Mochida ReFeel for Digital Nerve Injuries

ReFeel is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

ReFeel is a device used in applications for patients with peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Despite this common injury there is continued debate on the best treatment algorithm for digital nerve injuries. Digital nerve repair is usually not an option as the field of injury is too large for direct repair. Both conduits and nerve allograft have been used with varying success. Nerve conduits have traditionally been used for gaps less than 2 cm, with allograft for larger gaps.

ReFeel has received 510(k) clearance for a new alginate-based nerve cuff. We propose to conduct an Investigator-led Observational Clinical Research of ReFeel for patients treated with alginate nerve cuff to assess the clinical function following reconstruction.

Inclusion criteria

• Age 18-69 years
• Digital nerve injury in at least one digit requiring repair with a gap of 1-25mm
• Able to provide tension free end to end nerve coaptation
• Have uninjured contralateral or adjacent digit that is suitable to serve as a referenced digit for baseline functional assessments.
• Willing to comply with follow up for visits up to 12 months.

Exclusion criteria

• Estimated distance of recovery greater than 150 mm (from proximal site of to the tip of the digit)
• Injury distal to distal interphalangeal joint
• Extensive soft tissue injury that will impair recovery assessment
• Incomplete nerve transections
• Injury requiring replantation of the target digit
• Injuries to the affected nerve proximal to the superficial arch
• Nerve injuries > 24 weeks after initial injury
• End to side nerve repair
• Injuries with vascular damage resulting in inadequate perfusion despite repair
• Subjects with type 1 diabetes or type 2 diabetes requiring regular insulin therapy
• Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other know treatment that affects the growth of neural and/or vascular system
• History of neuropathy, diabetic neuropathy, or another known neuropathy
• Excepted use of medication during the study that is known to impact nerve regeneration or cause peripheral neuropathy such as immunosuppressant's and Chemotherapeutic
• History of chronic ischemic condition of the upper extremity.
• Workers Compensation