Active not recruitingNAINTERVENTIONAL

Total Ankle Replacement Versus Arthrodesis Trial

This research, called TARVA, is looking at two common surgical treatments for severe ankle arthritis in people aged 50 to 85. The two treatments are Total Ankle Replacement (replacing the joint with an artificial one) and Ankle Arthrodesis (which is a fancy way of saying ankle fusion, where the bones are permanently joined). The main goal is to figure out which surgery helps patients more by reducing pain and improving how well they can use their ankle. The study will also look at how these operations affect quality of life and what the potential risks are. Finally, it will compare the costs of both treatments to see which might be more efficient for the healthcare system. Everyone who takes part will be assigned one of the two surgeries by chance.

At a glance

Status

Active not recruiting

Phase

Sponsor

University College, London

Enrolment target

303

Start

01 Jan 2015

Estimated completion

28 Feb 2029

Osteoarthritis

What is this study about?

If you have severe arthritis in your ankle, you might be considering surgery to help with pain and stiffness. This study, called TARVA, is designed to help doctors understand the best way to treat this condition for people aged 50 to 85. There are two main types of surgery for severe ankle arthritis: Total Ankle Replacement (TAR) and Ankle Arthrodesis (Ankle Fusion).

A Total Ankle Replacement means your ankle joint is replaced with an artificial one, similar to a hip or knee replacement. The aim is to keep your ankle moving. Ankle Fusion, on the other hand, involves joining the bones in your ankle so they grow together into one solid bone. This stops the joint from moving, which can relieve pain, but it also means you won't be able to bend your ankle up and down anymore.

Doctors want to compare these two operations to see which one gives patients better results, particularly in terms of reducing pain when walking and standing, and improving their overall quality of life. The study will also look at how much movement people have after each surgery and any problems that might come up. By comparing both the health benefits and the costs, this research will help doctors make even better recommendations for future patients.

Key takeaways

This study compares two ankle surgeries for severe arthritis.
It aims to find which surgery gives better pain relief and movement.
You will be randomly assigned to either ankle replacement or ankle fusion.
The study involves questionnaires and movement checks for about a year.
It helps doctors understand the best treatment for specific patients.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to have severe ankle arthritis. You should be between 50 and 85 years old. Your surgeon must believe that both types of surgery (ankle replacement and ankle fusion) would be suitable options for your ankle, taking into account things like your ankle shape, bone strength, and general health.

You also need to be able to read and understand the information about the study and be willing to give your written permission to take part. This ensures you fully understand what's involved and agree to it.

There are some reasons why you might not be able to join. For example, if you've already had certain ankle surgeries, or if you have more than four fused joints in your lower body. If you can't have an MRI or CT scan, or if you've had a recent infection in your bone or joint, you wouldn't be able to participate. Also, if you have other health problems that your doctor feels are too severe or would prevent you from completing the study assessments, you wouldn't be eligible.

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.

Do you have severe ankle arthritis?
Are you between 50 and 85 years old?
Has your surgeon said both ankle replacement and fusion are options for you?
Can you read and understand study materials and provide consent?
Have you had very few or no previous surgeries on your ankle or nearby joints?
Do you have good general health without severe conditions that might affect the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of the two surgical groups (either Total Ankle Replacement or Ankle Arthrodesis) by chance, like flipping a coin. You won't get to choose which surgery you have. You and your healthcare team will know which surgery you're having.

Before your surgery, and then at various times after, you'll be asked to complete questionnaires about your pain and how well you can use your ankle. You'll also have your ankle movement measured. These assessments usually happen before your operation, and then at 52 weeks (about a year) after your surgery. The study aims to follow participants for a total of 52 weeks after their operation.

Potential risks and benefits

Taking part in this study might offer you the benefit of receiving one of two established surgical treatments for severe ankle arthritis. By comparing these treatments, the study aims to improve future care for patients like you. However, as with any surgery, there are potential risks involved with both total ankle replacement and ankle fusion, such as infection, problems with healing, or the need for further surgery. These risks will be fully explained by your surgeon. You are free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (17)

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

Royal Cornwall Hospitals NHS Trust
Verified postcode
Truro, United Kingdom
Brighton & Sussex University Hospitals NHS Trust
Verified postcode
Brighton, United Kingdom
North Bristol NHS Trust
Verified postcode
Bristol, United Kingdom
Cardiff and Vale Orthopaedic Centre
Verified postcode
Cardiff, United Kingdom
Royal Derby Hospital
Verified postcode
Derby, United Kingdom
Royal Surrey County Hospital
Verified postcode
Guildford, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Verified postcode
Hull, United Kingdom
Aintree University Hospital
Verified postcode
Liverpool, United Kingdom
Freeman Hospital
Verified postcode
Newcastle, United Kingdom
Northumbria Healthcare NHS Foundation Trust
Verified postcode
Newcastle, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Verified postcode
Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
Verified postcode
Nottingham, United Kingdom

Common questions

What is the main goal of this study?

To find out if total ankle replacement or ankle fusion works better for people with severe ankle arthritis, looking at pain, movement, and quality of life.

Will I get to choose which surgery I have?

No, you will be assigned to one of the two surgeries by chance, similar to drawing lots.

How long will I be involved in the study?

You will be followed up for about one year (52 weeks) after your surgery.

What kind of information will the study collect from me?

You'll fill out questionnaires about your pain and ankle function, and your ankle movement will be measured.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.