Not yet recruitingNAINTERVENTIONAL

Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis

This research is looking into two types of total knee replacement surgery for people with knee osteoarthritis. One is the traditional ‘manual’ surgery, and the other uses a new device called the VELYS Robotic-Assisted Solution. The main goal is to find out if the robotic-assisted surgery leads to better results for patients, such as less pain, improved movement, and overall happiness with their new knee. Researchers will also check if the robotic method is safer, leads to fewer complications, and if patients recover faster or have a shorter hospital stay. They'll also consider the economic effects and how healthcare teams adapt to this new technology.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Golden Jubilee National Hospital

Enrolment target

346

Start

08 May 2026

Estimated completion

08 May 2030

Knee Osteoarthritis Osteoarthritis (Knee)Osteo Arthritis of the Knee Osteo Arthritis Osteoarthritis (OA)Osteoarthritis Osteoarthritis in the Knee

What is this study about?

This study is designed to help us understand if a newer, robotic-assisted way of performing total knee replacement surgery offers benefits over the traditional manual method. Both types of surgery are for people suffering from knee osteoarthritis, a common condition where the cartilage cushioning the knee joint wears away, causing pain and stiffness.

The main idea is to see if using the VELYS Robotic-Assisted Solution (VRAS) can lead to better outcomes for patients. This includes looking at things like how well patients can move their knee, how much pain they have, and how generally satisfied they are with their new knee. The study will also consider important practical aspects, such as whether the robotic method reduces the risk of further surgery later on, lowers the chance of complications, or shortens the time patients need to spend in hospital.

Beyond patient health, the research will explore how this new technology impacts the healthcare system. This involves looking at the costs involved, how efficient the process is, and how surgical teams learn to use the new equipment. By gathering all this information, doctors and healthcare providers can make more informed decisions about the best ways to treat knee osteoarthritis in the future.

Key takeaways

Compares traditional vs. robotic knee replacement for osteoarthritis.
Aims to find out if robotic surgery improves pain, function, and satisfaction.
Participation involves being randomly assigned to one surgery type.
Includes physical assessments, X-rays, and questionnaires over 12 months.
Long-term outcomes (up to 10 years) tracked via national health records.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be over 18 years old and have osteoarthritis in your knee requiring a full knee replacement. You should also be generally suitable for either the traditional or robotic-assisted surgery, and be able to understand and sign consent forms, as well as complete questionnaires throughout the study.

There are some reasons why you wouldn't be able to join. For example, if you have other types of arthritis that cause inflammation, significant pain in your hip, ankle, or other knee, or if you've already had a knee replacement or major injury to the knee being operated on. People with certain nerve or muscle conditions affecting how they walk, those with a very high body mass index (BMI over 45), or severe knee deformities might also not be eligible. If your bone loss is so severe that it would need special implants, or if you couldn't commit to the follow-up appointments and questionnaires, you also wouldn't be able to take part.

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 18 years old or older?
Do you have knee osteoarthritis and need a total knee replacement?
Are you able to provide written consent and complete questionnaires?
Do you have any other significant painful conditions in your hip, ankle, or other knee?
Do you have a very high BMI (over 45)?
Have you had a previous knee replacement or major injury to the knee being looked at?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive a total knee replacement using either the standard manual method or the new VELYS robotic-assisted method. You won't get to choose which one you receive.

Before your operation, you'll have an assessment at the clinic, which will include answering questionnaires and having an X-ray. After your surgery, you'll have follow-up appointments at 6 weeks, 6 months, and 12 months. At each of these appointments, you'll complete more questionnaires. You'll also have another X-ray at 6 months after your operation. A smaller group of participants will also have their movement analysed in a special laboratory before their surgery and again at 6 months.

After the 12-month appointment, you won't have any more direct clinic visits for the study. However, your long-term results, including any need for further surgery on your knee, will be monitored for up to 10 years using existing national health registries. This means the research team will track your progress through anonymous, routinely collected healthcare data, without you needing to do anything further.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving an innovative robotic-assisted surgery, which some evidence suggests could lead to better outcomes, though this is what the study aims to confirm. You would also be contributing valuable information that could improve future care for others with knee osteoarthritis. As with any surgery, there are potential risks, including those associated with knee replacement itself (like infection, blood clots, or nerve damage), and those specific to the study, such as uncertainty about which surgical method you'll receive. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Golden Jubilee University National Hospital
Verified postcode
Glasgow, United Kingdom

Common questions

What is knee osteoarthritis?

Knee osteoarthritis is a common condition where the protective cartilage in your knee joint wears away, leading to pain, stiffness, and difficulty with movement.

What's the difference between manual and robotic-assisted knee replacement?

Manual surgery is the traditional method, while robotic-assisted surgery uses a machine to help the surgeon with precision during the operation. Both aim to replace the damaged knee joint.

Will I get to choose which type of surgery I have?

No, if you participate in this study, you'll be randomly assigned to either the manual or robotic-assisted surgery, similar to a lottery.

How long will I be involved in the study?

You'll have clinic visits and assessments for 12 months after your surgery. After that, your results will be followed through national health records for up to 10 years.

Is this new robotic surgery available outside of the study?

The study aims to evaluate the benefits of this robotic system, so whether it becomes widely available often depends on the study's findings.

How to find out more

Jon V Clarke, PhD, FRCS (Tr & Orth)

jon.clarke@gjnh.scot.nhs.uk +44 (0)141 951 5564 Official trial record

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