Active not recruitingOBSERVATIONAL

Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

This study is investigating a treatment called Arthrosamid® for people living with knee osteoarthritis. It's designed to observe how patients who are already suitable for and receiving this treatment fare over a five-year period. Researchers will be following up with participants to understand the long-term effects of Arthrosamid® on their knee pain and overall joint health. This isn't a trial testing a new drug; instead, it's an 'observational' study, meaning doctors will simply keep an eye on patients' progress as part of their routine care. The aim is to gather valuable information from many clinics to see how this treatment works in real-world settings over time.

At a glance

Status

Active not recruiting

Sponsor

Contura

Enrolment target

201

Start

21 Apr 2021

Estimated completion

01 Jul 2028

Knee Osteoarthritis

What is this study about?

This study is called an 'observational investigation', which means we're looking at how a specific treatment, called Arthrosamid®, works for people who have knee osteoarthritis in their everyday lives. It's not a study where we're trying out a new treatment; instead, it's about carefully watching the progress of people who are already being treated with Arthrosamid® because their doctor believes it's suitable for them.

The main goal is to understand the long-term effects of Arthrosamid®. We want to see how it helps people with knee osteoarthritis over five years. This involves collecting information from many different clinics across the country. By doing this, we hope to get a clearer picture of how this treatment performs for a wide range of patients in real-world situations, which can help doctors and patients make informed decisions in the future.

Participation in this study won't change your usual medical care or how you receive your Arthrosamid® treatment. It simply means clinic staff will collect some extra information about your condition and progress during your regular follow-up appointments, or through phone calls. This helps us learn more about managing knee osteoarthritis with this type of treatment.

Key takeaways

This study observes the long-term effects of Arthrosamid® for knee osteoarthritis.
It lasts five years, with mostly phone call check-ups.
You participate if you're already receiving Arthrosamid®.
Your standard medical care will not change.
Your information helps doctors understand the treatment better.

Who may be eligible?

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.

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.

Are you 18 years old or older?
Do you have a diagnosis of knee osteoarthritis?
Do you already qualify for and receive Arthrosamid® treatment?
Do you NOT have an active skin infection or very inflamed knee?
Have you NOT had a knee replacement or other permanent foreign material in your knee?
Have you NOT had knee surgery (like arthroscopy) in the last 6 months?

Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

Participating in this study doesn't involve any changes to your medical care or treatment plan; you'll receive Arthrosamid® as your doctor normally prescribes. The potential benefit is that your information will help improve our understanding of how well Arthrosamid® works long-term for people with knee osteoarthritis, which could benefit future patients. As this is an observational study of a treatment you'd receive anyway, there are no additional risks beyond those associated with Arthrosamid® itself. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Parker Institute
Verified postcode
Copenhagen, Denmark
Reumatolog i Odense
Verified postcode
Odense, Denmark
AP-HM hopitaux
Verified postcode
Marseille, France
Clinique Saint Louis
Verified postcode
Poissy, France
AmBeNet Hausarztpraxis
Verified postcode
Leipzig, Germany
University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)
Verified postcode
Mainz, Germany
Ospedale San Pietro Fatebenefratelli
Verified postcode
Rome, Italy
London North West University Healthcare
Verified postcode
London, United Kingdom
Royal Cornwall Hospital
Verified postcode
Truro, United Kingdom

Common questions

What is knee osteoarthritis?

Knee osteoarthritis is a common condition where the cartilage cushioning your knee joint wears down, leading to pain, stiffness, and sometimes swelling.

What is Arthrosamid®?

Arthrosamid® is a type of injection given into the knee joint to help relieve symptoms of osteoarthritis. It's a non-absorbable treatment, meaning it stays in the joint.

Will I get Arthrosamid® as part of this study?

No, you would already be receiving Arthrosamid® as part of your standard medical care and would be invited to participate in the study if you are eligible.

How often will I need follow-ups?

You'll have an initial follow-up about six months after treatment, and then yearly follow-ups for five years. Many of these can be done over the phone.

Can I leave the study at any time?

Yes, you can withdraw from the study at any point without it affecting your medical treatment or relationship with your healthcare team.