REPOSEA 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

Date de début de l'étude : 10 octobre 2018

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.