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Active not recruitingOBSERVATIONAL

JOURNEY™ II CR Total Knee System

This study is checking how well a specific knee replacement system, called the JOURNEY™ II CR Total Knee System, works for people who have knee arthritis (degenerative joint disease) and need a knee replacement. It aims to see if the new knee is safe and effective over time. Researchers will follow around 170 patients from different hospitals for up to 10 years after their surgery. This long-term follow-up will help them understand the benefits and any potential issues with this particular knee replacement. The study involves people aged 22 to 75 who are having their first knee replacement surgery.

At a glance

Status
Active not recruiting
Sponsor
Smith & Nephew, Inc.
Enrolment target
170
Start
01 Sep 2015
Estimated completion
01 Jun 2028

What is this study about?

Imagine you have knee arthritis, causing pain and making everyday activities difficult. Your doctor might suggest a total knee replacement. This study is all about one specific type of knee replacement called the JOURNEY™ II CR Total Knee System. Doctors want to understand how well this particular system helps people like you. They'll be checking its safety, meaning they'll look for any problems or side effects, and its effectiveness, meaning how well it improves your knee function and reduces pain.

This study will follow about 170 people who get this knee replacement at different hospitals around the world. These patients will have what's called 'degenerative joint disease,' which is a common type of arthritis that wears away the knee joint. The aim is to see how patients recover and how their new knee performs over a long period, up to 10 years after the operation.

By carefully watching these patients, the researchers hope to gather important information about the JOURNEY™ II CR system. This information will help doctors understand if it's a good choice for people needing their first total knee replacement, offering valuable insights for future patient care.

Key takeaways

  • This study evaluates a specific knee replacement system.
  • It's for people with knee arthritis needing their first knee replacement.
  • Participation involves follow-up appointments for up to 10 years.
  • It aims to understand long-term safety and effectiveness.
  • You must be aged 22-75 and in good overall health.

Who may be eligible?

To join this study, you would generally need to be between 22 and 75 years old and have knee arthritis that requires your first total knee replacement with the JOURNEY™ II CR system. You should be in good general health, able to walk independently, and willing to attend all follow-up appointments for up to 10 years.

Reasons why you might not be able to join include having already had a knee replacement in the same knee, having very weak bones (like severe osteoporosis), or if another joint like your hip has ongoing problems or a recent surgery that isn't fully healed. Also, if you need particular adjustments during surgery, like patella resurfacing, this study might not be for you.

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 knee arthritis that needs a full knee replacement?
  3. Is this your very first knee replacement on this knee?
  4. Are you able to attend follow-up appointments for up to 10 years?
  5. Do you generally feel healthy enough for surgery?
  6. Do you not have severe bone weakness (like severe osteoporosis)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign a consent form, making sure you understand everything involved. Then, you'll have your total knee replacement surgery using the JOURNEY™ II CR system. After your operation, you would need to attend follow-up check-ups at 3 months, 1 year, 2 years, 5 years, and 10 years. These visits will involve assessments to see how your new knee is doing, how you're feeling, and to check for any issues. The total duration of your involvement in the study could be up to 10 years.

Potential risks and benefits

Potential benefits of participating might include receiving a knee replacement that could improve your mobility and reduce pain, and contributing valuable information that helps others in the future. As with any surgery, there are risks, such as infection, pain, or complications from the anaesthesia. Your doctor will discuss all the specific risks of knee replacement surgery with you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Orthopedic Institute of the West
    Verified postcode
    Phoenix, United States
  • Rush University Medical Center
    Verified postcode
    Chicago, United States
  • Anne Arundel Health System Research Institute, Inc
    Verified postcode
    Annapolis, United States
  • Center for Hip and Knee Replacement at Columbia University Medical Center
    Verified postcode
    New York, United States
  • Wake Forest University
    Verified postcode
    Winston-Salem, United States
  • The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network
    Verified postcode
    Cincinnati, United States
  • Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia
    Verified postcode
    Barcelona, Spain
  • Royal National Orthopaedic Hospital NHS Trust
    Verified postcode
    Stanmore, United Kingdom
  • Barts Health NHS Trust
    Verified postcode
    Whitechapel, United Kingdom

Common questions

What is 'degenerative joint disease'?

It's a common type of arthritis, often called osteoarthritis, where the protective cartilage on the ends of your bones wears down over time, causing pain and stiffness.

What does 'primary total knee replacement' mean?

It means this is your first full knee replacement surgery on that particular knee, rather than a repeat or 'revision' surgery.

How long will I be followed up for?

The study will follow your progress with the new knee for up to 10 years after your surgery.

Will I get paid to join the study?

The study information provided doesn't mention payment for participation; specific details would be discussed when you review the consent form.

Can I leave the study if I change my mind?

Yes, you are always free to withdraw from the study at any time without it affecting your medical care.

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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