<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/NCT02189408</url>
  </required_header>
  <id_info>
    <org_study_id>PRP-Bochum</org_study_id>
    <nct_id>NCT02189408</nct_id>
  </id_info>
  <brief_title>Clinical Study of Pain Reduction by Peri-arthroscopic PRP Application in Knee Degeneration</brief_title>
  <acronym>PRP-Bochum</acronym>
  <official_title>Effect of Platelet Rich Plasma ( PRP ) Applied During Knee Arthroscopy on Pain, Function and Quality of Life - A RCT With a Follow up of 12 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate reduction of pain, gain of function and&#xD;
      improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during&#xD;
      knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized-&#xD;
      controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months&#xD;
      and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain ( VAS )</measure>
    <time_frame>6 months</time_frame>
    <description>measurement of pain using a 100 mm VAS as platelet- rich-plasma demonstrated temporarily analgetic effects up to 6-9 months after application.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain ( VAS )</measure>
    <time_frame>6 weeks, 12 months</time_frame>
    <description>To investigate the pain development over the follow up period at the beginning and the end of our trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knee function (Lysholm-score )</measure>
    <time_frame>6 weeks, 6 months, 12 months</time_frame>
    <description>to determine PRP-related gain of function according to time after application</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life ( physical und mental summaries of SF-36 German version )</measure>
    <time_frame>6 weeks, 6 months and 12 months</time_frame>
    <description>to identify a possible effect of PRP application on life quality ( physical and mental summaries )</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Cartilage Damage</condition>
  <condition>Meniscal Tear</condition>
  <arm_group>
    <arm_group_label>PRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one intraoperative application of PRP in the interventional group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No application of any substance during knee arthroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet rich plasma</intervention_name>
    <arm_group_label>PRP</arm_group_label>
    <other_name>ACP ( Arthrex )</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion Criteria:&#xD;
&#xD;
          -  degenerative knee pain&#xD;
&#xD;
          -  age: &gt; 18 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  none to moderate comorbidity&#xD;
&#xD;
          -  arthroscopy under general anaesthesia indicated&#xD;
&#xD;
        exclusion Criteria:&#xD;
&#xD;
          -  trauma of the knee within the last 6 weeks before surgery&#xD;
&#xD;
          -  circumscribed cartilage lesion with possibility of repair microfracture or autologous&#xD;
             chondrocyte transplantation - procedures&#xD;
&#xD;
          -  contraindications against PRP. application&#xD;
&#xD;
          -  malignancies&#xD;
&#xD;
          -  severe comorbidities&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  physically or mentally not able to provide informed consent&#xD;
&#xD;
          -  severe knee instability&#xD;
&#xD;
          -  corticosteroid injections within the last 6 weeks before surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph von Schulze Pellengahr, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Orthopaedics, University Clinic of the Ruhr- University Bochum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopaedics at the St. Josef- Hospital</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Christian Duif MD</investigator_full_name>
    <investigator_title>PostDoc Department of Orthopaedics</investigator_title>
  </responsible_party>
  <keyword>Platelet rich plasma</keyword>
  <keyword>Autologous conditioned plasma</keyword>
  <keyword>Outerbridge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02189408
org study id: PRP-Bochum
nct id: NCT02189408
lead sponsor: 
has dmc: No
The purpose of this study is to investigate reduction of pain, gain of function and
      improvement of life quality by intraoperative applied platelet- rich- plasma ( PRP ) during
      knee arthroscopy for degeneration and osteoarthritis OA by conducting a randomized-
      controlled, double-blinded trial ( RCT ) including 58 patients with a follow up of 12 months
      and pain, assessed by Visual- Analogue Scale (VAS) after 6 months as primary endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: pain ( VAS )
time frame: 6 months
description: measurement of pain using a 100 mm VAS as platelet- rich-plasma demonstrated temporarily analgetic effects up to 6-9 months after application.
measure: pain ( VAS )
time frame: 6 weeks, 12 months
description: To investigate the pain development over the follow up period at the beginning and the end of our trial
measure: knee function (Lysholm-score )
time frame: 6 weeks, 6 months, 12 months
description: to determine PRP-related gain of function according to time after application
measure: quality of life ( physical und mental summaries of SF-36 German version )
time frame: 6 weeks, 6 months and 12 months
description: to identify a possible effect of PRP application on life quality ( physical and mental summaries )
arm group label: PRP
arm group type: Experimental
description: one intraoperative application of PRP in the interventional group
arm group label: Control
arm group type: No Intervention
description: No application of any substance during knee arthroscopy
intervention type: Biological
intervention name: Platelet rich plasma
arm group label: PRP
other name: ACP ( Arthrex )
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph von Schulze Pellengahr, MD
role: Study Director
affiliation: Department of Orthopaedics, University Clinic of the Ruhr- University Bochum
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Christian Duif MD
investigator title: PostDoc Department of Orthopaedics
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee