RecruitingNAINTERVENTIONAL

Mako Cementless TKA vs Mako Cemented TKA

This research is looking into knee replacement surgery, specifically comparing two different methods for fitting the new knee joint. Both methods use a special robotic arm called Mako. One method uses bone cement to fix the new joint in place (cemented TKA), while the other allows the bone to grow directly onto the implant without cement (cementless TKA). The study wants to see which method leads to better long-term outcomes for patients with knee arthritis. Researchers will be checking things like how well the new knee works, what X-rays show, and how happy patients are with their new knee. It's hoped this study will help doctors choose the best way to do knee replacements for different people.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

120

Start

29 Sep 2025

Estimated completion

01 Aug 2031

Total Knee Replacement Total Knee Replacement Surgery Total Knee Arthroplasty Osteoarthritis (OA) of the Knee

What is this study about?

When you have a total knee replacement, the damaged parts of your knee joint are removed and replaced with artificial ones. This operation helps people who have severe knee arthritis, which causes pain and makes it hard to move.

This particular study focuses on how the new knee joint is attached to your existing bones. There are two main ways this is done: either with a special bone cement, or by using implants that have a special surface which your bone can grow onto, fixing it naturally without cement. Both methods in this study use a special robotic arm, called Mako, during the surgery. This robotic arm helps the surgeon to be very precise when placing the new knee parts.

The main goal of this research is to compare these two ways of attaching the knee implants to see which one works better over time. They will look at how well people can move their knee, what X-rays show about the implant, and how satisfied people are with their new knee. This is really important because, even though knee replacements are very successful, some people still feel their knee isn't quite right afterwards. Also, as more younger people are having knee replacements, doctors want to make sure the joint lasts as long as possible and gives the best results.

Key takeaways

This study compares two ways to fit knee replacement implants: with or without cement.
A robotic arm (Mako) is used for both types of surgery in the study.
The goal is to find out which method gives patients better long-term results.
Participants will be randomly assigned to receive either a cemented or cementless implant.
Regular follow-up appointments, including X-rays, will be needed after surgery.

Who may be eligible?

To be able to take part in this study, you would typically need to be over 18 years old and have painful knee arthritis that is severe enough to need a full knee replacement. Both you and your surgeon would need to agree that this operation is the best treatment for you. You must also be generally healthy enough to have surgery and be able to give your full permission to take part in the study and come to all the follow-up appointments.

There are certain reasons why someone might not be able to join. For example, if you have other serious health problems that make surgery very risky, or if your knee problem is complex and needs a very specific type of implant that isn't part of this study. If you've had a previous knee replacement on the same knee or a serious bone fracture there, you also wouldn't be able to participate.

Also, if you have a condition that affects your bones, like very weak bones (osteoporosis) detected by a special scan, or if you have difficulty moving around a lot due to other health issues, you might not be suitable for this research. Lastly, you need to be able to understand what the study involves and be willing to attend all the scheduled check-ups after your surgery.

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.

Do you have knee arthritis that is severe enough for surgery?
Are you generally fit and healthy enough for a major operation?
Are you over 18 years old?
Can you attend regular hospital appointments for several years after surgery?
Have you had no previous knee replacement or serious bone problems on the same knee?
Do you have normal bone strength (no severe osteoporosis)?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, you will have a total knee replacement operation. During your surgery, a robotic arm will be used to help the surgeon. You will be assigned by chance (like flipping a coin) to receive either a 'cemented' or a 'cementless' knee implant; neither you nor your surgeon will choose which one. After your operation, you will have regular check-ups at the hospital. These check-ups will include physical examinations to see how well your new knee is working, and X-rays to check the position and health of the implant. You'll also be asked questions about your pain, how easily you can move, and your general satisfaction with your knee. The study will continue for several years to see the long-term results of your new knee. You'll be told the exact schedule of visits and assessments if you're thinking of joining.

Potential risks and benefits

Like any surgery, there are potential risks with a knee replacement, such as infection, blood clots, or problems with the anaesthetic. Specific to this study, you will be randomly assigned one of the two implant methods, and while both are established treatments, one might theoretically have a different recovery or long-term outcome than the other. However, both methods are widely used and considered safe. A potential benefit of taking part is contributing to important research that will help improve knee replacement surgery for future patients. You might also receive very close monitoring of your new knee. Remember, you can decide to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

UCL Hospitals NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'Mako' robotic-arm?

It's a special tool that helps your surgeon place the knee replacement parts very accurately during the operation.

What's the difference between 'cemented' and 'cementless' knee replacements?

Cemented means the new knee parts are fixed with a special bone glue. Cementless means your bone grows directly onto the new parts to hold them in place.

Will I get to choose which type of implant I receive?

No, it's decided randomly, like drawing lots, to make sure the study results are fair and unbiased.

Why is this research important?

It helps doctors understand which method of fitting knee implants works best for patients in the long run, leading to better care.

Will my surgery and aftercare be different if I join the study?

Your surgery will use a robotic arm and the specific implant method assigned. Your follow-up will involve more regular checks to monitor your progress for the study.

How to find out more

Jenni Tahmassebi, BSc MSc

jenni.tahmassebi1@nhs.net +442034479403 Official trial record

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