Boeckstyns Michel E H, Sørensen Allan Ibsen, Viñeta Joaquin Fores, Rosén Birgitta, Navarro Xavier, Archibald Simon J, Valss-Solé Josep, Moldovan Mihai, Krarup Christian
Clinic of Hand Surgery, Gentofte Hospital, University of Copenhagen; Section of Hand Surgery, Rigshospitalet, University of Copenhagen; Department of Clinical Neurophysiology, The Neuroscience Center, Rigshospitalet, University of Copenhagen; Institute of Neuroscience and Pharmacology, University of Copenhagen, Denmark; Department of Orthopedic Surgery, Hospital Clínic, University of Barcelona; Department of Cell Biology, Physiology, and Immunology, and Institute of Neurosciences, Universitat Autònoma de Barcelona; Institute of Biomedical Investigations August Pi i Sunyer, Barcelona, Spain; Department of Hand Surgery, Skåne University Hospital, Malmö, Sweden; Integra LifeSciences, Plainsboro, New Jersey.
J Hand Surg Am. 2013 Dec;38(12):2405-11. doi: 10.1016/j.jhsa.2013.09.038. Epub 2013 Nov 5.
To compare repair of acute lacerations of mixed sensory-motor nerves in humans using a collagen tube versus conventional repair.
In a prospective randomized trial, we repaired the ulnar or the median nerve with a collagen nerve conduit or with conventional microsurgical techniques. We enrolled 43 patients with 44 nerve lacerations. We performed electrophysiological tests and hand function using a standardized clinical evaluation instrument, the Rosen scoring system, after 12 and 24 months.
Operation time using the collagen conduit was significantly shorter than for conventional neurorrhaphy. There were no complications in terms of infection, extrusion of the conduit, or other local adverse reaction. Thirty-one patients with 32 nerve lesions, repaired with collagen conduits or direct suture, attended the 24-month follow-up. There was no difference between sensory function, discomfort, or total Rosen scores. Motor scores were significantly better for the direct suture group after 12 months, but after 24 months, there were no differences between the treatment groups. There was a general further recovery of both motor and sensory conduction parameters at 24 months compared with 12 months. There were no statistically significant differences in amplitudes, latencies, or conduction velocities between the groups.
Use of a collagen conduit produced recovery of sensory and motor functions that were equivalent to direct suture 24 months after repair when the nerve gap inside the tube was 6 mm or less, and the collagen conduit proved to be safe for these nerve lacerations in the forearm.
TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.
比较使用胶原管与传统修复方法对人类混合感觉运动神经急性撕裂伤的修复效果。
在一项前瞻性随机试验中，我们用胶原神经导管或传统显微外科技术修复尺神经或正中神经。我们纳入了43例患者的44处神经撕裂伤。在12个月和24个月后，我们使用标准化临床评估工具——罗森评分系统进行电生理测试和手部功能评估。
使用胶原导管的手术时间明显短于传统神经缝合术。在感染、导管挤出或其他局部不良反应方面没有并发症。31例有32处神经损伤的患者，用胶原导管或直接缝合修复后参加了24个月的随访。感觉功能、不适或罗森总分之间没有差异。12个月后，直接缝合组的运动评分明显更好，但24个月后，治疗组之间没有差异。与12个月相比，24个月时运动和感觉传导参数普遍进一步恢复。两组之间的波幅、潜伏期或传导速度没有统计学上的显著差异。
当管内神经间隙为6mm或更小时，使用胶原导管在修复24个月后产生的感觉和运动功能恢复与直接缝合相当，并且胶原导管被证明对前臂的这些神经撕裂伤是安全的。
研究类型/证据水平：治疗性II级。
