In Vivo Efficacy Of A Novel Nerve Coaptation Device As A Suture-Less Alternative For Repairing Peripheral Nerve Defects
Geetanjali S Bendale, PhD1; Lida Daniel, BS1; Matt Smith, MD1; Isabelle deBruler, BS1; Mariana Gragnani, BS1; Ryan Clement, PhD2; Jules McNeice, MS2; Fletcher Griffitts, MS2; Maximilian Sonntag, MS2; Jack Griffis, MS2; Isaac Clements, PhD2; Jonathan Isaacs, MD3
1Virginia Commonwealth University, Richmond, VA; 2BioCircuit Technologies, Atlanta, GA; 3Department of Orthopaedics, Virginia Commonwealth University, Richmond, VA
Introduction: Though microsuture neurorrhaphy is the accepted clinical standard treatment for severed peripheral nerves, this technique requires high microsurgical proficiency and still often fails to provide adequate nerve approximation. Entubulation utilizing commercially available conduits may technically enhance the nerve alignment and potentially provide a pro-regenerative microenvironment, but still requires precise suture placement. In response, we have developed Nerve Tape®, a suture-less coaptation device that incorporates tissue grabbing Nitinol microhooks within a flexible porcine small intestine sub-mucosa (SIS) backing. These tiny microhooks engage the outer epineurium of the nerve while the backing wraps the coaptation to provides a stable, entubulated repair. We hypothesized that the Nerve Tape would provide equal or enhanced axon regeneration compared to commercially available conduits or microsuture only assisted repairs.
Materials & Methods: Thirty male and female New Zealand White rabbits underwent a tibial nerve transection, immediately repaired with either 1) Nerve Tape, 2) conduit (AxoGuard Nerve Connector) plus anchoring sutures or 3) four 9-0 nylon microsutures spaced 90° apart within the epineurium. At sixteen weeks post-injury, the nerves were re-exposed to test sensory and motor nerve conduction, measure target muscle weight and girth, and perform nerve tissue histology.
Results: There were no statistically significant differences in gross morphology or muscle characteristics between the three repair groups. Nerve conduction velocity and amplitude were significantly higher for Nerve Tape as compared to the conduit group (p<0.05), but not greater than the microsuture group. Average total axon counts distal to the repair were 13859±1454 for Nerve Tape, 12466±1265 for conduit repair, and 12139±2442 for microsutures (not statistically different; p=0.18). Average g-ratio for nerve tape, conduit repairs, and microsuture repairs were 0.54, 0.52, and 0.48 respectively (not statistically different; p=0.49). Axon counts proximal to the repair were 11468±1512 for Nerve Tape, 12539±2334for conduit (AxoGuard), and 11971±2523 for microsutures and average g-ratios were 0.62, 0.6 and 0.64 respectively (not statistically different).
Conclusion: Nerve Tape repairs provide axon regeneration equivalent to that of conduit and microsuture repairs and is an effective suture-less alternative that may offer enhanced functional recovery and repair consistency.
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