<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/NCT02997891</url>
  </required_header>
  <id_info>
    <org_study_id>UKE 0545/110</org_study_id>
    <nct_id>NCT02997891</nct_id>
  </id_info>
  <brief_title>Change of Cognitive Performance Through Hip Replacement</brief_title>
  <acronym>KogniTEP</acronym>
  <official_title>Change of Cognitive Performance for Older People Through Artificial Hip Replacement Implantation [German Title: Veränderungen Der Kognitiven Leistungsfähigkeit älterer Menschen Durch Hüft-TEP Implantation]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stiftung Endoprothetik</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effectiveness of a hip arthroplasty for&#xD;
      chronic pain, caused by a unilateral primary Coxartrhrose, regarding the cognitive&#xD;
      performance. It is based on the hypothesis that the combination of chronic pain along with&#xD;
      relative immobilization causes impairment of cognitive performance. The total hip replacement&#xD;
      reduces pain, increases the mobility level and finally improves the cognitive performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have shown that cognitive performance, especially in the elderly is limited due to&#xD;
      chronic pain. In a recent study, significantly less brain activity in various regions of the&#xD;
      brain (the anterior cingulate cortex (ACC), insula and operculum, dorsolateral prefrontal&#xD;
      cortex and orbitofrontal cortex) was detected in patients with unilateral primary&#xD;
      coxarthrosis compared to a healthy control group. After eliminating the pain by the&#xD;
      implantation of a total hip replacement, a significant increase in brain activity in the&#xD;
      affected areas was observed in these patients. Whether this observation is accompanied by an&#xD;
      effect on cognition, is not known and will be investigated in the proposed study. The purpose&#xD;
      of this study is to investigate the effectiveness of a hip arthroplasty for chronic pain,&#xD;
      caused by a unilateral primary Coxartrhrose, regarding the cognitive performance. It is based&#xD;
      on the hypothesis that the combination of chronic pain along with relative immobilization&#xD;
      causes impairment of cognitive performance. The total hip replacement reduces pain, increases&#xD;
      the mobility level and finally improves the cognitive performance.&#xD;
&#xD;
      The main issue concerns the short and mid-term influence of hip replacement on cognitive&#xD;
      performance in the perioperative care continuum in comparison to a control group that does&#xD;
      not have chronic pain. To objectively quantify the everyday activity, there are a variety of&#xD;
      instruments, without a currently gold standard. Therefore, in addition the investigators use&#xD;
      objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every&#xD;
      three measuring time points (before surgery, 3 months after surgery, 6 months after surgery).&#xD;
&#xD;
      Standardized neuropsychological assessment methods are used to assess the cognitive&#xD;
      performance. To assess the degree of mobility, health status and the physical activity&#xD;
      standardized questionnaires are used.&#xD;
&#xD;
      Primary hypothesis: After implantation of an artificial hip replacement and reduction of&#xD;
      experienced pain patients with primary coxarthrosis indicate an improvement of cognitive&#xD;
      performance 3 and 6 month after surgery compared to the pre-surgical status. In addition, the&#xD;
      investigators measure how severe the cognitive performance is reduced compared to a healthy&#xD;
      control group prior to surgery and to what extend the cognitive performance is reversible in&#xD;
      the aftermath.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>attention and concentration performance (assessed by d2 Test of Attention)</measure>
    <time_frame>Change from Baseline attention and concentration performance at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>conceptual tracking, planning and flexibility (assessed by Trail Making Tests (Parts A and B)</measure>
    <time_frame>Change from Baseline conceptual tracking, planning and flexibility at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>semantic memory (assessed by FAS-Test [Verbal Fluency])</measure>
    <time_frame>Change from Baseline semantic memory at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>verbal episodic memory (Rivermead Behavioural Memory Test (RBMT) - story recall subtest) subtest</measure>
    <time_frame>Change from Baseline verbal episodic memory at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>visuospatial constructional ability and visual memory (assessed by Rey-Osterrieth Complex Figure Test)</measure>
    <time_frame>Change from Baseline visuospatial constructional ability and visual memory at 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective physical activity (assessed by Physical Activity Scale for the Elderly (PASE))</measure>
    <time_frame>Change from Baseline subjective physical activity at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>objective physical activity (assessed by pedometer GARAMIN vivofit)</measure>
    <time_frame>Change from Baseline objective physical activity at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety (assessed by the Generalized Anxiety Disorder 7-Scale (GAD-7))</measure>
    <time_frame>Change from Baseline anxiety at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression (assessed by the Patient Health Questionnaire (PHQ-9))</measure>
    <time_frame>Change from Baseline depression at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life (assessed by the SF-12 health survey)</measure>
    <time_frame>Change from Baseline quality of life at 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <description>Patients with primary, unilateral hip osteoarthritis in inpatient orthopedic acute treatment, who have a medical indication of a necessary artificial hip replacement implantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>Volunteers without chronic pain. As a control condition for comparing the variation in cognitive performance and everyday activity the investigators use a group of pain-free and mobility-unrestricted subjects, who do not receive or have an artificial hip.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>everyday activity</intervention_name>
    <description>To objectively quantify the everyday activity, there are a variety of instruments, without a currently gold standard. Therefore, in addition the investigators use objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every three measuring time points (before surgery, 3 months after surgery, 6 months after surgery).</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>cognitive performance</intervention_name>
    <description>Standardized neuropsychological assessment methods are used to assess the cognitive performance. To assess the degree of mobility, health status and the physical activity standardized questionnaires are used.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are enrolled in this study, who are diagnosed in the orthopedic clinic of Klinikum&#xD;
        Bad Bramstedt or in the orthopedic clinic at University Medical Center Hamburg-Eppendorf.&#xD;
        Study participants with the diagnosis of primary, unilateral coxarthrosis (ICD-10-GM:&#xD;
        M16.1) are added consecutively in the intervention group, if they need a hip replacement&#xD;
        because of their condition and decide to undergo this hip replacement in the orthopedic&#xD;
        clinic of Klinikum Bad Bramstedt.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary, unilateral coxarthrosis&#xD;
&#xD;
          -  planning for hip replacement surgery in Bad Bramstedt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dementia / cognitive impairment (Mini Mental Status Test &lt;25)&#xD;
&#xD;
          -  chronic pain otherwise genesis&#xD;
&#xD;
          -  reduced physical activity otherwise genesis&#xD;
&#xD;
          -  lack of German language skills&#xD;
&#xD;
          -  uncorrected serious impairment of vision or hearing&#xD;
&#xD;
          -  serious additional psychiatric diagnoses (e.g. substance abuse / addiction)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Niemeier, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andreas Niemeier, Prof. Dr.</last_name>
    <phone>+49(0)40 7410 54745</phone>
    <email>niemeier@uke.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sönke Arlt, PD Dr.</last_name>
    <phone>+49 (0)40 7410 53437</phone>
    <email>arlt@uke.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinikum Bad Bramstedt</name>
      <address>
        <city>Bad Bramstedt</city>
        <zip>24576</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Niemeier, Prof. Dr.</last_name>
      <phone>+49(0) 4192 902415</phone>
      <email>niemeier@uke.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sönke Arlt, PD Dr.</last_name>
      <phone>+49(0) 40 7410 53437</phone>
      <email>arlt@uke.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A. Brain gray matter decrease in chronic pain is the consequence and not the cause of pain. J Neurosci. 2009 Nov 4;29(44):13746-50. doi: 10.1523/JNEUROSCI.3687-09.2009.</citation>
    <PMID>19889986</PMID>
  </reference>
  <reference>
    <citation>Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A. Structural brain changes in chronic pain reflect probably neither damage nor atrophy. PLoS One. 2013;8(2):e54475. doi: 10.1371/journal.pone.0054475. Epub 2013 Feb 6.</citation>
    <PMID>23405082</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>October 17, 2017</last_update_submitted>
  <last_update_submitted_qc>October 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognition</keyword>
  <keyword>hip replacement</keyword>
  <keyword>physical activity</keyword>
  <keyword>quality of life</keyword>
  <keyword>psychological distress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT02997891
org study id: UKE 0545/110
nct id: NCT02997891
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the effectiveness of a hip arthroplasty for
      chronic pain, caused by a unilateral primary Coxartrhrose, regarding the cognitive
      performance. It is based on the hypothesis that the combination of chronic pain along with
      relative immobilization causes impairment of cognitive performance. The total hip replacement
      reduces pain, increases the mobility level and finally improves the cognitive performance.
Studies have shown that cognitive performance, especially in the elderly is limited due to
      chronic pain. In a recent study, significantly less brain activity in various regions of the
      brain (the anterior cingulate cortex (ACC), insula and operculum, dorsolateral prefrontal
      cortex and orbitofrontal cortex) was detected in patients with unilateral primary
      coxarthrosis compared to a healthy control group. After eliminating the pain by the
      implantation of a total hip replacement, a significant increase in brain activity in the
      affected areas was observed in these patients. Whether this observation is accompanied by an
      effect on cognition, is not known and will be investigated in the proposed study. The purpose
      of this study is to investigate the effectiveness of a hip arthroplasty for chronic pain,
      caused by a unilateral primary Coxartrhrose, regarding the cognitive performance. It is based
      on the hypothesis that the combination of chronic pain along with relative immobilization
      causes impairment of cognitive performance. The total hip replacement reduces pain, increases
      the mobility level and finally improves the cognitive performance.

      The main issue concerns the short and mid-term influence of hip replacement on cognitive
      performance in the perioperative care continuum in comparison to a control group that does
      not have chronic pain. To objectively quantify the everyday activity, there are a variety of
      instruments, without a currently gold standard. Therefore, in addition the investigators use
      objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every
      three measuring time points (before surgery, 3 months after surgery, 6 months after surgery).

      Standardized neuropsychological assessment methods are used to assess the cognitive
      performance. To assess the degree of mobility, health status and the physical activity
      standardized questionnaires are used.

      Primary hypothesis: After implantation of an artificial hip replacement and reduction of
      experienced pain patients with primary coxarthrosis indicate an improvement of cognitive
      performance 3 and 6 month after surgery compared to the pre-surgical status. In addition, the
      investigators measure how severe the cognitive performance is reduced compared to a healthy
      control group prior to surgery and to what extend the cognitive performance is reversible in
      the aftermath.
observational model: Case-Control
time perspective: Prospective
measure: attention and concentration performance (assessed by d2 Test of Attention)
time frame: Change from Baseline attention and concentration performance at 6 months
measure: conceptual tracking, planning and flexibility (assessed by Trail Making Tests (Parts A and B)
time frame: Change from Baseline conceptual tracking, planning and flexibility at 6 months
measure: semantic memory (assessed by FAS-Test [Verbal Fluency])
time frame: Change from Baseline semantic memory at 6 months
measure: verbal episodic memory (Rivermead Behavioural Memory Test (RBMT) - story recall subtest) subtest
time frame: Change from Baseline verbal episodic memory at 6 months
measure: visuospatial constructional ability and visual memory (assessed by Rey-Osterrieth Complex Figure Test)
time frame: Change from Baseline visuospatial constructional ability and visual memory at 6 months
measure: subjective physical activity (assessed by Physical Activity Scale for the Elderly (PASE))
time frame: Change from Baseline subjective physical activity at 6 months
measure: objective physical activity (assessed by pedometer GARAMIN vivofit)
time frame: Change from Baseline objective physical activity at 6 months
measure: anxiety (assessed by the Generalized Anxiety Disorder 7-Scale (GAD-7))
time frame: Change from Baseline anxiety at 6 months
measure: depression (assessed by the Patient Health Questionnaire (PHQ-9))
time frame: Change from Baseline depression at 6 months
measure: quality of life (assessed by the SF-12 health survey)
time frame: Change from Baseline quality of life at 6 months
arm group label: intervention group
description: Patients with primary, unilateral hip osteoarthritis in inpatient orthopedic acute treatment, who have a medical indication of a necessary artificial hip replacement implantation.
arm group label: control group
description: Volunteers without chronic pain. As a control condition for comparing the variation in cognitive performance and everyday activity the investigators use a group of pain-free and mobility-unrestricted subjects, who do not receive or have an artificial hip.
intervention type: Diagnostic Test
intervention name: everyday activity
description: To objectively quantify the everyday activity, there are a variety of instruments, without a currently gold standard. Therefore, in addition the investigators use objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every three measuring time points (before surgery, 3 months after surgery, 6 months after surgery).
arm group label: control group
arm group label: intervention group
intervention type: Diagnostic Test
intervention name: cognitive performance
description: Standardized neuropsychological assessment methods are used to assess the cognitive performance. To assess the degree of mobility, health status and the physical activity standardized questionnaires are used.
arm group label: control group
arm group label: intervention group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Niemeier, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Hamburg-Eppendorf
last name: Andreas Niemeier, Prof. Dr.
phone: +49(0)40 7410 54745
email: niemeier@uke.de
last name: Sönke Arlt, PD Dr.
phone: +49 (0)40 7410 53437
email: arlt@uke.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
citation: Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A. Brain gray matter decrease in chronic pain is the consequence and not the cause of pain. J Neurosci. 2009 Nov 4;29(44):13746-50. doi: 10.1523/JNEUROSCI.3687-09.2009.
PMID: 19889986
citation: Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A. Structural brain changes in chronic pain reflect probably neither damage nor atrophy. PLoS One. 2013;8(2):e54475. doi: 10.1371/journal.pone.0054475. Epub 2013 Feb 6.
PMID: 23405082
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip
sharing ipd: No