An Open-Label, Multicenter, Pilot Study to Evaluate the Performance and Safety of NeuraGen® 3D Nerve Guide Matrix.

Integra LifeSciences Corporation4 sites in 1 country1 target enrollmentMay 15, 2022

ConditionsDigital Nerve Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Digital Nerve Injury
Sponsor: Integra LifeSciences Corporation
Enrollment: 1
Locations: 4
Primary Endpoint: The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix.

Detailed Description

The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where tension-free closure can be achieved by flexion of the digit or extremity.

Registry

clinicaltrials.gov

Start Date

May 15, 2022

End Date

May 13, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Integra LifeSciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has one, single level, digital nerve injury that:
•Involves complete traumatic nerve section of the common or proper nerve of the palmar aspect of hand.
•Occurred less than and up to 21 days prior to the nerve repair surgery detailed in this protocol.
•In the opinion of the investigator, has a gap which can be easily closed without placing undue tension on the ends of the nerves with the device (i.e., the gap must be shorter than the maximum length of the device being used).
•Subject has adequate vascular perfusion of the target hand as assessed by the investigator
•Subject can accommodate immobilization of the injured hand post-operatively.
•Subject's contralateral hand is intact and of normal function.

Exclusion Criteria

•Nerve to be repaired is a mixed motor nerve
•Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
•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's hand injury or general physical presentation of the target hand is of a nature which would prevent adequate measurement of functional nerve healing assessments.
•Subject has gross contamination of the wound in which the nerve to be studied in this protocol resides (i.e., presence of glass, metal, other large debris).
•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 active infection of the area around the nerve defect.
•Subject has unstable vital signs.
•Subject has a disorder known to affect the peripheral nervous system (PNS) such as:
•Subject has any systemic disease which may confound study results Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.

Outcomes

Primary Outcomes

The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.

Time Frame: 12 Months

To be assessed during in office visits using the DeMayo 2-point discrimination device

Secondary Outcomes

Semmes-Weinstein Monofilament Testing at each post-operative timepoint of the study(12 Months)
Moving 2 Point Discrimination Test (m2PD) at each post-operative timepoint of the study:(12 Months)
Pinch Strength Test at each post-operative timepoint of the study(12 Months)
Continuous Visual Analog Scale for Pain at each post-operative timepoint of the study(12 Months)
Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study(12 Months)
Grip Strength Test at each post-operative timepoint of the study(12 Months)
Michigan Hand Outcomes Questionnaire (MHQ) at each post-operative timepoint of the study(12 Months)