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

Inclusion Criteria (Potential Subjects must):

• 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.

Exclusion Criteria (Potential Subjects must not):

• 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;
• Have a known allergy to anesthetic agents;
• Have a known sensitivity to porcine derived materials; or
• Be, in the opinion of the Investigator, unsuitable for inclusion in the study.