The role of CT and MRI fusion reconstruction-guided 3D printing navigation template for puncture during sacral neuromodulation: a clinical randomized controlled trial / 中华放射学杂志

ABSTRACT

Objective:To evaluate the safety and effectiveness of the accurate puncture during sacral neuromodulation (SNM) guided with 3D printing navigation template based on reconstruction techniques using fusing sacral CT and MRI images.Methods:Totally 42 patients operated with SNM were selected in Renji Hospital, School of Medicine, Shanghai Jiaotong University from July 2016 to August 2017. The patients were randomly divided into control group ( n=22) and experimental group ( n=20) using random number table. The conventional cross-positioning technique under X-ray was used for puncture during SNM in the control group. While in the experimental group, the sacral CT and MRI images were fused for reconstruction and design of the navigation template, printed by 3D technique for the puncture in SNM. The times of punctures, the average time for puncture operation, the time of intraoperative testing of the stimulator device, the minimum onset voltage of the stimulator, the X-ray radiation dose, postoperative curative effect (rate of secondary transformation) and the incidence rate of complications were compared between the two methods using independent-simple t test or χ 2 test. Results:Compared to control group, fewer times of punctures, shorter time needed for puncture operation, shorter time of intraoperative testing of the stimulator, smaller radiation dose and minimum effective voltage were found in the experimental group ( P<0.05). There were 15 and 16 patients who completed the secondary transformation in the control group and experimental group, and there was no significant difference between the two groups (χ2=0.757, P=0.384). There were 3 cases of complications in the control group, including 2 cases of infection and 1 case of bleeding, while no complications in the experimental group. Conclusions:CT and MRI images fusion reconstruction-guided 3D printing navigation template can help perform accurate and safe punctures in SNM. Compared to conventional puncture positioned under X-ray, it can effectively improve the puncture efficiency, and reduce the radiation dose in the operation.