Clinical evaluation of an innovative nerve termination cap for treatment and prevention of stump neuroma pain: Results from a prospective pilot clinical study

Le résumé fourni par la source

Following nerve injury or transection, a disorganized sprouting of axons can result in painful neuroma formation due to disruptions and damage in the peripheral nerve tissue. Currently, there are various neuroma treatments; however, nonsurgical treatment is inconsistent and there is a high rate of residual pain postoperatively. This study reports results from the pilot phase of a multicenter clinical study on the use of Axoguard Nerve Cap® (nerve cap, Axogen) for capping the distal nerve stump after surgical resection of Morton's neuroma. Fifteen adults were enrolled (12 females and 3 males) with a painful, symptomatic neuroma in at least one nerve in the foot that could not be repaired to a distal target after resection. All participants received standard neurectomy resection of the affected nerve segment, followed by placement of the nerve cap over the distal nerve stump. Participants were followed for one year post-operatively and outcomes for pain, symptomatic neuroma recurrence, and quality of life (using the Patient-Reported Outcomes Measurement Information Systems), Foot Health Status Questionnaire, and Work Productivity and Activity Impairment were collected and compared to baseline, pre-surgical levels. Participants experienced a clinically significant reduction in pain at 3 months post-surgery that was sustained throughout the 12-month study follow-up. Additionally, clinical improvements were observed across all quality of life metrics. These results are promising, and future studies may provide further evidence by using a comparative group using the standard of care for neuroma management.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.