NCT03940963

Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Axogen Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or ankle. Study consists of 86 subjects randomized between the treatment groups followed for 12 months.

Conditions

• Symptomatic Neuroma
• Morton's Neuroma
• Chronic Nerve Pain

Interventions

Type	Name	Description
DEVICE	AxoGuard® Nerve Cap	Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma
PROCEDURE	Standard Neurectomy	Surgical excision of symptomatic neuroma

Timeline

• Start date: 2018-10-10
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2019-05-07
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study