Primary Knee Replacement SurgeryNCT03762603
Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)
A study testing Robotic exoskeleton device in people with Primary Knee Replacement Surgery, run by Stanford University at 1 site in United States.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Primary Knee Replacement Surgery
- What is being tested?
- Robotic exoskeleton device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94063
About this study
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
- Conditions
- Primary Knee Replacement Surgery
- Being tested
- Robotic exoskeleton device
- Keywords
- Pneumatic, exoskeleton
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic exoskeleton deviceDevice
It is a non invasive and non significant risk medical device which wraps around operated knee to support motion.
| Study group | Role | What they receive |
|---|---|---|
| robotic exoskeleton device | Experimental | 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. Receives: Device: Robotic exoskeleton device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (10)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study startSep 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2027 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary Knee Replacement SurgeryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Amanatullah, Stanford University
- Investigators
- Derek Amanatullah, M.D. PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762603
- Sponsor's protocol ID
- 45810
- Status last verified
- May 2022
- First submitted
- 9 Aug 2018
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005 Jul;87(7):1487-97. doi: 10.2106/JBJS.D.02441.
PubMed 15995115Losina E, Walensky RP, Kessler CL, Emrani PS, Reichmann WM, Wright EA, Holt HL, Solomon DH, Yelin E, Paltiel AD, Katz JN. Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume. Arch Intern Med. 2009 Jun 22;169(12):1113-21; discussion 1121-2. doi: 10.1001/archinternmed.2009.136.
PubMed 19546411Healy WL, Rana AJ, Iorio R. Hospital economics of primary total knee arthroplasty at a teaching hospital. Clin Orthop Relat Res. 2011 Jan;469(1):87-94. doi: 10.1007/s11999-010-1486-2.
PubMed 20694537Schwarzkopf R, Ho J, Quinn JR, Snir N, Mukamel D. Factors Influencing Discharge Destination After Total Knee Arthroplasty: A Database Analysis. Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):95-9. doi: 10.1177/2151458516645635. Epub 2016 Apr 26.
PubMed 27239383Goto K, Morishita T, Kamada S, Saita K, Fukuda H, Shiota E, Sankai Y, Inoue T. Feasibility of rehabilitation using the single-joint hybrid assistive limb to facilitate early recovery following total knee arthroplasty: A pilot study. Assist Technol. 2017 Winter;29(4):197-201. doi: 10.1080/10400435.2016.1219883. Epub 2016 Aug 10.
PubMed 27689789
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Supplementing of Quadriceps Strength With Exoskeleton After Total Knee Arthroplasty in High Risk Population Reduce Transfer to Extended Care Facility (ECF)
- ClinicalTrials.gov ID
- NCT03762603
- Acronym / sponsor ID
- 45810
- Conditions
- Primary Knee Replacement Surgery
- Keywords
- Pneumatic, exoskeleton
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| robotic exoskeleton device | Experimental | Device: Robotic exoskeleton devicePatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic exoskeleton deviceIt is a non invasive and non significant risk medical device which wraps around operated knee to support motion. | Device | robotic exoskeleton device |
Primary outcome
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.
10 secondary outcomes
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
Time frame: upto 2 weeks
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
Time frame: upto 2 weeks
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
Time frame: upto 2 weeks
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
Time frame: 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
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
Time frame: 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
Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
Time frame: 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
Evaluate the effectiveness of the robotic exoskeleton device at post operative follow up
Time frame: 2 weeks and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Results publication: PubMed 15995115Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M. Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am. 2005 Jul;87(7):1487-97. doi: 10.2106/JBJS.D.02441.
- Results publication: PubMed 19546411Losina E, Walensky RP, Kessler CL, Emrani PS, Reichmann WM, Wright EA, Holt HL, Solomon DH, Yelin E, Paltiel AD, Katz JN. Cost-effectiveness of total knee arthroplasty in the United States: patient risk and hospital volume. Arch Intern Med. 2009 Jun 22;169(12):1113-21; discussion 1121-2. doi: 10.1001/archinternmed.2009.136.
- Results publication: PubMed 20694537Healy WL, Rana AJ, Iorio R. Hospital economics of primary total knee arthroplasty at a teaching hospital. Clin Orthop Relat Res. 2011 Jan;469(1):87-94. doi: 10.1007/s11999-010-1486-2.
- Results publication: PubMed 27239383Schwarzkopf R, Ho J, Quinn JR, Snir N, Mukamel D. Factors Influencing Discharge Destination After Total Knee Arthroplasty: A Database Analysis. Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):95-9. doi: 10.1177/2151458516645635. Epub 2016 Apr 26.
- Results publication: PubMed 27689789Goto K, Morishita T, Kamada S, Saita K, Fukuda H, Shiota E, Sankai Y, Inoue T. Feasibility of rehabilitation using the single-joint hybrid assistive limb to facilitate early recovery following total knee arthroplasty: A pilot study. Assist Technol. 2017 Winter;29(4):197-201. doi: 10.1080/10400435.2016.1219883. Epub 2016 Aug 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek Amanatullah, M.D. PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic exoskeleton device in people with Primary Knee Replacement Surgery, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predicting discharge location after TKA (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762603, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.