Active not recruitingNAINTERVENTIONAL

14022 ATTUNE Cementless RP Clinical Performance Evaluation

This study is investigating a new type of knee replacement designed to be used without cement, called the ATTUNE Cementless Total Knee Arthroplasty. It's for individuals suffering from osteoarthritis. The main goal is to see how much people's ability to perform daily activities improves two years after getting one of two specific versions of the ATTUNE knee replacement. Researchers will also closely monitor other important factors such as pain levels, how happy people are with their new knee, any problems that might occur, and how long the knee replacement lasts. They'll also check how well the new knee replacement stays in place using X-rays and how well it aligns with the leg. The results will help understand if this new knee replacement system is effective and safe.

At a glance

Status

Active not recruiting

Phase

Sponsor

DePuy Orthopaedics

Enrolment target

540

Start

01 Sep 2016

Estimated completion

01 Sep 2027

Osteoarthritis

What is this study about?

This study is about a new type of knee replacement called the ATTUNE Cementless Total Knee Arthroplasty. Normally, knee replacements are fixed into place using special bone cement. However, this new design aims to avoid using cement, which might have some benefits for certain patients. The researchers want to see how well these cementless knee replacements work for people who have osteoarthritis, a condition that causes pain and stiffness in the joints.

The main thing the study wants to find out is how much better people feel when doing everyday tasks, like walking, climbing stairs, or getting dressed, two years after their surgery. They are looking at two slightly different versions of this ATTUNE cementless knee replacement. They will use special questionnaires to measure these improvements.

Beyond daily activities, the study will also track other important things. This includes how much pain people have, their overall satisfaction with the surgery, and any problems or side effects that might happen. They'll also use X-rays to check if the new knee stays securely in place and is properly aligned over time. Understanding these aspects will help doctors decide if this new cementless knee replacement is a good option for future patients.

Key takeaways

This study evaluates a new cementless knee replacement for osteoarthritis.
It aims to improve daily activities and reduce pain.
Participation involves surgery, questionnaires, and follow-up visits for 2 years.
Potential benefits include close monitoring; risks are similar to standard knee surgery.
You can leave the study at any point without affecting your care.

Who may be eligible?

To be considered for this study, you need to be an adult between 22 and 80 years old who has been diagnosed with osteoarthritis in your knee. Your doctor must also believe that this specific type of cementless knee replacement is suitable for you. You should be able to understand what the study involves, be willing to sign a consent form, and commit to attending all follow-up appointments and completing questionnaires.

There are also reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you cannot take part. You also can't participate if you've already had a partial knee replacement or other major knee surgery on the affected knee. If you have severe back pain affecting your leg, or if you've been in another medical study recently, you would also be excluded. The researchers also need you to be generally healthy enough to participate and to be able to follow instructions.

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?
Do you have knee osteoarthritis?
Are you able to attend all clinic appointments for up to 2 years?
Are you willing to complete questionnaires about your health and pain?
Have you NOT had other knee surgery (like a partial knee replacement) on the affected knee?
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 undergo surgery to receive the ATTUNE cementless knee replacement. Before and after your surgery, you'll be asked to complete several questionnaires about your pain, daily activities, and general quality of life. These questionnaires will help researchers understand how you're feeling and how well your new knee is working.

You'll have several follow-up visits, including appointments at 6 weeks, 6 months, 1 year, and 2 years after your surgery. During these visits, doctors will likely take X-rays of your knee to check how it's healing and if the knee replacement is staying in place. They will also assess your knee's alignment. The total duration of your active participation, including follow-up appointments, will be about two years, with additional data collected from your medical records up to five years after surgery.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as contributing to medical knowledge that could help future patients. You would receive a new knee replacement system that is being closely monitored by doctors and researchers. However, as with any surgery, there are risks, including those surgical complications usually associated with knee replacement, such as infection or issues with healing. There's also the chance that the new knee replacement might not work as well for you as expected. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (20)

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

Colorado Joint Replacement
Verified postcode
Denver, United States
Florida Research Associates
Verified postcode
DeLand, United States
Dartmouth-Hitchcock Medical Center
Verified postcode
Lebanon, United States
New London Hospital
Verified postcode
New London, United States
Rothman Institute
Verified postcode
Egg Harbor, United States
SUNY downstate Medical Center
Verified postcode
Brooklyn, United States
UNC Chapel Hill
Verified postcode
Chapel Hill, United States
Associated Orthopaedics of Kingsport
Verified postcode
Kingsport, United States
Texas Tech University Heath Science Center
Verified postcode
Lubbock, United States
Hampton Roads Orthopaedics and Sports Medicine
Verified postcode
Newport News, United States
Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
Verified postcode
Ried im Innkreis, Austria
Foothills Medical Centre, University of Calgary
Verified postcode
Calgary, Canada

Common questions

What is 'cementless' knee replacement?

A 'cementless' knee replacement means the new joint is designed to grow into your bone over time, rather than being fixed in place with special bone cement during surgery.

What is osteoarthritis?

Osteoarthritis is a common type of arthritis where the protective cartilage on the ends of your bones wears down over time, causing pain, swelling, and stiffness in your joints.

Will I know which type of ATTUNE knee replacement I get?

The study is looking at two types of ATTUNE cementless knee replacements. Your doctor will discuss which one is most suitable for you, but the study will involve both.

How long will I be involved in the study?

You'll have follow-up appointments for approximately two years after your surgery, during which you'll complete questionnaires and have X-rays. Longer-term data will be collected for up to five years.

What if I change my mind about participating?

You are absolutely free to withdraw from the study at any time, for any reason, without it affecting the standard of care you receive.