Genicular artEry embolizatioN in patiEnts with oSteoarthrItiS of the Knee (GENESIS) Using Permanent Microspheres: Interim Analysis

Abstract

Purpose Planned interim analysis of GENESIS; a prospective pilot study investigating the role of genicular artery embolization (GAE) in patients with mild to moderate osteoarthritis of the knee using permanent microspheres. Methods Thirty-eight patients, median age = 60 (45–83), attended for GAE using 100–300 μm permanent microspheres. All patients had mild to moderate knee OA, resistant to conservative treatments over 6 months. Knee MRI was performed at baseline, and 12 months, enabling semi-quantitative analysis using Whole-Organ Magnetic Resonance Imaging Score (WORMS). Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analogue scale (VAS) (0–100 mm) were completed at baseline, 6 weeks, 3 months (n = 32), and 1-year (n = 16). Adverse events were recorded prospectively. Results Technical success of accessing and embolizing the target genicular arteries was 84%. Six patients were not embolized: four due to a presumed risk of non-target embolization, and two due to a lack of hyperaemic target. Mean VAS improved from 60 (SD = 20, 95% CI 53–66) at baseline to 36 (SD = 24, 95% CI 28–44) at 3 months (p < 0.001) and 45 (SD = 30, 95% CI 30–60) at 1-year (p < 0.05). All KOOS subscales showed a significant improvement at 6-weeks, 3-months, and 1-year follow-up, except function in daily living, which reached borderline significance (p = 0.06) at 1-year. Four patients experienced mild self-limiting skin discoloration over the embolized territory. One patient experienced a small self-limiting groin haematoma. WORMS scores at 1-year follow-up showed significant improvement in synovitis (p < 0.05). There were no cases of osteonecrosis. Conclusion GAE using permanent microspheres in patients with mild to moderate knee OA is safe, with potential efficacy at early follow-up.

Musculoskeletal Interventions: A Review on Genicular Artery Embolization

“…Of the studies that used only permanent embolics, Little et al had one of the lowest rates of discoloration which may be due to placing ice packs on the skin overlying the targeted genicular arteries, resulting in vasoconstriction of cutaneous vessels. 15 Other AEs that have been reported include self-resolving fever in one patient and foot numbness in two patients which resolved with gabapentin.…”

“…11 Major differences in study designs included variation in patient scoring tools. Visual analog scale (VAS) was not used by Landers et al, 14 while the Western Ontario and McMaster Universities Arthritis Index (WOMAC) was not used by Lee et al, 7 Landers et al, 14 and Little et al 15 Instead, both Landers et al 14 and Little et al 15 used the Knee injury and Osteoarthritis Outcome Score (KOOS). Additionally, Embozene was the most used embolic material, but imipenem/cilastatin sodium (IPM/CS) and polyvinyl alcohol have also been used.…”

“…8-10 Since the initial trial by Okuno et al in 2013, multiple studies have been conducted worldwide culminating in a randomized control study in the United States that highlighted the effectiveness of GAE compared to a sham procedure. [11][12][13][14][15] The purpose of this article is to describe the literature on GAE and highlight the latest findings from the randomized sham-controlled trial.…”

Percutaneous Management of Osteoarthritis in the Knee: Proceedings from the Society of Interventional Radiology Research Consensus Panel

“…The limited published data available suggest that GAE is effective in reducing knee pain from OA (36,37,(41)(42)(43). These studies include single-arm prospective trials, a retrospective case series, and a systematic review.…”

Genicular Artery Embolisation for Knee Osteoarthritis Pain Relief: In the Way for the Evidence

“…In this issue of CVIR, Little et al [5] showed the results of an interim analysis of a two-year follow-up single-institution prospective cohort study without control group. GENESIS (Genicular artEry embolizatioN in patients with oSteoarthrItiS of the knee) is a safety and feasibility study conducted by a multidisciplinary team that includes orthopedic surgeons and was approved by the National Institute for Health Research.…”