Active not recruitingNAINTERVENTIONAL

SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

This research study is investigating a new treatment named SakuraBead for chronic knee pain caused by osteoarthritis, a common ‘wear and tear’ condition affecting joints. It’s an open study comparing SakuraBead, a type of gel that helps reduce blood flow to inflamed areas, with standard corticosteroid injections. Researchers want to find out if SakuraBead is a safe and effective way to relieve pain for people with moderate knee osteoarthritis, especially when other treatments haven’t worked. Around 89 patients will take part, with follow-up for two years to see the long-term effects. The study aims to offer new hope for those struggling with persistent knee pain.

At a glance

Status

Active not recruiting

Phase

Sponsor

CrannMed

Enrolment target

Start

28 Nov 2024

Estimated completion

01 Oct 2028

Osteo Arthritis Knee Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Arthritis Osteoarthritis

What is this study about?

This study is designed to explore a new way of treating knee pain caused by osteoarthritis. Osteoarthritis is a condition where the cartilage cushioning your joints wears down, leading to pain, stiffness, and swelling. If you've been living with this type of knee pain, you might have tried different treatments like pain relievers, physiotherapy, or injections directly into the knee.

Researchers in this study are looking at a treatment called SakuraBead. This involves a procedure called genicular artery embolization (GAE), where tiny beads (SakuraBead) are injected into small blood vessels around the knee. The idea is to reduce the blood supply to the inflamed areas, which can lessen pain. The study compares this new approach with a more common treatment: corticosteroid injections, where anti-inflammatory medicine is injected into the knee joint.

The main goal is to see if SakuraBead is as safe and effective as, or even better than, corticosteroid injections for reducing pain in people with moderate knee osteoarthritis whose pain hasn't improved with other treatments. Around 89 people will take part in this study across different medical centres. They will be carefully monitored for two years to understand how well each treatment works over time.

Key takeaways

Exploring a new treatment (SakuraBead) for knee osteoarthritis pain.
Compares SakuraBead with standard corticosteroid injections.
Aims for pain relief in people whose other treatments failed.
Around 89 participants, followed for two years.
Open to adults aged 40-79 with moderate knee osteoarthritis.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be an adult between 40 and 79 years old with a clear diagnosis of knee osteoarthritis. Your knee pain should be moderate to severe and should have been bothering you for at least three months, even after trying common treatments like anti-inflammatory drugs, physiotherapy, or other injections. Your knee's condition will be assessed with X-rays, and you'll generally need to have a moderate level of osteoarthritis rather than a very mild or very severe case.

There are also reasons why you might not be able to join. For example, if you have very severe osteoarthritis, an infection in your knee, or certain other serious health problems like advanced heart disease or specific autoimmune conditions such as rheumatoid arthritis. If you've had knee replacement surgery before, are pregnant or breastfeeding, or have certain allergies to medical dyes, you also wouldn't be able to participate. Your doctor will carefully check all these points to make sure the study is right for you.

Quick self-check

Are you between 40 and 79 years old?
Have you been diagnosed with knee osteoarthritis?
Is your knee pain moderate to severe and has it lasted at least 3 months, even after trying other treatments?
Do you have moderate osteoarthritis rather than very mild or very severe?
Are you able to attend all clinic visits and follow-ups for two years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive either the SakuraBead treatment or a corticosteroid injection. This is like flipping a coin, so neither you nor the doctors can choose which treatment you get. Both treatments are given in a medical setting. You'll have regular follow-up appointments over two years to check on your pain levels, how well your knee is moving, and your general health. These check-ups will involve answering questionnaires, having physical examinations, and potentially further scans like X-rays or MRI scans. The total duration of your active participation, including treatments and follow-up, will be for two years.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving a new, potentially effective treatment for your knee pain if other options haven't worked well. You'll also receive careful monitoring of your knee and overall health over two years. However, all medical procedures carry some risks. For SakuraBead, these could include problems related to the injection, such as bruising, infection, or reaction to the material. Corticosteroid injections also have potential risks like temporary pain or swelling, or very rarely, infection. It's important to understand that your pain might not improve, or you might experience side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

University of Alabama Medicine
Birmingham, United States
Harbor UCLA Medical Center
Torrance, United States
Advanced Vascular Institute
Panama City, United States
IR Centers
Raleigh, United States
IR Centers
Leesburg, United States
Bokhua Memorial Cardiovascular Center
Tbilisi, Georgia
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Nano Medical Clinic
Tashkent, Uzbekistan

Common questions

What is osteoarthritis?

Osteoarthritis is a common joint condition where the protective cartilage on the ends of your bones wears down over time, causing pain, stiffness, and swelling.

What is SakuraBead?

SakuraBead is a special gel material used in a procedure called genicular artery embolization (GAE) to reduce blood flow to inflamed areas in the knee, aiming to lessen pain.

Will I know which treatment I'm getting?

No, you will be randomly assigned to receive either the SakuraBead treatment or a corticosteroid injection, chosen by chance, like flipping a coin.

How long will the study last?

If you join, your participation will involve treatments and follow-up appointments over a period of two years.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.