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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.
Hospital for Special Surgery
New York, New York, United States
Duke University
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
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.
To be assessed during in office visits using the DeMayo 2-point discrimination device
Time frame: 12 Months
Moving 2 Point Discrimination Test (m2PD) at each post-operative timepoint of the study:
To be assessed during in office visits using the DeMayo 2-point discrimination device
Time frame: 12 Months
Grip Strength Test at each post-operative timepoint of the study
To be assessed during in office visits using the Camry hand dynamometer
Time frame: 12 Months
Pinch Strength Test at each post-operative timepoint of the study
To be assessed during in office visits using the Baseline Digital Pinch Gauge
Time frame: 12 Months
Semmes-Weinstein Monofilament Testing at each post-operative timepoint of the study
To be assessed during in office visits using the Baseline Tactile Semmes-Weinstein monofilament
Time frame: 12 Months
Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study
To be completed via in office visits
Time frame: 12 Months
Michigan Hand Outcomes Questionnaire (MHQ) at each post-operative timepoint of the study
To be completed via in office visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 Months
Continuous Visual Analog Scale for Pain at each post-operative timepoint of the study
0-100 Scale, 0-no pain at all, 100- worst possible pain. To be completed via in office visits
Time frame: 12 Months