RecruitingOBSERVATIONAL

VRAS (Velys Robot-Assisted Solution) Operational Excellence Study

This study looks at a new way to do total knee replacement surgery using a robot called VRAS, compared to the traditional surgical method. Knee replacement operations are becoming more common, which can put a strain on hospitals and surgical teams. While robots are being used more for their precision, there's a question about whether they make surgeries take longer. This research aims to understand if the robot-assisted approach improves how quickly surgeries are set up, how efficient they are, how much work the surgical team has, the number of instruments needed, and the overall cost. Around 10 hospitals across Europe and the UK will take part, with experienced surgeons performing both types of surgery.

At a glance

Status

Recruiting

Sponsor

DEO NV

Enrolment target

Start

27 Aug 2024

Estimated completion

01 Jul 2026

Total Knee Arthroplasty (TKA)

What is this study about?

This study is designed to help us understand the differences between traditional knee replacement surgery and a newer method that uses a special robot called VRAS (Velys Robotic Assisted Solution). Total knee replacement is a common operation, and as more people need it, hospitals and surgical teams can get very busy. Technology like robotic assistance is being introduced to try and make these operations more precise and efficient. However, some people wonder if using a robot might actually make the surgery take longer.

The main goal of this research is to see if the robot-assisted surgery changes several important things. They want to find out if it makes the operating room (OR) setup quicker or simpler, how smoothly the surgery itself runs, how much work the surgical team needs to do, if fewer different instruments are needed, and how it affects the overall cost for the hospital. By looking at these factors, the study hopes to figure out if the robot-assisted method is a better or more efficient way to perform knee replacements.

To make sure the results are reliable, this study will take place in 10 different hospitals across Europe and the UK. In each hospital, an experienced knee surgeon will perform both the traditional and the robotic-assisted knee replacement surgeries. For each surgeon, at least five robot-assisted operations and five traditional operations will be carefully watched. The way the operating room is set up will be kept consistent for all surgeries within the same hospital, which helps to ensure a fair comparison.

Key takeaways

This study compares traditional knee replacement surgery with robot-assisted surgery (VRAS).
It aims to find out if robot assistance makes surgeries more efficient, quicker, or less costly for hospitals.
Data will be collected by observing experienced surgeons in 10 hospitals across Europe and the UK.
The research focuses on how surgeries are performed, not on testing new treatments for patients.
Potential benefits are for future patients and healthcare systems, through improved surgical practices.

Who may be eligible?

To explain who can take part, this study is actually focusing on the surgeons who perform the operations, rather than the patients. It's about comparing the surgical methods themselves. So, if you are a patient, you wouldn't directly "join" this study in the same way you might a new drug trial.

However, if you are an orthopaedic surgeon who routinely performs both traditional knee replacement surgery and also uses the VRAS robot for knee replacements, you might be someone the researchers would consider for this study.

Patients aged 18 to 100 facing a knee replacement from a surgeon involved in this study might have their surgery observed as part of the data collection on the different surgical methods. Anyone else, such as surgeons who don't perform both types of surgery, would not be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an orthopaedic surgeon who performs both traditional and robot-assisted knee replacements?
Do you want to contribute to research on surgical efficiency?
Are you based in one of the selected countries in Europe or the UK?
Are you able to allow researchers to observe several of your surgeries?

Answer every question to see your result.

What does participation involve?

If a surgeon is chosen to participate, they would continue performing total knee replacement surgeries as they usually do, using both the traditional method and the VRAS robot. Researchers would then observe and record details about at least five robot-assisted surgeries and at least five traditional surgeries performed by that surgeon. This would involve collecting information about the operating room setup, how long things take, how the team works, the instruments used, and financial aspects. This study focuses on observing standard procedures and does not involve any additional visits, assessments, medication, or follow-up for patients beyond their usual care.

Potential risks and benefits

Patients who have knee replacement surgery by a surgeon involved in this study will receive the standard of care for their procedure, whether it's traditional or robot-assisted, meaning no additional risks are expected from the study itself. The potential benefit of this research isn't directly for individual patients, but rather for future patients, by helping healthcare providers understand if robot-assisted surgery can lead to more efficient and potentially better outcomes for knee replacements overall. While this study does not directly involve patient participation in decision-making, patients always have the right to discuss their treatment options and any concerns about their care with their surgeon.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Circle health group - BMI The Park hospital
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is VRAS?

VRAS (Velys Robotic Assisted Solution) is a type of robot that helps surgeons perform knee replacement operations more precisely.

Is this study about a new medicine?

No, this study is not about new medicines. It's comparing two different ways of doing knee replacement surgery: traditional and robot-assisted.

Will patients in the study get special treatment?

Patients will receive their usual knee replacement surgery, either traditional or robot-assisted, from an experienced surgeon. The study is observing these standard procedures, not changing them.

Who is expected to benefit from this research?

The results of this study could help hospitals and surgeons decide on the best and most efficient ways to perform knee replacements in the future, potentially benefiting many patients.

Are patients directly involved in making choices for this study?

No, this study observations the existing practices. Your surgeon will decide which type of surgery is best for you, as they usually would.

How to find out more

Aline BR Vandeputte, Msc.

aline@deo.care +32469154039 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.