Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Randomized, Prospective Study
Abstract
Over 50,000 finger amputation injuries occur in the United States each year. These injuries affect patients across all ages during work and leisure activities and cause varying degrees of permanent impairment and disability. Combat injuries, as well as active-duty non-combat injuries, also result in finger and partial hand amputations. For most patients that sustain these injuries, some amount of nerve damage is permanent. For over 10% of these amputation patients, this nerve damage results in painful, debilitating scars at the end of nerves called neuromas. These neuromas cause patients to suffer from chronic pain that limits function, worsens overall disability, and is associated with worse mental health and increased use of opioids. Medication treatments, whether with opioids or other pain modulators, are inadequate. Traditional surgical solutions are notorious for high recurrence rates and inadequate pain relief in a substantial percentage of patients. For such a common injury that has an immense impact on the health and function of afflicted patients, the available treatments leave civilian and military finger amputees with insufficient treatment. The Regenerative Peripheral Nerve Interface (RPNI) is a novel treatment strategy for the alleviation of pain associated with neuroma following amputation. Once the neuroma has been removed, the RPNI is created by surgically implanting the end of the nerve into a small piece of the patient’s own muscle. In this study, we seek to investigate RPNI surgery as a novel treatment strategy to reduce pain, prevent neuroma recurrence, and improve mental and physical health of patients that have sustained amputation injuries in the hand and fingers. This proposal addresses the “Retention Strategies” and “Tissue Regeneration Therapeutics” Focus Areas of the FY20 PRORP CTRA. The proposed research will evaluate RPNI surgery against the current standard of care surgery, and we will compare pain relief, improvements in mental and physical health, pain medication use, and return to performing work/duty-related tasks between the two procedures. Patients with finger, multiple finger, or partial hand amputations and associated painful neuromas will be randomized to one of the two surgical treatments. We will collect patient-reported and measured data before surgery and at intervals up to 6 months after surgery to compare outcomes of the two procedures. Aim 1 of the study will evaluate how RPNI surgery compares to standard-of-care surgery in reducing pain, reducing opioid and other pain medication use, improving quality of life and mental health, and reducing the effects of chronic pain and stress on a patient’s cardiovascular condition. Aim 2 of the study will determine how RPNI surgery facilitates improvements in range of motion, function, and complex hand/arm use as compared to standard of care surgery. We expect to complete both aims within the 4-year funding period. The outcomes from this study will provide much needed insights into the effectiveness of RPNI surgery in treating debilitating finger and hand neuromas, thereby improving the lives of military and civilian amputees alike. In the short term, this study will help inform surgeons as to the best available surgical treatments. This can direct the future surgical standard of care and change current clinical practice, potentially revolutionizing care for the millions of amputees who suffer from neuroma pain. This will directly enhance the productivity and quality of life for individuals suffering from painful neuromas while decreasing the costs associated with providing care for these patients. Additionally, by studying the impact of this surgery on reducing opioids, improving mental health, and improving cardiovascular condition, we will both support the benefits of this novel surgery and inform future research into these complex challenging areas that affect trauma patients more broadly. All of this will be
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110501
Entities
People
- Aviram Giladi
Organizations
- MedStar Health Research Institute
- United States Army