Genicular Artery Embolization for Osteoarthritis
(SHAM-PAIN Trial)

Recruiting in Palo Alto (17 mi)

Overseen byOsman Ahmed, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Double-Blind, 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.

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.

+3 more

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.

+20 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GAE ArmExperimental Treatment3 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 ArmPlacebo Group1 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.