RecruitingOBSERVATIONAL

Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Doctors are running a study to compare two types of knee replacement surgery for people with conditions like osteoarthritis or rheumatoid arthritis affecting their knee. One method uses a computer navigation system called OrthoPilot Elite, and the other uses a robot called MAKO to help with the surgery. This research will look at how safe and effective each method is. The main goal is to see if patients get similar good outcomes, like less pain and better movement, no matter which surgical technique is used. It's a randomised study, meaning participants will be assigned to one method by chance, and it's happening at one hospital.

At a glance

Status

Recruiting

Sponsor

Aesculap AG

Enrolment target

140

Start

03 Jul 2024

Estimated completion

01 Dec 2028

Osteoarthritis, Knee Joint Diseases Rheumatoid Arthritis of Knee Posttraumatic Arthropathy

What is this study about?

This study is looking into two different ways that surgeons perform total knee replacement surgery. A total knee replacement, often called TKA, is an operation to replace a damaged knee joint with an artificial one. This surgery is usually done for people who have severe knee pain and stiffness, often due to conditions like osteoarthritis, rheumatoid arthritis, or problems from old injuries.

The two techniques being compared are called 'navigation-assisted' and 'robot-assisted.' In navigation-assisted surgery, the surgeon uses a computer system (like the OrthoPilot Elite) that provides real-time information and guidance to help place the new knee joint very precisely. In robot-assisted surgery, a robotic arm (like the MAKO system) helps the surgeon follow a pre-planned surgical path with great accuracy.

The main aim of this research is to compare the results of these two surgical methods. Doctors want to find out if patients who have robot-assisted surgery have a similar recovery and long-term experience to those who have navigation-assisted surgery. They will look at things like pain levels, how well patients can move their new knee, and their overall quality of life. The study hopes to show that both methods are equally good at helping people get back to living active lives with less knee pain.

Key takeaways

Compares two knee replacement techniques: computer-navigated and robot-assisted.
Aims to see if both methods give similar good results for knee arthritis.
You'll be randomly assigned to one of the two surgery types.
Study involves surgery and follow-up appointments to track recovery.
For adults aged 18-90 needing a knee replacement due to arthritis.

Who may be eligible?

To join this study, you must be an adult between 18 and 90 years old and need a total knee replacement because of arthritis. You'll also need to agree in writing to take part in the study and be willing to come back for follow-up appointments after your surgery.

There are certain reasons why you might not be able to join. For example, if you are pregnant, or if tests show that you have other serious health problems that could make surgery too risky, you wouldn't be able to participate. Also, if a specific part of your kneecap needs a special type of replacement that isn't covered by this study, you wouldn't be eligible.

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 between 18 and 90 years old?
Do you need a total knee replacement for arthritis?
Are you able to attend follow-up appointments after surgery?
Are you not currently pregnant?
Do you understand and agree to sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a total knee replacement surgery. Before your surgery, you will be randomly assigned to either the navigation-assisted or robot-assisted surgical group (like flipping a coin). After your surgery, you will have regular follow-up appointments over a period of time, where doctors will check your recovery, pain levels, and how well your new knee is working. These appointments might involve physical examinations and answering questionnaires. The exact number and timing of these visits will be explained to you in detail, but they are important for the study to track your progress.

Potential risks and benefits

Taking part in this study means you'll receive a standard knee replacement surgery, which aims to reduce your pain and improve your knee function. You might benefit from the close monitoring and care that comes with being part of a research study, but there’s no guarantee your outcome will be better than if you had the surgery outside the study. As with all surgeries, there are potential risks like infection, bleeding, or problems with the new joint, which your doctor will discuss with you. Remember, you can choose to leave the study at any time without affecting your medical care.

Locations (1)

Bundeswehr Krankenhaus Ulm
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is osteoarthritis?

Osteoarthritis is a common type of arthritis where the protective cartilage on the ends of your bones wears down over time, causing pain, swelling, and stiffness.

What's the difference between navigation-assisted and robot-assisted surgery?

Both use technology to help the surgeon. Navigation-assisted provides a real-time computer guide, while robot-assisted uses a robotic arm to help the surgeon make very precise cuts.

Will I know which type of surgery I'm getting?

Yes, before your surgery, you will be told if you are in the navigation-assisted or robot-assisted group, as you will be randomly assigned.

Is a total knee replacement a big operation?

Yes, it's a major surgery that involves replacing parts of your knee joint with artificial components. It usually requires a hospital stay and a period of rehabilitation.

How long will I be followed up after surgey?

The study will involve regular check-ups after your surgery for a period of time to track your recovery. The exact duration will be explained to you.

How to find out more

Kristin Maier, Dr.

info@aesculap.de +49746195 Official trial record

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