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.
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
17
NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.
NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
Washington University at St Louis
St Louis, Missouri, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
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).
Time frame: 18 Months
Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device
To be assessed via in office visits
Time frame: 18 Months
Evaluation of Moving 2PD using DeMayo 2-point discrimination device
To be assessed via in office visits
Time frame: 18 months
Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)
To be assessed via web based tool during at home visits
Time frame: 15 Months
Evaluation of Visual Analog Scale for Pain (VAS)
To be assessed via web based tool during at home visits
Time frame: 15 Months
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University of Virginia
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States