Embolization for Knee Osteoarthritis

AM
LC
RE
Overseen ByRenato Escobar
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lucas R. Cusumano, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how genicular artery embolization (GAE) can help people with knee osteoarthritis. Researchers aim to determine if changes in knee appearance on special scans can predict the level of pain relief from the treatment. It targets individuals with moderate to severe knee pain and osteoarthritis for at least three months who haven't found relief from other treatments like physical therapy or injections.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for knee osteoarthritis.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that genicular artery embolization is safe for knee osteoarthritis?

Research has shown that genicular artery embolization (GAE) is generally safe for treating knee osteoarthritis. Studies have identified temporary skin color changes as the most common side effect. Some individuals have experienced a tingling or prickling sensation, though this occurs less frequently.

A review of studies found that GAE improves knee pain and movement. As a minimally invasive procedure, it does not require large incisions, making it more manageable for many patients.

Overall, GAE is considered safe for most patients. However, like any medical procedure, it carries some risks. Discussing these with a healthcare provider is crucial before deciding to participate.12345

Why are researchers excited about this trial?

Unlike the standard treatments for knee osteoarthritis, which often include pain medications, physical therapy, and sometimes surgery, Genicular Artery Embolization (GAE) offers a unique approach by targeting the blood vessels around the knee. GAE works by reducing blood flow to certain areas of the knee, which may decrease inflammation and pain. Researchers are excited about this treatment because it could offer a minimally invasive option with potentially fewer side effects and shorter recovery times compared to traditional surgical methods.

What evidence suggests that genicular artery embolization is effective for knee osteoarthritis?

Research has shown that genicular artery embolization (GAE), the treatment under study in this trial, effectively treats knee osteoarthritis. Approximately 70% to 80% of patients experienced significant pain relief after undergoing GAE. Many also reported improved movement and quality of life. In one study, up to 92% of patients felt their pain was reduced by at least half within a year. While most patients benefit, some do not, so individual results may vary.23467

Who Is on the Research Team?

LC

Lucas Cusumano, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for people aged 40 or older with moderate to severe knee pain from osteoarthritis (seen on X-ray) who haven't improved after at least 3 months of standard treatments and can't or don't want surgery. People with mild pain, recent smoking, certain medical conditions, metal implants not safe for MRI, or prior knee replacement can't join.

Inclusion Criteria

Osteoarthritis based on X-ray. Kellgren-Lawrence score > 2 based on radiograph completed within 3 months of procedure date
Provided informed consent
I have not improved after at least 3 months of standard treatments for my condition.
See 4 more

Exclusion Criteria

I currently have an active infection or another cancer.
Recent (within 12 months) or active cigarette use
Active pregnancy
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo genicular artery embolization (GAE) and are monitored for changes in metabolic activity using PET/MRI

6 months
Monthly visits for imaging and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in WOMAC and VAS scores

6 months
Quarterly visits

What Are the Treatments Tested in This Trial?

Interventions

  • Genicular Artery Embolization

Trial Overview

The study tests genicular artery embolization (GAE), a procedure that blocks small blood vessels in the knee to reduce pain and swelling. It also uses PET/MRI scans before and after treatment to see if changes in imaging relate to symptom improvement.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lucas R. Cusumano, MD

Lead Sponsor

Citations

Genicular artery embolization for knee osteoarthritis - PMC - NIH

Functional outcomes were mixed; one trial reported significant improvement in WOMAC function, and another found enhanced quality of life in ...

Genicular Artery Embolization for Treatment of ...

Patients with KL 2, KL 3, and KL 4 OA demonstrated 24-month success rate of 57.1 % (4/7), 47.1% (8/17), and 42.9% (6/14), respectively. Figure ...

Meta-Analysis of Genicular Artery Embolization in Knee ...

About 78–92% of patients achieved clinically meaningful improvement (≥50% pain reduction or ≥10–15 point change) by 12 months. However, sham-controlled RCTs ...

Long-term outcomes of genicular artery embolization for knee ...

Findings There was no significant difference in pain reduction or synovitis between the two groups. Clinical relevance Pain reduction after GAE ...

Genicular artery embolization for treatment of knee ... - PMC

Results. In 10 groups (9 studies; 270 patients; 339 knees), GAE technical success was 99.7%. Over 12 months, the WMD ranged ...

Safety of Knee Arthroplasty Following Genicular Artery ... - PMC

KA was performed in 48 knees following GAE by 16 orthopedic surgeons at 10 different hospitals. 45 (93.8%) total and three (6.3%) partial KAs ...

SAFETY OF GENICULAR ARTERY EMBOLIZATION FOR ...

These results indicate that the most common AE attributable to GAE is transient skin discoloration. Persisting AEs reported were paresthesia.