Enhancing pain management for knee replacement patients through an innovative non-invasive and opioid-sparing device

PROJECT SUMMARY As the population ages, knee replacement surgery has become one of the most common elective surgical procedures. By 2030, over 3 million people per year are expected to undergo total knee arthroplasty (TKA). 90% of individuals experience postoperative pain, and 80% of those affected control the pain using prescribed opioids. Unfortunately, long-term postoperative pain after TKA often leads to opioid use disorders, increases the risk of complications, extends the length of hospital stay, and increases overall medical cost. There is currently an unmet need for the development of alternative non-opioid therapies for postoperative pain management associated with TKA. nCAP Medical in collaboration with the University of Pittsburgh seeks to address the unmet need for better postoperative pain management tools by developing a patented, state-of-the-art, easy-to-use, nonpharmacological pain relief device (NEUROCUPLE™) for patients undergoing TKA. Preliminary data from a pilot study with 60 patients undergoing TKA demonstrated that the NEUROCUPLE device reduced opioid refills in the first 30 postoperative days by 47% in the NEUROCUPLE group (29%) versus standard of care group (55%). The goal of this Phase I project is to evaluate the use of NEUROCUPLE as a non-pharmacological postoperative pain relief treatment following TKA in a randomized placebo-controlled clinical trial. For this study, 120 patients will be randomized (1:1 ratio) to the NEUROCUPLE group or placebo group before surgery. TKA will be performed using approved enhanced recovery protocol for pain management (standardized at UPMC). After surgery, an active NEUROCUPLE device (intervention group) or an identical placebo device (placebo group) will be applied over the knee for 2 weeks. All patients will receive standard of perioperative care including multimodal pain management. Primary endpoints are pain at rest and prescribed opioid refills in the first 6 weeks. Secondary endpoints are pain while walking, time to discharge, functional recovery (i.e., range of motion, ability to walk), and total postoperative opioid consumption. Successful completion of this Phase I program will demonstrate effectiveness and superiority of the NEUROCUPLE device vs placebo as a non-invasive, non-pharmacological alternative to opioids for the treatment of postoperative pain following TKA. This will support the FDA device approval for the indication of postoperative pain relief following TKA and payor reimbursements. In our Phase II STTR, we will explore other indications using a larger patient population, patients with mood disorders, and a placebo control design for other procedures such as hip replacement and spine surgeries.