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

Peripheral Nerve Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05339594
• Other study ID #: T-INVENT-001
• Status: Active, not recruiting
• Start date: May 30, 2022
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: June 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Nerve Injuries

Intervention

Device:
• NeuraGen
NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.
• NeuraGen 3D
NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	University of Florida	Gainesville	Florida
United States	Indiana Hand to Shoulder Center	Indianapolis	Indiana
United States	West Virginia University	Morgantown	West Virginia
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	Washington University at St Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

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