Our Society supports the use of thermal radiofrequency ablation, also known as thermal ablation or denervation for patients diagnosed with moderate to severe osteoarthritis of the knee. Patients afflicted with knee OA who may be refractory to conservative care including hyaluronic acid and corticosteroid injection, do not have durable non-surgical alternatives available to deliver pain relief and functional improvement beyond a few weeks to months1,2.

Based upon the review of the body of peer-reviewed published evidence, approval by the United States Food and Drug Administration (FDA), real world experience and long-term patient outcomes, NJSIPP recommends qualified physicians consider use of this minimally invasive intervention and inform patients in their treatment plans based upon the clinical need and presentation. Because of proven safety and durable effectiveness, radiofrequency ablation of the genicular nerves of the knee using thermal RFA systems are within the clinical community’s standard of care for their indicated use. Based upon the body of Level I-IV peer-reviewed published evidence, FDA approval, and demonstration of cost-effectiveness, NJSIPP further recommends policymakers and payers enable timely access to thermal radiofrequency ablation of the genicular nerves for osteoarthritis of the knee when prescribed by a qualified physician who has used his or her best medical judgement for care most suitable to the individual diagnosed with moderate to severe knee osteoarthritis when this therapy is the best suited for the patient given their clinical presentation, when refractory to standard treatment, or when comorbidities preclude alternate treatment.

Knee Osteoarthritis: Burden of Disease

Although knee osteoarthritis, or degenerative joint disease of the knee, is closely correlated with age, it is typically the result of wear and tear and progressive loss of articular cartilage. It frequently manifests as a progressive disease leading to disability.3 Osteoarthritis of the knee is the most common type of arthritis affecting more than 30 million adults in the United States.4

Among the 18 million symptomatic OA knee pain sufferers, 6 million are between age 45- 65 and 2 million are under 45 years of age.5 A significant treatment gap exists for many of these people due to the low efficacy and short duration of current conservative therapies, lack of patient access to safe and effective minimally invasive treatments and need for avoidance of surgery. 6

Clinical presentation, patient history along with radiographic confirmation of osteoarthritis, via x-ray, MRI, or CT, of grade 2 (mild), 3(moderate) or 4 (severe) in the past 12 months, pain of at least 6 out of 10 on a NRS is supported by the inclusion criteria of studies used to obtain FDA clearance for use of genicular radiofrequency ablation for knee OA pain. 

Clinical Presentation 

The intensity of knee OA symptoms vary from individual to individual.

The clinical symptoms of Knee OA include a chief complaint of knee pain: 

• Typically of gradual onset
• Worse with prolonged activity, repetitive bending or stairs, inactivity
• Worsening over time
• Better with rest, ice, or anti-inflammatory medication
• Knee stiffness and swelling
• Decreased walking ability

Articular cartilage is composed of type II collagen, proteoglycans, chondrocytes, and water. In healthy joints, equilibrium between these components is maintained in that any degradation of cartilage is matched by synthesis. With osteoarthritis, the matrix metalloproteases, or degradative enzymes, are overexpressed resulting in loss of collagens and proteoglycans. 7 I

n the early stages of OA, chondrocytes secrete tissue inhibitors in an attempt to increase the synthesis of proteoglycans to overcome the degradation, but this reparative attempt is not enough and eventually a loss of equilibrium results in loss of articular cartilage and elasticity, cracking and fissuring and erosion of the articular surface.

Primary knee osteoarthritis is the result of degenerative articular cartilage without any known reason. This may be due to age or wear and tear. Secondary knee osteoarthritis results from a known reason and can be due to trauma, surgery, limb malformation or malposition, chondrocalcinosis, infectious or psoriatic arthritis or other disease process.

Physical examination findings include visual inspection of the knee and may reveal periarticular erythema and swelling, quadriceps atrophy or varus/valgus deformity. Range of motion is an important finding with typical OA presenting as gross limitation of flexion and slight limitation of extension.

Low Efficacy & Durability of Non-Operative Alternatives

Medications aimed to treat inflammatory conditions may help, but they do not slow the progression and to date there are no disease modifying agents for the treatment of knee osteoarthritis.8 Non-surgical treatment for the pain and dysfunction of OA of the knee has remain largely unchanged over the past 20 years.

Conservative treatment options begin with weight loss, physical therapy, opioid or non- opioid medications and typically progress to corticosteroid or hyaluronic acid injections with the definitive treatment for OA of the knee being total knee arthroplasty (TKA). However, a significant treatment gap exists for millions of symptomatic OA knee pain sufferers due to low efficacy conservative therapies. The mean duration of their pain from onset is 10 years with 7 years of disability.9 Even when TKA is an appropriate option, factors including age, BMI or comorbidities are often considered and may preclude or necessitate deferment of surgery until more optimal medical conditions exist.

Intra-articular steroid (IAS) injection has long been a standard of care for the treatment of OA knee pain. However, IAS injections offer only short-term relief, often pose side effects, and lack strong evidence of efficacy. The reported duration of pain relief of intraarticular corticosteroid injections is one to two weeks with some trials demonstrating pain relief of up to three to four weeks. 10

Viscosupplementation with hyaluronic acid, or its derivatives, is injected into the affected knee as a multi- or single dose application to provide lubrication and shock absorption. While some studies suggest reduced pain through 26 weeks, 11 the FDA has questioned its mechanism of action and current clinical practice guidelines do not support use of HA for the treatment of OA knee pain.12,13

Neither opioids, IAS nor HA are recommended by the American Academy of Orthopedic Surgeons (AAOS) for the treatment of knee osteoarthritis in their Clinical Practice Guidelines.14

Radiofrequency ablation (RFA) was first described in the literature for treating chronic back pain in 1975.15 Radiofrequency is a minimally invasive, non-surgical outpatient procedure used to target the genicular nerves of the knee causing chronic pain. The procedure involves minimal sedation and typically is completed in less than 45 minutes using a RF generator to transmit a small current of RF thermal energy through an insulated electrode placed within the tissue.

Radiofrequency ablation delivers targeted thermal damage in excess of 43˚ C to neuronal tissue in order to modulate transmission of pain signals using a simple electrode structure that generates RF energy.16 While genicular nerve course variability is high, the consensus and data supports clinical effect from targeting the following three primary nerve targets: the superomedial and inferomedial branches of the saphenous nerve and the superolateral branch of the femoral nerve.17,18 Radiofrequency of the genicular nerves can address the treatment gap between conservative therapy and TKA by offering a clinically superior and more durable option when patients are refractory to current standard care. Studies show that radiofrequency of the genicular nerves can reduce pain and improve function for at least 6-12 months.

With a projected 401% growth in demand for TKA’s over the next twenty years,19 thermal radiofrequency for OA of the knee can combat this escalating trajectory by deferring surgery for younger patients, of which 40% are performed on patients under age 65,20 and reduce the lifetime risk and cost associated with TKA revisions.

Prior to genicular thermal radiofrequency ablation, OHSIPP recommends conservative care for at least 3-6 months, the choice of what options for which should be individualized to the specific needs of the patients and be at the discretion of the treating physician.

Physician Qualification & Patient Selection 

• Physician Qualifications

Thermal radiofrequency ablation should be performed only by qualified physicians,trained in the management of patients suffering from chronic pain of osteoarthritisand experienced in the application of radiofrequency ablation and nerve denervationin patients for which the procedure is appropriately indicated.

• Inadequate Response or Contraindicated for Conservative Therapies

Thermal radiofrequency ablation is intended for creating radiofrequency lesions of thegenicular nerves for the management of moderate to severe knee pain of more than 6months in patients with radiologically-confirmed osteoarthritis (grade 2-4) and apositive response (≥50% reduction in pain) to a diagnostic genicular nerve block. Select candidates may have undergone prior conservative therapy, includingmedication. Prior treatments received may include physical therapy, weight loss,exercise, NSAIDs, opioids, and intraarticular steroid or hyaluronic acid injections.

• Physical therapy for a duration of four to six weeks may be employed to reducepatient pain, disability, and reliance of pain medication
  
  
• Modification in the patient’s activities of daily living may be considered.Sustainability and patient compliance, however, must be considered for each patientrelative to other clinical and psychological needs, age, occupation, vocation, and geography.
  
  
• Oral medications including the use of non-narcotic analgesics and opiates may beprescribed. NSAIDS, while commonly utilized to help with pain management, are notwithout risks that include gastrointestinal, cardiovascular, renal, and respiratoryadverse effects.21 
  
  
• Caution is warranted in the use of opioid therapy, particularly for the elderly. Opioiddrugs have become a widespread non-surgical intervention for chronicmusculoskeletal conditions. An estimated 20% of patients presenting to thephysician office with non-cancer pain symptoms or pain-related diagnoses receive anopioid prescription.22 In addition to physical side effects such as drowsiness andconstipation, opiates are known to cause dependence with as many as one in fivepatients becoming a routine user after 10 days of narcotic analgesia. 23 

Patients with imaging studies correlative with presentation of the patient’s signs and symptoms, refractory to conservative care, or those for whom conservative therapies are not indicated and who otherwise meet the indications for thermal radiofrequency of the genicular nerves should be considered as well as those medically incapable or unwilling to undergo surgical intervention. 

• Informed Consent

Treatment options, risks associated with conservative care, injections, opioid use, andsurgical options must be well understood by the patient when developing care plansfor the individual. Physicians must ensure informed consent of the patient.

Contraindications and Relative Contraindications

1. For patients with cardiac pacemakers, a variety of changes can occur duringand after the treatment. In sensing mode the pacemaker may interpret the RFsignal as a heartbeat and may fail to pace the heart. Contact the pacemakercompany to determine if the pacemaker should be converted to a fixed-ratepacing during the radiofrequency procedure. Evaluate the patient’s pacingsystem after the procedure.
2. Check the compatibility and safety of combinations of other physiologicalmonitoring and electrical apparatus to be used on the patient in addition to theRF Generator.
3. If the patient has a spinal cord, deep brain, or other stimulator, contact themanufacturer to determine if the stimulator needs to be in the bipolarstimulation mode or in the OFF position.
4. This procedure should be reconsidered in patients with any prior neurologicaldeficit.
5. The use of general anesthesia is contraindicated. To allow for patient feedbackand response during the procedure, it should be performed under localanesthesia.
6. Systemic infection or local infection in area of the procedure.
7. Blood coagulation disorders or anticoagulant use.

Evidence-Based Rationale

Results of a prospective RCT of thermal radiofrequency ablation of the genicular nerves using water-cooled probes (CRFA) compared to hyaluronic acid injection (HA) demonstrates greater improvement in NRS pain scores and WOMAC functional ability in the CRFA group vs the HA group at 6-months and at 12-month follow-up. The mean NRS at 6 months 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 at 6 months from baseline was 48 % in the CRFA group and 23% in the HA group (p<0.0001). At 6-months 72% of the CRFA subjects reported improvement in Global Perceived Effect compared to 40% in the HA group (p<0.0001). 24 At 12-months, 65.2% of the CRFA cohort reported > 50% pain relief from baseline. Mean NRS was 2.8±2.4 at 12 months (baseline 6.9±0.8), representing a 4.1% decrease in NRS pain score (p<0.0001). Subjects in the CRFA cohort had a 46.2% improvement in total WOMAC score at the 12-month timepoint.25

Similarly, another prospective RCT compared thermal ablation of the genicular nerves using water-cooled probes (CRFA) to intraarticular steroid injection (IAS). At both 6 and 12 months, the CRFA group demonstrated greater pain relief and improved function as measured by NRS and Oxford Knee Score (OKS). At 6 months, the mean NRS was 2.5 ± 2.3 for the CRFA group and 5.9 ± 2.2 for the IAS group (p < 0.0001), representing a 4.9 -point drop in NRS for the CRFA group. The mean OKS was 35.7 ± 8.8 in the CRFA group at 6 months compared to 22.4 ± 8.5 in the IAS group (p < 0.0001). At 6 months, 91.4% of subjects in the CRFA group reported improvement in Global Perceived Effect compared to 23.9% in the IAS group (p < 0.0001). 26 At 12 months, 65% of the original CRFA group had pain reduction ≥50%, as measured by the NRS, and the mean overall drop was 4.3 points (p<0.0001). Seventy-five per cent reported “improved” effects. The OKS increase from  baseline in the original CRFA cohort was 17.3±12 points (N=52, p<0.0001, Student’s paired t-test), with an absolute mean of 34.3±11.1 points. 27

A comparison study of thermal radiofrequency (RFA) of the genicular nerves to conventional analgesics demonstrated statistically significant improvement in VAS for RFA patients over analgesics at 3 (2.83±0.5 vs 4.93±0.2) and 6 months (3.13±0.3 vs 5.73±0.26). The total WOMAC index showed significant difference between the two groups by the 6th month only; however, WOMAC domains (pain, and stiffness) showed significant differences in the 3rd, and 6th months, with lower values in the RFA group.28

A trial of thermal radiofrequency (RFA) compared to hyaluronic acid (HA) demonstrated statistically significant improvement in VAS and Lysholm Knee Score (LKS) scores at 3, 6, 9, and 12 months. 29 When compared to sham, thermal genicular radiofrequency (RFA) under fluoroscopic guidance showed VAS scores in the RFA group to be less at 4 (p < 0.001) and 12 (p < 0.001) weeks compared with the control group. Oxford Knee Scores showed similar findings (p < 0.001).30

In their Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hip, Hand and Knee, The American College of Rheumatology states that “radiofrequency ablation is conditionally recommended for patients with OA of the hand, hip and knee. 31

The American Society of Pain and Neuroscience recommends that “genicular nerve radiofrequency neurotomy may be used for the treatment of osteoarthritis related and post-surgical knee joint pain with a GRADE of II-1B.32

Cost Effectiveness

A cost-effectiveness analysis based on trial data evaluated the costs and health outcomes of patients undergoing cooled thermal radiofrequency ablation (CRFA) of the genicular nerves for OA knee pain compared to intraarticular steroid injections (IAS). The economic model calculated health benefits in the form of QALYs by mapping trial-based changes in function as measured using the Oxford Knee Score (OKS). The OKS captures patients’ assessment of knee symptoms and function. Costs were derived from the Centers for Medicare and Medicaid Services fee schedules and included standard physician (in-office or in-hospital) and hospital payments for IAS, CRFA and genicular nerve block procedures. At a time-horizon of 6 months post-treatment, CRFA was associated with a 0.091 gain in QALYs and an incremental cost effectiveness ration (ICER)of US$1711 compared with IAS. CRFA therefore cost US$18,773 per QALY gained.

Conclusions & Recommendations

The body of Level I-IV published evidence, long-term outcomes demonstrating durable treatment effect, avoidance of more invasive procedures and drug therapies, as well as consideration for the patient populations most likely to be candidates for thermal radiofrequency ablation of the genicular nerves should be considered within the standards of care for osteoarthritis related and post-surgical knee pain. 

Policymakers and payers are strongly encouraged to enable timely access to FDA cleared technologies, when deemed medically necessary and indicated for this procedure. 

Technology Definitions of Thermal Radiofrequency 

Standard Radiofrequency (RFA) is a thermal ablation procedure. Treatment protocols typically apply 90 seconds of heating with a target temperature of 80 -90˚C. While nerve tissue begins to degrade at temperatures greater than 43˚ C, the 80˚ C protocol was derived from in vitro studies and is thought to be related to the highest temperature that early RF generators could attain.33 

Water-Cooled Radiofrequency (CRFA) is a thermal ablation procedure offering physicians an alternate probe choice. Circulated water helps to carry heat away from the electrode-tissue interface to reduce charring allowing more energy to be delivered to surrounding tissues creating a larger area for ionic heating to occur. When using water- cooled probes studies have demonstrated the tissue temperature beyond the electrode tissue interface reach 80˚ C and greater and that the lesions created are larger than those of standard RF.34 

References 

1 Cheng OT, Souzdalnitski D, Vrooman B, et al. Evidence-based knee injections for the management of arthritis. Pain Med. 2012; 13(6):740-753. 

2 Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomized, multicentre, double-blind, placebo-controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. 

3 Hsu H, Siwiec RM. Osteoarthritis, Knee. [Updated 2018 Jun 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507884/. Accessed Mar 4, 2022. 

4 Cisternas MG, Murphy L, Sacks JJ, Solomon DH, Pasta DJ, Helmick CG. Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population-Based Survey. Arthritis Care Res (Hoboken). 2016; 68(5):574–580. abstract 

5 Deshpande B, Katz J, Solomon D, et al. The number of persons with symptomatic knee osteoarthritis in the United States: Impact of race/ethnicity, age, sex and obesity. Arthritis Care Res (Hoboken). 2016 December; 68(12): 1743–1750. doi:10.1002/acr.22897. 

6 London N, Miller L, Block J. Clinical and economic consequences of the treatment gap in knee osteoarthritis management. Medical Hypotheses 76 (2011) 887–892 

7 Hsu H, Siwiec RM. Osteoarthritis, Knee. [Updated 2018 Jun 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507884/. Accessed Mar 4, 2022. 

8 Hsu H, Siwiec RM. Osteoarthritis, Knee. [Updated 2018 Jun 15]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2018 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507884/. Accessed Mar 4, 2022. 

9 OA Pain Landscape & Patient Journey; Research Results, KS&R, 2015. 

10 Cheng OT, Souzdalnitski D, Vrooman B, et al. Evidence-based knee injections for the management of arthritis. Pain Med. 2012; 13(6):740-753. 

11 Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomized, multicentre, double-blind, placebo-controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. 

12FDA Intent to Consider the Appropriate Classification of Hyaluronic Acid Intra-Articular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence. Docket No. FDA-2018-N-4627. 

13 Jevsevar DS. (2013). Treatment of Osteoarthritis of the Knee: Evidence-Based Guideline, 2nd Edition. J Am Acad Orthop Surg. 2013; 21:571-6. 

14 American Academy of Orthopaedic Surgeons. Treatment of Osteoarthritis of the Knee: Evidence-Based Guideline. 2nd ed. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2013. www.aaos.org/Research/guidelines/TreatmentofOsteoarthritis oftheKneeGuideline.pdf. 15 Shealy CN, Percutaneous radiofrequency denervation of spinal facets. Treatment for chronic back pain and sciatica. J Neurosurg., 43(4) 1975, pp. 448-451. 16 Kapural L, Deering J. A technological overview of cooled radiofrequency ablation and its effectiveness in the management of chronic knee pain. Pain Manag.2020. 10(3):133-140 17 Franco CD, et al. Innervation of the Anterior Capsule of the Human Knee: Implications for Radiofrequency Ablation. Regional Anesthesia and Pain Medicine 2015; 40:363-368 18 Tran J, Peng P, Lam K, Baig E, Agur A, Gofeld M. Anatomical Study of the Innervation of Anterior Knee Joint Capsule Implication for Image-Guided Intervention. Regional Anesthesia and Pain Medicine. Volume 43, Number 4, May 2018 19 Singh J, Yu S, Chen L, Cleveland J. Rates of total joint replacement in the United States: Future projections to 2020-2040 using the national inpatient sample. Jrhem 2019(47)2; DOI: https://doi.org/10.3899/jrheum.170990 20 Losina E, Paltiel D, Weinstein A et al. Lifetime medical costs of knee osteoarthritis management in the United States: Impact of extending indications for total knee arthroplasty. Arthritis Care Res (Hoboken). 2015 February; 67(2): 203–215. doi:10.1002/acr.22412 21 Solomon D., Nonselective NDAIDs: Overview of adverse effects. UpToDate. Accessed 5/10/2019 https://www.uptodate.com/contents/nonselective-nsaids-overview-of-adverse-effects 22 Daubresse M, Chang HY, Yu Y, et al. Ambulatory diagnosis and treatment of nonmalignant pain in the United States, 2000-2010. Med Care 2013; 51:870–8. CrossRef PubMed 23 Centers for Disease Control and Prevention (CDC). Characteristics of initial prescription episodes and likelihood of long-term opioid use—United States, 2006-2015. https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm. Accessed Mar 7, 2022. 24 Chen A, Khalouf F, Zora K et al. Cooled radiofrequency ablation compared with a single injection of hyaluronic acid for chronic knee pain. A multi-center, randomized, clinical trial demonstrating greater efficacy and equivalent safety for cooled radiofrequency ablation. J Bone Joint Surg. 2020; 102(17):1501-1510. doi: 10.2106/JBJS.19.00935 25 Chen A, Khalouf F, Zora K et al. 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. BMC Musculoskeletal Disorders (2020) 21:363. https://doi.org/10.1186/s12891-020-03380-5 26 Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation with Corticosteroid Injection in the Management of Knee Pain from Osteoarthritis. Reg Anesth Pain Med. 2018; 43(1):84-91. 27 Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Cook E, Kapural L. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multi-center, randomized, cross-over trial. Reg Anesth Pain Med 2019;(0):1–8. DOI:10.1136/rapm-2018-100051. PMID: 30772821 28 El Hakeim E et al. Fluoroscopic guided radiofrequency of genicular nerves for pain alleviation in chronic knee osteoarthritis: A single-blind randomized controlled trial. Pain Physician 2018; 21:169-177 • ISSN 1533-3159 29 Xiao l et al. Highly selective peripheral nerve radio frequency ablation for the treatment of severe knee osteoarthritis. Experimental and Therapeutic Medicine 16: 3973-3977.2018 30 Choi et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: A double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4. PMID: 21055873. 31 Kolasinski S, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arth Care & Res. 72(2). 2000: 149-162 32 Lee D et al. Latest Evidence-Based Application for Radiofrequency Neurotomy (LEARN): Best Practice Guidelines from the American Society of Pain and Neuroscience (ASPN). J of Pain Res. 2021:14 2807-2831 33 Ball, R., The science of conventional and water-cooled monopolar lumbar radiofrequency rhizotomy; an electrical engineering point of view. Pain Physician 2014; 17: E175-211. 34Cedeno DL, Vallejo A, Kelley CA, Tilley DM, Kumar N. Comparisons of lesion volumes and shapes produced by a radiofrequency ˜ system with a cooled, a protruding, or a monopolar probe. Pain Physician 8, E915–E922 (2017).