Minimally Invasive Robotic Versus Open Fluoroscopic-guided Spinal Instrumented Fusions A Randomized Controlled Trial
Minimally Invasive Robotic Versus Open Fluoroscopic-guided Spinal Instrumented Fusions A Randomized Controlled Trial
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DOI：
10.1097/brs.0000000000001778
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发表时间：
2017-03-15
期刊：
影响因子：
3
通讯作者：
Kim, Hyun-Jib
中科院分区：
文献类型：
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作者：
Hyun, Seung-Jae;Kim, Ki-Jeong;Kim, Hyun-Jib
研究设计.一项前瞻性随机临床试验。比较微创脊柱手术（MIS）中机器人引导与透视引导开放入路腰椎融合术的影响。背景资料总结。MIS需要一个漫长的学习曲线，并使患者和手术团队过度暴露于有害辐射。在大多数研究中，机器人引导已被证明可以提高准确性和辐射，但有相互矛盾的前瞻性数据。将适用于接受单节段或双节段脊柱融合术的患者随机分为机器人引导MIS（RO）和透视引导开放手术（FA）。记录患者的人口统计学资料和结局。每组招募30名患者，平均年龄66.7岁，71.5%为女性，平均体重指数为25.2。RO中35个节段植入130枚椎弓根螺钉，FA中40个节段植入140枚螺钉，或每次手术分别植入4.3枚和4.7枚螺钉。RO和FA的透视使用时间分别为3.5秒和13.3秒（FA中P <2mm和> 4mm，P = 0.500）。研究中发生1例近端关节突侵犯，发生在FA（P = 1.000）。RO和FA距近侧关节面的平均距离分别为5.8和4.6mm（P< 0.001）。RO组平均住院时间为6.8 d，FA组为9.4 d，两组比较差异有统计学意义（P = 0.020）。使用机器人引导的MIS显著减少了辐射暴露和住院时间。患者结局不受手术技术的影响。
Study Design. A prospective randomized clinical trial.Objective. To compare the impact of robotic guidance in a minimally invasive spine surgery (MIS) to a fluoroscopy-guided open approach in lumbar fusions.Summary of Background Data. MIS requires a protracted learning curve and excessively exposes the patient and surgical team to harmful radiation. Robotic-guidance has been shown to improve accuracy and radiation in most studies, but there is conflicting prospective data.Methods. Patients indicated to undergo a 1 or 2 level spinal fusion were randomized between robotic-guided MIS (RO) and fluoroscopic-guided open surgery (FA). Patient demographics and outcomes were recorded.Results. Thirty patients were recruited to each arm. Average age was 66.7 years, 71.5% were females, and average body mass index was 25.2. Thirty-five levels were instrumented with 130 pedicle screws in RO versus 40 levels with 140 screws in FA, or 4.3 and 4.7 screws per surgery, respectively. Use of fluoroscopy was 3.5 versus 13.3 seconds in the RO and FA respectively (P 2mm and > 4mm) in FA P = 0.500). One proximal facet violation occurred in the study, it was in FA (P = 1.000). The average distance from the proximal facets was 5.8 versus 4.6mm in the RO and FA respectively (P< 0.001). The average length of stay was 6.8 versus 9.4 days in RO compared with FA (P = 0.020).Conclusion. MIS using robotic-guidance significantly reduced radiation exposure and length of stay. Patient outcomes were not affected by the surgical technique.