CLINICAL TRIAL

Robotic exoskeleton device for Primary Knee Replacement Surgery

High Risk
Waitlist Available · 18+ · All Sexes · Palo Alto, CA

This study is evaluating whether a robotic exoskeleton device can improve quadriceps muscle strength in patients after total knee arthroplasty.

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About the trial for Primary Knee Replacement Surgery

Treatment Groups

This trial involves 2 different treatments. Robotic Exoskeleton Device is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Robotic exoskeleton device
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients undergoing unilateral primary knee replacement surgery
A patient who is willing and able to sign a written informed consent form is someone who understands the information presented in the form and agrees to participate in the treatment. show original
Patients who pre-operatively desire discharged to ECF
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Robotic exoskeleton device will improve 1 primary outcome and 3 secondary outcomes in patients with Primary Knee Replacement Surgery. Measurement will happen over the course of upto 2 weeks.

Evaluate the effectiveness of the robotic exoskeleton device at time of discharge
UPTO 2 WEEKS
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 post operative follow up
2 WEEKS AND 3 MONTHS
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
Evaluate the effectiveness of the robotic exoskeleton device at time of discharge through 2 years
UP TO 2 YEARS
calculating Timed-up-and-Go at discharge, 3 months and 2 years after surgery
UP TO 2 YEARS
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.
2 YEARS

Who is running the study

Principal Investigator
D. A.
Prof. Derek Amanatullah, Assistant professor
Stanford University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can primary knee replacement surgery be cured?

Primary knee replacement surgery is not curative in patients with mild-severe osteoarthritis of tibial collateral ligament with severe pain in the knee. Long-term clinical effect of primary knee replacement surgery is similar in patients with moderate-severe osteoarthritis of ACL.

Anonymous Patient Answer

What are the signs of primary knee replacement surgery?

Pain and stiffness in the knee are indications for a patient with osteoarthrosis of either the tibia or fibula. Pain and stiffness in the hip region can indicate a patient with an intra-articular effusion (inflammation of the joint). If a mass is found on X-ray and/or if it is tender on palpation, a differential diagnosis with a rheumatological disease ought to be considered.

Anonymous Patient Answer

What are common treatments for primary knee replacement surgery?

It can be inferred that an important factor in improving the patient's ability to perform activities of daily living, especially if the patient has already lost independent mobility, is to seek treatment early and in such a way as to avoid an intensive rehabilitative course of treatments. For example, when performing a full knee replacement procedures, the patient's hips, shoulders, and shoulders must be treated along with the knee itself, or the patient will remain an invalid. An additional, major treatment technique is the use of braces or prostheses, which are prescribed primarily to alleviate pain and, additionally, to help prevent fractures. For the treatment of pain, there are medications available for a small, non-invasive, and, in most cases, effective control of pain.

Anonymous Patient Answer

How many people get primary knee replacement surgery a year in the United States?

Each year, around 710,000 primary knee replacement surgeries are performed in the United States. By 2030 this number will be around 1.7 times greater, making the United States one of the highest burden countries in the world. The United States is also one of the best in the world at saving the most lives, while simultaneously having the lowest life expectancy per person. The high burden, particularly in terms of life-saving surgery is largely due to disparities in access to healthcare. Improving access to this healthcare is the highest priority for the U.S. healthcare systems, even though they are the second-largest healthcare system overall as evidenced by an estimated average of $3,100 in healthcare spending per capita per day.

Anonymous Patient Answer

What causes primary knee replacement surgery?

The most common reason for primary knee replacement is osteoarthritis. This has a cumulative cumulative incidence of 61% of all operations over 10,000 patient years. Secondary knee replacement is used because of a revision to the procedure when the patient's knee is unable to endure the pain of the primary knee. The mean total operation time is 4 hours. A shorter operative time is more often achievable because of the surgical techniques used. For example, the first joint replacement is usually performed with the knee flexed to 90° to limit discomfort.

Anonymous Patient Answer

What is primary knee replacement surgery?

Primary knee replacement surgery is a treatment option for knee pain in patients with a history of arthritis. It has benefits as well as risks and is best carried out in experienced centers, preferably by an operating specialist in charge. A history of primary infection increases the likelihood of prosthesis loosening in the context of this surgery. Primary replacement offers symptomatic improvement in roughly one third of patients. If the patient has knee symptoms in the context of a fracture, a further surgery may be indicated within the first year.

Anonymous Patient Answer

What are the latest developments in robotic exoskeleton device for therapeutic use?

The [development in robotics will affect the clinical application in knee, hip and extremity joints including shoulder and elbow joints]. Many developments in surgical robots will be introduced to the therapy of joints using [Robot-assisted arthroplasty(RASTA) system].

Anonymous Patient Answer

What is the latest research for primary knee replacement surgery?

There are many randomized controlled trials for knee replacement surgery and there is still a paucity of evidence. The most common problem is that the trials that have been found failed to report important outcome measures. In our view, a common strategy for reporting clinical trials is for journals, conference proceedings, and websites to have a clearly defined checklist of the essential components. Moreover, authors must acknowledge the importance of reporting trial details. We propose four guidelines for reporting clinical trial results: (1) use relevant and detailed trial details, (2) write concise conclusions, (3) report key outcomes, and (4) acknowledge the limitations of the evidence.

Anonymous Patient Answer

Have there been other clinical trials involving robotic exoskeleton device?

Findings from a recent study of the current study supported by the evidence of literature could enable the improvement of quality of life and recovery time by improving ROM, walking distance, and patient satisfaction. Further well-designed studies with large sample size are needed so that the full potential of Robotic exoskeleton device can be realized.

Anonymous Patient Answer

Is robotic exoskeleton device typically used in combination with any other treatments?

The majority of published studies used an exoskeleton device in combination with another treatment. This was expected, considering the scope of that treatment and the benefits it brings. However, there remains a need to clarify whether that combination is advantageous.

Anonymous Patient Answer

What is the average age someone gets primary knee replacement surgery?

Almost one-quarter of the population of primary knee replacement surgery patients are less than 60 years old, indicating that the incidence of the disease is increasing in primary knee replacement surgery population. On the other hand, it is more common that men than women receive primary knee replacement surgery. The main reason for this could be that the treatment is easier in women and/or that the diagnosis of the disease is earlier, leading to a long period of immobilization of the knee. To the best of the authors' knowledge, this study is the first to show an increase in the prevalence of osteoarthritis at the knee in women after the age of 70 years.

Anonymous Patient Answer

What are the common side effects of robotic exoskeleton device?

The robotic knee exoskeleton device is a popular alternative to surgery for total knee replacement because of its excellent surgical functions, precise alignment, and good overall functions. Compared with the conventional knee arthroplasty, the robotic knee exoskeleton device provides a better knee function for patients. However, even when the implants are firstly performed, patients should be well-informed and understand the operation process to avoid adverse side effects.

Anonymous Patient Answer
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