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/NCT05998538</url>
    </required_header>
    <id_info>
      <org_study_id>23082020</org_study_id>
      <nct_id>NCT05998538</nct_id>
    </id_info>
    <brief_title>Patients With Higher BMI Produces More Postoperative Drainage Volume and Length of Stay in Cross-Sectional Study</brief_title>
    <official_title>Patients With Higher BMI Produces More Postoperative Drainage Volume and Longer Length of Stay in Cross-Sectional Study: a Comparison of Total vs Partial Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia University</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>
        Partial knee arthroplasty theoretically produces less blood loss compared to total knee&#xD;
        arthroplasty (TKA) due to a lesser invasive procedure. Medial unicompartmental knee&#xD;
        arthroplasty (UKA) is the most common partial knee arthroplasty performed due used due to the&#xD;
        most commonly impacted medial knee. This study compared the postoperative drainage volume and&#xD;
        length of stay (LOS) of TKA vs UKA and evaluated its comparison with patient characteristics.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Theoretically, UKA will produce less blood loss due to a shorter skin incision, quadriceps&#xD;
        sparing muscle approach, persistence of cruciate ligaments, and less femorotibial&#xD;
        dislocation.7 However, studies investigating drainage volume in UKA are still limited. In&#xD;
        this study, we compared the drainage volume of patients undergoing TKA vs UKA and evaluated&#xD;
        several parameters that contributed the production. This study has not received any funding&#xD;
        or grant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 23, 2019</start_date>
    <completion_date type="Actual">December 7, 2022</completion_date>
    <primary_completion_date type="Actual">October 21, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Drainage Volume</measure>
      <time_frame>3-5 days post op</time_frame>
      <description>total drainage volume</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>LOS</measure>
      <time_frame>pre-op until drainage removed, 3-6 days post op</time_frame>
      <description>length of stay</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">120</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <arm_group>
      <arm_group_label>TKA (Total Knee Arthroplasty) procedure</arm_group_label>
      <description>Total Knee Arthroplasty</description>
    </arm_group>
    <arm_group>
      <arm_group_label>UKA (Uni Knee Arthroplasty) procedure</arm_group_label>
      <description>Uni Knee Arthroplasty</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Knee Replacement</intervention_name>
      <description>Total vs Partial Knee Replacement</description>
      <arm_group_label>TKA (Total Knee Arthroplasty) procedure</arm_group_label>
      <arm_group_label>UKA (Uni Knee Arthroplasty) procedure</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          medical records of patients who underwent primary TKA and UKA between December 2019 and&#xD;
          October 2022&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  grade 4 Osteoarthritis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  previous trauma&#xD;
  &#xD;
            -  infection&#xD;
  &#xD;
            -  blood coagulation disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ismail H Dilogo, Prof</last_name>
      <role>Study Director</role>
      <affiliation>Indonesia University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pondok Indah Hospital</name>
        <address>
          <city>Jakarta</city>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Ludwig Andre Pontoh</investigator_full_name>
      <investigator_title>DR</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05998538
  org study id: 23082020
  nct id: NCT05998538
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Partial knee arthroplasty theoretically produces less blood loss compared to total knee
        arthroplasty (TKA) due to a lesser invasive procedure. Medial unicompartmental knee
        arthroplasty (UKA) is the most common partial knee arthroplasty performed due used due to the
        most commonly impacted medial knee. This study compared the postoperative drainage volume and
        length of stay (LOS) of TKA vs UKA and evaluated its comparison with patient characteristics.
  Theoretically, UKA will produce less blood loss due to a shorter skin incision, quadriceps
        sparing muscle approach, persistence of cruciate ligaments, and less femorotibial
        dislocation.7 However, studies investigating drainage volume in UKA are still limited. In
        this study, we compared the drainage volume of patients undergoing TKA vs UKA and evaluated
        several parameters that contributed the production. This study has not received any funding
        or grant.
  observational model: Case-Crossover
  time perspective: Retrospective
  measure: Drainage Volume
  time frame: 3-5 days post op
  description: total drainage volume
  measure: LOS
  time frame: pre-op until drainage removed, 3-6 days post op
  description: length of stay
  arm group label: TKA (Total Knee Arthroplasty) procedure
  description: Total Knee Arthroplasty
  arm group label: UKA (Uni Knee Arthroplasty) procedure
  description: Uni Knee Arthroplasty
  intervention type: Procedure
  intervention name: Knee Replacement
  description: Total vs Partial Knee Replacement
  arm group label: TKA (Total Knee Arthroplasty) procedure
  arm group label: UKA (Uni Knee Arthroplasty) procedure
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ismail H Dilogo, Prof
  role: Study Director
  affiliation: Indonesia University
  facility: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Ludwig Andre Pontoh
  investigator title: DR
  mesh term: Osteoarthritis, Knee
  sharing ipd: No