<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/NCT04419116</url>
  </required_header>
  <id_info>
    <org_study_id>MTU-EC-OT-1-137/62</org_study_id>
    <nct_id>NCT04419116</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes Between Tibial Preservation Bone Cut and Conventional Tibial Bone Cut Following Medial UKA</brief_title>
  <official_title>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>No</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 mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome&#xD;
      and survivorship. However, some studies have shown that the patients still had medial knee&#xD;
      pain and shown worst the clinical outcome, even though the survivorship was excellent. The&#xD;
      medial knee pain after operation was the one cause of revision. The incidence of medial knee&#xD;
      pain was 0%-9%. The cause of medial knee pain was overloading on the medial plateau, local&#xD;
      inflammation, over hanging of the tibial component and overstretching of the MCL due to the&#xD;
      application of excessive polyethylene. Therefore, the tibia in this study was cut with under&#xD;
      resection technique for reducing the overloading on the medial tibial plateau. The purpose of&#xD;
      this study is to compare medial knee pain between tibial bone cut preservation technique and&#xD;
      conventional tibial bone cut technique following mobile bearing UKA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized control trial study was conducted at Thammasat University hospital, Thailand.&#xD;
      The inclusion criteria were patients with medial osteoarthritis (OA) of the knee with an&#xD;
      Alhback score of 2, 3 and 4, who were older than 50 years of age, with a range of movement&#xD;
      (ROM) &gt; 90°, a varus deformity &lt; 25°, and flexion contracture &lt; 20° who underwent a medial&#xD;
      mobile bearing UKA (Oxford UKA; Zimmer Biomet, Inc, Warsaw, IN, USA), performed by a single&#xD;
      surgeon. The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis&#xD;
      of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency,&#xD;
      inflammatory joint disease, gout, post-traumatic arthritis, and primary PF arthritis. The&#xD;
      patients were randomized with computer technique into 2 groups, group (gp) I, conventional&#xD;
      tibial bone cut technique and gp II, tibial bone cut preservation technique. The baseline&#xD;
      patient characteristics included age, sex, site, the Knee Society Score© (KSS) (knee score,&#xD;
      pain score, and functional score), Oxford knee score (OKS), KOOS, Kujara score, body mass&#xD;
      index (BMI), degree of varus deformity, flexion contracture, genu recurvatum, and range of&#xD;
      motion (ROM) were recorded. The patients were followed up at 2 weeks, 6 weeks, 3months,&#xD;
      6months, 1 years, and annually. The VAS ofr medial knee and incidence of medial knee pain&#xD;
      were assessed in a blinded fashion by a research assistant at each visit using VAS scale&#xD;
      (0-10). The KSS, OKS, KOOS, and Kujara score also were recorded. At each follow-up, the&#xD;
      patients underwent AP standing, lateral standing, skyline view, and long-leg radiographs and&#xD;
      the component alignment, tibiofemoral angle and joint line of femur and tibia recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</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>visual analog scale (VAS) for pain</measure>
    <time_frame>2 years</time_frame>
    <description>pain at medial tibial plateau</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>knee society score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard knee score for determining function after knee arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford knee score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard knee score for determining function after knee arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>joint forgotten score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard knee score for determining function after knee arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knee injury osteoarthritis outcome score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard knee score for determining function after knee arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kujala score</measure>
    <time_frame>2 years</time_frame>
    <description>The standard knee score for determining function after knee arthroplasty</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Knee Arthropathy</condition>
  <arm_group>
    <arm_group_label>tibial preservation bone cut</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tibial preservation bone cut following mobile bearing UKA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tibial conventional bone cut</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tibial conventional bone cut following mobilebearing UKA</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tibial preservation bone cut</intervention_name>
    <description>tibial preservation bone cut: removing of proximal tibial less than conventional tibial bone cut with 2mm.</description>
    <arm_group_label>tibial conventional bone cut</arm_group_label>
    <arm_group_label>tibial preservation bone cut</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medial osteoarthritis of knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  posttraumatic arthritis&#xD;
&#xD;
          -  gout&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  anterior cruciate ligament insufficiency&#xD;
&#xD;
          -  osteonecrosis of knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boonchana Pongcharoen</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>June 1, 2020</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>Associated professor</investigator_title>
  </responsible_party>
  <keyword>mobile bearing UKA</keyword>
  <keyword>Oxford UKA</keyword>
  <keyword>medial knee pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Joint Diseases</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/NCT04419116
org study id: MTU-EC-OT-1-137/62
nct id: NCT04419116
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome
      and survivorship. However, some studies have shown that the patients still had medial knee
      pain and shown worst the clinical outcome, even though the survivorship was excellent. The
      medial knee pain after operation was the one cause of revision. The incidence of medial knee
      pain was 0%-9%. The cause of medial knee pain was overloading on the medial plateau, local
      inflammation, over hanging of the tibial component and overstretching of the MCL due to the
      application of excessive polyethylene. Therefore, the tibia in this study was cut with under
      resection technique for reducing the overloading on the medial tibial plateau. The purpose of
      this study is to compare medial knee pain between tibial bone cut preservation technique and
      conventional tibial bone cut technique following mobile bearing UKA.
A randomized control trial study was conducted at Thammasat University hospital, Thailand.
      The inclusion criteria were patients with medial osteoarthritis (OA) of the knee with an
      Alhback score of 2, 3 and 4, who were older than 50 years of age, with a range of movement
      (ROM) > 90°, a varus deformity < 25°, and flexion contracture < 20° who underwent a medial
      mobile bearing UKA (Oxford UKA; Zimmer Biomet, Inc, Warsaw, IN, USA), performed by a single
      surgeon. The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis
      of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency,
      inflammatory joint disease, gout, post-traumatic arthritis, and primary PF arthritis. The
      patients were randomized with computer technique into 2 groups, group (gp) I, conventional
      tibial bone cut technique and gp II, tibial bone cut preservation technique. The baseline
      patient characteristics included age, sex, site, the Knee Society Score© (KSS) (knee score,
      pain score, and functional score), Oxford knee score (OKS), KOOS, Kujara score, body mass
      index (BMI), degree of varus deformity, flexion contracture, genu recurvatum, and range of
      motion (ROM) were recorded. The patients were followed up at 2 weeks, 6 weeks, 3months,
      6months, 1 years, and annually. The VAS ofr medial knee and incidence of medial knee pain
      were assessed in a blinded fashion by a research assistant at each visit using VAS scale
      (0-10). The KSS, OKS, KOOS, and Kujara score also were recorded. At each follow-up, the
      patients underwent AP standing, lateral standing, skyline view, and long-leg radiographs and
      the component alignment, tibiofemoral angle and joint line of femur and tibia recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: visual analog scale (VAS) for pain
time frame: 2 years
description: pain at medial tibial plateau
measure: knee society score
time frame: 2 years
description: The standard knee score for determining function after knee arthroplasty
measure: Oxford knee score
time frame: 2 years
description: The standard knee score for determining function after knee arthroplasty
measure: joint forgotten score
time frame: 2 years
description: The standard knee score for determining function after knee arthroplasty
measure: knee injury osteoarthritis outcome score
time frame: 2 years
description: The standard knee score for determining function after knee arthroplasty
measure: Kujala score
time frame: 2 years
description: The standard knee score for determining function after knee arthroplasty
arm group label: tibial preservation bone cut
arm group type: Experimental
description: tibial preservation bone cut following mobile bearing UKA
arm group label: tibial conventional bone cut
arm group type: Experimental
description: tibial conventional bone cut following mobilebearing UKA
intervention type: Procedure
intervention name: tibial preservation bone cut
description: tibial preservation bone cut: removing of proximal tibial less than conventional tibial bone cut with 2mm.
arm group label: tibial conventional bone cut
arm group label: tibial preservation bone cut
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Boonchana Pongcharoen
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: Associated professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Joint Diseases
sharing ipd: No