Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap

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 results in basic science studies and anecdotally in early clinical use cases. In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap when used to prevent symptomatic digital nerve neuroma following traumatic digital amputation.

Background and Significance 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 healthcare and societal 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 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 largely descriptive, 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 reduce mechanical pressure by transposing nerve ends to the dorsal aspect of the hand. However, that study used heterogeneous outcome measures and did not assess the emotional and social impact of pain. Currently, two randomized controlled trials (RCTs) are enrolling patients. One compares surgical techniques for the treatment of neuroma rather than its prevention. The other excludes patients with injuries to digits distal to the interphalangeal joint. Both studies focus on more complex surgical techniques. Given the scope of this problem, there has been recent innovation aimed at preventing neuroma formation. One promising intervention is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging results in preclinical research and early clinical experience. In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap in preventing symptomatic digital nerve neuroma following traumatic digital amputation. General Description of Study Design This is a prospective trial. The investigators will enroll 20 patients. Questionnaires will be administered at the first post-operative appointment and again at 4-6 weeks, 3 months, 6 months, and 12 months post-operatively. The following validated outcome measures will be used throughout patient participation: Numerical Rating Scale (NRS): A standard 11-point pain scale (0 = no pain, 10 = worst possible pain). While no clinically significant change has been defined for digital amputation pain, studies on other chronic pain conditions have suggested that a reduction of 2 points represents a clinically meaningful difference. Patient-Reported Outcomes Measurement Information S trial.show_full_description

Inclusion Criteria: * Patients undergoing traumatic amputation of a single or multiple digits at MGB * English-speaking Exclusion Criteria: * Patients undergoing revision amputation or non-traumatic amputation * Patients under 22 years old * Patients who are pregnant and/or breastfeeding * Unable or unwilling to participate in a trial study * Patients with a known allergy to poly (ethylene glycol) (PEG) or the color additives FD\&C Yellow No. 5 Dye (tartrazine) or FD\&C Blue No. l Dye (brilliant blue FCF).