Wounds and Injuries

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Peripheral Nerve Injuries

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Neoplasms, Nerve Tissue

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Chronic Graft Versus Host Disease

Active Comparator: Porcine derived extracellular matrix (ECM) based Nerve Termination Device

Implantation of appropriate diameter of Axoguard Nerve Cap® (sizes 5-7 mm) at the time of surgery

Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma

Axoguard Nerve Cap®

Ray A Rivera, MD

Kyle Icke, PhD

Ian Valerio, MD

Brendan MacKay, MD

This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.

Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

Nerve end size as measured by MRI or CT scan prior to required secondary TMR or RPNI procedure recorded in cubic millimeters (mm3).

Explanted tissue will be cut into thin slices, affixed to microscope slides, and stained with Hematoxylin and Eosin (H\&E), Masson's Trichrome (MT) and Neurofilament 200 (NF200) to allow for histological evaluation of axonal swirling, nerve cap remodeling, and overall tissue response.

The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure.

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".

Final VAS score will be collected either just prior to TMR or RPNI procedure or 12- months post op if subject will not undergo the secondary TMR or RPNI procedure

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 pain related measures include domains evaluating fatigue, pain intensity, pain 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 measured where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue).

Final PROMIS® Pain Related Measure will be collected either just prior to TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure.

In this study, the Work Productivity and Activity Impairment (WPAI:SHP) questionnaire is an instrument to measure impairments in both paid work and unpaid work (leisure/regular activities) due nerve injury post-surgical intervention. It measures (1) absenteeism (work time missed), (2) presenteeism (impairment at work / reduced on-the-job effectiveness), (3) work productivity loss (overall work impairment / absenteeism plus presenteeism), as well as the (4) impairments in unpaid activity because of nerve injury post-surgical intervention during the past seven days. Scores for these 4 measures are expressed as impairment percentages with higher percentage scores indicating greater impairment in than lower percentage scores.

Final WPAI:SHP will be collected either at the office visit following the TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure

The BAM-ULA is a 10-item observational measure of activity performance. The 10 items are as follows: tuck a shirt in pants, lift a 20-lb bag, open a water bottle, remove a wallet from back pocket, replace the wallet in back pocket, take a gallon of water from the refrigerator and place on the counter (lift gallon jug), pour water from a gallon jug, brush or comb hair, use a fork, and open a door with knob. Items are scored with either a 0 (cannot complete all subtasks) or 1 (can complete all subtasks). Lower scores area associated with greater impairment of activity performance and higher scores are associated with less impairment of activity performance.

An observational test used to evaluate functional mobility in terms of postural stability, gait, stride length, and sway. Patients wear their regular footwear and can use a walking aid. They are asked to sit in a chair, stand up from that chair, walk to a line on the floor (10 ft. away) at their normal pace, turn around, walk back to the chair at a normal pace, and sit down again.

A performance measure used evaluate functional mobility and gait. It assesses walking speed in meters per second over 10-meter distance.

Quantity and class of pain medication use for subjects who were implanted with the Axoguard Nerve Cap® will be captured during the following visits: Screening (baseline), 2-weeks, 1, 3, 6, 9, 12, and 15 months post-op for comparison to baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends	NCT04865679	Symptomatic Neu... Amputation Chronic Nerve P...	Axoguard Nerve ...	18 Years - 80 Years	Axogen Corporation
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends	NCT04865679	Symptomatic Neu... Amputation Chronic Nerve P...	Axoguard Nerve ...	18 Years - 80 Years	Axogen Corporation

Spots Global Cancer Trial Database for peripheral nerve injuries