Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain

Study Overview
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Brief Summary
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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. Study consists of a 15 subject pilot phase with Axoguard® Nerve Cap implants followed for 3 months and then a comparative study of 86 subjects randomized between the treatment groups followed for 12 months.

Official Title
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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

Conditions
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Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain

Intervention / Treatment
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* Device: AxoGuard® Nerve Cap
* Procedure: Standard Neurectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Potential Subjects must): 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. Exclusion Criteria (Potential Subjects must not): Have undergone surgical treatment of pain from symptomatic neuroma in the target nerve(s)on three or more occasions; Have biomechanical pathology and associated pain (such as plantar fasciitis, bursitis, sesamoid bone pain, tendinitis, etc); Have a life expectancy of less than 12 months; Have a history of or planned radiotherapy in the area of the end-neuroma; be contraindicated for soft tissue implants.; this includes but is not limited to any pathology that would limit the blood supply; compromise healing or indicate the presence of a local infection; Have a history of chronic ischemic conditions of the extremity; Have a diagnosis of type 1 Diabetes Mellitus; or uncontrolled Type 2 Diabetes Mellitus (at the discretion of the investigator); Have a history of diabetic neuropathy; Be undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system; Be immunosuppressed, immunocompromised or have planned immunosuppressive therapy within 12 months following the study procedure; Have a History of congenital neuropathy or compressive neuropathy affecting the target limb; Have a history of prior surgical management of more proximal compressive neuropathies or spinal conditions (e.g. spinal stenosis) not related to the symptomatic neuroma that affect the target limb; Currently use or likely need to use medication during the study known to impact nerve regeneration or to cause peripheral neuropathy; Be pregnant or plan to become pregnant during the duration of the study; Be or have been enrolled in another interventional study within 30 days prior to consenting; Have a known allergy to anesthetic agents; Have a known sensitivity to porcine derived materials; or Be, in the opinion of the Investigator, unsuitable for inclusion in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AxoGuard® Nerve Cap<br>Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of AxoGuard® Nerve Cap at the time of surgery | Device: AxoGuard® Nerve Cap<br>* Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma<br>|
| Active Comparator: Standard Neurectomy<br>Standard surgical treatment for symptomatic neuroma entailing neuroma excision. | Procedure: Standard Neurectomy<br>* Surgical excision of symptomatic neuroma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) For Pain Score at 3 post-operative months in Pilot Phase Subjects | The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing the worst pain imaginable. | 3 months | 
| Change in Visual Analog Scale (VAS) For Pain Score at 12 post-operative months in Comparative Phase Subjects. | The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing the worst pain imaginable. | 12 months | 
| Safety: Serious Adverse Events (SAEs) | The primary safety endpoint will compare the nature and incidence of SAEs between treatment groups | 3 months | 
| Safety: Adverse Events (AEs) or Unanticipated Adverse Device Effects (UADEs) | The primary safety endpoint will compare the nature and incidence of AEs between treatment groups | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Visual Analog Scale (VAS) For Pain score through 12 post-operative months compared to baseline. | The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing the worst pain imaginable. | 1, 3, 6, 9, and 12 months | 
| 2. Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through 12 post-operative months compared to baseline. | The Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain. The PROMIS - pain related measures include domains evaluating fatigue, pain intensity, paint interference, sleep Disturbance, and Pain Behavior. Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measures where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue). PROMIS instruments are scored using item-level calibrations based on response patterns by HealthMeasures Scoring Service (https://www.assessmentcenter.net/ac_scoringservice). | Time Frame: 1, 3, 6, 9 and 12 months | 
| Change in Foot Health Status Questionnaire (FHSQ) Score at 1,3,6,9, and 12 post-operative months compared to baseline. | The Foot Health Status Questionnaire (FHSQ) measures foot health related to quality of life based on responsiveness in overall foot health status in 4 subscale areas (foot function, foot health, footwear and foot pain). The FHSQ is comprised of 13 questions. The questionnaire is self-administered. Subscale ratings are summed and the FHSQ score is reported as 0 (representing poorest state of foot health) to 100 (representing optimal foot health) with higher scores reflecting better foot health and quality of life. | Time Frame: 1, 3, 6, 9 and 12 months | 
| Changes in quantity, quality and class of pain medication use at 1,3,6,9 and 12 months comparted to baseline. | Subjects will maintain a daily pain medication and concomitant medication diary which logs the quantity, quality, and class of pain medication administered and taken at 1,3,6,9 and 12 post-operative months. | Time Frame: 1, 3, 6, 9 and 12 months | 
| SAEs, AEs, and/or UADEs | The secondary safety endpoint will compare the nature and incidence of SAEs, AEs, and UADEs between treatment groups | 6, 9, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wounds and Injuries, Peripheral Nerve Injuries, Peripheral Nervous System Disease, Foot Neuroma, Foot Pain, Nerve Foot Pain, Nervous System Diseases, Trauma - Nervous System, Nerve Repair, Surgical Treatment of Pain