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

NCT05339594 | Terminated FDA Device

• 1 other identifier: T-INVENT-001
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 6

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.

Conditions

Peripheral Nerve Injuries

Keywords

Digital Nerve Gap Repair

Outcome Measures

Primary Outcomes (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).

  The primary endpoint success is when each subject reaches meaningful recovery, which is defined as an MRC score of S3+ or S4 (fair, good or excellent 2PD) of the pulp assessment of the distal phalanx of the affected digit(s).

  18 Months

Secondary Outcomes (4)

• Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device

  18 Months

• Evaluation of Moving 2PD using DeMayo 2-point discrimination device

  18 months

• Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)

  15 Months

• Evaluation of Visual Analog Scale for Pain (VAS)

  15 Months

Study Arms (2)

NeuraGen Nerve Guide

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

Device: NeuraGen

NeuraGen 3D Nerve Guide Matrix

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

Device: NeuraGen 3D

Interventions

NeuraGen DEVICE

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

NeuraGen Nerve Guide

NeuraGen 3D DEVICE

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

NeuraGen 3D Nerve Guide Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects with have had a repair of a peripheral nerve injury in the upper extremity distal to the palmer crease of the hand and without previous repairs.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (6)

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

Washington University at St Louis

St Louis, Missouri, 63110, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

West Virginia University

Morgantown, West Virginia, 26501, United States

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Maria Leonard, BSN,RN,CTBS

  Integra LifeSciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 21, 2022
• Study Start: May 30, 2022
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

US (6)