To investigate the clinical effect of homemade spinal brace repositioner in the treatment of osteoporotic vertebral compression fractures. Methods A random number table method was used to randomize the group. 42 cases in the treatment group totaling 56 vertebrae and 54 cases in the control group totaling 68 vertebrae were followed up for 2.5 years. X-rays and CT scans were taken in all cases, and MRI was added in 27 cases to exclude tumor secondary fractures and old fractures, and all were diagnosed as osteoporotic spinal compression fractures.
The posterior wall of the vertebral body was intact without spinal canal occupancy on CT scan, and none had symptoms of spinal nerve damage. The degree of osteoporosis was graded by L3 X-ray bone trabecular changes. In the treatment group, bone cement was injected into the vertebral body via the pedicle in 56 vertebrae with a spinal traction repositioner, and in the control group, vertebroplasty was performed in 68 vertebrae. The visual analogue pain score (VAS) was used; the height compression rate and recovery rate of the vertebral body were measured according to the method of Lee [1]; and the leakage rate of bone cement was measured.
Results VAS decreased from 8.6±0.8 to 1.7±0.5 preoperatively in the treatment group and from 8.5±0.4 to 3.5±1.4 in the control group, with p<0.05 being a significant difference. There was a significant difference in the preoperative and postoperative anterior and intermediate height compression rates of the vertebral body in the treatment group (p< 0.05). There was no significant difference in the postoperative anterior wall and intermediate height compression rates in the control group (p> 0.05). The recovery rate of the posterior convexity angle in the treatment group was at 71.8%. The recovery rate in the control group was 37.8%. There was a significant difference by t-test (p< 0.05).
No cement leakage occurred in the treatment group; the leakage rate in the control group was 47%. Efficacy assessment: WHO criteria [3] were used to classify pain relief into CR (complete relief), PR (partial relief), MR (slightly effective), and NR (ineffective). In the treatment group, 36 cases had CR and 4 cases had PR, and the CR+PR was 95.24%. In the control group, 43 cases had CR, 3 cases had PR, and the CR+PR was 84.19%. By t-test, p<0.05 was considered a significant difference. Conclusion The homemade spinal brace repositioner is a minimally invasive technique that can replace the imported balloon, provide rapid pain relief, no cement leakage, and restore the vertebral body height.
1. Clinical data
A random number table method was used to randomly group 54 cases in the control group with 68 vertebrae and 42 cases in the treatment group with 56 vertebrae. All cases were diagnosed as osteoporotic spinal compression fractures after taking X-rays and CT scans, of which 27 cases underwent MRI to exclude tumor secondary fractures and old fractures. The degree of osteoporosis was graded by L3 x-ray trabecular changes. A total of 96 cases in both groups had a history of obvious fall and sit trauma in 29 cases, pain after minor sprain in 24 cases, pain from bending and lifting heavy objects in 21 cases, and no obvious cause in 24 cases.
There were no symptoms of spinal nerve damage in both groups. Among the 42 cases in the treatment group, there were 10 cases of osteoporosis I, 18 cases of osteoporosis II, and 14 cases of osteoporosis III. Among the 56 vertebrae, there were 3 T8 vertebrae, 5 T9 vertebrae, 9 T10 vertebrae, 9 T11 vertebrae, 10 T12 vertebrae, 8 L1 vertebrae, 7 L2 vertebrae, and 5 L3 vertebrae. Among the 54 cases in the control group, there were 15 cases of osteoporosis I, 20 cases of osteoporosis II, and 19 cases of osteoporosis III.
Among the 68 vertebrae, there were 4 T8 vertebrae, 5 T9 vertebrae, 7 T10 vertebrae, 13 T11 vertebrae, 16 T12 vertebrae, 11 L1 vertebrae, 7 L2 vertebrae, and 5 L3 vertebrae. There were no differences between the two groups in terms of gender, number of vertebrae, mean age, and time from surgery to injury, which were comparable. See Table 1
Table 1 Comparison of general data of cases in the treatment group and the control group
Table 1 Comparison of general data of treatment group and control group
Group Number of cases Male Female Number of vertebrae Mean age (years) Time from surgery to injury (days)
Treatment group
Control group 42
54 14
19 28
35 56
68 63.4
67 8.6
7.6
2. treatment methods.
Control group Vertebroplasty (PVP) was used [2].
Treatment group
2.1 Preoperative preparation: acrylate bone cement III; homemade spinal brace repositioner including: spinal traction bed and brace repositioner and series of puncture needles. (See Figure Ia, b)
2.2 prone position on the spinal traction bed, thoracic and pelvic restraint after traction, the maximum force is less than 10% of body weight, the abdomen is suspended in a posterior extension position on the saber and under the pubic symphysis pad away from the bed, fluoroscopic vertebral body height can be restored, if not good, increase the height of both ends, the operator with the palm of the hand to lightly press the lumbar back to increase the posterior extension angle until satisfied.
2.4 hyperextension traction lower abdomen padded, determine the puncture point under local anesthesia the end of the working channel of the 4 mm puncture trocar needle into the posterior wall of the vertebral body 2-3 mm via the pedicle, after pulling out the needle core, replace the 3.5 mm drill bit to reach about the anterior 1/3 of the vertebral body; connect the spreader reducer to the syringe with pressure gauge, implant the balloon without pressure; inject the Onepac contrast agent into the spreader balloon expansion, dynamic monitoring is performed to correct residual compression deformity.
If the upper endplate is collapsed, the opening of the injection hole in the balloon is oriented toward the upper endplate and vice versa. If the vertebral body is collapsed in the middle, the opening of the injection hole in the balloon is expanded in two stages in the direction of the upper and lower endplates. The vertebral body can be elevated by starting pressure of 50 psi, with a maximum pressure of 220 psi; the balloon is withdrawn by pumping and the bone cement is infused into the cavity while it is in paste form.
The spreader balloon can be reconstructed from one side, or from both sides of the vertebral arch; the sharp part of the vertebral body may rupture the balloon, but it is rare and not harmful; the thoracic entry can be in the head of the rib and the lateral side of the vertebral arch; 1-4 ml can be injected on each side, up to 2-6 ml bilaterally; the general volume created is 2.6 ml (0.5-5.0 ml). Postoperative treatment: keep the hyperextension position for 10-20min to move around, observe the vital signs for 6h, take oral antibiotics for 2-3d. wear a lumbar brace to leave the bed after 4-6h of bed rest.
3.Observation index
3.1 Visual analogue pain score (VAS);
3.2 Vertebral body height compression rate: referring to the method of Lee [1], the anterior wall height a0, intermediate height m0 and posterior wall height p0 of the lateral X-ray VCF vertebral body were measured, while the anterior wall height a1, intermediate height m1 and posterior wall height p1 of the superior vertebral body and the anterior wall height a2, intermediate height m2 and posterior wall height p2 of the inferior vertebral body were measured at the corresponding sites (Figure IIb).
Compression fracture vertebral body original anterior wall height A=(a1+a2)/2, intermediate height M=(m1+m2)/2, posterior wall height P=(p1+p2)/2. vertebral body anterior wall compression rate=(A-a0)/A, intermediate compression rate=(M-m0)/M, posterior wall compression rate=(P-p0)/P, height recovery rate=(preoperative compression rate – postoperative compression rate)/preoperative compression rate.
3.3 Recovery rate of vertebral body kyphosis angle: the upper and lower endplates of the normal vertebral body are parallel on lateral x-ray. (The angle of intersection of the upper and lower endplates of the VCF vertebral body on the preoperative and postoperative lateral X-rays is the vertebral body kyphosis angle, and the kyphosis recovery rate = (preoperative kyphosis angle – postoperative kyphosis angle)/preoperative kyphosis angle.
3.4 Leakage rate of bone cement: all patients were examined by radiographs and/or CT scans after surgery.
3.5 Statistical treatment: The t-test for comparison of means of paired data and t-test for comparison of means of two samples were used for the measurement data of this clinical study, and the Ridit test was used for the grade count data, and the results obtained were statistically processed with SAS 6.12 software.
4. Results
Forty of the 42 patients in the treatment group were followed up for a period of 8 months to 5 years (mean 2.5 years). In the control group, 46 out of 54 patients were followed up for 6 months to 5 years (mean 2.3 years).
4.1 Visual analogue pain score (VAS): the treatment group decreased from 8.6±0.8 points before surgery to 1.7±0.5 points by t-test, t=3.112, p< 0.05 as a significant difference. The control group decreased from 8.5±0.4 points preoperatively to 3.5±1.4 points by t-test, t=5.046, p<0.05 as a significant difference.
4.2 Rate of vertebral body height compression and recovery of vertebral body kyphosis angle
Treatment group: the cases (42/56) were wedge compression fractures, the anterior wall and middle compression of vertebral body were more obvious, the anterior wall and middle height of vertebral body recovered significantly after surgery, while the posterior wall height did not change significantly, after statistical processing, there was a significant difference between the preoperative and postoperative anterior wall and middle height compression rate of vertebral body (p< 0.05). There was no significant difference in the preoperative and postoperative compression rates of the posterior wall of the vertebral body (p> 0.05). The recovery rate of the posterior convexity angle of the vertebral body before and after surgery was at 71.8%. (As shown in Figure 3)
Control group : The cases (54/68) were wedge compression fractures with relatively obvious compression of the anterior and middle vertebral walls. There was no significant recovery of the anterior and middle vertebral walls after PVP, and there was no significant change in the height of the posterior wall, and after statistical processing, there was no significant difference in the rate of compression of the anterior and middle vertebral walls after PVP (p> 0.05). There was no significant difference in the preoperative and postoperative compression rates of the posterior wall of the vertebral body (p> 0.05). the recovery rate of the posterior convexity angle of the vertebral body after PVP was at 37.8%. See Table 2.
Table 2 Comparison of preoperative and postoperative data of treatment group and control group
Table 2 Comparison of data of treatment group and control group
Group Anterior wall height Intermediate height Posterior wall height Posterior convexity angle
Pre-operative Post-operative Pre-operative Post-operative Pre-operative Post-operative Post-operative Recovery rate
Treatment group 42.9±26.2 26.1±21.6▲ 37.4±23.5 20.7±17.3▲ 13.2±12.8 11.3±6.3● 18.1±10.2 10.6±8.5▲ 42.5±29.3
Control group 39.9±23.2 36.1±17.6● 34.4±22.5 30.7±14.3● 12.2±11.8 11.3±6.3● 17.1±9.2 15.6±8.8● 21.5±16.3
Note: Compared with preoperative ▲p<0.05, ●p>0.05
Note:Compared with preoperative ▲p<0.05, ●p>0.05
There was a significant difference between the preoperative and postoperative recovery rates of the posterior convex angle in the treatment group (p< 0.05); there was no significant difference between the preoperative and postoperative recovery rates of the posterior convex angle in the control group (p>0.05).
4.3 Leakage rate of bone cement: the cement filling rate of the treatment group was >50%, and there was no leakage of bone cement; the cement filling rate of the control group was >50%, and the leakage rate of bone cement was 47%.
4.4 Evaluation of efficacy Using WHO criteria [3], the degree of pain relief was classified as CR (complete relief), PR (partial relief), MR (slightly effective), and NR (ineffective). In the treatment group, 36 cases had CR and 4 cases had PR, and the CR+PR was 95.24%. In the control group, 43 cases had CR, 3 cases had PR, and the CR+PR was 84.19%. By t-test, p<0.05 was considered a significant difference.
Itching and choking in the pharynx occurred in 4 patients during bone cement injection, which disappeared after the operation. 1 case had a transient drop in blood pressure during the operation, which was recovered after suspension of the injection and symptomatic treatment. The amount of bone cement injected in 56 vertebrae was at least 3 ml and at most 9 ml (average 5.8 ml); the pain started to be relieved 4-6 h after surgery.
5. Discussion
PVP treatment of osteoporotic vertebral compression fractures has been promoted, and the percentage of cement leakage was as high as 20%-67%, and the height of the anterior edge of the vertebral body was not restored. In view of the insignificant role of PVP in restoring vertebral body height and correcting posterior convexity deformity and complications, the future direction of its development is mainly in trying to restore vertebral body height and correct posterior convexity deformity. Posterior kyphoplasty (PKP) has overcome the shortcomings of PVP. However, the instruments used: the Kyphon instrumentation in the United States and the sky expansion instrumentation in Israel are patented technologies in the United States and Israel, respectively, and are expensive.
This method is first orthopedic through homemade spinal traction reset bed manipulation, drawing on the advantages of traditional Chinese medicine two-table reset method, according to the characteristics of the anterior longitudinal ligament intact, the anterior edge of the vertebral body trabecular gap increased, the continuous tension of the anterior longitudinal ligament on the ventral side of the vertebral body, manipulation of the dorsal side of the vertebral body to act a force, so that the height of the vertebral body to restore or close to restore normal, and then use the brace reset device to further correct the residual collapse, and finally injected bone cement. The entire procedure is safe, convenient, simple, and tolerated by the patient without new injuries and without the need for anesthesia or painkillers;
In contrast, the PVP procedure is performed in the flat prone position, and the compressed vertebral body lacks longitudinal repositioning space and effective ventral-dorsal tension, and the height of the vertebral body cannot be restored. This method is also better than the imported devices such as Kyphon balloon which is used for balloon expansion and repositioning alone. The injection hole of the balloon of the spreader is designed to open unilaterally and expand the balloon in a directional manner to achieve a directional spreading effect on the vertebral body. The unidirectional valve can keep the pressure inside the balloon constant; the balloon is directly connected to the injection tube, which simplifies the operation steps compared to imported devices.
The imported balloon is uniformly dilated and cannot be directed to open, and the pressure inside the balloon fluctuates during the expansion and does not reach a continuous and constant pressure. During traction repositioning, the fracture at the posterior edge of the vertebral body becomes smaller, and the pressure is low during the injection of bone cement, preventing leakage of bone cement into the spinal canal. The cost is low, the use is reliable, the operation is simple, and it can completely replace imported products. The cost is only 1/8 of the cost of the American-made balloon expansion device.