Genicular Artery Embolization for Knee Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrew Picel

Disqualifiers: Rheumatoid arthritis, Atherosclerosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial includes patients who have tried anti-inflammatory medications, it seems you may continue them.

What data supports the idea that Genicular Artery Embolization for Knee Osteoarthritis is an effective treatment?

The available research shows that Genicular Artery Embolization (GAE) is considered a promising treatment for knee osteoarthritis. Studies have investigated its effectiveness in reducing chronic pain associated with the condition. A systematic review and meta-analysis highlighted in the research suggests that GAE can be a supplementary method to alleviate knee pain caused by osteoarthritis. This indicates that GAE may be a beneficial option for those seeking relief from knee osteoarthritis symptoms. ^{1 2 3 4 5}

What safety data is available for Genicular Artery Embolization in treating knee osteoarthritis?

The safety of Genicular Artery Embolization (GAE) for knee osteoarthritis has been evaluated in several studies. The study titled 'Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis' specifically assesses the safety and efficacy of GAE. Additionally, systematic reviews and meta-analyses, such as those in 'Genicular Artery Embolization as a Treatment for Osteoarthritis Related Knee Pain' and 'Osteoarthritis-Related Knee Pain Treated With Genicular Artery Embolization,' provide comprehensive evaluations of existing evidence on the safety and effectiveness of GAE for knee OA. ^{1 3 4 5 6}

Is Genicular Artery Embolization a promising treatment for knee osteoarthritis?

Yes, Genicular Artery Embolization (GAE) is a promising treatment for knee osteoarthritis. It is a new and innovative method that has shown potential in reducing knee pain associated with osteoarthritis. GAE is minimally invasive, meaning it doesn't require large incisions, and it targets the blood vessels in the knee to help manage pain. ^{1 2 3 4 6}

What is the purpose of this trial?

The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Research Team

Andrew Picel, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 40 with moderate to severe knee pain due to osteoarthritis, who haven't found relief from anti-inflammatory meds, physical therapy, or injections. They should have certain MRI features of active synovitis and not be candidates for surgery. People with life-threatening allergies to iodine, recent major knee surgeries (except minor arthroscopic), serious coagulation issues, kidney problems or other types of arthritis are excluded.

Inclusion Criteria

My pain hasn't improved after 3 months of treatments like anti-inflammatory meds, physical therapy, or injections.

Your MRI shows signs of active joint inflammation.

I cannot or will not undergo surgery for my condition.

Exclusion Criteria

I have rheumatoid or infectious arthritis.

You have a blood clotting problem that cannot be fixed.

You are expected to live for less than 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo the genicular artery embolization (GAE) procedure with HydroPearl® Microspheres

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

4 visits (in-person) at 1, 6, 12, and 24 months post GAE

Treatment Details

Interventions

• Genicular Artery Embolization (GAE)

Trial Overview The trial tests the safety of genicular artery embolization (GAE) using HydroPearl® Microspheres in patients with osteoarthritic knee pain. GAE blocks abnormal blood vessels in the knee that contribute to arthritis pain. The study will follow participants for up to 24 months.

Participant Groups

Group I: Genicular artery embolization Experimental Treatment 1 Intervention

Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.

Genicular Artery Embolization (GAE) is already approved in United States, European Union for the following indications:

Approved in United States as Genicular Artery Embolization for:

• Osteoarthritic knee pain

Approved in European Union as Genicular Artery Embolization for:

• Pain from osteoarthritis of the knee not responsive to conservative treatment

Who Is Running the Clinical Trial?

Andrew Picel

Lead Sponsor

Trials

2

Findings from Research

Genicular artery embolization (GAE) shows promise as a treatment for knee osteoarthritis, with pain being the most commonly reported outcome in 95.8% of the 24 studies reviewed.

However, the studies exhibit significant variability in design and methodology, which limits the ability to draw strong conclusions about the efficacy and safety of GAE, highlighting the need for more standardized research protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. Bolsegui, ML., Ghozy, S., Kobeissi, H., et al.[2023]

Genicular artery embolisation (GAE) is a promising treatment for knee osteoarthritis, and understanding the anatomy of the genicular arteries is crucial for ensuring the safety and effectiveness of the procedure, as demonstrated by a detailed dissection of 20 human lower limb specimens.

The study found that the descending genicular artery (DGA) is the primary vessel involved in medial osteoarthritis, with significant risks of non-target embolisation (NTE) due to anastomoses between key arteries, highlighting the need for careful planning during GAE to avoid damaging critical structures like the cruciate ligaments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cadaveric and Angiographic Anatomical Considerations in the Genicular Arterial System: Implications for Genicular Artery Embolisation in Patients with Knee Osteoarthritis. O'Grady, A., Welsh, L., Gibson, M., et al.[2021]

A study of 205 patients who underwent genicular artery embolization (GAE) revealed that the anatomy of the genicular arteries is complex, with various branching patterns identified, which is crucial for effective treatment of knee osteoarthritis.

Using cone-beam computed tomography (CBCT) during the procedure allows for better visualization of these arteries, helping to accurately target the right vessels for embolization and reducing the risk of affecting unintended areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classification of Genicular Artery Anatomic Variants Using Intraoperative Cone-Beam Computed Tomography. Callese, TE., Cusumano, L., Redwood, KD., et al.[2023]

Genicular artery embolization (GAE) has been shown to significantly reduce knee pain in patients with osteoarthritis, with improvements in pain scores observed from 54% to 80% over a two-year follow-up based on the visual analog scale (VAS).

The procedure is generally safe, with no severe complications reported, and it also led to a notable decrease in the need for pain medications, including a 73% reduction in the use of intra-articular hyaluronic acid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteoarthritis-Related Knee Pain Treated With Genicular Artery Embolization: A Systematic Review and Meta-analysis. Torkian, P., Golzarian, J., Chalian, M., et al.[2022]

Genicular artery embolization (GAE) is a promising treatment for symptomatic knee osteoarthritis, showing a significant reduction in pain and symptoms over 12 months, with 68% of patients experiencing at least a 50% reduction in pain scores.

The procedure was found to be technically successful in all 40 participants, with a generally acceptable safety profile, although some patients experienced mild and transient side effects, such as skin discoloration and knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. Padia, SA., Genshaft, S., Blumstein, G., et al.[2022]

Genicular artery embolization (GAE) is an effective minimally invasive treatment for knee pain due to osteoarthritis, showing significant reductions in pain scores at 1, 3, 6, and 12 months after the procedure, based on a systematic review of 10 studies involving 351 treated knees.

Patients experienced substantial declines in pain, with a Hedge's g effect size indicating strong pain relief, particularly at 6 months with a score decrease of 41 points on the Visual Analog Scale, demonstrating GAE's potential as a durable pain management option for osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization as a Treatment for Osteoarthritis Related Knee Pain: A Systematic Review and Meta-analysis. Epelboym, Y., Mandell, JC., Collins, JE., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cadaveric and Angiographic Anatomical Considerations in the Genicular Arterial System: Implications for Genicular Artery Embolisation in Patients with Knee Osteoarthritis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Classification of Genicular Artery Anatomic Variants Using Intraoperative Cone-Beam Computed Tomography. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Osteoarthritis-Related Knee Pain Treated With Genicular Artery Embolization: A Systematic Review and Meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization as a Treatment for Osteoarthritis Related Knee Pain: A Systematic Review and Meta-analysis. [2023]