xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06033625</url>
    </required_header>
    <id_info>
      <org_study_id>2470</org_study_id>
      <nct_id>NCT06033625</nct_id>
    </id_info>
    <brief_title>JOINT AWARENESS AFTER TOTAL KNEE REPLACEMENT</brief_title>
    <official_title>JOINT AWARENESS AFTER CEMENTED OR CEMENTLESS TOTAL KNEE REPLACEMENT: DOES IT CHANGE?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Total knee replacement (TKR) is accepted as treatment of choice for end stage gonarthrosis.&#xD;
        It is performed cemented or cementless and although cemented implants were shown to decrease&#xD;
        bone density more than cementless fixations there is no evidence-based difference between&#xD;
        them in the literature. As far as the investigators are concerned, the effect of cementation&#xD;
        on patients' joint perception has never been studied so far.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this longitudinal case-control study, joint awareness in prosthetic reconstruction was&#xD;
        evaluated in 150 knees (75 cemented TKR, 75 cementless TKR) of 136 patients. They were&#xD;
        operated between 2015 and 2017 in our institution with minimum 5 years of follow up. All the&#xD;
        patients in each group were operated by two senior surgeons that were experienced for more&#xD;
        than 10 years in arthroplasty. To reduce selection bias, logistic regression was used to&#xD;
        develop propensity-matched pairs based on gender, age, body mass index (BMI), preoperative&#xD;
        coronal plane deformity, preoperative range of motion (ROM) and appropriateness for TKA&#xD;
        indication. Demographic and clinical data including sex, age and time since surgery were&#xD;
        collected. The subjects' joint perception and the WOMAC clinical scores were recorded and&#xD;
        compared. Joint awareness is assessed with Forgotten Joint Score (FJS) which has 12 questions&#xD;
        and with Patient's Joint Perception questionnaire (PJP) which is a single question with 5&#xD;
        possible answers, rating from the highest expected result &quot;like a native or natural joint&quot; to&#xD;
        the worse possible case &quot;a non-functional joint&quot;. Other than clinical scores, laboratory&#xD;
        parameters, blood transfusion needs, tourniquet time, complications (septic/aseptic&#xD;
        loosening, periprosthetic fracture, instability) and revision rates were also compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2015</start_date>
    <completion_date type="Actual">January 2019</completion_date>
    <primary_completion_date type="Actual">January 2017</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>Forgotten Joint Score-12 (FJS-12)</measure>
      <time_frame>1 year after index surgery and at the end of 5th year</time_frame>
      <description>a patient-reported outcome measure intended to determine a patient's ability to &quot;forget&quot; about their affected joint after surgery or treatment and uses a 5-point Likert response format (0, never; 1, almost; 2, seldom; 3,sometimes; and 4, mostly) with high scores indicate good outcome, which means a high degree of &quot;forgetting&quot; the joint</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient's Joint Perception questionnaire (PJP)</measure>
      <time_frame>1 year after index surgery and at the end of 5th year</time_frame>
      <description>The PJP is a single question with 5 possible answers, rating from the highest expected result &quot;like a native or natural joint&quot; to the worsening gradually as Artificial joint with no restriction, Artificial joint with minimal restriction, Artificial joint with major restriction and &quot;a non-functional joint&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
      <time_frame>1 year after index surgery and at the end of 5th year</time_frame>
      <description>The WOMAC is a specific, valid, and reliable measure for OA, consisting of 24 questions in three subcategories: pain, stiffness, and physical function. Each question is scored using a Likert scale as follows: 0=nothing, 1=mild, 2=moderate, 3=severe, 4=very severe. The score for each section is calculated separately, and the total score ranges from 0 to 100. Higher scores indicate an increase in pain and stiffness, as well as a deterioration in physical function.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">150</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <condition>Arthroplasty Complications</condition>
    <arm_group>
      <arm_group_label>Cd-TKR</arm_group_label>
      <description>Bicompartmental cemented cruciate retaining Total knee replacement</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cs-TKR</arm_group_label>
      <description>Bicompartmental cementless cruciate retaining Total knee replacement</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>CEMENTLESS TOTAL KNEE REPLACEMENT</intervention_name>
      <description>CEMENTLESS CRUCIATE RETAINING BICOMPARTMENTAL TOTAL KNEE REPLACEMENT</description>
      <arm_group_label>Cs-TKR</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with primary end stage varus osteoarthritis of the knee&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  primary knee osteoarthritis&#xD;
  &#xD;
            -  &quot;appropriate'' TKA indication according to Modified Escobar System&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  secondary osteoarthritis&#xD;
  &#xD;
            -  previous surgery to the knee&#xD;
  &#xD;
            -  valgus knee&#xD;
  &#xD;
            -  uncontrolled diabetes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
      <investigator_full_name>İsmail Demirkale</investigator_full_name>
      <investigator_title>Clinical professor</investigator_title>
    </responsible_party>
    <keyword>Joint Awareness</keyword>
    <keyword>Total Knee Replacement</keyword>
    <keyword>Cementless</keyword>
    <keyword>Forgotten Joint Score</keyword>
    <keyword>Patient's Joint Perception</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06033625
  org study id: 2470
  nct id: NCT06033625
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Total knee replacement (TKR) is accepted as treatment of choice for end stage gonarthrosis.
        It is performed cemented or cementless and although cemented implants were shown to decrease
        bone density more than cementless fixations there is no evidence-based difference between
        them in the literature. As far as the investigators are concerned, the effect of cementation
        on patients' joint perception has never been studied so far.
  In this longitudinal case-control study, joint awareness in prosthetic reconstruction was
        evaluated in 150 knees (75 cemented TKR, 75 cementless TKR) of 136 patients. They were
        operated between 2015 and 2017 in our institution with minimum 5 years of follow up. All the
        patients in each group were operated by two senior surgeons that were experienced for more
        than 10 years in arthroplasty. To reduce selection bias, logistic regression was used to
        develop propensity-matched pairs based on gender, age, body mass index (BMI), preoperative
        coronal plane deformity, preoperative range of motion (ROM) and appropriateness for TKA
        indication. Demographic and clinical data including sex, age and time since surgery were
        collected. The subjects' joint perception and the WOMAC clinical scores were recorded and
        compared. Joint awareness is assessed with Forgotten Joint Score (FJS) which has 12 questions
        and with Patient's Joint Perception questionnaire (PJP) which is a single question with 5
        possible answers, rating from the highest expected result "like a native or natural joint" to
        the worse possible case "a non-functional joint". Other than clinical scores, laboratory
        parameters, blood transfusion needs, tourniquet time, complications (septic/aseptic
        loosening, periprosthetic fracture, instability) and revision rates were also compared.
  observational model: Case-Control
  time perspective: Other
  measure: Forgotten Joint Score-12 (FJS-12)
  time frame: 1 year after index surgery and at the end of 5th year
  description: a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment and uses a 5-point Likert response format (0, never; 1, almost; 2, seldom; 3,sometimes; and 4, mostly) with high scores indicate good outcome, which means a high degree of "forgetting" the joint
  measure: Patient's Joint Perception questionnaire (PJP)
  time frame: 1 year after index surgery and at the end of 5th year
  description: The PJP is a single question with 5 possible answers, rating from the highest expected result "like a native or natural joint" to the worsening gradually as Artificial joint with no restriction, Artificial joint with minimal restriction, Artificial joint with major restriction and "a non-functional joint"
  measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
  time frame: 1 year after index surgery and at the end of 5th year
  description: The WOMAC is a specific, valid, and reliable measure for OA, consisting of 24 questions in three subcategories: pain, stiffness, and physical function. Each question is scored using a Likert scale as follows: 0=nothing, 1=mild, 2=moderate, 3=severe, 4=very severe. The score for each section is calculated separately, and the total score ranges from 0 to 100. Higher scores indicate an increase in pain and stiffness, as well as a deterioration in physical function.
  arm group label: Cd-TKR
  description: Bicompartmental cemented cruciate retaining Total knee replacement
  arm group label: Cs-TKR
  description: Bicompartmental cementless cruciate retaining Total knee replacement
  intervention type: Procedure
  intervention name: CEMENTLESS TOTAL KNEE REPLACEMENT
  description: CEMENTLESS CRUCIATE RETAINING BICOMPARTMENTAL TOTAL KNEE REPLACEMENT
  arm group label: Cs-TKR
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 80 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi
  investigator full name: İsmail Demirkale
  investigator title: Clinical professor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee