Join The SURE Clinical Study

The SURE study is a registered Clinical Trial to determine whether Genicular Artery Embolization (GAE) is superior to standard of care steroid injection in reducing knee pain caused by osteoarthritis.

GAE Procedure and the SURE Trial

Hear Dr. Ari Isaacson, the SURE trial Principal Investigator, explain the GAE procedure and what participation in the trial will be like for patients.

Are You Suffering From Knee Osteoarthritis (OA)?

Knee osteoarthritis causes pain and swelling as the cartilage and other tissues in the joint breaks down. Early treatments like physical therapy and pain relievers can help, but managing pain becomes harder as the condition progresses.

Patients living with knee OA often struggle performing daily activities such as:

Walking

Caring for Family

Exercise

Using Stairs

Sleeping

The SURE Clinical Trial is evaluating if patients with knee osteoarthritis who are treated with a SakuraBead GAE experience better pain relief than those treated with a standard of care steroid injection.

Of the 89 participants, 60 will be treated with the GAE procedure and 29 will be treated with a steroid injection. Participants are randomly assigned to either group, with a 2:1 chance of receiving GAE over the steroid injection.

Those who are initially treated with steroid injection will have the opportunity to “cross over” and receive further treatment after cross over with a GAE procedure, should they so wish.

The study received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA). The Trial is registered with clinicaltrials.gov

Results from our First Trial

The first study using SakuraBead in the treatment of knee osteoarthritis involved 15 patients and was completed in early 2024.

Who Can Participate

Participating in this trial is entirely voluntary. You may be eligible to participate if you:

  • Are aged 40-79
  • Have been diagnosed with mild to moderate knee OA
  • Have tried other treatments with little to no improvement or improvement for a limited time
  • Have not had knee replacement surgery

Are you interested in participating in this study?

Please complete the contact form below:
Receiving Communication

Frequently Asked Questions

How long does the procedure take?

You will spend about 4 or 5 hours in the doctor’s clinic. The actual procedure is much shorter and in most cases is complete in 1 –2 hrs.

Will it hurt?

The GAE procedure should not be particularly painful. You will feel a pinch of pain when the physician uses a needle to get access to your blood vessels. Some patients feel pain similar to their osteoarthritis knee pain at the time of injection. None of these pains last more than a few seconds. After the procedure you may continue to have some pain from the access site for a day or two. This pain should be well managed with regular over the counter pain medication.

If the treatment doesn’t work for me, can I still get a knee replacement?

Yes – Having either a GAE or Steroid injection will not impact your suitability for knee replacement surgery.

Is the treatment effective?

The procedure has been shown to be effective for the majority of patients in a previous trial however SakuraBead remains an investigational device.

Can I have additional steroid injections in follow-up if I want them?

This trial does not preclude you from any future treatments, however the trial is intended to compare the effectiveness of GAE versus a single steroid injection for a period of 3 or 6 months. If you wish to receive additional steroid injections you will have to leave the trial

When will I know if I get the SakuraBead GAE or the steroid injection?

Once you give your consent to participate in this trial the doctor will take your medical details and baseline pain and you will then be randomly allocated to receive either a steroid injection or the Genicular Artery Embolization treatment. If you are selected to have a steroid first, you will automatically have the option to receive a GAE within 6 months.

How long will the follow-ups take?

Follow-ups visits will be relatively short. They will vary in length from 20mins to at most 1 hour. These visits can in some instances be done remotely but we encourage patients to visit the doctor in person.

Who will decide if I get the steroid or the GAE?

To ensure the trial is fair and impartial this decision is totally random so the doctor or the study team will not have any direct influence on the decision.

Can I leave the trial if it is not working for me?

While we encourage people to remain within the trial, your participation is entirely voluntary, and you may leave at any point without cause. If you are leaving the trial for a particular reason we would love to hear about this and make a final recording of your pain and wellbeing.

Who will do the GAE procedure?

The GAE procedure will only be performed by board certified interventional radiologist. The physicians chosen for this trial are all experts in the procedure.

Is it free?

The cost of the procedure will be billed to your insurance, you will be responsible for any co-pay costs. The cost of all the follow-ups will be covered by the sponsor company.

Is there a payment for attending follow-up visits?

A stipend of between $50 and $200 will be paid for follow-up visits. The payment varies depending on whether the follow-up visit is a visit to the doctors office or an online meeting.

What are the risks?

There most common side effects of this procedure are skin discolorations at the site of the embolization. This areas of discolouration are expected to be short term and should resolve within a few hours without additional treatment.

What is WOMAC pain and how is it measured?

A WOMAC is short for The Western Ontario and McMaster Universities Arthritis Index. It is widely used among orthopaedic researchers to evaluate the condition of patients with osteoarthritis of the knee. It consists of 24 simple questions divided into 3 categories: Pain (5 Questions), Stiffness (2 Questions) and Knee Function (13 Questions)