A 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
Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or ankle. Study consists of 86 subjects randomized between the treatment groups followed for 12 months.
• Be able and willing to provide documented informed consent prior to the conduct of any study procedures;
• Be an adult male or non-pregnant female ≥ 18 years of age;
• Report baseline pain scores of \>65mm on a 100mm Visual Analog Scale (VAS) at screening;
• 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;
• 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
• Be candidates indicated for surgery to address a symptomatic neuroma;
• Have sufficient healthy soft tissue available to adequately cover the Axoguard® Nerve Cap;
• 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;
• Be willing and able to comply with all aspects of the treatment and evaluation schedule over a 12-month duration.