<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/NCT04479462</url>
  </required_header>
  <id_info>
    <org_study_id>202001045B0</org_study_id>
    <nct_id>NCT04479462</nct_id>
  </id_info>
  <brief_title>The Establishment of Total Joint Arthroplasty Registry Database</brief_title>
  <official_title>The Establishment of Total Joint Arthroplasty Registry Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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 purpose of this study will establish total joint arthroplasty registry database in&#xD;
      Kaohsiung Chang Gung Memorial Hospital and collect patient-reported outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>3 Years</target_duration>
  <primary_outcome>
    <measure>PROMIS Global--10 Score</measure>
    <time_frame>From the pre-operative assessment until 3 years after the srugery</time_frame>
    <description>Enrolled subjects with total joint arthroplasty of hip and knee will be asked to complete an on-line (web-based) survey (PROMIS-10 global) using a computer. Most patients will only be asked to complete this survey over a maximum 3 year period. The PROMIS-10 Global consists of ten items that measure global physical health (GPH) and general mental health (GMH). The raw PROMIS scores are continuous and range from 4-20. The GPH and GMH scores are converted based on a T-Score Metric allowing for comparisons to a general population. A higher score indicates a better general health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR)</measure>
    <time_frame>From the pre-operative assessment until 3 years after the srugery</time_frame>
    <description>The HOOS, JR is a 6-item instrument that includes 2 of the 5 subscales from the original HOOS (pain, and function and daily living). In the HOOS, JR questionnaire, pain is assessed by 2 items; and function and daily living is assessed by 4 items. These items were assigned a score 0-4 based on the options to the questions (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme). A raw score is summed from the 6 items with a minimum score of 0 and a maximum score of 24. High subscale and raw scores represent worse signs and symptoms. Subsequently, the raw summed score is converted to an interval score out of 100, where 0 represents total hip disability and 100 represents perfect hip health. Using the process, a HOOS, JR score was calculated for each patient included in our study from the original HOOS survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR)</measure>
    <time_frame>From the pre-operative assessment until 3 years after the srugery</time_frame>
    <description>The KOOS, JR is a 7-item instrument that includes 3 of the 5 subscales from the original KOOS (symptoms, pain, and function and daily living). In the KOOS, JR questionnaire, stiffness/ symptom is assessed by 1 item; pain is assessed by 4 items; and function and daily living is assessed by 2 items. These items were assigned a score 0-4 based on the options to the questions (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme). A raw score is summed from the 7 items with a minimum score of 0 and a maximum score of 28. High subscale and raw scores represent worse signs and symptoms. Subsequently, the raw summed score is converted to an interval score out of 100, where 0 represents total knee disability and 100 represents perfect knee health. Using the process, a KOOS, JR score was calculated for each patient included in our study from the original KOOS survey.</description>
  </primary_outcome>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Arthritis Knee</condition>
  <condition>Arthritis Hip</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>total joint arthroplasty</intervention_name>
    <description>The surgery includes primary, revision or partial joint arthroplasty.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will include the participants who will receive total joint arthroplasty&#xD;
        in our institutte.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing primary hip or knee arthroplasty&#xD;
&#xD;
          -  Patients undergoing revision hip or knee arthroplasty&#xD;
&#xD;
          -  Patients undergoing partial hip or knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete patients' data&#xD;
&#xD;
          -  Follow up less than 1 year after surgery&#xD;
&#xD;
          -  Unwillingness to sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Feng-Chih Kuo, MD</last_name>
    <phone>886-7-7317123</phone>
    <phone_ext>8003</phone_ext>
    <email>fongchikuo@cgmh.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Wang Jun-Wen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT04479462
org study id: 202001045B0
nct id: NCT04479462
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study will establish total joint arthroplasty registry database in
      Kaohsiung Chang Gung Memorial Hospital and collect patient-reported outcome.
observational model: Cohort
time perspective: Prospective
measure: PROMIS Global--10 Score
time frame: From the pre-operative assessment until 3 years after the srugery
description: Enrolled subjects with total joint arthroplasty of hip and knee will be asked to complete an on-line (web-based) survey (PROMIS-10 global) using a computer. Most patients will only be asked to complete this survey over a maximum 3 year period. The PROMIS-10 Global consists of ten items that measure global physical health (GPH) and general mental health (GMH). The raw PROMIS scores are continuous and range from 4-20. The GPH and GMH scores are converted based on a T-Score Metric allowing for comparisons to a general population. A higher score indicates a better general health
measure: Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR)
time frame: From the pre-operative assessment until 3 years after the srugery
description: The HOOS, JR is a 6-item instrument that includes 2 of the 5 subscales from the original HOOS (pain, and function and daily living). In the HOOS, JR questionnaire, pain is assessed by 2 items; and function and daily living is assessed by 4 items. These items were assigned a score 0-4 based on the options to the questions (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme). A raw score is summed from the 6 items with a minimum score of 0 and a maximum score of 24. High subscale and raw scores represent worse signs and symptoms. Subsequently, the raw summed score is converted to an interval score out of 100, where 0 represents total hip disability and 100 represents perfect hip health. Using the process, a HOOS, JR score was calculated for each patient included in our study from the original HOOS survey.
measure: Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR)
time frame: From the pre-operative assessment until 3 years after the srugery
description: The KOOS, JR is a 7-item instrument that includes 3 of the 5 subscales from the original KOOS (symptoms, pain, and function and daily living). In the KOOS, JR questionnaire, stiffness/ symptom is assessed by 1 item; pain is assessed by 4 items; and function and daily living is assessed by 2 items. These items were assigned a score 0-4 based on the options to the questions (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = extreme). A raw score is summed from the 7 items with a minimum score of 0 and a maximum score of 28. High subscale and raw scores represent worse signs and symptoms. Subsequently, the raw summed score is converted to an interval score out of 100, where 0 represents total knee disability and 100 represents perfect knee health. Using the process, a KOOS, JR score was calculated for each patient included in our study from the original KOOS survey.
intervention type: Procedure
intervention name: total joint arthroplasty
description: The surgery includes primary, revision or partial joint arthroplasty.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Feng-Chih Kuo, MD
phone: 886-7-7317123
phone ext: 8003
email: fongchikuo@cgmh.org.tw
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Wang Jun-Wen
investigator title: Principal Investigator
mesh term: Arthritis
sharing ipd: No