Abstract

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. Key words: Surgical procedures, minimally invasive; Spine; Surgical instruments

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