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Outcomes from a Multi-center, Prospective, Randomized, Blinded, Comparison Study of Processed Nerve Allografts and Hollow-Tube Conduit for Nerve Reconstructions in the Hand
Brian D. Rinker, MD1; Gregory A. Merrell, MD2; S. Houston Payne Jr, MD3; E. F. Shaw Wilgis, MD4; James P. Higgins, MD4
1Division of Plastic Surgery, University of Kentucky, Lexington, KY; 2Department of Orthopaedic Surgery & Rehabilitation, Indiana Hand to Shoulder Center, Indianapolis, IN; 3Georgia Hand, Shoulder & Elbow, Atlanta, GA; 4The Curtis National Hand Center, Baltimore, MD

Introduction: Current repair options for peripheral nerve injuries where tension-free gap closure is not possible include processed nerve allograft and hollow tube conduit. As the availability of published Level 1 clinical studies in peripheral nerve reconstruction are limited, we seek to evaluate the difference in functional recovery outcomes with these repair methods for digital repairs in the hand. Here we report on the outcomes from a multi-center prospective, randomized, single blind, comparison pilot study of processed nerve allograft and hollow-tube conduit for nerve reconstructions in the hand.

Methods: This IRB approved study was conducted across 4 study centers. Consented subjects meeting inclusion exclusion criteria were randomized intraopeatively to either processed nerve allograft or hollow conduit. Pre-operative preparation and injury site dissection was based on institutions standard of care. Placement of study product was completed following the product Instructions for Use. The subjects in were followed for a total of 12 months. Standard sensory and safety assessments were conducted at baseline, 1, 3, 6, 9 and 12 months after reconstruction. All sensory assessments were performed by a blinded assessor. The contralateral digit served as the control for all subjects in this study. Subjects completing the study were evaluated for recovery of static two point discrimination and incidence of adverse events.

Results: The study randomized 23 subjects with 31 repairs. Fifteen repairs completed the month 12 visit. There were no significant differences in demographics, medical history, and baseline characteristics between treatment groups. The predominant nerve injury was laceration/sharp transaction with similar concomitant injuries in each treatment group involving bone, tendon, and vascular artery. The mean ± SD length of nerve gap prior to repair with processed nerve allograft and hollow nerve conduit were 12.5 ± 3.9 mm and 12.2 ± 4.5 mm, respectively (5- 20mm). All injuries randomized to processed nerve allograft returned s2PD as compared to 66% of the repairs in conduit group. The average s2PD was 5 mm ±1.5mm (n=6) and 8mm ±4.8mm (n= 9). See Figure 1. There were two adverse events reported resulting in the removal of the hollow tube conduits.

Conclusions: In this pilot study, process nerve allografts reported superior levels of static two point discrimination at more consistent level as compared to hollow tube conduit. This data should be considered when powering future larger randomized controlled studies.

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