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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Primary Knee Replacement Surgery

Intervention / Treatment
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* Device: Robotic exoskeleton device


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients undergoing unilateral primary knee replacement surgery Patients who pre-operatively desire discharged to ECF Patients willing and capable to sign the written informed consent Exclusion criteria Patients undergoing bilateral primary knee replacement surgery Patients undergoing revision knee replacement surgery Patients who pre-operatively desire discharged to Home Patients not willing and capable to sign the written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic exoskeleton device<br>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<br>* It is a non invasive and non significant risk medical device which wraps around operated knee to support motion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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 | 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. | 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 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumatic, exoskeleton