Image

GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA

Recruiting
21 years of age
Both
Phase N/A

Powered by AI

Overview

This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.

Description

This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteroarthritis.

Eligibility

Key Inclusion Criteria:

Provides written informed consent

Age ≥21 years

Mild to severe knee pain, defined as a numerical rating scale (NRS) score of ≥4 out of 10.

        Pain refractory to conservative therapies for at least 90 days prior to
        enrollment/randomization.
        Kellgren-Lawrence grade 1, 2, 3 or 4
        Key Exclusion Criteria:
        Planned major surgical or endovascular procedures ≤ 30 days after the index procedure.
        Advanced atherosclerosis
        Known history of rheumatoid or infectious arthritis.
        Prior knee replacement surgery of the target knee.

Study details

Knee Osteoarthritis

NCT05818150

Merit Medical Systems, Inc.

21 March 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.