Active not recruitingNAINTERVENTIONAL

The Medacta International GMK Sphere Post-Marketing Surveillance Study

This study is looking at how well a specific type of knee replacement, called the GMK Sphere, performs in real-world situations. It’s for people who need a knee replacement because of conditions like arthritis. Rather than being a new drug trial, this is a 'post-marketing surveillance' study, meaning the knee replacement is already available. Doctors will track how patients in different hospitals get on after their surgery. They'll be checking to see if the knee replacement helps people move better, reduces pain, and improves their quality of life. The main goal is to make sure this new knee replacement works as expected for those who receive it.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medacta International SA

Enrolment target

500

Start

01 Oct 2012

Estimated completion

01 Oct 2029

Arthritis Traumatic Arthritis Rheumatoid Arthritis Poly-arthritis Avascular Necrosis

What is this study about?

Imagine you're having knee replacement surgery. A study is currently underway to carefully check how a specific type of artificial knee, called the GMK Sphere, works for patients. This isn't a brand new product being tested for the first time on people; instead, it's already used by surgeons. The study's purpose is to gather more information about how well it performs in many different patients over time.

Think of it like a thorough check-up for the new knee. Doctors want to see how patients recover after their surgery, how much pain they have (or don't have!), and how much their movement and daily activities improve. This kind of study, called 'post-marketing surveillance,' helps medical experts understand the long-term effects and benefits of medical devices like knee replacements once they are in regular use.

Several hospitals across the UK are working together on this. They aim to include about 500 patients in total, collecting information from each patient after they've had their GMK Sphere knee replacement. This gathered information will help ensure that this knee replacement continues to be a good option for people who need it, providing valuable insights for both patients and healthcare professionals alike.

Key takeaways

This study evaluates an existing knee replacement, not a new experiment.
It helps doctors understand how the GMK Sphere knee works for patients.
Participation involves sharing routine medical information after your surgery.
You won't have extra treatments or appointments due to the study.
Your privacy will be protected.
You can stop participating at any time.

Who may be eligible?

This study is for adults generally between the ages of 18 and 80 who are planning to have a full knee replacement operation. You would need to have specific knee problems like arthritis (including rheumatoid arthritis) or other conditions that have severely damaged your knee joint and made it difficult for you to move.

There are also some reasons why you might not be able to join. For example, if you have a current infection in your body or leg, or if you have certain muscle, nerve, or blood flow problems in your leg that might make the surgery too risky or not helpful. Also, if your knee is very unstable due to damaged ligaments, or if you have other serious health issues that might prevent you from recovering well.

Finally, you must be able to understand what the study involves and be willing to give your written permission (called 'informed consent') to take part. If your Body Mass Index (BMI) is over 40, you would not be able to join this study.

Quick self-check

Am I between 18 and 80 years old?
Am I scheduled for a total knee replacement surgery?
Do I have a severely damaged knee due to arthritis or a similar condition?
Do I understand what the study involves and can I give written permission to take part?
Is my Body Mass Index (BMI) 40 or below?

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, it means that you will be receiving the GMK Sphere knee replacement as part of your planned surgery. The study doesn't involve any extra appointments or medications beyond what your usual knee replacement care would include. What will happen is that your medical information and how you recover after the surgery will be carefully recorded and followed up by the study team. This typically means your doctors and nurses will be noting your progress during your regular hospital visits and follow-up appointments. The total duration of your participation will depend on how long your regular medical team continues to monitor your knee replacement, but it mainly focuses on observing your recovery after the operation.

Potential risks and benefits

The main benefit of taking part is that your medical information contributes to a better understanding of how the GMK Sphere knee replacement works for patients. This helps improve care for future patients. Since this knee replacement is already in use, you wouldn't be exposed to new or unknown risks specifically because of the study; you would experience the usual potential risks and benefits associated with any knee replacement surgery. You are free to withdraw from the study at any time without affecting the care you receive for your knee, though you would still receive your planned surgery.

Locations (4)

AZ Maria Middelares
Ghent, Belgium
Royal London Hospital
Whitechapel, United Kingdom
Royal National Orthopaedic Hospital NHS Trust
Stanmore, United Kingdom
The Elective Orthopaedic Centre (EOC)
Epsom, United Kingdom

Common questions

What is the GMK Sphere knee replacement?

It's a specific type of artificial knee joint used in surgery to replace a damaged knee.

Is this a new or experimental treatment?

No, the GMK Sphere knee replacement is already available and used by surgeons. This study is just checking how well it works in many patients.

Will I get extra appointments or medicines if I join?

No, you won't have extra appointments or be given different medicines just for the study. Your standard care will be followed.

How long will I be part of the study?

Your participation involves sharing your recovery information after your knee surgery. This will happen during your regular check-ups with your medical team.

What if I change my mind about taking part?

You can decide to stop participating in the study at any time, and it won't affect the medical care you receive for your knee.