scholarly journals Vertebroplasty Using Calcium Triglyceride Bone Cement (Kryptonite™) for Vertebral Compression Fractures

2014 ◽  
Vol 20 (5) ◽  
pp. 576-582 ◽  
Author(s):  
Gianluigi Guarnieri ◽  
Mario Tecame ◽  
Roberto Izzo ◽  
Pasquale Vassallo ◽  
Angela Sardaro ◽  
...  

This study assessed the one-year clinical and radiographic outcomes, in terms of pain-relief, vertebral re-fracture and complications, after vertebroplasty (VP) using a new osteoconductive cement (calcium triglyceride bone cement - Kryptonite™ bone cement, Doctors Research Group Inc., Southbury, CT, USA) to treat osteoporotic vertebral compression fractures. Sixteen consecutive osteoporotic patients (12 women and four men, mean age 68+/-10.5) were treated with VP using Kryptonite™ bone cement for a total of 20 vertebral fractures. All the patients complained of a pain syndrome resistant to medical therapy and all procedures were performed under fluoroscopy control with neuroleptoanalgesia using a monopedicular approach in 12 patients and bipedicular approach in four patients. All patients were studied by MR and MDCT and were evaluated with the visual analogue scale (VAS) and the Oswestry disability index (ODI) before treatment and at one and 12 months after the procedure. A successful outcome was observed in 80% of patients, with a complete resolution of pain. Differences in pre and post treatment VAS and ODI at one-year follow-up were significant (P<0.0001). We observed a disk and venous leakage in 66% of patients but only in one case did an asymptomatic pulmonary embolism occur during cement injection. Two cases of vertebral re-fractures at distant metamers were observed during follow-up. VP using Kryptonite bone cement is a helpful procedure that allows complete and long-lasting resolution of painful vertebral symptoms. The cost of the material is very high and the rate of disk and venous leakage is too high compared to standard cement.

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Qiujiang Li ◽  
Xingxia Long ◽  
Yinbin Wang ◽  
Xiaomin Fang ◽  
Donggeng Guo ◽  
...  

Abstract Introduction New vertebral compression fractures (NVCFs) are adverse events after vertebral augmentation of osteoporotic vertebral compression fractures (OVCFs). Predicting the risk of vertebral compression fractures (VCFs) accurately after surgery is still a significant challenge for spinal surgeons. The aim of our study was to identify risk factors of NCVFs after vertebral augmentation of OVCFs and develop a nomogram. Methods We retrospectively reviewed the medical records of patients with OVCFs who underwent percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). Patients were divided into the NVCFs group and control group, base on the patients with or without NVCFs within 2 years follow-up period after surgery. A training cohort of 403 patients diagnosed in our hospital from June 2014 to December 2016 was used for model development. The independent predictive factors of postoperative VCFs were determined by least absolute shrinkage and selection operator (LASSO) logistic regression, univariate analysis and multivariate logistic regression analysis. We provided a nomogram for predicting the risk of NVCFs based on independent predictive factors and used the receiver operating characteristic curve (ROC), calibration curve, and decision curve analyses (DCA) to evaluated the prognostic performance. After internal validation, the nomogram was further evaluated in a validation cohort of 159 patients included between January 2017 and June 2018. Results Of the 403 patients in the training cohort, 49(12.16%) were NVCFs at an average of 16.7 (1 to 23) months within the 2 years follow-up period. Of the 159 patients in the validation cohort, 17(10.69%) were NVCFs at an average of 8.7 (1 to 15) months within the 2 years follow-up period. In the training cohort, the proportions of elderly patients older than 80 years were 32.65 and 13.56% in the NVCFs and control group, respectively (p = 0.003). The percentages of patients with previous fracture history were 26.53 and 12.71% in the NVCFs and control group, respectively (p = 0.010). The volume of bone cement were 4.43 ± 0.88 mL and 4.02 ± 1.13 mL in the NVCFs and Control group, respectively (p = 0.014). The differences have statistical significance in the bone cement leakage, bone cement dispersion, contact with endplate, anti-osteoporotic treatment, post-op Cobb angle and Cobb angle restoration characteristics between the two groups. The model was established by multivariate logistic regression analysis to obtain independent predictors. In the training and validation cohort, the AUC of the nomogram were 0.882 (95% confidence interval (CI), 0.824-0.940) and 0.869 (95% CI: 0.811-0.927), respectively. The C index of the nomogram was 0.886 in the training cohort and 0.893 in the validation cohort, demonstrating good discrimination. In the training and validation cohort, the optimal calibration curves demonstrated the coincidence between prediction and actual status, and the decision curve analysis demonstrated that the full model had the highest clinical net benefit across the entire range of threshold probabilities. Conclusion A nomogram for predicting NVCFs after vertebral augmentation was established and validated. For patients evaluated by this model with predictive high risk of developing postoperative VCFs, postoperative management strategies such as enhance osteoporosis-related health education and management should be considered.


2020 ◽  
Vol 33 (09) ◽  
pp. 856-861
Author(s):  
Steven F. Harwin ◽  
William DeGouveia ◽  
Nipun Sodhi ◽  
Peter A. Gold ◽  
Luke J. Garbarino ◽  
...  

AbstractBecause of the early follow-up positive outcomes with cementless fixation, continued evaluations need to be performed to ensure longer-term efficacy. Additionally, although many studies report on the results of femoral and tibial component fixation, few studies report specifically on patellar outcomes. Therefore, the purpose of this study was to report on the: (1) implant survivorship; (2) complications; and (3) radiographic outcomes in a large cohort of patients who received cementless total knee arthroplasties (TKAs), with particular attention to the patellar component. A total of 261 patients who underwent cementless TKA by a single, high-volume academic surgeon were studied. Patients had a mean age of 66 years and were distributed between 192 women (74%) and 69 men. All patients received the same cementless tibial, femoral, and patellar components. Mean follow-up period was 4.5 years (range, 4–5 years). Primary outcomes evaluated included all postoperative complications, with particular emphasis on the patellar component. Only one patellar loosened leading to a patellar aseptic loosening rate of 0.3% (1 of 261). The one patellar loosening was the component being dislodged after a manipulation under anesthesia (MUA) at 6 weeks. This was revised to a cemented component and the patient is doing well 4 years later. A second patient experienced a patellar tendon rupture, later surgically repaired. Another patient sustained a patella fracture that was managed nonoperatively. The fracture healed by 1 year and the patient continued to have an otherwise successful outcome, now at 2 years follow-up. No progressive radiolucencies, subsidence, or changes in initial postoperative axial alignment were observed at final follow-up. The results from this study highlight a 98% success rate at mean 4.5 years follow-up in a large cohort of patients with a diverse spread of demographic details. Specific to the patella, only one patient experienced an adverse event, which was managed nonoperatively. Therefore, based on this data, patellar fixation in cementless TKA can be considered a safe technique.


2020 ◽  
Author(s):  
Wenye Yao ◽  
Bin Zhang ◽  
Qi Lai ◽  
Song Gao ◽  
Runsheng Guo

Abstract Objective To evaluate the efficacy of percutaneous kyphoplasty (PKP) for thoracolumbar osteoporotic vertebral compression fractures (OVCFs) via unilateral versus bilateral approach. Methods All patients who underwent PKP surgery for OVCFs in our hospital between June 2016 and December 2018 were included in this study. The pedicles were divided into two groups according to the manner of vertebral body puncture, which were as follows: unilateral pedicle puncture group (unilateral group, n=47) and bilateral pedicle puncture group (bilateral group, n=39).The operative time, amount of cement perfusion, correction angle of kyphosis, pain score before and after surgery, and leakage rate of bone cement were evaluated in all patients. The average follow-up was 19 months (range 13-34 months). Results The average age of patients who met the inclusion criteria, but not the exclusion criteria, was 76 years, and a total of 121 vertebral bodies were studied. There were 7 cases of postoperative bone cement leakage (unilateral group, 14.9%) and 6 cases of postoperative bone cement leakage (bilateral groups, 15.4%). There were differences in operative time and amount of cement perfusion between the two groups were statistically significant (P<0.05). There was no significant increase in age, body mass index, pain index during follow-up, treatment outcome, correction angle of kyphosis, and cement leakage rate between the two groups (P>0.05). Moreover, there was no significant difference in sex and bone cement leakage rate between the two groups by Pearson x 2 test (P>0.05). Conclusion Patients with OVCFs could obtain similar satisfactory clinical results via both unilateral and bilateral PKP approaches. However, the unilateral PKP approach is more advantageous as it has a shorter operative time, requires lesser cement volume, causes minimal trauma, is less costly, and results in lesser complications than the bilateral approach.


2020 ◽  
Author(s):  
Li Fan Jie ◽  
Li Yang ◽  
Wang Yan Jie ◽  
Du YiBin

Abstract Purpose: To evaluate the clinical efficacy and complications of percutaneous curved vertebroplasty in treatment of osteoporotic vertebral compression fractures.Methods: Patients with single vertebral osteoporotic vertebral compression fractures were selected. The patients were divided into Percutaneous curved vertebroplasty group and Percutaneous vertebroplasty group.Distribution and leakage of bone cement and recovery of the height of the anterior edge of the injured vertebra were observed. VAS and ODI were assessed preoperatively 1 day and 1 year postoperatively. Postoperative follow-up was conducted for 1 year to observe the occurrence of adjacent vertebral fractures. The trial was approved by the Ethics Committee of the Third Affiliated Hospital of Anhui Medical University. Results: Compared with the percutaneous vertebroplasty group, distribution of bone cement was more uniform and satisfactory, the leakage rate of bone cement was lower in the percutaneous curved vertebroplasty group. Both the visual analogue scale score and Oswestry disability index of the two groups at 1 day and I year after surgery were significantly improved compared with those before surgery (P < 0.05). There was no significant difference in VAS and ODI. The height of the anterior edge of the injured vertebral body of the two groups improved significantly(P < 0.05), and there was no significant difference between the two groups . There was no significant difference in the incidence of adjacent vertebral fractures between the two groups..Conclusion: The results show that PCVP has beneficial to the uniform distribution of bone cement in the fracture vertebrae and reduce the leakage of bone cement.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Fei Lei ◽  
Wen He ◽  
Xinggui Tian ◽  
Zhongyang Li ◽  
Lipeng Zheng ◽  
...  

Purpose. The occurrence of new vertebral compression fractures (VCFs) is a common complication after percutaneous kyphoplasty (PKP). Secondary VCFs after PKP occur predominantly in the thoracolumbar segment (T11 to L2). Prophylactic injections of cement into vertebral bodies in order to reduce new VCFs have rarely been reported. The main purpose of this study was to investigate whether prophylactically injecting cement into a nonfractured vertebral body at the thoracolumbar level (T11-L2) could reduce the occurrence of new VCFs. Methods. From July 2011 to July 2018, PKP was performed in 86 consecutive patients with osteoporotic vertebral compression fractures (OVCFs) in the thoracolumbar region (T11-L2). All patients selected underwent PKP because of existing OVCFs (nonprophylactic group). Additionally, 78 consecutive patients with fractured vertebrae in the thoracolumbar region (T11-L2) with OVCFs underwent PKP and received prophylactic injections of cement into their nonfractured vertebrae in the thoracolumbar region (T11-L2) (prophylactic group). The visual analog scale (VAS) scores and incidence of new VCFs after PKP were compared between the two groups. Results. The mean VAS scores improved from 8.00±0.79 preoperatively to 1.62±0.56 at the last follow-up in the nonprophylactic group and improved from 8.17±0.84 to 1.76±0.34 in the prophylactic group (P>0.05). In the nonprophylactic group, 21 of 86 patients (24.4%) developed new VCFs within one year after PKP, of whom 15 patients (71.4%) developed VCFs within 3 months. In the prophylactic group, 8 of 78 patients (10.3%) developed new VCFs within one year, and 6 of these 8 patients (75%) developed new VCFs within 3 months. The incidence of new VCFs was significantly higher in the nonprophylactic group than that in the prophylactic group at one year (P=0.018), but there were no statistically significant differences at three months (P=0.847). Conclusions. Prophylactic injections of cement into nonfractured (T11-L2) vertebral bodies reduced the incidence of secondary VCFs after PKP in patients with OVCFs, but there was no significant difference in local back pain (VAS) scores between the two groups.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Qiujiang Li ◽  
Xingxia Long ◽  
Yinbin Wang ◽  
Tao Guan ◽  
Xiaomin Fang ◽  
...  

Abstract Background Current findings suggest that percutaneous vertebroplasty(PVP) is a suitable therapeutic approach for osteoporotic vertebral compression fractures (OVCFs). The present retrospective study aimed to investigate the differences in clinical efficacy and related complications between the two bone cement distribution modes. Methods We retrospectively reviewed the medical records of the patients with single-segment OVCFs who underwent bilateral percutaneous vertebroplasty. Patients were divided into blocky and spongy group according to the type of postoperative bone cement distribution. Clinical efficacy and related complications was compared between the two bone cement distribution modes on 24 h after the operation and last follow-up. Results A total of 329 patients with an average follow up time of 17.54 months were included. The blocky group included 131 patients, 109 females(83.2 %) and 22 males(16.8 %) with a median age of 72.69 ± 7.76 years, while the Spongy group was made up of 198 patients, 38 females(19.2 %) and 160 males(80.8 %) with a median age of 71.11 ± 7.36 years. The VAS and ODI after operation improved significantly in both two groups. The VAS and ODI in the spongy group was significantly lower than that in the blocky group, 24 h postoperatively, and at the last follow-up. There were 42 cases (12.8 %) of adjacent vertebral fractures, 26 cases (19.8 %) in the blocky group and 16 cases (8.1 %) in the spongy group. There were 57 cases (17.3 %) of bone cement leakage, 18 cases (13.7 %) in blocky group and 39 cases (19.7 %) in the spongy group. At 24 h postoperatively and at the last follow-up, local kyphosis and anterior vertebral height were significantly corrected in both groups, but gradually decreased over time, and the degree of correction was significantly higher in the spongy group than in the block group. The change of local kyphosis and loss of vertebral body height were also less severe in the spongy group at the last follow-up. Conclusions Compared with blocky group, spongy group can better maintain the height of the vertebral body, correct local kyphosis, reduce the risk of the vertebral body recompression, long-term pain and restore functions.


2021 ◽  
Author(s):  
Qiujiang Li ◽  
Xingxia Long ◽  
Yinbin Wang ◽  
Tao Guan ◽  
Xiaomin Fang ◽  
...  

Abstract Background:Current findings suggest that percutaneous vertebroplasty(PVP) is a suitable therapeutic approach for osteoporotic vertebral compression fractures (OVCFs).The present retrospective study aimed to investigate the differences in clinical efficacy and related complications between the two bone cement distribution modes. Methods:We retrospectively reviewed the medical records of the patients with single-segment OVCFs who underwent bilateral percutaneous vertebroplasty.Patients were divided into blocky and spongy group according to the type of postoperative bone cement distribution. Clinical efficacy and related complications was compared between the two bone cement distribution modes on 24h after the operation and last follow-up.RESULTS: The mean follow-up time was 17.54 months. The VAS and ODI after operation improved significantly in both two groups. The VAS and ODI in the spongy group was significantly lower than that in the blocky group, 24h postoperatively, and at the last follow-up. There were 42 cases (12.8%) of adjacent vertebral fractures, 26 cases (19.8%) in the blocky group and 16 cases (8.1%) in the spongy group. There were 57 cases (17.3%) of bone cement leakage, 18 cases (13.7%) in blocky group and 39 cases (19.7%) in the spongy group. At 24 hour postoperatively and at the last follow-up, local kyphosis and anterior vertebral height were significantly corrected in both groups, but gradually decreased over time, and the degree of correction was significantly higher in the spongy group than in the block group. Loss of local kyphosis and loss of vertebral body height were also less severe in the spongy group at the last follow-up.Conclusions: Compared with blocky group, spongy group can better maintain the height of the vertebral body, correct local kyphosis, reduce the risk of the vertebral body recompression, long-term pain and restore functions.


2015 ◽  
Vol 2;18 (2;3) ◽  
pp. E187-E194
Author(s):  
Lin Nie

Background: Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures (OVCFs). But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use. Balloon kyphoplasty (BKP) and high-viscosity cement vertebroplasty (HVCV) are 2 modifications of vertebroplasty designed to decrease cement leakage. Objective: To assess the safety and efficacy of HVCV compared with BKP. Study Design: A prospective cohort study. Setting: Department of Spine Surgery, an affiliated hospital of a medical university. Method: One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups. Visual Analog Scale (VAS), Oswestry Disability Index (ODI), cement leakage, and vertebral height restoration were evaluated. All occurring complications and injected cement volumes were recorded. The follow-up time was one year. Results: VAS and ODI scores improved in both groups, and did not differ significantly between the 2 groups. More cement was used in the BKP group than in HVCV group (4.22 vs. 3.31 mL, P < 0.0001). The incidence of cement leakage in the HVCV group was lower than that of the BKP group (13.24% vs 30.56%, P < 0.05). No symptomatic cement leakages occurred in the HVCV group. In the BKP group, one patient experienced discogenic back pain related to a disc leak, and another patient had asymptomatic cement emboli in the lung related to venous leakage. The mean compression rate before the procedure was 29.98% in the HVCV group and 28.67% in the BKP group (P = 0.94). The vertebral height was improved significantly and maintained at one-year follow-up in both groups. BKP was more effective in vertebral height restoration than HVCV (44.87% vs. 23.93%, P < 0.0001). There was one case of a new adjacent vertebral fracture in the HVCV group (2%), and 4 cases of new nonadjacent vertebral fractures in the BKP group (7.84%) (P = 0.18). Limitations: A single-center and relatively small-sample size study. Conclusion: HVCV and BKP are safe and effective in improving quality of life and relieving pain. HVCV has a lower cement leakage rate, whereas BKP is more effective in vertebral height restoration. Subsequent fractures are not different between the 2 groups. Key words: Vertebral compression fracture, spine, osteoporosis, cement augmentation, balloon kyphoplasty, vertebroplasty, cement leakage


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