A Multicenter, Prospective, Randomized, Subject Blinded Comparative Study of Axoguard Nerve Cap® and Neurectomy for the Treatment of Symptomatic Neuroma and Prevention of Recurrent End-Neuroma Pain (REPOSE).

Abstract

Nerve injuries causing axonal disruption can lead to neuroma formation, often treated by neurectomy; however, up to 30% of patients report pain recurrence. This multicenter, prospective, randomized, subject-blinded study compared a porcine small intestine submucosa-derived nerve cap to standard-of-care neurectomy. Seventy-three adults underwent surgery: 37 Neurectomy Control and 36 Nerve Cap. Evaluations through one year included visual analog scale (VAS) for pain, medication usage, and patient-reported outcomes. Patients in both groups showed reductions in pain and functional improvements over time. There were more pain-free Nerve Cap-treated patients at 12 months than in Neurectomy Control (76.9% vs. 48.3%) and significantly lower total pain scores in the Nerve Cap group at 12 months (0.104 vs. 0.187). Both groups showed a peak in total Milligrams of Morphine Equivalence (MME) and Medication Quantification Scale (MQS) 2 weeks postoperative, which decreased over time. Nerve Cap-treated subjects reported a significantly lower cumulative MQS at 2 weeks, sustained through 12 months, which suggested reduced medication reliance. Neurectomy Control subjects demonstrated greater improvement in Foot Health Status Questionnaire (FHSQ) foot function and foot pain scores at 2 weeks; however, by 3 months and beyond there were no significant differences between groups. Nerve Cap subjects demonstrated better Work Productivity and Activity Impairment (WPAI) absenteeism scores at 1 month. Results indicated potential clinical benefits in pain reduction and foot health with Nerve Cap use in the treatment of transected nerve ends. While the mechanisms for development of symptomatic neuroma are similar for peripheral nerves across the body, continued research should be undertaken to describe the generalizability of these findings for all peripheral nerves. Therapeutic Level 1 - RCT.