Genicular Artery Embolization for Osteoarthritis

(SHAM-PAIN Trial)

Overseen By Osman Ahmed, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Must not be taking: Long-acting corticosteroids

Disqualifiers: Active malignancy, Rheumatoid arthritis, Pregnancy, Type 1 diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Procedure

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Genicular Artery Embolization (GAE) to determine its effectiveness in reducing knee pain caused by osteoarthritis, a common joint condition. Participants will receive either the GAE procedure or a sham treatment (a fake version with no active treatment) to compare the effects. The study seeks individuals who have experienced knee pain from osteoarthritis for more than six months and have not found relief with other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients should not have had a corticosteroid injection in the affected knee within 3 months before joining the trial and should not be using long-acting corticosteroids within 6 months (or short-acting within 3 months).

What prior data suggests that Genicular Artery Embolization is safe for reducing pain in knee osteoarthritis?

Research has shown that Genicular Artery Embolization (GAE) is generally a safe procedure for treating knee osteoarthritis. Studies have found that the most common side effect is temporary changes in skin color. Some patients reported a tingling sensation, like pins and needles, though this was less common.

In terms of effectiveness, about 78% to 92% of patients experienced significant pain relief, with their pain reduced by at least half. These findings suggest that while GAE can have some mild side effects, most patients tolerate it well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for osteoarthritis?

Researchers are excited about Genicular Artery Embolization (GAE) for osteoarthritis because it targets the blood vessels that contribute to inflammation and pain directly. Unlike standard treatments such as pain relievers, physical therapy, or injections, which manage symptoms, GAE addresses the root cause by reducing blood flow to the affected area using a temporary embolic agent. This technique, specifically using the Lipiojoint method, offers the potential for quick relief without lasting damage to surrounding tissues. Such an innovative approach might lead to more effective and longer-lasting pain management for osteoarthritis patients.

What evidence suggests that Genicular Artery Embolization might be an effective treatment for knee osteoarthritis?

Research has shown that genicular artery embolization (GAE), which participants in this trial may receive, can help reduce pain for people with knee osteoarthritis. Studies indicate that about 78–92% of patients experienced a significant decrease in pain, with at least a 50% reduction within a year. In some cases, pain relief ranged from 60–80% over six to 24 months. The procedure provided lasting relief for moderate-to-severe knee pain without harming nearby tissues. Overall, GAE presents a promising option for managing knee pain from osteoarthritis. ^{2 3 4 6 7}

Who Is on the Research Team?

Osman Ahmed, MD

Principal Investigator

University of Chicago Department of Radiology

Are You a Good Fit for This Trial?

This trial is for individuals with severe knee osteoarthritis pain that hasn't improved with regular medical treatments. Participants should be willing to undergo a procedure and follow-up assessments. Specific eligibility details are not provided, so interested individuals should inquire further.

Inclusion Criteria

I have knee pain due to arthritis.

I am between 40 and 80 years old.

I have refused joint injections for treatment.

Exclusion Criteria

Subjects with history of hypersensitivity reactions to contrast agents

History of suicide attempt/suicidal behaviour within 30 days before screening

Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the protocol

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) or a sham procedure to assess pain reduction in knee osteoarthritis

Procedure

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain and analgesic use at multiple time points post-intervention

12 months

Multiple visits at 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Genicular Artery Embolization

Trial Overview The study tests Genicular Artery Embolization (GAE) against a sham intervention to see if GAE can reduce knee pain more effectively at 3 months, using the KOOS pain subscore. It's a pilot randomized trial also considering psychological factors and changes in cartilage.

How Is the Trial Designed?

Group I: GAE Arm Experimental Treatment 3 Interventions

In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm.

Group II: Sham Arm Placebo Group 1 Intervention

Participants assigned to the sham group undergo a similar preparatory process, including angiography and catheterization of all genicular arteries. However, no embolic agent is administered. Instead, after performing selective angiograms, these participants do not receive any embolization. 20 participants will be randomly allocated to this arm.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

In a study of 21 patients with mild to moderate knee osteoarthritis, genicular artery embolization (GAE) significantly reduced pain and disability compared to a sham procedure, with notable improvements observed at 1 month.

Only minor adverse events were reported, indicating that GAE is a safe intervention for treating knee pain associated with osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. Bagla, S., Piechowiak, R., Sajan, A., et al.[2022]

Genicular artery embolization is a safe and effective treatment for recurrent hemarthrosis after total knee arthroplasty, achieving clinical success rates of 56%, 79%, and 85% after the first, second, and third treatments, respectively, across 117 procedures.

The procedure had a high technical success rate with minimal serious complications (12.8%), primarily transient cutaneous ischemia, and 83% of patients reported satisfaction with the results, indicating its potential as a reliable option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for Refractory Hemarthrosis following Total Knee Arthroplasty: Technique, Safety, Efficacy, and Patient-Reported Outcomes. Cornman-Homonoff, J., Kishore, SA., Waddell, BS., et al.[2021]

Genicular artery embolization has been shown to be a potentially effective treatment for chronic pain in patients with knee osteoarthritis, based on a review of 13 studies involving 914 patients.

The procedure is associated with only minor complications, suggesting it is a safe alternative for patients who do not respond to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. Guevara-Noriega, KA., Chavez-Abiega, R., Castro-Rios, JG.[2022]

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]

Selective genicular artery embolization (GAE) showed a high clinical improvement rate of 95.6% at 1 month and maintained significant pain relief at 6 months for patients with knee pain due to osteoarthritis, based on assessments using the Visual Analogue Scale (VAS) and WOMAC scores.

The procedure had a low incidence of adverse reactions, with only minor issues reported, such as skin ecchymosis and temporary knee stiffness, indicating that GAE is a safe and effective treatment option for patients who do not respond to conservative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. Sun, CH., Gao, ZL., Lin, K., et al.[2022]

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) is a safe and effective treatment for symptomatic knee osteoarthritis, with a 100% technical success rate and no major adverse events reported in a study of 16 patients.

At the 12-month follow-up, 83% of patients achieved a clinically meaningful reduction in pain, and there was a significant decrease in nerve growth factor levels, which may help explain the pain relief and potential slowing of cartilage degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers. Taslakian, B., Swilling, D., Attur, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9971280/

Genicular artery embolization for treatment of knee ... Results. In 10 groups (9 studies; 270 patients; 339 knees), GAE technical success was 99.7%. Over 12 months, the WMD ranged ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633225004398

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- ...

3. aaos.org aaos.org/aaosnow/2025/aug-sept/clinical/clinical01/

Data review presents geniculate artery embolization as an ... Several uncontrolled prospective studies have shown 60-80% pain reduction on the visual analog scale at six and 24 months after GAE, suggesting ...

4. jvir.org jvir.org/article/S1051-0443(24)00581-5/fulltext

Genicular Artery Embolization for Treatment of ... GAE is effective in achieving sustained symptom relief related to moderate-to-severe knee OA for up to 24 months with an acceptable safety ...

5. rheumatologyadvisor.com rheumatologyadvisor.com/news/genicular-artery-embolization-safe-relieves-pain-for-symptomatic-knee-oa/

Genicular Artery Embolization Safe, Relieves Pain for ... There was a 62 percent clinical success rate. The mean visual analog scale pain score for the target knee decreased by 48.5, 50.8, and 55.4 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40219609

Safety and Efficacy of Genicular Artery Embolization for ... Clinical success rates, defined variably across studies, ranged from 30% to 100%, depending on the study's follow-up period and outcome measures ...

7. oarsijournal.com oarsijournal.com/article/S1063-4584(22)00615-X/fulltext

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.