This single-cohort, prospective case series is designed to evaluate and characterize the use of Axoguard HA+ Nerve Protectorâ„¢ to protect the ulnar nerve in a first revision cubital tunnel decompression procedure. Data on the primary cubital tunnel syndrome decompression, first revision decompression utilizing Axoguard HA+ Nerve Protector, participant-reported pain, motor and sensory functional outcomes, quality of life (QoL) outcomes, and recurrence/revision will be collected. This case series will help to establish the ability of Axoguard HA+ Nerve Protector to provide clinical benefits for patients undergoing a first revision cubital tunnel decompression procedure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be ≥ 18 years of age;
✓. Have symptoms of ulnar nerve neuropathy near the elbow present at 180 days or greater following a primary cubital tunnel decompression procedure.
✓. Be eligible for surgical intervention;
✓. Have a preoperative diagnostic such as a nerve conduction study, electromyography, or ultrasound evaluation documenting ulnar neuropathy at the elbow;
✓. 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;
✓. Have at least one of the following:
✓. 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;
✓. Be willing and able to comply with all aspects of the treatment and evaluation schedule over 18 months; and
. Have had a previous revision cubital tunnel decompression procedure;
✕. Have documented evidence of concomitant neuropathic conditions affecting the subject arm or any proximal condition affecting the subject arm including, but not limited to:
✕. 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;
✕. 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;
✕. Have a condition(s) that could confound assessments or health-related quality of life including, but not limited to:
✕. Be a smoker or tobacco user;
✕. Currently have or have a history of alcohol or drug abuse;
✕. Have uncontrolled Diabetes Mellitus at the discretion of the treating surgeon or have diabetic neuropathy in the upper extremities;