REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
Sponsored by Integra LifeSciences Corporation
About this trial
Last updated a year ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
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.