Active not recruitingOBSERVATIONAL

ORIGIN® PS Modular & Associated Instruments

This research is investigating a new type of knee replacement device, called ORIGIN® PS Modular, for people undergoing a total knee replacement operation. The main goal is to understand how safe and effective this new device is. To do this, doctors will look at how many patients might need another operation on the same knee within two years. They will also measure how much people's knee function and comfort improve after surgery using a special scoring system. The study hopes that patients will feel a big improvement in their knee's natural feel during the first year, with continued good results and better overall satisfaction after two years with the new knee replacement.

At a glance

Status

Active not recruiting

Sponsor

Symbios Orthopedie SA

Enrolment target

200

Start

18 Apr 2023

Estimated completion

01 Sep 2025

Total Knee Replacement

What is this study about?

Imagine you need a new knee because yours is causing pain and making it hard to move. This study is all about a specific new type of knee replacement called ORIGIN® PS Modular. It's designed to help people who are having their knee replaced for the first time. The doctors and researchers want to make sure this new knee replacement is both safe and effective for patients.

To check for safety, they will be looking at how many people might need more surgery on that knee within two years after the first operation. It's normal for doctors to track this kind of information to understand how well a new medical device performs over time. They also want to see how well the new knee helps people move and feel. They'll use a special scoring system to measure improvements in knee function and overall comfort at different times after the surgery.

The researchers have a good feeling that people who receive this new knee replacement will notice a big improvement in how their knee feels and works, especially in the first year. They also expect that people will be generally happier with their new knee after two years. This study is important because it helps doctors understand if this new knee replacement can offer a good solution for patients needing a total knee replacement.

Key takeaways

This study is testing a new knee replacement called ORIGIN® PS Modular.
It aims to check the safety and how well the new knee helps people move.
Patients will be followed for two years after their surgery.
It's for people having their first total knee replacement.
The goal is to see if it improves knee comfort and function for patients.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or over. You must be having your very first total knee replacement, meaning you haven't had a full or partial knee replacement before. It's also important that you're able to understand the study and agree to take part, or have a legal guardian who can do so for you. You should also live in a stable place and be willing to come back for all the planned follow-up appointments.

There are also some reasons why you might not be able to join the study. For example, if you have any active infections, problems with your muscles, ligaments, nerves, or blood flow, or if your bones are too weak. You also can't participate if you have very severe issues with the shape of your knee, certain allergies to the materials used in the knee replacement, or other health problems that could affect how well the new knee works or heals.

Finally, if you have existing metal implants (like a screw or plate) that might get in the way of the new knee replacement, or if you have certain types of severe bone loss in your knee, you wouldn't be able to join this study. The doctors need to make sure the new knee can be properly fitted and work well for you.

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?
Are you having your very first total knee replacement?
Are you able to attend follow-up appointments for two years?
Are you free from severe infections or significant bone weakness?
Do you have no severe deformities or allergies to knee replacement materials?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be followed for a total of two years after your knee replacement surgery. During this time, the hospital staff will collect information about your health. You will have your knee replacement surgery as planned, and then you will have follow-up appointments at specific times, usually between 2 and 6 months, at 1 year, and at 2 years after your operation. At these appointments, the doctors will check on your knee and ask you questions about how you are feeling and how well your knee is working. They will use specific questionnaires, like the Knee Society Score, to measure your knee's function and any improvements you experience. You might also be asked to complete some self-report scores from home. No extra medication is involved; it's about observing how this specific knee replacement works for you.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the new ORIGIN® PS Modular knee replacement proves to be very effective, leading to improved knee function and satisfaction. However, as with any surgery, there are always potential risks, including those generally associated with total knee replacement surgery. These could include infection, blood clots, nerve damage, or issues with the implant itself, although the study is specifically designed to monitor safety. It's important to remember that you are free to withdraw from the study at any time without it affecting your medical care.

Locations (2)

Polyclinique Medipole Saint Roch
Verified postcode
Cabestany, France
Clinique Juge
Verified postcode
Marseille, France

Common questions

What is a 'postero-stabilized' knee replacement?

It's a type of knee replacement that has a special design feature, often involving a post and cam mechanism, to help give the knee more stability and mimic the action of one of your natural ligaments.

Will I get special treatment if I'm in the study?

You will receive excellent care, just like any other patient undergoing knee replacement surgery. The main difference is that your progress will be closely monitored as part of the study requirements to gather information about this specific device.

How long will the study last for me?

Once you have your surgery, you will be followed for two years. You'll have check-ups at a few specific times during that period.

What is the Knee Society Score (KSS)?

It's a common scoring system doctors use to measure how well your knee is working and how much pain you have, to track your progress after knee replacement surgery.

Will my information be kept private?

Yes, all your personal and medical information will be kept strictly confidential according to privacy laws and research guidelines.