xml: <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/NCT06024161</url>
    </required_header>
    <id_info>
      <org_study_id>p-2023-14578</org_study_id>
      <nct_id>NCT06024161</nct_id>
    </id_info>
    <brief_title>Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties</brief_title>
    <official_title>Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties: A Nationwide Registry-based Cohort Survey Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bispebjerg Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bispebjerg Hospital</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>
        The study is a nationwide, register-based cohort survey study. The objective of this study is&#xD;
        to investigate whether weight change is associated with the incidence of persistent&#xD;
        postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese&#xD;
        and obese and patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>15 Months</target_duration>
    <primary_outcome>
      <measure>Moderate/Severe Persistent Postoperative Pain</measure>
      <time_frame>11-15 months postsurgically</time_frame>
      <description>The primary outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated hip or knee, defined as patients with a numerical rating scale (NRS) score higher than 3.&#xD;
  The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Satisfaction</measure>
      <time_frame>11-15 months postsurgically</time_frame>
      <description>Answering with &quot;satisfied&quot; or &quot;very satisfied&quot; in satisfaction question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Willingness to repeat the surgery</measure>
      <time_frame>11-15 months postsurgically</time_frame>
      <description>Answering &quot;yes&quot; in willlingness question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequent pain</measure>
      <time_frame>11-15 months postsurgically</time_frame>
      <description>Experiencing pain constantly, daily or few times a week The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of analgaesic</measure>
      <time_frame>11-15 months postsurgically</time_frame>
      <description>The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interference with daily activities</measure>
      <time_frame>11-15 months postsurgically</time_frame>
      <description>Answering &quot;some&quot;, &quot;much&quot; and &quot;very much&quot; in the interference question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WOMAC pain score</measure>
      <time_frame>11-15 months postsurgically</time_frame>
      <description>mean (standard deviaiton [SD]). We will report the mean difference (MD) and the corresponding 95% CI</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">6400</enrollment>
    <condition>Persistent Postsurgical Pain</condition>
    <condition>Arthritis Knee</condition>
    <condition>Arthropathy of Knee</condition>
    <condition>Arthropathy of Hip</condition>
    <condition>Weight Loss</condition>
    <condition>Weight Gain</condition>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Weight gainers</arm_group_label>
      <description>Weight gain 11-15 months after arthroplasty</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Weight losers</arm_group_label>
      <description>Weight loss11-15 months after arthroplasty</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Weight unchanged</arm_group_label>
      <description>Weight unchanged 11-15 months after arthroplasty</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Weight gain</intervention_name>
      <description>≥5% weight gain</description>
      <arm_group_label>Weight gainers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Weight loss</intervention_name>
      <description>≥5% weight loss after arthroplasty</description>
      <arm_group_label>Weight losers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Weight unchanged</intervention_name>
      <description>&lt;5% weight change after arthroplasty</description>
      <arm_group_label>Weight unchanged</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients will be identified based on the NOMESCO (Nordic Medico-Statistical Committee)&#xD;
          Classification of Surgical Procedures from the the Danish National Patient Register by&#xD;
          using SKS-code the codes for THA patients will be SKS-code DM16 [hip osteoarthritis] +&#xD;
          KNFB20 or KNFB30 or KNFB40[Primary Total Hip Arthroplasty]. For total knee arthroplasty&#xD;
          (TKA), SKS-code DM17 [knee osteoarthritis] + KNGB20, KNGB30 or KNGB40 [primary total knee&#xD;
          arthroplasty]. For medial unicompartmental knee arthroplasty (UKA), SKS-code DM17 [knee&#xD;
          osteoarthritis] + KNGB01 or KNGB11 [primary medial unicompartmental knee arthroplasty].&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Patients operated with primary hip or knee arthroplasty for osteoarthritis 11-15 months&#xD;
          before survey distribution&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked&#xD;
               to participate.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Søren Overgaard, MD,DMSc,Prof</last_name>
      <role>Study Director</role>
      <affiliation>Department of orthopedic surgery, Bispebjerg University Hospital, Denmark</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Saber M. Saber, MD</last_name>
      <phone>004521299265</phone>
      <email>ssab0009@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jens Laigaard, MD</last_name>
      <email>jens.holm.laigaard@regionh.dk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
      <investigator_full_name>Saber Muthanna Saber</investigator_full_name>
      <investigator_title>MD, PhD fellow</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Diseases</mesh_term>
      <mesh_term>Body Weight</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Weight Loss</mesh_term>
      <mesh_term>Weight Gain</mesh_term>
      <mesh_term>Body Weight Changes</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 29, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT06024161/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024161
  org study id: p-2023-14578
  nct id: NCT06024161
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study is a nationwide, register-based cohort survey study. The objective of this study is
        to investigate whether weight change is associated with the incidence of persistent
        postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese
        and obese and patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Moderate/Severe Persistent Postoperative Pain
  time frame: 11-15 months postsurgically
  description: The primary outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated hip or knee, defined as patients with a numerical rating scale (NRS) score higher than 3.
  The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
  measure: Satisfaction
  time frame: 11-15 months postsurgically
  description: Answering with "satisfied" or "very satisfied" in satisfaction question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
  measure: Willingness to repeat the surgery
  time frame: 11-15 months postsurgically
  description: Answering "yes" in willlingness question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
  measure: Frequent pain
  time frame: 11-15 months postsurgically
  description: Experiencing pain constantly, daily or few times a week The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
  measure: Use of analgaesic
  time frame: 11-15 months postsurgically
  description: The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
  measure: Interference with daily activities
  time frame: 11-15 months postsurgically
  description: Answering "some", "much" and "very much" in the interference question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
  measure: WOMAC pain score
  time frame: 11-15 months postsurgically
  description: mean (standard deviaiton [SD]). We will report the mean difference (MD) and the corresponding 95% CI
  arm group label: Weight gainers
  description: Weight gain 11-15 months after arthroplasty
  arm group label: Weight losers
  description: Weight loss11-15 months after arthroplasty
  arm group label: Weight unchanged
  description: Weight unchanged 11-15 months after arthroplasty
  intervention type: Other
  intervention name: Weight gain
  description: ≥5% weight gain
  arm group label: Weight gainers
  intervention type: Other
  intervention name: Weight loss
  description: ≥5% weight loss after arthroplasty
  arm group label: Weight losers
  intervention type: Other
  intervention name: Weight unchanged
  description: <5% weight change after arthroplasty
  arm group label: Weight unchanged
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  last name: Søren Overgaard, MD,DMSc,Prof
  role: Study Director
  affiliation: Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
  last name: Saber M. Saber, MD
  phone: 004521299265
  email: ssab0009@regionh.dk
  last name: Jens Laigaard, MD
  email: jens.holm.laigaard@regionh.dk
  responsible party type: Principal Investigator
  investigator affiliation: Bispebjerg Hospital
  investigator full name: Saber Muthanna Saber
  investigator title: MD, PhD fellow
  mesh term: Joint Diseases
  mesh term: Body Weight
  mesh term: Chronic Pain
  mesh term: Weight Loss
  mesh term: Weight Gain
  mesh term: Body Weight Changes
  mesh term: Pain, Postoperative
  provided document: 