<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/NCT03761472</url>
  </required_header>
  <id_info>
    <org_study_id>71306642-050.01.04-</org_study_id>
    <nct_id>NCT03761472</nct_id>
  </id_info>
  <brief_title>Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections</brief_title>
  <official_title>Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif 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>
      This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma&#xD;
      injection in terms of pain, physical function and femoral cartilage thickness in short term&#xD;
      treatment in patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly&#xD;
      used for treatment of knee osteoarthritis. Even though there are many studies investigating&#xD;
      the effectiveness of these treatments, the results are mostly qualitative. Also there are a&#xD;
      few studies comparing these two treatment modalities. In this study the investigators aim to&#xD;
      compare these modalities both for self-reported data (pain, physical function) and objective&#xD;
      measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral&#xD;
      osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be&#xD;
      controls for each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 13, 2020</completion_date>
  <primary_completion_date type="Actual">January 13, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of numeric rating scale (rest, movement)</measure>
    <time_frame>0, 1st, 6th, months</time_frame>
    <description>Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)</measure>
    <time_frame>0, 1st, 6th months</time_frame>
    <description>Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of femoral cartilage thickness via ultrasonography.</measure>
    <time_frame>0, 1st, 6th months</time_frame>
    <description>Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Hyaluronic acid injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hyaluronic acid 48 mg 2.0% in 2 ml solution, once initially.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Platelet-rich plasma injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Platelet-rich plasma 5 ml, once initially</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unaffected side Hyaluronic acid</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Unaffected sides of the patients will be controls for hyaluronic acid group, no intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unaffected side Platelet-rich plasma</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Unaffected sides of the patients will be controls for Platelet-rich plasma group, no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hyaluronic acid injection</intervention_name>
    <description>Hyaluronic acid 48 mg 2.0% in 2.4 ml solution</description>
    <arm_group_label>Hyaluronic acid injection</arm_group_label>
    <other_name>Reviscon Mono</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet-rich plasma injection</intervention_name>
    <description>Platelet-rich plasma injection 5ml</description>
    <arm_group_label>Platelet-rich plasma injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is able to consent&#xD;
&#xD;
          -  Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee&#xD;
             osteoarthritis&#xD;
&#xD;
          -  Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis&#xD;
&#xD;
          -  Unilateral osteoarthritis/complaint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past or actual knee infection&#xD;
&#xD;
          -  History of surgery, fracture on knee&#xD;
&#xD;
          -  Collagen tissue disease&#xD;
&#xD;
          -  Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)&#xD;
&#xD;
          -  Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure,&#xD;
             liver failure)&#xD;
&#xD;
          -  Knee injection in past 6 months&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Pregnant/breastfeeding&#xD;
&#xD;
          -  Malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teoman Aydın, Prof, MD</last_name>
    <role>Study Director</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ozan Volkan Yurdakul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bezmialem Vakif University</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21. Erratum In: Am J Sports Med. 2017 Apr;45(5):NP10.</citation>
    <PMID>28146403</PMID>
  </reference>
  <reference>
    <citation>Keen HI, Hensor EM, Wakefield RJ, Mease PJ, Bingham CO 3rd, Conaghan PG. Ultrasound assessment of response to intra-articular therapy in osteoarthritis of the knee. Rheumatology (Oxford). 2015 Aug;54(8):1385-91. doi: 10.1093/rheumatology/keu529. Epub 2015 Feb 16.</citation>
    <PMID>25691769</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Hyaluronic acid</keyword>
  <keyword>Platelet-rich plasma</keyword>
  <keyword>Injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03761472
org study id: 71306642-050.01.04-
nct id: NCT03761472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma
      injection in terms of pain, physical function and femoral cartilage thickness in short term
      treatment in patients with knee osteoarthritis.
Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly
      used for treatment of knee osteoarthritis. Even though there are many studies investigating
      the effectiveness of these treatments, the results are mostly qualitative. Also there are a
      few studies comparing these two treatment modalities. In this study the investigators aim to
      compare these modalities both for self-reported data (pain, physical function) and objective
      measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral
      osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be
      controls for each group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of numeric rating scale (rest, movement)
time frame: 0, 1st, 6th, months
description: Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
measure: Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)
time frame: 0, 1st, 6th months
description: Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.
measure: Change of femoral cartilage thickness via ultrasonography.
time frame: 0, 1st, 6th months
description: Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.
arm group label: Hyaluronic acid injection
arm group type: Active Comparator
description: Hyaluronic acid 48 mg 2.0% in 2 ml solution, once initially.
arm group label: Platelet-rich plasma injection
arm group type: Active Comparator
description: Platelet-rich plasma 5 ml, once initially
arm group label: Unaffected side Hyaluronic acid
arm group type: No Intervention
description: Unaffected sides of the patients will be controls for hyaluronic acid group, no intervention.
arm group label: Unaffected side Platelet-rich plasma
arm group type: No Intervention
description: Unaffected sides of the patients will be controls for Platelet-rich plasma group, no intervention.
intervention type: Biological
intervention name: Hyaluronic acid injection
description: Hyaluronic acid 48 mg 2.0% in 2.4 ml solution
arm group label: Hyaluronic acid injection
other name: Reviscon Mono
intervention type: Biological
intervention name: Platelet-rich plasma injection
description: Platelet-rich plasma injection 5ml
arm group label: Platelet-rich plasma injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Teoman Aydın, Prof, MD
role: Study Director
affiliation: Bezmialem Vakif University
last name: Ozan Volkan Yurdakul, MD
role: Principal Investigator
affiliation: Bezmialem Vakif University
facility: 
country: Turkey
citation: Cole BJ, Karas V, Hussey K, Pilz K, Fortier LA. Hyaluronic Acid Versus Platelet-Rich Plasma: A Prospective, Double-Blind Randomized Controlled Trial Comparing Clinical Outcomes and Effects on Intra-articular Biology for the Treatment of Knee Osteoarthritis. Am J Sports Med. 2017 Feb;45(2):339-346. doi: 10.1177/0363546516665809. Epub 2016 Oct 21. Erratum In: Am J Sports Med. 2017 Apr;45(5):NP10.
PMID: 28146403
citation: Keen HI, Hensor EM, Wakefield RJ, Mease PJ, Bingham CO 3rd, Conaghan PG. Ultrasound assessment of response to intra-articular therapy in osteoarthritis of the knee. Rheumatology (Oxford). 2015 Aug;54(8):1385-91. doi: 10.1093/rheumatology/keu529. Epub 2015 Feb 16.
PMID: 25691769
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Hyaluronic Acid
sharing ipd: No