Regenerative Peripheral Nerve Interfaces for the Treatment of Painful Neuromas in Major Limb Amputees

There are currently 1.6 million people in the U.S. living with limb loss. More than 185,000 people undergo amputations in the US alone each year, and the total number of amputees is expected to be nearly 3.6 million people by 2050. Moreover, there have been approximately 1,700 combat service-related amputations between 2001 and 2015 resulting from recent U.S. military operations. Almost one-third of these individuals will form painful neuromas as a result of nerve injury that occurs at the time of amputation. This study investigates the novel use of Regenerative Peripheral Nerve Interfaces (RPNIs) to alleviate neuroma pain. Aim 1 of the study will determine the ability of RPNI surgery to treat existing painful neuromas in major lower limb amputees. Aim 2of the study will assess the efficacy of RPNI surgery to prevent the formation of painful neuromas in patients undergoing major lower limb amputation. Aim 3will assess both peripheral and central nervous system changes and responses to RPNI treatment. Peripheral changes will be assessed using MR neurography and DTI. Central brain changes in response to neuroma treatment will be analyzed using fMRI. The outcomes of this study will provide much needed insight into the effectiveness of RPNI surgery to treat the debilitating effects of painful neuromas on lower limb amputees. The results will also direct the future surgical standard of care for these individuals, potentially revolutionizing the standard of care for the millions of amputees.