<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/NCT01697423</url>
  </required_header>
  <id_info>
    <org_study_id>2012-003565-18</org_study_id>
    <secondary_id>2011-25</secondary_id>
    <nct_id>NCT01697423</nct_id>
  </id_info>
  <brief_title>Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis</brief_title>
  <official_title>Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of cartilage pathology has grown due to the ageing population, and the increase&#xD;
      in sports participation and its associated trauma. The aim of the treatment of symptomatic&#xD;
      osteoarthritis consists in reducing pain and improving the knee function in order to limit&#xD;
      the sport, professional and social negative impact in the youngest patients.&#xD;
&#xD;
      The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti&#xD;
      inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular&#xD;
      injections are proposed.&#xD;
&#xD;
      Intra articular injections of hyaluronic acid are recommended by the American College of&#xD;
      Rheumatology and the European League against Rheumatism for the treatment of knee&#xD;
      osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the&#xD;
      duration of clinical improvement which does not exceed 6 months.&#xD;
&#xD;
      The articular cartilage has a limited capacity for self-repair due to the low mitotic&#xD;
      activity of chondrocytes and its avascularity.&#xD;
&#xD;
      Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and&#xD;
      the cytokines, liberated by platelet degranulation. The influence of these growth factors in&#xD;
      the cartilage repair is being widely investigated in vivo and in vitro. These factors could&#xD;
      stimulate the chondral reparation via a neovascularization, a collagen synthesis and an&#xD;
      activation of the chondrocytes.&#xD;
&#xD;
      The hypothesis is that the intra articular injection of PRP, with its capacity to enhance&#xD;
      articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the&#xD;
      treatment of knee osteoarthritis resisting the oral drugs.&#xD;
&#xD;
      Material and methods: We intend to conduct a comparative, monocentric prospective randomized,&#xD;
      double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results&#xD;
      of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2012</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 30, 2016</primary_completion_date>
  <phase>Phase 2</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variation of the functional score of WOMAC</measure>
    <time_frame>12 months</time_frame>
    <description>evaluate the non inferiority between platelet-rich plasma (PRP) and hyaluronic acid. onthé evolution of the knee function, by assessing the difference with a functional score (WOMAC), before and 3 months after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the evolution of pain</measure>
    <time_frame>12month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>the Treatment of Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>platelet-rich plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>durolane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>platelet-rich plasma</intervention_name>
    <arm_group_label>platelet-rich plasma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>durolane</intervention_name>
    <arm_group_label>durolane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Males and females between 20 to 75 years of age 2. Symptomatic knee arthritis 3.&#xD;
             Axial deformity of the lower limb equal or lower than 5° 4. BMI between 20 to 30 5.&#xD;
             Written informed consent, signed by patient or legal representative (if patient unable&#xD;
             to sign).&#xD;
&#xD;
             6. HB &gt; 10g/dl 7. Negative pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Axial deformity of the lower limb over 5°&#xD;
&#xD;
          2. Knee instability&#xD;
&#xD;
          3. BMI &lt; 20 or &gt; 30&#xD;
&#xD;
          4. Thrombocytopenia &lt; 150 G/L&#xD;
&#xD;
          5. Thrombopathy&#xD;
&#xD;
          6. Anaemia: HB &lt; 10g/dl&#xD;
&#xD;
          7. Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA&#xD;
&#xD;
          8. Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks&#xD;
             before inclusion&#xD;
&#xD;
          9. Intra articular knee injection of corticosteroid or completed more than 8 weeks before&#xD;
             inclusion&#xD;
&#xD;
         10. Intra articular knee injection of hyaluronic or completed more than 24 weeks before&#xD;
             inclusion&#xD;
&#xD;
         11. NSAI treatment completed more than 2 weeks before inclusion&#xD;
&#xD;
         12. Fever or recent disease&#xD;
&#xD;
         13. Auto immune disease&#xD;
&#xD;
         14. Inflammatory Arthritis&#xD;
&#xD;
         15. Immune deficit&#xD;
&#xD;
         16. Infectious disease&#xD;
&#xD;
         17. Pregnancy&#xD;
&#xD;
         18. Patient under guardianship.&#xD;
&#xD;
         19. Participation in another investigational trial within this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BERNARD BELAIGUES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <overall_official>
    <last_name>marie laure LOUIS</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP HM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01697423
org study id: 2012-003565-18
secondary id: 2011-25
nct id: NCT01697423
lead sponsor: 
has dmc: Yes
The incidence of cartilage pathology has grown due to the ageing population, and the increase
      in sports participation and its associated trauma. The aim of the treatment of symptomatic
      osteoarthritis consists in reducing pain and improving the knee function in order to limit
      the sport, professional and social negative impact in the youngest patients.

      The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti
      inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular
      injections are proposed.

      Intra articular injections of hyaluronic acid are recommended by the American College of
      Rheumatology and the European League against Rheumatism for the treatment of knee
      osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the
      duration of clinical improvement which does not exceed 6 months.

      The articular cartilage has a limited capacity for self-repair due to the low mitotic
      activity of chondrocytes and its avascularity.

      Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and
      the cytokines, liberated by platelet degranulation. The influence of these growth factors in
      the cartilage repair is being widely investigated in vivo and in vitro. These factors could
      stimulate the chondral reparation via a neovascularization, a collagen synthesis and an
      activation of the chondrocytes.

      The hypothesis is that the intra articular injection of PRP, with its capacity to enhance
      articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the
      treatment of knee osteoarthritis resisting the oral drugs.

      Material and methods: We intend to conduct a comparative, monocentric prospective randomized,
      double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results
      of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Variation of the functional score of WOMAC
time frame: 12 months
description: evaluate the non inferiority between platelet-rich plasma (PRP) and hyaluronic acid. onthé evolution of the knee function, by assessing the difference with a functional score (WOMAC), before and 3 months after treatment.
measure: the evolution of pain
time frame: 12month
arm group label: platelet-rich plasma
arm group type: Experimental
arm group label: durolane
arm group type: Active Comparator
intervention type: Drug
intervention name: platelet-rich plasma
arm group label: platelet-rich plasma
intervention type: Drug
intervention name: durolane
arm group label: durolane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: BERNARD BELAIGUES
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
last name: marie laure LOUIS
role: Principal Investigator
affiliation: AP HM
facility: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee