A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options

Exclusion Criteria

• •Nerve gaps of \< 5 mm or \> 20 mm;
• •Estimated distance of regeneration of \>125 mm (distance from injury site to sensory target)
• •Nerve crush or avulsion injuries;
• •Incomplete nerve transections;
• •Injury requiring replantation of target digit;
• •Contralateral digital injuries corresponding to the target digit;
• •Nerve injuries in the affected limb proximal to the crease of the wrist;
• •End to side nerve repair;
• •Injuries with significant vascular damage which may impair adequate perfusion of the target limb;
• •Subjects who are undergoing treatment with chemotherapy, radiation therapy, or other know treatment which affects the growth of neural and/or vascular system;
• •Use of bovine collagen based hollow nerve conduit in a subject with known or suspected bovine sensitivity;
• •Subjects age ≤18 years or ≥70 years;
• •History neuropathy, diabetic or any other known neuropathy;
• •Secondary nerve repair \>12 weeks post initial injury;
• •Currently enrolled in another investigational study;
• •Expected use of medications during the study that are known to cause peripheral neuropathy;
• •History or Reynaud's or other disorder known to compromise circulation or sensation in the upper extremity; and
• •Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.