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

Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Nerve Injuries
• Intervention / Treatment: Device: NeuraGen; Device: NeuraGen 3D

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.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hand to Shoulder Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University at St Louis
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center (UPMC)
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
  • West Virginia
    • Morgantown, West Virginia, United States, 26501
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NeuraGen Nerve Guide; Integra NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.	Device: NeuraGen; 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.	Device: NeuraGen 3D; NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device	To be assessed via in office visits	18 Months
Evaluation of Moving 2PD using DeMayo 2-point discrimination device	To be assessed via in office visits	18 months
Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)	To be assessed via web based tool during at home visits	15 Months
Evaluation of Visual Analog Scale for Pain (VAS)	To be assessed via web based tool during at home visits	15 Months

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Maria Leonard, BSN,RN,CTBS, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Digital Nerve Gap Repair
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: T-INVENT-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No