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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03762603

Enrollment

Registered

2018-12-04

Start date

2025-09-30

Completion date

2027-12-20

Last updated

2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Knee Replacement Surgery

Keywords

Pneumatic, exoskeleton

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

Interventions

DEVICERobotic exoskeleton device

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Predicting discharge location after TKA	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

Measure	Time frame	Description
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge	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
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years	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
Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up	2 weeks and 3 months	calculating device compliance (on/off) at 2 weeks and 3 months after surgery using a questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026