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

NCT03940963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-01-09

Study results available
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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

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

Sponsors & Collaborators

  • Axogen Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2023-07-17
Completion
2023-07-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03940963 on ClinicalTrials.gov