Cooled radiofrequency ablation provides extended clinical utility in the management of knee osteoarthritis: 12-month results from a prospective, multi-center, randomized, cross-over trial comparing cooled radiofrequency ablation to a single hyaluronic acid injection

Antonia F Chen, Fred Khalouf, Keith Zora, Michael DePalma, Lynn Kohan, Maged Guirguis, Douglas Beall, Eric Loudermilk, Matthew J Pingree, Ignacio Badiola, Jeffrey Lyman, Antonia F Chen, Fred Khalouf, Keith Zora, Michael DePalma, Lynn Kohan, Maged Guirguis, Douglas Beall, Eric Loudermilk, Matthew J Pingree, Ignacio Badiola, Jeffrey Lyman

Abstract

Background: Safe and effective non-surgical treatments are an important part of the knee osteoarthritis (OA) treatment algorithm. Cooled radiofrequency ablation (CRFA) and hyaluronic acid (HA) injections are two commonly used modalities to manage symptoms associated with knee OA.

Methods: A prospective 1:1 randomized study was conducted in 177 patients comparing CRFA to HA injection with follow-ups at 1, 3, 6 and 12 months. HA subjects with unsatisfactory outcomes at 6-months were allowed to crossover and receive CRFA. Knee pain (numeric rating scale = NRS), WOMAC Index (pain, stiffness and physical function), overall quality of life (global perceived effect = GPE, EQ-5D-5 L), and adverse events were measured.

Results: At 12-months, 65.2% of subjects in the CRFA cohort reported ≥50% pain relief from baseline. Mean NRS pain score was 2.8 ± 2.4 at 12 months (baseline 6.9 ± 0.8). Subjects in the CRFA cohort saw a 46.2% improvement in total WOMAC score at the 12-month timepoint. 64.5% of subjects in the crossover cohort reported ≥50% pain relief from baseline, with a mean NRS pain score of 3.0 ± 2.4 at 12 months (baseline 7.0 ± 1.0). After receiving CRFA, subjects in the crossover cohort had a 27.5% improvement in total WOMAC score. All subjects receiving CRFA reported significant improvement in quality of life. There were no serious adverse events related to either procedure and overall adverse event profiles were similar.

Conclusion: A majority of subjects treated with CRFA demonstrated sustained knee pain relief for at least 12-months. Additionally, CRFA provided significant pain relief for HA subjects who crossed over 6 months after treatment.

Trial registration: This trial was registered on ClinicalTrials.gov, NCT03381248. Registered 27 December 2017.

Keywords: Denervation; Non-surgical; Osteoarthritis; Radiofrequency ablation.

Conflict of interest statement

Dr. Badiola reports personal fees to the University of Pennsylvania from Avanos during the conduct of the study.

Dr. Beall reports grants from Medtronic, Spineology, Merit Medical, Lilly, Johnson & Johnson, SpinTech, Imaging3, IZI, Medlantis, Techlamed, Consultant, Peterson Enterprises, Medical Metrics, Radius Pharmaceuticals, Avanos, Vertiflex, Sollis Pharmaceuticals, Simplify Medical, Stryker, Lenoss Medical, Spine BioPharma, Piramal, ReGelTec, grants from Medtronic, SpinTech, Medical Metrics, Avanos, Relievant, Vertiflex, Stryker, Sollis Pharmaceuticals, Simplify Medical, Lenoss Medical, Spine BioPharma, other from Medtronic, Imaging3, ReGelTec, Nanofuse, SpinTech, Nocimed, other from Artio, Sophiris, Eleven Biotherapeutics, Radius Pharmaceuticals, Flow Forward, Lenoss Medical, Spine BioPharma, other from Thieme, Springer, Humana other from Eli Lilly, Radius Pharmaceuticals, Stryker, Medtronic, Vivex, Vertiflex, Merit, Medlantis, Avanos, Piramal during the conduct of the study.

Dr. Chen reports personal fees from Avanos, during the conduct of the study; personal fees from SLACK publishing, other from Joint Purification Systems, personal fees from ACI, personal fees from Stryker, personal fees from bOne, other from Sonoran Biosciences, other from Graftworx, grants from OREF, personal fees from Pfizer, personal fees from Irrisept, personal fees from Convatec, personal fees from 3 M, personal fees from Recro, personal fees from Zimmer, personal fees from Heraeus, personal fees from American Medical Foundation, personal fees from Zimmer, other from Hyalex, personal fees from DePuy, outside the submitted work.

Dr. DePalma reports other from Avanos during the conduct of the study and has served on the clinical advisory board to Avanos and am also a co-investigator on this clinical trial .

Dr. Guirguis reports personal fees from Avanos outside the submitted work.

Dr. Khalouf has nothing to disclose.

Dr. Kohan reports personal fees from Avanos during the conduct of the study.

Dr. Loudermilk has nothing to disclose.

Dr. Lyman reports grants, personal fees and non-financial support from Avanos, during the conduct of the study; grants and personal fees from Stryker Orthopedics outside the submitted work.

Dr. Pingree reports other from Avanos during the conduct of the study; other from Avanos outside the submitted work.

Dr. Zora has nothing to disclose.

Figures

Fig. 1
Fig. 1
CONSORT Diagram (XO = crossover)
Fig. 2
Fig. 2
Percent of Subjects Reporting ≥50% Pain Relief (CRFA = cooled radiofrequency ablation, XO = crossover)
Fig. 3
Fig. 3
Numeric Rating Scale Pain Scores (SS = statistically significant, BL = baseline, CRFA = cooled radiofrequency ablation, XO = crossover)
Fig. 4
Fig. 4
Total Western Ontario & McMaster University Osteoarthritis Index (WOMAC) Score (SS = statistically significant, BL = baseline, CRFA = cooled radiofrequency ablation, XO = crossover)
Fig. 5
Fig. 5
Percent of Subjects Reporting Improved Global Perceived Effect (GPE) (CRFA = cooled radiofrequency ablation, XO = crossover)
Fig. 6
Fig. 6
EQ-5D-5 L Scores (CRFA = cooled radiofrequency ablation, XO = crossover)

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