All studies
Active not recruitingNAINTERVENTIONAL

Survivorship of Attune Primary Total Knee Prosthesis

This study is investigating how well a particular type of knee replacement, the Attune Primary Knee System, performs for people over a long period, specifically up to 15 years after surgery. It's for individuals aged 22 to 75 who are having a total knee replacement because of wear-and-tear arthritis, known medically as non-inflammatory degenerative joint disease. Researchers are collecting information from patients who have received one of four common versions of this knee replacement. This will help them understand its long-term success, including how long it lasts and if there are any issues. The goal is to gather real-world data to make sure this knee replacement is effective and durable for patients.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
DePuy International
Enrolment target
1,542
Start
01 Feb 2013
Estimated completion
01 Feb 2030

What is this study about?

This study, called "Survivorship of Attune Primary Total Knee Prosthesis," is an important investigation into a specific knee replacement, the Attune Knee System. If you have been told you need a total knee replacement due to wear-and-tear arthritis, this study is looking at how well this particular knee system holds up over a long time, up to 15 years after your operation.

The main aim is to understand how durable the Attune knee replacement is in real-world use. Doctors want to see how long it continues to function effectively without needing further surgery, which is often called 'survivorship'. They are collecting information from many patients who have had different versions of the Attune knee replaced. This will help them build a clear picture of its long-term performance and benefit doctors and future patients.

Researchers are gathering information from over 1,500 patients worldwide who have received this knee replacement. The study follows patients who have either recently had the surgery or those who had it a couple of years ago and are now being asked if they'd like to continue being monitored. This allows them to collect a wide range of data on how the knee replacement performs over many years.

Key takeaways

  • Studies the long-term performance of the Attune Knee System.
  • Aims to understand how long the knee replacement lasts (up to 15 years).
  • For people aged 22-75 with wear-and-tear knee arthritis.
  • Involves regular follow-up after your knee replacement surgery.
  • Helps improve knowledge about knee replacement effectiveness.

Who may be eligible?

To be considered for this study, you would generally need to be a man or woman between 22 and 75 years old at the time of your knee replacement surgery. You must have been diagnosed with wear-and-tear arthritis (non-inflammatory degenerative joint disease) in your knee and be a suitable candidate for a total knee replacement using the Attune system. You'd also need to be able to understand the study and be willing to attend follow-up appointments.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you've already had certain other knee surgeries on the affected knee, like a partial knee replacement. They also couldn't include you if you're currently dealing with specific legal claims related to personal injury or if you have certain other serious medical conditions or psychological issues that might make it hard to participate fully.

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.

  1. Are you between 22 and 75 years old?
  2. Do you have wear-and-tear arthritis in your knee?
  3. Are you having a total knee replacement with the Attune system?
  4. Are you willing and able to attend follow-up appointments for many years?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first need to give your informed consent, meaning you understand what's involved and agree to participate. The study involves being fitted with the Attune Primary Knee System during your total knee replacement surgery.

After your surgery, you would have regular follow-up visits with your care team. These visits are where doctors and nurses will check how your knee is healing and performing. You might be asked to complete questionnaires about your pain, daily activities, and how you feel your knee is working. These assessments help researchers understand the long-term success of the knee replacement. The study plans to follow patients for a very long time, up to 15 years after their surgery, so it's a significant commitment.

Potential risks and benefits

Participating in this study might offer the benefit of contributing to our understanding of knee replacement surgery, which could help future patients. You would also receive close monitoring of your knee replacement by medical professionals, which is part of your standard care. As with any medical procedure, there are potential risks associated with knee replacement surgery itself, which your surgeon will explain. There are no additional risks directly from being in this study beyond those of the surgery itself and regular follow-up appointments. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mayo Clinic Arizona
    Verified postcode
    Scottsdale, United States
  • Orthopaedic Specialty Institute
    Verified postcode
    Orange, United States
  • Florida Research Associates, LLC
    Verified postcode
    DeLand, United States
  • Center for Hip and Knee Surgery
    Verified postcode
    Mooresville, United States
  • University of Iowa Hospitals & Clinics
    Verified postcode
    Iowa City, United States
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States
  • Orthopedic One
    Verified postcode
    Columbus, United States
  • OrthoNeuro
    Verified postcode
    New Albany, United States
  • Penn State Hershey Bone & Joint Institute
    Verified postcode
    Hershey, United States
  • Texas Institute for Hip and Knee Surgery, LLC
    Verified postcode
    Austin, United States
  • Canberra Hospital-Trauma & Orthopaedic Research Unit
    Verified postcode
    Adelaide, Australia
  • Univ.-Klinik für Orthopädie
    Unverified
    Vienna, Austria

Common questions

What is the Attune Knee System?

It's a specific type of knee replacement used in total knee replacement surgery for people with arthritis.

What does 'survivorship' mean in this study?

It means how long the knee replacement continues to work well without needing further surgery or having problems.

How long will I be followed in this study?

The study aims to follow patients for up to 15 years after their knee replacement surgery.

Do I get to choose which type of Attune knee replacement I get?

No, your surgeon will use the type they normally recommend as standard care for you during the surgery.

Will I have more doctor's appointments if I join this study?

You will have regular follow-up appointments to check on your knee replacement, which are part of the study's plan to collect long-term information.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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