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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.
3:1 emulsion of Lipiodol to Optiray
Simple angiogram of the genicular arteries
University of Chicago
Chicago, Illinois, United States
RECRUITINGReduction 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
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