Xiangyu Wang1, Lun Tan2, Xu Lin3, Chao Wu3, Jun Zeng3, Haigang Hu3. 1. Departmen of Orthopedics, the Fourth People's Hospital of Zigong, Zigong Sichuan, 643000, P.R.China;Southwest Medical University, Luzhou Sichuan, 646000, P.R.China. 2. Departmen of Orthopedics, the Fourth People's Hospital of Zigong, Zigong Sichuan, 643000, P.R.China.1098726536@qq.com. 3. Departmen of Orthopedics, the Fourth People's Hospital of Zigong, Zigong Sichuan, 643000, P.R.China.
Abstract
Objective: To evaluate the safety of photoelectric guided navigation unilateral puncture of the percutaneous kyphoplasty (PKP) in the treatment of thoracolumbar osteoporotic vertebral compression fracture (OVCF). Methods: A randomized controlled clinical research was performed between June 2015 and January 2017. Eighty-five cases of OVCF were treated with photoelectric guided navigation unilateral puncture of the PKP (trial group, 43 cases) or C arm fluoroscopy unilateral puncture of the PKP (control group, 42 cases) respectively. There was no significant difference in gender, age, disease duration, segmental fracture, AO classification, bone mineral density, and preoperative visual analogue scale (VAS) score between 2 groups ( P>0.05). The concordance rate of puncture path and design path, the incidence of pedicle wall breaking, the incidence of bone cement leakage, and the rate of bone cement distribution center were observed and calculated on postoperative CT images; the intraoperative X-ray exposure frequency, frequency of puncture, operation time, VAS scores before operation and at 2 days after operation, and postoperative blood vessel or nerve injury were recorded and compared. Results: The intraoperative X-ray exposure frequency and puncture frequency in trial group were significantly less than those in control group ( P<0.05), but there was no significant difference in operation time between 2 groups ( t=0.440, P=0.661). The VAS scores of 2 groups at 2 days after operation were significantly improved when compared with preoperative ones ( P<0.05), but there was no significant difference in VAS score at 2 days after operation between 2 groups ( t=0.406, P=0.685). All the patients were followed up 6-18 months (mean, 10 months). No blood vessel or nerve injury occurred in 2 groups. The incidence of pedicle wall breaking, the incidence of bone cement leakage, the concordance rate of puncture path and design path, and the rate of bone cement distribution center in trial group were 2.33% (1/43), 2.33% (1/43), 86.05% (37/43), and 88.37% (38/43) respectively, all showing significant differences when compared with those of control group [19.05% (8/42), 21.43% (9/42), 45.24% (19/42), and 50.00% (21/42) respectively] ( P<0.05). Conclusion:Intraoperative photoelectric guided navigation unilateral puncture of the PKP can improve the success rate of target puncture and reduce the incidence of pedicle wall breaking effectively, and achieve better bone cement distribution and better security.
RCT Entities:
Objective: To evaluate the safety of photoelectric guided navigation unilateral puncture of the percutaneous kyphoplasty (PKP) in the treatment of thoracolumbar osteoporotic vertebral compression fracture (OVCF). Methods: A randomized controlled clinical research was performed between June 2015 and January 2017. Eighty-five cases of OVCF were treated with photoelectric guided navigation unilateral puncture of the PKP (trial group, 43 cases) or C arm fluoroscopy unilateral puncture of the PKP (control group, 42 cases) respectively. There was no significant difference in gender, age, disease duration, segmental fracture, AO classification, bone mineral density, and preoperative visual analogue scale (VAS) score between 2 groups ( P>0.05). The concordance rate of puncture path and design path, the incidence of pedicle wall breaking, the incidence of bone cement leakage, and the rate of bone cement distribution center were observed and calculated on postoperative CT images; the intraoperative X-ray exposure frequency, frequency of puncture, operation time, VAS scores before operation and at 2 days after operation, and postoperative blood vessel or nerve injury were recorded and compared. Results: The intraoperative X-ray exposure frequency and puncture frequency in trial group were significantly less than those in control group ( P<0.05), but there was no significant difference in operation time between 2 groups ( t=0.440, P=0.661). The VAS scores of 2 groups at 2 days after operation were significantly improved when compared with preoperative ones ( P<0.05), but there was no significant difference in VAS score at 2 days after operation between 2 groups ( t=0.406, P=0.685). All the patients were followed up 6-18 months (mean, 10 months). No blood vessel or nerve injury occurred in 2 groups. The incidence of pedicle wall breaking, the incidence of bone cement leakage, the concordance rate of puncture path and design path, and the rate of bone cement distribution center in trial group were 2.33% (1/43), 2.33% (1/43), 86.05% (37/43), and 88.37% (38/43) respectively, all showing significant differences when compared with those of control group [19.05% (8/42), 21.43% (9/42), 45.24% (19/42), and 50.00% (21/42) respectively] ( P<0.05). Conclusion: Intraoperative photoelectric guided navigation unilateral puncture of the PKP can improve the success rate of target puncture and reduce the incidence of pedicle wall breaking effectively, and achieve better bone cement distribution and better security.