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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-12-20

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

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Detailed Description

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Conditions

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Primary Knee Replacement Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Robotic exoskeleton device

Intervention Type DEVICE

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

Interventions

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Robotic exoskeleton device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No