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

Trial Summary

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 data supports the effectiveness of the treatment Genicular Artery Embolization for Osteoarthritis?

Research shows that Genicular Artery Embolization (GAE) can significantly reduce knee pain and improve function in patients with osteoarthritis. In a study, 95.6% of patients reported improvement in pain and function one month after the procedure, with sustained benefits at six months. ^{1 2 3 4 5}

Is genicular artery embolization safe for treating knee osteoarthritis?

Genicular artery embolization (GAE) appears to be generally safe for treating knee osteoarthritis, with most patients experiencing only minor side effects like temporary knee stiffness or skin bruising. No major procedure-related adverse events were reported in the studies. ^{3 4 5 6 7}

How is the treatment Genicular Artery Embolization different from other treatments for knee osteoarthritis?

Genicular Artery Embolization (GAE) is a unique treatment for knee osteoarthritis that involves blocking blood flow to certain arteries in the knee to reduce pain and inflammation, unlike traditional treatments that often rely on medications or surgery. This minimally invasive procedure is particularly considered for patients with persistent pain who do not respond well to other therapies. ^{2 3 4 6 7}

What is the purpose of this trial?

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.

Research Team

Osman Ahmed, MD

Principal Investigator

University of Chicago Department of Radiology

Eligibility Criteria

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

I haven't had a steroid injection in my knee in the last 3 months.

Timeline

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

Treatment Details

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.

Participant Groups

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+

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 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) 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]

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]

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]

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]

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

Genicular Artery Embolization for Refractory Hemarthrosis following Total Knee Arthroplasty: Technique, Safety, Efficacy, and Patient-Reported Outcomes. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. [2022]

4. United States 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. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. [2022]

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

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. [2022]

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

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