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目的 介绍经皮脊柱三维定位器的应用.方法 2012年12月至2014年6月,对6具尸体标本行经皮椎间孔、椎间盘穿刺定位(尸体试验)及56例骨质疏松性椎体压缩骨折患者行经皮椎体成形术(临床试验).双侧穿刺,随机一侧使用自主研制的获得国家实用新型专利的经皮脊柱三维定位器辅助穿刺定位并设为试验组,另一侧采用常规徒手穿刺并设为对照组.比较两组穿刺定位时间、“C”型臂X线透视剂量及术后相关并发症的发生率.结果 尸体试验试验组经皮椎间孔、椎间盘穿刺用时(9.42±1.33)min,对照组穿刺用时(13.59±1.26) min,差异有统计学意义.临床试验试验组经皮穿刺每椎体平均用时(23.55±6.03) min,对照组(29.86±8.96) min,差异有统计学意义.尸体试验试验组每次经椎间孔、椎间盘穿刺中X线透视剂量为(0.40±0.10) mSv,对照组为(0.65±0.11) mSv,差异有统计学意义;临床试验试验组经皮穿刺每椎X线透视剂量为(1.04±0.37) mSv,对照组为(1.33±0.40) mSv,差异有统计学意义.尸体试验试验组发生不良穿刺2次,对照组8次,临床试验均未发生不良穿刺;临床试验试验组骨水泥渗漏发生率为4.62%,对照组为10.78%,差异有统计学意义.结论 经皮脊柱三维定位器可个性化精确辅助经皮椎间孔、椎间盘穿刺定位,较传统徒手方法能显著缩短操作时间,减少医患双方的放射性损伤及穿刺并发症,增强手术安全性.“,”Objective To study the application of a novel three-dimensional (3D) guider of percutaneous minimally invasive spine surgery (MISS).Methods Between December 2012 and June 2014,percutaneous intervertebral foramen and disc puncture was performed on 6 cadavers (cadaveric experiment);percutaneous vertebroplasty (PVP) was performed on 56 patients with osteoporosis vertebral compression fracture (clinical trial).The 3D guider for percutaneous MISS was self-developed,and a national utility model patent was obtained;the device was randomly used on one side to aid the positioning of the puncture in the test group.The conventional manual puncture was used on the other side in the control group.Compared puncture positioning time,radiation dose of the C-arm X-ray fluoroscopy,and the incidence of surgical complications of two groups.Results The puncture times of the cadaveric experiment were 9.42±1.33 min in the experimental group and 13.59±1.26 min in the control group.The average puncture time of each vertebra of the clinical trial was 23.55±6.03 min in the test group and 29.86±8.96 min in the control group.The intraoperative fluoroscopy dose of each puncture in the cadaveric experiment was 0.40±0.10 mSv in test group and 0.65±0.11 mSv in control group.The intraoperative fluoroscopy dose of each vertebra in clinical trial was 1.04±0.37 mSv in test group and 1.33±0.40 mSv in control group.In cadaveric experiment,the test group had 2 cases of adverse punctures,while the control group had 8 cases of adverse punctures.In clinical trial,the incidence rates of bone cement leakage were 4.62% in test group and 10.78% in control group.In both cadaveric and clinical experiments,the puncture positioning time,radiation dose,and the incidence of surgical complications were statistically significant between the two groups.Conclusion The self-developed 3D guider for percutaneous MISS could personalize and precisely aid puncture positioning in PVP and percutaneous intervertebral foramen and disc puncture.Compared with the traditional manual method,3D guider could significantly shorten surgical time,which could reduce the risk of surgical exposure;in addition,the device could also reduce radiation injury to both doctors and patients and reduce the incidence of complications,thus could increase surgical safety.