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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2023-07-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Symptomatic Neuroma Morton's Neuroma Chronic Nerve Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AxoGuard® Nerve Cap

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.

Group Type ACTIVE_COMPARATOR

AxoGuard® Nerve Cap

Intervention Type DEVICE

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

Standard Neurectomy

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

Group Type ACTIVE_COMPARATOR

Standard Neurectomy

Intervention Type PROCEDURE

Surgical excision of symptomatic neuroma

Interventions

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AxoGuard® Nerve Cap

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

Intervention Type DEVICE

Standard Neurectomy

Surgical excision of symptomatic neuroma

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Be able and willing to provide documented informed consent prior to the conduct of any study procedures;
2. Be an adult male or non-pregnant female ≥ 18 years of age;
3. Report baseline pain scores of \>65mm on a 100mm Visual Analog Scale (VAS) at screening;
4. 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;
5. 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
6. Be candidates indicated for surgery to address a symptomatic neuroma;
7. Have sufficient healthy soft tissue available to adequately cover the Axoguard® Nerve Cap;
8. 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;
9. Be willing and able to comply with all aspects of the treatment and evaluation schedule over a 12-month duration.

Exclusion Criteria

1. Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions;
2. Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc);
3. Have a life expectancy of less than 12 months;
4. Have a history of or planned radiotherapy in the area of the end-neuroma;
5. 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;
6. Have a history of chronic ischemic conditions of the extremity;
7. Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator);
8. Have a history of diabetic neuropathy;
9. 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;
10. Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy within 12 months following the study procedure;
11. Have a History of congenital neuropathy or compressive neuropathy affecting the target limb;
12. 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;
13. Currently use or likely need to use medication during the study known to impact nerve regeneration or to cause peripheral neuropathy;
14. Be pregnant or plan to become pregnant during the duration of the study;
15. Be or have been enrolled in another interventional study within 30 days prior to consenting;
16. Have a known allergy to anesthetic agents;
17. Have a known sensitivity to porcine derived materials; or
18. Be, in the opinion of the Investigator, unsuitable for inclusion in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No