RecruitingPHASE4INTERVENTIONAL

Kinematic and Mechanical Alignment Randomized Trial

If you need a knee replacement for arthritis, this study is looking into two different ways surgeons can fit your new knee. One is the traditional approach, called 'mechanical alignment', which aims to make everyone's knee perfectly straight. The other is a newer, more personalised method called 'restricted kinematic alignment', which tries to match your knee's natural shape more closely. We're using robot-assisted surgery to make sure each method is done very precisely. The main goal is to find out which technique gives patients better results, a more natural feel, and improves how well they can use their knee after surgery. You'd be randomly assigned to one of the two surgery types and we'd check your progress afterwards.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

McMaster University

Enrolment target

260

Start

20 Feb 2025

Estimated completion

01 Feb 2029

Total Knee Arthroplasty Osteoarthritis

What is this study about?

Knee replacement surgery is a common operation in the UK for people suffering from very painful knee arthritis. While it's generally very successful at easing pain and helping people move better, some patients still feel their knee isn't quite right afterwards. This might be because the new knee doesn't always move as naturally as their original one, or they might still have some discomfort.

Traditionally, during a knee replacement, surgeons have aimed to make everyone's knee as straight as possible, a method known as 'mechanical alignment'. The idea behind this is to help the new knee last a long time. However, everyone's knee shape is unique, and some experts believe it makes more sense to fit the new knee in a way that respects these individual differences. This newer approach is called 'restricted kinematic alignment' and tries to place the new knee in a way that matches your natural knee shape and movement more closely.

This study wants to figure out which of these two methods leads to better results for patients. We believe that the more personalised 'restricted kinematic alignment' might make your knee feel more natural, be more stable, and give you better overall movement. Both types of surgery in this study will be done using robotic assistance, which helps surgeons place the new knee very accurately. By doing this, we hope to understand if a more personalised approach truly makes a difference to how you feel and move after your knee replacement.

Key takeaways

Compares two knee replacement techniques: traditional straight alignment and personalized natural alignment.
Both surgery types use robotic assistance for high precision.
Aims to find which method gives patients a more natural-feeling knee and better movement.
Involves check-ups and simple walking tests for two years after surgery.
Helps advance understanding for future knee replacement patients.

Who may be eligible?

You might be able to join this study if you are an adult, aged 18 or over, and you need a total knee replacement because of knee arthritis. It's really important that you can understand the study information and agree to take part.

However, you won't be able to join if you've already had a knee replacement on that knee, or if you're having both knees replaced at the same time. If you've recently had another leg or foot injury or surgery that might affect how you walk, this study might not be right for you. Also, you need to be able to have a special scan called a CT scan before your surgery. If you can't have this scan, or if you're unable or unwilling to follow the study's plan, you won'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 need a total knee replacement for arthritis?
Can you understand the study details and agree to take part?
Have you NOT had a knee replacement on the same knee before?
Are you NOT having both knees replaced at the same time?
Can you have a CT scan before your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be randomly assigned to receive one of two types of knee replacement surgery: either the standard 'mechanical alignment' or the newer, more personalised 'restricted kinematic alignment'. Both surgeries will be performed with the help of a robot to ensure very precise placement of your new knee.

Before your surgery, we'll ask you to do some tasks in a special area with cameras that measure how you walk. You'll also fill out some questionnaires about your knee pain and how well you can do daily activities. We'll ask you to repeat these walking tests and questionnaires at 6 months and 12 months after your surgery. You'll also complete questionnaires at 24 months after your surgery. The total duration of your active involvement in the study will be about two years.

Potential risks and benefits

Participating in this study might offer you the potential benefit of a state-of-the-art robot-assisted knee replacement, and could help us discover which surgical method leads to better, more natural outcomes for patients like you in the future. As with any surgery, there are potential risks associated with knee replacement, such as infection or issues with healing, and these risks are the same whether you're in the study or not. There are no additional surgical risks specifically from being part of this research. You are free to withdraw from the study at any time without affecting your future medical care.

Locations (1)

St. Joseph's Healthcare
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is the difference between the two types of knee surgery?

One type, 'mechanical alignment', aims to make your knee perfectly straight. The other, 'restricted kinematic alignment', tries to match your knee's natural shape more closely.

Will both surgeries use robotic assistance?

Yes, regardless of which type of surgery you receive, it will be done with robotic assistance for very precise results.

How long will I be involved in the study?

You'll be involved for about two years, with check-ups and questionnaires over that time following your surgery.

What kind of tests will I have?

You'll do some walking tests in a special motion lab and fill out questionnaires before and after your surgery.

Can I choose which surgery type I get?

No, you'll be randomly assigned to one of the two surgery types, like drawing lots, to keep the study fair.

How to find out more

Kim Madden, PhD

maddenk@mcmaster.ca 289-237-7380 Official trial record

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