Active not recruitingNAINTERVENTIONAL

Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study

This research is looking into two main types of surgery for people with ongoing ankle arthritis: total ankle replacement (arthroplasty) and ankle fusion (arthrodesis). The aim is to understand which surgical option provides better long-term results over a period of 10 years. Doctors want to see if ankle replacement leads to less new arthritis in nearby foot joints compared to ankle fusion. They will also compare how often complications happen and if patients need more surgery afterwards for both procedures. By gathering this information, the study hopes to help doctors and patients make more informed decisions about the best way to treat severe ankle arthritis, improving quality of life for those affected.

At a glance

Status

Active not recruiting

Phase

Sponsor

Nova Scotia Health Authority

Enrolment target

250

Start

30 May 2005

Estimated completion

01 Apr 2030

Ankle Arthritis

What is this study about?

This study is designed to help us understand the best surgical option for people who suffer from ankle arthritis. Ankle arthritis is a condition where the smooth cartilage that covers the ends of your ankle bones wears away, causing pain, stiffness, and swelling. When other treatments like special shoes, braces, or physiotherapy haven't helped enough, surgery might be an option.

The study is comparing two main types of surgery: ankle replacement (also called total ankle arthroplasty) and ankle fusion (called ankle arthrodesis). In an ankle replacement, the damaged joint surfaces are removed and replaced with artificial parts, similar to a hip or knee replacement. Ankle fusion involves ‘welding’ the bones of the ankle together so they no longer move, which can reduce pain but also reduces movement.

Over a 10-year period, the researchers will be carefully observing people who have had one of these surgeries. They want to see which surgery leads to better long-term outcomes. This includes looking at whether ankle replacement might reduce the chances of developing arthritis in other nearby foot joints compared to fusion. They will also compare how frequently patients experience problems or need further operations after each type of surgery. The goal is to provide clear evidence to help doctors and patients decide which surgical route might be best for them, helping people get back to living more comfortably.

Key takeaways

Compares two types of ankle surgery: replacement vs. fusion.
Aims to find out which surgery works better over 10 years.
Looks at pain, further arthritis, and need for more surgery.
Participation involves surgery and long-term follow-up (up to 10 years).
Helps doctors and patients make better treatment decisions for ankle arthritis.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with ankle arthritis for more than six months. Importantly, you should have already tried other treatments like changing your activities, physiotherapy, special shoe inserts, or braces, and your ankle hasn't gotten better. Your ankle arthritis also needs to be severe enough based on special questionnaires.

There are some reasons why you might not be able to join. These include if you have 'dead bone' in your ankle, a very twisted foot or ankle, or if you've already had ankle fusion or replacement surgery before. You also couldn't take part if you have an active or previous infection in your ankle, are severely overweight (over 250 lbs), or have other serious health problems that would make surgery unsafe. Conditions affecting your nerves or muscles, or severe thinning of your bones (osteoporosis), would also prevent participation.

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 18 years or older?
Have you had ankle arthritis for more than 6 months?
Have you tried other treatments (like physiotherapy, braces) without enough improvement?
Is your ankle arthritis severe according to doctor's assessments?
Are you willing to participate in the study for up to 10 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive detailed information about the study and be asked to sign a consent form, showing you understand and agree. You would then undergo either an ankle replacement or an ankle fusion surgery, as decided by you and your doctor based on what's best for your condition within the study guidelines. After your surgery, you would have regular follow-up appointments with the study team and your surgeon for a period of up to 10 years. These appointments will involve checking your ankle's recovery, asking you some questions about your pain and activity levels (using questionnaires), and possibly taking X-rays. You won't be given any experimental medication; the study is comparing two established surgical procedures. The total duration of your participation would be 10 years, with check-ups at specific times during this period.

Potential risks and benefits

Taking part in this study might offer a potential benefit by helping you and your doctors understand which surgery for ankle arthritis could give you the best long-term outcome. You would receive close monitoring and care from a specialist team. However, as with any surgery, there are risks, including pain, infection, blood clots, nerve damage, or needing further operations. These risks are associated with both ankle fusion and ankle replacement procedures. It is important to remember that you can decide to leave the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

QEII Health Sciences Centre
Verified postcode
Halifax, Canada

Common questions

What is ankle arthritis?

Ankle arthritis is when the smooth cushioning ('cartilage') in your ankle joint wears away, causing pain, stiffness, and trouble moving your ankle.

What is the difference between ankle replacement and ankle fusion?

Ankle replacement removes the damaged parts and replaces them with artificial ones, allowing movement. Ankle fusion 'welds' the bones together so the joint doesn't move, which stops the pain.

Why is this study important for me?

This study aims to find out which surgery works better in the long run for people with ankle arthritis, potentially helping you and your doctor make a more informed decision about your treatment.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related procedures and follow-up care that are part of the research will be covered.

How long will I be followed up for if I join the study?

If you join the study, you will be followed up for a period of up to 10 years after your surgery.