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

NCT ID: NCT05339594

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2024-06-03

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 registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.

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. 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.

Conditions

Peripheral Nerve Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NeuraGen Nerve Guide

Integra NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.

NeuraGen

Intervention Type: DEVICE

NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.

NeuraGen 3D Nerve Guide Matrix

Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.

NeuraGen 3D

Intervention Type: DEVICE

NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.

Interventions

NeuraGen

NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.

Intervention Type: DEVICE

NeuraGen 3D

NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Leonard, BSN,RN,CTBS

Role: STUDY_DIRECTOR

Integra LifeSciences

Locations

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Washington University at St Louis

St Louis, Missouri, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

T-INVENT-001

Identifier Type: -

Identifier Source: org_study_id