RecruitingOBSERVATIONAL

Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type

This research wants to find out if people are happier with a special, custom-made knee replacement compared to a standard knee replacement implant. The study is for adults with knee arthritis (gonarthrosis) who are already planning to have a total knee replacement operation. Researchers will follow patients for two years after their surgery to compare how satisfied they are with their new knee. They'll also look at other important things like how well the knee works, how much pain people have, and their overall quality of life. The study aims to understand if the personalised implants offer a better experience for patients needing a knee replacement.

At a glance

Status

Recruiting

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

480

Start

27 Oct 2021

Estimated completion

31 Oct 2025

Gonarthrosis

What is this study about?

This study is looking into knee replacement surgery, which is a common operation for people with painful knee arthritis. When you have a knee replacement, a surgeon replaces the damaged parts of your knee with artificial parts, called implants or prostheses. There are different types of implants available.

This research specifically wants to compare two types of knee implants: the standard ones that are widely used, and newer, special implants that are custom-made to fit each person’s knee more precisely. The main goal is to see if people who receive the custom-made implants are more satisfied with their knee replacement two years after surgery compared to those who get standard implants.

Besides looking at patient satisfaction, the study will also compare other important things between the two groups. These include how well the knee moves and functions after surgery, how much pain people experience, and their general quality of life. Researchers will also check surgical details like how long the operation takes and how long people stay in hospital, as well as any problems that might occur after surgery.

Key takeaways

Compares standard vs. custom-made knee replacements.
Aims to see which type leads to greater patient satisfaction.
Looks at knee function, pain, and quality of life over two years.
For adults with knee arthritis already needing total knee replacement.
Your doctor decides if you need a knee replacement first.

Who may be eligible?

To join this study, you must be an adult man or woman who has agreed to take part. You must have painful knee arthritis, also known as gonarthrosis, in one or both knees, and your doctor must have already decided that you need a total knee replacement.

However, you won't be able to join if you've already had a knee replacement or surgery to reshape your knee (osteotomy) in the past. People who have had a knee fracture, or have certain types of arthritis (like inflammatory arthritis) or other health conditions that might affect how their knee works, also cannot participate.

Additionally, if you have a condition that makes it hard to understand or follow study instructions, or if you're already in another medical study or have been in one in the last three months, you wouldn't be able to join this particular research.

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 an adult (18 or over)?
Do you have knee arthritis (gonarthrosis)?
Has your doctor already told you that you need a total knee replacement?
Have you never had a knee replacement or certain other knee surgeries before?
Do you understand what taking part in a study involves?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your knee replacement surgery as planned. You will be randomly assigned to receive either a standard knee implant or a custom-made implant, like drawing names from a hat. You won't know which type of implant you've received, but your doctors will. After your surgery, the research team will check in with you at various times over two years. This will involve answering questions about your satisfaction, pain levels, and how well your knee is working. They might also ask about your overall quality of life. The total duration of your participation in the study will be two years, including follow-up appointments.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of knee replacement surgery, which could help future patients. You might also receive a custom-made implant which could, in theory, offer a better fit and potentially better outcomes, although this is what the study aims to find out. As with any surgery, there are risks, such as infection, pain, or problems with the implant. The study itself adds very little extra risk beyond the surgery you are already having, but you will have follow-up assessments. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Centre Orthopédique Santy
Verified postcode
Lyon, France· Recruiting

Common questions

What is 'gonarthrosis'?

Gonarthrosis is the medical term for arthritis in the knee, which causes pain and stiffness. It's often called osteoarthritis of the knee.

Will I know if I get a standard or custom-made implant?

No, you won't know which type of implant you receive. This helps ensure the study results are fair and unbiased.

How long will the study follow me?

You will be followed by the research team for two years after your knee replacement surgery.

Do I have to pay to be in the study?

No, you do not have to pay to participate in the study. Your standard care for knee replacement would be covered as usual.

What if I change my mind about participating?

You can withdraw from the study at any time, for any reason, without it affecting the medical care you receive.

How to find out more

Michel BONNIN, MD

bonnin.michel@gmail.com 04 37 53 00 26 Official trial record

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