Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

Eligibility Criteria

• 1. Be ≥ 18 years of age;
• 2. Have symptoms of ulnar nerve neuropathy near the elbow present at 180 days or greater following a primary cubital tunnel decompression procedure.
• 3. Be eligible for surgical intervention;
• 4. Have a preoperative diagnostic such as a nerve conduction study, electromyography, or ultrasound evaluation documenting ulnar neuropathy at the elbow;
• 5. Have a baseline pain visual analogue scale (VAS) score due to ulnar nerve neuropathy of no less than 40/100 mm for the affected elbow;
• 6. Have at least one of the following:
• * Paresthesia or numbness in the ulnar nerve distribution;
• * Weakness or wasting of the small muscles of the hand (full hand muscle wasting is excluded);
• * A positive elbow flexion provocation test.
• 7. Undergo a first revision cubital tunnel decompression surgery with placement of Axoguard HA+ Nerve Protector circumferentially around the section of ulnar nerve affected by neuropathy;
• 8. Be willing and able to comply with all aspects of the treatment and evaluation schedule over 18 months; and
• 9. Sign and date an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent prior to initiation of any study procedures.
• 1. Have had a previous revision cubital tunnel decompression procedure;
• 2. Have documented evidence of concomitant neuropathic conditions affecting the subject arm or any proximal condition affecting the subject arm including, but not limited to:
• * Previously treated carpal tunnel syndrome with unresolved symptoms or current carpal tunnel syndrome that will not be treated concurrently with the revision cubital tunnel;
• * Cervical or brachial plexus abnormalities or injuries;
• * Cervical spine or shoulder disease;
• * Thoracic outlet syndrome;
• * Complex regional pain syndrome;
• * Polyneuropathy, systemic neuropathy or Lyme disease related neuropathy;
• * Previous or current surgery of the ulnar nerve at the wrist (Guyon's canal release)
• * Ulnar nerve compression at the wrist/Guyon's canal;
• 3. Have current trauma or past trauma with ongoing pathology that interferes with evaluation or treatment of the ulnar nerve to either side shoulder or upper extremity;
• 4. Have previous radiofrequency ablation, presence of nerve stimulator or received nerve implant(s) in the subject arm or be receiving an implant(s) other than Axoguard HA+ Nerve Protector during the study surgical procedure, that will impact the ulnar nerve or planned study evaluations;
• 5. Have a condition(s) that could confound assessments or health-related quality of life including, but not limited to:
• * Rheumatoid arthritis
• * Fibromyalgia
• * Connective tissue disorder
• * Wrist tenosynovitis
• 6. Be a smoker or tobacco user;
• 7. Currently have or have a history of alcohol or drug abuse;
• 8. Have uncontrolled Diabetes Mellitus at the discretion of the treating surgeon or have diabetic neuropathy in the upper extremities;
• 9. Have documented poorly controlled hyperthyroidism or hypothyroidism;
• 10. Have a known sensitivity to porcine derived materials or those containing hyaluronate or alginate or their components;
• 11. Be currently taking or likely to need medication(s) that may cause or contribute to peripheral neuropathy or peripheral nerve dysfunction at the discretion of the treating surgeon;
• 12. Be taking prescribed medication(s) including, but not limited to, narcotics 2 or more times per week for the treatment of chronic pain or chronic nerve related symptoms NOT associated with the subject ulnar nerve neuropathy; or
• 13. Be deemed unsuitable for inclusion in the study at the discretion of the investigator.