A Prospective, Multi-center, Randomized, Clinical Trial Comparing the Effectiveness and Safety of Cooled Radiofrequency Ablation versus a Single Injection of Hyaluronic Acid in the Management of OA Knee Pain

Antonia Chen¹, Fred Khalouf ², Michael DePalma ³, Keith Zora ⁴, Lynn Kohan ⁵, Maged Guirguis ⁶, Douglas Beall ⁷, Eric Loudermilk ⁸, Matthew Pingree ⁹, Ignacio Badiola ¹⁰ and Jeffrey Lyman ¹¹, ¹Brigham and Women’s Hospital, Boston, MA, ²University Orthopedics Center, Altoona, PA, ³Virginia iSpine Physicians, Richmond, VA, ⁴University Orthopedics Center, State College, PA, ⁵University of Virginia School of Medicine, Charlottesville, VA, ⁶Ochsner Clinic Foundation, New Orleans, LA, ⁷Clinical Investigations, Edmond, OK, ⁸PCPMG Clinical Research Unit LLC, Anderson, SC, ⁹Mayo Clinic, Rochester, MN, ¹⁰University of Pennsylvania, Philadelphia, PA, ¹¹Institute for Orthopedic Research and Innovation, Coeur d'Alene, IN

Meeting: ACR/ARP Annual Meeting 2019

Keywords: Knee, Osteoarthritis, Total Knee Arthroplasty (TKA) and non-pharmacologic intervention

Session Information

Date: Monday, November 11, 2019

Title: Osteoarthritis – Clinical Poster I

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: This prospective, randomized, multi-center study was conducted to compare pain relief, functional improvement, and the safety of cooled radiofrequency ablation (CRFA) to hyaluronic acid (HA) to treat OA knee pain.

Methods: 177 patients underwent diagnostic block injections and those who had a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single intraarticular HA injection. 175 patients were treated (n=88 CRFA and 89 HA) and subsequently evaluated for pain (numerical rating system=NRS), function (WOMAC), Global Perceived Effect (GPE), and safety at 1, 3, and 6 months.

Results: The two treatment groups had statistically similar demographics and pain at baseline. One hundred and fifty-eight patients completed 6-months post treatment (n=76 CRFA and 82 HA). In the CRFA group, 71.1% of patients (95%CI 60.9-81.2) had ≥50% reduction in NRS pain score compared to 37.8% (95%CI 27.3-48.3) in the HA group (p< 0.0001, primary endpoint) (Table 1). The mean NRS was 2.7 ± 2.3 for the CRFA group and 4.5 ± 2.7 for the HA group (p< 0.0001). The mean WOMAC score improvement from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p< 0.0001) (Table 2). At 6 months, 72.4% (55/76) of subjects in the CRFA group reported improvement in Global Perceived Effect compared to 40.2% (33/82) in the HA group (p< 0.0001) (Table 3). No serious adverse events related to either procedure were noted, and overall adverse event profiles were similar.

Conclusion: In this study, CRFA treated patients demonstrated a significant improvement in pain relief and overall function compared to patients treated with HA. Further follow-up from this study will evaluate the long-term durability of cooled RFA in this patient population.

Table 1- Numeric Rating Scale Through 6 Months- Usual Level of Pain -Index Knee-

Table 2- WOMAC Total Normalized Score Through 6 Months

Table 3- Global Perceived Effect After 6 Months

Disclosure: A. Chen, Avanos Medical, 2, 5, 8; F. Khalouf, Avanos Medical, 2, 5, 8; M. DePalma, Avanos Medical, 2, 5, 8; K. Zora, Avanos Medical, 2, 5, 8; L. Kohan, Avanos Medical, 2, 5, 8; M. Guirguis, Avanos Medical, 2, 5, 8; D. Beall, Avanos Medical, 2, 5, 8; E. Loudermilk, Avanos Medical, 2, 5, 8; M. Pingree, Avanos Medical, 2, 5, 8; I. Badiola, Avanos Medical, 2, 5, 8; J. Lyman, Avanos Medical, 2, 5, 8.

To cite this abstract in AMA style:

Chen A, Khalouf F, DePalma M, Zora K, Kohan L, Guirguis M, Beall D, Loudermilk E, Pingree M, Badiola I, Lyman J. A Prospective, Multi-center, Randomized, Clinical Trial Comparing the Effectiveness and Safety of Cooled Radiofrequency Ablation versus a Single Injection of Hyaluronic Acid in the Management of OA Knee Pain [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/a-prospective-multi-center-randomized-clinical-trial-comparing-the-effectiveness-and-safety-of-cooled-radiofrequency-ablation-versus-a-single-injection-of-hyaluronic-acid-in-the-management-of-oa-kn/. Accessed .

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