Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

To be part of this study, you need to be an adult (18 years or older) with a clear diagnosis of knee osteoarthritis. You also need to be willing to follow the study procedures for its full duration, which is about five years.

There are certain reasons why you might not be able to join. For example, if you have a skin infection or disease around your knee, or if the knee joint itself is infected or very inflamed. If you've recently had certain other injections in your knee (like hyaluronic acid that hasn't fully cleared yet) or if you've had a knee operation (like an arthroscopy) in the last six months, you might not be eligible. Also, if you've received other long-lasting injections in your knee before, or if you have a full knee replacement or other foreign material in the knee, you wouldn't be able to participate. Finally, if you have a bleeding disorder like haemophilia or are on blood-thinning medication that isn't properly controlled, you wouldn't be able to take part.

If you decide to participate, you will be followed for a period of five years. Your first check-up will be about six months after you receive your Arthrosamid® treatment. After that, you'll have yearly check-ups. These follow-up visits can often be done over the phone, making them more convenient for you. During these check-ups, the study team will gather information about your knee osteoarthritis and how you are feeling generally. You won't be given any new medications specifically for the study; instead, your usual care with Arthrosamid® will be observed.