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.
एक नजर में
यह अध्ययन किस बारे में है?
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.
मुख्य निष्कर्ष
- 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.
कौन पात्र हो सकता है?
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.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- क्या आप 18 वर्ष या उससे अधिक आयु के हैं?
- 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?
भागीदारी में क्या शामिल है?
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.
संभावित जोखिम और लाभ
स्थान (9)
- The Parker Instituteसत्यापित पोस्टकोडकोपेनहेगन, डेनमार्क
- Reumatolog i Odenseसत्यापित पोस्टकोडओडेंस, डेनमार्क
- AP-HM hopitauxसत्यापित पोस्टकोडमार्से, फ्रांस
- Clinique Saint Louisसत्यापित पोस्टकोडPoissy, France
- AmBeNet Hausarztpraxisसत्यापित पोस्टकोडलाइपज़िग, जर्मनी
- University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz)सत्यापित पोस्टकोडमाइंज़, जर्मनी
- Ospedale San Pietro Fatebenefratelliसत्यापित पोस्टकोडRome, Italy
- London North West University Healthcareसत्यापित पोस्टकोडलंदन, यूनाइटेड किंगडम
- Royal Cornwall Hospitalसत्यापित पोस्टकोडTruro, United Kingdom
सामान्य प्रश्न
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.
क्या मैं किसी भी समय अध्ययन छोड़ सकता हूँ?
Yes, you can withdraw from the study at any point without it affecting your medical treatment or relationship with your healthcare team.
और अधिक जानने के लिए कैसे पता करें
किसी अध्ययन में भाग लेने का निर्णय लेने से पहले हमेशा अपने जीपी या विशेषज्ञ से बात करें।.
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