Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap

Study Summary

In 2016, one in five individuals in the United States (US) experienced chronic pain, and approximately 40% of them suffered from neuropathic pain. The physical and emotional burden on patients results in costs of billions of dollars annually. Digital amputations affect over 23,000 people each year in the US and may lead to neuropathic pain and neuroma formation in the transected nerves. Previous studies have reported a 6.6% incidence of symptomatic neuroma, and more than 60% of these patients require surgery to reduce the negative impact on their daily living activities. To minimize neuroma formation after digital amputation, various techniques have been described, such as traction neurectomies (TN) and dorsal transpositions (DT), with and without nerve coaptation. However, it remains unclear whether these techniques improve patient-reported outcome measures in individuals undergoing this type of procedure. Previously published studies are descriptive in nature, focus on a single surgical technique, or include patients with established symptomatic neuromas. The only prospective trial on this topic was published in 2000 and compared two conventional techniques that have since been modified to better minimize neuroma formation or to reduce mechanical pressure by transposing the nerve ends to the dorsal aspect of the hand. However, that study used different scales to measure outcomes and did not incorporate aspects of pain that affect patients' emotional and social well-being. Currently, two randomized controlled trials are enrolling patients. One compares surgical techniques for the treatment of neuroma rather than its prevention. The other excludes digits with injuries located distal to the interphalangeal joints. Both studies focus on more complex surgical techniques. Given the extent of this problem, there has been recent innovation aimed at preventing neuroma formation. One promising product is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging res

Primary Outcome

• Numerical Rating Scale (NRS): is a standard pain scale measured on a 11 point (0-10) where 0=no pain and 10=worst possible pain. There are no values defined as a clinically important difference for painful conditions in amputated digits, but previous studies on chronic painful conditions define a reduction of 2 points as a clinically important difference.

Interventions

• DEVICE Tulavi allay Nerve Cap