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Abstract Number: 1307

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: 2019 ACR/ARP Annual Meeting

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

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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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