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.
במבט חטוף
על מה המחקר הזה?
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.
נקודות עיקריות
- 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.
מי עשוי להיות זכאי?
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.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בן 18 או יותר?
- 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?
מה כרוך בהשתתפות?
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.
סיכונים ותועלות פוטנציאליים
מיקומים (9)
- The Parker Instituteמיקוד מאומתCopenhagen, Denmark
- Reumatolog i Odenseמיקוד מאומתOdense, Denmark
- AP-HM hopitauxמיקוד מאומתמרסיי, צרפת
- Clinique Saint Louisמיקוד מאומתPoissy, France
- AmBeNet Hausarztpraxisמיקוד מאומתלייפציג, גרמניה
- University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)מיקוד מאומתמיינץ, גרמניה
- Ospedale San Pietro Fatebenefratelliמיקוד מאומתרומא, איטליה
- London North West University Healthcareמיקוד מאומתלונדון, הממלכה המאוחדת
- Royal Cornwall Hospitalמיקוד מאומתTruro, United Kingdom
שאלות נפוצות
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.
האם אני יכול לעזוב את המחקר בכל עת?
Yes, you can withdraw from the study at any point without it affecting your medical treatment or relationship with your healthcare team.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
דיון
דיון קהילתי
מופעל על ידי הפורום שלנו ב community.patient.info. אנא היו מכבדים — זה אינו ייעוץ רפואי.