RecruitingNAINTERVENTIONAL

Functional Impact at 12 Months Post-op of Posterior Cruciate Ligament Conservation During Robotic-assisted Surgery (MAKO) for Total Knee Replacement.

This research is looking at robotic-assisted total knee replacement surgery. Specifically, it wants to find out if keeping a particular ligament in your knee, called the posterior cruciate ligament (PCL), makes a difference to how well your knee works one year after the operation. Most previous studies on this topic were done before robotic surgery became common. Robotic surgery offers more precision, so doctors are keen to see if keeping the PCL, which helps with knee stability, leads to better outcomes now. The study aims to compare patients who have the PCL preserved with those who have it removed during their surgery to see if one approach leads to a better recovery and overall knee function.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

300

Start

10 Oct 2025

Estimated completion

01 Sep 2028

Knee Arthroplasty, Total

What is this study about?

When you have a total knee replacement, surgeons replace damaged parts of your knee joint with artificial ones. One important decision they make during the surgery is whether to keep or remove a natural ligament called the posterior cruciate ligament, or PCL. This ligament is like a strong band that helps keep your knee stable, stopping it from sliding too far forward or backward, and it helps with bending.

Traditionally, there's been a debate among doctors about whether keeping the PCL makes a real difference to how well people recover and use their knee after surgery. However, new robotic technology is now being used for knee replacements. This technology allows surgeons to carry out the operation with much greater accuracy and control. Because of this improved precision, doctors want to re-examine if keeping the PCL helps patients more when using these advanced robotic methods.

This study will compare patients undergoing robotic knee replacement where the PCL is kept versus patients where it is removed. The main goal is to understand if one approach leads to better knee function and fewer problems 12 months after the operation. We hope this research will help doctors decide the best way to perform these crucial surgeries in the future.

Key takeaways

Compares two ways of doing robotic knee replacement surgery.
Investigates if keeping a knee ligament (PCL) leads to better recovery.
Focuses on knee function 12 months after the operation.
Uses new robotic technology for precise surgery.
Aims to improve future knee replacement techniques.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over, who is scheduled for your first robotic-assisted total knee replacement using the MAKO system. Your surgery can be on either your left or right knee. You must also be able to answer questionnaires about your health and be willing to attend follow-up appointments for 12 months after your surgery. Most importantly, you need to understand what the study involves and agree to take part by signing a consent form.

However, some people won't be able to join. This includes if your surgeon finds it impossible to keep your PCL during the operation, or if you've already had surgery on this ligament before. You also can't take part if your knee arthritis was caused by a major injury, or if you have a specific type of knee bend that is very pronounced. If you have any infection, are pregnant, or are already involved in another study that involves treatments, you won't be eligible. Also, individuals under legal protection or who cannot understand the study information won't be able to participate.

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 or older?
Are you having your first robotic-assisted knee replacement?
Can you answer questionnaires in English?
Are you willing to attend follow-up appointments for 12 months?
Have you *not* had previous PCL surgery on this knee?
Are you *not* pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be scheduled for a robotic-assisted total knee replacement. During the surgery, the decision to keep or remove your PCL will be made based on the study's protocol. After your operation, you will need to complete questionnaires about your knee function and overall recovery. You will also have follow-up appointments with your medical team over the course of 12 months to monitor your progress. The total duration of your participation in the study will be 12 months, tracking your recovery from the time of your surgery.

Potential risks and benefits

The main benefit of taking part is contributing to important medical knowledge that could improve knee replacement surgery for many people in the future. You will receive standard high-quality care for your knee replacement. As with any surgery, there are potential risks, including those associated with total knee replacement itself. The specific risks related to keeping or removing the PCL are what the study is trying to understand better. You are free to withdraw from the study at any time without affecting your medical care.

Locations (3)

Clinique Tivoli-Ducos
Verified postcode
Bordeaux, France· Recruiting
Hôpital Croix Rousse
Verified postcode
Lyon, France· Recruiting
Nîmes University Hospital
Verified postcode
Nîmes, France· Recruiting

Common questions

What is the PCL?

The PCL is a strong ligament inside your knee that helps keep it stable and stops it from moving too much. It's like a natural support band.

What is robotic-assisted surgery?

This is a type of surgery where doctors use a special robot to help them perform the knee replacement with very high precision and accuracy, guiding the surgical tools.

Will I know if my PCL was kept or removed?

Yes, your study doctor will discuss this with you, and the decision will be part of the study's design to compare both approaches.

Will I have extra appointments if I join?

You will have regular follow-up appointments for 12 months after your surgery, which are part of the study to check your recovery. These appointments are usually part of standard care, but the study will specifically collect information at these visits.

What if I change my mind about participating?

You have the right to withdraw from the study at any time, for any reason, and it will not affect the quality of medical care you receive.

How to find out more

Rémy COULOMB, Dr

remy.coulomb@chu-nimes.fr +334.66.68.31.56 Official trial record

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