| The efficacy,minimally invasive and safety of vertebroplasty have formed a basic consensus around the world.However,some scholars still believe that severe osteoporotic vertebral compression fractures(SOVCFs)are absolute or relative contrarindication for vertebroplasty.Puncture technology is the core and key technology of vertebroplasty,which is related to the success or failure of surgery.With the development of technology,scholars have made fruitful exploration in the aspects of puncture approach,auxiliary device,navigation and imaging equipment.The number of reports on vertebroplasty in the treatment of severe compression fractures has increased in recent years.However,compared with light and moderate compression fractures,such patients have difficulty in puncture,high cement leakage rate,and more dangerous in operation.Scholars have to take bilateral transpedicular puncture method,thereby increasing operation time,radiation exposure and medical expenses.Meanwhile,high quality prospective randomized controlled clinical trials are relatively scarce.In order to attempt to improve the puncture technique,the study used 3D printing and digital methods to study the core problem of puncture,and anatomic and clinical studies were carried out in turn.First,the key parameters were obtained through digital measurement,so as to improve the method of unilateral extrapedicular puncture.In addition,with the aid of 3D printing digital technology,combined with traditional Chinese medicine,the modified vertebroplasty was formed.explore the efficacy and safety of the modified vertebroplasty for the treatment of SOVCFs,and to provide a new idea and new method for the clinical practice which combined with Chinese and Western medicine.Part 1:Digital measurement of key anatomical parameters associated with thoracic vertebral percutaneous vertebroplasty by unilateral extrapedicular approachObjective:To perform digital 3D measurement of key anatomic parameters associated with thoracic vertebral percutaneous vertebroplasty by unilateral extrapedicular approach,providing evidence for clinical application.1.Explore the feasibility of Vertebroplasty for the thoracic vertebra by unilateral extrapedicular approach.2.Study the anatomical features of T5-T10 of old people,discuss the best punctual angle and the safe range of it.3.To establish the puncture entry point using the pedicle as the reference material,provides a imaging basis for the accurate puncturing in the vertebroplasty for the thoracic vertebra.Methods:The thoracic vertebrae of 30 elderly patients were scanned by CT.The data were imported into the computer and the three-dimensional model of the thoracic vertebra was established by Mimics software.By Mimics software,the following data were measured in both the extrapedicular approach group(observation group)and the transpedicular approach group(control group):the distance between entry point and the middle line;the maximum puncture abduction angle;the minimum puncture abduction angle;safe range of puncture abduction angle;the sagittal inclination angle;the puncture success value and the puncture success rate.At the same time,the distance between the most medial puncture entry point(the optimal puncture point)to the middle line is also measured on the premise of ensuring the success of the puncture.1.The distance from the puncture point to the middle line of the vertebral body,the maximum abduction angle,the minimum abduction angle,the safety range of the abduction angle,the sagittal plane inclination,the success value and the success rate of puncture were compared between the two groups.2.The distance from the optimal puncture point to the entry point of transpedicular approach(EF)and the distance between the entry point of transpedicular approach and extrapedicular approach(EG)was calculated.The parameters of left and right side is compared.3.The parameters of left and right side such as the distance from the puncture point to the middle line,the maximum abduction angle,the minimum abduction angle,the safety range of the abduction angle,the sagittal plane angle,the successful puncture value and rate of puncture were compared.Results:1.The maximum abduction angle in observation group changes from 35.39 to 43.63 degrees,the minimum abduction angle changes from 13.30 to 21.52 degrees,the safety range of the abduction angle is 20.27 to 22.55 degrees,the maximum abduction angle in control group was 10.68 to 13.49 degrees,the minimum abduction angle changes from 5.99 to 8.99 degrees,the safety range of the abduction angle is 2.97 to 7.50 degrees.The correlation parameters of each segment of the observation group were greater than those of the control group,and the difference was statistically significant(P<0.05).There was a difference between the left and right abduction angles in the left and right sides of the T10(P<0.05),and there was no significant difference between the left and right sides of the other parameters(P>0.05).2.The distance between the puncture point and the median line of the observation group(GM)is 24.64 to 26.88mm.The distance between the puncture point and the middle line of the control group(EM)is 13.08 to 15.61mm,the difference was statistically significant(P<0.05).There was no significant difference between the left and right sides(P>0.05).3.The success value of puncture in the observation group was 45.32 to 54.80,and the success rate of puncture was 96.67%to 100%.The success value of puncture in control group was-26.59 to-10.15,and the success rate of puncture was 23.33%to 26.67%.There was a statistically significant difference between the two groups(P<0.05).There was no significant difference between the left and the right side(P>0.05).4.The EF value of left side was 4.29 to 5.78mm,the right side was 3.78 to 5.50mm,there is no significant difference between the left and the right side(P>0.05);The EG value of left side was 9.03 to 13.32mm,the right side was 9.32 to 12.98mm.There was no significant difference between the left and the right side(P>0.05).5.The sagittal inclination angle is 20.37 to 27.45 degrees on the left,and 20.97 to 27.19 degrees on the right side.There is no significant difference in T5,T6,T7 and T10 between the left and right sides(P>0.05),T8 and T9 have significant difference(P<0.05).Conclusions:1.T5-T10 unilateral extrapedicular approach vertebroplasty is safe and feasible.2.The success rate of the transpedicular approach is very low,while that of extrapedicular approach is higher.3.The pedicle was used as the reference material to determine the puncture entry point of the extrapedicular approach.It was simple and safe.The accuracy of the puncture was high and the maneuverability was very strong.4.For severe compression fractures,the entry point is 6-9mm outward to the lower edge of the pedicle projection,and appropriately adjust the inclination angle and abduction angle,so that we can finish the puncture successfully.Part 2:Clinical efficacy of modified vertebroplasty assisted by 3D printing and digital technique in the treatment of severe osteoporotic vertebral compression fracturesObjective:To evaluate the clinical outcome of percutaneous vertebroplasty assisted by 3D print and digital technique in the treatment of severe osteoporotic vertebral compression fractures(SO V CF s).1.Observe the effects of 3D printing and digital technology on operation time,fluoroscopy frequency,leakage rate and distribution of bone cement.2.The effect of reduction manipulation on vertebral compression rate and vertebral height restoration rate.3.To observe the effect of Chinese medicine Qianggu Capsule on bone density,functional state and incidence of new vertebral fracture after operation.Methods:60 cases of single thoracic/lumbral SOVCFs were divided into two groups according to random numbers method.Both groups performed a reduction manipulation technique before puncturing.In control group(30 cases)All the PVP procedure were completed according to the traditional method.Caltrate D,calcitriol and alendronate were used postoperative to treat osteoporosis.In the observation group(30 cases),the fracture vertebral body was three-dimensionally reconstructed with mimics software,and the optimal puncture path was designed.After the model of the vertebral body was 3D printed,The simulation operation is performed preoperatively.During the operation,the puncture procedure was performed according to the path designed before the operation.In addition to Western medicine,Qianggu capsule was added after surgery.The operation time,the fluoroscopic frequency and the cement amount of the two groups were compared respectively.Visual analogue scale(VAS)and Oswestry Disability Index(ODI)of all patients were measured pre-operation and 1 days、1 month、12 months post-operation respectively.Gender、age、the fracture level、bone mineral density、vertebral body fracture type of both groups were measured.The statistics were compared.The imaging parameter such the vertebral height compression rate,the vertebral body height recovery rate,the bone cement distribution and the bone density were evaluated of both groups.The rate of bone cement leakage and new fractures were used to evaluate complications and long-term conditions.Results:1.There was no significant difference in gender,age,fracture site,bone density and type of fracture between the two groups(P>0.05).2.Between the observation and control group,the puncture procedure time was(7.42±3.29)min and(14.82±5.8)min,the radioactive frequency was(9.41 ±2.58)and(14.37 ±3.72)time,The mean injected cement volume was(3.78± 0.55)ml and(3.02 ± 1.22)ml respectively.There was a statistical significance of above-mentioned items between the two groups(P<0.05).3.The operation was completed successfully and the clinical symptoms were obviously relieved in all 60 cases.The VAS and ODI score of two groups were significant decreased after operation.There are significant difference between pre-operation and 1 day post-operation(P<0.05).There was no statistical significance at 1 month postoperative(P<0.05).There was no statistically difference in VAS score at 12 months postoperative.The ODI index at 12 months postoperative was statistically significant(P<0.05).4.There was no significant difference in the vertebral height compression rate between the two groups before surgery,after manipulative reduction,and 1 and 12 months after operation(P>0.05).Comparing the two groups intragroup:Compared the vertebral height compression rate pre-operative with after manipulative reduction,the difference was statistically significant(P<0.05).There was no significant difference in vertebral height recovery rate of after manual reduction and one day postoperative.5.In the observation group,there was 1 case of poor puncture location,and the unilateral distribution rate was 3.33%;in the control group,there were 8 cases of poor puncture location,and the unilateral distribution rate was 26.67%;the difference between the two groups was statistically significant(P<0.05).6.There was no statistically significant difference in bone mineral density between the two groups before surgery and one month after operation(P>0.05).Bone mineral density was higher in the observation group than in the control group at 12 months after operation(P<0.05).In-group comparisons:There was no statistical difference between preoperative and postoperative one month in both groups(P>0.05).There was statistical difference Preoperative and postoperative 12 months(P<0.05).7.The cement leakage rate was 80%in control group,which was lower than 56.7%in observation group(P<0.05).The most commonly of cement leakage was the disc space.8.During the follow-up period,2 patients in the observation group developed a new compression fracture with a an incidence of 6.7%,while 6 patients developed new compression fractures In the control group with an incidence of 20.0%,of which 1 was a vertebral compression fracture in the adjacent segment.The incidence of new fractures in the two groups was statistically significant(P<0.05).Conclusions:1.Percutaneous vertebroplasty assisted by 3D printing and digital technique in the treatment of severe vertebral compression fractures can significantly shortened the puncture procedure time,reduced the intraoperative radioactive frequency,reduce radiation damage,improve bilateral distribution rate of bone cement,and reduce leakage rate of bone cement.2.Manupulation can partly restore the height of the vertebral body to a certain extent.However,3D printing and digital techniques have no obvious advantages to it.3.Qianggu capsule can increase bone minaral density and improve long-term functional status.4.The low incidence of new fractures in the observation group may be related to the use of Chinese medicine and digital technology. |
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