Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™
This study is a check-up on a new knee replacement called LEGION™ Primary Total Knee System with VERILAST™. This knee system is already available and used by surgeons for people with joint damage, but this study will help us understand how it performs over time in a real-world setting. Patients receiving this knee replacement as part of their normal care will have their progress followed. Researchers will compare their results with information from people who had an older type of knee replacement. The main goal is to see how safe and effective the LEGION™ Primary TKS with VERILAST™ is for people aged 18 to 75 who need a new knee due to conditions like arthritis.
At a glance
What is this study about?
This study is looking at how a new knee replacement, called the LEGION™ Primary Total Knee System with VERILAST™, works for people who need a knee operation. Many people suffer from conditions like arthritis where the joints become worn, stiff, and painful, and a knee replacement can help fix this.
The LEGION™ knee replacement is already available and has a special surface called VERILAST™. This study is like a long-term check to make sure it's working well and safely for patients in their everyday lives. Researchers will gather information from people who receive this new knee replacement as part of their usual medical care. They will then compare these results to information from patients who had an older type of knee replacement called the Genesis II.
The main aim of this study is to confirm that the LEGION™ knee replacement is both safe and effective over several years. This kind of study, called a 'post-market' study, is really important because it helps doctors and patients understand the true benefits and possible long-term outcomes of new medical devices once they are being used widely.
Key takeaways
- Checks how a specific knee replacement performs long-term.
- Compares it to older knee replacement results.
- Your progress will be monitored for up to 10 years.
- Aims to confirm safety and effectiveness in daily life.
- Only for people already planning to get this specific knee replacement.
Who may be eligible?
To be part of this study, you would generally need to be between 18 and 75 years old and be having a full knee replacement because of problems like arthritis. You would specifically need to be getting the LEGION™ Primary Total Knee System with VERILAST™ as your new knee.
There are also some reasons why you might not be able to join. For example, if you are over 75, have certain serious health conditions like an active infection, or have had major surgery on the same knee before, you wouldn't be eligible. Also, if you have other joint replacements that aren't fully healed, or certain conditions that could affect your recovery or the knee replacement, you might not be able to take part.
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 between 18 and 75 years old?
- Are you having a full knee replacement because of joint issues like arthritis?
- Is your surgeon planning to use the LEGION™ Primary Total Knee System with VERILAST™?
- Are you able to attend follow-up appointments for up to 10 years?
- Do you have any serious health conditions that might prevent you from having surgery?
What does participation involve?
If you take part in this study, you will receive the LEGION™ Primary Total Knee System with VERILAST™ as your knee replacement, as planned with your surgeon. You won't be given a different knee than what was already decided. After your surgery, you’ll be asked to attend follow-up appointments and have routine X-rays taken, just as you normally would after a knee replacement. These appointments will help doctors check how your new knee is performing.
The study will follow your progress for up to ten years after your surgery. This long follow-up helps researchers understand how the knee replacement works over a long period. You’ll be asked to sign a form that explains everything about the study and confirms you're happy to take part and attend these visits.
Potential risks and benefits
Locations (7)
- Evangelisches Krankenhaus WienVerified postcodeVienna, Austria
- Orthopadische Krankenhaus GersthofVerified postcodeVienna, Austria
- AMEOS Klinikum Seepark GeestlandVerified postcodeLangen, Germany
- OrthoCentrumVerified postcodeHamburg, Germany
- CaritasKlinikum St. Joseph Saarbrücken-DudweilerCity onlySaarbrücken-Dudweiler, Germany
- KniePraxis Prof. Dr. TibeskuVerified postcodeStraubing, Germany
- Servicio de C.O.T. Hospital Clínico Universitario de Santiago de CompostelaVerified postcodeSantiago de Compostela, Spain
Common questions
What is 'degenerative joint disease'?
This is a common term for conditions like arthritis, where the protective cartilage in your joints wears away, causing pain, stiffness, and swelling.
What is a 'post-market study'?
It's a study that checks how a medical device, like a knee replacement, performs after it's already been approved and is being used by patients in their everyday lives.
How long will I be followed in the study?
If you participate, your progress will be followed for up to ten years after your knee replacement surgery.
Will I get a different type of knee replacement if I join this study?
No, you will receive the LEGION™ Primary Total Knee System with VERILAST™ because that was already planned as part of your normal care.
Who is sponsoring this study?
The study is sponsored by a medical device company who makes the LEGION™ Primary Total Knee System.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.