RecruitingOBSERVATIONAL

ORIGIN® vs. VANGUARD® PS Observational Study

This study is looking at two types of knee replacement systems, called ORIGIN and VANGUARD. The main goal is to find out which system leads to greater patient happiness after surgery. Researchers will also be checking how well the ORIGIN system performs in knee replacement operations that happen every day in hospitals. They want to see how it works for many patients over two years. This information will help doctors understand the best options for people needing a new knee joint. The study involves comparing patients who receive one system with those who receive the other. It's an observational study, meaning doctors will simply watch and record how patients do after their surgery.

At a glance

Status

Recruiting

Sponsor

Symbios Orthopedie SA

Enrolment target

140

Start

25 Mar 2021

Estimated completion

01 Feb 2027

Arthroplasty Replacement Knee

What is this study about?

This study is about knee replacement surgery, which is a common operation for people with severe knee pain or damage. When you have a knee replacement, surgeons use special parts called implants to replace the worn-out parts of your knee joint. There are different types of these implants available, and this study focuses on two of them: the ORIGIN PS System and the VANGUARD PS System.

The main aim of this research is to see which of these two knee replacement systems makes patients happier and more satisfied after their surgery. Researchers also want to carefully observe how well the ORIGIN system works in real-life hospital settings. They will be looking at things like how quickly people recover, how much pain they have, and how well they can move their knee after the operation.

By comparing these two systems and closely watching many patients who receive the ORIGIN system, doctors hope to learn more about which implants are most effective and lead to the best results for people having total knee replacement surgery. This information can help improve future knee replacement treatments for everyone.

Key takeaways

Compares two different knee replacement systems: ORIGIN and VANGUARD.
Aims to understand patient satisfaction and system performance after surgery.
Involves patients having total knee replacement surgery.
Requires follow-up for two years after the operation.
Anyone 18 or older having knee replacement surgery may be eligible.

Who may be eligible?

This study is looking for both men and women who are at least 18 years old. There's no upper age limit, so older adults can also take part. The most important thing is that you are having a total knee replacement operation.

To join, you would need to be suitable for knee replacement surgery in general. The doctors running the study will check your health to make sure you can safely take part. They will also look at other specific details about your medical history and current health conditions because certain things might mean you can't join.

If you're interested, the study team at the hospital would discuss these details with you. They will explain exactly what they are looking for and answer any questions you have to help you decide if it's right 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 planning to have a total knee replacement operation?
Are you able to attend follow-up appointments for two years?
Do you want to help improve future knee replacement treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have a total knee replacement operation, just as planned. During your surgery, you would receive either the ORIGIN PS System or the VANGUARD PS System as your new knee joint. The study is designed to include a total of 140 patients.

After your surgery, the study team would follow up with you regularly for two years. These follow-up visits or phone calls would involve checking how your new knee is doing, how you're feeling, and answering some questions about your satisfaction and pain levels. You might also have physical examinations to assess your knee's movement and strength. The exact number and timing of these check-ups would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in this study could offer some benefits, such as contributing to new knowledge that may improve knee replacement surgery for others in the future. You would also receive close monitoring of your recovery. As with any surgery, there are potential risks associated with knee replacement itself, such as infection, pain, or problems with the implant. The specific risks related to the knee systems being studied are similar to those of standard knee replacements. Your safety is paramount, and if you choose to participate, you would receive the same high standard of care as any patient. Remember, you can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Medical Center of Johannes Gutenberg-University Mainz
Verified postcode
Mainz, Germany· Recruiting

Common questions

What is a knee replacement?

A knee replacement is surgery to replace damaged parts of your knee joint with artificial parts, called implants, to relieve pain and improve movement.

What's the difference between the two knee systems?

The study is comparing two different types of knee implants, ORIGIN and VANGUARD, to see which one performs better and makes patients happier after surgery.

Will I know which knee system I receive?

Because this study is 'randomised,' you won't choose which system you get. The study team will assign you to one or the other, and sometimes this is done without you or your doctor knowing, to ensure fair results.

How long will I be involved in the study?

If you join, the study team will follow your progress and check on you for two years after your knee replacement surgery.

What does 'observational' mean?

It means the doctors will simply observe and record information about how you recover and how your knee works after surgery, rather than giving you any extra treatments or tests that aren't part of usual care.

How to find out more

Lukas Eckhard

lukas.eckhard@unimedizin-mainz.de +496131177302 Official trial record

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