Active not recruitingNAINTERVENTIONAL

ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

This study is following people who are having a second knee replacement operation, often called a 'revision' surgery. They will receive a specific new knee system called ATTUNE Revision. The main goal is to see how well this new knee system holds up over five years. Researchers are particularly interested in its durability and how long it lasts before any further surgery is needed. They will also look at things like pain levels, how satisfied patients are, and how much their knee function improves. This information will help doctors understand if this new system is a good option for people needing revision knee surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

DePuy Orthopaedics

Enrolment target

400

Start

30 May 2017

Estimated completion

31 Mar 2029

Revision Total Knee Arthroplasty

What is this study about?

Imagine you've had a knee replacement operation in the past, but for some reason, it's not working as well as it should. Perhaps you're still experiencing pain, or the knee doesn't feel stable. In such cases, doctors might recommend another operation to replace parts or all of the original knee replacement. This second operation is known as a 'revision total knee replacement'.

This particular study is all about a new type of knee replacement system designed for these revision surgeries, called the ATTUNE Revision System. Doctors want to see how well this new system works in real-life patients over a five-year period. They're looking at hundreds of people across different hospitals to get a good picture of its performance.

The main thing they'll be checking is how long the ATTUNE Revision System lasts without needing further surgery. They'll also be tracking other important things like how much pain people have, how satisfied they are with their new knee, and how much their movement and daily activities improve. This helps doctors learn if this new system is a good and lasting solution for patients who need a second chance at a good knee replacement.

Key takeaways

This study evaluates a new knee replacement system for patients needing a second knee operation.
It's a long-term study, following patients for five years after their surgery.
The main aim is to see how durable the new knee system is and if it reduces pain and improves movement.
Over 400 patients will be involved across many hospitals worldwide.
Participation requires being between 22 and 80 years old and having a failed previous knee replacement.

Who may be eligible?

To join this study, you need to be a man or woman between 22 and 80 years old. You must have had a previous knee replacement (either a full knee or just part of it) or even a previous revision knee replacement that isn't working properly and needs to be replaced again. Most importantly, your doctor must believe the ATTUNE Revision System is suitable for your upcoming surgery. You also need to be able to understand the study information and fill out questionnaires.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you've recently taken part in another medical study involving a new treatment or device. If you have certain medical conditions that severely affect your movement or ability to follow up, or if you've recently had problems with drug or alcohol abuse, you likely wouldn't be eligible. Also, if you have ongoing legal claims related to your personal injury or workers' compensation, you can't join this study.

Quick self-check

Am I between 22 and 80 years old?
Do I need a second knee replacement surgery because a previous one has failed?
Am I able to understand study information and fill out questionnaires?
Am I currently pregnant or breastfeeding? (If yes, you likely can't join.)
Have I taken part in another medical study for a new treatment in the last three months? (If yes, you likely can't join.)

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will have your revision knee replacement surgery using the ATTUNE Revision System. After your operation, you will have several follow-up visits with your care team over a period of five years. These visits are important for the doctors to check on your progress, how your knee is healing, and how you're feeling. You'll likely answer questions about your pain, satisfaction, and how well you can move your knee. This long-term monitoring helps understand the full picture of the new knee system's effectiveness and durability.

Potential risks and benefits

Taking part in this study means you'll receive a new knee replacement system designed for revision surgery, which could offer you benefits like reduced pain and improved movement, similar to what's expected from any successful knee replacement. As with any surgery, there are potential risks involved, such as infection or complications from the operation itself, which your doctor will discuss with you. There's also the chance the new system might not work as well as hoped, or even fail, requiring further surgery. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (38)

Scripps Clinic Torrey Pines
San Diego, United States
Colorado Joint Replacement
Denver, United States
Orthopaedic Center of the Rockies
Fort Collins, United States
Orthopedic Partners
Niantic, United States
Florida Orthopedic Associates
DeLand, United States
Arthroplasty Foundation
Louisville, United States
University of Mississippi Medical Center
Jackson, United States
Mery Hospital
Ozark, United States
Dartmouth-Hitchcock Medical Center
Lebanon, United States
Rothman Institute
Egg Harbor, United States
UNC Orthopaedics
Chapel Hill, United States
OrthoCarolina Hip and Knee Center
Charlotte, United States

+26 more sites — see the official record for the full list.

Common questions

What exactly is a 'revision total knee replacement'?

It's a second operation to replace parts or all of a previous knee replacement that isn't working well anymore.

What is the ATTUNE Revision System?

It's the specific new type of knee replacement implant that doctors are studying for these revision surgeries.

How long will I be involved in this study?

The study involves following up on your knee replacement for five years after your surgery.

Will I have to pay to be in this study?

No, you should not have to pay to participate in the study itself. Any standard medical costs for your surgery and care would still apply, as determined by the NHS or your insurance.

Can I leave the study once I've joined?

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