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Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)

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ClinicalTrials.gov Identifier: NCT03762603
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Derek Amanatullah, Stanford University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Primary Knee Replacement Surgery Device: Robotic exoskeleton device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : December 20, 2023
Estimated Study Completion Date : December 20, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: robotic exoskeleton device
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.
 Device: Robotic exoskeleton device
It is a non invasive and non significant risk medical device which wraps around operated knee to support motion.


Outcome Measures
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Primary Outcome Measures :
  1. Predicting discharge location after TKA [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Evaluate the effectiveness of the robotic exoskeleton device at time of discharge [ Time Frame: upto 2 weeks ]
    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

  2. Evaluate the effectiveness of the robotic exoskeleton device at time of discharge [ Time Frame: upto 2 weeks ]
    We plan to determine patient length of stay in hospital ( in hours)

  3. Evaluate the effectiveness of the robotic exoskeleton device at time of discharge [ Time Frame: upto 2 weeks ]
    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

  4. Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years [ Time Frame: up to 2 years ]
    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

  5. Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years [ Time Frame: up to 2 years ]
    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.

  6. Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years [ Time Frame: up to 2 years ]
    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

  7. Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years [ Time Frame: up to 2 years ]
    calculating Timed-up-and-Go at discharge, 3 months and 2 years after surgery

  8. Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up [ Time Frame: 2 weeks and 3 months ]
    calculating device compliance (on/off) at 2 weeks and 3 months after surgery using a questionnaire

  9. Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up [ Time Frame: 2 weeks and 3 months ]
    To assess the effectiveness of device by calculating number of Falls at 2 weeks and 3 months using a questionnaire

  10. Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up [ Time Frame: 2 weeks and 3 months ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Patients undergoing unilateral primary knee replacement surgery
  2. Patients who pre-operatively desire discharged to ECF
  3. Patients willing and capable to sign the written informed consent

Exclusion criteria

  1. Patients undergoing bilateral primary knee replacement surgery
  2. Patients undergoing revision knee replacement surgery
  3. Patients who pre-operatively desire discharged to Home
  4. Patients not willing and capable to sign the written informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762603


Locations
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United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94063
Contact: Study team    650-721-7631    arprerna@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Derek Amanatullah, M.D. PhD Stanford University
More Information
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Publications of Results:

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Responsible Party: Derek Amanatullah, Assistant professor, Stanford University
ClinicalTrials.gov Identifier: NCT03762603    
Other Study ID Numbers: 45810
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Derek Amanatullah, Stanford University:
Pneumatic
exoskeleton