<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/NCT04454164</url>
  </required_header>
  <id_info>
    <org_study_id>PRP2018</org_study_id>
    <nct_id>NCT04454164</nct_id>
  </id_info>
  <brief_title>Platelet Rich Plasma Injection for Knee Osteoarthritis</brief_title>
  <official_title>Platelet Rich Plasma In Knee Osteoarthritis: A Prospective, Double-Blind Randomized, Placebo Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferhat Say</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ondokuz Mayıs University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research questions of this study are;&#xD;
&#xD;
        1. Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)?&#xD;
&#xD;
        2. What are the indications for PRP treatment?&#xD;
&#xD;
        3. Which patients are the most suitable for the PRP treatment method?&#xD;
&#xD;
        4. How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages&#xD;
           affect the success of the PRP treatment?&#xD;
&#xD;
        5. Is there any advantage of multiple PRP doses?&#xD;
&#xD;
        6. What is the therapeutic effect of placebo?&#xD;
&#xD;
      This study was designed to find answers of these questions.&#xD;
&#xD;
      The hypotheses of this study are; &quot;PRP treatment is more effective than placebo; PRP&#xD;
      treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that&#xD;
      negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of&#xD;
      the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple&#xD;
      dose of PRP affects the effectiveness and duration of PRP as positively compared to single&#xD;
      dose of PRP&quot;.&#xD;
&#xD;
      The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain&#xD;
      and functions in patients with knee OA by comparing it with the placebo control group.&#xD;
      Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower&#xD;
      limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized,&#xD;
      double-blind and placebo control group, with a high level of scientific evidence. Thus, it&#xD;
      will be scientifically possible to find answers to the investigators research questions and&#xD;
      to prove the investigators hypothesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The power analysis of this study was calculated based on the sample size studies of previous&#xD;
      studies. The difference of d = 3 units between the two means is to have a standard deviation&#xD;
      of 6 units. The sample size 200 required to detect with 95% power in the 95% confidence&#xD;
      interval to detect.&#xD;
&#xD;
      This study covers 324 patients. All patients were selected according to predefined and&#xD;
      established inclusion and exclusion criteria.&#xD;
&#xD;
      Inclusion criteria were: stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence&#xD;
      staging, age between 18 and 80 years, mean Visual Analogue Score (VAS) of &gt;4 of 10 (worst&#xD;
      possible pain) over the course of 7 days during the previous month were included on a&#xD;
      voluntary basis. Only one knee injection was made to the patients.&#xD;
&#xD;
      Exclusion criteria were OA secondary to joint inflammatory diseases; patients with&#xD;
      generalized OA, metabolic diseases of the bone, coexisting backache, the presence of&#xD;
      hematological disease (coagulopathy), bilateral symptomatic lesions and advanced stages&#xD;
      (grade 4) of OA; patients who had received intra-articular injections within three months or&#xD;
      arthroscopic lavage in the previous one year or who were receiving immunosuppressive;&#xD;
      patients with current use of anticoagulant medications or NSAIDs used in the five days before&#xD;
      blood donation, major axis deviation (more than 15 degree of varus or more than 5 degree of&#xD;
      valgus deviation); and patients with a hemoglobin level less than 11.5 g/dL and platelets&#xD;
      level less than 100,000/μL or associated co-morbidities, infection, tumor, crystal&#xD;
      arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.&#xD;
&#xD;
      The voluntary patients included in this study were divided into four different groups with a&#xD;
      computer-assisted randomization program. This groups; group A (n:67) were given a single&#xD;
      injection of PRP, group B (n:69) were given a single injection of normal saline&#xD;
      (physiological control/placebo), group C (n:66) were given three injection (one per month) of&#xD;
      PRP, group D (n:65) were given three injection of normal saline (one per month)&#xD;
      (physiological control/placebo).&#xD;
&#xD;
      All patients were evaluated by a blinded researcher with VAS, Knee injury and Osteoarthritis&#xD;
      Outcome Score (KOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC),&#xD;
      KUJALA, knee range of motion (ROM) and knee circumference measurement at 1st, 3rd, 6th, 12th&#xD;
      and 24th months after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 23, 2019</primary_completion_date>
  <phase>Early Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>Baseline VAS score</time_frame>
    <description>Visual Analogue scale (0-10 higher scores mean a worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>VAS score at 1st months</time_frame>
    <description>Visual Analogue scale (0-10 higher scores mean a worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>VAS score at 3th months</time_frame>
    <description>Visual Analogue scale (0-10 higher scores mean a worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>VAS score at 6th months</time_frame>
    <description>Visual Analogue scale (0-10 higher scores mean a worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>VAS score at 12th months</time_frame>
    <description>Visual Analogue scale (0-10 higher scores mean a worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>VAS score at 24th months</time_frame>
    <description>Visual Analogue scale (0-10 higher scores mean a worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>Baseline KOOS score</time_frame>
    <description>Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>KOOS score at 1st months</time_frame>
    <description>Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>KOOS score at 3th months</time_frame>
    <description>Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>KOOS score at 6th months</time_frame>
    <description>Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>KOOS score at 12th months</time_frame>
    <description>Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>KOOS</measure>
    <time_frame>KOOS score at 24th months</time_frame>
    <description>Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC</measure>
    <time_frame>Baseline WOMAC score</time_frame>
    <description>Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC</measure>
    <time_frame>WOMAC score at 1st months</time_frame>
    <description>Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC</measure>
    <time_frame>WOMAC score at 3th months</time_frame>
    <description>Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC</measure>
    <time_frame>WOMAC score at 6th months</time_frame>
    <description>Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC</measure>
    <time_frame>WOMAC score at 12th months</time_frame>
    <description>Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WOMAC</measure>
    <time_frame>WOMAC score at 24th months</time_frame>
    <description>Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kujala</measure>
    <time_frame>Baseline Kujala score</time_frame>
    <description>Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kujala</measure>
    <time_frame>Kujala score at 1st months</time_frame>
    <description>Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kujala</measure>
    <time_frame>Kujala score at 3th months</time_frame>
    <description>Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kujala</measure>
    <time_frame>Kujala score at 6th months</time_frame>
    <description>Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kujala</measure>
    <time_frame>Kujala score at 12th months</time_frame>
    <description>Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kujala</measure>
    <time_frame>Kujala score at 24th months</time_frame>
    <description>Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee movement</measure>
    <time_frame>1st, 3rd, 6th, 12th and 24th months</time_frame>
    <description>knee joint range of motion (measured by goniometer as degree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knee circumference</measure>
    <time_frame>1st, 3rd, 6th, 12th and 24th months</time_frame>
    <description>Knee Trans patella circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanical axis angle</measure>
    <time_frame>baseline</time_frame>
    <description>angle measured from radiological axes graphs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>age</measure>
    <time_frame>baseline</time_frame>
    <description>age of the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stage</measure>
    <time_frame>baseline</time_frame>
    <description>stage of the osteoarthritis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>baseline</time_frame>
    <description>body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient global satisfaction</measure>
    <time_frame>24 months</time_frame>
    <description>subjective satisfaction level of the patient</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">324</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Cartilage Degeneration</condition>
  <arm_group>
    <arm_group_label>PRP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraarticular 5 ml single PRP injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intraarticular 5 ml single saline injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple PRP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraarticular 3 dose of 5 ml PRP injection (0, 1, 3 month injection)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple saline group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intraarticular 3 dose of 5 ml saline injection (0, 1, 3 month injection)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRP</intervention_name>
    <description>platelet rich plasma</description>
    <arm_group_label>Multiple PRP group</arm_group_label>
    <arm_group_label>PRP group</arm_group_label>
    <other_name>platelet rich plasma</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>serum physiologic</description>
    <arm_group_label>Multiple saline group</arm_group_label>
    <arm_group_label>Saline group</arm_group_label>
    <other_name>serum physiologic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging&#xD;
&#xD;
          -  mean VAS pain score of &gt;4 of 10 (worst possible pain) over the course of 7 days during&#xD;
             the previous month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  OA secondary to joint inflammatory diseases,&#xD;
&#xD;
          -  generalized OA,&#xD;
&#xD;
          -  metabolic diseases of the bone,&#xD;
&#xD;
          -  coexisting backache,&#xD;
&#xD;
          -  the presence of hematological disease (coagulopathy),&#xD;
&#xD;
          -  bilateral symptomatic lesions and advanced stages (grade 4) of OA,&#xD;
&#xD;
          -  patients who had received intra-articular injections within 3 months or arthroscopic&#xD;
             lavage in the previous 1 year,&#xD;
&#xD;
          -  patients who were receiving immunosuppressive,&#xD;
&#xD;
          -  patients with current use of anticoagulant medications,&#xD;
&#xD;
          -  NSAIDs used in the 5 days before blood donation,&#xD;
&#xD;
          -  major axis deviation (more than 15 degree of varus or more than 5 degree of valgus&#xD;
             deviation),&#xD;
&#xD;
          -  patients with a hemoglobin level less than 11.5 g/dL,&#xD;
&#xD;
          -  platelets level less than 100,000/μL,&#xD;
&#xD;
          -  associated comorbidities, infection, tumor, crystal arthropathies, anemia, tense joint&#xD;
             effusion and pregnancy or possibility of pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Orthopedic and Trauma, Faculty of Medicine, Ondokuz Mayıs University</name>
      <address>
        <city>Samsun</city>
        <state>Atakum</state>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.</citation>
    <PMID>30611335</PMID>
  </reference>
  <reference>
    <citation>Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.</citation>
    <PMID>26831629</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.</citation>
    <PMID>26233594</PMID>
  </reference>
  <reference>
    <citation>Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.</citation>
    <PMID>30545242</PMID>
  </reference>
  <reference>
    <citation>Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.</citation>
    <PMID>25952818</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation>
    <investigator_full_name>Ferhat Say</investigator_full_name>
    <investigator_title>M.D. Associate Professor</investigator_title>
  </responsible_party>
  <keyword>platelet-rich plasma</keyword>
  <keyword>placebo</keyword>
  <keyword>growth factors</keyword>
  <keyword>osteoarthritis</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/NCT04454164
org study id: PRP2018
nct id: NCT04454164
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research questions of this study are;

        1. Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)?

        2. What are the indications for PRP treatment?

        3. Which patients are the most suitable for the PRP treatment method?

        4. How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages
           affect the success of the PRP treatment?

        5. Is there any advantage of multiple PRP doses?

        6. What is the therapeutic effect of placebo?

      This study was designed to find answers of these questions.

      The hypotheses of this study are; "PRP treatment is more effective than placebo; PRP
      treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that
      negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of
      the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple
      dose of PRP affects the effectiveness and duration of PRP as positively compared to single
      dose of PRP".

      The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain
      and functions in patients with knee OA by comparing it with the placebo control group.
      Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower
      limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized,
      double-blind and placebo control group, with a high level of scientific evidence. Thus, it
      will be scientifically possible to find answers to the investigators research questions and
      to prove the investigators hypothesis.
The power analysis of this study was calculated based on the sample size studies of previous
      studies. The difference of d = 3 units between the two means is to have a standard deviation
      of 6 units. The sample size 200 required to detect with 95% power in the 95% confidence
      interval to detect.

      This study covers 324 patients. All patients were selected according to predefined and
      established inclusion and exclusion criteria.

      Inclusion criteria were: stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence
      staging, age between 18 and 80 years, mean Visual Analogue Score (VAS) of >4 of 10 (worst
      possible pain) over the course of 7 days during the previous month were included on a
      voluntary basis. Only one knee injection was made to the patients.

      Exclusion criteria were OA secondary to joint inflammatory diseases; patients with
      generalized OA, metabolic diseases of the bone, coexisting backache, the presence of
      hematological disease (coagulopathy), bilateral symptomatic lesions and advanced stages
      (grade 4) of OA; patients who had received intra-articular injections within three months or
      arthroscopic lavage in the previous one year or who were receiving immunosuppressive;
      patients with current use of anticoagulant medications or NSAIDs used in the five days before
      blood donation, major axis deviation (more than 15 degree of varus or more than 5 degree of
      valgus deviation); and patients with a hemoglobin level less than 11.5 g/dL and platelets
      level less than 100,000/μL or associated co-morbidities, infection, tumor, crystal
      arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.

      The voluntary patients included in this study were divided into four different groups with a
      computer-assisted randomization program. This groups; group A (n:67) were given a single
      injection of PRP, group B (n:69) were given a single injection of normal saline
      (physiological control/placebo), group C (n:66) were given three injection (one per month) of
      PRP, group D (n:65) were given three injection of normal saline (one per month)
      (physiological control/placebo).

      All patients were evaluated by a blinded researcher with VAS, Knee injury and Osteoarthritis
      Outcome Score (KOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC),
      KUJALA, knee range of motion (ROM) and knee circumference measurement at 1st, 3rd, 6th, 12th
      and 24th months after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: VAS
time frame: Baseline VAS score
description: Visual Analogue scale (0-10 higher scores mean a worse outcome)
measure: VAS
time frame: VAS score at 1st months
description: Visual Analogue scale (0-10 higher scores mean a worse outcome)
measure: VAS
time frame: VAS score at 3th months
description: Visual Analogue scale (0-10 higher scores mean a worse outcome)
measure: VAS
time frame: VAS score at 6th months
description: Visual Analogue scale (0-10 higher scores mean a worse outcome)
measure: VAS
time frame: VAS score at 12th months
description: Visual Analogue scale (0-10 higher scores mean a worse outcome)
measure: VAS
time frame: VAS score at 24th months
description: Visual Analogue scale (0-10 higher scores mean a worse outcome)
measure: KOOS
time frame: Baseline KOOS score
description: Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
measure: KOOS
time frame: KOOS score at 1st months
description: Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
measure: KOOS
time frame: KOOS score at 3th months
description: Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
measure: KOOS
time frame: KOOS score at 6th months
description: Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
measure: KOOS
time frame: KOOS score at 12th months
description: Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
measure: KOOS
time frame: KOOS score at 24th months
description: Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
measure: WOMAC
time frame: Baseline WOMAC score
description: Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
measure: WOMAC
time frame: WOMAC score at 1st months
description: Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
measure: WOMAC
time frame: WOMAC score at 3th months
description: Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
measure: WOMAC
time frame: WOMAC score at 6th months
description: Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
measure: WOMAC
time frame: WOMAC score at 12th months
description: Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
measure: WOMAC
time frame: WOMAC score at 24th months
description: Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
measure: Kujala
time frame: Baseline Kujala score
description: Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
measure: Kujala
time frame: Kujala score at 1st months
description: Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
measure: Kujala
time frame: Kujala score at 3th months
description: Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
measure: Kujala
time frame: Kujala score at 6th months
description: Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
measure: Kujala
time frame: Kujala score at 12th months
description: Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
measure: Kujala
time frame: Kujala score at 24th months
description: Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
measure: Knee movement
time frame: 1st, 3rd, 6th, 12th and 24th months
description: knee joint range of motion (measured by goniometer as degree)
measure: knee circumference
time frame: 1st, 3rd, 6th, 12th and 24th months
description: Knee Trans patella circumference
measure: mechanical axis angle
time frame: baseline
description: angle measured from radiological axes graphs
measure: age
time frame: baseline
description: age of the patient
measure: stage
time frame: baseline
description: stage of the osteoarthritis
measure: BMI
time frame: baseline
description: body mass index
measure: patient global satisfaction
time frame: 24 months
description: subjective satisfaction level of the patient
arm group label: PRP group
arm group type: Experimental
description: Intraarticular 5 ml single PRP injection
arm group label: Saline group
arm group type: Placebo Comparator
description: Intraarticular 5 ml single saline injection
arm group label: Multiple PRP group
arm group type: Experimental
description: Intraarticular 3 dose of 5 ml PRP injection (0, 1, 3 month injection)
arm group label: Multiple saline group
arm group type: Placebo Comparator
description: Intraarticular 3 dose of 5 ml saline injection (0, 1, 3 month injection)
intervention type: Biological
intervention name: PRP
description: platelet rich plasma
arm group label: Multiple PRP group
arm group label: PRP group
other name: platelet rich plasma
intervention type: Drug
intervention name: Saline
description: serum physiologic
arm group label: Multiple saline group
arm group label: Saline group
other name: serum physiologic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.
PMID: 30611335
citation: Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
PMID: 26831629
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: Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.
PMID: 26233594
citation: Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.
PMID: 30545242
citation: Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
PMID: 25952818
responsible party type: Sponsor-Investigator
investigator affiliation: Ondokuz Mayıs University
investigator full name: Ferhat Say
investigator title: M.D. Associate Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee