Abstract Objectives To determine if genicular artery embolization (GAE) is more effective in relieving pain symptoms after 12 months compared to a sham procedure in patients with mild to moderate knee osteoarthritis. A secondary aim was to investigate changes in synovitis observed at 4 months and the correlation with other clinical outcomes. Materials and methods A randomized controlled trial included patients with mild to moderate knee osteoarthritis unresponsive to conservative treatment, who were randomly assigned to receive either GAE or sham treatment. Follow-up was at 1, 4, 8, and 12 months. Pain was assessed using the Knee Injury and Osteoarthritis Outcome Score, and synovitis was imaged with contrast-enhanced MRI at baseline, 1, and 4 months. Outcomes were compared using generalized estimating equations. Results Fifty-eight patients were included (GAE group: 29, sham group: 29). Pain scores improved from 44.44 (95% CI: 38.87–50.02) at baseline to 65.61 (95% CI: 57.16–74.06) after 12 months in the GAE group and from 42.34 (95% CI: 36.45–48.22) to 58.15 (95% CI: 48.7–67.6) in the sham group. The between-group difference after 12 months was not significant (7.46; 95% CI: −13.63 to −28.56; p = 0.25). There were no significant within-group or between-group changes for synovitis. Conclusion Patients undergoing GAE and sham GAE both demonstrate an equal sustained pain reduction at 12 months follow-up, with no differences in synovitis reduction or other clinical outcomes. These results suggest a sustained placebo effect in the long term and do not support the clinical implementation of GAE as a treatment for KOA patients. Key Points Question Is GAE more effective than a sham procedure for mild-to-moderate knee osteoarthritis in the long term, and how does it affect synovitis? Findings There was no significant difference in pain reduction or synovitis between the two groups . Clinical relevance Pain reduction after GAE appears mainly placebo-driven. The placebo effect is sustained up to 12 months. Furthermore, synovitis was unaffected by the procedure. Therefore, our findings do not support clinical implementation . Graphical Abstract
Zadelhoff et al. (Mon,) studied this question.