Lyman J, Khalouf F, Zora K, DePalma M, Loudermilk E, Guiguis M, Beall D, Kohan L, Chen AF
Objective To assess long-term outcomes of cooled radiofrequency ablation (CRFA) of genicular nerves for chronic knee pain due to osteoarthritis (OA). Methods A prospective, observational extension of a randomized, controlled trial was conducted on adults randomized to CRFA. Subjects were part of a 12-month clinical trial comparing CRFA of genicular nerves to a single hyaluronic injection for treatment of chronic OA knee pain, who then agreed to visits at 18- and 24-months post CRFA and had not undergone another knee procedure since. The subjects were evaluated for pain using the Numeric Rating Scale (NRS) function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), subjective benefit using the Global Perceived Effect (GPE) scale, quality of life using the EuroQol-5-Dimensions-5 Level (EQ-5D-5L) questionnaire, and safety. Results Of 57 subjects eligible, 36 enrolled; 32 completed the 18-month visit with a mean NRS score of 2.4 and 22 (69%) reporting >= 50% reduction in pain from baseline (primary endpoint); 27 completed the 24-month visit, with a mean NRS of 3.4 and 17 (63%) reporting >= 50% pain relief. Functional and quality of life improvements persisted similarly, with mean changes from baseline of 53.5% and 34.9% in WOMAC total scores, and 24.8% and 10.7% in EQ-5D-5L Index scores, at 18- and 24-months, respectively. There were no identified safety concerns in this patient cohort. Conclusion In this subset of subjects, CRFA of genicular nerves provided durable pain relief, improved function, and improved quality of life extending to 24 months post procedure, with no significant safety concerns.