<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/NCT02239029</url>
  </required_header>
  <id_info>
    <org_study_id>TSGHIRB-2-103-05-075</org_study_id>
    <secondary_id>TSGHIRB-2-103-05-075, Taiwan</secondary_id>
    <nct_id>NCT02239029</nct_id>
  </id_info>
  <brief_title>Platelet Rich Plasma on Osteoarthritis of Knee</brief_title>
  <official_title>The Effect of Platelet Rich Plasma on Osteoarthritis of Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yung-Tsan Wu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tri-Service General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although few studies have showed beneficial effect of platelet rich plasma (PRP) for&#xD;
      osteoarthritis of knee (OA knee), only one study applied randomized, control method and none&#xD;
      of them has the objective measurements such as balance test or muscle strength which were&#xD;
      reported as decrease in patients with OA knees. We assess the analgesic effect and the extent&#xD;
      of improved muscle strength and balance after PRP in patients with OA knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with bilateral OA knee will be enrolled and randomized into intervention and control&#xD;
      knee. One dose of PRP is applied in the intervention knee and normal saline in control side.&#xD;
      Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western&#xD;
      Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and&#xD;
      isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month&#xD;
      and 6th month after treatment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.</measure>
    <time_frame>Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.</time_frame>
    <description>Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.</measure>
    <time_frame>Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..</time_frame>
    <description>Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.</measure>
    <time_frame>Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.</time_frame>
    <description>Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.</measure>
    <time_frame>Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.</time_frame>
    <description>Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.</measure>
    <time_frame>Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.</time_frame>
    <description>Using the isokinetic strengthening test to measure the muscle strength of lower extremities before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Platelet rich plasma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.&#xD;
Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline was injected into the other side of knee as the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>platelet rich plasma</intervention_name>
    <description>Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.</description>
    <arm_group_label>Platelet rich plasma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>The normal salin as the placebo intervention was injection in the other side of knee.</description>
    <arm_group_label>normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 35 to 75 y/o.&#xD;
&#xD;
          2. Alert consciousness&#xD;
&#xD;
          3. Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by&#xD;
             Ahlbäck grading system&#xD;
&#xD;
          4. The pain score measured by VAS at least 4 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has received hyaluronic acid or steroid injection within 6 monts&#xD;
&#xD;
          2. Has received NSAIDs or steroid within one week&#xD;
&#xD;
          3. Tumor or metastasis surrounding the knee joint&#xD;
&#xD;
          4. Has received total knee replacement, major surgery in knee, rheumatoid arthritis&#xD;
&#xD;
          5. Patient who cant tolerance the balance or muscle strength test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liang-Cheng Chen, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tri-Service General Hospital, National Defense Medical Center,</name>
      <address>
        <city>Taipei</city>
        <state>Neihu District</state>
        <zip>886</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Matava MJ. Platelet-rich plasma: the next big thing?: commentary on an article by Ujash Sheth, BHSc, et al.: &quot;Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis&quot;. J Bone Joint Surg Am. 2012 Feb 15;94(4):e25. doi: 10.2106/JBJS.K.01423. No abstract available.</citation>
    <PMID>22241605</PMID>
  </results_reference>
  <results_reference>
    <citation>Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.</citation>
    <PMID>23299850</PMID>
  </results_reference>
  <results_reference>
    <citation>Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.</citation>
    <PMID>22513879</PMID>
  </results_reference>
  <results_reference>
    <citation>Khalaj N, Abu Osman NA, Mokhtar AH, Mehdikhani M, Wan Abas WA. Balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis. PLoS One. 2014 Mar 18;9(3):e92270. doi: 10.1371/journal.pone.0092270. eCollection 2014.</citation>
    <PMID>24642715</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
    <investigator_full_name>Yung-Tsan Wu</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Platelet rich plasma</keyword>
  <keyword>Osteoarthritis of knee</keyword>
  <keyword>Balance</keyword>
  <keyword>Strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02239029
org study id: TSGHIRB-2-103-05-075
secondary id: TSGHIRB-2-103-05-075, Taiwan
nct id: NCT02239029
lead sponsor: 
has dmc: Yes
Although few studies have showed beneficial effect of platelet rich plasma (PRP) for
      osteoarthritis of knee (OA knee), only one study applied randomized, control method and none
      of them has the objective measurements such as balance test or muscle strength which were
      reported as decrease in patients with OA knees. We assess the analgesic effect and the extent
      of improved muscle strength and balance after PRP in patients with OA knee.
Patients with bilateral OA knee will be enrolled and randomized into intervention and control
      knee. One dose of PRP is applied in the intervention knee and normal saline in control side.
      Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western
      Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and
      isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month
      and 6th month after treatment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP.
time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP.
description: Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
measure: Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
time frame: Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment..
description: Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment.
measure: Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment.
time frame: Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment.
description: Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment.
measure: Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment.
time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
description: Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment.
measure: Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment.
time frame: Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment.
description: Using the isokinetic strengthening test to measure the muscle strength of lower extremities before treatment and multiple time frame after treatment.
arm group label: Platelet rich plasma
arm group type: Active Comparator
description: Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side.
arm group label: normal saline
arm group type: Placebo Comparator
description: Normal saline was injected into the other side of knee as the control group.
intervention type: Drug
intervention name: platelet rich plasma
description: Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
arm group label: Platelet rich plasma
intervention type: Drug
intervention name: Normal saline
description: The normal salin as the placebo intervention was injection in the other side of knee.
arm group label: normal saline
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Liang-Cheng Chen, MD, MS
role: Principal Investigator
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center
facility: 
country: Taiwan
citation: Matava MJ. Platelet-rich plasma: the next big thing?: commentary on an article by Ujash Sheth, BHSc, et al.: "Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis". J Bone Joint Surg Am. 2012 Feb 15;94(4):e25. doi: 10.2106/JBJS.K.01423. No abstract available.
PMID: 22241605
citation: Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
PMID: 23299850
citation: Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.
PMID: 22513879
citation: Khalaj N, Abu Osman NA, Mokhtar AH, Mehdikhani M, Wan Abas WA. Balance and risk of fall in individuals with bilateral mild and moderate knee osteoarthritis. PLoS One. 2014 Mar 18;9(3):e92270. doi: 10.1371/journal.pone.0092270. eCollection 2014.
PMID: 24642715
responsible party type: Sponsor-Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yung-Tsan Wu
investigator title: Attending Physician
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee