<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/NCT04419129</url>
  </required_header>
  <id_info>
    <org_study_id>ThmmasatU</org_study_id>
    <nct_id>NCT04419129</nct_id>
  </id_info>
  <brief_title>Comparison of Functional Recovery Between Mobile Bearing Unicompartmental Knee Arthroplasty and Total Knee Arthroplasty</brief_title>
  <official_title>Department of Orthopedics, Faculty of Medicine, Thammasat University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thammasat University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thammasat University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The total knee replacement (TKA) has shown excellent survival. However, some patients were up&#xD;
      to 20%, they still had pain and make them dissatisfy after operation. The medial&#xD;
      unicompartmental knee arthroplasty (UKA) also has shown excellent survivorship. The patient&#xD;
      who underwent UKA fell like normal knee because restoring natural kinematic and biomechanic&#xD;
      compare to TKA. However, The previous studies did not include the same characteristic of&#xD;
      patient in their studies. Therefor, UKA should be better than TKA. This study will compare&#xD;
      TKA to mobile bearing medial UKA or Oxford medial UKA. The mobile bearing UKA is different to&#xD;
      fixed bearing UKA. The mobile bearing UKA will be back knee alignment to pre-disease stage,&#xD;
      restore knee stability and restore natural knee kinematic and biomechanic. Therefore,&#xD;
      patients who underwent mobile bearing UKA will feel like normal knee and restore function to&#xD;
      near or nearly normal. The measurement of clinical outcome after knee arthroplasty is&#xD;
      questionable. The self-report questionnaire was used in the past. However, this score can not&#xD;
      estimate the true function of patients. The patient have shown high score, but they still had&#xD;
      pain and did not show satisfy after operation.The performance-based test such as 2-minute&#xD;
      walk test (2MWT), 6-minute walk test (6MWT) and Timed get-up-and-go test (TUG) should show&#xD;
      the exactly clinical outcome of patient following knee arthroplasty compare to self-report&#xD;
      questionnaire. Today, no randomized controlled trial study to compare performance-based test&#xD;
      between TKA and mobile bearing UKA. Therefor, this study will compare 2MWT and TUG between&#xD;
      TKA and mobile bearing UKA in medial OA knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The inclusion criteria were patients with medial of the knee with an Alhback score of 2, 3 or&#xD;
      4, those who were older than 40 years of age, those with a range of motion (ROM) &gt; 90°, those&#xD;
      with a varus deformity &lt; 25°, and those with a flexion contracture &lt; 20°. They were&#xD;
      randomized into 2 groups using computer program. Group I was 50 UKAs and group II was 50&#xD;
      TKAs. All patients in group I received medial mobile-bearing UKA (Oxford® UKA; Zimmer Biomet,&#xD;
      Inc, Warsaw, IN, USA) and group II received posterior stabilized fixed bearing total knee&#xD;
      arthroplasty (Vanguard®; Zimmer Biomet, Inc, Warsaw, IN, USA). The exclusion criteria were&#xD;
      patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative&#xD;
      anterior cruciate ligament (ACL) insufficiency or completely rupture of ACL, inflammatory&#xD;
      joint disease, gout, posttraumatic arthritis, or primary patellofemoral arthritis.The&#xD;
      recorded baseline patient characteristics included age and sex and the knee side, Knee&#xD;
      Society Score (KSS), Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score&#xD;
      (KOOS),(2MWT), (6MWT), (TUG), body mass index (BMI), degree of varus deformity, degree of&#xD;
      flexion contracture, genu recurvatum, and ROM. Patients were followed at 6 weeks, 3 months, 6&#xD;
      months, and 1 year and then annually thereafter. At each follow-up, the following data were&#xD;
      recorded: Joint Forgotten Score (JFS), KSS, OKS, Knee Injury and Osteoarthritis Outcome Score&#xD;
      (KOOS), Kujala score, (2MWT), (TUG), ROM and knee alignment. In addition, the following knee&#xD;
      X-rays were performed: anteroposterior (AP) and lateral standing, skyline and long-leg views;&#xD;
      from these, the tibiofemoral angles were measured. Complications such as infection, component&#xD;
      loosening, fractures, and bearing dislocations were also recorded. We determined differences&#xD;
      in the KSS, OKS, KOOS, JFS, Kujala score,(2MWT), (TUG),ROM, tibiofemoral angle, flexion&#xD;
      contractures, and genu recurvatum using Student's t tests. All analyses were two sided, and a&#xD;
      p value of ≤ 0.05 denoted statistical significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>2 minutes walk test (2MWT)</measure>
    <time_frame>2 years</time_frame>
    <description>measurement of endurance that assesses walking distance over 2 minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time up and go test (TUG)</measure>
    <time_frame>2 years</time_frame>
    <description>It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford knee score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgotten Joint Score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kujala score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Patient Reported Outcome Measure</condition>
  <arm_group>
    <arm_group_label>Mobile bearing unicompartmental knee arthroplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 mobile bearing UKA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>posterior stabilized fixed bearing total knee arthroplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 posterior stabilized fixed bearing cemented total knee arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxford UKA</intervention_name>
    <description>knee arthroplasty</description>
    <arm_group_label>Mobile bearing unicompartmental knee arthroplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vanguard TKA</intervention_name>
    <description>knee arthroplasty</description>
    <arm_group_label>posterior stabilized fixed bearing total knee arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  anteromedial OA knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  varus deformity &gt; 15 degrees&#xD;
&#xD;
          -  ROM &lt; 90 degrees&#xD;
&#xD;
          -  fixed varus deformity&#xD;
&#xD;
          -  post-traumatic arthritis&#xD;
&#xD;
          -  inflammatory arthritis&#xD;
&#xD;
          -  anterior cruciate ligament insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boonchana Pongcharoen, MD</last_name>
    <role>Study Director</role>
    <affiliation>faculty of medicine, Thammasat university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boonchana Pongcharoen</name>
      <address>
        <city>Pathum Thani</city>
        <zip>12120</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 28, 2017</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 29, 2021</last_update_submitted>
  <last_update_submitted_qc>August 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thammasat University</investigator_affiliation>
    <investigator_full_name>Boonchana Pongcharoen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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/NCT04419129
org study id: ThmmasatU
nct id: NCT04419129
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The total knee replacement (TKA) has shown excellent survival. However, some patients were up
      to 20%, they still had pain and make them dissatisfy after operation. The medial
      unicompartmental knee arthroplasty (UKA) also has shown excellent survivorship. The patient
      who underwent UKA fell like normal knee because restoring natural kinematic and biomechanic
      compare to TKA. However, The previous studies did not include the same characteristic of
      patient in their studies. Therefor, UKA should be better than TKA. This study will compare
      TKA to mobile bearing medial UKA or Oxford medial UKA. The mobile bearing UKA is different to
      fixed bearing UKA. The mobile bearing UKA will be back knee alignment to pre-disease stage,
      restore knee stability and restore natural knee kinematic and biomechanic. Therefore,
      patients who underwent mobile bearing UKA will feel like normal knee and restore function to
      near or nearly normal. The measurement of clinical outcome after knee arthroplasty is
      questionable. The self-report questionnaire was used in the past. However, this score can not
      estimate the true function of patients. The patient have shown high score, but they still had
      pain and did not show satisfy after operation.The performance-based test such as 2-minute
      walk test (2MWT), 6-minute walk test (6MWT) and Timed get-up-and-go test (TUG) should show
      the exactly clinical outcome of patient following knee arthroplasty compare to self-report
      questionnaire. Today, no randomized controlled trial study to compare performance-based test
      between TKA and mobile bearing UKA. Therefor, this study will compare 2MWT and TUG between
      TKA and mobile bearing UKA in medial OA knee.
The inclusion criteria were patients with medial of the knee with an Alhback score of 2, 3 or
      4, those who were older than 40 years of age, those with a range of motion (ROM) > 90°, those
      with a varus deformity < 25°, and those with a flexion contracture < 20°. They were
      randomized into 2 groups using computer program. Group I was 50 UKAs and group II was 50
      TKAs. All patients in group I received medial mobile-bearing UKA (Oxford® UKA; Zimmer Biomet,
      Inc, Warsaw, IN, USA) and group II received posterior stabilized fixed bearing total knee
      arthroplasty (Vanguard®; Zimmer Biomet, Inc, Warsaw, IN, USA). The exclusion criteria were
      patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative
      anterior cruciate ligament (ACL) insufficiency or completely rupture of ACL, inflammatory
      joint disease, gout, posttraumatic arthritis, or primary patellofemoral arthritis.The
      recorded baseline patient characteristics included age and sex and the knee side, Knee
      Society Score (KSS), Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score
      (KOOS),(2MWT), (6MWT), (TUG), body mass index (BMI), degree of varus deformity, degree of
      flexion contracture, genu recurvatum, and ROM. Patients were followed at 6 weeks, 3 months, 6
      months, and 1 year and then annually thereafter. At each follow-up, the following data were
      recorded: Joint Forgotten Score (JFS), KSS, OKS, Knee Injury and Osteoarthritis Outcome Score
      (KOOS), Kujala score, (2MWT), (TUG), ROM and knee alignment. In addition, the following knee
      X-rays were performed: anteroposterior (AP) and lateral standing, skyline and long-leg views;
      from these, the tibiofemoral angles were measured. Complications such as infection, component
      loosening, fractures, and bearing dislocations were also recorded. We determined differences
      in the KSS, OKS, KOOS, JFS, Kujala score,(2MWT), (TUG),ROM, tibiofemoral angle, flexion
      contractures, and genu recurvatum using Student's t tests. All analyses were two sided, and a
      p value of ≤ 0.05 denoted statistical significance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: 2 minutes walk test (2MWT)
time frame: 2 years
description: measurement of endurance that assesses walking distance over 2 minutes
measure: time up and go test (TUG)
time frame: 2 years
description: It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Knee Society Score
time frame: 2 years
description: The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
measure: Oxford knee score
time frame: 2 years
description: The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
measure: Forgotten Joint Score
time frame: 2 years
description: The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
measure: Kujala score
time frame: 2 years
description: The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
arm group label: Mobile bearing unicompartmental knee arthroplasty
arm group type: Active Comparator
description: 50 mobile bearing UKA
arm group label: posterior stabilized fixed bearing total knee arthroplasty
arm group type: Active Comparator
description: 50 posterior stabilized fixed bearing cemented total knee arthroplasty
intervention type: Device
intervention name: Oxford UKA
description: knee arthroplasty
arm group label: Mobile bearing unicompartmental knee arthroplasty
intervention type: Device
intervention name: Vanguard TKA
description: knee arthroplasty
arm group label: posterior stabilized fixed bearing total knee arthroplasty
criteria: 
gender: All
minimum age: 55 Years
maximum age: 70 Years
healthy volunteers: No
last name: Boonchana Pongcharoen, MD
role: Study Director
affiliation: faculty of medicine, Thammasat university
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Thammasat University
investigator full name: Boonchana Pongcharoen
investigator title: Associate Professor
sharing ipd: No