<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/NCT03809962</url>
  </required_header>
  <id_info>
    <org_study_id>OSTH-PMCF-DE-2018-01</org_study_id>
    <nct_id>NCT03809962</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis</brief_title>
  <official_title>Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TRB Chemedica AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TRB Chemedica AG</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and&#xD;
      restricted mobility in degenerative and traumatic changes of the Hip Joint.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Pain Intensity compared to Baseline (VAS-slider)</measure>
    <time_frame>Day 7, Day 14, Day 84 after last injection, Day 168 after last injection</time_frame>
    <description>Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider (10 cm equals the most pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Range of Motion compared to Baseline (Goniometer measurement)</measure>
    <time_frame>Day 7, Day 14, Day 84 after last injection, Day 168 after last injection</time_frame>
    <description>Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)</measure>
    <time_frame>Day 7, Day 14, Day 84 after last injection, Day 168 after last injection</time_frame>
    <description>The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>Up to Day 252 after the last injection</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline</measure>
    <time_frame>Day 84 after last injection, Day 168 after last injection</time_frame>
    <description>Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline</measure>
    <time_frame>Day 84 after last injection, Day 168 after last injection</time_frame>
    <description>Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline</measure>
    <time_frame>Day 84 after last injection, Day 168 after last injection</time_frame>
    <description>Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline</measure>
    <time_frame>Day 84 after last injection, Day 168 after last injection</time_frame>
    <description>Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Coxarthrosis</condition>
  <arm_group>
    <arm_group_label>Ostenil® Plus</arm_group_label>
    <description>1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ostenil® Plus</intervention_name>
    <description>Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation</description>
    <arm_group_label>Ostenil® Plus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects ≥ 18 years of age and in good general health condition&#xD;
&#xD;
          2. Signed informed consent&#xD;
&#xD;
          3. Existing Ostenil® Plus recommendation for the treatment of coxarthrosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity to one of the OSTENIL® PLUS components&#xD;
&#xD;
          2. Known pregnancy or lactating females&#xD;
&#xD;
          3. Previous/concomitant participation in clinical investigation within the last 3 months&#xD;
             prior to study inclusion&#xD;
&#xD;
          4. Subjects not capable of contracting and of understanding the nature, risks,&#xD;
             significance and implications of the clinical investigation and unable to form a&#xD;
             rational intention in the light of these facts&#xD;
&#xD;
          5. Subjects unable to understand informed consent or having a high probability of non&#xD;
             compliance to the study procedures and / or non completion of the study according to&#xD;
             investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Knut Behle, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthopädieZentrum Maschen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Darja Becker, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopädie Praxis Dr. Darja Becker</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raphaela Geiger</last_name>
    <phone>+49 89 461483-27</phone>
    <email>geiger@trbchemedica.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucia Hopp</last_name>
    <phone>+49 89 461483-29</phone>
    <email>hopp@trbchemedica.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gemeinschaftspraxis für Orthopädie und Unfallchirurgie</name>
      <address>
        <city>Bad Oldesloe</city>
        <state>Schleswig-Holstein</state>
        <zip>23843</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Orthopraxis Kiel</name>
      <address>
        <city>Gettorf</city>
        <state>Schleswig-Holstein</state>
        <zip>24214</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zentrum für Medizin des Bewegungsapparates</name>
      <address>
        <city>Heide</city>
        <state>Schleswig-Holstein</state>
        <zip>25746</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Volker Müller, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orthopädische Gemeinschaftspraxis Eutin</name>
      <address>
        <city>Eutin</city>
        <zip>23701</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernd Schulte</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Orthopädische Praxis Rahlstedt</name>
      <address>
        <city>Hamburg</city>
        <zip>22143</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Orthopädie Praxis</name>
      <address>
        <city>Ramelsloh</city>
        <zip>21220</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>OrthopädieZentrum Maschen</name>
      <address>
        <city>Seevetal</city>
        <zip>21220</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 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, Hip</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/NCT03809962
org study id: OSTH-PMCF-DE-2018-01
nct id: NCT03809962
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and
      restricted mobility in degenerative and traumatic changes of the Hip Joint.
observational model: Other
time perspective: Prospective
measure: Change of Pain Intensity compared to Baseline (VAS-slider)
time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
description: Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider (10 cm equals the most pain)
measure: Change of Range of Motion compared to Baseline (Goniometer measurement)
time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
description: Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer.
measure: Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)
time frame: Day 7, Day 14, Day 84 after last injection, Day 168 after last injection
description: The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).
measure: Incidence of Treatment-Emergent Adverse Events
time frame: Up to Day 252 after the last injection
measure: Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline
time frame: Day 84 after last injection, Day 168 after last injection
description: Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale
measure: Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline
time frame: Day 84 after last injection, Day 168 after last injection
description: Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale
measure: Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline
time frame: Day 84 after last injection, Day 168 after last injection
description: Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale
measure: Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline
time frame: Day 84 after last injection, Day 168 after last injection
description: Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale
arm group label: Ostenil® Plus
description: 1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval.
intervention type: Device
intervention name: Ostenil® Plus
description: Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation
arm group label: Ostenil® Plus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Knut Behle, Dr. med.
role: Principal Investigator
affiliation: OrthopädieZentrum Maschen
last name: Darja Becker, Dr. med.
role: Principal Investigator
affiliation: Orthopädie Praxis Dr. Darja Becker
last name: Raphaela Geiger
phone: +49 89 461483-27
email: geiger@trbchemedica.de
last name: Lucia Hopp
phone: +49 89 461483-29
email: hopp@trbchemedica.de
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
country: Germany
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip