Radiofrequency Ablation After Total Knee Arthroplasty

Exclusion Criteria

• •1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
• •2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in Section 5.3.1 during the study period
• •3. Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
• •4. Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
• •5. Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
• •6. Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 30 days prior to the Screening Visit, or planned participation in any such trial
• •7. Use of anticoagulants and inability to withhold for three days prior to the study RFA procedure with clearance by the prescribing physician
• •8. Other conditions that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation