Post-market surveillance study of the ADAPTIS Total Ankle Replacement with EVERLAST polyethylene insert
This study is testing a new ankle replacement part called INFINITY™ with ADAPTIS™ and EVERLAST™. Ankle replacements help people with worn-out joints move better and feel less pain. This new design aims to attach better and last longer. Researchers will follow patients after their surgery for up to five years, collecting information through appointments, X-rays, and questionnaires. The study hopes this new implant will lead to better results, like less pain and improved movement, compared to older versions. It will also help doctors understand how to treat future patients needing ankle replacements.
At a glance
What is this study about?
Imagine your ankle joint is like a well-oiled hinge. Over time, this hinge can wear out, causing pain and making it hard to move. An ankle replacement operation replaces these worn-out parts with new metal and plastic ones, like fixing a creaky door with a brand-new hinge. There are many types of ankle replacements, but they don't always last as long as doctors would like. This study is all about a newer type of ankle replacement called INFINITY™ with ADAPTIS™ and EVERLAST™.
The INFINITY™ ankle implant is already used in NHS hospitals, but this new version has been specially designed to fit better and wear out more slowly. This means it could potentially give patients even better results than current options. The main goal of this study is to closely watch how patients who receive this new implant get on after their surgery. By carefully collecting information over several years, doctors hope to learn how well this new design works in real-life situations.
Taking part in this study means you would be one of the first people to receive this specific INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system in an NHS hospital. The information gathered from people like you will be crucial for understanding if this new design truly offers better long-term benefits, such as less pain and easier movement, for patients needing ankle surgery in the future. It helps doctors decide on the best treatments and shapes future research.
Key takeaways
- This study tests a new ankle replacement designed to last longer and fit better.
- It's for people having their first total ankle replacement.
- Taking part means extra check-ups and X-rays for up to 5 years after surgery.
- The surgery and hospital care will be the same as usual.
- The aim is to improve pain relief and movement for future patients.
- Any risks are similar to standard ankle replacement surgery.
Who may be eligible?
To be considered for this study, you need to be at least 21 years old and on the waiting list for your very first ankle replacement surgery. Your surgeon will need to decide that this specific INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement is a good choice for you.
It's important that you are able and willing to attend all the follow-up appointments and X-rays after your surgery, and that you can understand and sign the consent forms. People who have had ankle fusion surgery before, or who need a replacement of an artificial ankle they already have, won't be able to join this study.
Also, if you have any other significant health conditions that would make an ankle replacement unsuitable for you, you wouldn't be able to participate.
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.
- I am 21 years old or older.
- I am on the waiting list for my first ankle replacement surgery.
- My surgeon thinks the INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement is right for me.
- I am able and willing to attend follow-up appointments for up to 5 years.
- I have not had a previous ankle fusion or another artificial ankle that needs replacing.
What does participation involve?
If you decide to take part in this study, the process will generally involve several steps over up to five years. Before your surgery, the research team will gather information from your medical records and X-rays. They will also contact you to complete some questionnaires, which can be done at an appointment, over the phone, or by email.
During your surgery, you will receive the INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement. Your care in the hospital will be exactly the same as for any other patient having this surgery. Following surgery, you'll have extra follow-up. This means attending appointments and having X-rays at 6 weeks, 6 months, 1 year, 2 years, and 5 years after your operation. At these visits, the medical team will check how you're doing and collect information. You'll also be asked to fill out questionnaires at 6 months, 1 year, 2 years, and 5 years after surgery. These can be completed in person, by phone, or email. The total duration of your active participation, including follow-up, could be up to five years after your surgery.
Potential risks and benefits
Locations (11)
- Royal National Orthopaedic HospitalCity onlyStanmore, United Kingdom
- The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation TrustCity onlyOswestry, United Kingdom
- NIHR Nottingham Biomedical Research CentreCity onlyNottingham, United Kingdom
- NHS LothianApproximateEdinburgh, United Kingdom
- Poole HospitalApproximatePoole, United Kingdom
- Royal Devon University Healthcare NHS Foundation TrustCity onlyExeter, United Kingdom
- Royal Albert Edward InfirmaryApproximateWigan, United Kingdom
- North Tyneside General HospitalApproximateNorth Shields, United Kingdom
- Northern General HospitalApproximateSheffield, United Kingdom
- Southmead HospitalApproximateBristol, United Kingdom
- Torbay HospitalUnverifiedTorquay, United Kingdom
Common questions
What is an ankle replacement?
It's an operation to replace worn-out parts of your ankle joint with new metal and plastic pieces to help you move better and reduce pain.
What's special about this new ankle replacement?
This new version, called INFINITY™ with ADAPTIS™ and EVERLAST™, is designed to attach more securely to your bone and last longer than other types.
How long will I be followed up if I join?
You will have appointments and check-ups for up to five years after your surgery to see how the new ankle replacement is doing.
Will my hospital care be different if I join the study?
No, your actual surgery and hospital care will be exactly the same as standard care for an ankle replacement.
Can I stop being part of the study if I change my mind?
Yes, you can leave the study at any time, and this will not affect your medical care.
How to find out more
David Townshend
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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