PPSF is widely used in treating mild and severe spinal compression fractures, as it can recover the spinal height and achieve immediate spinal stability.24,25
With the development of minimally invasive concepts and medical instruments, percutaneous pedicle surgery provides a new idea for the treatment of vertebral compression fractures. Compared with traditional pedicle screw fixation, percutaneous pedicle surgery has the advantages of less trauma and faster postoperative recovery,26–28 For the whole PPSF operation, pedicle positioning and puncture is extremely important. Accurate positioning and puncture can correctly guide the placement of percutaneous pedicle screw. Otherwise, fixation failure may result, or even damage the spinal cord, nerves and other important tissues.29 Furthermore, how to accurately position and puncture the pedicle has become more and more important.
Fady J. Aky, et al.30 successfully inserted pedicle screws into 105 patients using computer navigation. The trial showed that the operation time was significantly shorter in the experimental group than in the control group, and the rate of pedicle screw dislocation was significantly lower than in the control group (1.0% vs 3.3%), demonstrating the accuracy of computer navigation in pedicle puncture. Jing - ye Wu et al.31 successfully inserted 24 pedicle screws into 10 patients by using robot-assisted technology. the test results showed that the intraoperative navigation precision translation error 1.09 ± 0.17 mm, Angle error2.17 °±0.39 °, no postoperative neurological complications, proved that the robot assisted technology in the accuracy and safety in the process of pedicle puncture. Liming Wang, et al.16 applied the mixed reality (MR) technology to PKP surgery for osteoporotic thoracolumbar compression fractures. Compared with the conventional surgery group, the experimental group could significantly improve the accuracy of pedicle puncture, and effectively reduce the numbers of puncture, fluoroscopy and operation time. However, real-time image signal instability and even image loss exist in MR system during operation, so the stability of the system needs to be further optimized. A. Prokop et al.18 treated 36 patients with thoracolumbar compression fractures by the minimally invasive treatment, compared with the control group, experimental group integrated by percutaneous pedicle screws were accurate placement corresponding to the thoracolumbar vertebral body, the average operation time were 49 minutes and the blood loss was 10–20 ml, the test showed the custom instrument in shorten the operation time, reduce the bleeding and other advantages, but due to the patient and each segment of the vertebral body specificity, custom equipment in use process will appear different degree of error with a custom instrument sextant. Qi Fei, et al.22 using 3D printing, computer simulations based on patients with preoperative CT scan data puncture, and print out the individualized percutaneous plate used for auxiliary pedicle puncture, the results shown, percutaneous guide assisted surgery effectively reduces the number of intraoperative fluoroscopy and radiation, shorten the operation time, is beneficial to patients with postoperative recovery, this proved that percutaneous guide in order to increase the effectiveness of pedicle puncture accuracy. But because the soft tissues such as skin, muscle, portability and scalability, in the process of percutaneous guide assisted pedicle puncture, the needle will often appear deviation, make the first wear success rate is not ideal, and as a result of percutaneous navigation guide tube single pipe design, not easy to adjust puncture, later still need to use the C arm machine multiple perspective in order to achieve the ideal puncture point and Angle positioning.
Aiming at the puncture error and the low success rate of the first puncture caused by the skin, muscle and other soft tissue to the percutaneous guide plate and the flat end lotus-style regulator. In this experiment, our research group optimized the design of the lotus-style regulator, the regulator sophisticated processing and combined with percutaneous plate at one end, and trial by percutaneous puncture positioning plate, then insert the porous regulator cutting-edge and reach to puncture the pedicle bone, and to verify its accuracy and the pedicle core-needle security.
Our result showed, before the first wear rate, needle to reach the ideal position of puncture times, number of perspective, radiation dose, operation time and total number of perspective, total dose radiation and surgery total time, etc., was better than group A and group B, group C that percutaneous plate combined with lotus root tip type controller can effectively improve the accuracy of pedicle puncture and then effectively shortened the pedicle puncture times, number of perspective, operation time, reduce the radiation dose, this is because the type of lotus root tip type regulator under the guidance of percutaneous navigation guide tube reach pedicle bone surface, To the greatest extent, the interference of skin, muscle and other soft tissue to the needle can be avoided, so as to achieve accurate pedicle puncture. Test results, in terms of intraoperative blood loss, no difference between the three groups, which suggests that the early stage of the sophisticated type lotus root type regulator insert will not bring to patients with massive hemorrhage, this may be due to sophisticated type lotus root type regulator in small incision, to a certain extent of vascular tissue caused by oppression, so there would not be a lot of bleeding.
Our results showed that there was no significant difference in postoperative KA and KA change rate among the three groups, indicating that PPSF under the three auxiliary methods could effectively fix the diseased vertebra and restore the height of the diseased vertebra, showing the same advantage. B and C group in 1 day, 7 days of VAS score higher than group A and no obvious difference between group B and C, B and C group of short-term on lower back pain relief after surgery was better than that of group A, this may be due to puncture the number of B and C group was obviously less than group A, for soft tissue damage and vertebrae lighter, postoperative lumbar back pain from group A was obvious. The results showed that there was no significant difference in VAS and ODI scores of the three groups at 1 month, 3 months and 6 months after surgery, indicating that there was no significant difference in long-term relief of lower back pain after surgery among the three groups. This might be due to the fact that soft tissue and bone could be effectively recovered after a long time, and lower back pain could be effectively relieved compared with before. Postoperative patients in all three groups showed no obvious symptoms of nerve injury, indicating that percutaneous pedicle screw could be placed smoothly and safely along the puncture needle with the assistance of the three devices, and the three groups showed the same safety.
We also recognize the limitations in our study. The sample size of each group is relatively small, so large sample size is still needed to verify its reliability. There is a certain mismatch between the virtual design of percutaneous guide plate and the actual printed model, and the design software still needs to be further upgraded and optimized. Because lotus root type controller combined with percutaneous guide, and percutaneous guide contact with the skin, so in actual operation, a little shift of percutaneous guide will cause deviation of the lotus root type controller and produce puncture error, which we will explore in the later work in the case of wrong percutaneous plate deformation effectively fixed method.
In conclusion, the clinical effect of percutaneous guide plate combined with pointed lotus-style regulator is satisfactory. Percutaneous navigation guide punch through the skin for the first-time orientation, while pointed lotus-style regulator reach into the bone surface, avoiding the skin, muscles and other soft tissue to locate the accurate puncture, puncture in effectively reducing the number of times, operation time, perspective and accepted by the patient during radiation, reduce the postoperative patients with lower back pain symptoms, short-term improve the whole efficiency and safety operation.