<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/NCT04419311</url>
  </required_header>
  <id_info>
    <org_study_id>1585/2017</org_study_id>
    <nct_id>NCT04419311</nct_id>
  </id_info>
  <brief_title>Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties</brief_title>
  <official_title>Isokinetic Performance After Cruciate-substituting Ultra-congruent and Posterior Stabilized Total Knee Arthroplasties: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aksaray University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aksaray University Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS)&#xD;
      insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains&#xD;
      debatable. Despite the potential advantages of the UC insert over PS insert with its&#xD;
      different design, there are concerns about inferior clinical outcome related to its use.&#xD;
      Therefore, isokinetic performance was used in this study to objectively evaluate knee&#xD;
      function after TKA and the clinical scores of the patients were also evaluated. To the best&#xD;
      of our knowledge, no prospective randomized study has compared the isokinetic performance of&#xD;
      the knee following the use of UC and PS inserts in TKA. The hypothesis of the present study&#xD;
      was that compared with the PS insert, the UC insert would be associated with a lower clinical&#xD;
      outcome and isokinetic performance following TKA.&#xD;
&#xD;
      A total of 65 patients scheduled to undergo TKA on for primary knee osteoarthritis were&#xD;
      randomly assigned to either the UC (32 patients) or the PS group (33 patients). The Knee&#xD;
      Society Score (KSS) and isokinetic performance results of each patient were recorded&#xD;
      preoperatively and at postoperative 3, 6 and 12 months. The physiatrist performing isokinetic&#xD;
      tests and patients were blinded to the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligibility of all patients between 55 and 80 years, scheduled to undergo unilateral TKA on&#xD;
      for primary knee osteoarthritis will be evaluated. The exclusion criteria are rheumatological&#xD;
      joint diseases, previous knee surgery, neuromuscular diseases, bilateral TKA, or&#xD;
      insufficiency of collateral ligaments. Patients will be randomized in a 1:1 ratio via&#xD;
      computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle,&#xD;
      WA, USA) to be allocated in the UC insert or PS insert group before the operation. Unblinded&#xD;
      senior resident will implement the randomization. Patients and physiatrists performing&#xD;
      isokinetic measurements will be blinded to group allocation.&#xD;
&#xD;
      During the UC and PS operations, Vanguard® Complete Knee System prosthesis (Zimmer Biomet&#xD;
      Inc., Warsaw, IN, USA) will be implanted using the same surgical technique in all patients.&#xD;
      The Vanguard anterior-stabilized (AS) insert is a UC deep-dish design with a 10 mm prominent&#xD;
      anterior lip and 5mm posterior lip. This bone-conserving design prevents anterior femoral&#xD;
      subluxation because of the prominent anterior lip. The insert design allows it to be used&#xD;
      with the Vanguard cruciate-retaining femoral component and the highly congruent articulating&#xD;
      surface increases rotational stability. There is more contact area between the femoral&#xD;
      component and the weight-bearing surface to decrease the shear stress between the femur and&#xD;
      polyethylene insert.&#xD;
&#xD;
      A tourniquet will be inflated to pressure of 300 mmHg after spinal anesthesia. All operations&#xD;
      will be performed with the same surgical technique by a single senior surgeon. Patellar&#xD;
      surface arthroplasty will be performed in all the cases. Both femoral and tibial prostheses&#xD;
      will be implanted with pressured bone cement. A suction drain will be placed inside the knee&#xD;
      capsule. On the morning of the first day after surgery patients will be mobilized under the&#xD;
      supervision of the physical therapist. All patients will undergo the same rehabilitation&#xD;
      procedure during the outpatient period and will be examined by the same physiatrist at the&#xD;
      regular 3, 6, and 12-month follow-up visits.&#xD;
&#xD;
      The primary outcome is isokinetic performance, measured as peak knee extensor and flexor&#xD;
      torque values in Newton-meters, on the operated knee. Measurements wilil be done&#xD;
      preoperatively and at 3, 6, and 12-month follow-up examinations under the supervision of the&#xD;
      same physiatrist. At same time points, the Knee Society Score (KSS) will be evaluated as&#xD;
      well. Isokinetic measurements will be performed using a Biodex System III Isokinetic&#xD;
      Dynamometer, version 3.03 (Biodex Medical Inc., Shirley, NY, USA) by the same senior&#xD;
      physiatrist. Patients will be positioned on the dynamometer with the hip in 90° in a sitting&#xD;
      position for the knee flexion and extension measurements. Lateral movement of the knee will&#xD;
      be prevented during full extension and flexion of the knee by a thigh strap on the operated&#xD;
      leg. The physical therapist will help the patients to achieve proper positioning before each&#xD;
      test. Concentric isokinetic knee flexion-extensions will be assessed at a preset velocity of&#xD;
      60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10&#xD;
      flexion-extension repetitions will be completed by each patient. Instructions will be&#xD;
      provided, and one trial repetition will then performed by all patients before the&#xD;
      measurements were taken.&#xD;
&#xD;
      Sample size estimation will be performed using the extension peak torque as a primary effect&#xD;
      variable. As there is no similar study with isokinetic measurements regarding this subject, a&#xD;
      difference in mean values of 10 Nm and standard deviation of 12 Nm were assumed for each&#xD;
      group. The group sample sizes of 31 and 31 achieved a power of 0.90 to detect a difference of&#xD;
      10 Nm between the two groups with estimated group standard deviations of 12 for each group&#xD;
      and with a significance level (alpha) of 0.05 using a two-sided, two-sample test. Considering&#xD;
      the loss to follow-up, two patients were added to each group. Thus, recruitment will end&#xD;
      after 33 patients were assigned to either groups. All data will be calculated as mean and&#xD;
      standard deviation. The Student's t-test will be used for statistical analysis of the patient&#xD;
      data. Statistical calculations will be performed with SPSS 22.0 software (IBM SPSS Statistics&#xD;
      for Windows, Version 22.0. Armonk, NY: IBM Corp.). A value of p&lt; 0.05 will be considered&#xD;
      statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>
    <intervention_model_description>Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Patients and physiatrists performing isokinetic measurements were blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline Assessment of Peak Knee Extensor Torque Preoperatively</measure>
    <time_frame>Preoperative</time_frame>
    <description>Peak extensor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Assessment of Peak Knee Flexor Torque Preoperatively</measure>
    <time_frame>Preoperative</time_frame>
    <description>Peak flexor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline Knee Society Clinical Score Evaluation</measure>
    <time_frame>Preoperative</time_frame>
    <description>The Knee Society Score were applied preoperatively.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Clinical Score Evaluation at 3 Months Postoperatively</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>The Knee Society Clinical Score were applied at postoperative 3 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Clinical Score Evaluation at 6 Months Postoperatively</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>The Knee Society Clinical Score were applied at postoperative 6 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Clinical Score Evaluation at 12 Months Postoperatively</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>The Knee Society Clinical Score were applied at postoperative 12 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Knee Society Functional Score Evaluation</measure>
    <time_frame>Preoperative</time_frame>
    <description>The Knee Society Functional Score were applied preoperatively.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Functional Score Evaluation at 3 Months Postoperatively</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>The Knee Society Functional Score were applied at postoperative 3 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Functional Score Evaluation at 6 Months Postoperatively</measure>
    <time_frame>6 months postoperative</time_frame>
    <description>The Knee Society Functional Score were applied at postoperative 6 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Functional Score Evaluation at 12 Months Postoperatively</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>The Knee Society Functional Score were applied at postoperative 12 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Knee Arthritis</condition>
  <arm_group>
    <arm_group_label>Ultra-congruent insert group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Posterior cruciate ligament-stabilized insert</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vanguard® Knee System</intervention_name>
    <description>Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
    <arm_group_label>Posterior cruciate ligament-stabilized insert</arm_group_label>
    <arm_group_label>Ultra-congruent insert group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 55 and 80 years&#xD;
&#xD;
          -  Scheduled to undergo unilateral TKA on for primary knee osteoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatological joint diseases&#xD;
&#xD;
          -  Previous knee surgery&#xD;
&#xD;
          -  Neuromuscular diseases&#xD;
&#xD;
          -  Bilateral TKA&#xD;
&#xD;
          -  Insufficiency of collateral ligaments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deniz Çankaya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aksaray University Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aksaray University Training and Research Hospital</name>
      <address>
        <city>Aksaray</city>
        <zip>68200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 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>
  <results_first_submitted>January 12, 2021</results_first_submitted>
  <results_first_submitted_qc>February 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>February 20, 2021</last_update_submitted>
  <last_update_submitted_qc>February 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aksaray University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Erdem A Sezgin</investigator_full_name>
    <investigator_title>Co-Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ultra-congruent insert</keyword>
  <keyword>Posterior cruciate ligament-stabilized insert</keyword>
  <keyword>Isokinetic test</keyword>
  <keyword>Strength</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</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>June 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT04419311/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ultra-congruent Insert Group</title>
          <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.</description>
        </group>
        <group group_id="P2">
          <title>Posterior Cruciate Ligament-stabilized Insert</title>
          <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ultra-congruent Insert Group</title>
          <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.</description>
        </group>
        <group group_id="B2">
          <title>Posterior Cruciate Ligament-stabilized Insert</title>
          <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.18" spread="8.55"/>
                    <measurement group_id="B2" value="67.67" spread="8.12"/>
                    <measurement group_id="B3" value="68.42" spread="8.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="33"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline Assessment of Peak Knee Extensor Torque Preoperatively</title>
        <description>Peak extensor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>Preoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Assessment of Peak Knee Extensor Torque Preoperatively</title>
          <description>Peak extensor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.56" spread="8.65"/>
                    <measurement group_id="O2" value="58.33" spread="8.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline Assessment of Peak Knee Flexor Torque Preoperatively</title>
        <description>Peak flexor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>Preoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Assessment of Peak Knee Flexor Torque Preoperatively</title>
          <description>Peak flexor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.84" spread="9.56"/>
                    <measurement group_id="O2" value="40.3" spread="7.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively</title>
        <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>3 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively</title>
          <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.38" spread="7.37"/>
                    <measurement group_id="O2" value="45.85" spread="7.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively</title>
        <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>3 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively</title>
          <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.91" spread="10.11"/>
                    <measurement group_id="O2" value="29.39" spread="7.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively</title>
        <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>6 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively</title>
          <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.53" spread="7.95"/>
                    <measurement group_id="O2" value="52.64" spread="6.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively</title>
        <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>6 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively</title>
          <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.19" spread="9.86"/>
                    <measurement group_id="O2" value="35.27" spread="7.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively</title>
        <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>12 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively</title>
          <description>Peak extensor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.34" spread="8.97"/>
                    <measurement group_id="O2" value="61.52" spread="9.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively</title>
        <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
        <time_frame>12 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively</title>
          <description>Peak flexor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).</description>
          <units>Newton meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.94" spread="9.96"/>
                    <measurement group_id="O2" value="41.18" spread="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Knee Society Clinical Score Evaluation</title>
        <description>The Knee Society Score were applied preoperatively.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>Preoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Knee Society Clinical Score Evaluation</title>
          <description>The Knee Society Score were applied preoperatively.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.69" spread="12.6"/>
                    <measurement group_id="O2" value="49.15" spread="11.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Society Clinical Score Evaluation at 3 Months Postoperatively</title>
        <description>The Knee Society Clinical Score were applied at postoperative 3 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>3 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Society Clinical Score Evaluation at 3 Months Postoperatively</title>
          <description>The Knee Society Clinical Score were applied at postoperative 3 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.81" spread="11.73"/>
                    <measurement group_id="O2" value="79.48" spread="10.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Society Clinical Score Evaluation at 6 Months Postoperatively</title>
        <description>The Knee Society Clinical Score were applied at postoperative 6 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>6 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Society Clinical Score Evaluation at 6 Months Postoperatively</title>
          <description>The Knee Society Clinical Score were applied at postoperative 6 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.81" spread="5.64"/>
                    <measurement group_id="O2" value="88.39" spread="6.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Society Clinical Score Evaluation at 12 Months Postoperatively</title>
        <description>The Knee Society Clinical Score were applied at postoperative 12 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>12 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Society Clinical Score Evaluation at 12 Months Postoperatively</title>
          <description>The Knee Society Clinical Score were applied at postoperative 12 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.69" spread="4.41"/>
                    <measurement group_id="O2" value="92.24" spread="4.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Knee Society Functional Score Evaluation</title>
        <description>The Knee Society Functional Score were applied preoperatively.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>Preoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Knee Society Functional Score Evaluation</title>
          <description>The Knee Society Functional Score were applied preoperatively.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.53" spread="14.11"/>
                    <measurement group_id="O2" value="51.27" spread="11.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Society Functional Score Evaluation at 3 Months Postoperatively</title>
        <description>The Knee Society Functional Score were applied at postoperative 3 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>3 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Society Functional Score Evaluation at 3 Months Postoperatively</title>
          <description>The Knee Society Functional Score were applied at postoperative 3 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.47" spread="14.19"/>
                    <measurement group_id="O2" value="65.73" spread="11.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Society Functional Score Evaluation at 6 Months Postoperatively</title>
        <description>The Knee Society Functional Score were applied at postoperative 6 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>6 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Society Functional Score Evaluation at 6 Months Postoperatively</title>
          <description>The Knee Society Functional Score were applied at postoperative 6 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.22" spread="12.98"/>
                    <measurement group_id="O2" value="72.21" spread="11.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Society Functional Score Evaluation at 12 Months Postoperatively</title>
        <description>The Knee Society Functional Score were applied at postoperative 12 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
        <time_frame>12 months postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultra-congruent Insert Group</title>
            <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
          <group group_id="O2">
            <title>Posterior Cruciate Ligament-stabilized Insert</title>
            <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.&#xD;
Vanguard® Knee System: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Society Functional Score Evaluation at 12 Months Postoperatively</title>
          <description>The Knee Society Functional Score were applied at postoperative 12 months.&#xD;
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; &lt; 60, poor.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.47" spread="10.45"/>
                    <measurement group_id="O2" value="82.79" spread="10.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Definition of adverse event does not differ from the clinicaltrials.gov definitions.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ultra-congruent Insert Group</title>
          <description>Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.</description>
        </group>
        <group group_id="E2">
          <title>Posterior Cruciate Ligament-stabilized Insert</title>
          <description>Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Superficial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Erdem Aras Sezgin</name_or_title>
      <organization>Aksaray University Training and Research Hospital</organization>
      <phone>+905057777697</phone>
      <email>sezginmd@hotmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04419311
org study id: 1585/2017
nct id: NCT04419311
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The choice between ultra-congruent (UC) insert or posterior cruciate ligament-stabilized (PS)
      insert in posterior cruciate ligament (PCL) sacrificing total knee arthroplasty (TKA) remains
      debatable. Despite the potential advantages of the UC insert over PS insert with its
      different design, there are concerns about inferior clinical outcome related to its use.
      Therefore, isokinetic performance was used in this study to objectively evaluate knee
      function after TKA and the clinical scores of the patients were also evaluated. To the best
      of our knowledge, no prospective randomized study has compared the isokinetic performance of
      the knee following the use of UC and PS inserts in TKA. The hypothesis of the present study
      was that compared with the PS insert, the UC insert would be associated with a lower clinical
      outcome and isokinetic performance following TKA.

      A total of 65 patients scheduled to undergo TKA on for primary knee osteoarthritis were
      randomly assigned to either the UC (32 patients) or the PS group (33 patients). The Knee
      Society Score (KSS) and isokinetic performance results of each patient were recorded
      preoperatively and at postoperative 3, 6 and 12 months. The physiatrist performing isokinetic
      tests and patients were blinded to the study.
Eligibility of all patients between 55 and 80 years, scheduled to undergo unilateral TKA on
      for primary knee osteoarthritis will be evaluated. The exclusion criteria are rheumatological
      joint diseases, previous knee surgery, neuromuscular diseases, bilateral TKA, or
      insufficiency of collateral ligaments. Patients will be randomized in a 1:1 ratio via
      computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle,
      WA, USA) to be allocated in the UC insert or PS insert group before the operation. Unblinded
      senior resident will implement the randomization. Patients and physiatrists performing
      isokinetic measurements will be blinded to group allocation.

      During the UC and PS operations, Vanguard® Complete Knee System prosthesis (Zimmer Biomet
      Inc., Warsaw, IN, USA) will be implanted using the same surgical technique in all patients.
      The Vanguard anterior-stabilized (AS) insert is a UC deep-dish design with a 10 mm prominent
      anterior lip and 5mm posterior lip. This bone-conserving design prevents anterior femoral
      subluxation because of the prominent anterior lip. The insert design allows it to be used
      with the Vanguard cruciate-retaining femoral component and the highly congruent articulating
      surface increases rotational stability. There is more contact area between the femoral
      component and the weight-bearing surface to decrease the shear stress between the femur and
      polyethylene insert.

      A tourniquet will be inflated to pressure of 300 mmHg after spinal anesthesia. All operations
      will be performed with the same surgical technique by a single senior surgeon. Patellar
      surface arthroplasty will be performed in all the cases. Both femoral and tibial prostheses
      will be implanted with pressured bone cement. A suction drain will be placed inside the knee
      capsule. On the morning of the first day after surgery patients will be mobilized under the
      supervision of the physical therapist. All patients will undergo the same rehabilitation
      procedure during the outpatient period and will be examined by the same physiatrist at the
      regular 3, 6, and 12-month follow-up visits.

      The primary outcome is isokinetic performance, measured as peak knee extensor and flexor
      torque values in Newton-meters, on the operated knee. Measurements wilil be done
      preoperatively and at 3, 6, and 12-month follow-up examinations under the supervision of the
      same physiatrist. At same time points, the Knee Society Score (KSS) will be evaluated as
      well. Isokinetic measurements will be performed using a Biodex System III Isokinetic
      Dynamometer, version 3.03 (Biodex Medical Inc., Shirley, NY, USA) by the same senior
      physiatrist. Patients will be positioned on the dynamometer with the hip in 90° in a sitting
      position for the knee flexion and extension measurements. Lateral movement of the knee will
      be prevented during full extension and flexion of the knee by a thigh strap on the operated
      leg. The physical therapist will help the patients to achieve proper positioning before each
      test. Concentric isokinetic knee flexion-extensions will be assessed at a preset velocity of
      60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10
      flexion-extension repetitions will be completed by each patient. Instructions will be
      provided, and one trial repetition will then performed by all patients before the
      measurements were taken.

      Sample size estimation will be performed using the extension peak torque as a primary effect
      variable. As there is no similar study with isokinetic measurements regarding this subject, a
      difference in mean values of 10 Nm and standard deviation of 12 Nm were assumed for each
      group. The group sample sizes of 31 and 31 achieved a power of 0.90 to detect a difference of
      10 Nm between the two groups with estimated group standard deviations of 12 for each group
      and with a significance level (alpha) of 0.05 using a two-sided, two-sample test. Considering
      the loss to follow-up, two patients were added to each group. Thus, recruitment will end
      after 33 patients were assigned to either groups. All data will be calculated as mean and
      standard deviation. The Student's t-test will be used for statistical analysis of the patient
      data. Statistical calculations will be performed with SPSS 22.0 software (IBM SPSS Statistics
      for Windows, Version 22.0. Armonk, NY: IBM Corp.). A value of p< 0.05 will be considered
      statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were randomized in a 1:1 ratio via computer-generated randomization using Microsoft Excel 2016 (Microsoft Corporation, Seattle, WA, USA) to be allocated in the UC insert or PS insert group before the TKA operation (Figure 1). Unblinded senior resident implemented the randomization. Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Patients and physiatrists performing isokinetic measurements were blinded to group allocation.
measure: Baseline Assessment of Peak Knee Extensor Torque Preoperatively
time frame: Preoperative
description: Peak extensor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Baseline Assessment of Peak Knee Flexor Torque Preoperatively
time frame: Preoperative
description: Peak flexor torque values of each patient was recorded for the operated knee preoperatively under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Assessment of Peak Knee Extensor Torque at 3 Months Postoperatively
time frame: 3 months postoperative
description: Peak extensor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Assessment of Peak Knee Flexor Torque at 3 Months Postoperatively
time frame: 3 months postoperative
description: Peak flexor torque values of each patient was recorded for the operated knee at postoperative 3 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Assessment of Peak Knee Extensor Torque at 6 Months Postoperatively
time frame: 6 months postoperative
description: Peak extensor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Assessment of Peak Knee Flexor Torque at 6 Months Postoperatively
time frame: 6 months postoperative
description: Peak flexor torque values of each patient was recorded for the operated knee at postoperative 6 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Assessment of Peak Knee Extensor Torque at 12 Months Postoperatively
time frame: 12 months postoperative
description: Peak extensor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Assessment of Peak Knee Flexor Torque at 12 Months Postoperatively
time frame: 12 months postoperative
description: Peak flexor torque values of each patient was recorded for the operated knee at postoperative 12 months under the supervision of the same physiatrist. The Isokinetic measurements were performed using a Biodex System III Isokinetic Dynamometer, version 3.03 (Biodex Medical Inc.,Shirley, NY, USA). Concentric isokinetic knee flexion-extensions were assessed at a preset velocity of 60º/sec, over a range of motion of 0º to 110º for both parameters. A fixed number of 10 flexion-extension repetitions was completed by each patient. Torque was assessed in Newton-meters (N m).
measure: Baseline Knee Society Clinical Score Evaluation
time frame: Preoperative
description: The Knee Society Score were applied preoperatively.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
measure: Knee Society Clinical Score Evaluation at 3 Months Postoperatively
time frame: 3 months postoperative
description: The Knee Society Clinical Score were applied at postoperative 3 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
measure: Knee Society Clinical Score Evaluation at 6 Months Postoperatively
time frame: 6 months postoperative
description: The Knee Society Clinical Score were applied at postoperative 6 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
measure: Knee Society Clinical Score Evaluation at 12 Months Postoperatively
time frame: 12 months postoperative
description: The Knee Society Clinical Score were applied at postoperative 12 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
measure: Baseline Knee Society Functional Score Evaluation
time frame: Preoperative
description: The Knee Society Functional Score were applied preoperatively.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
measure: Knee Society Functional Score Evaluation at 3 Months Postoperatively
time frame: 3 months postoperative
description: The Knee Society Functional Score were applied at postoperative 3 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
measure: Knee Society Functional Score Evaluation at 6 Months Postoperatively
time frame: 6 months postoperative
description: The Knee Society Functional Score were applied at postoperative 6 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
measure: Knee Society Functional Score Evaluation at 12 Months Postoperatively
time frame: 12 months postoperative
description: The Knee Society Functional Score were applied at postoperative 12 months.
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. The KSS Scale ranges from 0 to 200. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The KSCS ranges from 0 to 100. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. The KSFS ranges from 0 to 100. For each section, a score of 80-100 was considered excellent; 70-79, good; 60-69, fair; < 60, poor.
arm group label: Ultra-congruent insert group
arm group type: Experimental
description: Ultra-congruent inserts were used during total knee arthroplasty in patients randomized to this group.
arm group label: Posterior cruciate ligament-stabilized insert
arm group type: Experimental
description: Posterior cruciate ligament-stabilized inserts were used during total knee arthroplasty in patients randomized to this group.
intervention type: Device
intervention name: Vanguard® Knee System
description: Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.
arm group label: Posterior cruciate ligament-stabilized insert
arm group label: Ultra-congruent insert group
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Deniz Çankaya, MD
role: Principal Investigator
affiliation: Aksaray University Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Aksaray University Training and Research Hospital
investigator full name: Erdem A Sezgin
investigator title: Co-Principal Investigator
mesh term: Osteoarthritis, Knee
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 