Wormald Justin C R, Gardiner Matthew D, Jerosch-Herold Christina, Cook Jonathan, Pinedo Villanueva Rafael, O'Hanlon Ciaron, Vides Naomi, Fabiano Gianluca, Parsons Scott, Davies Loretta, Fletcher Heidi, Glaze Molly, Cooper Cushla, Power Dominic, Jain Abhilash, Beard David
Surgical Interventional Trials Unit (SITU), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Department of Plastic and Reconstructive Surgery, Oxford University Healthcare NHS Foundation Trust, Oxford, UK.
Br J Surg. 2025 Sep 2;112(9). doi: 10.1093/bjs/znaf174.
Digital nerves provide sensibility to the fingers. They are commonly injured through accidental sharp laceration. The aim of the NEON (Nerve rEpair Or Not) study was to investigate whether microsurgical suture repair of lacerated digital nerves is superior to nerve alignment alone without suture repair.
A two-arm, parallel group, double-blind, multicentre RCT was undertaken over 2 years. Participants with suspected unilateral digital nerve injury underwent surgical exploration and were randomized to microsurgical suture repair or nerve alignment alone. The primary outcome was the Impact of Hand Nerve Disorders (I-HaND v2) patient-reported outcome measure (PROM) at 12 months post-randomization. Secondary outcomes assessed were: objective neurosensory and functional recovery; health-related quality of life to examine cost-effectiveness; complications of surgery and clinically problematic neuroma rates (Elliot score). Both participants and assessors were blind to allocation.
A total of 122 adults were randomized to microsurgical suture repair (n = 61) or nerve alignment alone (n = 61). Primary outcome data using the I-HaND (v2) were available for 106 participants (87%) at 12 months. There were no statistically significant differences in I-HaND scores at all time points, including the 12-month primary end point (15.9 versus 20.2, P = 0.09; 95% c.i. [-0.9, 10.8]). There were also no differences in all secondary outcome measures, including Patient Evaluation Measure and EQ-5D-5L scores at 12 months. Complications were similar at 6 weeks and 12 months. The trial was closed early by the funder owing to slow recruitment and did not reach the intended sample size.
Based on the available data from the NEON trial, there is no evidence to support the beneficial effect of suture repair over nerve alignment alone for isolated digital nerve injury. This multicentre RCT can be used to inform future trials, inform patients and guide clinical practice.
NIHR Health Technology Assessment (NIHR127807-18/37).
ISRCTN16211574.
指神经为手指提供感觉功能。它们常因意外锐器切割而受伤。NEON（神经修复与否）研究的目的是调查手指神经撕裂伤的显微外科缝合修复是否优于单纯神经对合而不进行缝合修复。
一项双臂、平行组、双盲、多中心随机对照试验进行了2年。疑似单侧指神经损伤的参与者接受手术探查，并随机分为显微外科缝合修复组或单纯神经对合组。主要结局是随机分组后12个月时患者报告的手部神经障碍影响（I-HaND v2）结局指标（PROM）。评估的次要结局包括：客观神经感觉和功能恢复；用于检查成本效益的健康相关生活质量；手术并发症和临床问题性神经瘤发生率（艾略特评分）。参与者和评估者均对分组情况不知情。
共有122名成年人被随机分为显微外科缝合修复组（n = 61）或单纯神经对合组（n = 61）。12个月时，106名参与者（87%）可获得使用I-HaND（v2）的主要结局数据。在所有时间点，包括12个月的主要终点，I-HaND评分均无统计学显著差异（15.9对20.2，P = 0.09；95%置信区间[-0.9, 10.8]）。在所有次要结局指标中也无差异，包括12个月时的患者评估指标和EQ-5D-5L评分。6周和12个月时的并发症相似。由于招募缓慢，资助者提前终止了试验，未达到预定样本量。
基于NEON试验的现有数据，没有证据支持对于孤立性指神经损伤，缝合修复比单纯神经对合更有益。这项多中心随机对照试验可用于为未来试验提供信息、告知患者并指导临床实践。
英国国家卫生研究院卫生技术评估（NIHR127807-18/37）。
ISRCTN16211574。
