Active not recruitingNAINTERVENTIONAL

Zimmer Trabecular Metal Total Ankle PMCF

Doctors are studying a special ankle replacement called the Zimmer Trabecular Metal Total Ankle System. This study is for people who have severe ankle arthritis, including common wear-and-tear arthritis, rheumatoid arthritis (which causes your immune system to attack your joints), or arthritis that developed after an injury. The main goal is to see how long these new ankle implants last and how well they help patients. Researchers will check if the new ankle helps reduce pain, improves how people move, and generally makes their lives better. They will also take X-rays to see how the implant settles in. This helps doctors understand if this new ankle replacement is a good long-term solution for patients needing ankle surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Zimmer Biomet

Enrolment target

120

Start

01 Mar 2014

Estimated completion

01 Mar 2027

Degenerative Arthritis Rheumatoid Arthritis Post Traumatic Arthritis

What is this study about?

Imagine your ankle joint is really worn out, causing you a lot of pain and making it hard to walk. Sometimes, the best solution is to replace the joint with an artificial one. This study is all about a specific type of artificial ankle joint called the Zimmer Trabecular Metal Total Ankle System. Doctors want to understand how well this particular joint works for people suffering from different types of arthritis in their ankle, whether it's from everyday wear and tear, an immune system condition, or an old injury.

The main aim of this research is to see how durable this new ankle replacement is over many years. They'll also be looking at how much it helps people feel better – specifically, if it reduces their pain, makes it easier for them to move around, and generally improves their day-to-day life. Alongside this, they'll be closely monitoring the new ankle with X-rays to see how it settles in and works inside the body. This information is really important because it helps doctors decide if this specific ankle replacement is a good choice for future patients.

Taking part in this study means doctors will gather information about your health before and after your ankle replacement surgery. This helps confirm that the new ankle replacement is safe and effective for people needing this kind of operation. By collecting real-world information from many patients, researchers can get a clear picture of how this new ankle joint performs over time.

Key takeaways

New ankle replacement (Zimmer Trabecular Metal Total Ankle) for arthritis.
Aims to check how long implant lasts, pain relief, and movement.
Requires long-term follow-up (up to 10 years) with check-ups and X-rays.
For adults (18+) with various ankle arthritis types.
Participation is voluntary; you can withdraw anytime.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and your bones must have finished growing. You'd be considered if your doctor thinks you need a total ankle replacement because of arthritis – this could be due to general wear and tear, rheumatoid arthritis, or arthritis that started after an injury. You also need to be able to understand what the study involves and be willing to give your written permission to take part, as well as attend all the follow-up appointments and do any recommended exercises.

There are certain reasons why you might not be able to join. For instance, if you're pregnant, a prisoner, or if doctors think you wouldn't be able to follow the study's instructions. You also couldn't join if you have certain serious health problems in your leg, such as severe nerve or blood vessel issues, or if your ankle replacement site has poor bone quality (like with severe osteoporosis) or has had a recent infection. If you're allergic to the materials used in the ankle replacement, you also wouldn't be able to join.

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 old or older?
Does your doctor say you need an ankle replacement for arthritis (wear and tear, rheumatoid, or post-injury)?
Are you willing and able to attend regular follow-up appointments for up to 10 years?
Do you not have any severe health issues in your leg that might prevent surgery, like serious infections or very weak bones?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it means you'll have close medical attention both before and for many years after your ankle replacement surgery. Before your operation, you'll have a full health check-up. After your surgery, doctors will regularly check on your progress. These follow-up appointments, which include clinical examinations and X-rays, will happen at 6 weeks, then 6 months, 1 year, 2 years, 3 years, 5 years, 7 years, and finally 10 years after your surgery. There will also be some surveys to complete in between these visits, specifically at 4, 6, 8, and 9 years. You won't be taking any extra medication specifically for the study, but you'll follow your doctor's usual advice for recovery and pain management after ankle surgery. The total duration of your participation will be 10 years to gather long-term information on the ankle replacement.

Potential risks and benefits

Taking part in this study means your new ankle replacement will be closely monitored for many years, which could offer reassurance about its performance. The potential benefit is a replacement that aims to reduce pain and improve your ankle function and quality of life, as with any ankle replacement. However, all surgeries carry risks, including infection, bleeding, and nerve damage, and there's no guarantee the implant will work perfectly or last indefinitely. You might also find the many follow-up appointments and questionnaires demanding. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

University California Davis
Verified postcode
Sacramento, United States
Orthopaedic Associates of Grand Rapids REI
Verified postcode
Grand Rapids, United States
OrthoCarolina Research Institute
Verified postcode
Charlotte, United States
Duke University
Verified postcode
Durham, United States
The Rothman Institute
Verified postcode
Philadelphia, United States
UBC Providence Health Care Research Institute
Verified postcode
Vancouver, Canada
Turku University Hospital Finland
Verified postcode
Turku, Finland
Klinikverbund St. Antonius und St. Josef GmbH
Verified postcode
Wuppertal, Germany
Humanitas San Pio X
Verified postcode
Milan, Italy
Inselspital-Stiftung Universitatsspital Bern
Verified postcode
Bern, Switzerland
Spital StS AG
Verified postcode
Thun, Switzerland

Common questions

What kind of ankle arthritis is this study for?

This study is for people with different types of ankle arthritis, including degenerative arthritis (wear and tear), rheumatoid arthritis, or arthritis that developed after an injury.

What is the new ankle replacement called?

The new ankle replacement being studied is called the Zimmer Trabecular Metal Total Ankle System.

How long will I need to be involved in the study?

You would be involved for up to 10 years after your surgery to allow doctors to see how well the new ankle works over a long period.

Will I have more doctor visits than usual if I join this study?

Yes, you will have regular check-ups with your doctor and X-rays at specific times over 10 years to monitor your ankle replacement, which is more frequent than standard care.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your medical care.