Active not recruitingNAINTERVENTIONAL

The UK ADAPTIS Study

The UK ADAPTIS Study is investigating a new and improved type of ankle replacement system called INFINITY™ with ADAPTIS™ and EVERLAST™. Ankle replacement surgery involves replacing damaged ankle joint surfaces with metal and plastic parts to restore movement and reduce pain. The Infinity ankle implant is already widely used in NHS hospitals, and this new system is an advanced version of it. The main goal is to see how well this new system works and performs in people undergoing their first ankle replacement. Doctors expect it to attach more securely to the bone and wear out more slowly over time. This study is collecting information from patients who receive this new ankle replacement to understand its effectiveness.

At a glance

Status

Active not recruiting

Phase

Sponsor

Northumbria Healthcare NHS Foundation Trust

Enrolment target

200

Start

23 Apr 2024

Estimated completion

01 Apr 2031

Total Ankle Replacement Total Ankle Arthroplasty

What is this study about?

Imagine your ankle joint is like a well-oiled hinge, allowing your foot to move smoothly. If this hinge becomes damaged due to severe arthritis from conditions like rheumatoid arthritis, old injuries, or general wear and tear, it can cause a lot of pain and limit how you can move. An ankle replacement operation replaces these damaged parts with special metal and plastic pieces, much like replacing a worn-out hinge with a new one.

The INFINITY™ with ADAPTIS™ and EVERLAST™ system is a new type of ankle replacement. It's a newer version of an existing, commonly used ankle replacement called Infinity. This new design has some clever features that doctors hope will make it attach more securely to your bone and last for a longer time before needing any further attention.

The UK ADAPTIS Study is about carefully watching and learning from people who receive this new ankle replacement. Doctors want to understand how well it helps with pain, how much movement people get back, and generally how good it is at improving their lives. This kind of study helps make sure new treatments are effective and safe for patients in the UK.

Key takeaways

This study is testing a new and improved ankle replacement called INFINITY™ with ADAPTIS™ and EVERLAST™.
The new design aims for better bone attachment and a longer lifespan for the implant.
It's for adults needing their very first ankle replacement due to severe arthritis.
Participants will have surgery and then be monitored with follow-up appointments and questionnaires.
The goal is to reduce pain, improve movement, and enhance the quality of life for patients.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 21 or older who need their first total ankle replacement because of severe damage to their ankle joint, often due to arthritis. You must be well enough and willing to come to follow-up appointments and take part in rehabilitation, which is a program to help you recover.

To join, you also need to be able to fully understand what the study involves and provide your written permission. You wouldn't be able to join if you've already had ankle fusion surgery (where the ankle bones are joined together) or if you need to have a pre-existing ankle replacement redone.

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 21 years old or older?
Do you need your first-ever ankle replacement because of serious ankle arthritis?
Are you able to attend follow-up appointments and take part in recovery exercises?
Have you not had a previous ankle fusion or another ankle replacement that needs fixing?
Can you understand information about the study and give your written permission to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have the new INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement surgery. After your operation, your healthcare team will monitor your progress closely. This will involve attending regular follow-up appointments at the hospital. During these visits, doctors will check how your new ankle is healing and moving. You'll also be asked to fill out questionnaires about your pain, how well you can move your ankle, and your general quality of life. These questionnaires help doctors understand how the new ankle replacement is affecting you day-to-day. The specific details of the follow-up schedule and total duration will be fully explained to you before you agree to participate.

Potential risks and benefits

Taking part in this study means you would receive a new ankle replacement designed to reduce pain, improve your walking, and restore movement in your ankle. This could significantly improve your quality of life. As with any surgery, there are potential risks, such as infection, bleeding, or issues with how the implant settles. The study is particularly interested in how this new design performs compared to existing ones, aiming for better attachment and longevity. All risks and benefits will be fully explained by your medical team. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northumbria Healthcare NHS Foundation Trust
Verified postcode
Newcastle, United Kingdom

Common questions

What is an ankle replacement?

It's a surgery to replace the worn-out parts of your ankle joint with artificial pieces made of metal and plastic to help reduce pain and improve movement.

What is unique about this new ankle replacement?

The INFINITY™ with ADAPTIS™ and EVERLAST™ system is a newer version of an existing ankle implant. It's designed to attach to the bone better and potentially last longer.

Who is this study for?

It's for adults (21+) who have severe ankle arthritis and need their very first ankle replacement operation.

What will happen if I join the study?

You'll have the new ankle replacement and then attend follow-up appointments where doctors will check your progress and ask you to fill out questionnaires about how you're feeling.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time without it affecting the care you receive from your doctors.