RecruitingPHASE4INTERVENTIONAL

Using ROSA for Challenging The TKA Standard of Care

This study looks at different ways to perform knee replacement surgery for people with knee arthritis. The main goal is to compare the usual surgical approach with a new method that uses a robotic arm called ROSA. Researchers want to see if using ROSA, with two slightly different ways of making the cut (parapatellar or subvastus), can lead to better results for patients. These better results could include improved pain relief, easier recovery, and overall higher satisfaction with their new knee. Participants will be followed for a year to check their recovery, how well their knee works, and their overall activity levels. This is to find the best way to help patients with knee osteoarthritis.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

16 Apr 2024

Estimated completion

01 Dec 2025

Knee Osteoarthritis

What is this study about?

Imagine your knee has severe arthritis, causing pain and making it hard to move. A total knee replacement (TKA) is a common operation to help. Usually, surgeons follow standard steps to replace the worn-out parts of your knee. This study is testing if a new technology, a robotic arm called ROSA, can help surgeons do an even better job.

ROSA helps surgeons be very precise when placing the new knee parts. Think of it like using a very smart guide during surgery. This study wants to find out if using this robotic help makes a difference in your recovery, how well your knee works, and if you're happier with the results one year after surgery. They're comparing the standard way with two slightly different robotic-assisted methods.

Traditionally, knee replacements aim for a perfectly straight leg. However, some newer ideas suggest that aligning the new knee closer to your natural leg shape might feel more comfortable and work better for some people. This study explores these ideas, hoping to find surgical approaches that lead to even better outcomes and satisfaction for individuals needing a total knee replacement.

Key takeaways

Compares standard vs. robotic-assisted knee replacement.
Aims to improve patient satisfaction and knee function.
Follow-up for one year to track recovery.
Participation involves random assignment to a treatment group.
Suitable for people with knee osteoarthritis aged 21-80.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would generally need to have ongoing knee pain from osteoarthritis that requires a knee replacement. Your age should be between 21 and 80 years old, and you need to be willing and able to come to all your follow-up appointments and complete any questionnaires.

There are also reasons why you might not be able to participate. For example, if you have an active infection, a serious medical condition that makes major surgery risky, or certain other types of inflammatory arthritis, you wouldn't be suitable.

Additionally, if you have very severe deformities in your knee, previously had certain types of knee trauma or surgery, or have a condition that affects your ability to walk, you might not be eligible. The study also cannot include individuals with specific bone issues that would require special implants.

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 osteoarthritis that needs a joint replacement?
Are you between 21 and 80 years old?
Can you attend follow-up appointments for a year?
Do you have a relatively stable knee structure without major deformities?
Do you not have an active infection or other serious medical conditions preventing 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 one of three groups: the standard knee surgery group or one of two groups using the ROSA robotic assistance. After your surgery, you will have several follow-up appointments over one year. These appointments will involve checking your recovery, how well your knee is moving, and possibly taking images like X-rays. You'll also be asked to complete questionnaires about your pain and how your knee feels, and your activity levels might be monitored. Some visits may also involve blood and tissue samples to understand your body's healing response. The total duration of your active participation, including follow-up, will be one year.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving a novel, potentially improved surgical approach that might lead to better long-term outcomes and satisfaction. However, as with any surgery, there are always risks, including those associated with anaesthesia, infection, blood clots, or complications from the surgery itself. Since you'll be randomly assigned a treatment, you might receive the standard surgery or the new robotic method. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital
Verified postcode
London, Canada· Recruiting

Common questions

What is ROSA?

ROSA is a robotic arm that helps surgeons during knee replacement surgery to be very precise when placing the new knee parts.

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

No, you will be randomly assigned to one of the three groups, meaning you won't choose which method you receive.

How long does the study last?

Your involvement in the study will last for one year after your surgery, with follow-up appointments during that time.

Is this a new type of knee replacement?

It's not a new knee replacement itself, but a new way of helping the surgeon perform the standard knee replacement more precisely.

Who is funding this study?

The information provided does not specify the funding source for this trial.

How to find out more

Lyndsay Somerville, PhD

lyndsay.somerville@lhsc.on.ca (519) 685-8500 Official trial record

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