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

April 8, 2025 updated by: Derek Amanatullah, Stanford University
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94063
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
upto 2 weeks
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)
upto 2 weeks
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
upto 2 weeks
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
up to 2 years
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.
up to 2 years
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
up to 2 years
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
up to 2 years
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
2 weeks and 3 months
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
2 weeks and 3 months
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
2 weeks and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Derek Amanatullah, M.D. PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 45810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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