<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/NCT02254499</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2014-090</org_study_id>
    <nct_id>NCT02254499</nct_id>
  </id_info>
  <brief_title>Prediction of Pain After Total Knee Arthroplasty</brief_title>
  <official_title>Prospective Descriptive Study of Nociceptive and Psychological Prediction of Pain After Total Knee Arthroplasty (TKA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite improvements in treatment, a significant part of patients have severe pain following&#xD;
      knee arthroplasty. Preoperative identification of high-risk patients would allow for an&#xD;
      intensive individualized analgesic treatment pre- and postoperatively and thus potentially in&#xD;
      reduced pain acute and chronically.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>Pain intensity on a NRS (numeric rank scale) from 0 to 10 upon ambulation 48 hours following surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>From day 1 to day 14 following surgery</time_frame>
    <description>Daily diary reported pain intensity on a NRS (numeric rank scale) from 0 to 10 in average and when worse the first two weeks following knee arthroplasty.</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with knee osteoarthritis referred for total knee arthroplasty.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary unilateral TKA&#xD;
&#xD;
          -  caucasian&#xD;
&#xD;
          -  50 - 80 years&#xD;
&#xD;
          -  osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deficient written or spoken danish&#xD;
&#xD;
          -  impairment from psychological og neurological disease&#xD;
&#xD;
          -  expected discharged to rehabilitation facility&#xD;
&#xD;
          -  anticoagulant therapy&#xD;
&#xD;
          -  allergies to analgesic treatment&#xD;
&#xD;
          -  hypertension (systolic &gt; 160 / diastolic &gt; 100)&#xD;
&#xD;
          -  ASA class ≥ 4&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Iben Engelund Luna</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <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/NCT02254499
org study id: H-3-2014-090
nct id: NCT02254499
lead sponsor: 
collaborator: 
has dmc: No
Despite improvements in treatment, a significant part of patients have severe pain following
      knee arthroplasty. Preoperative identification of high-risk patients would allow for an
      intensive individualized analgesic treatment pre- and postoperatively and thus potentially in
      reduced pain acute and chronically.
observational model: Cohort
time perspective: Prospective
measure: Pain
time frame: 24 hours postoperatively
description: Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery
measure: Pain
time frame: 48 hours postoperatively
description: Pain intensity on a NRS (numeric rank scale) from 0 to 10 upon ambulation 48 hours following surgery
measure: Pain
time frame: From day 1 to day 14 following surgery
description: Daily diary reported pain intensity on a NRS (numeric rank scale) from 0 to 10 in average and when worse the first two weeks following knee arthroplasty.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Iben Engelund Luna
investigator title: Research Fellow
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee