Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

INCLUSION CRITERIA

• Age ≥ 21 years
• Able to understand the informed consent form and provide written informed consent and able to complete outcome measures
• Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
• Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])
• Positive response (defined as a decrease in numeric pain scores of at least 50%) to a single genicular nerve block of the index knee
• Pain on NRS ≥ 6 on an 11-point scale for the index knee
• Radiologic confirmation of arthritis (x-ray/MRI/CT) of Osteoarthritis (OA) grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee
• An intra-articular hyaluronic acid injection is indicated as an appropriate treatment option
• WOMAC Knee Score group at baseline of Score of ≥ 2 (0 to 4 scale) on WOMAC question 1 (Pain) and a mean score of ≥ 1.5 on all five questions of the WOMAC pain subscale.
• Analgesics including membrane stabilizers such as Neurontin/gabapentin and antidepressants for pain such as Cymbalta/duloxetine must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the course of the study without approval of the investigator
• Agree to see one physician (study physician) for knee pain during the study period
• Willing to utilize double barrier contraceptive method if of child bearing potential.
• Willing to delay any surgical intervention for the index knee for the period of the study follow up
• Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study

EXCLUSION CRITERIA

• Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
• Evidence of neuropathic pain affecting the index knee
• Previous or pending lower limb amputation
• Intra-articular steroid injection into the index knee within 90 days from randomization
• Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
• Prior radiofrequency ablation of the genicular nerves of the index knee
• Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
• Clinically significant ligamentous laxity of the index knee
• Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations
• Body mass index (BMI) > 40 kg/m2
• Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14 mm in diameter to limit the risk of skin burns
• Pending or active compensation claim, litigation or disability remuneration (secondary gain)
• Pregnant, nursing or intent on becoming pregnant during the study period
• Chronic pain associated with significant psychosocial dysfunction
• Beck's Depression Index score of > 22 (indicates clinically depressed state)
• Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry)
• Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
• History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted f