Cooled Radiofrequency Ablation Treatment of the Genicular Nerves in the Treatment of Osteoarthritic Knee Pain: 18- and 24-Month Results.

Corey Hunter,Tim Davis,Eric Loudermilk,Michael Depalma,Leonardo Kapural

doi:10.1111/papr.12844

Abstract

ObjectiveThe primary objective of this observational, prospective, multicenter study was to evaluate the long‐term outcomes, including pain, function, and perceived effect of treatment, in subjects undergoing cooled radiofrequency ablation (CRFA) who have pain due to osteoarthritis (OA) of the knee.MethodsThis analysis included a subset of subjects previously enrolled in a prospective, multicenter randomized study comparing the safety and effectiveness of CRFA and intra‐articular steroid injection in patients with knee OA through 12 months who were contacted to participate in this extension study. Subjects were enrolled if they agreed to participate in up to 2 additional follow‐ups, at 18 and 24 months.ResultsEighty‐three subjects from the 5 participating sites underwent CRFA during the original study and were contacted for this extension study. Of the 33 subjects enrolled, 25 were evaluated at 18 months after CRFA treatment, and their mean numeric rating scale (NRS) score was 3.1 ± 2.7, with 12 subjects reporting ≥50% pain relief compared to baseline. At 24 months, 18 subjects reported a mean NRS score of 3.6 ± 2.8, with 11 demonstrating ≥50% pain relief. Functional improvement as measured by the Oxford Knee Score continued to be present, with an overall mean change from baseline of 26.0 ± 9.6 points at 18 months and 29.9 ± 10.4 points at 24 months.ConclusionIn this subset of subjects from a randomized controlled trial, CRFA provided sustained pain relief, improved function, and perceived positive effect through 24 months for subjects with OA knee pain with no safety concerns identified.

Highlights

Osteoarthritis (OA) is a chronic degenerative condition that can cause substantial pain and negatively impact patient function
Given the results identified during the 12-month analysis, it was decided to attempt to capture data describing the 18- and 24-month outcomes, including pain, function, and perceived effect from subjects treated with Cooled radiofrequency ablation (CRFA) in the original study
From the 5 sites participating, 83 subjects were treated in the original study, with 42 randomized to and treated with CRFA, and 41 randomized to and treated with Intra-articular steroid (IAS) who chose to XO to CRFA after 6 months

Summary

Introduction

Osteoarthritis (OA) is a chronic degenerative condition that can cause substantial pain and negatively impact patient function. While total joint replacement is a wellestablished treatment of last resort for late-stage OA of Cooled Genicular RFA for Knee Pain 239 the major joints, such as the hip and knee, not all patients are candidates for this procedure due to earlystage disease, age, health, or other factors. Joint arthroplasty procedures can present an increased risk for morbidity and mortality and may result in significant postoperative pain.[1] A limited number of treatment options are available for patients who are not candidates for total joint replacement and/or for whom pharmacological therapy is either ineffective or interferes with their quality of life and general health due to serious side effects. Intra-articular steroid (IAS) injection provides significant short-term pain relief,[2] but requires multiple treatments to maintain efficacy, which in turn increases the risk for serious adverse events such as septic arthritis and may exacerbate cartilage destruction.[3,4] Viscosupplementation, while showing moderate effectiveness,[3] is not recommended in the treatment paradigm for knee OA by the American Academy of Orthopaedic Surgeons due to limited supporting data.[5]

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Conclusion