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Active not recruitingOBSERVATIONAL

Zimmer POLAR Persona - TKA (EMEA Study)

This study is gathering information on the Zimmer Persona Total Knee System, a type of knee replacement. It's for people suffering from severe knee pain and disability, often due to conditions like osteoarthritis or rheumatoid arthritis. The main goals are to see how long these knee implants last, check for any safety concerns, and understand how well they improve pain, movement, and overall quality of life for patients. Researchers will follow participants for several years, collecting details about their recovery and knee function. This type of study helps doctors and patients make informed decisions about knee replacement surgery.

At a glance

Status
Active not recruiting
Sponsor
Zimmer, GmbH
Enrolment target
777
Start
18 Nov 2013
Estimated completion
01 Dec 2026

What is this study about?

Imagine you're dealing with severe knee pain and finding it hard to move around, perhaps because of arthritis. A knee replacement operation might be an option. This particular study is looking closely at a specific type of knee replacement called the Zimmer Persona Total Knee System, which is already approved for use.

The main purpose of this study isn't to test a brand-new, experimental treatment. Instead, it's about seeing how well this established knee replacement performs in real-world conditions for people in Europe, the Middle East, and Africa. Researchers want to understand its long-term success, how safe it is, and whether it truly improves patients' comfort and ability to do everyday activities. They'll also look at X-rays to see how the implant settles in.

By carefully collecting all this information over several years, the study aims to give doctors and patients a clearer picture of what to expect from the Zimmer Persona knee. This helps ensure that the best possible care is provided when someone needs a total knee replacement.

Key takeaways

  • This study looks at an existing knee replacement device, not a new one.
  • It aims to understand the long-term performance, safety, and patient outcomes of the Zimmer Persona Total Knee System.
  • Participants will have severe knee pain and disability requiring a knee replacement.
  • Follow-up appointments will occur for at least five years after surgery.
  • The study helps improve patient care information for knee replacements.
  • Participation is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged between 18 and 75 who need a total knee replacement because of severe knee pain and difficulty moving. This pain might be caused by various types of arthritis, like osteoarthritis or rheumatoid arthritis, or other knee problems that have led to significant damage.

You would need to be well enough for the operation and willing to attend follow-up appointments. It's also important that you haven't had a partial or total knee replacement on the same knee before and aren't currently involved in other studies that focus on surgery or pain management.

However, you wouldn't be able to join if you have certain conditions like an active infection in the knee, very weak bones (osteoporosis), uncontrolled health problems, or if you're pregnant. Also, if you have known allergies to the materials used in the knee implant, you wouldn't be suitable.

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.

  1. Are you between 18 and 75 years old?
  2. Do you have severe knee pain and disability needing a total knee replacement?
  3. Are you able and willing to attend follow-up appointments for at least five years?
  4. Have you *not* had a previous total or partial knee replacement on the same knee?
  5. Do you *not* have an active infection in your knee or very weak bones?
  6. Are you *not* currently pregnant or involved in other surgical studies?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a full conversation with the study team to make sure you understand everything involved before giving your consent. Before your knee replacement surgery, you'll have a check-up. After the operation, you'll have several follow-up appointments with the study team. These check-ups will usually happen around 5 days to 6 weeks after your surgery, then again at 3 to 6 months, and annually for the next five years. During these visits, the team will check how you're doing, ask about your pain and daily activities, and take X-rays of your knee. Some participants might also be asked to come back for voluntary visits at 7 and 10 years. You won't receive any specific study medication, as this study is observing an already approved knee replacement.

Potential risks and benefits

Taking part in this study may offer the benefit of closely monitored care after your knee replacement, contributing to future understanding of knee implants. However, as with any surgery, there are potential risks associated with the knee replacement itself, such as infection, pain, or issues with the implant, which the study will monitor closely. You also have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Orthopädisches Spital Speising
    Verified postcode
    Vienna, Austria
  • CHU de Clermont-Ferrand
    Verified postcode
    Clermont-Ferrand, France
  • Centre Hospitalier régional Universitaire de Montpellier
    Verified postcode
    Montpellier, France
  • HEH Braunschweig
    Verified postcode
    Braunschweig, Germany
  • Atos Klinik Heidelberg
    Verified postcode
    Heidelberg, Germany
  • Stichting Research Orthopedie & Reinier de Graaf Groep
    Verified postcode
    Delft, Netherlands
  • Hospital Parc Tauli
    Verified postcode
    Sabadell, Spain
  • Hospital Miguel Servet
    Verified postcode
    Zaragoza, Spain
  • University of Leeds
    Verified postcode
    Leeds, United Kingdom
  • Golden Jubilee National Hospital
    Verified postcode
    Clydebank, United Kingdom
  • Harrogate and District NHS
    Verified postcode
    Harrogate, United Kingdom
  • The Newcastle Upon Tyne Hospitals
    Verified postcode
    Newcastle, United Kingdom

Common questions

What is the Zimmer Persona Total Knee System?

It's a specific type of artificial knee that surgeons use to replace damaged knee joints during an operation called a total knee replacement.

Why is this study being done?

The study aims to see how well the Zimmer Persona knee replacement performs over time in terms of how long it lasts, its safety, and how it improves patients' quality of life.

Will I get a different type of knee replacement in this study?

No, this study is observing the Zimmer Persona Total Knee System, which is already available for use, not testing a new, experimental device.

How long will I need to be involved in the study?

You'll have follow-up appointments for at least five years after your surgery, with some voluntary visits potentially lasting up to 10 years.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

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

Discussion

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