Active not recruitingOBSERVATIONAL

Post Market Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts

This study is checking how well a specific knee replacement, called the EVOLUTION® Total Knee Arthroplasty, works for people who have already had it fitted. The aim is to see if it's safe and effective over many years. This type of study is a standard requirement for medical devices in Europe, especially when there isn't much long-term information available when they first get approved. Researchers will follow up with patients to see how long the knee replacement lasts, if any further surgery is needed, how well patients can move, and how happy they are with their new knee. This helps medical authorities ensure that devices like this are reliable and continue to meet safety standards for patients.

At a glance

Status

Active not recruiting

Sponsor

MicroPort Orthopedics Inc.

Enrolment target

150

Start

15 Jun 2015

Estimated completion

01 Dec 2028

Joint Disease

What is this study about?

Imagine you've had a knee replacement – a new joint to help you move better and reduce pain. This study is all about one particular type of knee replacement called the EVOLUTION® Total Knee Arthroplasty. It’s like a long-term check-up to make sure this new knee is working as well as everyone hopes it will, years after it's been put in.

Medical devices, like knee replacements, need to prove they are safe and effective before they can be widely used. But sometimes, when a device is first approved in places like the European Union, there isn't a lot of information yet on how it performs over many years. That's where this study comes in. It’s designed to gather that important long-term information.

The main goal is to follow people who have already received this EVOLUTION® knee replacement. Researchers will be looking at things like how long the knee replacement lasts, if there's a need for any more operations on that knee, how well people can use their knee in daily life, and how satisfied they are with their new joint. This helps doctors and regulatory bodies understand the full picture of how the device performs, ultimately ensuring patients get the best and safest care.

Key takeaways

Studies the EVOLUTION® Total Knee Replacement in people who've already had it.
Checks how safe and effective the knee replacement is over many years.
Required for medical devices by European regulators to gather long-term evidence.
Participants are followed for up to 10 years after their surgery.
Focuses on how long the knee lasts, function, and patient satisfaction.

Who may be eligible?

This study is for people who have already had an EVOLUTION® knee replacement. You would need to have had the surgery to replace your knee because of conditions like arthritis or to correct a major knee problem.

To join, you must be at least two years past your knee replacement surgery. You'll also need to be willing and able to attend follow-up visits and assessments over the next ten years. If you've had both knees replaced with the EVOLUTION® system, both could potentially be included.

However, you can't join if you were under 21 when you had your surgery, are currently in another medical study, or have certain medical or personal circumstances that would make it hard for you to take part reliably. Your Body Mass Index (BMI) also needs to be 40 or less.

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.

Have you already had an EVOLUTION® knee replacement?
Was your knee replacement surgery at least two years ago?
Are you willing to attend follow-up visits for up to 10 years?
Are you generally in good health and able to participate reliably?
Are you aged 21 years or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be followed for up to 10 years after your knee replacement operation. This will involve attending study visits where doctors will check how your knee is doing and ask you about your experience. You might fill out questionnaires about your pain and how well you can move your knee, giving important information about your daily life. There are no new medications or treatments involved; this study simply observes how your existing knee replacement performs over time. The team will ensure you know exactly what is involved at each stage.

Potential risks and benefits

Taking part in this study could help future patients by providing valuable long-term information about the EVOLUTION® knee replacement. While there are no direct medical benefits to you, your participation contributes to medical knowledge that improves healthcare for everyone. The main risks are the time commitment for follow-up visits and the potential for discomfort during assessments, though these are typically minimal. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Illinois Bone & Joint Institute
Verified postcode
Morton Grove, United States
AZ Maria-Middelares
Verified postcode
Ghent, Belgium
The Ottawa Hospital
Verified postcode
Ottawa, Canada
Klinik für Orthopädie, Unfall- und Wiederherstellungschirurgie, St. Marien Hospital Mülheim an der Ruhr
Verified postcode
Mülheim, Germany
University Hospital Llandough
Verified postcode
Penarth, United Kingdom

Common questions

What kind of knee replacement is being studied?

This study is looking at the EVOLUTION® Total Knee Arthroplasty System.

Do I have to have recently had surgery to join?

No, you must have had your knee replacement at least two years ago to be considered for this study.

How long will I be involved in the study?

You'll be followed for up to 10 years after your knee replacement operation.

Will I receive new treatments or medicines?

No, this study only observes how your existing knee replacement is performing; there are no new treatments.

Why is this study important?

It helps ensure that knee replacements like EVOLUTION® are safe and work well for patients over the long term, contributing to better healthcare.