Genicular Artery Embolisation for Knee Osteoarthritis II
This study is investigating a treatment called Genicular Artery Embolisation (GAE) for people suffering from knee pain due to osteoarthritis. This is for those whose pain hasn't gotten better with usual treatments like physiotherapy. The aim is to see if GAE can reduce this pain. Participants will be split into two groups: one receiving the GAE treatment and another receiving a 'dummy' procedure (a saline injection). Neither the patients nor their doctors will know who received which treatment at first. After six months, those who had the dummy procedure will be offered the GAE treatment. The study plans to include up to 110 people aged 45 and over and will follow them for up to 24 months.
De un vistazo
¿De qué trata este estudio?
If you're living with ongoing knee pain from osteoarthritis that hasn't improved with various treatments, this study might be of interest to you. It's designed to investigate a new approach called Genicular Artery Embolisation (GAE). Osteoarthritis can sometimes cause new, tiny blood vessels to grow around the knee, which some experts believe might contribute to pain. GAE aims to block these specific tiny blood vessels, potentially reducing your pain.
A key aspect of this research is comparing GAE to a 'sham' or dummy procedure. This is done to make sure that any improvements seen are truly due to the GAE treatment and not just a placebo effect (where people feel better because they expect to). You won't know whether you're receiving the actual GAE treatment or the dummy procedure, and neither will your doctors – this is called a 'double-blind' study. This method helps to get the most accurate results possible.
The study will follow participants for a significant period, up to 24 months. If you are initially in the dummy procedure group, you'll have the option to receive the GAE treatment after six months. This careful approach helps researchers understand the long-term effects and safety of the GAE treatment for knee osteoarthritis.
Puntos clave
- This study explores a new treatment (GAE) for knee osteoarthritis pain.
- It uses a 'double-blind' approach to ensure fair results.
- Participants may receive GAE or a dummy procedure initially.
- If you get the dummy procedure, you can still receive GAE after 6 months.
- The study involves follow-up appointments over up to 24 months.
- It's for people aged 45+ whose knee pain hasn’t responded to other treatments.
¿Quién puede ser elegible?
To join this study, you generally need to be 45 years old or older and have mild to moderate knee osteoarthritis that has caused pain for at least three months. This pain should also be something that hasn't improved much with standard treatments like physiotherapy or injections. You should be able to lie flat comfortably for about six hours.
There are also some reasons why you might not be able to join. For example, if you have rheumatoid arthritis, very severe knee osteoarthritis, certain kidney problems, or issues with blood clotting, you might not be eligible. Also, if you need oxygen all the time, are pregnant, or have allergies to certain medical dyes or materials, you won't be able to take part. Researchers will check your medical history to make sure it's safe for you to participate.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Are you 45 years old or older?
- Do you have knee pain from osteoarthritis that hasn't improved with other treatments for at least 3 months?
- Can you lie flat comfortably for at least 6 hours?
- Do you have mild to moderate knee osteoarthritis, not severe?
- Are you able to provide your informed consent to participate?
¿En qué consiste la participación?
If you decide to take part, you'll first have a thorough check-up including a physical exam, a magnetic resonance imaging (MRI) scan of your knee, and some blood tests. You'll then be randomly assigned to one of two groups: either receiving the Genicular Artery Embolisation (GAE) procedure or a 'sham' (dummy) procedure which involves a saline injection.
Both procedures involve a small tube inserted through your groin. For GAE, tiny particles are delivered to block specific blood vessels in your knee, while the sham procedure involves a simple saline injection. You won't know which one you received. After the procedure, you'll have follow-up visits at 1 month, 3 months, and other regular times up to 24 months. At the 6-month mark, if you were in the sham group, you'll be offered the chance to have the GAE procedure. The total time you'll be followed by the study team will be up to 24 months.
Riesgos y beneficios potenciales
Ubicaciones (1)
- Royal Berkshire NHS Foundation TrustCódigo postal verificadoReading, United Kingdom· Reclutamiento
Preguntas comunes
What is Genicular Artery Embolisation (GAE)?
GAE is a procedure that aims to block tiny blood vessels around the knee that are thought to contribute to osteoarthritis pain.
What does 'double-blind' mean?
It means neither you nor your doctors will know if you received the GAE treatment or the dummy procedure. This helps make the study results more reliable.
What is a 'sham' procedure?
A sham procedure is a dummy treatment, in this case, a saline injection, designed to look and feel similar to the real procedure without delivering the active treatment.
What if I get the dummy treatment first?
If you're in the dummy treatment group, you'll be offered the actual GAE procedure after 6 months.
¿Cuánto tiempo estaré involucrado en el estudio?
You'll be followed by the study team for up to 24 months in total.
Cómo obtener más información
Heike S Hausen, MD
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.