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

Stanford University

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Primary Knee Replacement Surgery

Interventions

Robotic exoskeleton deviceDEVICE

It is a non invasive and non significant risk medical device which wraps around operated knee to support motion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Palo Alto, California, United States

Outcomes

Primary Outcomes

Predicting discharge location after TKA

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.

Time frame: 2 years

Secondary Outcomes

Evaluate the effectiveness of the robotic exoskeleton device at time of discharge

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

Time frame: upto 2 weeks

Evaluate the effectiveness of the robotic exoskeleton device at time of discharge

We plan to determine patient length of stay in hospital ( in hours)

Time frame: upto 2 weeks

Evaluate the effectiveness of the robotic exoskeleton device at time of discharge

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

Time frame: upto 2 weeks

Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 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

Time frame: up to 2 years

Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 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.

Data from ClinicalTrials.gov

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