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Objective:To investigate the effect of self-made Bushen Jiangu Decoction on bone transformation markers in elderly patients with osteoporotic vertebral compression fracture after operation, and to evaluate the clinical efficacy.Methods:Prospective cohort study. A total of 92 patients with osteoporotic vertebral compression fracture after operation in Fangshan Hospital of Beijing University of Chinese Medicine from April 2020 to December 2021 who met the inclusion criteria were divided into 2 groups by random drawing method, with 46 in each group. The control group was treated with routine western medicine after operation, and the observation group was treated with self-made Bushen Jiangu Decoction on the basis of the control group. Both groups were treated for 3 months. TCM symptom scores were performed before and after treatment, and the prognosis of the patients was evaluated with the Chinese Osteoporosis Quality of Life (COQOL), VAS scale, and the Oswestry Dysfunction Index (ODI). The levels of amino terminal propeptide (PINP), cross-linked terminal peptide β special sequence (β-CTX) and bone morphogenetic protein 6 (BMP6) of type Ⅰ procollagen were determined by contrast chromogenic method with o-benzaldehyde. The adverse reactions during treatment were recorded and the clinical efficacy was evaluated.Results:The total effective rate was 95.7% (44/46) in the observation group and 82.6% (38/46) in the control group, and there was a significant difference between the two groups ( χ 2=4.04 , P=0.044). After treatment, the scores of fracture nonunion, pain in back and loin, chilliness and lassitude, and pallor in the observation group were significantly lower than those in the control group ( t values were 4.84, 4.09, 4.87, 4.14, respectively, P<0.01). The scores of COQOL, VAS and ODI in the observation group were significantly lower than those in the control group ( t values were 6.26, 10.57 and 6.15, respectively, P<0.01). The levels of PINP [(44.93±5.86)μg/L vs. (49.76±6.02)μg/L, t=3.90] and β-CTX [(0.49±0.17) μg/L vs. (0.68±0.20) μg/L, t=4.91] in observation group were significantly lower than those in the control group after treatment ( P<0.05). The level of BMP6 [(81.23±9.14) μg/L vs. (75.14±8.25) μg/L, t=3.36] in observation group was significantly higher than that of the control group ( P<0.05). During the treatment,the incidence of adverse reactions in the observation group was 13.0% (6/46), while that in the control group was 8.7% (4/46), and there was no significant difference between the two groups ( χ 2=0.45, P=0.503). Conclusion:The self-made Bushen Jiangu Decoction combined with conventional western medicine therapy can adjust the level of bone transformation markers in elderly patients with osteoporotic vertebral compression fractures, improve the lumbar function and quality of life, and improve the clinical efficacy.
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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.
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Male , Female , Humans , Aged , Kyphoplasty/methods , Bone Cements , Fractures, Compression/surgery , Spinal Fractures/surgery , Retrospective Studies , Osteoporotic Fractures/etiology , Treatment Outcome , Vertebroplasty/methodsABSTRACT
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.
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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.
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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.
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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.
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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.
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Objective:To investigate the clinical effect of remote injection device assisted percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures.Methods:Using retrospective research and analysis methods, 168 patients with osteoporotic vertebral compression fractures admitted to Heze Municipal Hospital from September 2019 to August 2020 were selected. A total of 139 cases were followed up, with a follow-up rate of 82.7%, including 22 males and 117 females, with an average age of 74.17 years. According to the different equipment used, they were divided into two groups. Seventy-two cases used remote injection device to assist percutaneous vertebroplasty (observation group), 67 cases used traditional puncture needle puncture percutaneous vertebroplasty (control group). All patients were completed follow-up at 3 months after surgery. The operation time, intraoperative blood loss, bone cement injection volume, bone cement leakage rate, VAS score and ODI score of 1 day, 1 month and 3 months after operation were observed. Measurement data were expressed as ( Mean± SD), using t test, counting data were expressed as percentage [ n(%)], using χ2 test. Results:Both groups of patients successfully completed the operation without complications such as paraplegia, pulmonary embolism, or infection. There was no statistically significant difference between the two groups in operation time of two groups[(47.71±6.05) min vs (47.61±5.66) min, t=0.100, P=0.920]. The intraoperative blood loss of the two groups was no statistically significant difference [(7.08±3.00) mL vs (8.06±3.48) mL, t=1.782, P=0.079]. The difference between two groups of the amount of bone cement injected was statistically significant, [(6.44±1.03) mL vs (5.73±1.41) mL, t=3.369, P=0.001]. The bone cement leakage rate of the observation group was 27.78% (19/72), and the control group was 43.28% (29/67), and there was statistically significant( χ2=4.382, P=0.036). The preoperative VAS score of the observation group was (6.75±1.14) , and the control group was (6.64±1.08), and there was no significant difference between two groups( t=0.583, P=0.561) The VAS scores of the observation group and the control group were (1.28±0.75) and (1.21±0.77) respectively at 1 day after surgery. There was no statistically significant difference between two groups( t=0.583, P=0.588). The VAS scores of the observation group and the control group were (0.89±0.76) and (1.09±0.67) respectively at 1 month after operation. There was no statistically significant difference between two groups( t=1.641, P=0.103). The VAS scores of the observation group and the control group were (0.74±0.63) and (0.87±0.74) respectively at 3 months after operation. There was no statistically significant difference between two groups( t=1.118, P=0.266). The preoperative ODI scores of the observation group and the control group were (60.32±7.46) and (61.96±9.76) respectively, and there was no statistically significant difference between two groups( t=1.121, P=0.264). The ODI scores of the observation group and the control group were (14.93±6.01) and (15.10±6.43) respectively at 1 day after operation, there was no statistically significant difference between two groups( t=0.161, P=0.872). The ODI scores of the observation group and the control group were (10.54±4.24) and (11.31±3.71) respectively at 1 month after operation, and there was no statistically significant difference between two groups( t=1.136, P=0.258). The ODI scores of the observation group and the control group were (10.64±3.70) and (10.39±3.74) respectively at 3 months after operation, and there was no statistically significant difference between two groups( t=0.396, P=0.693). Conclusion:Compared with traditional puncture needle puncture percutaneous vertebroplasty, the remote injection device assisted percutaneous vertebroplasty has a definite clinical effect in the treatment of osteoporotic vertebral compression fractures, and the bone cement leakage rate is low.
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BACKGROUND: Percutaneous vertebral body stenting system (VBS) can alleviate patient's pain, recover the height of vertebral body, and correct local kyphosis, but there is no definite clinical study to show that It has obvious advantages over percutaneous kyphoplasty (PKP). OBJECTIVE: To compare the short-term effect of VBS versus PKP in the treatment of osteoporotic vertebral compression fracture. METHODS: Forty patients with osteoporotic vertebral compression fracture who received VBS or PKP between January 2017 and December 2018 In the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine were included in this study. They were divided into a VBS group (n=15) and a PKP group (n=25) according to surgery method. According to whether fluoroscopic operation was performed in retroextension position, two subgroups were designated: VBS retroextension group (n=7) and PKP retroextension group (n=14). RESULTS AND CONCLUSION: Compared with the PKP group, the amount of bone cement injected Into the vertebra was greater in the VBS group (P 0.05). Compared with preoperative situations, Visual Analogue Scale score was significantly decreased after surgery In both VBS and PKP groups, and further decreased at the last follow-up (P 0.05). These results suggest that VBS and PKP are effective in the treatment of osteoporotic vertebral compression fractures. VBS can better correct compression kyphosis deformity when more bone cement Is injected. The difference of therapeutic efficacy between two surgical approaches can be reduced with proper surgical position, keeping the surgical segment In the retroextension position.
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OBJECTIVE: It remains disputed whether percutaneous curved vertebroplasty and unilateral pedicle approach percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fracture. This study systematically analyzed the efficacy and safety of percutaneous curved vertebroplasty and unilateral pedicle approach percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fracture. METHODS: A computer-based online search of Wanfang, VIP, CNKI, PubMed, EMBASE, The Cochrane library, and CBM was performed to retrieve randomized controlled trial studies regarding percutaneous curved vertebroplasty and unilateral pedicle approach percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fracture published before January 2020. Related papers were manually searched. After two evaluators independently selected literature, data were extracted and the quality of methodology included in the study was evaluated. Meta-analysis was carried out by using Stata/SE 12.0 software. RESULTS: (1) A total of eight randomized controlled trials were conducted, including 628 patients, of whom 394 were treated with percutaneous curved vertebroplasty and 404 with unilateral pedicle approach percutaneous vertebroplasty. (2) The meta-analysis results showed that visual analogue scale score [MD=-0.20, 95%CI(-0.28,-0.12), P < 0.05], the leakage rate of bone cement [RR=0.30, 95%CI(0.15, 0.58), P < 0.05], and the total distribution rate of bone cement in the center of vertebral body [RR=1.27, 95%CI(1.12, 1.45), P < 0.05] were better in the percutaneous curved vertebroplasty group than those in the unilateral pedicle approach percutaneous vertebroplasty group. (3) There was no significant difference in Oswestry disability index score [MD=-4.83, 95%CI (-9.71, 0.05), P=0.052], operation time [MD=-1.45, 95%CI(-5.91, 2.82), P=0.488]and X-ray exposure times [MD=-0.70, 95%CI(-2.11, 0.71), P=0.33] between the two methods. CONCLUSION: Percutaneous curved vertebroplasty exhibits significant advantages in analgesic effect, low leakage rate of bone cement and the high total distribution rate of bone cement in the center over unilateral pedicle approach percutaneous vertebroplasty. Therefore, a large number of high-quality multicenter randomized controlled trials are needed to provide more evidence.
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BACKGROUND: Percutaneous curved vertebroplasty is a new method for the treatment of osteoporotic vertebral compression fractures, which can achieve a good therapeutic effect, while the distribution of bone cement has not been explored thoroughly. OBJECTIVE: To retrospectively analyze the therapeutic effect of percutaneous curved vertebroplasty and the distribution characteristics of bone cement in the treatment of osteoporotic vertebral compression fractures. METHODS: A total of 28 patients with osteoporotic vertebral compression fractures of a single thoracic or lumbar vertebrate, who were admitted to Qingdao Municipal Hospital from June 2017 to February 2018, including 2 males and 26 females, aged 62-86 years old, underwent percutaneous curved vertebroplasty and were retrospectively reviewed. The bone cement was injected at the puncture side, the middle of the vertebrate and the contralateral side respectively. The change of anterior vertebral body height of the injured vertebrae and the leakage of bone cement postoperatively were observed according to X-ray images preoperatively, 48 hours and 6 months postoperatively. The bone cement distribution within the vertebrate was observed by CT scanning. Visual analogue scale score and Oswestry disability index were recorded for the evaluation of recovery. All protocols were approved by the Ethical Committee of Qingdao Municipal Hospital. RESULTS AND CONCLUSION: (1) There were 6 out of 28 cases of bone cement leakage, including 4 cases of paravertebral leakage and 2 cases of intervertebral space leakage, and no clinical symptoms were observed in all the 6 cases. CT scanning showed that the bone cement was mainly distributed in the anterior 2/3 of the vertebral body. The maximum distribution area of bone cement was (4.5±0.9) cm2, with the contralateral area (2.0±0.5) cm2 and the puncture side area (2.5±0.7) cm2, which makes the ratio of the puncture side area versus contralateral area 0.85±0.27. (2) The anterior vertebral body heights preoperatively showed no significant difference than those postoperatively in 28 patients (P > 0.05). (3) The visual analogue scale score and Oswestry disability index 48 hours and 6 months postoperatively were both significantly different from those before operation (P < 0.05). (4) The results showed that percutaneous curved vertebroplasty treatment of osteoporotic vertebral compression fractures has the advantages of accurate surgical effects and even distribution of bone cement.
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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.
Subject(s)
Humans , Bone Cements , Fractures, Compression , Spinal Fractures , Treatment OutcomeABSTRACT
OBJECTIVE@#To investigate the risk factors of vertebral refracture after percutaneous kyphoplasty (PKP) for osteoprotic vertebral compression fractures (OVCFs), and to provide reference for clinical prevention.@*METHODS@#A retrospective analysis of 228 OVCFs patients who met the inclusion criteria admitted from November 6, 2013 to December 14, 2018. There were 35 males and 193 females, with a male-to-female ratio of 3∶20, and aged 58 to 91 years with an average of (69.70±7.03) years. All patients were treated with PKP and had complete clinical data. According to whether refracture occurred after operation, they were divided into refracture group (24 cases) and non refracture group (204 cases). Factors that may be related to refracture (including gender, age, surgical segment, number of vertebral bodies in the surgical segment, whether combined with degenerative scoliosis, whether anti-osteoporosis treatment) were included in the univariate analyses, and the single factor analysis of statistically significant risk factors was carried out with multiple Logistic regression analysis to further clarify the independent risk factors for vertebral body refracture after PKP. Survival analysis was performed using the time of vertebral refracture after PKP as the end time of follow up, the occurrence of refracture after PKP as the endpoint event, and the presence or absence of degenerative lateral curvature as a variable factor.@*RESULTS@#All 228 patients were followed up for 1.8 to 63.6 months with an average of (28.8±15.6) months, and the refracture rate was 10.5%(24/228). There were statistically significant differences between two groups in age, number of operative vertebral bodies, whether combinedwith degenerative scoliosis and whether anti osteoporosis treatment (@*CONCLUSION@#Combined scoliosis is an independent risk factor for refracture after OVCFs vertebroplasty, and it is also a possible high-risk factor for refracture after surgery.
Subject(s)
Female , Humans , Male , Fractures, Compression/surgery , Kyphoplasty/adverse effects , Osteoporotic Fractures , Retrospective Studies , Risk Factors , Spinal Fractures/surgery , Vertebral BodyABSTRACT
Introduction: Osteoporotic vertebral fractures that produce increased morbidity, persistent back pain, risk of collapse with time, and increased fracture risk. Subsequently, these vertebral fractures produce kyphotic deformity and effect on lung capacity. In our study purpose is to assess the clinical outcome, safety, and efficacy of transpedicular percutaneous vertebroplasty in osteoporotic vertebral compression fractures (VCFs). Methodology: The study done between December 2017 and December 2019 at our institute. Atotal of 10 patients with 21 vertebral body collapse in that 13 dorsal vertebra and 8 lumbar vertebral body included in the study in neurologically intact individuals. Patients are considered for treatment, those with chronic pain refractory to medical therapy and bracing and those with severe disabling pain caused by fractures. Severe cardiopulmonary disease, coagulopathy, and cord compression are contraindications to vertebroplasty. Severe vertebral compression may also be a contraindication to treatment, because the vertebra may be compressed to such a degree that needle placement and cement injection become impossible. After treatment, they selected one of three possible responses for each: Significantly improved, worse, or approximately the same. As an overall assessment analgesic requirement, visual analog scale, grading of subjective satisfaction score, sleep, and ambulation improvement assessed. To ensure uniformity despite the variable follow-up period, patients were instructed to indicate their status at 2 weeks after the procedure, 6 months, and 1-year follow-up. Results: Both pain and functional outcome improved significantly in immediate post-procedure at 2 weeks, 6 months, and 1 year. The majority (70%) of the patients were treated for 2 levels while 2 patients were treated for 3 levels and 1 patient was treated for 1 level. Visual analog scale (VAS) in the pre-procedure period is 8.3 which decrease in the post-procedure period at 2 weeks and 6 months is 2.6 and 3.6 subsequently and at 1-year average VAS score is 4. Mobility and sleep pattern is significantly improved in 8 patients (80%) at 1-year follow-up whereas remain same in 2 patients. Conclusion: Significant relief in pain in the post-procedure period with minimum risk noticed for VCFs.
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BACKGROUND: Percutaneous kyphoplasty is of breakthrough significance in minimally invasive treatment of vertebral compression fractures, but it also has shortcomings, such as bone cement leakage, limited height recovery of the vertebral body, and increased risk of fracture of adjacent vertebral bodies. In recent years, a variety of spinal implants have been developed, and the application of these implants in the treatment of vertebral compression fractures in percutaneous kyphoplasty has achieved good clinical efficacy, and is beneficial to reduce the complications of traditional percutaneous kyphoplasty. OBJECTIVE: To describe the types and characteristics of various spinal implants and explore their clinical applications in percutaneous kyphoplasty. METHODS: CNKI, PubMed and Elsevier were retrieved for relevant literature. The key words were "percutaneous kyphoplasty, spinal implants, vertebral stents, vertebral compression fractures". Relevant articles published from January 2000 to June 2019 were reviewed, including review, basic research and clinical research. Preliminary screening was conducted by reading the article title and abstract, and the literatures with low relevance to the article topic were excluded. According to the inclusion and exclusion criteria, 62 articles were finally included for analysis. RESULTS AND CONCLUSION: (1) Spinal implants used in percutaneous kyphoplasty include VBS stent, Jack vertebra expander, SKY bone expander system, Osseofix system, SpineJack, KIVA system and memory alloy vertebral stent. (2) They are modified and developed on the basis of classic percutaneous kyphoplasty to achieve the same clinical efficacy while minimizing complications such as cement leakage, loss of vertebral height, and increased risk of adjacent vertebral body fracture.
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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).
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BACKGROUND: Percutaneous kyphosis is improved on the basis of vertebroplasty, which can well restore the height of compressed vertebral body and reduce bone cement leakage. In recent years, it has been widely used in the treatment of osteoporotic vertebral compression fracture. However, it is often reported that there are recurrent fractures of the enhanced vertebral body and adjacent vertebral body after surgery, and the related factors affecting the recurrent fracture are still controversial. OBJECTIVE: To identify the risk factors for the fractures secondary to percutaneous kyphoplasty for treating osteoporotic vertebral compression fractures in the elderly by meta-analysis. METHODS: A comprehensive search was conducted for the studies published from January 2009 to April 2019 on the risk factors for secondary fractures after percutaneous kyphoplasty in the Cochrane Library, PubMed, CBM, CNKI and WanFang databases and manually as well. After the relevant data were extracted, statistical analysis was carried out with RevMan 5.3 software. RESULTS AND CONCLUSION: (1) The secondary fracture after percutaneous kyphoplasty for osteoporotic vertebral compression fracture was related to age [WMD=1.87, 95%C/ (0.79, 2.95), P 0.05], body mass index [WMD=-0.27, 95% Cl (-1.06, 0.51), P=0.49], cement volume [WMD=0.06, 95% Cl (-0.21, 0.32), P=0.68], surgical approach [OR=0.87, 95%C/(0.61,1.25), P=0.46], primary fracture was thoracolumbar segment (T11-L2) [OR=1.48, 95% C/(0.93, 2.38), P=0.1]. These results suggest that age, bone mineral density, bone cement leakage, correction of kyphosis angle after primary operation and recovery rate of vertebral height after primary operation may be the risk factors closely correlative to the secondary fracture after percutaneous kyphoplasty. There has not been enough evidence to support the associations between the secondary fracture and sex, body mass index, cement volume, surgical approach or thoracolumbar spine, and the above conclusions need to be studied and verified by more high quality literature in the future.
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BACKGROUND: Simple bone cement is easy to cause refracture of adjacent vertebra due to its high hardness. Currently, a material that can reduce the incidence of adjacent vertebra fracture is urgently needed. OBJECTIVE: To observe the clinical efficacy of percutaneous vertebroplasty using mineralized collagen modified bone cement. METHODS: Totally 60 patients with fresh single osteoporotic vertebral compression fractures who underwent percutaneous vertebroplasty were randomly divided into two groups, with 30 cases in each group. Patients in the simple bone cement group were given polymethyl methacrylate bone cement. Patients in the modified bone cement group were given mineralized collagen modified bone cement mixed with artificial bone repair material and simple polymethyl methacrylate bone cement. All patients signed the informed consent. This study was approved by the Hospital Ethics Committee. The follow-up time was 6-12 months. The clinical effect was assessed by the visual analogue scale, Oswestry Disability Index, Cobb angle and percentage of vertebral anterior edge height before surgery, at 2 days after surgery and during the last follow-up. Postoperative complications were recorded. RESULTS AND CONCLUSION: (1) All patients underwent successful operation. A total of four patients were found to have different degrees of bone cement leakage, and none of the patients presented obvious clinical discomfort symptoms. (2) Compared with pre-operation, visual analogue scale and Oswestry Disability Index were significantly improved (P 0.05) at 2 days after operation and during the last follow-up in the two groups. There were no significant differences in above indexes between the two groups at the same time point (P > 0.05). (3) The number of adjacent fractures in the simple bone cement group was more than that in the modified bone cement group, but there was no statistically significant difference in the incidence of adjacent vertebral fractures between the two groups (P > 0.05). (4) It is confirmed that compared with simple bone cement, mineralized collagen modified bone cement has no obvious disadvantages. In addition, mineralized collagen modified bone cement can give better biological properties while ensuring the strength of bone cement support and reducing pain. Further studies are needed to reduce the incidence of adjacent vertebral fractures.
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BACKGROUND: Percutaneous vertebroplasty has been extensively applied In the treatment of senile osteoporotic vertebral compression fracture with pain. However, the appropriate dose of bone cement remains controversial. OBJECTIVE: To compare the efficacy and complications of different viscosities of high-dose bone cement applied In the treatment of osteoporotic vertebral compression fractures by percutaneous vertebroplasty. METHODS: One hundred and sixty-nine patients with single-segment osteoporotic fractures at thoracolumbar level (T12-L2) admitted at Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine from February 2014 to December 2018 were Included. All patients were treated by percutaneous vertebroplasty with high-dose (> 4 mL) bone cement at low viscosity (n=85, control group) and high viscosity (n=84, observation group). The Visual Analogue Scale score, anterior vertebral height, Cobb angle and bone cement leakage were recorded before and 2 days after surgery. The study was approved by the Medical Ethics Committee of Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, China (approval No. SH9H-2019-T90-1). RESULTS AND CONCLUSION: (1) The Visual Analogue Scale score at postoperative 2 days in both groups were significantly lower than that at baseline (P 0.05). (2) The anterior vertebral height at postoperative 2 days in both groups was significantly higher than that at baseline (P 0.05). (3) Compared with the baseline level, the Cobb angle at postoperative 2 days in both groups was significantly decreased (P 0.05). (4) The incidence of bone cement leakage in the observation group (36/84,42.9%) was significantly lower than that in the control group (57/85, 67.1 %) (P < 0.05). The incidence of leakage In paravertebral vessels and spinal canal in the observation group was significantly lower than that in the control group (P < 0.05). (5) Peri-Implant Infection, allergic reaction, Immune and rejection reactions occurred in neither groups. (6) These results Indicate that treatment of senile osteoporotic vertebral compression fractures with high dose of low- and high-viscosity bone cement can result In good clinical outcomes. However, the Incidence of leakage is higher in the low-viscosity bone cement, and high-viscosity bone cement can significantly reduce the risk of leakage, especially the leakage of paravertebral blood vessels and spinal canal.
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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.