Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

Inclusion Criteria:

1. Be ≥ 18 years of age;

2. Have symptoms of ulnar nerve neuropathy near the elbow present at 180 days orgreater 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 neuropathyof 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 wastingis excluded);

• A positive elbow flexion provocation test.

7. Undergo a first revision cubital tunnel decompression surgery with placement ofAxoguard HA+ Nerve Protector circumferentially around the section of ulnar nerveaffected by neuropathy;

8. Be willing and able to comply with all aspects of the treatment and evaluationschedule 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.

Exclusion Criteria:

1. Have had a previous revision cubital tunnel decompression procedure;

2. Have documented evidence of concomitant neuropathic conditions affecting the subjectarm or any proximal condition affecting the subject arm including, but not limitedto:

• Previously treated carpal tunnel syndrome with unresolved symptoms or currentcarpal tunnel syndrome that will not be treated concurrently with the revisioncubital 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 canalrelease)

• Ulnar nerve compression at the wrist/Guyon's canal;

3. Have current trauma or past trauma with ongoing pathology that interferes withevaluation or treatment of the ulnar nerve to either side shoulder or upperextremity;

4. Have previous radiofrequency ablation, presence of nerve stimulator or receivednerve implant(s) in the subject arm or be receiving an implant(s) other thanAxoguard HA+ Nerve Protector during the study surgical procedure, that will impactthe ulnar nerve or planned study evaluations;

5. Have a condition(s) that could confound assessments or health-related quality oflife 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 orhave 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 containinghyaluronate or alginate or their components;

11. Be currently taking or likely to need medication(s) that may cause or contribute toperipheral neuropathy or peripheral nerve dysfunction at the discretion of thetreating surgeon;

12. Be taking prescribed medication(s) including, but not limited to, narcotics 2 ormore times per week for the treatment of chronic pain or chronic nerve relatedsymptoms NOT associated with the subject ulnar nerve neuropathy; or

13. Be deemed unsuitable for inclusion in the study at the discretion of theinvestigator.