<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/NCT02991300</url>
  </required_header>
  <id_info>
    <org_study_id>1251001 V2.0</org_study_id>
    <nct_id>NCT02991300</nct_id>
  </id_info>
  <brief_title>BioPoly® RS Partial Resurfacing Patella Registry Study</brief_title>
  <official_title>Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioPoly LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioPoly LLC</source>
  <brief_summary>
    <textblock>
      The data registry will increase the knowledge of outcomes for treatment of focal cartilage&#xD;
      defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring&#xD;
      of the clinical safety and performance of the device and surgical implantation kit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The data registry will increase the knowledge of outcomes for treatment of focal cartilage&#xD;
      defects of the patella treated with the BioPoly RS Patella Implant This study will also allow&#xD;
      monitoring of the clinical safety and performance of the device and surgical implantation kit&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">September 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>KOOS Subscores</measure>
    <time_frame>2 year post-op</time_frame>
    <description>KOOS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kujala Anterior Knee Pain Scale</measure>
    <time_frame>2 year post-op</time_frame>
    <description>Kujala</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Outcomes Study (SF-36) for generic &quot;quality of life&quot;</measure>
    <time_frame>2 years post-op</time_frame>
    <description>SF-36</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity using Tegner Score</measure>
    <time_frame>2 years post-op</time_frame>
    <description>Tegner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain using VAS Pain</measure>
    <time_frame>2 years post-op</time_frame>
    <description>VAS Pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic Assessment</measure>
    <time_frame>Annually through 5 years post-op</time_frame>
    <description>Radiographic Assessment</description>
  </secondary_outcome>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Cartilage Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioPoly RS Partial Resurfacing Patella Implant</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population who will participate in this clinical study includes those patients 21 years&#xD;
        of age or older who otherwise meet the inclusion/exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 years and older&#xD;
&#xD;
          -  Cartilage lesion(s) located in the facets of the patella that have failed prior&#xD;
             therapy (conservative or surgical)&#xD;
&#xD;
          -  Symptomatic lesions classified as ICRS grade 2, 3, or 4&#xD;
&#xD;
          -  Lesion size may not exceed 3.1 cm2 and must be circumscribed by a 15 mm or 20 mm&#xD;
             circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall depth&#xD;
             less than 4 mm from the articulating surface&#xD;
&#xD;
          -  Subchondral bone quality sufficient to support the implant&#xD;
&#xD;
          -  Understanding and willingness to comply with the post-operative rehabilitation&#xD;
             instructions and follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 35&#xD;
&#xD;
          -  Generalized degenerative or autoimmune arthritis&#xD;
&#xD;
          -  Gout&#xD;
&#xD;
          -  Uncorrected chronic malalignment of the patella (may be corrected at the same time as&#xD;
             the implantation of the BioPoly device).&#xD;
&#xD;
          -  Uncorrected ligamentous instability (may be corrected at the same time as the&#xD;
             implantation of the BioPoly device).&#xD;
&#xD;
          -  Kissing lesion on femur&#xD;
&#xD;
          -  More than one implant required to accommodate lesion&#xD;
&#xD;
          -  Allergy to ultra-high molecular weight polyethylene (UHMWPE), or hyaluronan/&#xD;
             hyaluronic acid (HA)&#xD;
&#xD;
          -  Use with opposing articulating femoral components&#xD;
&#xD;
          -  Any concomitant painful or disabling disease of the spine, hips, or lower limbs that&#xD;
             would interfere with evaluation of the afflicted knee&#xD;
&#xD;
          -  Pregnant, prisoner, vulnerable population, or unable to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dinesh Nathwani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charing Cross Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dinesh Nathwani, MD</last_name>
    <phone>02070346125</phone>
    <email>Info@precisionsurgery.co.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>W1G 6HL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dinesh Nathwani, MD</last_name>
      <phone>02070346125</phone>
      <email>d.nathwani@imperial.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Dinesh Nathwani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mid Yorkshire Hosp NHS</name>
      <address>
        <city>Wakefield</city>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Newman, MD</last_name>
      <email>james.newman6@nhs.net</email>
    </contact>
    <investigator>
      <last_name>James Newman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>focal defect</keyword>
  <keyword>focal lesion</keyword>
  <keyword>chondral lesion</keyword>
  <keyword>osteochondral lesion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cartilage Diseases</mesh_term>
  </condition_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/NCT02991300
org study id: 1251001 V2.0
nct id: NCT02991300
lead sponsor: 
The data registry will increase the knowledge of outcomes for treatment of focal cartilage
      defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring
      of the clinical safety and performance of the device and surgical implantation kit
The data registry will increase the knowledge of outcomes for treatment of focal cartilage
      defects of the patella treated with the BioPoly RS Patella Implant This study will also allow
      monitoring of the clinical safety and performance of the device and surgical implantation kit
observational model: Case-Only
time perspective: Other
measure: KOOS Subscores
time frame: 2 year post-op
description: KOOS
measure: Kujala Anterior Knee Pain Scale
time frame: 2 year post-op
description: Kujala
measure: Medical Outcomes Study (SF-36) for generic "quality of life"
time frame: 2 years post-op
description: SF-36
measure: Activity using Tegner Score
time frame: 2 years post-op
description: Tegner
measure: Pain using VAS Pain
time frame: 2 years post-op
description: VAS Pain
measure: Radiographic Assessment
time frame: Annually through 5 years post-op
description: Radiographic Assessment
intervention type: Device
intervention name: BioPoly RS Partial Resurfacing Patella Implant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dinesh Nathwani, MD
role: Principal Investigator
affiliation: Charing Cross Hospital
last name: Dinesh Nathwani, MD
phone: 02070346125
email: Info@precisionsurgery.co.uk
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cartilage Diseases
sharing ipd: No