1.1 clinical data
1.1.1 inclusion and exclusion criteria
1) inclusion criteria: patients over the age of 60 who were diagnosed with fresh osteoporotic thoracolumbar compression fracture with vertebral posterior wall breakage (all patients received percutaneous kyphoplasty after CT scan confirmed fractured vertebral posterior wall breakage or partial fracture and then transferred into spinal canal less than 1/3 sagittal diameter of spinal canal); 2) exclusion criteria: (1) primary or metastatic bone tumor, 2 vertebral bodies without painful osteoporotic thoracolumbar vertebral compression fractures, (3) multiple segmental thoracolumbar fracture, (4) the nerve injury, (5)the combining rear ligament complex injury, (6)follow-up time is less than 6 months after treatment.
1.1.2 case data
This study included 82 patients, who were divided into two groups A and B according to different surgical methods. Group A: percutaneous kyphoplasty group (PVP); group B: percutaneous kyphoplasty group (PKP). There were 40 patients in group A, including 12 males and 28 females. The mean age was 71.47 ± 5.33 years old. The time from injury to operation was 2 ~ 20 days (4.35 ± 2.41) on average. Follow-up time: 8 to 24 months, average 12.39 ± 2.57 months. Fracture vertebral distribution: T7 l cases, T8 l cases, T9 2 cases, T10 1 case, T11 5 cases, T12 11 cases, L1 9 cases, L2 6 cases, L3 2 cases, L4 2 cases. There were 42 patients in group B, including 12 males and 30 females. The mean age was 72.79 ± 7.59 years. The time from injury to operation was 1 ~ 20 days (4.53 ± 2.19) on average. Follow-up time: 8 to 25 months, average 12.88 ± 4.27 months. Fracture vertebral distribution: T6 l cases, T8 l cases, T9 1 cases, T10 2 cases, T11 6 cases, T12 12 cases, L1 8 cases, L2 7 cases, L3 2 cases, L4 2 cases. There was no significant difference in age, gender, fracture vertebral distribution, injury distance from surgery, and follow-up time between the two groups (P > 0.05).The two groups were comparable.(Table1)
Table 1
Comparison of general information between group A and group B
Characteristics | A | B | X2 | P |
Age(year) | ༜70 | 18(45.00) | 20(47.62) | 0.361 | 0.859 |
≥ 70 | 22(55.00) | 22(52.38) | | |
gender | Male | 12(30.00) | 13(30.95) | 0.835 | 0.672 |
Female | 28(70.00) | 29(69.05) | | |
fracture vertebral distribution | thoracic | 21(52.50) | 23(54.76) | 1.615 | 0.721 |
lumbar vertebra | 19(47.50) | 19(45.24) | | |
injury distance from surgery (days) | ༜7 | 28(70.00) | 30(71.43) | 1.719 | 0.713 |
≥ 7 | 12(30.00) | 12(28.57) | | |
follow-up time (months) | ༜18 | 19(47.50) | 20(47.62) | 0.935 | 0.892 |
≥ 18 | 21(52.50) | 22(52.38) | | |
1. 2 surgical methods
Group A: the patients were in the prone position, chest and waist heighted with the body position pad, and the abdomen was suspended. Before surgery, the patients were treated with the closed reduction by over-extension traction in the prone position, and the surface projection of the fractured vertebral pedicle was located under the perspective of C-arm X-ray machine. Local anesthesia with 1% lidocaine was performed at the location of puncture point, and bilateral pedicle puncture was performed in both groups A and B. Choose pedicle projection at 10 o 'clock position in left and 2 o 'clock position in right. Puncture path along the pedicle, oblique perspective puncture needle point reached fanterior about 1/3, tip the pedicle is a perspective projection point and spines projection, pull out the needle core, to the bone drill work along the pipe screwing in vertebral bodies to distance fanterior 1/3, pulls out the bone drill. To prepare bone cement and start injection when the bone cement is in the shape of wire drawing. The expected amount of bone cement infusion is 1/4 of the volume of the vertebral body. However, when the bone cement spreads to 1/4 to 1/5 of the posterior edge of the vertebral body, the injection of bone cement should be stopped, or when it is found by fluoroscopy that the bone cement leaks to the bone, such as the intervertebral space, paravertebral, vein, etc. After the bone cement solidifies, rotate to pull out the puncture needle. Pressure dressing was applied at the puncture site and the operation was completed. The patients' vital signs and sensory movement of lower limbs were observed during the operation. One day after the operation, patients got out of bed and had conventional anti-osteoporosis treatment.
Group B: posture, preoperative closed reduction, anesthesia, puncture and bone drill enlargement were the same as group A. After pulling out the bone drill, the balloon was implanted along the working catheter. Under the monitoring of C-arm, it was found that the balloon was in A good position, then the balloon was gradually expanded by slowly injecting contrast agent, and the balloon was stopped when the height of the vertebral body was satisfied and recovered, and the contrast agent was withdrawn slowly, and the subsequent treatment was the same as that of group A.
1. 3 surgical materials
The instruments used in percutaneous kyphoplasty were manufactured by Shandong Guanlong company, and the bone cement used in the surgery was manufactured by Germany's heraeus company, polymethyl-methacrylate (PMMA).
1.4 observation indexes
The operative time, intraoperative fluoroscopy times and injection of bone cement of the two groups were recorded. Visual analog score (VAS) and Oswestry disability index (ODI) in postoperative follow-up were recorded in the two groups. The height of the fractured vertebral body on the lateral X-ray (converted according to the marking scale) was measured before surgery, 1 day after surgery and 6 months after surgery in the two groups. The height of the fractured vertebral body = the distance between the center of the upper and lower endplate of the fractured vertebral body (the midpoint of the continuous front and rear edge of the endplate). The height of recovery of fractured vertebral body 1 day after surgery was calculated, and the height of loss of fractured vertebral body 6 months after surgery was calculated. Intraoperative and postoperative complications including the incidence of bone cement leakage, the incidence of nerve injury, puncture infection rate, and the incidence of pulmonary embolism were recorded. The incidence of adjacent vertebral fractures was followed up.
1.5 statistical processing
SPSS13.0 statistical software was used for statistical analysis. The significance level was set as 0.05, and P value < 0.05 was considered statistically significant. Measurement data were expressed as mean ± standard deviation (x ± s), mean comparison was performed by t test (bilateral), enumeration data were performed by chi-square test of four-lattice table, and gender comparison was performed by mann-whitney test.