Status:
TERMINATED
REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Peripheral Nerve Injuries
Eligibility:
All Genders
18+ years
Brief 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 r...
Detailed Description
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. In...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05339594
Start Date
May 30 2022
End Date
June 3 2024
Last Update
July 11 2024
Active Locations (6)
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1
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
2
Washington University at St Louis
St Louis, Missouri, United States, 63110
3
Montefiore Medical Center
The Bronx, New York, United States, 10461
4
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213