REINVENT Registry (Registry of the Nerve Gap Repair From Integra)

Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra

This is a prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.

Integra NeuraGen Nerve Guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. Integra NeuraGen Nerve Guide is used in this registry as a comparator to a next-generation advanced nerve guide, Integra NeuraGen 3D Nerve Guide Matrix, that is based on the original Integra NeuraGen Nerve Guide technology but contains a regenerative matrix in the lumen.

Centers chosen for participation will be current users of Integra's collagen nerve gap repair products listed above.

Inclusion Criteria:

• Subject has undergone nerve gap repair utilizing NeuraGen or NeuraGen 3D
• Subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc.
• Subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol.
• Subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand.
• Subject requires only a single repair per proper digital nerve branch

Exclusion Criteria:

• Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
• Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.
• Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve
• Subject has debris due to injury of the affected hand where contamination cannot be ruled out.
• Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome)
• Subject has an infection of the area around the nerve defect.
• Subjects with diagnosed Peripheral Vascular Disease and Peripheral Arterial Disease
• Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.
• Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.
• Subject has a history of injury to or a congenital abnormality of the target or contralateral hand or limb which may impact nerve healing or confound study results.