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

doi:10.1186/s12891-020-03380-5

Abstract

BackgroundSafe 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.MethodsA 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.ResultsAt 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.ConclusionA 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 registrationThis trial was registered on ClinicalTrials.gov, NCT03381248. Registered 27 December 2017

Highlights

Safe and effective non-surgical treatments are an important part of the knee osteoarthritis (OA) treatment algorithm
68 (82.9%) elected to crossover and receive Cooled radiofrequency ablation (CRFA) treatment. 62 of these subjects returned for their 6-month crossover follow-up. 14 subjects in the original hyaluronic acid (HA) cohort did not elect to crossover and 11 completed their 12-month follow-up (Fig. 1)
Demographic characteristics between the CRFA and crossover cohort were similar, with no statistically significant differences except for body mass index (BMI), which was higher in the CRFA group (Additional file 1 Table 1)

Summary

Introduction

Safe and effective non-surgical treatments are an important part of the knee osteoarthritis (OA) treatment algorithm. Patients experiencing knee OA suffer from pain an average of 9 years before becoming candidates for surgical intervention [2]. Nonsurgical treatment options for knee OA symptoms include weight loss, activity modification and physical therapy [3]. If these do not provide adequate relief, nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen can be taken to mitigate pain. Intraarticular steroids (IAS) injections have been utilized to manage knee OA symptoms, but studies have demonstrated they may only provide short-term pain relief [5, 6]. Some clinical trials have shown modest effects of HA injections when managing knee OA pain [11], but larger statistical analysis have concluded the benefits of HA are clinically insignificant [12]

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Discussion

Conclusion