<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/NCT03762603</url>
  </required_header>
  <id_info>
    <org_study_id>45810</org_study_id>
    <nct_id>NCT03762603</nct_id>
  </id_info>
  <brief_title>Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)</brief_title>
  <official_title>Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study involves an exoskeleton which is believed to increase quadriceps muscle strength&#xD;
      in the rehabilitation phase after TKA and reduce the discharge the such patients in Extended&#xD;
      care facility (ECF) . The purpose of this study is to access efficacy of the robotic&#xD;
      exoskeleton device wrapped around the operated knee on patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2021</start_date>
  <completion_date type="Anticipated">December 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Predicting discharge location after TKA</measure>
    <time_frame>2 years</time_frame>
    <description>The objective of this study is to observe how many patients are not transferred to ECF in the post-surgery time period as a result of using a robotic exoskeleton on operated knee. We will list number of patients NOT going for ECF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at time of discharge</measure>
    <time_frame>upto 2 weeks</time_frame>
    <description>To assess the effectiveness of the device by evaluating the number of patients discharge with exoskeleton device along with Home Health Services all by using questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at time of discharge</measure>
    <time_frame>upto 2 weeks</time_frame>
    <description>We plan to determine patient length of stay in hospital ( in hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at time of discharge</measure>
    <time_frame>upto 2 weeks</time_frame>
    <description>Determining patients performance of Stairs at discharge. Patients at the time of discharge are asked to step 3 stairs and answer related questions using a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>To assess the effectiveness of the device by calculating Initial knee society score (KSS) and Knee society score at 2 weeks, 3 months and 2 years after surgery. The scale ranges from 0-100 with grading as Score 80-100 - Excellent Score 70-79 - Good Score 60-69 - Fair Score below 60 - Poor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>To assess the effectiveness of the device by calculating initial Range of motion ( ROM) at the time of discharge and at 2 weeks, 3 months and 2 years after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>To assess the effectiveness of the device by examining Gait Aide use at discharge, 2 weeks, 3 months and 2 years after surgery. This is done to examine performance . The gait aide use provident ranges as Nothing &gt; Cane &gt; crutch &gt; walker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years</measure>
    <time_frame>up to 2 years</time_frame>
    <description>calculating Timed-up-and-Go at discharge, 3 months and 2 years after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up</measure>
    <time_frame>2 weeks and 3 months</time_frame>
    <description>calculating device compliance (on/off) at 2 weeks and 3 months after surgery using a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up</measure>
    <time_frame>2 weeks and 3 months</time_frame>
    <description>To assess the effectiveness of device by calculating number of Falls at 2 weeks and 3 months using a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up</measure>
    <time_frame>2 weeks and 3 months</time_frame>
    <description>To assess the effectiveness of device by calculating Initial satisfaction with the device and satisfaction at 2 weeks and 3 months after surgery using a questionnaire. The scale ranges from:&#xD;
Very satisfied Satisfied Neutral Not satisfied</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Primary Knee Replacement Surgery</condition>
  <arm_group>
    <arm_group_label>robotic exoskeleton device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who are scheduled to be discharged to a ECF will be asked if they would want to use the exoskeleton device ( for which safety and comfort has been established) instead of going for ECF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic exoskeleton device</intervention_name>
    <description>It is a non invasive and non significant risk medical device which wraps around operated knee to support motion.</description>
    <arm_group_label>robotic exoskeleton device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Patients undergoing unilateral primary knee replacement surgery&#xD;
&#xD;
          2. Patients who pre-operatively desire discharged to ECF&#xD;
&#xD;
          3. Patients willing and capable to sign the written informed consent&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Patients undergoing bilateral primary knee replacement surgery&#xD;
&#xD;
          2. Patients undergoing revision knee replacement surgery&#xD;
&#xD;
          3. Patients who pre-operatively desire discharged to Home&#xD;
&#xD;
          4. Patients not willing and capable to sign the written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek Amanatullah, M.D. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005 Jul;87(7):1487-97. doi: 10.2106/JBJS.D.02441.</citation>
    <PMID>15995115</PMID>
  </results_reference>
  <results_reference>
    <citation>Losina E, Walensky RP, Kessler CL, Emrani PS, Reichmann WM, Wright EA, Holt HL, Solomon DH, Yelin E, Paltiel AD, Katz JN. Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume. Arch Intern Med. 2009 Jun 22;169(12):1113-21; discussion 1121-2. doi: 10.1001/archinternmed.2009.136.</citation>
    <PMID>19546411</PMID>
  </results_reference>
  <results_reference>
    <citation>Healy WL, Rana AJ, Iorio R. Hospital economics of primary total knee arthroplasty at a teaching hospital. Clin Orthop Relat Res. 2011 Jan;469(1):87-94. doi: 10.1007/s11999-010-1486-2.</citation>
    <PMID>20694537</PMID>
  </results_reference>
  <results_reference>
    <citation>Schwarzkopf R, Ho J, Quinn JR, Snir N, Mukamel D. Factors Influencing Discharge Destination After Total Knee Arthroplasty: A Database Analysis. Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):95-9. doi: 10.1177/2151458516645635. Epub 2016 Apr 26.</citation>
    <PMID>27239383</PMID>
  </results_reference>
  <results_reference>
    <citation>Goto K, Morishita T, Kamada S, Saita K, Fukuda H, Shiota E, Sankai Y, Inoue T. Feasibility of rehabilitation using the single-joint hybrid assistive limb to facilitate early recovery following total knee arthroplasty: A pilot study. Assist Technol. 2017 Winter;29(4):197-201. doi: 10.1080/10400435.2016.1219883. Epub 2016 Aug 10.</citation>
    <PMID>27689789</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Derek Amanatullah</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Pneumatic</keyword>
  <keyword>exoskeleton</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03762603
org study id: 45810
nct id: NCT03762603
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study involves an exoskeleton which is believed to increase quadriceps muscle strength
      in the rehabilitation phase after TKA and reduce the discharge the such patients in Extended
      care facility (ECF) . The purpose of this study is to access efficacy of the robotic
      exoskeleton device wrapped around the operated knee on patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Predicting discharge location after TKA
time frame: 2 years
description: The objective of this study is to observe how many patients are not transferred to ECF in the post-surgery time period as a result of using a robotic exoskeleton on operated knee. We will list number of patients NOT going for ECF.
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
time frame: upto 2 weeks
description: To assess the effectiveness of the device by evaluating the number of patients discharge with exoskeleton device along with Home Health Services all by using questionnaire
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
time frame: upto 2 weeks
description: We plan to determine patient length of stay in hospital ( in hours)
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
time frame: upto 2 weeks
description: Determining patients performance of Stairs at discharge. Patients at the time of discharge are asked to step 3 stairs and answer related questions using a questionnaire
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
time frame: up to 2 years
description: To assess the effectiveness of the device by calculating Initial knee society score (KSS) and Knee society score at 2 weeks, 3 months and 2 years after surgery. The scale ranges from 0-100 with grading as Score 80-100 - Excellent Score 70-79 - Good Score 60-69 - Fair Score below 60 - Poor
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
time frame: up to 2 years
description: To assess the effectiveness of the device by calculating initial Range of motion ( ROM) at the time of discharge and at 2 weeks, 3 months and 2 years after surgery.
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
time frame: up to 2 years
description: To assess the effectiveness of the device by examining Gait Aide use at discharge, 2 weeks, 3 months and 2 years after surgery. This is done to examine performance . The gait aide use provident ranges as Nothing > Cane > crutch > walker
measure: Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
time frame: up to 2 years
description: calculating Timed-up-and-Go at discharge, 3 months and 2 years after surgery
measure: Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
time frame: 2 weeks and 3 months
description: calculating device compliance (on/off) at 2 weeks and 3 months after surgery using a questionnaire
measure: Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
time frame: 2 weeks and 3 months
description: To assess the effectiveness of device by calculating number of Falls at 2 weeks and 3 months using a questionnaire
measure: Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
time frame: 2 weeks and 3 months
description: To assess the effectiveness of device by calculating Initial satisfaction with the device and satisfaction at 2 weeks and 3 months after surgery using a questionnaire. The scale ranges from:
Very satisfied Satisfied Neutral Not satisfied
arm group label: robotic exoskeleton device
arm group type: Experimental
description: Patients who are scheduled to be discharged to a ECF will be asked if they would want to use the exoskeleton device ( for which safety and comfort has been established) instead of going for ECF.
intervention type: Device
intervention name: Robotic exoskeleton device
description: It is a non invasive and non significant risk medical device which wraps around operated knee to support motion.
arm group label: robotic exoskeleton device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Derek Amanatullah, M.D. PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005 Jul;87(7):1487-97. doi: 10.2106/JBJS.D.02441.
PMID: 15995115
citation: Losina E, Walensky RP, Kessler CL, Emrani PS, Reichmann WM, Wright EA, Holt HL, Solomon DH, Yelin E, Paltiel AD, Katz JN. Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume. Arch Intern Med. 2009 Jun 22;169(12):1113-21; discussion 1121-2. doi: 10.1001/archinternmed.2009.136.
PMID: 19546411
citation: Healy WL, Rana AJ, Iorio R. Hospital economics of primary total knee arthroplasty at a teaching hospital. Clin Orthop Relat Res. 2011 Jan;469(1):87-94. doi: 10.1007/s11999-010-1486-2.
PMID: 20694537
citation: Schwarzkopf R, Ho J, Quinn JR, Snir N, Mukamel D. Factors Influencing Discharge Destination After Total Knee Arthroplasty: A Database Analysis. Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):95-9. doi: 10.1177/2151458516645635. Epub 2016 Apr 26.
PMID: 27239383
citation: Goto K, Morishita T, Kamada S, Saita K, Fukuda H, Shiota E, Sankai Y, Inoue T. Feasibility of rehabilitation using the single-joint hybrid assistive limb to facilitate early recovery following total knee arthroplasty: A pilot study. Assist Technol. 2017 Winter;29(4):197-201. doi: 10.1080/10400435.2016.1219883. Epub 2016 Aug 10.
PMID: 27689789
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Derek Amanatullah
investigator title: Assistant professor
sharing ipd: No