<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/NCT01705366</url>
  </required_header>
  <id_info>
    <org_study_id>MAKO-01</org_study_id>
    <secondary_id>Borus 2015-005</secondary_id>
    <nct_id>NCT01705366</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of Knee Replacement</brief_title>
  <official_title>Clinical Outcomes of Joint Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwest Surgical Specialists, Vancouver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker MAKO 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 objective of this study is to document the demographic and clinical characteristics and&#xD;
      the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.&#xD;
&#xD;
      The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the&#xD;
      knee joint has 10 year implant survival and clinical outcomes that are equivalent to other&#xD;
      knee replacement systems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Changes in funding.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 19, 2018</completion_date>
  <primary_completion_date type="Actual">September 19, 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>Survivorship of Components</measure>
    <time_frame>10 years</time_frame>
    <description>Survivorship of components is defined as knee implant device(s) remaining in patient.</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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">316</enrollment>
  <condition>Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
    <description>Patients undergoing total knee arthroplasty. This may be Non-MAKO® Robot Assisted Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty or MAKO® Robot Assisted Medial and PF Knee Arthroplasty&#xD;
The Non-MAKO® Robot Assisted Total Knee Arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. The MAKO® Robot Assisted Arthroplasty uses the RESTORIS Multicompartmental Knee System .</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-MAKO® Robot Assisted Total Knee Arthroplasty</intervention_name>
    <description>Patients undergoing a non-MAKO® robot assisted surgery to replace one or more 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>
    <other_name>Revision Knee Arthroplasty</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>Unicompartmental Knee Arthroplasty (UKA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MAKO® Robot Assisted Medial and PF Knee Arthroplasty</intervention_name>
    <description>Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee</description>
    <arm_group_label>Knee Arthroplasty</arm_group_label>
    <other_name>Bi-compartmental Knee Arthroplasty</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>
        All male and non-pregnant females undergoing knee replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  requires either primary or revision knee replacement surgery because of pain and joint&#xD;
             stiffness that interferes with performance of normal daily activities&#xD;
&#xD;
          -  has failed non-operative management of their joint disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitively unable to complete study health-related quality of life forms&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</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>September 2018</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>September 24, 2018</last_update_submitted>
  <last_update_submitted_qc>September 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2018</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>
  <!-- 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/NCT01705366
org study id: MAKO-01
secondary id: Borus 2015-005
nct id: NCT01705366
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to document the demographic and clinical characteristics and
      the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.

      The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the
      knee joint has 10 year implant survival and clinical outcomes that are equivalent to other
      knee replacement systems.
observational model: Cohort
time perspective: Prospective
measure: Survivorship of Components
time frame: 10 years
description: Survivorship of components is defined as knee implant device(s) remaining in patient.
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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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, 2 years, 5 years, and 10 years 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.
arm group label: Knee Arthroplasty
description: Patients undergoing total knee arthroplasty. This may be Non-MAKO® Robot Assisted Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty or MAKO® Robot Assisted Medial and PF Knee Arthroplasty
The Non-MAKO® Robot Assisted Total Knee Arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. The MAKO® Robot Assisted Arthroplasty uses the RESTORIS Multicompartmental Knee System .
intervention type: Procedure
intervention name: Non-MAKO® Robot Assisted Total Knee Arthroplasty
description: Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.
arm group label: Knee Arthroplasty
other name: TKA
other name: Total Knee Replacement
other name: Revision Knee Arthroplasty
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: Unicompartmental Knee Arthroplasty (UKA)
intervention type: Procedure
intervention name: MAKO® Robot Assisted Medial and PF Knee Arthroplasty
description: Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee
arm group label: Knee Arthroplasty
other name: Bi-compartmental Knee Arthroplasty
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: N/A
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