A Novel Hydrogel for Treatment and Prevention of Symptomatic Neuroma: Early Clinical Experience.

Background: Symptomatic neuroma is a debilitating complication of peripheral nerve injury. Techniques like targeted muscle reinnervation and regenerative peripheral nerve interfaces have shown promise but have critical limitations, including inconsistent efficacy, increased operative time and morbidity, and the need for microsurgical training specific to peripheral nerves. We present the first clinical experience with a sutureless, bioresorbable hydrogel (allay Nerve Cap) for the treatment and prevention of symptomatic neuroma. Methods: A single-center retrospective review of 11 patients who underwent 12 nerve procedures (23 nerves) involving hydrogel nerve cap placement was conducted. Ten of the 12 procedures were prophylactic, and 2 were for established diagnosis of symptomatic neuroma. In the symptomatic neuroma group, pre- and postoperative visual analog scale scores were obtained. All patients had a minimum 6 months of follow-up and were monitored for the development of neuropathic symptoms. The time required for intraoperative nerve hydrogel application was recorded. Results: No patients in the prophylactic group developed symptomatic neuromas or neuropathic symptoms postoperatively. Both patients with established symptomatic neuroma experienced a significant decrease in visual analog scale score (4 and 7 points, respectively). There were no hydrogel-related complications. Minor wound issues occurred in 3 patients, and 1 patient died approximately 6 months postoperatively due to her underlying medical condition. The duration of hydrogel application averaged 55 seconds per nerve. Conclusions: Early experience with the hydrogel cap suggests it is a safe, effective, and scalable device for prevention and treatment of symptomatic neuroma across a broad range of procedures and anatomical locations.