UK Infinity, Post-Market Clinical Follow-up Study
This UK study is following 500 people who have had an INFINITY® total ankle replacement for ankle arthritis. The main goal is to see how long the ankle replacement lasts, up to 10 years after surgery. Researchers will also check for any issues like loosening or new bone growth, and how much the implant helps with pain and daily activities. They will look at different types of arthritis, including rheumatoid and arthritis from injury or wear and tear. This study helps doctors understand the long-term effects and benefits of this specific ankle replacement for patients in the UK.
At a glance
What is this study about?
This study is called the UK Infinity Post-Market Clinical Follow-up Study. Essentially, it's a way for doctors and researchers to keep a close eye on a specific type of ankle replacement called the INFINITY® Total Ankle System after it's been used in real patients. They want to understand how well it works and if there are any long-term issues.
The main thing they want to find out is how long this ankle replacement lasts in people. They are following 500 patients across 10 hospitals in the UK for up to 10 years after their surgery. By doing this, they can see if the replacement stays in place, if it causes any problems with the surrounding bone, and how much it improves people's pain and their ability to do everyday things like walking or socialising.
This kind of study is really important because it helps ensure that new medical devices are safe and effective in the long run. The information gathered will help doctors and patients make informed decisions about ankle replacement surgery, especially for those suffering from conditions like rheumatoid arthritis, arthritis caused by injuries, or general wear-and-tear arthritis.
Key takeaways
- This study follows patients for up to 10 years after ankle replacement surgery.
- It aims to understand how long the INFINITY® ankle replacement lasts and if it causes problems.
- Researchers will check for pain relief and improved daily activities.
- It includes patients with various types of ankle arthritis.
- Your visits will involve X-rays and questionnaires.
- Your participation helps improve future ankle treatment.
Who may be eligible?
To be part of this study, you need to be at least 21 years old when you have your ankle surgery. You must have ankle pain or damage in one or both ankles, caused by rheumatoid arthritis, arthritis from an injury, or simply general wear-and-tear arthritis.
It's very important that you are willing and able to understand and sign the consent forms, and that you can attend all the follow-up appointments. Your surgeon will also need to agree that the INFINITY® Total Ankle System is the right choice for your type of ankle problem.
However, you can't join the study if your surgeon thinks an ankle replacement isn't suitable for you, or if you're having surgery to replace an ankle replacement you've already had (known as a revision surgery). This study is for people having their first INFINITY® ankle replacement.
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 at least 21 years old?
- Do you have ankle joint disease (arthritis) in one or both ankles?
- Is your ankle arthritis due to rheumatoid arthritis, injury, or wear and tear?
- Are you able to attend follow-up appointments and provide consent?
- Has your doctor said you are a good candidate for the INFINITY® Total Ankle System?
What does participation involve?
If you decide to take part in this study, you will have regular check-ups with your medical team. There will be an appointment before your surgery, during the surgery itself, and then at 6 months, 1 year, 2 years, 5 years, 7 years, and 10 years after your operation. There might also be extra appointments if your doctor thinks they are needed.
At these visits, the medical team will take X-rays of your ankle to see how the implant is doing. You'll also be asked to fill out questionnaires about your pain levels, how well you can move around, and how your quality of life has changed. This helps the researchers understand the benefits you're getting from the ankle replacement over time. You won't be given any new or additional medication just for the study; you'll follow your doctor's usual advice for recovery.
Potential risks and benefits
Locations (12)
- Torbay HospitalVerified postcodeTorquay, United Kingdom
- Royal Bournemouth HosptialVerified postcodeBournemouth, United Kingdom
- University Hairmyres HospitalVerified postcodeBothwell, United Kingdom
- RJAH Orthopaedic HospitalVerified postcodeOswestry, United Kingdom
- Sheffield Teaching HospitalVerified postcodeSheffield, United Kingdom
- North Bristol NHS Trust Southmead HospitalVerified postcodeBristol, United Kingdom
- Royal Infirmary of EdinburghVerified postcodeEdinburgh, United Kingdom
- Royal Devon and Exeter NHS Foundation TrustVerified postcodeExeter, United Kingdom
- Royal National Orthopaedic HospitalVerified postcodeMiddlesex, United Kingdom
- North Tyneside General HospitalVerified postcodeNewcastle upon Tyne, United Kingdom
- Nottingham University Hospitals NHS TrustVerified postcodeNottingham, United Kingdom
- Wrightington HospitalVerified postcodeWigan, United Kingdom
Common questions
What is the INFINITY® ankle system?
It's a specific type of artificial ankle joint used to replace a damaged ankle in people with arthritis.
Why is this study being done?
It's to see how well the INFINITY® ankle replacement works over a long time (up to 10 years) for people in the UK.
What kind of arthritis is included?
The study includes people with rheumatoid arthritis, arthritis from an injury, or arthritis from general wear and tear in their ankle.
How many times will I need to visit the hospital?
You'll have visits before surgery, during surgery, and then at 6 months, 1, 2, 5, 7, and 10 years after your operation.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, 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.
Discussion
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