Genicular artery embolization for early-stage knee osteoarthritis: results from a triple-blind single-centre randomized controlled trial

Abstract

AimsThis study investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure.MethodsA total of 59 participants with symptomatic Kellgren-Lawrence grade 2 knee OA were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests.ResultsOverall, 58 participants provided questionnaire data at 12 months. No significant differences were found for the primary and secondary outcomes, with both groups improving following the procedure. At 12 months, KOOS pain scores improved by 41.3% and 29.4% in the intervention and control groups, respectively. No adverse events occurred. Subgroup analysis indicated that the complete embolization group had significantly better KOOS Sports and Recreation, KOOS Quality of Life, and Global Change scores than the control group; 76.5% of participants who received complete embolization reporting being moderately or much better compared to 37.9% of the control group.ConclusionTAE might produce benefits above placebo, but only when complete embolization of all genicular arteries is performed. Further comparative studies are required before definitive conclusions regarding the effectiveness of TAE can be made.Level of evidence: ICite this article: Bone Jt Open 2023;4(3):158–167.

Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results

“…There is increasing literature supporting the use of GAE for the treatment of patients with mild-to-moderate knee OA. These findings coalesce with previous literature highlighting that GAE can be performed safely to produce meaningful reductions in pain and functional limitation [16,[32][33][34][35][36][37][38][39][40][41][42]. This study expands on previous findings by presenting prospective data on patients treated with permanent microspheres with clinical and imaging followup to 24 months.…”

“…Now, improved anatomical understanding and the application of intraprocedural cross-sectional imaging allows GAE to be safely undertaken in more morphologically complex cases. Alongside this, embolisation endpoint is another important area of developing understanding with early signals that complete embolisation of a diseased territory is important for clinical success [35].…”

“…As with all treatments designed to treat pain, the placebo effect requires consideration. Two previous randomised controlled trials have reported improved clinical success in patients undergoing complete GAE of diseased territories when compared to a sham procedure [33,35]. The GEN-ESIS 2 trial is a randomised sham-controlled trial that is currently recruiting and builds on the experience gained from the current work [43].…”

Advanced Interventional Procedures for Knee Osteoarthritis: What Is the Current Evidence?

“…Landers et al included a subgroup analysis, and median KOOS scores were significantly better for the complete embolization group compared with sham. 76 Global responses also showed a significant difference with 76.5% of the complete embolization group feeling "moderately better" or "much better" compared with 37.9% in the control (P ¼ 0.012).…”

“…However, there is a paucity of comparative clinical trials that are critical in evaluating pain, a subjective parameter. 75 The only prospective randomized clinical trials were recently published by Bagla et al and Landers et al 67,69,76 The first was a multicenter single-blinded RCT comparing GAE with a sham procedure in 21 patients using a 2:1 randomization and allowing crossover to GAE at 1 month. Based on the predefined minimum clinically relevant improvement (16% improvement in WOMAC or 12% improvement in VAS), the response rates were 79%, 0%, and 43% for GAE, sham, and crossover groups, respectively.…”