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

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.

Inclusion Criteria (Potential Subjects must):

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 (Potential Subjects must not):

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.