REINVENT Registry (Registry of the Nerve Gap Repair From Integra) (NCT05339594) | Clinical Trial Compass
TerminatedNot Applicable
REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
Stopped: Slow Enrollment, Sponsor Decision
United States17 participantsStarted 2022-05-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 P…
What they're measuring
1
The primary clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD).