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/NCT06010979</url>
    </required_header>
    <id_info>
      <org_study_id>TKAcohort</org_study_id>
      <nct_id>NCT06010979</nct_id>
    </id_info>
    <brief_title>Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology</brief_title>
    <official_title>Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tian Hua</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Through this cohort study, previous clinical data can be systematically reviewed and&#xD;
        supplemented through clinical follow-up. Prospective enrollment and follow-up observation of&#xD;
        subsequent patients can also be carried out to build a retrospective-prospective two-way&#xD;
        cohort study. The intraoperative, perioperative, clinical follow-up and health economics of&#xD;
        surgical robot, computer navigation, personalized osteotomy guide and other digital&#xD;
        technologies and traditional TKA were comprehensively and objectively compared, the results&#xD;
        and conclusions of the center were summarized and reported, and the effectiveness and safety&#xD;
        of digital assistive technology applied to TKA were explored, providing references for&#xD;
        clinical diagnosis and follow-up research.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Through this cohort study, previous clinical data can be systematically reviewed and&#xD;
        supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients&#xD;
        can also be carried out to build a retrospective-prospective two-way cohort study. The&#xD;
        preoperative situation (general statistical information, educational level, preoperative&#xD;
        clinical function score, etc.), intraoperative situation (operative time, intraoperative&#xD;
        blood loss, intraoperative complications, etc.), perioperative situation (total postoperative&#xD;
        blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up&#xD;
        situation were comprehensively and objectively compared with surgical robot, computer&#xD;
        navigation, personalized osteotomy guide and other digital technologies and traditional TKA&#xD;
        We summarized and reported the results and conclusions of the center (postoperative force&#xD;
        line, implant location, pain, mobility, clinical function score, patient satisfaction and&#xD;
        postoperative complications, etc.) and health economics (average length of stay,&#xD;
        hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up&#xD;
        research.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>3 Years</target_duration>
    <primary_outcome>
      <measure>mechanical axis</measure>
      <time_frame>Postoperative day 3</time_frame>
      <description>The postoperative HKA Angle was measured, that is, the Angle between the center of the hip joint and the center of the knee joint and the center of the knee joint and the center of the ankle joint on the full-length X-ray film of the lower limb. The target Angle was defined as 0°, the Angle was positive when the knee was varus, the Angle was negative when the knee was varus, and the acceptable range was ±3°, beyond which the line deviation was defined.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>operation time</measure>
      <time_frame>immediately after the surgery</time_frame>
      <description>The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative blood loss</measure>
      <time_frame>immediately after the surgery</time_frame>
      <description>Intraoperative blood loss = total amount of fluid drawn during the operation - intraoperative irrigation volume + intraoperative gauze infiltration blood loss, accurate to ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative complications</measure>
      <time_frame>immediately after the surgery</time_frame>
      <description>Various complications occurred during the operation were recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total postoperative blood loss</measure>
      <time_frame>Postoperative day 3</time_frame>
      <description>Gross linear equation was used to calculate total blood loss and latent blood loss 3 days after surgery. Total blood loss = preoperative blood volume (PBV) × (preoperative hematocrit - postoperative hematocrit). PBV was calculated using Nadler method: PBV=K1× height (m) 3+K2× weight (kg) +K3, where male K1=0.3669, K2=0.03219, K3=0.6041; Female K1=0.3561, K2=0.03308, K3=0.1833. Postoperative total blood loss = total blood loss - intraoperative blood loss;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood transfusion rate</measure>
      <time_frame>At discharge</time_frame>
      <description>The postoperative blood transfusion situation and the amount of blood transfusion were recorded. The blood was transfused mainly with suspended red blood cells, and the amount of a single transfusion was 400ml. The Hb situation was evaluated again by blood routine review on the morning of the second day after transfusion.&#xD;
  Indications for postoperative blood transfusion: No blood transfusion for Hb up to 8g/L or above; Hb up to 7g/L (including) must be transfused; Hb is between 7-8g/L, and blood transfusion should be given when anemia symptoms such as dizziness, weakness, palpitation, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative complication</measure>
      <time_frame>3 years postoperatively</time_frame>
      <description>The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rotation Angle of femur prosthesis</measure>
      <time_frame>Postoperative day 3</time_frame>
      <description>On the horizontal plane of CT scan of the affected knee, the Angle between the line of the posterior condyle of the femoral prosthesis and the line of the transcondyle of the femur was shown. The target Angle was defined as 0° external rotation of the femoral prosthesis, positive Angle during external rotation, negative Angle during internal rotation, acceptable range of ±2°, beyond which was defined as angular deviation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>Postoperative day 3</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>2 weeks postoperatively</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>6 weeks postoperatively</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>3 months postoperatively</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>6 months postoperatively</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>12 months postoperatively</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>24 months postoperatively</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>36 months postoperatively</time_frame>
      <description>The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>3 days postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>2 weeks postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>6 weeks postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>3 months postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>6 months postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>12 months postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>24 months postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>36 months postoperatively</time_frame>
      <description>The Range of motion of the knee on the operative side of the patient was measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>knee society score</measure>
      <time_frame>6 weeks postoperatively</time_frame>
      <description>This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>knee society score</measure>
      <time_frame>3 months postoperatively</time_frame>
      <description>This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>knee society score</measure>
      <time_frame>6 months postoperatively</time_frame>
      <description>This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>knee society score</measure>
      <time_frame>12 months postoperatively</time_frame>
      <description>This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>knee society score</measure>
      <time_frame>24 months postoperatively</time_frame>
      <description>This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>knee society score</measure>
      <time_frame>36 months postoperatively</time_frame>
      <description>This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>6 weeks postoperatively</time_frame>
      <description>This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>3 months postoperatively</time_frame>
      <description>This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>6 months postoperatively</time_frame>
      <description>This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>12 months postoperatively</time_frame>
      <description>This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>24 months postoperatively</time_frame>
      <description>This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>36 months postoperatively</time_frame>
      <description>This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>6 months postoperatively</time_frame>
      <description>At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>12 months postoperatively</time_frame>
      <description>At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>24 months postoperatively</time_frame>
      <description>At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>36 months postoperatively</time_frame>
      <description>At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay</measure>
      <time_frame>an average of 3 days postoperatively</time_frame>
      <description>The number of days a patient stays in hospital from admission to discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical expenses</measure>
      <time_frame>an average of 3 days postoperatively</time_frame>
      <description>The total cost of a patient from admission to discharge</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">12000</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>conventional group</arm_group_label>
      <description>Conventional instrument-assisted knee arthroplasty</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAS group</arm_group_label>
      <description>computer navigation assisted knee arthroplasty</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RAS group</arm_group_label>
      <description>robotic system assisted knee arthroplasty</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PSI group</arm_group_label>
      <description>patient-spercific instrumentation assisted knee arthroplasty</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>conventional intrumentation assisted knee arthroplasty</intervention_name>
      <description>conventional intrumentation assisted knee arthroplasty</description>
      <arm_group_label>conventional group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>computer navigation assisted knee arthroplasty</intervention_name>
      <description>computer navigation assisted knee arthroplasty</description>
      <arm_group_label>CAS group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>robotic system assisted knee arthroplasty</intervention_name>
      <description>robotic system assisted knee arthroplasty</description>
      <arm_group_label>RAS group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>patient-spercific assisted knee arthroplasty</intervention_name>
      <description>patient-spercific assisted knee arthroplasty</description>
      <arm_group_label>PSI group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing knee replacement in our hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a. primary knee osteoarthritis;&#xD;
  &#xD;
            -  b. Unilateral primary knee replacement;&#xD;
  &#xD;
            -  c. Surgical methods were traditional surgery, surgical robot, computer navigation or&#xD;
               personalized osteotomy guide&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  a. A history of renal insufficiency (Cr &gt; 2.5), liver insufficiency, severe heart&#xD;
               disease (or coronary stenting within the last 12 months), severe respiratory disease,&#xD;
               history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease),&#xD;
               cotting disorder, stroke, and malignancy;&#xD;
  &#xD;
            -  b. Those who do not accept this test for any reason and refuse to sign the informed&#xD;
               consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tian Hua, MD</last_name>
      <role>Study Director</role>
      <affiliation>Director</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tian Hua, MD</last_name>
      <phone>86-13511065187</phone>
      <email>tianhua@bjmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zheng Yuhang, MD</last_name>
      <phone>86-18811185091</phone>
      <email>1710301104@pku.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100181</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tian Hua, MD</last_name>
        <phone>86-18211070116</phone>
        <email>tianhua@bjmu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Zheng Yuhang, bachelor</last_name>
        <phone>86-18811185091</phone>
        <email>1710301104@pku.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
      <investigator_full_name>Tian Hua</investigator_full_name>
      <investigator_title>archiater</investigator_title>
    </responsible_party>
    <keyword>total knee arthroplasty</keyword>
    <keyword>knee osteoarthritis</keyword>
    <keyword>computer navigation</keyword>
    <keyword>robotic system</keyword>
    <keyword>patient-spercific instrumentation</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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>It will be published as an academic paper</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>When data collection is complete</ipd_time_frame>
      <ipd_access_criteria>All the researchers who need it</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06010979
  org study id: TKAcohort
  nct id: NCT06010979
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Through this cohort study, previous clinical data can be systematically reviewed and
        supplemented through clinical follow-up. Prospective enrollment and follow-up observation of
        subsequent patients can also be carried out to build a retrospective-prospective two-way
        cohort study. The intraoperative, perioperative, clinical follow-up and health economics of
        surgical robot, computer navigation, personalized osteotomy guide and other digital
        technologies and traditional TKA were comprehensively and objectively compared, the results
        and conclusions of the center were summarized and reported, and the effectiveness and safety
        of digital assistive technology applied to TKA were explored, providing references for
        clinical diagnosis and follow-up research.
  Through this cohort study, previous clinical data can be systematically reviewed and
        supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients
        can also be carried out to build a retrospective-prospective two-way cohort study. The
        preoperative situation (general statistical information, educational level, preoperative
        clinical function score, etc.), intraoperative situation (operative time, intraoperative
        blood loss, intraoperative complications, etc.), perioperative situation (total postoperative
        blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up
        situation were comprehensively and objectively compared with surgical robot, computer
        navigation, personalized osteotomy guide and other digital technologies and traditional TKA
        We summarized and reported the results and conclusions of the center (postoperative force
        line, implant location, pain, mobility, clinical function score, patient satisfaction and
        postoperative complications, etc.) and health economics (average length of stay,
        hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up
        research.
  observational model: Cohort
  time perspective: Other
  measure: mechanical axis
  time frame: Postoperative day 3
  description: The postoperative HKA Angle was measured, that is, the Angle between the center of the hip joint and the center of the knee joint and the center of the knee joint and the center of the ankle joint on the full-length X-ray film of the lower limb. The target Angle was defined as 0°, the Angle was positive when the knee was varus, the Angle was negative when the knee was varus, and the acceptable range was ±3°, beyond which the line deviation was defined.
  measure: operation time
  time frame: immediately after the surgery
  description: The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes
  measure: Intraoperative blood loss
  time frame: immediately after the surgery
  description: Intraoperative blood loss = total amount of fluid drawn during the operation - intraoperative irrigation volume + intraoperative gauze infiltration blood loss, accurate to ml
  measure: Intraoperative complications
  time frame: immediately after the surgery
  description: Various complications occurred during the operation were recorded
  measure: Total postoperative blood loss
  time frame: Postoperative day 3
  description: Gross linear equation was used to calculate total blood loss and latent blood loss 3 days after surgery. Total blood loss = preoperative blood volume (PBV) × (preoperative hematocrit - postoperative hematocrit). PBV was calculated using Nadler method: PBV=K1× height (m) 3+K2× weight (kg) +K3, where male K1=0.3669, K2=0.03219, K3=0.6041; Female K1=0.3561, K2=0.03308, K3=0.1833. Postoperative total blood loss = total blood loss - intraoperative blood loss;
  measure: Blood transfusion rate
  time frame: At discharge
  description: The postoperative blood transfusion situation and the amount of blood transfusion were recorded. The blood was transfused mainly with suspended red blood cells, and the amount of a single transfusion was 400ml. The Hb situation was evaluated again by blood routine review on the morning of the second day after transfusion.
  Indications for postoperative blood transfusion: No blood transfusion for Hb up to 8g/L or above; Hb up to 7g/L (including) must be transfused; Hb is between 7-8g/L, and blood transfusion should be given when anemia symptoms such as dizziness, weakness, palpitation, etc.
  measure: Postoperative complication
  time frame: 3 years postoperatively
  description: The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.
  measure: Rotation Angle of femur prosthesis
  time frame: Postoperative day 3
  description: On the horizontal plane of CT scan of the affected knee, the Angle between the line of the posterior condyle of the femoral prosthesis and the line of the transcondyle of the femur was shown. The target Angle was defined as 0° external rotation of the femoral prosthesis, positive Angle during external rotation, negative Angle during internal rotation, acceptable range of ±2°, beyond which was defined as angular deviation
  measure: Visual analogue scale
  time frame: Postoperative day 3
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Visual analogue scale
  time frame: 2 weeks postoperatively
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Visual analogue scale
  time frame: 6 weeks postoperatively
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Visual analogue scale
  time frame: 3 months postoperatively
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Visual analogue scale
  time frame: 6 months postoperatively
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Visual analogue scale
  time frame: 12 months postoperatively
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Visual analogue scale
  time frame: 24 months postoperatively
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Visual analogue scale
  time frame: 36 months postoperatively
  description: The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
  measure: Range of motion
  time frame: 3 days postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: Range of motion
  time frame: 2 weeks postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: Range of motion
  time frame: 6 weeks postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: Range of motion
  time frame: 3 months postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: Range of motion
  time frame: 6 months postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: Range of motion
  time frame: 12 months postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: Range of motion
  time frame: 24 months postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: Range of motion
  time frame: 36 months postoperatively
  description: The Range of motion of the knee on the operative side of the patient was measured
  measure: knee society score
  time frame: 6 weeks postoperatively
  description: This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
  measure: knee society score
  time frame: 3 months postoperatively
  description: This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
  measure: knee society score
  time frame: 6 months postoperatively
  description: This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
  measure: knee society score
  time frame: 12 months postoperatively
  description: This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
  measure: knee society score
  time frame: 24 months postoperatively
  description: This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
  measure: knee society score
  time frame: 36 months postoperatively
  description: This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 6 weeks postoperatively
  description: This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 3 months postoperatively
  description: This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 6 months postoperatively
  description: This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 12 months postoperatively
  description: This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 24 months postoperatively
  description: This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 36 months postoperatively
  description: This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
  measure: Patient satisfaction
  time frame: 6 months postoperatively
  description: At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
  measure: Patient satisfaction
  time frame: 12 months postoperatively
  description: At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
  measure: Patient satisfaction
  time frame: 24 months postoperatively
  description: At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
  measure: Patient satisfaction
  time frame: 36 months postoperatively
  description: At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
  measure: Length of stay
  time frame: an average of 3 days postoperatively
  description: The number of days a patient stays in hospital from admission to discharge
  measure: Medical expenses
  time frame: an average of 3 days postoperatively
  description: The total cost of a patient from admission to discharge
  arm group label: conventional group
  description: Conventional instrument-assisted knee arthroplasty
  arm group label: CAS group
  description: computer navigation assisted knee arthroplasty
  arm group label: RAS group
  description: robotic system assisted knee arthroplasty
  arm group label: PSI group
  description: patient-spercific instrumentation assisted knee arthroplasty
  intervention type: Procedure
  intervention name: conventional intrumentation assisted knee arthroplasty
  description: conventional intrumentation assisted knee arthroplasty
  arm group label: conventional group
  intervention type: Procedure
  intervention name: computer navigation assisted knee arthroplasty
  description: computer navigation assisted knee arthroplasty
  arm group label: CAS group
  intervention type: Procedure
  intervention name: robotic system assisted knee arthroplasty
  description: robotic system assisted knee arthroplasty
  arm group label: RAS group
  intervention type: Procedure
  intervention name: patient-spercific assisted knee arthroplasty
  description: patient-spercific assisted knee arthroplasty
  arm group label: PSI group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Tian Hua, MD
  role: Study Director
  affiliation: Director
  last name: Tian Hua, MD
  phone: 86-13511065187
  email: tianhua@bjmu.edu.cn
  last name: Zheng Yuhang, MD
  phone: 86-18811185091
  email: 1710301104@pku.edu.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Peking University Third Hospital
  investigator full name: Tian Hua
  investigator title: archiater
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: Yes
  ipd description: It will be published as an academic paper
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: When data collection is complete
  ipd access criteria: All the researchers who need it