This study focuses on patients who are having knee replacement surgery, known as Total Knee Arthroplasty (TKA). It aims to evaluate the safety and effectiveness of a system called NOVABLOC in helping manage pain, improving functional recovery, and reducing the need for opioid painkillers after surgery. This research is important because managing pain effectively after surgery can help patients recover faster and reduce the reliance on opioids, which have significant side effects and potential for addiction. Participants in this study are randomly assigned to one of two groups. One group receives the actual NOVABLOC system, while the other group receives a sham treatment, meaning they do not get the real device but think they might be. This helps researchers compare the outcomes accurately. The study measures how well the NOVABLOC system controls pain, aids recovery, and affects opioid use after surgery. Safety is also closely monitored to ensure the treatment does not cause harm. The study is conducted in a blinded manner, meaning neither the participants nor the researchers know who receives which treatment, to ensure unbiased results.
Inclusion Criteria: 1. Male or non-pregnant females age ≥ 21 years of age; 2. Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines; 3. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI); 4. Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days. 5. Able to read and understand instructions and information presented in English. Exclusion Criteria: 1. Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure; 2. Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure; 3. History of substance abuse or misuse; 4. History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities); 5. Prior radiofrequency ablation or cryotherapy for pain on the operative knee; 6. Prior TKA on the operative knee; 7. BMI \> 40; 8. History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions; 9. Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \[ear\] stimulator); 10. History of hip or knee dislocation or bone fractures on the operative leg; 11. Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin; 12. Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score \>10) or depression (PHQ-9 score \>15); 13. Pregnant, actively planning a pregnancy or breast-feeding a child; 14. Uncontrolled diabetes (A1C \> 7.5%); 15. History of bleeding disorder; 16. Participating in another clinical trial/investigation within 45 days prior to signing informed consent.
are designated in this study
of being blinded to the placebo group