Study of StimRouter for Chronic Knee OA Pain

You may not qualify if:

• Subject has undergone previous joint arthroplasty procedure (partial, total, patella-femoral) to the index knee
• Unresolved effusion of the target knee clinically requiring aspiration within 12 weeks prior to Visit 1 (Baseline)
• Treatment of the index knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 6 weeks prior to Visit 1 (Baseline)
• Visco-supplementation (e.g., hyaluronic acid) in the index knee within 6 weeks prior to Visit 1 (Baseline)
• Subject has an active systemic infection or an active local infection in or near the index knee joint, or has a previous history of joint infection.
• Subject with bleeding disorders or active anticoagulation that cannot be stopped for a few days prior to the time of the surgical procedure.
• Subject who has an active or existing skin disorder or irritation, which, in the opinion of the Investigator, precludes the use of skin gel electrodes.
• Subjects has or plans to have a pacemaker, defibrillator, cochlear implant, and/or a sleep apnea implant.
• Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
• Female subject who is pregnant or nursing or plans to become pregnant during the study. The effects of electrical stimulation on pregnancy are not known. Do not use electrical stimulation (including StimRouter) during pregnancy.
• Any condition and findings in the medical history or in the pre-study assessments, 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
• Comorbid conditions that could affect pain assessment of the target knee, including, but not limited to, inflammatory rheumatic conditions such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus