Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain

Exclusion Criteria

• •1. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic inflammatory condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause knee pain
• •2. Evidence of neuropathic pain affecting the index knee
• •3. Previous or pending lower limb amputation
• •4. Intra-articular steroid injection into the index knee within 90 days from randomization
• •5. Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 180 days from randomization
• •6. Prior radiofrequency ablation of the genicular nerves of the index knee
• •7. Prior partial, resurfacing, or total knee arthroplasty of the index knee (residual hardware)
• •8. Clinically significant ligamentous laxity of the index knee
• •9. 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
• •10. Body mass index (BMI) \> 40 kg/m2
• •11. 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
• •12. Pending or active compensation claim, litigation, or disability remuneration (secondary gain)
• •13. Pregnant, nursing or intent of becoming pregnant during the study period
• •14. Chronic pain associated with significant psychosocial dysfunction
• •15. Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the investigator
• •16. Allergies to any of the medications to be used during the procedures
• •17. Active joint infection or systemic or localized infection at needle entry sites (subject may be considered for inclusion once infection is resolved)
• •18. History of uncontrolled coagulopathy, ongoing coagulation treatment that cannot be safely interrupted for procedure, or unexplained or uncontrollable bleeding that is uncorrectable
• •19. Identifiable anatomical variability that would materially alter the procedure as described in the protocol
• •20. Within the preceding 2 years, subject has suffered from active narcotic addiction, substance, or alcohol abuse
• •21. Current prescribed opioid medications greater than 60 mg morphine equivalent daily opioid dose
• •22. Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
• •23. Subject currently implanted with pacemaker, stimulator or defibrillator
• •24. Participating in another clinical trial/investigation which included therapeutic treatment within 30 days prior to signing informed consent
• •25. Subject unwilling or unable to comply with follow up schedule, protocol requirements or procedures