Curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture after PVP / 药学实践杂志

Objective To study the curative effects of traditional Chinese medicine paste combined with Baduanjin in treatment of osteoporotic vertebral compression fracture (OVCF) after percutaneous vertebroplasty (PVP). Methods 120 OVCF patients treated with PVP in our hospital from January 2016 to September 2017 were divided into the observation group (60 cases) and the control group (60 cases) according to the random number table method. The control group was given calcium carbonate D3 chewable tablets orally with routine guidance. In addition to the same treatment as the control group, the observation group received the traditional Chinese medicine paste orally with Baduanjin exercise. Both groups were treated for 6 months and followed-up for 3 years. The curative effects in the two groups after 6 months treatment and the low back pain after 1, 3 and 6 months of treatment were recorded. The changes of bone mineral density (BMD), kyphosis angle (Cobb angle), anterior wall height of vertebral body (AVBH) and level of bone metabolism indexes in the two groups were compared before and after treatment for 6 months. The follow-up times and the incidences of push-back fracture after PVP during follow-up were recorded. Results After 6 months of treatment, the clinical cure rate of the observation group was 73.33%, which was higher than 53.33% of the control group(P<0.05). Compared with pretreatment, the scores of visual analogue scale (VAS) in the two groups gradually decreased after 3 and 6 months of treatment, and the observation group had a lower scores than the control group (P<0.05). After 6 months treatment, BMD and AVBH of lumbar vertebrae and femoral neck in both groups increased, and the observation group was higher than that in the control group. The Cobb angle and serum levels of Type I procollagen degradation products (β-Cross I), the n-terminal middle osteocalcin (N-MID Ost) and parathyroid hormone (PTH) decreased in both groups, and the observation group was lower than those in the control group (P<0.05). There was no significant difference in fracture incidence after PVP in the year 1, year 1 to 3 follow up between the two groups (P>0.05). During the 3 years follow-up, the incidence of push-body fracture after PVP in the observation group was 3.33%, which was lower than that in the control group 20.00%( P<0.05). Conclusion Traditional Chinese medicine paste combined with Baduanjin reduced the serum levels of β-Cross I, N-MID Ost and PTH, regulated bone metabolism, improved BMD and AVBH of lumbar vertebrae and femoral neck, reduced Cobb angle, promoted the recovery of lumbar function, alleviated patients' back pain, lowered the incidence of push-body fracture after PVP. The curative effects were remarkable.

Effect of injury degree of osteoporotic vertebral compression fracture on bone cement cortical leakage after percutaneous kyphoplasty / 中国修复重建外科杂志

OBJECTIVE@#To analyze the correlation between bone cement cortical leakage and injury degree of osteoporotic vertebral compression fracture (OVCF) after percutaneous kyphoplasty (PKP), and to provide guidance for reducing clinical complications.@*METHODS@#A clinical data of 125 patients with OVCF who received PKP between November 2019 and December 2021 and met the selection criteria was selected and analyzed. There were 20 males and 105 females. The median age was 72 years (range, 55-96 years). There were 108 single-segment fractures, 16 two-segment fractures, and 1 three-segment fracture. The disease duration ranged from 1 to 20 days (mean, 7.2 days). The amount of bone cement injected during operation was 2.5-8.0 mL, with an average of 6.04 mL. Based on the preoperative CT images, the standard S/H ratio of the injured vertebra was measured (S: the standard maximum rectangular area of the cross-section of the injured vertebral body, H: the standard minimum height of the sagittal position of the injured vertebral body). Based on postoperative X-ray films and CT images, the occurrence of bone cement leakage after operation and the cortical rupture at the cortical leakage site before operation were recorded. The correlation between the standard S/H ratio of the injured vertebra and the number of cortical leakage was analyzed.@*RESULTS@#Vascular leakage occurred in 67 patients at 123 sites of injured vertebrae, and cortical leakage in 97 patients at 299 sites. Preoperative CT image analysis showed that there were 287 sites (95.99%, 287/299) of cortical leakage had cortical rupture before operation. Thirteen patients were excluded because of vertebral compression of adjacent vertebrae. The standard S/H ratio of 112 injured vertebrae was 1.12-3.17 (mean, 1.67), of which 87 cases (268 sites) had cortical leakage. The Spearman correlation analysis showed a positive correlation between the number of cortical leakage of injured vertebra and the standard S/H ratio of injured vertebra ( r=0.493, P<0.001).@*CONCLUSION@#The incidence of cortical leakage of bone cement after PKP in OVCF patients is high, and cortical rupture is the basis of cortical leakage. The more severe the vertebral injury, the greater the probability of cortical leakage.

Effect analysis of treating osteoporotic vertebral fracture combined reduction vertebroplasty with kyphoplasty / 中国综合临床

Objective:To compare postural reduction combined with percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral compression fractures (OVCFs).Methods:From January 2019 to January 2020,68 patients with OVCFs who met the inclusion and exclusion criteria in the Second Hospital of Tangshan Hebei Province were included in the observation study. A prospective randomized controlled study was used. The matched groups were divided into PVP combined group (adjust the overextension of the operating table by 20°-30°, if the posture reduction fails, pry the puncture needle on both sides in reverse according to the compression degree of the end plate before operation, and inject bone cement) and PKP group (do not adjust the operating table before operation, insert a balloon and expand on both sides after operation, and inject bone cement), with 34 cases in each group. The Cobb angle of the injured vertebrae was measured by taking the anterior and lateral X-ray film of the patient's lumbar spine before operation. The degree of pain and low back function were evaluated by visual analogue scale (VAS) and Oswetry disability index (ODI). The operation time and fluoroscopy times were recorded during the operation. On the second day after operation, the anterior and lateral X-ray of lumbar spine were taken to measure the Cobb angle of injured vertebrae. All patients were underwent computed tomography (CT) check the bone cement for leakage, record the VAS score, and record the ODI 3 months after operation to evaluate the patient's function. Follow up at the end of 12 months after operation to count the treatment cost and re-fracture of the patient. The data analysis and measurement data were compared by independent sample t-test between the two groups, paired sample t-test was used for intra-group comparison before and after operation. χ 2 test was used for counting data comparison between two groups. Results:All patients were followed up for 12 months. The operation time ((42.7±5.9) min), fluoroscopy times ((20.0±3.6) times) and treatment cost ((19 153±601) yuan) in the PVP combined group were better than those in the PKP Group ((67.4±7.3) min, (30.1±5.9) times, (27 496±669) yuan), and the difference was statistically significant ( t values were 15.39, 8.46, 54.12; all P<0.001). Cobb angle: Postoperative Cobb angle of injured vertebrae in the two groups (PVP combined group (10.7±4.5)°) and (PKP group (13.4±3.8)°) decreased compared with preoperative (PVP combined group (17.0±5.1)°) and (PKP group (16.7±5.1)°) ( t values were 10.61, 5.61; all P=0.001), and PVP combined group recovered better than PKP group, with statistically significant difference ( t=2.70, P=0.009). VAS score: Postoperative (PVP combined group (3.9±1.5) points) and (PKP group (4.1±1.6) points) was lower than preoperative the scores of (PVP combined group (6.9±1.1) points) and (PKP group (7.1±0.9) points), and the difference was statistically significant ( t values were 8.63, 8.88; all P=0.001). There was no significant difference in VAS scores between the two groups ( t=0.48, P=0.630). ODI scores: The scores of (PVP combined group (0.315±0.068)) and (PKP group (0.319±0.077)) after operation were lower than preoperative (PVP combined group (0.574±0.066), (PKP group (0.553±0.075)), and the difference was statistically significant ( t values were 18.54, 14.16, all P=0.001). There was no significant difference in ODI between the two groups ( t=0.25, P=0.803). There was no statistical significance in the two groups of postoperative bone cement leakage (χ 2=0.22, P=0.642). In PVP combined group, 1 case was re-fractured due to trauma, and there was no re-fracture in PKP group. Conclusion:Postural reduction combined with percutaneous needle prying reduction of PVP and PKP can alleviate the pain, improve the postoperative function and restore kyphosis in patients with OVCFs. Postural reduction combined with needle prying reduction of PVP has more advantages in operation time, radiation injury to doctors and patients, treatment cost, and the effect of correcting deformity is more significant.

Clinical Efficacy and Bone Turnover Markers of Buzhong Yiqitang in Treatment of Senile Osteoporotic Vertebral Compression Fracture After Operation Based on ''Spleen Governing Muscle'' / 中国实验方剂学杂志

ObjectiveTo study the effect on quality of life and the bone turnover markers of Buzhong Yiqitang in the treatment of senile osteoporotic vertebral compression fracture （OVCF， syndrome of Qi deficiency in spleen and stomach） after operation based on ''spleen governing muscle''. MethodA total of 135 senile patients with OVCF treated by percutaneous kyphoplasty in Rizhao Hospital of Traditional Chinese Medicine from January 2020 to January 2021 were enrolled in this study. They were randomly assigned to two groups on the basis of block randomization at a ratio of 2∶1 （90 cases in the observation group and 45 cases in the control group）. Both groups were administrated with calcitriol capsules （0.5 μg·d-1） and caltrate D （1 200 mg·d-1） for basic treatment of osteoporosis. The observation group was additionally treated with Buzhong Yiqitang. Bone mineral density （BMD）， procollagen type Ⅰ N-terminal propeptide （PINP）， osteocalcin （OST）， β cross-linked C-telopeptide of type 1 collagen （β-CTx）， appendicular skeletal muscle mass index （ASMI）， and quadriceps muscle strength were compared between the two groups before and 6， 12 months after treatment. Additionally， traditional Chinese medicine （TCM） symptom score and visual analogue score （VAS） before and 3， 6 months after treatment， as well as quality of life questionnaire of the European Foundation for osteoporosis （QUALEFFO） score before and 3， 6， 12 months after treatment， were compared between the two groups. ResultA total of 85 patients in the observation group and 41 patients in the control group were followed up. The general curative effect of the observation group was better than that of the control group （χ2=10.503， P<0.05）. Specifically， the observation group had higher PINP， BMD， ASMI， and quadriceps muscle strength but lower β-CTx， TCM symptom score， VAS， and QUALEFFO score than the control group （P<0.05， P<0.01）. No adverse reactions related to Buzhong Yiqitang were observed. ConclusionBuzhong Yiqitang can regulate bone metabolism indexes， promote osteogenesis， increase bone density， enhance skeleton appendiculare and quadriceps muscle strength， relieve clinical symptoms， and improve quality of life in patients with senile OVCF （syndrome of Qi deficiency in spleen and stomach）， being worthy of promotion in clinical application.

Perioperative nursing of robot assisted percutaneous kyphoplasty for senile osteoporotic vertebral compression fractures / 中国实用护理杂志

Objective:To summarize the perioperative nursing points of percutaneous kyphoplasty (PKP) in elderly patients with osteoporotic vertebral compression fractures assisted by robots, so as to provide reference for orthopedic nursing.Methods:From July 2019 to February 2021, the data of 72 patients undergoing robot-assisted PKP in the spinal surgery of the First Affiliated Hospital of Anhui Medical University were retrospectively analyzed. The perioperative nursing points were summarized, and the nursing experience was summarized. The nursing under the new measures of precise minimally invasive treatment was analyzed and discussed. The length of hospital stay, postoperative ambulation time, complications and satisfaction survey results of patients were collected and recorded. The Numerical Rating Scale(NRS) score, Self-rating Anxiety Scale(SAS) score and Oswestry Disability Index (ODI) score before and after surgery were compared. The correlation analysis of the scores of various factors was combined to comprehensively evaluate the surgical and nursing effects.Results:All patients had no complications related to machine use during and after operation, and their symptoms were improved to varying degrees. Fifty-seven cases of indwelling catheter, catheter time (19.00±14.24) h. The preoperative hospitalization time was (6.16±2.22) d, and the postoperative hospitalization time was (1.94±0.99) d. Postoperative bed time was (16.34±6.81) h. Postoperative nursing satisfaction was (98.55±2.44)%.The postoperative NRS and SAS scores were (1.00±0.55) and (32.06±5.33) points, respectively, which were lower than those before operation (3.51 ± 0.71) and (39.08±8.86) points, and the differences were statistically significant ( t values were 33.976, 8.184, P<0.01). There were statistically significant differences in six indicators of ODI scores before and after surgery, including low back pain, walking, standing, sitting, sleep and self-care ( P<0.01). Correlation analysis showed that there was a strong correlation between the six ODI score factors and the NRS score. The four factors of sitting, walking, low back pain and standing were highly correlated with SAS. Conclusions:The implementation of good perioperative nursing management for patients with PKP assisted by robot can effectively promote the rehabilitation of patients, reduce the incidence of complications and improve patient satisfaction.

Analysis of Key Points and Difficulties in Registration Application of Inflatable Bone Expander / 中国医疗器械杂志

With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.

Effect of unilateral percutaneous kyphoplasty combined with hyperextension reduction in the treatment of fresh osteoporotic vertebral compression fractures / 中国综合临床

Objective:To compare the effect and clinical significance of unilateral and bilateral percutaneous kyphoplasty (PKP) combined with hyperextension reduction in the treatment of fresh osteoporotic vertebral compression fracture (OVCF).Methods:The clinical data of OVCF patients treated in Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University from January to December 2018 were retrospectively analyzed.A total of 62 patients were included.According to the surgical approach, 62 patients were divided into unilateral puncture approach group and bilateral puncture approach group, with 31 cases in each group.The patients in the unilateral puncture group were treated with limb hyperextension reduction combined with unilateral PKP.In the bilateral puncture approach group, limb hyperextension reduction combined with bilateral PKP was used.The changes of visual analogue pain scale (VAS), Oswestry disability index (ODI), vertebral anterior height, vertebral midline height and Cobb angle were observed and compared before operation, 1 day and 2 weeks after operation.At the same time, the operation time, intraoperative fluoroscopy times, intraoperative bone cement injection and adverse reactions were compared between the two groups.Results:The VAS scores of patients in the unilateral puncture approach group before operation, 1 day and 2 weeks after operation were (8.10±0.17), (2.20±0.26) and (1.90±0.39), respectively.The scores of bilateral puncture approach group were (8.10±0.13), (2.30±0.26) and (2.00±0.30), respectively.The results of repeated measurement ANOVA showed that F intra-group=13 790.444, P<0.001, F inter-group=1.951, P=0.168, F interaction=0.735, P=0.481.There were significant differences in VAS scores between the two groups 1 day and 2 weeks after operation (all P<0.05). There was significant difference in VAS score between the two groups 1 day after operation and 2 weeks after operation (all P<0.05). The ODI scores of patients in the unilateral puncture group before operation, 1 day and 2 weeks after operation were (40.30±5.30), (23.20±3.40), (22.30±4.49) points respectively, and those in the bilateral puncture group were (41.00±4.49), (21.90±2.48), (20.70±5.70) points, respectively.The results of repeated measurement ANOVA showed that F intra-group=339.046, P<0.001, F inter-group=1.385, P=0.244, F interaction=1.083, P=0.342.There were significant differences in ODI scores between the two groups 1 day and 2 weeks after operation (all P<0.05). There was significant difference in ODI score between the two groups 1 day after operation and 2 weeks after operation (all P<0.05). The anterior height of vertebral body in unilateral puncture group was (18.26±2.40), (21.97±1.17), (22.03±1.35) mm before operation, 1 day and 2 weeks after operation, and that in bilateral puncture group was (18.94±1.80), (22.06±2.79), (20.29±1.19) mm.The results of repeated measurement ANOVA showed that F intra-group=51.228, P<0.001, F inter-group=1.594, P=0.212, F interaction=6.452, P=0.002.There were significant differences in the anterior vertebral height between the two groups 1 day and 2 weeks after operation (all P<0.05). The height of vertebral midline in the unilateral puncture group was (17.97±2.14), (26.13±1.43), (26.00±1.79) mm before operation, 1 day and 2 weeks after operation, and in the bilateral puncture group was (18.84±1.77), (24.74±1.77), (24.68±2.06) mm.The results of repeated measurement ANOVA showed that F intra-group=358.837, P<0.001, F inter-group=3.850, P=0.054, F interaction=9.117, P<0.001.There were significant differences in the height of vertebral midline between the two groups 1 day and 2 weeks after operation (all P<0.05). The Cobb angles in the unilateral puncture group were (21.74±2.11)°, (11.77±1.91)° and (10.94±1.12)° before operation, 1 day and 2 weeks after operation, respectively, and in the bilateral puncture group were (22.13±2.50)° and (12.0±2.38)° and (11.71±1.37°, respectively.The results of repeated measurement ANOVA showed that F intra-group=674.732, P<0.001, F inter-group=1.975, P=0.165, F interaction=0.376, P=0.688.There were significant differences in Cobb angle between the two groups 1 day and 2 weeks after operation (all P<0.05). There were significant differences in operation time ((52.0±3.8) min and (67.0±6.7) min), intraoperative fluoroscopy times ((15.0±5.8) times and (32.0±6.1) times), and bone cement injection volume ((4.6±0.3) mL and (5.0±0.1) mL) between unilateral puncture approach group and bilateral puncture approach group (all P<0.001). Conclusion:Unilateral and bilateral PKP combined with hyperextension reduction can alleviate the pain of OVCF, restore the lost vertebral height and correct kyphosis.The unilateral puncture approach PKP combined with hyperextension reduction has the advantages of shorter operation time, concise operation process, fewer times of intraoperative fluoroscopy and less use of bone cement.

Effectiveness comparison of low-temperature bone cement perfusion before and after improvement in percutaneous vertebroplasty / 中国修复重建外科杂志

Objective: To discuss the safety and effectiveness of the improved technique by comparing the effects of low temperature bone cement infusion before and after the improvement in the percutaneous vertebroplasty (PVP). Methods: The clinical data of 170 patients (184 vertebrae) with osteoporotic vertebral compression fracture who met the selection criteria between January 2016 and January 2018 were retrospectively analyzed. All patients were treated with PVP by low-temperature bone cement perfusion technology. According to the technical improvement or not, the patients were divided into two groups: the group before the technical improvement (group A, 95 cases) and the group after the technical improvement (group B, 75 cases). In group A, the patients were treated by keeping the temperature of bone cement at 0℃ and parallel puncture; in group B, the patients were treated by increasing the temperature of bone cement or reducing the time of bone cement in ice salt water and cross puncture. There was no significant difference in gender, age, disease duration, T value of bone mineral density, operative segment, and preoperative vertebral compression rate, visual analogue scale (VAS) score between the two groups ( P>0.05). CT examination was performed immediately after operation, and the leakage rate of bone cement was calculated. The amount of bone cement perfusion and the proportion of bone cement in contact with the upper and lower endplates at the same time were compared between the two groups. The vertebral compression rate was calculated and the VAS score was used to evaluate the pain before operation, at immediate after operation, and last follow-up. Results: There was no complication such as incision infection, spinal nerve injury, or pulmonary embolism in both groups. There was no significant difference in the amount of bone cement perfusion between groups A and B ( t=0.175, P=0.861). There were 38 vertebral bodies (36.89%) in group A and 49 vertebral bodies (60.49%) in group B exposed to bone cement contacting with the upper and lower endplates at the same time, showing significant difference ( χ2=10.132, P=0.001). Bone cement leakage occurred in 19 vertebral bodies (18.45%) in group A and 6 vertebral bodies (7.41%) in group B, also showing significant difference ( χ2=4.706, P=0.030). The patients in group A and group B were followed up (13.3±1.2) months and (11.5±1.1) months, respectively. The vertebral compression rates of the two groups at immediate after operation were significantly lower than those before operation ( P0.05). The VAS scores of the two groups at immediate after operation were significantly lower than those before operation ( P0.05). There was no significant difference in VAS scores between the two groups at immediate after operation ( t=0.380, P=0.705); but at last follow-up, VAS score in group B was significantly lower than that in group A ( t=3.627, P=0.000). Conclusion: The improved advanced low-temperature bone cement perfusion technology during PVP by increasing the viscosity of bone cement combined with cross-puncture technology, can reduce bone cement leakage, improve the distribution of bone cement in the vertebral body, and reduce the risk of vertebral collapse, and achieve better effectiveness.

Effect of percutaneous kyphoplasty with different phases bone cement for treatment of osteoporotic vertebral compression fractures / 中国修复重建外科杂志

Objective: To compare the effect of percutaneous kyphoplasty (PKP) with different phases bone cement for treatment of osteoporotic vertebral compression fracture (OVCF). Methods: The clinical data of 219 OVCF patients who treated with PKP and met the selection criteria between June 2016 and May 2018 were retrospectively analyzed. According to the different time of intraoperative injection of bone cement, they were divided into observation group [116 cases, intraoperative injection of polymethyl methacrylate (PMMA) bone cement in low-viscosity wet-sand phase)] and control group (103 cases, intraoperative injection of PMMA bone cement in low-viscosity wire-drawing phase). There was no significance in general date of gender, age, disease duration, body mass index, bone mineral density T value, fracture vertebral body, preoperative fracture severity of the responsible vertebral body, anterior height ratio of the responsible vertebral body, preoperative pain visual analogue scale (VAS) score, and Oswestry disability index (ODI) between the two groups ( P>0.05). The VAS score and ODI score were used to evaluate the improvement of patients' symptoms at immediate, 2 days, 3 months after operation and at last follow-up. At 1 day, 3 months after operation, and at last follow-up, X-ray film and CT of spine were reexamined to observe the distribution of bone cement in the vertebral body, bone cement leakage, and other complications. During the follow-up, the refracture rate of the responsible vertebral body and the fracture rate of the adjacent vertebral body were recorded. Results: The injection amount of bone cement in the observation group and control group were (4.53±0.45) mL and (4.49±0.57) mL, respectively, showing no significant difference between the two groups ( t=1.018, P=0.310). Patients in both groups were followed up 6-18 months (mean, 13.3 months). There were 95 cases (81.9%) and 72 cases (69.9%) of the bone cement distribution range more than 49% of the cross-sectional area of the vertebral body in the observation group and the control group, respectively, showing significant difference in the incidence between the two groups ( χ2=4.334, P=0.037). The VAS score and ODI score of the postoperative time points were significantly improved compared with those before operation ( P0.05). At 1 day after operation, the cement leakage occurred in 18 cases of the observation group (8 cases of venous leakage, 6 cases of paravertebral leakage, 4 cases of intradiscal leakage) and in 22 cases of the control group (9 cases of venous leakage, 8 cases of paravertebral leakage, 5 cases of intradiscal leakage). There was no significant difference between the two groups ( P>0.05). During the follow-up, 5 cases (4.3%) in the observation group, 12 cases (11.7%) in the control group had responsible vertebral refracture, and 6 cases (5.2%) in the observation group and 14 cases (13.6%) in the control group had adjacent vertebral fracture, the differences were significant ( χ2=4.105, P=0.043; χ2=4.661, P=0.031). Conclusion: Bone cement injection with wet-sand phase in PKP is beneficial for the bone cement evenly distributed, strengthening the responsible vertebral, relieving the short-term pain after operation, decreasing the rate of responsible vertebral refracture and adjacent vertebral fracture without increasing the incidence of relevant complications and can enhance the effectiveness.

Robot-guided percutaneous kyphoplasty in treatment of multi-segmental osteoporotic vertebral compression fracture / 中国修复重建外科杂志

Objective: To evaluate the safety and effectiveness of robot-guided percutaneous kyphoplasty (PKP) in treatment of multi-segmental thoracolumbar osteoporotic vertebral compression fracture (OVCF). Methods: A clinical data of 63 cases with multi-segmental thoracolumbar OVCF without neurologic deficit treated with PKP between October 2017 and February 2019 were analyzed retrospectively. The patients were divided into robot-guided group (33 cases) and traditional fluoroscopy group (30 cases). There was no significant difference in gender, age, fracture segment, bone mineral density, and preoperative visual analogue scale (VAS) score, midline vertebral height, and Cobb angle between the two groups ( P>0.05). The time to establish the tunnel, the times of fluoroscopy, the dose of fluoroscopy, the deviation of puncture, the distribution of bone cement, the leakage of bone cement, the puncture angle, and the postoperative VAS score, midline vertebral height, and Cobb angle were recorded and compared. Results: The patients in two groups were followed up 11-13 months (mean, 12 months). Compared with traditional fluoroscopy group, the time to establish the tunnel, the times and dose of fluoroscopy in robot-guided group were significantly lower, the deviation of puncture was slighter, the distribution of bone cement was better, and the puncture angle was larger, the differences between the two groups were significant ( P0.05). Conclusion: Robot-guided PKP in treatment of multi-segmental thoracolumbar OVCF can shorten the operation time, improve the accuracy of puncture, reduce the times and dose of fluoroscopy, reduce the leakage of bone cement, and achieve better cement distribution.

Short-term effectiveness comparison of unipedicular versus bipedicular percutaneous kyphoplasty for osteoporotic vertebral compression fractures with posterior wall broken / 中国修复重建外科杂志

Objective: To compare the short-term effectiveness and safety of unipedicular versus bipedicular percutaneous kyphoplasty (PKP) for osteoporotic vertebral compression fracture (OVCF) with posterior wall broken. Methods: The clinical data of 68 patients with OVCF with posterior wall broken and without posterior ligament complex injury and spinal cord nerve injury between June 2013 and December 2018 were retrospectively analyzed. According to the different operative approaches, the patients were divided into two groups: group A (36 cases received PKP via bilateral pedicle puncture) and group B (32 cases received PKP via unilateral pedicle paracentesis). There was no significant difference between the two groups in gender, age, fracture vertebra distribution, time from injury to operation, preoperative pain visual analogue scale (VAS) score, Oswestry disability index (ODI), and height of injured vertebra ( P>0.05). The operation time, intraoperative fluoroscopy times, and bone cement volume were recorded and compared between the two groups. The VAS score and ODI score were used to evaluate the effectiveness before operation, at 1 day and 6 months after operation; the height of injured vertebra was measured on the lateral X-ray film, and the recovery height of injured vertebra at 1 day after operation and the loss height of injured vertebra at 6 months after operation were calculated; the intraoperative and postoperative complications of the two groups were recorded. Results: The operation time, intraoperative fluoroscopy times, and bone cement volume of group B were significantly less than those of group A ( P0.05). However, at 6 months after operation, the height of injured vertebra in group B was significantly lower than that in group A ( P0.05). Conclusion: Both bipedicular and unipedicular PKP can obtain satisfactory effectiveness for the treatment of OVCF with posterior wall broken, but the former may have advantages of lower cement leakage rate and less height loss.

Relationship between thoracic and lumbar vertebral posterior wall morphology and bone cement leakage into the spinal canal during the percutaneous kyphoplasty / 中国组织工程研究

BACKGROUND: Percutaneous kyphoplasty (PKP) is an effective method for treating osteoporotic vertebral compression fracture. Although satisfactory clinical outcomes can be achieved, bone cement leakage is still one of the main complications of PKP. Based on previous studies, there are many high risk factors for bone cement leakage into the spinal canal; however, less attention to the posterior wall morphology of different vertebral bodies may be an important reason for bone cement leakage into spinal canal. OBJECTIVE: To investigate the effect of thoracic and lumbar vertebral posterior wall morphology in the patients with osteoporotic vertebral compression fracture on bone cement leakage into the spinal canal during the PKP. METHODS: The clinical data of osteoporotic vertebral compression fracture patients with PKP were selected. There were 98 osteoporotic vertebral compression fracture patients with CT scan and three-dimensional reconstruction image data from T6 to L5. The three-dimensional reconstruction of CT and multiplanar reconstruction were used to measure the depth of the concave vertebral posterior wall (OC) and the corresponding middle-sagittal diameter of the vertebra (PC) of the non-fractured vertebral body, the ratio of OC to PC was calculated. All subjects were divided into thoracic group (T6-T12) and lumbar group (L1-L5) based on the location of measured vertebral, and the differences of the OC between groups were compared. 357 patients (548 vertebrae) with osteoporotic vertebral compression fracture without CT three-dimensional reconstruction underwent PKP within the same period. They were also divided into thoracic vertebra and lumbar vertebra groups. The degree of bone cement leakage into the spinal canal was compared between thoracic and lumbar vertebra groups. RESULTS AND CONCLUSION: (1)The morphological parameters of posterior vertebral wall in 98 patients showed that the depth of the concave vertebral posterior wall gradually (OC) deepened from T6toT12, with an average of 4.6 mm. The depth became gradually shallow from L1 to L5, with an average of 0.6 mm. The ratio of the depth of the concave vertebral posterior wall to the corresponding middle-sagittal diameter of the vertebra was approximately 16% (1/6) from T6toT12. The average value of ratios from Li to U was 3%. The ratios in lumbar vertebra were significantly decreased compared with thoracic vertebra (16%, 1/6). (2) Results form 357 patients who underwent PKP at the same time showed that the rate of bone cement leakage into spinal canal was 10.2% (31/304) in the thoracic vertebra group during the PKP, and the rate of lumbar vertebra group was 3.7% (9/244). In the thoracic group, the average maximal sagittal diameter of the bone cement intruded spinal canal was (3.1 ±0.2) mm, the average maximal area of the bone cement intruded spinal canal was (30.8±0.3) mm2, and the spinal canal encroachment rate was (22.5±0.2)%. In the lumbar group, the average maximal sagittal diameter of the bone cement intruded spinal canal was (1.4±0.1) mm, the average maximal area of the bone cement intruded spinal canal was (14.9±0.2) mm2, and the spinal canal encroachment rate was (11,4±0.3)%. There was significant difference between thoracic and lumbar groups (P<0.05). (3) The above results imply that due to the presence of OC structure in the middle and lower thoracic vertebra, it is possible to reduce the occurrence of bone cement leakage into spinal canal through avoiding bone cement distribution over the posterior 1/6 (16%) of vertebral body in PKP. The effect of the difference between thoracic and lumbar vertebral posterior wall morphology in osteoporotic vertebral compression fracture patients on bone cement leakage into the spinal canal during the PKP may be one of the reasons why the rate of bone cement leakage into spinal canal in thoracic vertebra significantly higher than that in lumbar vertebra. The study protocol was approved by the Ethics Committee of the Affiliated Hospital of Southwest Medical University (approval No. K2018008).

Correlation of percutaneous vertebroplasty effect on osteoporotic vertebral compression fracture with injection amount and dispersion degree of bone cement / 中国组织工程研究

BACKGROUND: Previous studies show that the amount and diffusion degree of bone cement In vertebroplasty have some Influence on the postoperative recovery of patients with osteoporotic vertebral compression fracture, but there are few reports about the correlation between the amount and diffusion degree of bone cement In vertebroplasty and the recovery of vertebral body. OBJECTIVE: To Investigate the relationships between the effect of percutaneous vertebroplasty on osteoporotic vertebral compression fractures and the Injection amount and dispersion degree of bone cement. METHODS: Totally 102 osteoporotic vertebral compression fracture patients (109 vertebrae) who received treatment in the Sanya Hospital of Traditional Chinese Medicine from January 2017 to August 2018, including 42 males and 60 females at the age of 52-76 years, were retrospectively analyzed. All patients received percutaneous vertebroplasty. According to the Injection amount of bone cement, they were divided into two groups: observation group 1 (Injection > 4 mL, n=57) and control group 1 (injection ≤ 4 mL, n=45). According to the degree of dispersion of bone cement, they were divided into two groups: observation group 2 (filling rate > 15%, n=61) and control group 2 (filling rate > 15%, n=41). Visual analogue scale score, Oswestry disability index, anterior vertebral height, Cobb angle, and the occurrence of cement leakage were observed before and after surgery. The correlations of the Injection amount and dispersion degree of bone cement with the height of vertebral body recovered were analyzed. This study was approved by the Medical Ethics Committee of Sanya Hospital of Traditional Chinese Medicine. RESULTS AND CONCLUSION: (1) The visual analogue scale score and Oswestry dysfunction index of patients in the observation group 1 and control group 1 at 3 days after operation were decreased compared with before operation (P 0.05). There was no significant difference in the incidence of cement leakage between observation group 2 and control group 2 (P > 0.05). (4) The height of vertebral body recovery was positively correlated with the Injection amount and dispersion degree of bone cement (P < 0.05). (5) The results suggest that increases of the Injection amount and dispersion degree of bone cement properly can alleviate the pain, improve the mobility, correct the deformity of vertebral posterior concave, and restore the height of vertebral body of osteoporotic vertebral compression fracture patients. The Injection amount and dispersion degree of bone cement are positively correlated with the recovery height of vertebral body.

Zolidronic acid combined with percutaneous kyphoplasty in the treatment of osteoporotic compression fractures: A meta-analysis of bone density improvement, recurrent vertebral fractures prevention, and long-term efficacy evaluation / 中国组织工程研究

BACKGROUND: The clinical application of zoledronic acid in the treatment of osteoporosis lacks systematic scientific evaluation and evidence-based basis. Therefore, the clinical efficacy of zoledronic acid combined with percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fracture is still uncertain. OBJECTIVE: To systematically evaluate the efficacy of zoledronic acid combined with percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fracture. METHODS: A computer search of all randomized controlled studies and clinical trials of zolidronic acid combined with percutaneous kyphoplasty for the treatment of osteoporotic vertebral compression fracture published in CNKI, Wanfang, VIP, CBM, PubMed and Cochrane prior to September 2019 was performed. The experimental group was treated with zoledronic acid and percutaneous kyphoplasty, while the control group was treated with percutaneous kyphoplasty. Literature screening and data extraction were conducted by the two researchers independently. The quality of the included randomized controlled trials was evaluated one by one according to the Cochrane collaboration standards. Meta-analysis was performed on RevMan 5.3 for those that met the inclusion criteria. RESULTS AND CONCLUSION: (1) Five randomized controlled trials were included, including 175 in the experimental group and 184 in the control group. (2) Meta-analysis results showed that the bone mineral density was higher in the experimental group than in the control group [MD=0.12, 95%CI(0.08, 0.17), P < 0.000 01]. The visual analogue scale score was lower in the experimental group than that of the control group 6 and 12 months after treatment [MD=0.46, 95%CI(0.18, 0.75), P=0.002; MD=0.85, 95%CI(0.20, 1.50), P=0.01]. At 1 year after treatment, Oswestry disability index was lower in the experimental group than in the control group [MD=6.59, 95%CI(4.77，8.41), P < 0.000 01]. Bone cement leakage rate and recurrence rate of vertebral fractures were lower in the experimental group than in the control group [OR=0.22, 95%CI(0.08, 0.59), P=0.003; OR=0.18, 95%CI(0.07, 0.50), P=0.000 8]. Vertebral height recovery and kyphotic Cobb angle were not significantly different between the two groups [MD=0.65, 95%CI(-0.27, 1.56), P=0.16; MD=-0.60, 95%CI(-2.45, 1.25), P=0.53]. (3) Results showed that compared with percutaneous kyphoplasty alone, zoledronic acid combined with percutaneous kyphoplasty has significant advantages in improving bone mineral density, reducing the recurrence rate of vertebral fracture, improving the long-term clinical symptoms of patients, preventing the bone cement leakage, but a large number of high-quality multi-center randomized controlled studies are still needed to provide more sufficient evidence in the later stage.

Effect of bone cement distribution on adjacent vertebral body fracture after unilateral percutaneous vertebroplasty for single segment osteoporotic vertebral compression fracture / 中国组织工程研究

BACKGROUND: Previous studies on the risk factors of adjacent vertebral fractures after percutaneous vertebroplasty at home and abroad mainly focus on the leakage of bone cement, the amount of bone cement injected, the viscosity of bone cement, the number and location of vertebral fractures, the loss of vertebral height and sex. OBJECTIVE: To predict and analyze the influence of bone cement distribution on adjacent vertebral body fracture after unilateral percutaneous vertebroplasty for single segment osteoporotic vertebral compression fracture. METHODS: Forty patients with single segment osteoporotic vertebral compression fracture, including 16 males and 24 females, aged (71.4 ±5.3) years who received percutaneous vertebroplasty in the Second Affiliated Hospital of Shanxi Medical University from June 2017 to June 2018 were included in this study. These patients were divided into a unilateral group (13 vertebrae in 13 cases) and a bilateral group (27 vertebrae in 27 cases) according to the distribution of bone cement shown on X-ray film. Patients in the unilateral group were sub-divided into groups A (8 vertebrae in 8 cases, contacting the upper and lower endplates at the same time) and B (5 vertebrae in 5 cases, not contacting the upper and lower endplates at the same time) according to whether bone cement contacted the upper and lower endplates at the same time. Patients in the bilateral group were sub-divided into groups C (11 vertebrae in 11 cases, contacting the upper and lower endplates at the same time) and D (16 vertebrae in 16 cases, not contacting with the upper and lower endplates at the same time). Visual analogue scale score, Oswestry disability index, and Cobb angle were compared between unilateral and bilateral groups before and 1 year after surgery. The compression rate between adjacent vertebral bodies and the angle between the upper and lower endplates were compared between groups A, B, C and D. This study was approved by the Medical Ethics Committee of the Second Affiliated Hospital of Shanxi Medical University. RESULTS AND CONCLUSION: (1) At 1 year after surgery, the Visual Analogue Scale score, Oswestry disability index, and Cobb angle in both unilateral and bilateral groups were significantly decreased compared with before surgery (P 0.05). (2) At 1 year after surgery, the compression rate between adjacent vertebral bodies in groups A-D was significantly increased compared with before surgery (P < 0.05), and the angle between the upper and lower endplates in groups A-D was significantly increased compared with before surgery (P < 0.05). (3) Disordered multiclass logistic regression analysis taking group D as reference showed that the compression degree of adjacent vertebrae in group A was the largest after percutaneous vertebroplasty, which was the risk factor of the compression change of adjacent vertebrae after surgery (P=0.003). Group B and group C were not the risk factors of the compression change of adjacent vertebrae after percutaneous vertebroplasty [P=0.065, 0.660]. (4) These results show that after percutaneous vertebroplasty, if bone cement is distributed unilaterally and closer to the upper and lower endplates of the vertebral body at the same time, then the trend of adjacent vertebral body fracture is greater. Therefore, prediction of bone cement distribution of this type is a risk factor of adjacent vertebral body fracture after percutaneous vertebroplasty.

Application of G arm X-ray machine in minimally invasive treatment of thoracolumbar vertebral osteoporotic vertebral compression fractures / 中国综合临床

Objective To compare the clinical effects of G-arm X-ray machine and C-arm X-ray machine in percutaneous kyphoplasty (PKP) for osteoporotic vertebral compression fracture (OVCF) of thoracolumbar spine.Methods The clinical data of ninety-five patients with thoracolumbar OVCF treated with PKP from May 2016 to August 2017 in Yanan University Affiliated Hospital were retrospectively analyzed.They were divided into two groups according to the different guiding fluoroscopy methods used during the operation.Forty-six cases in G arm group completed PKP under the guidance of G arm X-ray machine,Forty-nine cases in C arm group completed PKP under the guidance of C arm X-ray machine.The operation time,fluoroscopy times,cement leakage cases,the height of injured vertebral leading edge,Cobb angle of kyphosis,visual analogue score and Oswestry dysfunction index were recorded before and after operation,and the related indexes were analyzed and compared.Results Two groups of patients were successfully completed surgery,no complications of vascular and nerve injury.The operation time and fluoroscopy times in G arm group were less than those in C arm group (operation time:(29.6±4.5) min vs.(42.5±5.3) min,and fluoroscopy times in G arm group:(9.1±2.0) vs.(16.9±3.2));the difference was statistically significant (t =-12.747,12.870,P＜ 0.01).Postoperative height of injured vertebral leading edge(G arm group (22.3±5.3) mm),C arm group (22.4±5.1) mm),kyphosis Cobb angle (G arm group (9.2±3.8)°,C arm group (9.3±3.7) o),visual analogue score (G arm group (2.1±0.7)points,C arm group (2.2±0.9) points),Oswestry dysfunction index (G arm group (21.3±8.5) points,C arm group(21.5 ± 8.3)points),compared with preoperative(the hight of injured vertebral leading edge of G arm group (18.2 ±5.3) mm,C arm group (18.4±5.2) mm,Cobb angle of injured vertebra G arm group (15.7±4.4) °,C arm group (15.9±4.3) °,visual analogue score of G arm group (7.8± 1.2) points,C arm group (7.7± 1.1) points,Oswestry dysfunction index score of G arm group(41.2±8.3)points,C arm group (41.5±8.2) points),the difference was statistically significant (t =-3.709,-3.844,-7.582,-8.144,27.827,27.088,11.360,11.999,P＜0.01),but there was no significant difference between the two groups (P ＞0.05).Conclusion Using G-arm X-ray machine to assist PKP in the treatment of thoracolumbar spine OVCF can effectively shorten the operation time,reduce the intraoperative fluoroscopy time,and the clinical effect is satisfactory.

Clinical study of percutaneous vertebroplasty through extreme extrapedicular approach in the treatment of osteoporotic vertebral compression fracture / 中国修复重建外科杂志

Objective: To evaluate the effectiveness of percutaneous vertebroplasty (PVP) in the treatment of osteoporotic vertebral compression fracture (OVCF) through unilateral puncture of extreme extrapedicular approach and bilateral injection of bone cement. Methods: The clinical data of 156 patients with OVCF who met the selection criteria between January 2014 and January 2016 were retrospectively analyzed. All patients were treated with PVP through unilateral puncture. According to different puncture methods, the patients were divided into two groups. In group A, 72 cases were performed PVP through the unilateral puncture of extreme extrapedicular approach and bilateral injection of bone cement, while in group B, 84 cases were performed PVP through the unilateral puncture of transpedicular approach. There was no significant difference in general data of gender, age, weight, bone mineral density, lesion segment, and disease duration between the two groups ( P>0.05). The radiation exposure time, operation time, volume of bone cement injection, rate of bone cement leakage, pre- and post-operative visual analogue scale (VAS) score and local Cobb angle were recorded and compared between the two groups. Results: There was no significant difference in radiation exposure time and operation time between the two groups ( P>0.05), but the volume of bone cement injection in group A was significantly more than that in group B ( t=20.024, P=0.000). Patients in both groups were followed up 24-32 months (mean, 26.7 months). There were 9 cases (12.5%) and 10 cases (11.9%) of cement leakage in group A and B, respectively. There was no significant difference in the incidence ( χ2=0.013, P=0.910). No neurological symptoms and discomfort was found in the two groups. The VAS scores of the two groups were significantly improved after operation ( P0.05); but the significant difference was found in local Cobb angle between at 2 years after operation and other time points in group B ( P<0.05). The VAS score and local Cobb angle in group A were significantly better than those in group B at 2 years after operation ( P<0.05). Conclusion: It is simple, safe, and feasible to use the unilateral puncture of extreme extrapedicular approach and bilateral injection of bone cement to treat OVCF. Compared with the transpedicular approach, the bone cement can be distributed bilaterally in the vertebral body without prolonging the operation time and radiation exposure time, and has an advantage of decreasing long-term local Cobb angle losing of the fractured vertebrae.

Early Adjacent Vertebral Fractures after Balloon Kyphoplasty for Osteoporotic Vertebral Compression Fractures

STUDY DESIGN: Retrospective cohort study. PURPOSE: To evaluate the incidence and risk factors for early adjacent vertebral fractures following balloon kyphoplasty (KP). OVERVIEW OF LITERATURE: KP is a safe and effective treatment for pain alleviation in patients with osteoporotic vertebral compression fractures (OVCF). However, some studies have reported that the risk of newly developed fractures increases at the adjacent vertebra after KP. METHODS: Total 123 consecutive patients with painful OVCF who underwent KP were enrolled from January 2009 to June 2016. Early adjacent vertebral fractures were defined as new fractures that had developed within 3 months after surgery. Sex, age, body mass index (BMI), bone mineral density (BMD), vertebral height, kyphotic angle, Visual Analog Scale score, cement amount, and leakage were evaluated as risk factors for adjacent vertebral fractures. Only cement leakage into the disc space was included in this study. RESULTS: Early adjacent vertebral fractures were identified in 20 (16.2%) of the 123 patients. The mean time to diagnosis of fractures was 1.7±0.7 months after KP. The average patient age was 78.0±0.7 years, average BMI was 23.06±3.83 kg/m², and mean BMD was −3.61±1.22 g/m². Cement leakage was present in 16 patients, and fractures developed in 11 (68.7%). In contrast, fractures developed in nine patients (8.2%) without cement leakage. There were no significant differences in terms of age, BMI, BMD, kyphotic angle, or vertebral body height ratio between the fracture and control groups. CONCLUSIONS: Cement leakage into the disc increased the risk of early adjacent vertebral fractures after balloon KP.

Percutaneous kyphoplasty treatment of osteoporotic vertebral compression fracture under the guidance of G-arm X-ray machine / 中国综合临床

Objective To explore the clinical application value of percutaneous kyphoplasty ( PKP ) under the guidance of G arm X ray machine in the treatment of osteoporotic vertebral compression fracture (OVCF). Methods The medical records of eighty-two patients (94 vertebral bodies) with OVCF treated with PKP were collected retrospectively. Thirty-nine cases ( 44 vertebral bodies ) were guided by G-arm X-ray machine to implement PKP,which were recorded as G-arm group. Forty-three cases (50 vertebral bodies) were guided by C-arm X-ray machine to carry out PKP,which were recorded as C-arm group. The operation time, intraoperative fluoroscopy times, bone cement leakage cases, preoperative and postoperative anterior height of injured vertebrae,Cobb angle of injured vertebrae,visual analogue scale scores and Oswestry disability index of the two groups were recorded. Results There was significant difference in operation time and intraoperative fluoroscopy times between the G-arm group and C-arm group (the operation time:(31. 6±5. 2) vs. (45. 8±6. 7) min,the intraoperative fluoroscopy times: (9. 5±2. 3) times vs. (18. 7±3. 5) times,t=-10. 64,-13. 91,P<0. 05) ,while there was no significant difference in the number of bone cement leakage ( P>0. 05) . Compared postoperative and preoperative anterior height of injured vertebrae, Cobb angle of injured vertebrae, visual analogue scale scores and Oswestry disability index scores of G-arm group and C-arm group respectively, the differences were significant ( t=-3. 41 vs. -3. 28, 6. 67 vs. 7. 66, 26. 63 vs. 25. 75 and 10. 41 vs. 11. 90, P<0. 05). There was no significant difference between the two groups (P>0. 05). Conclusion The treatment of OVCF with PKP guided by G-arm X-ray machine could significantly shorten operation time, reduce the intraoperative fluoroscopy times and the operative difficulty,and increase operation safety than PKP guided by traditional C-arm X-ray machine.

Prevalence of Frailty in Patients with Osteoporotic Vertebral Compression Fracture and Its Association with Numbers of Fractures

PURPOSE: To assess the association between frailty and osteoporotic vertebral compression fracture (OVCF) and to evaluate the relationship between numbers of OVCFs and frailty. MATERIALS AND METHODS: We enrolled 760 subjects, including 59 patients (with OVCF) and 701 controls (without OVCF). Successful matching provided 56 patient-control pairs. We analyzed principal clinical and demographic information, which included sex, age, height, weight, body mass index (BMI), variable frailty phenotypes, and Oswestry Disability Index (ODI) and EuroQol 5-dimension questionnaire (EQ-5D) scores. The association between frailty and OVCF was ascertained. In addition, the degrees of disability and quality of life attributable to frailty were determined. RESULTS: The prevalence of frailty was significantly higher in the OVCF group than in the control group (p < 0.001). Most of the frailty phenotypes, such as exhaustion, physical inactivity, slowness, and handgrip strength, were also significantly observed in the OVCF group. Within the OVCF group, the participants with frailty had significantly higher disability and lower quality of life than those in a robust state (p < 0.001 for ODI and EQ-5D). In addition, the multivariate logistic regression analysis demonstrated that the patients with low BMI [odds ratio (OR)=0.704; 95% confidence interval (CI), 0.543–0.913] and ≥3 fractures (OR=9.213; 95% CI, 1.529–55.501) within the OVCF group were associated with higher odds of frailty. CONCLUSION: The present study showed significant relationships between frailty and OVCF, severity of symptoms, and disability induced by OVCF. Furthermore, frailty could be a causal and/or resulting factor of OVCFs.