A Phase 2 interventional study of Genicular Artery Embolization and Lipiodol in Knee Osteoarthritis, Knee Osteoarthritis (Knee OA) and Knee Osteoarthritis (OA), sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by University of Chicago · Phase 2, Interventional, and Treatment
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 50 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Chicago is the lead sponsor of 924 studies on the registry; 186 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 71 (70%) have results posted.
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Exclusion Criteria:
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.
Procedure: Genicular Artery Embolization · Device: Lipiodol · Procedure: Simple angiogram
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.
Procedure: Simple angiogram
Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.
Also known as: GAE, Geniculate Artery Embolization
3:1 emulsion of Lipiodol to Optiray
Simple angiogram of the genicular arteries
Reduction in KOOS pain subscore
Percent change in KOOS pain subscale score, scaled to a range of 0-100, from baseline to 3 months post-randomization of both GAE and sham groups.
Time frame: 3 months
WOMAC knee pain and dysfunction
Reduction in knee pain and dysfunction (WOMAC) at 1, 3, 6, 9, and 12 months.
Time frame: 1, 3, 6, 9, and 12 months.
KOOS pain and dysfunction
Absolute reduction in knee pain and dysfunction (KOOS) at 1, 3, 6, 9, and 12 months
Time frame: 1, 3, 6, 9, and 12 months
VAS Score
Visual Analog Score (VAS) for pain at 0, 1, 6, 9, and 12 months post treatment
Time frame: 0, 1, 6, 9, and 12 months
Crossover
Rate of cross-over from sham to GAE at 3 months
Time frame: 3 months
Analgesic Reduction
Usage of opiate/analgesic medications at baseline, 1, 3, 6, 9, and 12 months post intervention
Time frame: Baseline, 1, 3, 6, 9, and 12 months post intervention
Whole Knee Synovitis Scoring
Contrast Enhanced MRI with Whole Knee Synovitis Scoring at baseline and 3 months
Time frame: Baseline and 3 months
Perfusion
Perfusion quantification using pre and post embolization using CT-Perfusion scanning
Time frame: Procedure
Knee replacement
Rate of total knee replacement at 3 months
Time frame: 3 months
Corticosteroid injection usage
Corticosteroid injection rate usage at baseline, 1, 3, 6, 9, and 12 months post intervention
Time frame: Baseline, 1, 3, 6, 9, and 12 months post intervention
Plan to share: Undecided — Will need to be considered on an individual basis given the desire to protect PHI
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