<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/NCT01705886</url>
  </required_header>
  <id_info>
    <org_study_id>MAKO-02</org_study_id>
    <secondary_id>2015-004</secondary_id>
    <nct_id>NCT01705886</nct_id>
  </id_info>
  <brief_title>Clinical and Economic Comparison of Robot Assisted Versus Manual Knee Replacement</brief_title>
  <official_title>Clinical and Economic Comparison of Robotic Versus Manual Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwest Surgical Specialists, Vancouver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker Surgical Corp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwest Surgical Specialists, Vancouver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to document and compare the surgical and after surgery costs,&#xD;
      recovery time, and outcomes of two procedure types:&#xD;
&#xD;
        -  Robotic assisted surgery replacing one compartment of the knee&#xD;
&#xD;
        -  Manual (robot is not used) surgery replacing all three compartments of the knee (total&#xD;
           knee replacement)&#xD;
&#xD;
      The hypothesis is that robot assisted partial knee replacement is cost effective and provides&#xD;
      clinical outcomes that are equivalent to a manual total knee replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Significance:&#xD;
&#xD;
      The primary indications for joint replacement surgery include severe lower extremity pain&#xD;
      that prevents individuals from performing normal daily activities. The level of pain&#xD;
      experienced by these patients cannot be managed successfully with oral medications, physical&#xD;
      therapy, or joint injections of steroids or hyaluronic acid. The source of the pain most&#xD;
      commonly is a result of arthritic changes in the joint; the arthritis may be due to&#xD;
      osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Patients who are appropriate&#xD;
      candidates for partial joint replacement surgery also may experience joint stiffness that&#xD;
      interferes with their normal daily activities. In addition, there usually is radiographic&#xD;
      evidence of changes in the joint caused by the arthritic process. Joint damage is evaluated&#xD;
      radiographically in order to classify the severity of the joint disease. Partial joint&#xD;
      replacement surgery is performed to replace the diseased parts of the joint with prosthesis.&#xD;
      There are a variety of options that surgeons and patients can choose for their joint&#xD;
      replacement surgery. There are many different joint replacement component systems&#xD;
      manufactured by several different companies; some systems are recommended for particular&#xD;
      types of patients while others can be used in a greater number of patients. Recently, new&#xD;
      techniques have been introduced that are classified as minimally invasive because they&#xD;
      require smaller surgical incisions to implant standard joint prostheses. Patients who are&#xD;
      younger, thinner, and in better overall health are usually the best surgical candidates for&#xD;
      minimally invasive procedures.&#xD;
&#xD;
      Osteoarthritis affects 40 million Americans and 15 million people in the United States suffer&#xD;
      from degenerative arthritis of the knee. Unicondylar knee arthroplasty (UKA) was introduced&#xD;
      as a treatment option for degenerative arthritis of the knee in the early 1970's[1]. The&#xD;
      procedure initially yielded variable results and this unpredictability resulted in broadly&#xD;
      low levels of usage[1]. Recent improvements in the surgical techniques and technology used&#xD;
      for UKA have increased the effectiveness of this surgery. As the average age of the United&#xD;
      States population increases, this surgical procedure will become even more common. It is&#xD;
      estimated by the Millennium Research Group that there will be 55,100 unicondylar knee&#xD;
      procedures in 2010 and the compound annual growth rate from 2009 to 2014 will be 8.3%.&#xD;
&#xD;
      UKA knee arthroplasty can be viewed as an attractive alternative to total knee arthroplasty&#xD;
      (TKA) assuming the patient's osteoarthritis has remained isolated in a single compartment or&#xD;
      two compartments. UKA knee arthroplasty are generally less invasive procedures than TKA.&#xD;
      Since the procedure is less invasive there is usually less blood loss; more cartilage,&#xD;
      tissue, and bone is sparred, which results in shorter recovery times than TKA. This procedure&#xD;
      is attractive to adults who are interested in remaining active pain-free lifestyles as they&#xD;
      age.&#xD;
&#xD;
      The cost-effectiveness of healthcare interventions, especially new technology, is becoming&#xD;
      essential. Comparing the procedural costs of robotic-assisted surgery and the outcomes of the&#xD;
      patients versus TKA, the gold standard, will help substantiate whether robotic-assisted&#xD;
      surgery from an economic viewpoint is a cost-effective treatment. In addition the&#xD;
      rehabilitation after knee replacement surgery is critical to achieving proper functional&#xD;
      outcomes. Information pertaining to knee replacement post discharge costs has been limited.&#xD;
      Due to the lack of studies and the continued growth in the number of knee arthroplasty&#xD;
      surgeries it is imperative to track post discharge costs of all variables. We will be&#xD;
      documenting and comparing the procedural and postoperative costs, recovery time, and outcomes&#xD;
      of three procedure types in robotic assisted unicompartmental knee arthroplasty, robotic&#xD;
      assisted bicompartmental knee arthroplasty and manual total knee arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cost per case at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>Cost per case for 1 year. The inpatient costs, analgesic use, physical therapy, durable medical equipment, and postoperative visits will be used to calculate the cost at 1 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Knee Society Knee Score</measure>
    <time_frame>1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery</time_frame>
    <description>The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reduced WOMAC</measure>
    <time_frame>1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery</time_frame>
    <description>The Reduced WOMAC is a truncated version of the Western Ontario and McMaster's University Osteoarthritis Index. The questionnaire is designed to assess pain, disability and joint stiffness in the osteoarthritis patient.</description>
  </other_outcome>
  <other_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score</measure>
    <time_frame>1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery</time_frame>
    <description>The KOOS or Knee injury and Osteoarthritis Outcome Score are patient completed questionnaires which assess the patient's opinion regarding their knee and its associated osteoarthritis.</description>
  </other_outcome>
  <other_outcome>
    <measure>EQ-5D</measure>
    <time_frame>1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery</time_frame>
    <description>The EQ-5D is a standardized instrument for use as a measure of health outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Forgotten Joint Score</measure>
    <time_frame>1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery</time_frame>
    <description>The Forgotten Joint Score is a 12-item questionnaire completed by the patient to determine how aware they are of their joint in their everyday life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of Stay</measure>
    <time_frame>At inpatient discharge which has an expected average of 2 days after surgery</time_frame>
    <description>Number of days patient stayed in hospital after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to physical therapy discharge</measure>
    <time_frame>At discharge from physical therapy which has an expected average of 6 weeks after surgery</time_frame>
    <description>Days after surgery to meet physical therapy discharge criteria of&#xD;
Range of motion 5 to 115 degrees&#xD;
Strength 4/5 for flexion and extension expressed as a percent of maximal isometric contraction from pre-operative assessment and determined with a dynamometer&#xD;
Gait with minimal limp without an assistive device for a distance of 250 feet&#xD;
Able to ascend/ descend a flight of stairs with step over gait with good control (and with use of handrail)</description>
  </other_outcome>
  <other_outcome>
    <measure>Timed Up and Go</measure>
    <time_frame>1-2 weeks prior to surgery, 6 weeks after surgery, 3 months after surgery</time_frame>
    <description>Timed up and Go (TUG) Test: Participants are instructed to stand up from a seated position from a standard chair, walk 3 m around a cone and then return to the chair and resume a seated position. Pace is self-selected. The time to complete the test is recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>6 Minute Walk Test (6MWT)</measure>
    <time_frame>1-2 weeks prior to surgery, 6 weeks after surgery, 3 months after surgery</time_frame>
    <description>Participants are instructed to cover as much distance walking in 6 minutes and can stop and rest if necessary. The course is 30 meters in length, marked at 1 meter intervals with cones marking the turn around point. Distance measured is rounded up to the nearest meter and recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stair Ascend/Descend Test</measure>
    <time_frame>1-2 weeks prior to surgery, 6 weeks after surgery, 3 months after surgery</time_frame>
    <description>Participants are asked to ascend and descend 11 steps using a hand rail if necessary. Stair height is 17.8 cm (7&quot;). Pace is self selected. The time to ascend/ descend 1 flight of stairs is recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Return to Driving Time</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>Number of days from surgery until patient returned to driving. In addition if the knee replacement procedure was a performed on the left leg or right leg will be documented because this could factor into time it takes to return to driving.</description>
  </other_outcome>
  <other_outcome>
    <measure>Return to Work Time</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>The number of days from surgery to return to work.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
    <description>Patients undergoing knee replacement surgery. This may be a Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty.&#xD;
The MAKO® Robot Assisted surgeries use the RESTORIS Multicompartmental Knee System.&#xD;
The total knee arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Knee Arthroplasty</intervention_name>
    <description>Patients undergoing manual (no robot used) surgery to replace of all 3 compartments of the knee</description>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
    <other_name>TKA</other_name>
    <other_name>Total Knee Replacement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MAKO® Robot Assisted Medial Knee Arthroplasty</intervention_name>
    <description>Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee</description>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
    <other_name>unilateral knee arthroplasty (UKA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RESTORIS Multicompartmental Knee System</intervention_name>
    <description>The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.</description>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
    <other_name>RESTORIS® MCK MultiCompartmental Knee System</other_name>
    <other_name>FDA 501K number K090763</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Depuy Knee Replacement System</intervention_name>
    <description>The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.</description>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stryker® Knee Replacement System</intervention_name>
    <description>The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.</description>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and non-pregnant females undergoing knee replacement who are between 21 and 80 years&#xD;
        of age with stable health and are willing and able to have physical therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age, 21-80 years&#xD;
&#xD;
          -  Sex, males and females will be included&#xD;
&#xD;
          -  BMI less than or equal to 39&#xD;
&#xD;
          -  Stable health, the patient would be able to undergo surgery and participate in the&#xD;
             follow-up program based on physical examination and medical history&#xD;
&#xD;
          -  Patient is willing and able to cooperate in follow-up therapy at Rebound facilities in&#xD;
             Vancouver, WA&#xD;
&#xD;
          -  Patient has stable and functional collateral ligaments&#xD;
&#xD;
          -  Patient or patient's legal representative has signed the Informed Consent form&#xD;
&#xD;
          -  Failed non-operative management of their joint disease&#xD;
&#xD;
          -  Need to obtain pain relief and improved function&#xD;
&#xD;
          -  Moderate or severe pain with either walking or at rest&#xD;
&#xD;
          -  Diagnosed with osteoarthritis in one or more compartments of the knee and non-surgical&#xD;
             treatment options have failed to provide relief for symptoms&#xD;
&#xD;
          -  Patient exhibits preoperative radiographic evidence of joint degeneration that cannot&#xD;
             be treated in non-operative fashion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who, in the opinion of the Investigator, have an existing condition that&#xD;
             would compromise their participation and follow-up in the study&#xD;
&#xD;
          -  Patients with pre-op flexion contracture greater than 10 degrees, overall flexion less&#xD;
             than 115 degrees, and varus/valgus greater than 10 degrees&#xD;
&#xD;
          -  Patient who is on workmen's compensation&#xD;
&#xD;
          -  Patients who are on chronic long acting preoperative narcotic pain medication&#xD;
&#xD;
          -  Patients with inflammatory polyarthritis&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Subjects who are known drug or alcohol abusers or with psychological disorders that&#xD;
             could effect follow-up care or treatment outcomes&#xD;
&#xD;
          -  Subjects who are currently involved in another clinical study with the exception to an&#xD;
             outcomes study&#xD;
&#xD;
          -  Patients with a pathology which, in the opinion of the Principal Investigator, will&#xD;
             adversely affect healing&#xD;
&#xD;
          -  A diagnosed systemic disease that would affect their welfare or the overall outcome of&#xD;
             study (i.e. Paget's disease, renal osteodystrophy)&#xD;
&#xD;
          -  Patients receiving an isolated patellofemoral UKA,lateral UKA, or bi-compartmental&#xD;
             arthroplasty&#xD;
&#xD;
          -  Patients with significant medical condition preventing a well-functioning&#xD;
             contralateral knee&#xD;
&#xD;
          -  cognitively unable to complete study health-related quality of life forms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd Borus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Donald Roberts, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rebound Orthopedics and Neurosurgery</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Joint Disease</keyword>
  <keyword>Arthritis</keyword>
  <keyword>Musculoskeletal Disease</keyword>
  <keyword>Knee osteoarthritis</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT01705886/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT01705886/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01705886
org study id: MAKO-02
secondary id: 2015-004
nct id: NCT01705886
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to document and compare the surgical and after surgery costs,
      recovery time, and outcomes of two procedure types:

        -  Robotic assisted surgery replacing one compartment of the knee

        -  Manual (robot is not used) surgery replacing all three compartments of the knee (total
           knee replacement)

      The hypothesis is that robot assisted partial knee replacement is cost effective and provides
      clinical outcomes that are equivalent to a manual total knee replacement.
Background and Significance:

      The primary indications for joint replacement surgery include severe lower extremity pain
      that prevents individuals from performing normal daily activities. The level of pain
      experienced by these patients cannot be managed successfully with oral medications, physical
      therapy, or joint injections of steroids or hyaluronic acid. The source of the pain most
      commonly is a result of arthritic changes in the joint; the arthritis may be due to
      osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Patients who are appropriate
      candidates for partial joint replacement surgery also may experience joint stiffness that
      interferes with their normal daily activities. In addition, there usually is radiographic
      evidence of changes in the joint caused by the arthritic process. Joint damage is evaluated
      radiographically in order to classify the severity of the joint disease. Partial joint
      replacement surgery is performed to replace the diseased parts of the joint with prosthesis.
      There are a variety of options that surgeons and patients can choose for their joint
      replacement surgery. There are many different joint replacement component systems
      manufactured by several different companies; some systems are recommended for particular
      types of patients while others can be used in a greater number of patients. Recently, new
      techniques have been introduced that are classified as minimally invasive because they
      require smaller surgical incisions to implant standard joint prostheses. Patients who are
      younger, thinner, and in better overall health are usually the best surgical candidates for
      minimally invasive procedures.

      Osteoarthritis affects 40 million Americans and 15 million people in the United States suffer
      from degenerative arthritis of the knee. Unicondylar knee arthroplasty (UKA) was introduced
      as a treatment option for degenerative arthritis of the knee in the early 1970's[1]. The
      procedure initially yielded variable results and this unpredictability resulted in broadly
      low levels of usage[1]. Recent improvements in the surgical techniques and technology used
      for UKA have increased the effectiveness of this surgery. As the average age of the United
      States population increases, this surgical procedure will become even more common. It is
      estimated by the Millennium Research Group that there will be 55,100 unicondylar knee
      procedures in 2010 and the compound annual growth rate from 2009 to 2014 will be 8.3%.

      UKA knee arthroplasty can be viewed as an attractive alternative to total knee arthroplasty
      (TKA) assuming the patient's osteoarthritis has remained isolated in a single compartment or
      two compartments. UKA knee arthroplasty are generally less invasive procedures than TKA.
      Since the procedure is less invasive there is usually less blood loss; more cartilage,
      tissue, and bone is sparred, which results in shorter recovery times than TKA. This procedure
      is attractive to adults who are interested in remaining active pain-free lifestyles as they
      age.

      The cost-effectiveness of healthcare interventions, especially new technology, is becoming
      essential. Comparing the procedural costs of robotic-assisted surgery and the outcomes of the
      patients versus TKA, the gold standard, will help substantiate whether robotic-assisted
      surgery from an economic viewpoint is a cost-effective treatment. In addition the
      rehabilitation after knee replacement surgery is critical to achieving proper functional
      outcomes. Information pertaining to knee replacement post discharge costs has been limited.
      Due to the lack of studies and the continued growth in the number of knee arthroplasty
      surgeries it is imperative to track post discharge costs of all variables. We will be
      documenting and comparing the procedural and postoperative costs, recovery time, and outcomes
      of three procedure types in robotic assisted unicompartmental knee arthroplasty, robotic
      assisted bicompartmental knee arthroplasty and manual total knee arthroplasty.
observational model: Cohort
time perspective: Prospective
measure: Cost per case at 1 year
time frame: 1 year
description: Cost per case for 1 year. The inpatient costs, analgesic use, physical therapy, durable medical equipment, and postoperative visits will be used to calculate the cost at 1 year.
measure: American Knee Society Knee Score
time frame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery
description: The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs.
measure: Reduced WOMAC
time frame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery
description: The Reduced WOMAC is a truncated version of the Western Ontario and McMaster's University Osteoarthritis Index. The questionnaire is designed to assess pain, disability and joint stiffness in the osteoarthritis patient.
measure: Knee injury and Osteoarthritis Outcome Score
time frame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery
description: The KOOS or Knee injury and Osteoarthritis Outcome Score are patient completed questionnaires which assess the patient's opinion regarding their knee and its associated osteoarthritis.
measure: EQ-5D
time frame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery
description: The EQ-5D is a standardized instrument for use as a measure of health outcome.
measure: Forgotten Joint Score
time frame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery
description: The Forgotten Joint Score is a 12-item questionnaire completed by the patient to determine how aware they are of their joint in their everyday life.
measure: Length of Stay
time frame: At inpatient discharge which has an expected average of 2 days after surgery
description: Number of days patient stayed in hospital after surgery
measure: Time to physical therapy discharge
time frame: At discharge from physical therapy which has an expected average of 6 weeks after surgery
description: Days after surgery to meet physical therapy discharge criteria of
Range of motion 5 to 115 degrees
Strength 4/5 for flexion and extension expressed as a percent of maximal isometric contraction from pre-operative assessment and determined with a dynamometer
Gait with minimal limp without an assistive device for a distance of 250 feet
Able to ascend/ descend a flight of stairs with step over gait with good control (and with use of handrail)
measure: Timed Up and Go
time frame: 1-2 weeks prior to surgery, 6 weeks after surgery, 3 months after surgery
description: Timed up and Go (TUG) Test: Participants are instructed to stand up from a seated position from a standard chair, walk 3 m around a cone and then return to the chair and resume a seated position. Pace is self-selected. The time to complete the test is recorded.
measure: 6 Minute Walk Test (6MWT)
time frame: 1-2 weeks prior to surgery, 6 weeks after surgery, 3 months after surgery
description: Participants are instructed to cover as much distance walking in 6 minutes and can stop and rest if necessary. The course is 30 meters in length, marked at 1 meter intervals with cones marking the turn around point. Distance measured is rounded up to the nearest meter and recorded.
measure: Stair Ascend/Descend Test
time frame: 1-2 weeks prior to surgery, 6 weeks after surgery, 3 months after surgery
description: Participants are asked to ascend and descend 11 steps using a hand rail if necessary. Stair height is 17.8 cm (7"). Pace is self selected. The time to ascend/ descend 1 flight of stairs is recorded.
measure: Return to Driving Time
time frame: 6 weeks after surgery
description: Number of days from surgery until patient returned to driving. In addition if the knee replacement procedure was a performed on the left leg or right leg will be documented because this could factor into time it takes to return to driving.
measure: Return to Work Time
time frame: 6 weeks after surgery
description: The number of days from surgery to return to work.
arm group label: Knee Arthroplasty
description: Patients undergoing knee replacement surgery. This may be a Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty.
The MAKO® Robot Assisted surgeries use the RESTORIS Multicompartmental Knee System.
The total knee arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System.
intervention type: Procedure
intervention name: Total Knee Arthroplasty
description: Patients undergoing manual (no robot used) surgery to replace of all 3 compartments of the knee
arm group label: Knee Arthroplasty
other name: TKA
other name: Total Knee Replacement
intervention type: Procedure
intervention name: MAKO® Robot Assisted Medial Knee Arthroplasty
description: Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee
arm group label: Knee Arthroplasty
other name: unilateral knee arthroplasty (UKA)
intervention type: Device
intervention name: RESTORIS Multicompartmental Knee System
description: The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.
arm group label: Knee Arthroplasty
other name: RESTORIS® MCK MultiCompartmental Knee System
other name: FDA 501K number K090763
intervention type: Device
intervention name: Depuy Knee Replacement System
description: The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
arm group label: Knee Arthroplasty
intervention type: Device
intervention name: Stryker® Knee Replacement System
description: The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
arm group label: Knee Arthroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Todd Borus, MD
role: Principal Investigator
affiliation: Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
last name: Donald Roberts, MD
role: Principal Investigator
affiliation: Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 