xml: <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/NCT05978180</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00547-38</org_study_id>
      <nct_id>NCT05978180</nct_id>
    </id_info>
    <brief_title>Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2)</brief_title>
    <acronym>PANDORA2</acronym>
    <official_title>Prospective, Multicenter, Randomized, Parallel Groups Study Comparing the Safety and the Efficacy of the Administration of One Intra-articular Injection of 4.8 ml (HO-1) or Three Intra-articular Injections of 2.2 ml (HS-3) of Pandora Gel to One Intra-articular Injection of 2.5 ml (SINOVIAL®ONE), in Symptomatic Gonarthrosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Labrha</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Statitec</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Labrha</source>
    <oversight_info>
      <has_dmc>Yes</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 knee osteoarthritis is a frequent degenerative condition that mainly affects subjects&#xD;
        over 60, population often weakened by numerous comorbidities and concomitant treatments,&#xD;
        justifying the development of new therapies.&#xD;
  &#xD;
        The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective&#xD;
        of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve&#xD;
        mobility. In practice, there are two protocols to administer viscosupplementation : in a&#xD;
        single injection or in three injections performed weekly.&#xD;
  &#xD;
        The present clinical investigation has the objective to evaluate the safety and efficacy of&#xD;
        use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection&#xD;
        (HO-1) or in three injections performed weekly (HS-3), compared to a referred and&#xD;
        commercialized medical device.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This clinical investigation is a prospective, multicenter, randomized, parallel groups study&#xD;
        of a class III Medical Device.&#xD;
  &#xD;
        This study is designed to compare the safety of use and the efficacy of Pandora in its two&#xD;
        forms : in a single injection (HO-1) or in three injections (HS-3) to a single&#xD;
        intra-articular injection of 2.5 ml (SINOVIAL®ONE)&#xD;
  &#xD;
        A descriptive analysis will be carried out to characterize the demographic data, the history&#xD;
        of the disease and its treatments, the clinical and radiological data of the patients at&#xD;
        inclusion.&#xD;
  &#xD;
        The efficacy of Pandora will be demonstrated by describing the variation of WOMAC A1 score&#xD;
        &quot;walking pain&quot; of target knee in repeated measures.&#xD;
  &#xD;
        In total, 252 participants will be enrolled across 40 study centers in France and Monaco.&#xD;
  &#xD;
        The total duration of subjects' participation is 12 months ; overall study duration including&#xD;
        the enrollment period is expected to take approximately 24 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>
      <intervention_model_description>Prospective, multicenter, controlled, single blind, randomized in parallel groups Clinical Investigation.&#xD;
  Subjects will receive one of three viscosupplementations depending on the randomization.&#xD;
  The study includes two periods :&#xD;
  The first period (26 weeks) : prospective, multicenter, randomized in three parallel groups study, comparing the two forms of Pandora gel (HO-1 and HS-3) to SINOVIAL® ONE. The comparison between HO-1 and SINOVIAL® ONE is realized in single blind and the comparison between HS-3 and SINOVIAL® ONE is realized without masking.&#xD;
  The second period (26 weeks) is an exploratory, prospective, multicenter phase comparing these same devices without masking.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the efficacy of the two medical devices containing Pandora gel, HO-1 and HS-3, on walking pain in the target knee, compared to the SINOVIAL® ONE.</measure>
      <time_frame>6 months</time_frame>
      <description>Variation of the WOMAC A1 score &quot;walking pain&quot; of the target knee in repeated measures (weeks 4,12 and 26), between the first or single injection and the potential injection at week 26.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on walking pain of the target knee between day 1 and week 12.</measure>
      <time_frame>3 months</time_frame>
      <description>Variation of the WOMAC A1 score &quot;walking pain&quot; of the target knee between day 1 and week 12 considering the repeated measures at weeks 4 and 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the pain of the target knee at weeks 4, 12 and 26 and week 12 as well as week 52 for patients who didn't require an injection at week 26.</measure>
      <time_frame>12 months</time_frame>
      <description>Variation of the pain on target knee, with repeated measures by WOMAC A score, constituted of 5 questions about knee pain, between day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection of HO-1 at week 26.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the function of target knee at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.</measure>
      <time_frame>12 months</time_frame>
      <description>Variation of the function , with repeated measures by the WOMAC C constituted of 17 questions, between day 1 and week 4, day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection at week 26.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the efficacy of viscosupplémentation by HO-1 and HS-3 on the analgesic drug consumption at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.</measure>
      <time_frame>12 months</time_frame>
      <description>Evaluation by the patient of his analgesic drug consumption during the two weeks prior each visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To determine the number (and percentage) of patients &quot;OMERACT-OARSI responsive&quot; at weeks 4,12,26 as well as week 52 for patients who didn't require an injection at week 26.</measure>
      <time_frame>12 months</time_frame>
      <description>Number (%) of &quot;responsive&quot; patients according to OMERACT OARSI criterion, at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To determine the number (and percentage) of &quot;highly responsive&quot; patients at weeks 4, 12 and 26 as well as week 52 for patients who didn't require an injection at week 26.</measure>
      <time_frame>12 months</time_frame>
      <description>Number (%) of &quot;highly responsive&quot; patients with a decrease of WOMAC A1 &gt; 50% at weeks 4, 12 and 26 (and week 52 for patients who didn't have HO-1 injection at S26).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To determine the number (and percentage) of patients in whom target knee pain is considered acceptable according to the PASS criterion at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.</measure>
      <time_frame>12 months</time_frame>
      <description>Number (%) of patients reaching the threshold of PASS at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To determine the number (and percentage) of patients in whom the decrease of the target knee pain is considered important (MCII criterion) at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.</measure>
      <time_frame>12 months</time_frame>
      <description>Number (%) of patients whom the improvement at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26), is superior to the MCII.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To determine the number (and percentage) of patients requiring a new injection at S26.</measure>
      <time_frame>6 months</time_frame>
      <description>Number (%) of patients requiring an injection of HO-1 at week 26.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate, at S52, the efficacy of the additional injection of HO-1 at S26 on pain and function of the target knee.</measure>
      <time_frame>12 months</time_frame>
      <description>Variation of WOMAC between week 26 and week 52 at patients receiving injection of HO-1 at week 26.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate, at S52, the benefit of the additional injection of HO-1 at S26 on analgesic drug consumption.</measure>
      <time_frame>12 months</time_frame>
      <description>Decrease of analgesic drug consumption between week 26 and week 52 at patients receiving injection of HO-1 at week 26.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To measure the self-reported treatment efficacy by the patient at weeks 4, 12, 26 and 52.</measure>
      <time_frame>12 months</time_frame>
      <description>Evaluation of the efficacy of the treatment by the patient based on a 11 points numerical scale (0-10) at weeks 12,26 and 52.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the local tolerability (at the target knee), after each injection of HO-1 and HS-3, compared to SINOVIAL® ONE.</measure>
      <time_frame>1 month</time_frame>
      <description>Number of adverse events occurring, at the target knee, after each injection during the 4 weeks following the first or only one injection, whose treatments causality is not evaluated as &quot;not related&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the global tolerability of HO-1 and HS-3 throughout the follow-up between day 1 and week 52 in comparison with SINOVIAL® ONE.</measure>
      <time_frame>12 months</time_frame>
      <description>Number of adverse events occurring during the 52 weeks of follow up, whose treatments causality is not evaluated as &quot;not related&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess patient's satisfaction regarding tolerability of HO-1 and HS-3 treatment between day 1 and week 4, compared to SINOVIAL® ONE.</measure>
      <time_frame>1 month</time_frame>
      <description>Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to &quot;Very Good&quot; and 4 &quot;Very Bad&quot; at day 8, day 15 and week 4 for group's patients HO-1 and SINOVIAL® ONE.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess patient's satisfaction regarding the tolerability of HO-1 treatment at week 27 for patients who received an injection at week 26.</measure>
      <time_frame>6 months and one week (=27 weeks)</time_frame>
      <description>Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to &quot;Very Good&quot; and 4 &quot;Very Bad&quot; at week 27 for patients receiving injection of HO-1 at week 26.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">252</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Medical Device : HO-1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single injection Hyaluronic acid associated with tranexamic acid 4.8 ml will be injected in one time Intra-articular single injection&#xD;
  Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.&#xD;
  The injection will be performed at Day 1.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Medical Device : HS-3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Three injections Hyaluronic acid associated with tranexamic acid 2.2 ml will be injected in three times (one injection per week) Intra-articular single injection&#xD;
  Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.&#xD;
  The injections will be performed at Days 1, 8 and 15.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Medical Device : SINOVIAL® ONE</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Hyaluronic acid 2.5 ml will be injected in one time Intra-articular single injection&#xD;
  Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.&#xD;
  The injection will be performed at Day 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Medical Device : HO-1</intervention_name>
      <description>The injection will be performed at Day 1.</description>
      <arm_group_label>Medical Device : HO-1</arm_group_label>
      <other_name>Intra-articular single injection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Medical Device : HS-3</intervention_name>
      <description>The three injections will be performed at Days 1, 8 and 15.</description>
      <arm_group_label>Medical Device : HS-3</arm_group_label>
      <other_name>Intra-articular three injections</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Medical Device : SINOVIAL® ONE</intervention_name>
      <description>The injection will be performed at Day 1.</description>
      <arm_group_label>Medical Device : SINOVIAL® ONE</arm_group_label>
      <other_name>Intra-articular single injection</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria :&#xD;
  &#xD;
            -  Patient aged between 35 and 85 years.&#xD;
  &#xD;
            -  Body mass index (BMI) &lt; 35 kg.m2.&#xD;
  &#xD;
            -  Medial or lateral femoro-tibial knee osteoarthritis, diagnosed according to the&#xD;
               American College of Rheumatology criteria, radiological stage 2 and 3 according to the&#xD;
               Kellgren-Lawrence criteria modified by Felson on an X-ray, of the knee in extension,&#xD;
               less than 6 months old.&#xD;
  &#xD;
            -  Knee osteoarthritis responsible for walking pain in the target knee, assessed between&#xD;
               4 and 8 inclusive on an 11 points numerical scale (0 = none to 10 = extreme).&#xD;
  &#xD;
            -  Unilateral or bilateral knee osteoarthritis if the walking pain in the contralateral&#xD;
               knee is &lt; 3 based on 11 points numerical scale (0-10).&#xD;
  &#xD;
            -  Ambulatory patient able to walk 50 meters without a cane, crutch or walker.&#xD;
  &#xD;
            -  Patient giving his informed consent.&#xD;
  &#xD;
            -  Patient agreeing to follow-up study visits.&#xD;
  &#xD;
            -  Patient affiliated to the health social security system or beneficiary of such plan.&#xD;
  &#xD;
            -  Patient requiring viscosupplementation according to the investigator.&#xD;
  &#xD;
          Exclusion Criteria :&#xD;
  &#xD;
            -  Patient presenting knee osteoarthritis without impingement joint space narrowing of&#xD;
               the femoro-tibial compartment (modified Kellgren stage 0-1) or with complete&#xD;
               impingement joint space narrowing on the knee weight-bearing radiograph in extension&#xD;
               (modified Kellgren stage 4).&#xD;
  &#xD;
            -  Patient with bilateral symptomatic gonarthrosis with walking pain of contralateral&#xD;
               knee &gt; 3.&#xD;
  &#xD;
            -  Patient with stage 4 patello-femoral osteoarthritis associated with femoro-tibial&#xD;
               osteoarthritis.&#xD;
  &#xD;
            -  Patient with a flare of osteoarthritis of the target or contralateral knee.&#xD;
  &#xD;
            -  Patient who received viscosupplementation or Platelet Rich Plasma (PRP) injection, in&#xD;
               the target knee, in the 6 months prior to inclusion.&#xD;
  &#xD;
            -  Patient who received an intra-articular injection of corticosteroids in the target&#xD;
               knee in the 2 months prior to inclusion.&#xD;
  &#xD;
            -  Patients with a skin condition or a wound next to or near the injection site.&#xD;
  &#xD;
            -  Patients refusing to discontinue treatment with NSAIDs or cox-2 inhibitors during the&#xD;
               follow-up period.&#xD;
  &#xD;
            -  Patient receiving treatment with level III analgesics (strong opioids).&#xD;
  &#xD;
            -  Patients receiving treatment with diacerhein, avocado and soy unsaponifiables,&#xD;
               glucosamine or chondroitin initiated less than 2 months prior to inclusion.&#xD;
  &#xD;
            -  Patient with hypersensitivity to hyaluronic acid or tranexamic acid.&#xD;
  &#xD;
            -  Patient with a history of seizures.&#xD;
  &#xD;
            -  Patient who had arthroscopy of the target knee or major trauma to the target knee&#xD;
               during the 3 months preceding inclusion.&#xD;
  &#xD;
            -  Patient scheduled to undergo surgery, for any cause, of the target knee or other joint&#xD;
               of the lower limbs, planned within 6 months of inclusion, likely to interfere with&#xD;
               follow-up or evaluation of the patient in the study.&#xD;
  &#xD;
            -  Patient with Fibromyalgia.&#xD;
  &#xD;
            -  Patient with an active neurological or vascular musculoskeletal disorder (such as&#xD;
               rheumatoid arthritis, lupus, psoriatic arthritis, spondyloarthritis or any other&#xD;
               autoimmune disease, Paget's disease, gout, coxopathy, tendinopathy of the lower limb,&#xD;
               sciatic or crural radiculalgia) which, in the opinion of the investigator, would be&#xD;
               likely to disrupt regular monitoring and/or interfere with the measurement of&#xD;
               evaluated knee treatment efficacy.&#xD;
  &#xD;
            -  Patient with serious hemostasis disorders, venous or lymphatic stenosis of the lower&#xD;
               limbs, history of thromboembolic disease - phlebitis or pulmonary embolism - or a high&#xD;
               risk of thromboembolism.&#xD;
  &#xD;
            -  Patients with renal insufficiency.&#xD;
  &#xD;
            -  Patients with all evolving general condition as cardiac, digestive, endocrine,&#xD;
               haematological or broncho-pulmonary which, in the opinion of the investigator, would&#xD;
               be likely to disrupt regular monitoring and/or interfere with the measurement of&#xD;
               evaluated knee treatment efficacy.&#xD;
  &#xD;
            -  Breastfeeding patient, pregnant or wishing to be during the 12 months of the study.&#xD;
  &#xD;
            -  Patients of childbearing age, sexually active without contraception.&#xD;
  &#xD;
            -  Patients unable to give personal consent.&#xD;
  &#xD;
            -  Patients participating or having participated in interventional research and whose&#xD;
               follow-up ended within 2 months prior to inclusion.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Patrick Sac-Epee</last_name>
      <role>Study Director</role>
      <affiliation>Labrha</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jean-Charles Balblanc, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hôpital Nord Franche-Comté, HNFC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leslie Genet</last_name>
      <phone>06 82 29 36 07</phone>
      <phone_ext>33</phone_ext>
      <email>leslie.genet@labrha.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thierry Conrozier, Dr</last_name>
      <phone>03 84 98 22 22</phone>
      <phone_ext>33</phone_ext>
      <email>thierry.conrozier@hnfc.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre de Recherche Rhumatologique et Thermal</name>
        <address>
          <city>Aix-les-Bains</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Romain Forestier, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Annecy</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Matthieu Monreal, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clinique d'Arnogay</name>
        <address>
          <city>Argonay</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean-Luc Le Masle Lastiolas, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Auch</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jérôme Porterie, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie La Savoureuse</name>
        <address>
          <city>Belfort</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marie Bossert, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Nord Franche Comté</name>
        <address>
          <city>Belfort</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean-Charles Balblanc, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie de Palente</name>
        <address>
          <city>Besançon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Benoit Auge, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Castelnaudary</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Anissa Hacene-Beniddir, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie de Cornebarrieu</name>
        <address>
          <city>Cornebarrieu</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Mariana Huyghe-Valean, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Polyclinique des Alpes du Sud</name>
        <address>
          <city>Gap</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Ivan Prothoy, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Gourdon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Xavier Imart, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Médical Dulac</name>
        <address>
          <city>La Ciotat</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Sarah Steib, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical</name>
        <address>
          <city>La Crau</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean Fulpin, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>La Tour-du-Pin</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Elisabeth Sornay-Rendu, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical Tilsitt</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Frédéric Nectoux, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Orthopédique Paul Santy</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Bénédicte Rey, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clinique de la Sauvegarde</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Thibaut Rolland, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clinique Saint Charles</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Laurent Malterre, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Médico-Social du Lac</name>
        <address>
          <city>Mantes-la-Jolie</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean-Luc Renevier, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical Borely Mermoz</name>
        <address>
          <city>Marseille</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Roger Lecurieux-Clerville, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Lozère</name>
        <address>
          <city>Mende</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Raluca Angelescu-Prunel, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Françoise Roch-Bras, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Médical Saint Roch</name>
        <address>
          <city>Montpellier</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Véronique Ferrazzi, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical</name>
        <address>
          <city>Montélimar</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Franck Kandil, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Groupe Médical Adhémar</name>
        <address>
          <city>Montélimar</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Jacques Despaux, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Mulhouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Naji Afif, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical Pluridisciplinaire Wallach</name>
        <address>
          <city>Mulhouse</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Maxime Sondag, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Mâcon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Franck Mohnen, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical Maillot</name>
        <address>
          <city>Neuilly-sur-Seine</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Patrick Gepner, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Nîmes</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Cécile Guilyardi, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Hervé Bard, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clinique du Ter</name>
        <address>
          <city>Ploemeur</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Amrane Hadj Hamou, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical</name>
        <address>
          <city>Puyricard</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Julian Melchior, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet Médical</name>
        <address>
          <city>Saint-Paul-lès-Dax</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Danièle Prothery, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Groupe Médical Spécialisé - Le Premium</name>
        <address>
          <city>Strasbourg</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Etienne Dahan, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Groupe Hospitalier de la Haute Saône - Hôpital de Vesoul</name>
        <address>
          <city>Vesoul</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Violette Benier, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Villeurbanne</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Amal Benabdesselam, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cabinet de Rhumatologie</name>
        <address>
          <city>Viry-Châtillon</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Karim Sebaa, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>IM2S</name>
        <address>
          <city>Monaco</city>
          <country>Monaco</country>
        </address>
      </facility>
      <contact>
        <last_name>Jean-Marc Parisaux, Dr</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
      <country>Monaco</country>
    </location_countries>
    <reference>
      <citation>Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.</citation>
      <PMID>32931933</PMID>
    </reference>
    <reference>
      <citation>Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.</citation>
      <PMID>15455338</PMID>
    </reference>
    <reference>
      <citation>Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.</citation>
      <PMID>29268731</PMID>
    </reference>
    <reference>
      <citation>Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714.</citation>
      <PMID>27257981</PMID>
    </reference>
    <reference>
      <citation>Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10.</citation>
      <PMID>28618868</PMID>
    </reference>
    <reference>
      <citation>Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1.</citation>
      <PMID>33267906</PMID>
    </reference>
    <reference>
      <citation>Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.</citation>
      <PMID>25797505</PMID>
    </reference>
    <reference>
      <citation>Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.</citation>
      <PMID>31800425</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Osteoarthritis</keyword>
    <keyword>Viscosupplementation</keyword>
    <keyword>Hyaluronic acid</keyword>
    <keyword>Knee</keyword>
    <keyword>Intra-articular injection</keyword>
    <keyword>Tranexamic acid</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978180
  org study id: 2023-A00547-38
  nct id: NCT05978180
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects
        over 60, population often weakened by numerous comorbidities and concomitant treatments,
        justifying the development of new therapies.
  
        The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective
        of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve
        mobility. In practice, there are two protocols to administer viscosupplementation : in a
        single injection or in three injections performed weekly.
  
        The present clinical investigation has the objective to evaluate the safety and efficacy of
        use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection
        (HO-1) or in three injections performed weekly (HS-3), compared to a referred and
        commercialized medical device.
  This clinical investigation is a prospective, multicenter, randomized, parallel groups study
        of a class III Medical Device.
  
        This study is designed to compare the safety of use and the efficacy of Pandora in its two
        forms : in a single injection (HO-1) or in three injections (HS-3) to a single
        intra-articular injection of 2.5 ml (SINOVIAL®ONE)
  
        A descriptive analysis will be carried out to characterize the demographic data, the history
        of the disease and its treatments, the clinical and radiological data of the patients at
        inclusion.
  
        The efficacy of Pandora will be demonstrated by describing the variation of WOMAC A1 score
        "walking pain" of target knee in repeated measures.
  
        In total, 252 participants will be enrolled across 40 study centers in France and Monaco.
  
        The total duration of subjects' participation is 12 months ; overall study duration including
        the enrollment period is expected to take approximately 24 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, multicenter, controlled, single blind, randomized in parallel groups Clinical Investigation.
  Subjects will receive one of three viscosupplementations depending on the randomization.
  The study includes two periods :
  The first period (26 weeks) : prospective, multicenter, randomized in three parallel groups study, comparing the two forms of Pandora gel (HO-1 and HS-3) to SINOVIAL® ONE. The comparison between HO-1 and SINOVIAL® ONE is realized in single blind and the comparison between HS-3 and SINOVIAL® ONE is realized without masking.
  The second period (26 weeks) is an exploratory, prospective, multicenter phase comparing these same devices without masking.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Single blind
  measure: To evaluate the efficacy of the two medical devices containing Pandora gel, HO-1 and HS-3, on walking pain in the target knee, compared to the SINOVIAL® ONE.
  time frame: 6 months
  description: Variation of the WOMAC A1 score "walking pain" of the target knee in repeated measures (weeks 4,12 and 26), between the first or single injection and the potential injection at week 26.
  measure: To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on walking pain of the target knee between day 1 and week 12.
  time frame: 3 months
  description: Variation of the WOMAC A1 score "walking pain" of the target knee between day 1 and week 12 considering the repeated measures at weeks 4 and 12.
  measure: To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the pain of the target knee at weeks 4, 12 and 26 and week 12 as well as week 52 for patients who didn't require an injection at week 26.
  time frame: 12 months
  description: Variation of the pain on target knee, with repeated measures by WOMAC A score, constituted of 5 questions about knee pain, between day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection of HO-1 at week 26.
  measure: To evaluate the efficacy of viscosupplementation by HO-1 and HS-3 on the function of target knee at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.
  time frame: 12 months
  description: Variation of the function , with repeated measures by the WOMAC C constituted of 17 questions, between day 1 and week 4, day 1 and week 12, day 1 and week 26 as well as between day 1 and week 52 for patients who didn't require an injection at week 26.
  measure: To evaluate the efficacy of viscosupplémentation by HO-1 and HS-3 on the analgesic drug consumption at weeks 4, 12, 26 as well as week 52 for patients who didn't require an injection at week 26.
  time frame: 12 months
  description: Evaluation by the patient of his analgesic drug consumption during the two weeks prior each visit.
  measure: To determine the number (and percentage) of patients "OMERACT-OARSI responsive" at weeks 4,12,26 as well as week 52 for patients who didn't require an injection at week 26.
  time frame: 12 months
  description: Number (%) of "responsive" patients according to OMERACT OARSI criterion, at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).
  measure: To determine the number (and percentage) of "highly responsive" patients at weeks 4, 12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
  time frame: 12 months
  description: Number (%) of "highly responsive" patients with a decrease of WOMAC A1 > 50% at weeks 4, 12 and 26 (and week 52 for patients who didn't have HO-1 injection at S26).
  measure: To determine the number (and percentage) of patients in whom target knee pain is considered acceptable according to the PASS criterion at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
  time frame: 12 months
  description: Number (%) of patients reaching the threshold of PASS at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26).
  measure: To determine the number (and percentage) of patients in whom the decrease of the target knee pain is considered important (MCII criterion) at weeks 4,12 and 26 as well as week 52 for patients who didn't require an injection at week 26.
  time frame: 12 months
  description: Number (%) of patients whom the improvement at weeks 4, 12 and 26 (and week 52 for patients who didn't require an injection at week 26), is superior to the MCII.
  measure: To determine the number (and percentage) of patients requiring a new injection at S26.
  time frame: 6 months
  description: Number (%) of patients requiring an injection of HO-1 at week 26.
  measure: To evaluate, at S52, the efficacy of the additional injection of HO-1 at S26 on pain and function of the target knee.
  time frame: 12 months
  description: Variation of WOMAC between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
  measure: To evaluate, at S52, the benefit of the additional injection of HO-1 at S26 on analgesic drug consumption.
  time frame: 12 months
  description: Decrease of analgesic drug consumption between week 26 and week 52 at patients receiving injection of HO-1 at week 26.
  measure: To measure the self-reported treatment efficacy by the patient at weeks 4, 12, 26 and 52.
  time frame: 12 months
  description: Evaluation of the efficacy of the treatment by the patient based on a 11 points numerical scale (0-10) at weeks 12,26 and 52.
  measure: To evaluate the local tolerability (at the target knee), after each injection of HO-1 and HS-3, compared to SINOVIAL® ONE.
  time frame: 1 month
  description: Number of adverse events occurring, at the target knee, after each injection during the 4 weeks following the first or only one injection, whose treatments causality is not evaluated as "not related".
  measure: To evaluate the global tolerability of HO-1 and HS-3 throughout the follow-up between day 1 and week 52 in comparison with SINOVIAL® ONE.
  time frame: 12 months
  description: Number of adverse events occurring during the 52 weeks of follow up, whose treatments causality is not evaluated as "not related".
  measure: To assess patient's satisfaction regarding tolerability of HO-1 and HS-3 treatment between day 1 and week 4, compared to SINOVIAL® ONE.
  time frame: 1 month
  description: Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to "Very Good" and 4 "Very Bad" at day 8, day 15 and week 4 for group's patients HO-1 and SINOVIAL® ONE.
  measure: To assess patient's satisfaction regarding the tolerability of HO-1 treatment at week 27 for patients who received an injection at week 26.
  time frame: 6 months and one week (=27 weeks)
  description: Subjective assessment of tolerability by the patient, based on a 5 points numerical scale, 0 corresponding to "Very Good" and 4 "Very Bad" at week 27 for patients receiving injection of HO-1 at week 26.
  arm group label: Medical Device : HO-1
  arm group type: Experimental
  description: Single injection Hyaluronic acid associated with tranexamic acid 4.8 ml will be injected in one time Intra-articular single injection
  Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.
  The injection will be performed at Day 1.
  arm group label: Medical Device : HS-3
  arm group type: Experimental
  description: Three injections Hyaluronic acid associated with tranexamic acid 2.2 ml will be injected in three times (one injection per week) Intra-articular single injection
  Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.
  The injections will be performed at Days 1, 8 and 15.
  arm group label: Medical Device : SINOVIAL® ONE
  arm group type: Active Comparator
  description: Hyaluronic acid 2.5 ml will be injected in one time Intra-articular single injection
  Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.
  The injection will be performed at Day 1.
  intervention type: Device
  intervention name: Medical Device : HO-1
  description: The injection will be performed at Day 1.
  arm group label: Medical Device : HO-1
  other name: Intra-articular single injection
  intervention type: Device
  intervention name: Medical Device : HS-3
  description: The three injections will be performed at Days 1, 8 and 15.
  arm group label: Medical Device : HS-3
  other name: Intra-articular three injections
  intervention type: Device
  intervention name: Medical Device : SINOVIAL® ONE
  description: The injection will be performed at Day 1.
  arm group label: Medical Device : SINOVIAL® ONE
  other name: Intra-articular single injection
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Patrick Sac-Epee
  role: Study Director
  affiliation: Labrha
  last name: Jean-Charles Balblanc, Dr
  role: Principal Investigator
  affiliation: Hôpital Nord Franche-Comté, HNFC
  last name: Leslie Genet
  phone: 06 82 29 36 07
  phone ext: 33
  email: leslie.genet@labrha.com
  last name: Thierry Conrozier, Dr
  phone: 03 84 98 22 22
  phone ext: 33
  email: thierry.conrozier@hnfc.fr
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  country: Monaco
  citation: Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.
  PMID: 32931933
  citation: Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.
  PMID: 15455338
  citation: Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.
  PMID: 29268731
  citation: Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714.
  PMID: 27257981
  citation: Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10.
  PMID: 28618868
  citation: Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1.
  PMID: 33267906
  citation: Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
  PMID: 25797505
  citation: Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.
  PMID: 31800425
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No