Usability of Nerve Tape: A Novel Sutureless Nerve Coaptation Device
Kyle R. Eberlin, MD1, Bauback Safa, MD2, Rudy Buntic, MD3, Mark S. Rekant, MD4, Mark Richard, MD5, Joseph F Styron, MD PhD6, Geetanjali S Bendale, PhD7 and Jonathan Isaacs, MD8, (1)Massachusetts General Hospital/Harvard Medical School, Boston, MA, (2)The Buncke Clinic, San Francisco, CA, (3)Division of Plastic Surgery and Microsurgery, The Buncke Clinic, San Francisco, CA, (4)The Philadelphia Hand Center, Philadelphia, PA, (5)Duke University, Durham, NC, (6)Cleveland Clinic, Cleveland, OH, (7)Virginia Commonwealth University, Richmond, VA, (8)Department of Orthopaedics, Virginia Commonwealth University, Richmond, VA
Introduction: Microsuture neurorrhaphyis technically challenging and has inherent drawbacks. Nerve Tape is a novel sutureless nerve repair device designed to improve efficiency and precision, but these claims have not been validated.
Methods: Twelve surgeons participated in this study; 6 attending hand/microsurgeons and 6 trainees (orthopaedic and plastic surgery residents or hand surgery fellows). Twenty-four cadaver arm specimens were utilized, and nerve repairs were performed at six sites in each specimen: the median and ulnar nerves in the proximal forearm, the median and ulnar nerves in the distal forearm, and the common digital nerves to the second and third web spaces. Each study participant performed nerve repairs at all six injury locations in two different cadaver arms (n=12 total repairs for each participating surgeon). The nerve repairs were timed, tested for tensile strength, and graded for alignment and technical repair quality.
Results: There was a substantial reduction in time required to perform repairs with Nerve Tape (1.6 ± 0.8 min) compared to microsuture (7.2 ± 3.6 min) (p < 0.05). 97% of the Nerve Tape repairs were judged clinically acceptable (scoring “Excellent� or “Good� by a majority of the expert panel); the percentage of suture repairs receiving Excellent/Good scores by a majority of the expert panel was 69.4% for attending surgeons and 36.1% for trainees (p < 0.05). Nerve Tape repairs exhibited higher average peak tensile force (7.0 ± 3.6N) compared to suture repairs (2.6 ± 1.6N) (p < 0.05).
Conclusions: Nerve repairs with Nerve Tape were performed faster and with higher technical precision than those performed using microsutures. Nerve Tape repairs had substantially greater tensile strength than microsuture repairs.
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