Active not recruitingNAINTERVENTIONAL

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

This study is checking how well a special type of knee replacement, called the ATTUNE Revision system, performs in people who need a knee replacement for more complicated reasons. These might include situations where the knee is very misshapen, unstable, or has bone loss. The study will follow patients for five years to see how they recover and how long the knee replacement lasts, looking at things like their daily activities. It's a large study, involving different hospitals around the world, and will include people aged 22 to 80. The goal is to understand the real-world performance of this particular knee replacement for these complex cases.

At a glance

Status

Active not recruiting

Phase

Sponsor

DePuy Orthopaedics

Enrolment target

400

Start

19 Sep 2017

Estimated completion

17 Oct 2030

Primary Knee Arthroplasty

What is this study about?

When people need a knee replacement, sometimes their knee problems are a bit more challenging than usual. This might be due to things like being very overweight, having a knee that's badly twisted, or very wobbly ligaments. In these situations, surgeons might need to use special parts or techniques during the operation.

This study is looking at a specific type of knee replacement system, called the ATTUNE Revision knee system. Even though it's called 'Revision,' it can also be used in these more complex first-time knee replacements. The study wants to understand how well this system works for these specific patients. It will follow people for five years to see how they recover, how much pain they have, and how easily they can do their daily tasks.

The main aim is to check the short-to-medium term results, like how much movement and function people get back, and also how long the knee replacement is expected to last. Researchers will gather information from around 400 patients in different hospitals worldwide to get a good overall picture.

Key takeaways

This study evaluates a specific knee replacement for complex cases.
It aims to understand how well the ATTUNE Revision system works over five years.
Patients aged 22-80 with certain knee conditions might be eligible.
Participation involves extra clinic visits and filling out questionnaires.
The goal is to improve knowledge for future knee replacement patients.

Who may be eligible?

To join this study, you need to be a man or a woman between 22 and 80 years old. You must be planning to have your first knee replacement (called a primary knee arthroplasty) and your surgeon believes the ATTUNE Revision knee system is the right choice for your particular knee problem, which might be due to issues like deformity or instability. It's important that your decision to have this knee replacement isn't purely because of the study.

You won't be able to join if you are pregnant or breastfeeding, or if you've already had a partial or full knee replacement in the knee being studied. Also, if you have certain types of inflammatory arthritis like rheumatoid arthritis or gout, you can't take part. If you have severe nerve pain from your spine in the leg needing the knee replacement, this would also prevent you from joining. The study can also only include one knee per person, even if you're having both knees replaced.

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 between 22 and 80 years old?
Are you having your first knee replacement?
Has your doctor suggested the ATTUNE Revision knee system is right for your complex knee problem?
Are you able to attend follow-up appointments for five years?
Do you not have inflammatory arthritis like rheumatoid arthritis or gout?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be followed for five years after your knee replacement. This will involve several visits to the clinic where the study team will check your progress. You'll be asked to fill out questionnaires about your pain and how well you can do your daily activities. These questionnaires are an important way for the researchers to understand how the knee replacement is affecting your life. You'll also need to be able to understand the study information and be willing to attend all your follow-up appointments.

Potential risks and benefits

Participating in any medical study has potential benefits and risks. The main benefit here is helping doctors understand how well this specific knee replacement system works for complex cases, which could improve treatments for future patients. For you, there's no guarantee of a better outcome than standard treatment, but you will receive close follow-up care. Possible risks are generally those associated with having knee replacement surgery itself, such as infection or issues with the implant, and the inconvenience of extra appointments and questionnaires. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (34)

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

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

Common questions

What is the ATTUNE Revision knee system?

It's a specific type of knee replacement implant that can be used for first-time knee replacements, especially when the knee problem is more complex.

Why is this study only for 'complex primary' knee replacements?

Due to issues like severe deformity or instability, some knees need special implants and techniques for a first-time replacement. This study focuses on how well the ATTUNE system works for these particular situations.

How long will I be involved in the study?

If you join, you will be followed for five years after your knee replacement surgery.

Will I get special treatment if I join the study?

Your knee replacement decision should be made independently of the study. You'll receive standard excellent care from your medical team, with additional follow-up and assessments as part of the study.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time without needing to give a reason, and it will not affect your medical care.