Active not recruitingOBSERVATIONAL

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

This study is investigating a new knee replacement system called Vanguard 360. This system is designed for people who need knee surgery, often due to conditions like osteoarthritis, rheumatoid arthritis, or previous knee damage. Researchers want to understand how well this new knee system works in restoring a natural knee position, improving pain, movement, and overall patient satisfaction. They'll also check how long the knee replacement lasts and if there are any problems. The study uses standard surgical methods, ensuring no experimental procedures are involved. This will help doctors understand if the Vanguard 360 system is a good option for people seeking a knee replacement.

At a glance

Status

Active not recruiting

Sponsor

Zimmer Biomet

Enrolment target

255

Start

01 Mar 2012

Estimated completion

01 Dec 2031

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Post Traumatic Deformity Complications; Arthroplasty Deformity of Limb

What is this study about?

This research is looking into a new knee replacement system called Vanguard 360. When someone needs a knee replacement, it's often because conditions like arthritis (such as osteoarthritis or rheumatoid arthritis) have badly damaged their knee joint, causing pain and making it hard to move. Sometimes, past injuries or previous knee operations that haven't worked out well also lead to needing a new knee.

The main goal of this study is to see how well the Vanguard 360 system helps people. They're particularly interested in whether it can put the knee back into its correct position, reduce pain, improve how well the knee works, and make patients happier with their new knee. They'll also keep an eye on how long the new knee lasts and check for any issues along the way. Your doctor will use standard surgical techniques, so there's nothing experimental about the operation itself.

By carefully studying how people get on with this new knee system, researchers hope to gather important information. This information can then help doctors decide if the Vanguard 360 system is a good and reliable choice for future patients needing a knee replacement, helping them to live more comfortably and actively.

Key takeaways

Investigating a new type of knee replacement system (Vanguard 360).
Aims to improve pain, movement, and overall patient happiness.
Uses standard surgical techniques, nothing experimental.
Suitable for people with arthritis or previous knee damage.
Requires follow-up visits to check progress and knee health.

Who may be eligible?

To be able to take part in this study, you generally need to be at least 18 years old and have ongoing knee pain and difficulty moving, often due to types of arthritis or previous knee damage. This includes situations where your knee is bent inward or outward, or if you've had a previous knee operation that hasn't been successful.

You also need to be able and willing to come to follow-up appointments and give your written permission to join the study. It's important that you can understand and follow instructions from the medical team.

However, some things would mean you couldn't join. For example, if you have an infection in or around your knee, problems with your bones like severe thinning (osteoporosis) or softening (osteomalacia), or if you have certain other serious health conditions that might affect the surgery or your recovery. The team will carefully check all these points to make sure the study is safe and right for you.

Quick self-check

Are you at least 18 years old?
Do you have ongoing knee pain and difficulty due to arthritis or previous injury?
Are you able and willing to attend follow-up appointments?
Are you willing to discuss and sign a consent form?
Do you have any current infections, especially in your knee?

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 would undergo the standard knee replacement surgery using one of the Vanguard 360 knee systems. Before the operation, and then at various times afterwards, the study team would check your knee and how you're feeling. This would likely involve assessing your pain levels, how much you can move your knee, and how easily you can do everyday activities. They might also take x-rays to see how the new knee joint is doing inside your body. You would need to attend follow-up appointments, which are a normal part of having a knee replacement, for a certain period to allow the team to monitor your progress. There are no experimental medicines involved in this study; it's focused on the surgical device itself and your recovery.

Potential risks and benefits

Patients joining this study might benefit from improved pain relief, better knee function, and increased satisfaction with their new knee compared to their previous pain and mobility issues. As with any surgery, there are potential risks, such as infection or complications related to the operation or the new joint, which your medical team will discuss fully with you. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (12)

Illinois Bone and Joint
Morton Grove, United States
Orthopedic Institute of Henderson
Henderson, United States
University of Utah Orthopedic Center
Salt Lake City, United States
OrthoVirginia West End Orthopedic Clinic
Richmond, United States
University Hopital Pellenberg
Pellenberg, Belgium
Aarhus university hospital
Aarhus, Denmark
Ch Lyon Sud
Lyon, France
Klinik fur Endoprothetik und gelenkchirurgie
Bad Wildbad, Germany
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
University Hospital Mutua de Terrasa
Terrassa, Spain
Royal Orthopaedic Hospital
Birmingham, United Kingdom

Common questions

What kind of knee problems is this study for?

This study is for people mainly suffering from painful knee conditions like osteoarthritis, rheumatoid arthritis, or damage from injuries that affect how their knee works.

Is the surgery experimental?

No, the surgery itself uses standard methods your surgeon is already familiar with. The focus is on seeing how well a new knee joint system called Vanguard 360 performs.

How old do I need to be to join?

You need to be at least 18 years old to take part in this study. There is no upper age limit.

What will happen if I join the study?

You will have a knee replacement operation using the Vanguard 360 system, and then your pain, movement, and general well-being will be checked before and after the surgery at regular follow-up appointments.

What if I change my mind about taking part?

You are free to leave the study at any time, and this will not affect the medical care you receive.