>
    <citation>Omer Mei-Dan and Michael R. Carmont. Novel Applications of Platelet-Rich Plasma Technology in Musculoskeletal Medicine and Surgery. Oper Tech Orthop 22:56-63 © 2012 Elsevier</citation>
  </reference>
  <reference>
    <citation>Steven P. Arnoczky, Demetris Delos, Scott A. Rodeo. What Is Platelet-Rich Plasma? Oper Tech Sports Med 19:142-148 © 2011 Elsevier</citation>
  </reference>
  <reference>
    <citation>Mikel Sánchez, Javier Albillos, Francisco Angulo, Juanma Santisteban, Isabel Andia. Platelet-Rich Plasma in Muscle and Tendon Healing. Oper Tech Orthop 22:16-24 © 2012 Elsevier</citation>
  </reference>
  <reference>
    <citation>Andre F. Steinert, Kellie K. Middleton, Paulo H. Araujo, Freddie H. Fu. Platelet-Rich Plasma in Orthopaedic Surgery and Sports Medicine: Pearls, Pitfalls, and New Trends in Research. Oper Tech Orthop 22:91-103 © 2012 Elsevier</citation>
  </reference>
  <reference>
    <citation>Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.</citation>
    <PMID>14613558</PMID>
  </reference>
  <reference>
    <citation>J.F. Kaux. Exuberant inflammatory reaction as a side effect of an infiltration of PRP. Médecine du sport (2) : tendinopathies (actualités) / Annals of Physical and Rehabilitation Medicine 56S (2013) e215-e221</citation>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>March 7, 2018</results_first_submitted>
  <results_first_submitted_qc>March 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2020</results_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Baker's Cyst</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Popliteal Cyst</mesh_term>
  </condition_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>March 17, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02249377/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Platelets-Rich-Plasma Group</title>
          <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.&#xD;
Platelets-Rich-Plasma: Platelet-Rich Plasma</description>
        </group>
        <group group_id="P2">
          <title>Corticosteroid Group:</title>
          <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.&#xD;
Corticosteroid: Corticosteroid</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study terminated due to lack of funding</population>
      <group_list>
        <group group_id="B1">
          <title>Platelets-Rich-Plasma Group</title>
          <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.&#xD;
Platelets-Rich-Plasma: Platelet-Rich Plasma</description>
        </group>
        <group group_id="B2">
          <title>Corticosteroid Group:</title>
          <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.&#xD;
Corticosteroid: Corticosteroid</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="0"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
          </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="0"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="1"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="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 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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Outcome of Baker's Cysts With the Use of Platelets-Rich-Plasma Versus Corticosteroid</title>
        <description>Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.</description>
        <time_frame>6 Months</time_frame>
        <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelets-Rich-Plasma Group</title>
            <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.&#xD;
Platelets-Rich-Plasma: Platelet-Rich Plasma</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Group:</title>
            <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.&#xD;
Corticosteroid: Corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of Baker's Cysts With the Use of Platelets-Rich-Plasma Versus Corticosteroid</title>
          <description>Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.</description>
          <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</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>Recurrence of Baker's Cysts Treated on Each Group</title>
        <description>Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.</description>
        <time_frame>6 Months</time_frame>
        <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelets-Rich-Plasma Group</title>
            <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.&#xD;
Platelets-Rich-Plasma: Platelet-Rich Plasma</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Group:</title>
            <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.&#xD;
Corticosteroid: Corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence of Baker's Cysts Treated on Each Group</title>
          <description>Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.</description>
          <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</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>Complications</title>
        <description>All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.</description>
        <time_frame>6 Months</time_frame>
        <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelets-Rich-Plasma Group</title>
            <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.&#xD;
Platelets-Rich-Plasma: Platelet-Rich Plasma</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Group:</title>
            <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.&#xD;
Corticosteroid: Corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Complications</title>
          <description>All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.</description>
          <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</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>Side Effects</title>
        <description>All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.</description>
        <time_frame>6 Months</time_frame>
        <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Platelets-Rich-Plasma Group</title>
            <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.&#xD;
Platelets-Rich-Plasma: Platelet-Rich Plasma</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Group:</title>
            <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.&#xD;
Corticosteroid: Corticosteroid</description>
          </group>
        </group_list>
        <measure>
          <title>Side Effects</title>
          <description>All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.</description>
          <population>The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.</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>
      <desc>Study terminated due to lack of funding. All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed as a result.</desc>
      <group_list>
        <group group_id="E1">
          <title>Platelets-Rich-Plasma Group</title>
          <description>Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.&#xD;
Platelets-Rich-Plasma: Platelet-Rich Plasma</description>
        </group>
        <group group_id="E2">
          <title>Corticosteroid Group:</title>
          <description>Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.&#xD;
Corticosteroid: Corticosteroid</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="0"/>
                <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="0"/>
                <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="0"/>
                <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>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eric Strauss, MD</name_or_title>
      <organization>New York Langone Health</organization>
      <phone>646 501 7223</phone>
      <email>Eric.Strauss@nyumc.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/NCT02249377
org study id: 14-00457
nct id: NCT02249377
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a Prospective study with Randomized patients into either Ultrasound-guided
      Platelets-Rich-Plasma injection and Ultrasound guided Corticosteroid Injection, with 3 months
      and 6 months follow ups after aspiration at our institution. There will be 25 patients in
      each group, including any patient with symptomatic baker's cyst.
The treatment of Baker's Cysts are based on its presentation, asymptomatic cysts are
      currently managed conservatively, symptomatic cysts are treated with joint aspiration and
      Corticosteroid injection, which have shown according to literature a decrease of the cyst
      size in approximately two-thirds of patients within 2-7 days but only complete disappearance
      in approximately 7 %. Ultrasound guided cyst aspiration and Corticosteroid injection are also
      used with reduction of cyst's size with recurrence in 6 months of 19%. Surgical options to
      remove the cyst include, Open Resection with a recurrence of 50%, 25% of patients have motion
      limitation recurrence, 37% have wound healing problems or tense swelling of the calf and 75%
      of patients have joint pain lasting more than 2 days. Arthroscopic resection, with no
      recurrence in ultrasound performed 6 and 12 months after procedure, pain lasting more than 3
      days in 28% of patients, mild hematoma in 7% of patients and 7% where converted into an open
      procedure

      There is no study using ultrasound guided aspiration with platelet-rich-plasma injection
      (PRP). The rationale for the use of PRP is the belief that the additional platelets will
      exponentially increase the concentration and release of multiple growth and differentiation
      factors at the injury site to augment the natural healing process9. PRP does not have any
      described negative side effect due to the fact that is being prepared from subject's own
      blood, with no risk of allergy or cross infection, relatively easy for a practiced clinician,
      and reproducible.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Outcome of Baker's Cysts With the Use of Platelets-Rich-Plasma Versus Corticosteroid
time frame: 6 Months
description: Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.
measure: Recurrence of Baker's Cysts Treated on Each Group
time frame: 6 Months
description: Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.
measure: Complications
time frame: 6 Months
description: All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.
measure: Side Effects
time frame: 6 Months
description: All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.
arm group label: Platelets-Rich-Plasma Group
arm group type: Experimental
description: Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.
arm group label: Corticosteroid group:
arm group type: Active Comparator
description: Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.
intervention type: Other
intervention name: Platelets-Rich-Plasma
description: Platelet-Rich Plasma
arm group label: Platelets-Rich-Plasma Group
intervention type: Drug
intervention name: Corticosteroid
description: Corticosteroid
arm group label: Corticosteroid group:
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Eric J Strauss, MD
role: Principal Investigator
affiliation: NYU Langone Medical Center
facility: 
country: United States
citation: Handy JR. Popliteal cysts in adults: a review. Semin Arthritis Rheum. 2001 Oct;31(2):108-18. doi: 10.1053/sarh.2001.27659.
PMID: 11590580
citation: Johnson LL, van Dyk GE, Johnson CA, Bays BM, Gully SM. The popliteal bursa (Baker's cyst): an arthroscopic perspective and the epidemiology. Arthroscopy. 1997 Feb;13(1):66-72. doi: 10.1016/s0749-8063(97)90211-5.
PMID: 9043606
citation: Koroglu M, Callioglu M, Eris HN, Kayan M, Cetin M, Yener M, Gurses C, Erol B, Turkbey B, Parlak AE, Akhan O. Ultrasound guided percutaneous treatment and follow-up of Baker's cyst in knee osteoarthritis. Eur J Radiol. 2012 Nov;81(11):3466-71. doi: 10.1016/j.ejrad.2012.05.015. Epub 2012 Jun 20.
PMID: 22726355
citation: Ko S, Ahn J. Popliteal cystoscopic excisional debridement and removal of capsular fold of valvular mechanism of large recurrent popliteal cyst. Arthroscopy. 2004 Jan;20(1):37-44. doi: 10.1016/j.arthro.2003.10.017.
PMID: 14716277
citation: Acebes JC, Sanchez-Pernaute O, Diaz-Oca A, Herrero-Beaumont G. Ultrasonographic assessment of Baker's cysts after intra-articular corticosteroid injection in knee osteoarthritis. J Clin Ultrasound. 2006 Mar-Apr;34(3):113-7. doi: 10.1002/jcu.20210.
PMID: 16547992
citation: Omer Mei-Dan and Michael R. Carmont. Novel Applications of Platelet-Rich Plasma Technology in Musculoskeletal Medicine and Surgery. Oper Tech Orthop 22:56-63 © 2012 Elsevier
citation: Steven P. Arnoczky, Demetris Delos, Scott A. Rodeo. What Is Platelet-Rich Plasma? Oper Tech Sports Med 19:142-148 © 2011 Elsevier
citation: Mikel Sánchez, Javier Albillos, Francisco Angulo, Juanma Santisteban, Isabel Andia. Platelet-Rich Plasma in Muscle and Tendon Healing. Oper Tech Orthop 22:16-24 © 2012 Elsevier
citation: Andre F. Steinert, Kellie K. Middleton, Paulo H. Araujo, Freddie H. Fu. Platelet-Rich Plasma in Orthopaedic Surgery and Sports Medicine: Pearls, Pitfalls, and New Trends in Research. Oper Tech Orthop 22:91-103 © 2012 Elsevier
citation: Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
PMID: 14613558
citation: J.F. Kaux. Exuberant inflammatory reaction as a side effect of an infiltration of PRP. Médecine du sport (2) : tendinopathies (actualités) / Annals of Physical and Rehabilitation Medicine 56S (2013) e215-e221
responsible party type: Sponsor
mesh term: Cysts
mesh term: Popliteal Cyst
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 