scholarly journals Unilateral Versus Bilateral Balloon Kyphoplasty for Osteoporotic Vertebral Compression Fractures

2013 ◽  
Vol 5;16 (5;9) ◽  
pp. 447-453
Author(s):  
Huilin Yang

Background: Osteoporotic vertebral compression fractures (VCFs) commonly occur in aged people. Balloon kyphoplasty (KP) has been proven to be efficacious for pain relief and reduction of vertebral height for patients with osteoporotic VCFs. However, very little is known about the comparison of clinical and radiographic outcomes between unilateral and bilateral balloon KP in treating this kind of patients. Objective: To compare the safety and long-term radiographic and clinical outcomes of unilateral or bilateral balloon KP to treat patients with osteoporotic VCFs. Study Design: A systemic review and meta-analysis of all randomized controlled trials (RCTs) comparing the analgesic efficacy, radiographic outcomes, and complications between unilateral and bilateral balloon KP in patients with osteoporotic VCFs. Setting: The MEDLINE, EMBASE, Pubmed, CINAHL databases, Bandolier, and the Cochrane Controlled Trials Register were systematically searched for evidence from their inception to July 2012 by 2 of the authors (J.L. and L.Z.). Methods: Relevant reports were reviewed by 2 assessors independently and the reference lists of retrieved papers were scrutinized to identify further studies for inclusion, using guidelines set by PRISMA statement criteria. Results: Three RCTs were enrolled in this study. The VAS scores showed no statistical difference between the groups before surgery and either at short-term or long-term follow-up. There was no statistical significance in polymethylmethacrylate (PMMA) leakage between the groups. Analysis of 2 studies showed statistical significance in surgery time (WMD -23.77 [-27.83, -19.71]; P < 0.00001) and PMMA (WMD -1.65 [-2.28, -1.02]; P < 0.00001) consumption between the groups. Limitations: There were few data sources from which to extract abstracted data or published studies. There were only 3 RCTs that met criteria enrollment in this meta-analysis. The quality of these trials was quite low (Jadad score: 1-2). Variable reporting of end points and inconsistent definitions meant that we were not able to include every study for each outcome. There was also clinical heterogeneity among the studies. Conclusion: The efficacy of both unilateral and bilateral balloon KP to provide rapid, significant, and sustained pain relief for patients with osteoporotic VCFs is validated. Unilateral balloon KP is a reasonable treatment for patients with osteoporotic VCFs considering that it could achieve equivalent pain relief with less surgery time and PMMA consumption compared to bilateral balloon KP. There was no evidence to prove that unilateral balloon KP results in higher incidence of PMMA leakage than bilateral balloon KP. Although unilateral balloon KP was less efficacious in the reduction of fractured vertebral body, it is still unclear if the clinical results of balloon KP were positively correlated with the restoration of vertebral height and amount. Key words: Kyphoplasty, unilateral approach, bilateral approach, , postoperative pain, osteoporotic fractures

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Hongyu Wei ◽  
Chunke Dong ◽  
Yuting Zhu ◽  
Haoning Ma

Abstract Background A systematic review and meta-analysis to assess the pros and cons of percutaneous vertebroplasty (PVP) versus kyphoplasty (PKP) for osteoporotic vertebral compression fractures (OVCFs) with intravertebral cleft (IVC) including all available evidence from controlled trials. Methods Databases including Pubmed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang Data were searched to identify relevant studies comparing PVP and PKP for OVCFs with IVC. The outcomes mainly included visual analog scale (VAS), Oswestry Disability Index (ODI), local kyphotic angle (LKA), rate of vertebral height (VH%), and adverse events. Results Nine studies enrolling 688 patients were eligible for meta-analysis. The results indicated no significant differences between the two groups in the short-and long-term VAS, ODI, LKA, or VH% (P > 0.05). Compared with PVP, PKP was associated with significantly longer operation time (P < 0.05), higher cost (P > 0.05), and more injected cement volume (P < 0.05). In terms of adverse events, PKP has a lower risk of cement leakage (P < 0.05), while with no significant difference in adjacent-level fracture rates (P > 0.05). Conclusion The two procedures have similar short- and long-term pain relief, functional recovery, local kyphosis correction, and vertebral height maintenance in OVCFs with IVC. PKP is superior to PVP for the injected cement volume, and lower cement leakage rate, however, with longer operation time, more fluoroscopy times, and higher cost. Further randomized controlled trials (RCTs) should be conducted to confirm these results.


2016 ◽  
Vol 8;19 (8;11) ◽  
pp. 551-563
Author(s):  
Yang

Background: Kyphoplasty has been proven to be an efficient method to relieve patient suffering from osteoporotic vertebral compression fractures (OVCFs). Because of its technological superiority, unilateral kyphoplasty consumes less operative time and bone cement than traditional bilateral kyphoplasty. However, there is controversy about which method is most efficient in the treatment of OVCFs. Thus, an overall analysis should be performed to shed light on the facts corroborating both procedures. Objective: To evaluate the safety and efficacy of unipedicular kyphoplasty versus bipedicular kyphoplasty in treating OVCFs. Study Design: Inclusion criteria were randomized controlled trials focusing on comparing unilateral versus bilateral balloon kyphoplasty in treatment of OVCFs. The exclusion criteria contained infection, neoplastic etiology, traumatic fracture, neural compression, neurological deficit, spinal stenosis, previous surgery at the involved vertebral body, long-term use of steroids, and kyphoplasty with other invasive or semi-invasive intervention treatment. Retrospective studies, reviews, technology introductions, and biochemical trials were also excluded. Settings: The PubMed MEDLINE, Cochrane Library, Web of Science, and EMBASE were systematic searched. Only randomized controlled trials published up to June 2015 comparing unilateral kyphoplasty with bilateral kyphoplasty in treatment of OVCFs were identified. Methods: Two researchers independently screeded the works for inclusion and data extraction. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to assess the methodological quality and evidence synthesis. Results: Six articles with 563 patients were enrolled in this study. Results showed that the unilateral approach required less surgical time (MD, -23.19; 95% CI, [-27.08, -19.31]; P < 0.00001) and cement consumption (MD, -2.07; 95% CI, [-2.23, -1.91]; P < 0.00001), as well as a reduced cement leakage ratio (RR, 0.59; 95% CI, [0.35, 0.99]; P < 0.05) and improved short-term general health (MD, 1.48; 95% CI, [0.02, 2.93], P < 0.05). No significant difference was found in the visual analog scale score (short-term and long-term), Oswestry Disability Index score (mid-term and long-term) kyphotic angle reduction, restoration rate of anterior vertebral height, vertebral height loss rate, postoperative adjacent-level fractures, or in other assessments of 36-Item Short Form Health Survey parameters (short-term and long-term). Limitations: Only 6 studies were included, so that the sample size was still relatively small and publication bias could not be revealed in this study. Observation time of some data was inconsistent. All of these problems could influence the reliability of the results. Conclusion: Both unilateral kyphoplasty and bilateral kyphoplasty are safe and effective treatments for OVCFs. However, when operative time, cement volume, cement leakage, short-term general health, radiation dose, and hospitalization costs are taken into consideration, unilateral kyphoplasty may be the better choice. Yet, more high-quality RCTs with long-term follow-up are still required to make the final conclusion. Key words: Kyphoplasty, unilateral approach, bilateral approach, osteoporotic vertebral compression fractures, meta-analysis


2021 ◽  
Author(s):  
Hai-Tao Zhu ◽  
De-Gang Ding ◽  
Shui Wang ◽  
Yu-Long Zhu

Abstract Background & Aim: Osteoporotic vertebral compression fractures (OVCFs) are acknowledged as common occurred fractures among humans, especially for the elderly population. The minimally invasive percutaneous methods such as kyphoplasty as well as vertebroplasty have been valid and effective tools in terms of reducing clinical problems, which are associated with more beneficial effects as compared to traditional methods such as open surgery or conservative treatment. Hence, we conducted the current meta-analysis in order to gather updated evidence available for the systematical assessment of the clinical and radiographic outcomes of VP in comparison of KP.Methods: Publications on comparison kyphoplasty versus vertebroplasty in treatment of OVCFs were collected. After rigorous and thorough review of quality, we extracted the data on the basis of eligible trials, which analyzed the summary hazard ratios (HRs) of the endpoints of interested.Results: Totally, our inclusion criteria involved five studies. 561subjects involving 334 patients received VP and 227 patients received KP were included, of which patients receiving KP or VP failed to show any significant differences in the visual analog scale (VAS) scores (MD =-0.02, 95% CI -0.40 – 0.35; P = 0.91),and the risk of cement leakage (OR =1.60, 95% CI 0.82 – 3.12; P = 0.17). Nevertheless, the Oswestry Disability Index (ODI) scores (MD =-1.56, 95% CI -2.39 – -0.73; P = 0.0002), the injected cement volume (MD =-0.40, 95% CI -0.77 – -0.04; P = 0.03) and the operation time (MD =-9.67, 95% CI -11.55 – -7.80; P <0.00001) in VP group were linked to markedly lower trend in comparison of KP group with significant statistical difference.Conclusion: The present meta-analysis controls the acceptable level of the efficacy across the involved trials. The VP had ODI scores, the injected cement volume and the operation time exerted several advantages in this meta-analysis. Yet, VP failed to show benefits in terms of the VAS scores and cement leakage in comparison of KP therapy. Given the combined results of our study, the optimal treatment for patient harboring OVCFs should be determined by further high-quality and multi-center RCTs along with longer follow-ups as well as larger sample size.


2019 ◽  
Vol 27 (1) ◽  
pp. 19-25 ◽  
Author(s):  
Lin Zhang ◽  
Pei Zhai

Background. Osteoporotic vertebral compression fractures (OVCFs) are common in older patients, which can cause back pain and even increase morbidity. However, the optimal therapy for patients with OVCFs remains unknown. Percutaneous vertebroplasty (PVP), a minimally invasive procedure, has been a therapy option that is known to be effective in the pain management. Aim. The meta-analysis aims to summarize current best evidence on the efficacy of PVP and conservative treatment (CT) for pain management and functional results among OVCFs patients. Methods. We searched the publications on comparison of the efficacy of PVP versus CT for OVCFs patients up to November 2018. After rigorous reviewing on the quality, the data were extracted from eligible trials. All trials analyzed the summary hazard ratios of the endpoints of interest. Results. Moderate-strong evidence indicated that PVP had benefits on pain relief at 1 week and 1 month, but not at 3 months. With regard to the quality of life, no significant differences were found in the Roland-Morris Disability Questionnaire (RMDQ). However, there is significant difference in terms of EuroQol and Quality of Life Questionnaire of the European Foundation for Osteoporosis but not the RMDQ. Moreover, there were no any benefit in terms of vertebral fracture between groups. Conclusions. The meta-analysis showed that patients treated with vertebroplasty were associated with better pain relief and improved quality of life, without increasing the incidence of vertebral fracture compared with the CT group.


2013 ◽  
Vol 5;16 (5;9) ◽  
pp. 455-464
Author(s):  
Hong Jiang

Background: Osteoporotic vertebral compression fractures (OVCFs) are the most common osteoporotic fractures. Pain is the main symptom. Percutaneous vertebroplasty (PVP) is a therapeutic procedure performed to reduce pain in vertebral compression fractures. Numerous case series and several small, non-blinded, non-randomized controlled studies have suggested that vertebroplasty is an effective means of relieving pain from osteoporotic fractures. However, a recent pooled analysis from 2 multicenter randomized controlled trials concluded that the improvement in pain afforded by PVP was similar to placebo. Objective: To compare the amount of pain reduction measured using the visual analog scale when OVCF is treated with vertebroplasty or conservatively, and assess the clinical utility of PVP. Design: A meta-analysis and systematic review of randomized controlled trials was performed comparing pain reduction following vertebroplasty and conservative treatment. Limitations: There were few data sources from which to extract abstracted data or published studies. There were only 5 randomized controlled trials that met our criteria. The conservative treatments used as comparators in these trials were different. Methods: A search of MEDLINE from January 1980 to July 2012 using PubMed, the Cochrane Database of Systematic Reviews and Controlled Trials, CINAHL, and EMBASE. Relevant reports were examined by 2 independent reviewers and the references from these reports were searched for additional trials, using the criteria established in the QUOROM statement. Results: Pooled results from 5 randomized controlled trials are shown. There was no difference in pain relief in the PVP group at 2 weeks and one month when compared with the conservatively managed group. Pain relief in the PVP group was greater than that of the conservative group at 3 months, 6 months, and 12 months. However, after subgroup analysis, pain scores were similar between the PVP group and the sham injection group from 2 weeks to 6 months. Compared with non-operative therapy, PVP reduced pain at all times studied. Conclusion: PVP has some value for relieving pain; however, the possibility of a placebo effect should be considered. PVP has gained acceptance as a complementary treatment when conservative management has failed before its benefits have been fully understood. More large scale, double blinded, controlled trials are necessary in order to quantify the pain relief afforded by PVP more precisely. Key words: Vertebroplasty, osteoporosis, vertebral compression fracture, randomized controlled trials, systemic review, meta-analysis


2017 ◽  
Vol 1 (21;1) ◽  
pp. E13-E28 ◽  
Author(s):  
Tao Zhang

Background: Because of an aging population,osteoporotic vertebral fractures are becoming more frequent. Conservative therapy was considered the gold standard for treating osteoporotic vertebral compression fractures (OVCFs) in the past. Percutaneous vertebroplasty (PVP) or balloon kyphoplasty (BKP) as minimally invasive techniques are new treatments that arewidely used for painful OVCFs. However, an increase in new vertebral compression fractures at non-treated levels following augmentation is of concern. There is no convincing evidence that new fractures are inevitable after augmentation compared to after conservative treatment, and it is still unclear whether further fractures are the consequence of augmentation ora result of the natural progression of osteoporosis. Objective: The objective of this study was to evaluate the new-level fracture risk after PVP or BKP compared with conservative (non-operative) treatment and to determine the dominant risk factor associated with new OVCFs. Study Design: A meta-analysis of comparative studies was performed to evaluate the incidence of new vertebral fractures between vertebral augmentation, such as vertebroplasty and kyphoplasty, and no operation. Setting: The PubMed,ISI Web of Science, ELSEVIER ScienceDirect, and Cochrane Library databases and abstracts published in annual proceedings were systematically searched.In addition, we also retrieved data from references when titles met our inclusion criteria. Methods: Detailed searches of a number of online databases comparing operative and non-operative groups were performed. We included randomized controlled trials,clinical controlled trials,and prospective clinical studies to provide available data. All studies were reviewed by 2 reviewers independently, and all the references that met our inclusion criteria were searched for additional trials, using the guidelines set by the QUOROM (Quality of Reporting of Meta-analysis) statement. Results: We evaluated 12 studies encompassing 1,328 patients in total,including 768 who underwent operation with polymethylmethacrylateand 560 who received non-operative treatments. For new-level vertebral fractures, our meta-analysis found no significant difference between the 2 methods, including total new fractures (P = 0.55) and adjacent fractures (P = 0.5).For pre-existing vertebral fractures, there was no significant difference between the 2 groups (operative and non-operative groups) (P = 0.24). Additionally,there was no significant difference in bone mineral density, both in the lumbar (P = 0 .13) and femoral neck regions (P = 0.37), between the 2 interventions. Limitation: All studies we screened were published online except for unpublished articles. Moreover, only a few data sources could be extracted from the published studies. There were only 5 randomized clinical trials and 7 prospective studies that met our inclusion criteria. Conclusion: Vertebral augmentation techniques, such as vertebroplasty and kyphoplasty, have been widely used to treat osteoporotic vertebral fractures in order to alleviate back pain and correct the deformity, and it has been frequently reported that many new vertebral fractures occurred after this operation. Our analysis did not reveal evidence of an increased risk of fracture of vertebral bodies, especially those adjacent to the treated vertebrae, following augmentation with either method compared with conservative treatment. Key words: Vertebroplasty, kyphoplasty, new osteoporotic compression vertebral fracture, meta-analysis


2013 ◽  
Vol 4;16 (4;7) ◽  
pp. 277-290
Author(s):  
Qin Fu

Background: Kyphoplasty reduces the pain caused by osteoporotic vertebral compression fracture (OVCF). Although the procedure is typically carried out using a bilateral approach, it is now increasingly performed using a unilateral approach because of the concern for longterm adverse effects. However, little evidence is available to demonstrate superior safety of the unilateral approach. Objective: The purpose of this study was to compare the short- and long-term safety and efficacy of unilateral vs. bilateral kyphoplasty. Study Design: A systematic review and meta-analysis of randomized controlled trials. Settings: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and abstracts published in the related orthopedic journals were systematically searched up to September 2012, using “unilateral kyphoplasty” and “osteoporotic vertebral compression fractures” as key words. Methods: Two investigators independently searched and identified relevant reports and abstracts using the PRISMA statement criteria. Relevant studies cited by the identified papers were also included. The level of evidence was classified as good, fair, and limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Results: Four randomized controlled trials (RCTs) of 159 cases were enrolled. The methodological quality of the articles was determined as moderate. We did not find any significant difference between unilateral and bilateral kyphoplasty on pain relief, in either short-term or long-term follow-up (P = 0.65 and P = 0.69, respectively). The rate of adjacent vertebral fracture was not statistically different with a P value of 0.88 and 95% CI (confidence intervals) of 0.25-3.26. Cement leakage was comparable between unilateral and bilateral kyphoplasty (P = 0.56, 95% CI = 0.46-4.26). The loss of vertebral height in long-term follow-up was not different (P = 0.10, 95% CI = -0.39-4.54). Operation time and cement dosage were considerably less for unilateral kyphoplasty (P < 0.01 and P < 0.05, respectively). Limitations: Only 4 RCTs and 159 patients were included in this systematic review. Publication bias also existed among the studies included. Conclusions: Both unilateral and bilateral kyphoplasty are effective in alleviating the back pain caused by OVCF. Two approaches have the same degree of safety. More RCTs are needed to examine the efficacy and adverse reactions of the 2 approaches. Key words: Unilateral kyphoplasty, bilateral kyphoplasty, osteoporotic vertebral compression fractures, systematic review, meta-analysis, randomized controlled trials


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