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/NCT05987839</url>
    </required_header>
    <id_info>
      <org_study_id>robotTKARCT</org_study_id>
      <nct_id>NCT05987839</nct_id>
    </id_info>
    <brief_title>Early Radiographic and Clinical Outcomes of Robotic-Arm-Assisted Versus Conventional TKA</brief_title>
    <acronym>TKA</acronym>
    <official_title>Early Radiographic and Clinical Outcomes of Robotic-Arm-Assisted Versus Conventional Total Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Qianfoshan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chifeng Municipal Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University Third Hospital</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>
        Purpose: A robotic system was recently introduced to improve prosthetic alignment during&#xD;
        total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized&#xD;
        controlled trial (RCT) study was to determine whether robotic-arm-assisted TKA improves the&#xD;
        clinical and radiological outcomes in patients compared to conventional TKA.&#xD;
  &#xD;
        Methods: One hundred and thirty patients who underwent primary TKA were enrolled in this&#xD;
        prospective, multicenter RCT conducted in 3 hospitals. Five patients were lost to follow-up&#xD;
        at 6 weeks after surgery. Therefore, 125 patients (63 in the intervention group and 62 in the&#xD;
        control group) remained in the final analysis. The primary outcome was the rate of patients&#xD;
        whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the&#xD;
        tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks&#xD;
        postoperatively. Secondary outcomes will include operation times, 6-week postoperative&#xD;
        functional outcomes evaluated by the American Knee Society Score (KSS) and the Western&#xD;
        Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36, adverse events (AEs)&#xD;
        and serious adverse events (SAEs).&#xD;
  &#xD;
        Hypothesis: Robotic-arm-assisted TKA is safe and effective as demonstrated in this trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        2. Materials and methods 2.1 Study design Our study was a prospective, multicenter and&#xD;
        randomized controlled trial that was approved by the Institutional Review Board of Peking&#xD;
        University Third Hospital (IRB # 2022-134-02), the First Affiliated Hospital of Shandong&#xD;
        First Medical University (IRB # 2022-QX-S003-01) and Chifeng Municipal Hospital (IRB #&#xD;
        2022-LLSCGVK4-101-06). All patients had provided written informed consent.&#xD;
  &#xD;
        2.2 Patient recruitment From November 2022 to May 2023, a total of 130 patients were&#xD;
        randomized into two groups - 65 patients underwent robotic-assisted TKA and 65 underwent&#xD;
        conventional TKA. The inclusion criteria were as follows: older than 18 years old and younger&#xD;
        than 80 years old with knee osteoarthritis undergoing primary and unilateral TKA; after&#xD;
        receiving both an oral and a written explanation of the study protocol, they provided written&#xD;
        informed consent that they were willing to complete all of the assessments and potential&#xD;
        interventions. The exclusion criteria were as follows: patients with infection, severe&#xD;
        systemic disease (severe diabetes, severe osteoporosis, severe muscle loss, etc.),&#xD;
        neuromuscular dysfunction of lower limbs, who are allergic to metal implants, participated in&#xD;
        other clinical studies, whose knee joint has been fused for a long time without pain or&#xD;
        deformity, unable to tolerate surgery on a systemic assessment, women who are pregnant or&#xD;
        breastfeeding, or who expect to give birth during the clinical period, and there are other&#xD;
        factors that affect the efficacy of observation in this study. All operations were performed&#xD;
        by experienced surgeons for the conventional and robotic-assisted groups at three hospitals.&#xD;
        All patients who underwent TKA with the robotic-assisted or conventional operations underwent&#xD;
        the radiologic and clinical assessment.&#xD;
  &#xD;
        Main effectiveness evaluation index The main evaluation index of the knee navigation and&#xD;
        positioning system clinical trial was the proportion of subjects whose mechanical axis of the&#xD;
        femoris deviated from the mechanical axis of the tibia by ≤3° on the full-length lower&#xD;
        extremity weight-bearing X-ray at 6 weeks (±2 weeks) after surgery.&#xD;
  &#xD;
        X-ray shooting requirements: Full-length weight-bearing X-ray of both lower limbs, that is,&#xD;
        X-ray of both lower limbs including hip joint, full length of femur, knee joint, full length&#xD;
        of tibia and fibula and ankle joint taken by the patient in the standing state. Key points:&#xD;
        The patient stands upright on the camera frame, the back is close to the camera frame, the&#xD;
        hands naturally droop, the knee joint is as straight as possible, the feet are the same width&#xD;
        as the shoulders, and the internal rotation is about 15°, so that the small head of the&#xD;
        fibula overlaps with the tibia nearly one-third, and the patella is pointed vertically in&#xD;
        front.&#xD;
  &#xD;
        The lower limb force line was evaluated by non-surgeon.&#xD;
  &#xD;
          1. Measurement method of mechanical shaft of femur:&#xD;
  &#xD;
             The mechanical axis of the femur is the line from the center of the proximal joint&#xD;
             (center of the hip joint) to the center of the distal joint (center of the knee joint).&#xD;
  &#xD;
             The central point of the hip joint is located in the central point of the femoral head&#xD;
             circle, and the Mose circle is used to determine the central point of the femoral head.&#xD;
             When determining the central point of the knee joint, the apex of the femoral&#xD;
             intercondylar fossa was used as the central point of the knee joint, without measuring&#xD;
             the width of bone tissue or soft tissue.&#xD;
  &#xD;
          2. Measurement method of tibial mechanical axis:&#xD;
  &#xD;
             The mechanical axis of the tibia is the line from the center of the proximal joint&#xD;
             (center of the knee joint) to the center of the distal joint (center of the ankle&#xD;
             joint).&#xD;
  &#xD;
             The central point of the knee joint is located in the center of the tibial plateau.&#xD;
             Measure the midpoint of the talus width to determine the ankle joint center point.&#xD;
  &#xD;
          3. Measurement method of the medial Angle between the mechanical axis of femur and the&#xD;
             mechanical axis of tibia:&#xD;
  &#xD;
        The medial Angle between the mechanical axis of femur and the mechanical axis of tibia is the&#xD;
        hip knee ankle Angle (HKA).&#xD;
  &#xD;
        Criteria: After measurement, the Angle of HKA does not exceed 180°±3°, and it is regarded as&#xD;
        an example of compliance with the mechanical shaft deviation Angle ≤3°. The proportion of&#xD;
        subjects in the experimental group and the control group whose mechanical axis deviation&#xD;
        Angle was ≤3° on the full-length lower extremity weight-bearing X-ray film 6 weeks (±2 weeks)&#xD;
        after surgery was calculated.&#xD;
  &#xD;
        Secondary effectiveness evaluation index&#xD;
  &#xD;
          1. Operation time The operation time of control group was from the establishment of&#xD;
             surgical incision to the end of skin suture. The operation start time of the&#xD;
             experimental group was the first time when the equipment started to work and the&#xD;
             surgical incision was established, and the operation end time was the end time of skin&#xD;
             suture.&#xD;
  &#xD;
          2. KSS score The knee society score (KSS) is one of the most commonly used scores to&#xD;
             evaluate knee function. This method is to evaluate the patient's knee joint and its&#xD;
             function in two aspects according to the particularity of joint replacement surgery&#xD;
             through the evaluator interview and physical examination, that is, to obtain the&#xD;
             information of joint anatomy, biomechanics and other aspects, and to understand the&#xD;
             patient's functional recovery. Knee joint evaluation is to evaluate the impact of&#xD;
             surgery on the joint and the recovery of the joint after surgery, such as: joint pain,&#xD;
             joint range of motion, ligament stability, muscle strength, bone alignment, contracture&#xD;
             deformity; Functional assessments include activities of daily living, walking ability,&#xD;
             going up and down stairs, and the need for AIDS. Subjects and subjects were evaluated by&#xD;
             KSS scale.&#xD;
  &#xD;
          3. WOMAC score This score is used to assess the severity of arthritis and its therapeutic&#xD;
             effectiveness based on the patient's relevant signs and symptoms. The structure and&#xD;
             function of the knee joint were evaluated by pain, stiffness and joint function. The&#xD;
             functional description of the knee joint was mainly for the lower limbs. You can use the&#xD;
             entire system or pick a part of it when you use it. In terms of content, this rating&#xD;
             scale assesses the structure and function of the knee joint from the three aspects of&#xD;
             pain, stiffness, and joint function, with a total of 24 items, including the basic&#xD;
             symptoms and signs of the entire joint. The pain part had five items, the stiffness part&#xD;
             had two items, and the joint function part had 17 items. The reliability, validity and&#xD;
             sensitivity of the assessment of the knee joint were objectively evaluated by the WOMAC&#xD;
             scoring scale.&#xD;
  &#xD;
          4. SF-36 Health questionnaire The SF-36 Health Survey is a universal measurement scale&#xD;
             developed by the Medical Outcomes Study (MOS). It consists of 36 entries covering eight&#xD;
             areas: physical function, physical role, physical pain, general health, vitality, social&#xD;
             function, emotional role, and mental health. It is widely used in the measurement of the&#xD;
             quality of life of the general population, the evaluation of clinical trial effect and&#xD;
             the evaluation of health policy.&#xD;
  &#xD;
        Safety evaluation&#xD;
  &#xD;
          1. Incidence of adverse events Adverse events were collected and recorded throughout the&#xD;
             clinical trial, and the incidence rate was calculated.&#xD;
  &#xD;
          2. Incidence of serious adverse events Serious adverse events were collected and recorded&#xD;
             throughout the clinical trial, and the incidence rate was calculated.&#xD;
  &#xD;
        Statistical analysis and sample size calculation The description of quantitative indicators&#xD;
        will calculate the mean, standard deviation, median, minimum, maximum, lower quartile, upper&#xD;
        quartile, and qualitative indicators describe the frequency and frequency of each type. The&#xD;
        comparison of two groups of general conditions will be analyzed by appropriate methods&#xD;
        according to the type of indicators. Group t test or Wilcoxon rank sum test will be used for&#xD;
        comparison between groups of quantitative data, U-test, chi-square test or Fisher exact&#xD;
        probability method will be used for qualitative data, and Wilcoxon rank sum test will be used&#xD;
        for rank data.&#xD;
  &#xD;
        Test level α=0.025 (unilateral), according to β=0.2 to calculate the test grasp, the ratio of&#xD;
        test group and control group is 1:1. According to the results of efficacy analysis, the&#xD;
        required sample size was calculated to be 55 cases, and the sample size was expanded to 65&#xD;
        cases considering the 15% shedding rate. The experimental group and the control group&#xD;
        completed 65 subjects each.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">May 15, 2023</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>Intervention group: Total knee arthroplasty assisted by knee navigation and positioning system. Specification Model: OP-RKL22 Control group: Total knee arthroplasty without knee navigation and positioning system The same joint prosthesis was used in both the experimental group and the control group, and was approved by the manufacturer.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>rate of alignment inlier</measure>
      <time_frame>6 weeks postoperatively</time_frame>
      <description>the rate of patients whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks postoperatively</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>operation time</measure>
      <time_frame>Intraoperative</time_frame>
      <description>The operation time of control group was from the establishment of surgical incision to the end of skin suture. The operation start time of the experimental group was the first time when the equipment started to work and the surgical incision was established, and the operation end time was the end time of skin suture.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>knee society score</measure>
      <time_frame>through study completion, an average of 6 weeks after the surgery</time_frame>
      <description>The knee society score (KSS) is one of the most commonly used scores to evaluate knee function. 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. Subjects and subjects were evaluated by KSS scale. The higher the score, the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>through study completion, an average of 6 weeks after the surgery</time_frame>
      <description>This score is used to assess the severity of arthritis and its therapeutic effectiveness 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. The functional description of the knee joint was mainly for the lower limbs. You can use the entire system or pick a part of it when you use it. In terms of content, this rating scale assesses the structure and function of the knee joint from the three aspects of pain, stiffness, and joint function, with a total of 24 items, including the basic symptoms and signs of the entire joint. The pain part had five items, the stiffness part had two items, and the joint function part had 17 items. The reliability, validity and sensitivity of the assessment of the knee joint were objectively evaluated by the Western Ontario and McMaster Universities Osteoarthritis Index. The higher the score, the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SF-36</measure>
      <time_frame>through study completion, an average of 6 weeks after the surgery</time_frame>
      <description>The SF-36 Health Survey is a universal measurement scale developed by the Medical Outcomes Study (MOS). It consists of 36 entries covering eight areas: physical function, physical role, physical pain, general health, vitality, social function, emotional role, and mental health. It is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trial effect and the evaluation of health policy. The higher the score, the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>adverse events</measure>
      <time_frame>up to 6 weeks after the surgery</time_frame>
      <description>Adverse events were collected and recorded throughout the clinical trial, and the incidence rate was calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>serious adverse events</measure>
      <time_frame>up to 6 weeks after the surgery</time_frame>
      <description>Serious adverse events were collected and recorded throughout the clinical trial, and the incidence rate was calculated.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">130</enrollment>
    <condition>Total Knee Arthroplasty</condition>
    <condition>Robotic</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Total knee arthroplasty assisted by knee navigation and positioning system. Specification Model: OP-RKL22</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Total knee arthroplasty without knee navigation and positioning system</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>robotic system</intervention_name>
      <description>Total knee arthroplasty assisted by knee navigation and positioning system</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  older than 18 years old and younger than 80 years old with knee osteoarthritis&#xD;
               undergoing primary and unilateral TKA&#xD;
  &#xD;
            -  after receiving both an oral and a written explanation of the study protocol, they&#xD;
               provided written informed consent that they were willing to complete all of the&#xD;
               assessments and potential interventions&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergic to metal implants&#xD;
  &#xD;
            -  Any active systemic and local infection&#xD;
  &#xD;
            -  Paralysis of muscles around the knee joint or neuropathic arthropathy&#xD;
  &#xD;
            -  The knee joint has been fused for a long time without pain and deformity&#xD;
  &#xD;
            -  Patients with severe systemic diseases (severe diabetes, severe osteoporosis, severe&#xD;
               muscle loss, etc.), or those who cannot tolerate surgery through systemic evaluation&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding, or who expect to give birth during the&#xD;
               clinical period&#xD;
  &#xD;
            -  Patients who are also participating in other clinical studies&#xD;
  &#xD;
            -  In any case, if the investigator believes that the patient is not suitable for this&#xD;
               treatment (the patient's expectations are unrealistic or the patient has significant&#xD;
               emotional problems)&#xD;
  &#xD;
            -  There are other factors that affect the efficacy of observation in this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zheng Yuhang, MD</last_name>
      <role>Study Director</role>
      <affiliation>Director</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100191</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05987839
  org study id: robotTKARCT
  nct id: NCT05987839
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose: A robotic system was recently introduced to improve prosthetic alignment during
        total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized
        controlled trial (RCT) study was to determine whether robotic-arm-assisted TKA improves the
        clinical and radiological outcomes in patients compared to conventional TKA.
  
        Methods: One hundred and thirty patients who underwent primary TKA were enrolled in this
        prospective, multicenter RCT conducted in 3 hospitals. Five patients were lost to follow-up
        at 6 weeks after surgery. Therefore, 125 patients (63 in the intervention group and 62 in the
        control group) remained in the final analysis. The primary outcome was the rate of patients
        whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the
        tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks
        postoperatively. Secondary outcomes will include operation times, 6-week postoperative
        functional outcomes evaluated by the American Knee Society Score (KSS) and the Western
        Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-36, adverse events (AEs)
        and serious adverse events (SAEs).
  
        Hypothesis: Robotic-arm-assisted TKA is safe and effective as demonstrated in this trial.
  2. Materials and methods 2.1 Study design Our study was a prospective, multicenter and
        randomized controlled trial that was approved by the Institutional Review Board of Peking
        University Third Hospital (IRB # 2022-134-02), the First Affiliated Hospital of Shandong
        First Medical University (IRB # 2022-QX-S003-01) and Chifeng Municipal Hospital (IRB #
        2022-LLSCGVK4-101-06). All patients had provided written informed consent.
  
        2.2 Patient recruitment From November 2022 to May 2023, a total of 130 patients were
        randomized into two groups - 65 patients underwent robotic-assisted TKA and 65 underwent
        conventional TKA. The inclusion criteria were as follows: older than 18 years old and younger
        than 80 years old with knee osteoarthritis undergoing primary and unilateral TKA; after
        receiving both an oral and a written explanation of the study protocol, they provided written
        informed consent that they were willing to complete all of the assessments and potential
        interventions. The exclusion criteria were as follows: patients with infection, severe
        systemic disease (severe diabetes, severe osteoporosis, severe muscle loss, etc.),
        neuromuscular dysfunction of lower limbs, who are allergic to metal implants, participated in
        other clinical studies, whose knee joint has been fused for a long time without pain or
        deformity, unable to tolerate surgery on a systemic assessment, women who are pregnant or
        breastfeeding, or who expect to give birth during the clinical period, and there are other
        factors that affect the efficacy of observation in this study. All operations were performed
        by experienced surgeons for the conventional and robotic-assisted groups at three hospitals.
        All patients who underwent TKA with the robotic-assisted or conventional operations underwent
        the radiologic and clinical assessment.
  
        Main effectiveness evaluation index The main evaluation index of the knee navigation and
        positioning system clinical trial was the proportion of subjects whose mechanical axis of the
        femoris deviated from the mechanical axis of the tibia by ≤3° on the full-length lower
        extremity weight-bearing X-ray at 6 weeks (±2 weeks) after surgery.
  
        X-ray shooting requirements: Full-length weight-bearing X-ray of both lower limbs, that is,
        X-ray of both lower limbs including hip joint, full length of femur, knee joint, full length
        of tibia and fibula and ankle joint taken by the patient in the standing state. Key points:
        The patient stands upright on the camera frame, the back is close to the camera frame, the
        hands naturally droop, the knee joint is as straight as possible, the feet are the same width
        as the shoulders, and the internal rotation is about 15°, so that the small head of the
        fibula overlaps with the tibia nearly one-third, and the patella is pointed vertically in
        front.
  
        The lower limb force line was evaluated by non-surgeon.
  
          1. Measurement method of mechanical shaft of femur:
  
             The mechanical axis of the femur is the line from the center of the proximal joint
             (center of the hip joint) to the center of the distal joint (center of the knee joint).
  
             The central point of the hip joint is located in the central point of the femoral head
             circle, and the Mose circle is used to determine the central point of the femoral head.
             When determining the central point of the knee joint, the apex of the femoral
             intercondylar fossa was used as the central point of the knee joint, without measuring
             the width of bone tissue or soft tissue.
  
          2. Measurement method of tibial mechanical axis:
  
             The mechanical axis of the tibia is the line from the center of the proximal joint
             (center of the knee joint) to the center of the distal joint (center of the ankle
             joint).
  
             The central point of the knee joint is located in the center of the tibial plateau.
             Measure the midpoint of the talus width to determine the ankle joint center point.
  
          3. Measurement method of the medial Angle between the mechanical axis of femur and the
             mechanical axis of tibia:
  
        The medial Angle between the mechanical axis of femur and the mechanical axis of tibia is the
        hip knee ankle Angle (HKA).
  
        Criteria: After measurement, the Angle of HKA does not exceed 180°±3°, and it is regarded as
        an example of compliance with the mechanical shaft deviation Angle ≤3°. The proportion of
        subjects in the experimental group and the control group whose mechanical axis deviation
        Angle was ≤3° on the full-length lower extremity weight-bearing X-ray film 6 weeks (±2 weeks)
        after surgery was calculated.
  
        Secondary effectiveness evaluation index
  
          1. Operation time The operation time of control group was from the establishment of
             surgical incision to the end of skin suture. The operation start time of the
             experimental group was the first time when the equipment started to work and the
             surgical incision was established, and the operation end time was the end time of skin
             suture.
  
          2. KSS score The knee society score (KSS) is one of the most commonly used scores to
             evaluate knee function. 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. Subjects and subjects were evaluated by
             KSS scale.
  
          3. WOMAC score This score is used to assess the severity of arthritis and its therapeutic
             effectiveness 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. The
             functional description of the knee joint was mainly for the lower limbs. You can use the
             entire system or pick a part of it when you use it. In terms of content, this rating
             scale assesses the structure and function of the knee joint from the three aspects of
             pain, stiffness, and joint function, with a total of 24 items, including the basic
             symptoms and signs of the entire joint. The pain part had five items, the stiffness part
             had two items, and the joint function part had 17 items. The reliability, validity and
             sensitivity of the assessment of the knee joint were objectively evaluated by the WOMAC
             scoring scale.
  
          4. SF-36 Health questionnaire The SF-36 Health Survey is a universal measurement scale
             developed by the Medical Outcomes Study (MOS). It consists of 36 entries covering eight
             areas: physical function, physical role, physical pain, general health, vitality, social
             function, emotional role, and mental health. It is widely used in the measurement of the
             quality of life of the general population, the evaluation of clinical trial effect and
             the evaluation of health policy.
  
        Safety evaluation
  
          1. Incidence of adverse events Adverse events were collected and recorded throughout the
             clinical trial, and the incidence rate was calculated.
  
          2. Incidence of serious adverse events Serious adverse events were collected and recorded
             throughout the clinical trial, and the incidence rate was calculated.
  
        Statistical analysis and sample size calculation The description of quantitative indicators
        will calculate the mean, standard deviation, median, minimum, maximum, lower quartile, upper
        quartile, and qualitative indicators describe the frequency and frequency of each type. The
        comparison of two groups of general conditions will be analyzed by appropriate methods
        according to the type of indicators. Group t test or Wilcoxon rank sum test will be used for
        comparison between groups of quantitative data, U-test, chi-square test or Fisher exact
        probability method will be used for qualitative data, and Wilcoxon rank sum test will be used
        for rank data.
  
        Test level α=0.025 (unilateral), according to β=0.2 to calculate the test grasp, the ratio of
        test group and control group is 1:1. According to the results of efficacy analysis, the
        required sample size was calculated to be 55 cases, and the sample size was expanded to 65
        cases considering the 15% shedding rate. The experimental group and the control group
        completed 65 subjects each.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Intervention group: Total knee arthroplasty assisted by knee navigation and positioning system. Specification Model: OP-RKL22 Control group: Total knee arthroplasty without knee navigation and positioning system The same joint prosthesis was used in both the experimental group and the control group, and was approved by the manufacturer.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: rate of alignment inlier
  time frame: 6 weeks postoperatively
  description: the rate of patients whose mechanical axis of the femur was less than 3° deviated from the mechanical axis of the tibia evaluated by full-length weight-bearing X-rays of the lower limb at 6 weeks postoperatively
  measure: operation time
  time frame: Intraoperative
  description: The operation time of control group was from the establishment of surgical incision to the end of skin suture. The operation start time of the experimental group was the first time when the equipment started to work and the surgical incision was established, and the operation end time was the end time of skin suture.
  measure: knee society score
  time frame: through study completion, an average of 6 weeks after the surgery
  description: The knee society score (KSS) is one of the most commonly used scores to evaluate knee function. 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. Subjects and subjects were evaluated by KSS scale. The higher the score, the better.
  measure: the Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: through study completion, an average of 6 weeks after the surgery
  description: This score is used to assess the severity of arthritis and its therapeutic effectiveness 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. The functional description of the knee joint was mainly for the lower limbs. You can use the entire system or pick a part of it when you use it. In terms of content, this rating scale assesses the structure and function of the knee joint from the three aspects of pain, stiffness, and joint function, with a total of 24 items, including the basic symptoms and signs of the entire joint. The pain part had five items, the stiffness part had two items, and the joint function part had 17 items. The reliability, validity and sensitivity of the assessment of the knee joint were objectively evaluated by the Western Ontario and McMaster Universities Osteoarthritis Index. The higher the score, the better.
  measure: SF-36
  time frame: through study completion, an average of 6 weeks after the surgery
  description: The SF-36 Health Survey is a universal measurement scale developed by the Medical Outcomes Study (MOS). It consists of 36 entries covering eight areas: physical function, physical role, physical pain, general health, vitality, social function, emotional role, and mental health. It is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trial effect and the evaluation of health policy. The higher the score, the better.
  measure: adverse events
  time frame: up to 6 weeks after the surgery
  description: Adverse events were collected and recorded throughout the clinical trial, and the incidence rate was calculated.
  measure: serious adverse events
  time frame: up to 6 weeks after the surgery
  description: Serious adverse events were collected and recorded throughout the clinical trial, and the incidence rate was calculated.
  arm group label: intervention group
  arm group type: Active Comparator
  description: Total knee arthroplasty assisted by knee navigation and positioning system. Specification Model: OP-RKL22
  arm group label: control group
  arm group type: No Intervention
  description: Total knee arthroplasty without knee navigation and positioning system
  intervention type: Procedure
  intervention name: robotic system
  description: Total knee arthroplasty assisted by knee navigation and positioning system
  arm group label: intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Zheng Yuhang, MD
  role: Study Director
  affiliation: Director
  facility: 
  country: China
  responsible party type: Sponsor