Safa Bauback, Jain Sonu, Desai Mihir J, Greenberg Jeffrey A, Niacaris Timothy R, Nydick Jason A, Leversedge Fraser J, Megee David M, Zoldos Jozef, Rinker Brian D, McKee Desirae M, MacKay Brendan J, Ingari John V, Nesti Leon J, Cho Mickey, Valerio Ian Lee, Kao Dennis S, El-Sheikh Yasser, Weber Renata V, Shores Jaimie T, Styron Joseph F, Thayer Wesley P, Przylecki Wojciech H, Hoyen Harry A, Buncke Gregory M
Department of Plastic and Reconstructive Surgery, The Buncke Clinic, San Francisco, California.
Plastics and Reconstructive Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio.
Microsurgery. 2020 Jul;40(5):527-537. doi: 10.1002/micr.30574. Epub 2020 Feb 26.
Peripheral nerve damage resulting in pain, loss of sensation, or motor function may necessitate a reconstruction with a bridging material. The RANGER® Registry was designed to evaluate outcomes following nerve repair with processed nerve allograft (Avance® Nerve Graft; Axogen; Alachua, FL). Here we report on the results from the largest peripheral nerve registry to-date.
This multicenter IRB-approved registry study collected data from patients repaired with processed nerve allograft (PNA). Sites followed their own standard of care for patient treatment and follow-up. Data were assessed for meaningful recovery, defined as ≥S3/M3 to remain consistent with previously published results, and comparisons were made to reference literature.
The study included 385 subjects and 624 nerve repairs. Overall, 82% meaningful recovery (MR) was achieved across sensory, mixed, and motor nerve repairs up to gaps of 70 mm. No related adverse events were reported. There were no significant differences in MR across the nerve type, age, time-to-repair, and smoking status subgroups in the upper extremity (p > .05). Significant differences were noted by the mechanism of injury subgroups between complex injures (74%) as compared to lacerations (85%) or neuroma resections (94%) (p = .03) and by gap length between the <15 mm and 50-70 mm gap subgroups, 91 and 69% MR, respectively (p = .01). Results were comparable to historical literature for nerve autograft and exceed that of conduit.
These findings provide clinical evidence to support the continued use of PNA up to 70 mm in sensory, mixed and motor nerve repair throughout the body and across a broad patient population.
周围神经损伤导致疼痛、感觉丧失或运动功能障碍时，可能需要使用桥接材料进行重建。RANGER®注册研究旨在评估使用处理过的同种异体神经移植物（Avance®神经移植物；Axogen公司；佛罗里达州阿拉楚阿）进行神经修复后的效果。在此，我们报告迄今为止最大的周围神经注册研究结果。
这项经多中心机构审查委员会批准的注册研究收集了使用处理过的同种异体神经移植物（PNA）进行修复的患者数据。各研究点遵循各自的患者治疗和随访标准护理方案。对数据进行有意义恢复情况的评估，将其定义为≥S3/M3，以便与先前发表的结果保持一致，并与参考文献进行比较。
该研究纳入了385名受试者和624例神经修复病例。总体而言，在长达70毫米间隙的感觉神经、混合神经和运动神经修复中，有82%实现了有意义恢复（MR）。未报告相关不良事件。在上肢，神经类型、年龄、修复时间和吸烟状况亚组之间的MR无显著差异（p＞0.05）。在损伤机制亚组中，复杂损伤（74%）与撕裂伤（85%）或神经瘤切除术（94%）相比存在显著差异（p = 0.03），并且在间隙长度＜15毫米和50 - 70毫米间隙亚组之间也存在显著差异，MR分别为91%和69%（p = 0.01）。结果与神经自体移植的历史文献相当，且超过了导管的效果。
这些发现提供了临床证据，支持在全身广泛的患者群体中，在感觉神经、混合神经和运动神经修复中持续使用长达70毫米的PNA。
