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

NCT03940963 | Completed Results FDA Device

• 1 other identifier: CAP-CP-001
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 11

Brief 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

Keywords

Peripheral Nerve Injuries; Peripheral Nervous System Disease; Foot Neuroma; Foot Pain; Nerve Foot Pain; Nervous System Diseases; Trauma - Nervous System; Wounds and Injuries; Nerve Repair; Surgical Treatment of Pain

Outcome Measures

Primary Outcomes (3)

• Change in Visual Analog Scale (VAS) For Pain Score at 12 Post-operative Months in Comparative Phase Subjects

  The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the participant is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing "no pain" and 100 millimeters representing "the worst pain imaginable".

  12 months

• The Rate of Procedure- or Device-related Serious Adverse Events (SAEs) Through 3 Months

  The primary safety endpoint will compare the rate of SAEs related to the procedure or device between treatment groups. The rate of serious adverse events for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

  3 months

• The Rate of Procedure- or Device-related Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) Through 3 Months

  The primary safety endpoint will compare the rate of procedure- or device-related AEs or UADEs between treatment groups. The rate of events or effects for a given timepoint is given as the number of participants with one or more events up to that timepoint out of the population at risk.

  3 months

Secondary Outcomes (12)

• The Change From Baseline of Patient Reported Outcome Measurement Information System (PROMIS®) Pain Behavior Scale Score at Month 12

  12 months

• Change in Foot Health Status Questionnaire (FHSQ) General Foot Health Scale at 12 Post-operative Months Compared to Baseline.

  12 months

• As-Prescribed Opioid Medication

  12 Months

• As-Taken Medication

  12 Months

• Rate of Recurrence of Symptomatic Neuroma

  12 Months

Study Arms (2)

AxoGuard® Nerve Cap

ACTIVE COMPARATOR

Porcine derived extracellular matrix (ECM) based Nerve Termination Device. Excision of symptomatic neuroma of the foot or ankle with placement of Axoguard Nerve Cap over the proximal stump of the nerve.

Device: AxoGuard® Nerve Cap

Standard Neurectomy

ACTIVE COMPARATOR

Standard surgical treatment for symptomatic neuroma of the foot or ankle entailing neuroma excision (without placement of Axoguard Nerve Cap).

Procedure: Standard Neurectomy

Interventions

AxoGuard® Nerve Cap DEVICE

Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma

AxoGuard® Nerve Cap

Standard Neurectomy PROCEDURE

Surgical excision of symptomatic neuroma

Standard Neurectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able and willing to provide documented informed consent prior to the conduct of any study procedures;
• Be an adult male or non-pregnant female ≥ 18 years of age;
• Report baseline pain scores of \>65mm on a 100mm Visual Analog Scale (VAS) at screening;
• Have a documented diagnosis of symptomatic neuroma of at least one interdigital nerve in the foot which cannot be repaired to a distal nerve end;
• Must have the of the following:
• Pain with at least 3 of the following characteristics: burning, sharp, shooting, electric, parasthesias, numbness, cold intolerance;
• Symptoms in a defined neural anatomic distribution
• History of nerve injury or suspected nerve injury
• Must have at least 1:
• Positive response to local anesthetic injection
• US or MRI confirmation of neuroma
• Be candidates indicated for surgery to address a symptomatic neuroma;
• Have sufficient healthy soft tissue available to adequately cover the Axoguard® Nerve Cap;
• In the surgeon's opinion, be likely to achieve complete resection of the symptomatic neuroma and be able to undergo implantation with the Axoguard® Nerve Cap or complete the neurotomy procedure in the control group;
• Be willing and able to comply with all aspects of the treatment and evaluation schedule over a 12-month duration.

You may not qualify if:

• Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions;
• Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc);
• Have a life expectancy of less than 12 months;
• Have a history of or planned radiotherapy in the area of the end-neuroma;
• be contraindicated for soft tissue implants.; this includes but is not limited to any pathology that would limit the blood supply; compromise healing or indicate the presence of a local infection;
• Have a history of chronic ischemic conditions of the extremity;
• Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator);
• Have a history of diabetic neuropathy;
• Be undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system;
• Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy within 12 months following the study procedure;
• Have a History of congenital neuropathy or compressive neuropathy affecting the target limb;
• Have a history of prior surgical management of more proximal compressive neuropathies or spinal conditions (e.g. spinal stenosis) not related to the symptomatic neuroma that affect the target limb;
• Currently use or likely need to use medication during the study known to impact nerve regeneration or to cause peripheral neuropathy;
• Be pregnant or plan to become pregnant during the duration of the study;
• Be or have been enrolled in another interventional study within 30 days prior to consenting;

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (11)

New Hope Podiatry Group

Los Angeles, California, 90063, United States

Location

Anastasia Medical Group

Saint Augustine, Florida, 32080, United States

Location

EHI Clinical Research

Roswell, Georgia, 30076, United States

Location

Gateway Clinical Trials

O'Fallon, Illinois, 62269, United States

Location

OrthoIllinois

Rockford, Illinois, 61107, United States

Location

Foot and Ankle Center of Illinois

Springfield, Illinois, 62704, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Austin Foot and Ankle Specialists

Austin, Texas, 78746, United States

Location

Complete Foot and Ankle Care of North Texas

Denton, Texas, 76210, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

Foot & Ankle Institute

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Morton Neuroma; Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Condition Hierarchy (Ancestors)

Metatarsalgia; Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Neuralgia; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Each study site followed their standard post-operative care instructions. Variability in surgical technique for neurectomy procedures exists across study sites. The study considered sensory nerves in the foot and ankle and may be relevant to other nerve types and anatomic locations where symptomatic neuroma treatment is similar. Recurrence of neuroma was not diagnosed in the study, and additional follow-up may identify a recurrence of neuroma in some patients.

Results Point of Contact

• Title: Stacy Arnold, VP of Product Development and Clinical Research
• Organization: Axogen

sarnold@axogeninc.com

770-833-2570

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: October 10, 2018
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)