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Object①To investigate the safety and efficiency of a new percutaneous kyphoplasty surgical instrument with high viscosity bone cement.②To observe the clinical outcome of the osteoporosis thoracolumbar compression fractures. Methods1. 19 patients with osteoporosis thoracolumbar compression fractures were included (4 male and 15 female, age range 53-80 years old, average age 69.63±8.39 years old). 24 osteoporosis thoracolumbar compression fractures(T9:2, T11:4, T12:3, L1:5, L2:4, L3:4, L4:1, L5:1) were received a new percutaneous kyphoplasty surgical instrument with high viscosity bone cement, of which 18 vertebras were received unipedicular percutaneous kyphoplasty, while other 6 vertebras were received bipedicular percutaneous kyphoplasty. The indexes such as pump water seepage, bone cement leakage, bone biopsy needle bending or breaking, bleeding volume and postoperative adverse events were observed and recorded. The anterior, midline, posterior and average vertebral height, kyphosis Cobb’s angle, visual analogue scales(VAS) and modified Simplified Chinese Version of Oswestry Disability Index(ODI) were determined before and after operation 3 days and 1 month later.2、The dates of The anterior, midline, posterior and average vertebral height, kyphosis Cobb’s angle, VAS and ODI determined before and after operation 3 days and 1month later were analyzed by the PASW Statistics 18.0.ResultsThe percutaneous kyphoplasty surgical instrument with high viscosity bone cement was safe and efficient. There was no adverse events occurred in 30 operative procedures, 82.83±12.67 min for a vertebra, bleeding volume 3.91±4.21 ml, injected bone cement volume 3.27±0.99 ml. 4 bone cement leakage in front of vertebra were observed without clinical symptoms, No other complications were observed. One patient dead after the following visited 1 month later, and no fresh fracture or refracture were observed.The anterior vertebral height before operation: 20.57±6.87mm, the anterior vertebral height after operation: 24.70±9.03mm(P<0.01); the midline vertebral height before operation: 23.70±6.09mm, the midline vertebral height after operation: 25.68±6.37mm(P < 0.01); the posterior vertebral height before operation: 28.68±5.84mm, the posterior vertebral height after operation: 28.69±5.86mm(P=0.08); the average vertebral height before operation: 24.32±6.11mm, the average vertebral height after operation: 26.36±6.33mm(P < 0.01); the kyphosis Cobb’s angle before operation: 26.40±10.82°, the kyphosis Cobb’s angle after operation: 20.32±10.79°(P<0.01). The VAS score before operation:7.74±0.81, the VAS score after operation 3 days: 3.37±0.89(P<0.01), the VAS score after operation 1 month: 2.72±0.69(P<0.01, compared with the VAS score after operation 3 days); the ODI before operation:76.09±6.26%, the ODI after operation 3 days: 32.78±9.20%(P < 0.01), the ODI after operation 1 month: 31.43±8.08%(P=0.87 ,compared with the ODI after operation 3 days). According to the ODI scale, there were 4 patients excellent, 14 patient good and one medium after operation 3 days, there were 2 patients excellent, 16 patient good after operation 1 month. High bone cement volume group(>3.0ml) and low bone cement volume group(≤3.0ml) were compared. The improved VAS score in high bone cement volume group(n=11): 4.45±1.21, the improved VAS score in low bone cement volume group(n=8): 4.25±0.71(ρ=0.76); the improved ODI in high bone cement volume group(n=11): 42.59±6.67%, the improved VAS score in low bone cement volume group(n=8): 44.29±5.07%(ρ=0.56); the improved anterior vertebral height in high bone cement volume group(n=13): 5.09±1.15mm, the improved anterior vertebral height in low bone cement volume group(n=11): 3.00±1.09mm(ρ<0.01); the improved midline vertebral height in high bone cement volume group(n=13): 2.84±1.58mm, the improved midline vertebral height in low bone cement volume group(n=11): 0.98±1.01mm(ρ<0.01); the improved posterior vertebral height in high bone cement volume group(n=13): 0.02±0.04mm, the improved posterior vertebral height in low bone cement volume group(n=11): 0.00±0.00mm(ρ=0.09); the improved average vertebral height in high bone cement volume group(n=13): 2.65±0.89mm, the improved average vertebral height in low bone cement volume group(n=11): 1.32±0.59mm(ρ<0.01); the improved kyphosis Cobb’s angle in high bone cement volume group(n=12): 7.37±2.35°, the improved kyphosis Cobb’s angle in low bone cement volume group(n=11): 4.68±0.65°(ρ<0.01). Unipedicular group and bipedicular group were seted up according to unipedicular or bipedicular in operative procedures. The improved anterior vertebral height in unipedicular group (n=18): 4.08±1.69mm, the improved anterior vertebral height in bipedicular group(n=6): 4.28±0.99mm(ρ=0.69); the improved midline vertebral height in unipedicular group(n=18): 1.99±1.76mm, the improved midline vertebral height in bipedicular group(n=6): 1.97±1.24(ρ=0.62); the improved posterior vertebral height in unipedicular group(n=18):0.01±0.03mm, the improved posterior vertebral height in bipedicular group(n=6): 0.02±0.04mm(ρ=0.72); the improved average vertebral height in unipedicular group(n=18): 2.03±1.12mm, the improved average vertebral height in bipedicular group (n=6): 2.08±1.12mm(ρ=0.48); the improved kyphosis Cobb’s angle in unipedicular group(n=17): 6.08±2.29°, the improved kyphosis Cobb’s angle in low injected bone cement volume group(n=11): 6.08±2.10°(ρ=0.81).Conclusions1.There was no adverse events in the operations.The percutaneous kyphoplasty surgical instrument with high viscosity bone cement was safe and effective and easily operated.2. A apparent recovery was observed in the anterior, midline vertebral height, kyphosis angel, VAS and ODI via percutaneous kyphoplasty with high viscosity bone cement, but didn’t to the posterior and average vertebral height. High injected volume group had a better recovery in midline vertebral height and kyphosis Cobb’s angle. There was no different in recovery of vertebral height and kyphosis Cobb’s angle between unipedicular group and bipedicular group.
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