Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends (REPOSE-XL℠)

This is an interventional treatment trial for Symptomatic Neuroma focused on measuring Peripheral Nerve Injuries, Peripheral Nervous System Disease, Neuroma, Nerve Pain, Nervous System Diseases, Trauma - Nervous System, Amputation, Nerve Repair, Surgical Treatment of Pain Read More

Inclusion Criteria: Potential Subjects MUST:

1. Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures;
2. Be an adult male or female ≥ 18 and ≤ 50 years of age;
3. Present with limb trauma and/or planned amputation of a limb;
4. Be candidates who are planned for a secondary nerve surgery such as Targeted Muscle Reinnervation (TMR) procedure within 6-12 months from time of amputation;
5. Have at least one nerve end measuring greater than 4 mm and less than 7 mm in diameter after debridement and hemostasis of the proximal nerve stump;
6. Have sufficient soft tissue available to be adequately covered by the Axoguard Nerve Cap;
7. Be willing and able to comply with all aspects of the treatment and follow-up assessments and to return for all required study visits throughout the study duration.

Exclusion Criteria: Potential Subjects MUST NOT:

1. Currently undergoing or are expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment that affects the growth of neural and/or vascular tissues;
2. Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy;
3. Currently use or are likely to need to use any medication listed in Appendix C during the study.
4. Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy during the duration of the study;
5. Be pregnant, suspected of being pregnant or planning to become pregnant within 15 months;
6. Current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection;
7. Be contraindicated for soft tissue implants. This includes but is not limited to any pathology that would limit the blood supply to the target area or otherwise compromise healing;
8. Have a life expectancy of less than 15-months;
9. Have a history of or be planning to undergo radiotherapy in the area of the end-neuroma;
10. Have confirmed or suspected bony exostosis of the affected limb;
11. Have insufficient perfusion of the repair site that would affect wound or tissue healing in the opinion of the investigator;
12. Have Type 1 or Type 2 Diabetes Mellitus requiring regular insulin therapy;
13. Active, unstable peripheral vascular disease with inaudible doppler readings or other signs of inadequate perfusion proximal to the amputation site.
14. Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain;
15. Documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb;
16. Have a known allergy to anesthetic agents;
17. Have a known sensitivity to porcine-derived products;
18. Have any contraindications to MRI such as metallic implants, pacemakers, prosthetic heart valves, contrast allergy or body weight over the MRI table specific weight limitations;
19. Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
20. Be deemed unsuitable for inclusion in the study at the discretion of the Investigator.