Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
This study is checking how safe and effective a new knee replacement system, called EVOLUTION® NitrX™, really is. This system includes a special knee cap (femur), shin bone part (tibia), and a plastic insert. These parts are used together in knee replacement surgery for conditions like osteoarthritis or other joint diseases. Because these specific knee replacement parts are new to the market, health authorities require regular checks to make sure they are working well for patients over time. This study is designed to gather that important information, following patients for up to 10 years after their surgery. It's for people who have already had or are scheduled to have this particular type of knee replacement.
At a glance
What is this study about?
Imagine you're having knee replacement surgery. There are many different types of artificial joints available, and companies need to make sure their products are safe and work well for patients over a long time. This study is doing just that for a specific set of knee replacement parts made by a company called MicroPort Orthopedics. These parts are known as the EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur, used with a special plastic insert.
The main goal of this study is to closely watch how these particular knee replacement parts perform in real-life patients. Health regulators, who oversee medical devices, require this kind of study for newer products that don't yet have many years of patient information. It helps to confirm that the new knee parts are both safe to use and effective in helping people get back to daily activities after their operation.
In simple terms, this study is a long-term check-up to see how good these specific knee replacements are. It collects information from people who have already received these implants or are about to get them. By doing so, experts can learn more about how patients are doing years down the line, ensuring that the products continue to meet high standards of safety and effectiveness.
Key takeaways
- This study checks a new knee replacement system called EVOLUTION® NitrX™.
- It's for people having this specific knee replacement for conditions like arthritis.
- Participants will have long-term follow-up for up to 10 years.
- The main goal is to confirm the safety and effectiveness of these knee parts.
- Your participation helps to improve understanding for future patients.
Who may be eligible?
To be part of this study, you would need to have either already had, or be planning to have, a total knee replacement using a very specific set of new knee parts: the EVOLUTION® NitrX™ CS/CR Femur, the EVOLUTION® NitrX™ Keeled Tibia, and the EVOLUTION® CS Tibial Insert.
The knee replacement surgery must be due to conditions like wear-and-tear arthritis (osteoarthritis), damage from injury, or other types of joint problems including rheumatoid arthritis. You must be at least 21 years old. If you've already had the surgery, you need to be enrolled in the study within 14 months of your operation. You also need to be willing to sign a consent form, understand the study's requirements, and agree to attend follow-up appointments for up to 10 years.
If you are having both knees replaced with these specific components, both knees could potentially be included in the study. You'd need to discuss this with your doctor and agree to additional paperwork for the second knee.
- Are you 21 years old or older?
- Are you having a total knee replacement for arthritis or similar joint problems?
- Will your knee replacement use the EVOLUTION® NitrX™ parts (femur, tibia, and insert)?
- Are you able and willing to attend follow-up appointments for up to 10 years?
- If your surgery has already happened, was it within the last 14 months?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, it largely involves attending regular follow-up appointments after your knee replacement surgery. During these visits, doctors will check how your knee is healing and performing. You might be asked to fill out questionnaires about your pain, activities, and general well-being. There won't be any additional medication given specifically for the study, as it's observing the knee replacement you've already had or are planning to have.
The study will follow you after your operation for a long time – up to 10 years. This long-term follow-up is important to see how the knee replacement works over many years. You'll need to be able to come to these appointments and complete any forms throughout this period. The overall duration you're involved will depend on when you join relative to your surgery date, but the longest follow-up for any participant is 10 years.
Potential risks and benefits
Locations (2)
- Sah Orthopaedic AssociatesFremont, United States
- MSK Doctors, The Keep ClinicGrantham, United Kingdom
Common questions
What is the main purpose of this study?
The study aims to check how safe and effective a new type of knee replacement, called EVOLUTION® NitrX™, is over many years.
Who can join this study?
You can join if you're having or have just had a knee replacement using specific EVOLUTION® NitrX™ parts for conditions like arthritis, and you're over 21.
What will I need to do if I join?
You'll need to attend regular follow-up appointments for up to 10 years after your surgery, answering questions about your knee's progress.
Will I get any special treatment or medication?
No, this study only observes how your knee replacement performs; you won't receive extra medication or different treatment.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without giving a reason, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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