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European Spine Journal : Official... Sep 2012To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of... (Comparative Study)
Comparative Study Review
PURPOSE
To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of osteoporotic vertebral compression fractures (VCFs).
METHODS
As of February 1, 2011, a PubMed search (key words: kyphoplasty, vertebroplasty) resulted in 1,587 articles out of which 27 met basic selection criteria (prospective multiple-arm studies with cohorts of ≥ 20 patients). This systematic review adheres to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines.
RESULTS
Pain reduction in both BKP (-5.07/10 points, P < 0.01) and VP (-4.55/10, P < 0.01) was superior to that for NSM (-2.17/10), while no difference was found between BKP/VP (P = 0.35). Subsequent fractures occurred more frequently in the NSM group (22 %) compared with VP (11 %, P = 0.04) and BKP (11 %, P = 0.01). BKP resulted in greater kyphosis reduction than VP (4.8º vs. 1.7°, P < 0.01). Quality of life (QOL) improvement showed superiority of BKP over VP (P = 0.04), along with a trend for disability improvement (P = 0.08). Cement extravasation was less frequent in the BKP (P = 0.01). Surgical intervention within the first 7 weeks yielded greater pain reduction than VCFs treated later.
CONCLUSIONS
BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs. BKP is marginally favored over VP in disability improvement, and significantly favored in QOL improvement. BKP had a lower risk of cement extravasation and resulted in greater kyphosis correction. Despite this analysis being restricted to Level I and II studies, significant heterogeneity suggests that the current literature is delivering inconsistent messages and further trials are needed to delineate confounding variables.
Topics: Controlled Clinical Trials as Topic; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Pain; Spinal Fractures; Vertebroplasty
PubMed: 22543412
DOI: 10.1007/s00586-012-2314-z -
JBJS Reviews Oct 2021Osteoporotic vertebral fractures (OVFs) have become increasingly common, and previous nonrandomized and randomized controlled trials (RCTs) have compared the effects of... (Meta-Analysis)
Meta-Analysis
Systematic Review and Meta-Analysis of 3 Treatment Arms for Vertebral Compression Fractures: A Comparison of Improvement in Pain, Adjacent-Level Fractures, and Quality of Life Between Vertebroplasty, Kyphoplasty, and Nonoperative Management.
BACKGROUND
Osteoporotic vertebral fractures (OVFs) have become increasingly common, and previous nonrandomized and randomized controlled trials (RCTs) have compared the effects of cement augmentation versus nonoperative management on the clinical outcome. This meta-analysis focuses on RCTs and the calculated differences between cement augmentation techniques and nonsurgical management in outcome (e.g., pain reduction, adjacent-level fractures, and quality of life [QOL]).
METHODS
A systematic review was performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, and the following scientific search engines were used: MEDLINE, Embase, Cochrane, Web of Science, and Scopus. The inclusion criteria included RCTs that addressed different treatment strategies for OVF. The primary outcome was pain, which was determined by a visual analog scale (VAS) score; the secondary outcomes were the risk of adjacent-level fractures and QOL (as determined by the EuroQol-5 Dimension [EQ-5D] questionnaire, the Oswestry Disability Index [ODI], the Quality of Life Questionnaire of the European Foundation for Osteoporosis [QUALEFFO], and the Roland-Morris Disability Questionnaire [RDQ]). Patients were assigned to 3 groups according to their treatment: vertebroplasty (VP), kyphoplasty (KP), and nonoperative management (NOM). The short-term (weeks), midterm (months), and long-term (>1 year) effects were compared. A random effects model was used to summarize the treatment effect, including I2 for assessing heterogeneity and the revised Cochrane risk-of-bias 2 (RoB 2) tool for assessment of ROB. Funnel plots were used to assess risk of publication bias. The log of the odds ratio (OR) between treatments is reported.
RESULTS
After screening of 1,861 references, 53 underwent full-text analysis and 16 trials (30.2%) were included. Eleven trials (68.8%) compared VP and NOM, 1 (6.3%) compared KP and NOM, and 4 (25.0%) compared KP and VP. Improvement of pain was better by 1.31 points (95% confidence interval [CI], 0.41 to 2.21; p < 0.001) after VP when compared with NOM in short-term follow-up. Pain effects were similar after VP and KP (midterm difference of 0.0 points; 95% CI, -0.25 to 0.25). The risk of adjacent-level fractures was not increased after any treatment (log OR, -0.16; 95% CI, -0.83 to 0.5; NOM vs. VP or KP). QOL did not differ significantly between the VP or KP and NOM groups except in the short term when measured by the RDQ.
CONCLUSIONS
This meta-analysis provides evidence in favor of the surgical treatment of OVFs. Surgery was associated with greater improvement of pain and was unrelated to the development of adjacent-level fractures or QOL. Although improvements in sagittal balance after surgery were poorly documented, surgical treatment may be warranted if pain is a relevant problem.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Topics: Fractures, Compression; Humans; Kyphoplasty; Pain; Quality of Life; Vertebroplasty
PubMed: 34695056
DOI: 10.2106/JBJS.RVW.21.00045 -
Pain Physician 2013
Review
Topics: Fractures, Compression; Humans; Kyphoplasty; Randomized Controlled Trials as Topic; Treatment Outcome; Vertebroplasty
PubMed: 23877458
DOI: No ID Found -
Blood Cancer Journal Feb 2019Multiple myeloma (MM) represents approximately 15% of haematological malignancies and most of the patients present with bone involvement. Focal or diffuse spinal...
The role of cement augmentation with percutaneous vertebroplasty and balloon kyphoplasty for the treatment of vertebral compression fractures in multiple myeloma: a consensus statement from the International Myeloma Working Group (IMWG).
Multiple myeloma (MM) represents approximately 15% of haematological malignancies and most of the patients present with bone involvement. Focal or diffuse spinal osteolysis may result in significant morbidity by causing painful progressive vertebral compression fractures (VCFs) and deformities. Advances in the systemic treatment of myeloma have achieved high response rates and prolonged the survival significantly. Early diagnosis and management of skeletal events contribute to improving the prognosis and quality of life of MM patients. The management of patients with significant pain due to VCFs in the acute phase is not standardised. While some patients are successfully treated conservatively, and pain relief is achieved within a few weeks, a large percentage has disabling pain and morbidity and hence they are considered for surgical intervention. Balloon kyphoplasty and percutaneous vertebroplasty are minimally invasive procedures which have been shown to relieve pain and restore function. Despite increasing positive evidence for the use of these procedures, the indications, timing, efficacy, safety and their role in the treatment algorithm of myeloma spinal disease are yet to be elucidated. This paper reports an update of the consensus statement from the International Myeloma Working Group on the role of cement augmentation in myeloma patients with VCFs.
Topics: Bone Cements; Clinical Decision-Making; Decision Trees; Disease Management; Female; Fractures, Compression; Humans; Kyphoplasty; Male; Multiple Myeloma; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 30808868
DOI: 10.1038/s41408-019-0187-7 -
Pain Physician 2013Osteoporotic vertebral compression fractures (VCFs) commonly occur in aged people. Balloon kyphoplasty (KP) has been proven to be efficacious for pain relief and... (Meta-Analysis)
Meta-Analysis Review
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.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Pain, Postoperative; Randomized Controlled Trials as Topic; Vertebroplasty
PubMed: 24077191
DOI: No ID Found -
BMC Infectious Diseases Nov 2018Infection after vertebroplasty (VP) is a rare but serious complication. Previous literatures showed most pathogens for infection after VP were bacteria; tuberculosis...
BACKGROUND
Infection after vertebroplasty (VP) is a rare but serious complication. Previous literatures showed most pathogens for infection after VP were bacteria; tuberculosis (TB) induced infection after VP was extremely rare. We reported our treatment experiences of cases with infectious spondylitis after VP, and compared the differences between developed pyogenic and TB spondylitis.
METHODS
From January 2001 to December 2015, 5749 patients had undergone VP at our department were reviewed retrospectively. The causative organisms were obtained from tissue culture of revision surgery. Parameters including type of surgery, the interval between VP and revision surgery, neurologic status, and visual analog scale (VAS) of back pain were recorded. Laboratory data at the time of VP and revision surgery were collected. Charlson comorbidity index (CCI), preoperative bacteremia, urinary tract infection (UTI), pulmonary TB history were also analyzed.
RESULTS
Eighteen patients were confirmed with developed infectious spondylitis after VP (0.32%, 18/5749). Two were male and 16 were female. The median age at VP was 73.4 years. Nine patients were TB and the other nine patients were pyogenic. The interval between VP and revision surgery ranged from 7 to 1140 days (mean 123.2 days). The most common type of revision surgery was anterior combined with posterior surgery. Seven patients developed neurologic deficit before revision surgery. Three patients died within 6 months after revision surgery, with a mortality of 16.7%. Finally, VAS of back pain was improved from 7.4 to 3.1. Seven patients could walk normally, the other 8 patients had some degree of disability. Both pyogenic and TB group had similar age, sex, and CCI distribution. The interval between VP and revision surgery was shorter in the patients with pyogenic organisms (75.9 vs 170.6 days). At revision surgery, WBC and CRP were prominently elevated in the pyogenic group. Five in the pyogenic group had UTI and bacteremia; five in TB group had a history of lung TB.
CONCLUSIONS
Infection spondylitis after VP required major surgery for salvage with a relevant part of residual disability. Before VP, any bacteremia/UTI or history of pulmonary TB should be reviewed rigorously; any elevation of infection parameters should be scrutinized strictly.
Topics: Aged; Aged, 80 and over; Back Pain; Female; Humans; Male; Middle Aged; Pain Measurement; Postoperative Complications; Reoperation; Retrospective Studies; Spondylitis; Suppuration; Treatment Outcome; Tuberculosis, Spinal; Vertebroplasty
PubMed: 30419832
DOI: 10.1186/s12879-018-3486-x -
Annals of Saudi Medicine 2016Both kyphoplasty (KP) and vertebroplasty (VP) are effective for patients with osteoporotic vertebral compression fracture (OVCF), but which approach might be more... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Both kyphoplasty (KP) and vertebroplasty (VP) are effective for patients with osteoporotic vertebral compression fracture (OVCF), but which approach might be more effective remains unclear, so we decided to update earlier systematic reviews.
OBJECTIVE
Review and analyze studies published as of August 2015 that compared clinical outcomes and complications of KP versus VP.
DESIGN
Systematic review and meta-analysis.
SEARCH METHOD
Published reports up to August 2015 were found in PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL).
SELECTION CRITERIA
Randomized controlled trials (RCTs) and prospective and retrospective cohort stud.ies comparing KP and VP in patients with OVCF.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the studies and extracted data.
RESULTS
Thirty-two studies involving 3274 patients fulfilled the inclusion criteria. There were significant differences between the two groups in short- and long-term postoperative changes in measures of pain intensity and dysfunction (P < .01), in anterior and middle height (P < .01), kyphotic angle (P < .01), and time to injury, but not in posterior height (P=.178). There were no significant differences in the rate of postoperative fractures including adjacent and total fractures, but cement leakage to the intraspinal space was greater in the VP group (P=.035). KP surgery took longer and required a greater volume of injected cement.
CONCLUSIONS
KR resulted in better pain relief, improvements in Oswestry dysfunction and radiographic outcomes with less cement leakage, but further RCTs are needed to verify this conclusion.
LIMITATIONS
Only four RCTs with a certain of risk of bias. Most studies were observational.
Topics: Bone Cements; Disability Evaluation; Fractures, Compression; Humans; Kyphoplasty; Operative Time; Osteoporotic Fractures; Pain Measurement; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 27236387
DOI: 10.5144/0256-4947.2016.165 -
PloS One 2015Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic... (Review)
Review
CONTEXT
Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.
OBJECTIVE
To assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.
DATA SOURCES
A systematic review of articles in English or French listed in the MEDLINE, PASCAL, COCHRANE and National Health Service Economic Evaluation databases, with limits on publication date (up to the date of the review, March 2014).
STUDY SELECTION
We included only economic evaluations of vertebroplasty or kyphoplasty. Editorial and methodological articles were excluded.
DATA EXTRACTION
Data were extracted from articles by two authors working independently and using two analysis grids to measure the quality of economic evaluations.
DATA SYNTHESIS
Twenty-one studies met our inclusion criteria. All were published between 2008 and 2014. Eighteen (86%) were full economic evaluations. Cost-effectiveness analysis (CEA) was the most frequent type of economic evaluation, and was present in 11 (52%) studies. Only three CEAs complied fully with the British Medical Journal checklist. The quality of the data sources used in the 21 studies was high, but the CEAs conforming to methodological guidelines did not use high-quality data sources for all components of the analysis.
CONCLUSIONS
This systematic review shows that the level of evidence in economic evaluations of vertebroplasty and kyphoplasty is low, despite the recent publication of a large number of studies. This finding highlights the challenges to be faced to improve the quality of economic evaluations of medical devices.
Topics: Cost-Benefit Analysis; Equipment and Supplies; Humans; Kyphoplasty; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Vertebroplasty
PubMed: 26661078
DOI: 10.1371/journal.pone.0144892 -
BMC Surgery Nov 2019Although various studies have described the outcomes and complications of each treatment for OF 4 in osteoporotic vertebral compression fractures (OVCFs), there is still...
Vertebroplasty and vertebroplasty in combination with intermediate bilateral pedicle screw fixation for OF4 in osteoporotic vertebral compression fractures: a retrospective single-Centre cohort study.
BACKGROUND
Although various studies have described the outcomes and complications of each treatment for OF 4 in osteoporotic vertebral compression fractures (OVCFs), there is still no consensus on the optimal treatment regimen. This study aimed to investigate the clinical effect of OF 4 in patients with OVCFs treated with percutaneous vertebroplasty (PV) compared with PV in combination with intermediate bilateral pedicle screw fixation (IBPSF).
METHODS
A total of 110 patients with OF 4 in OVCFs from January 2011 to December 2013 were reviewed retrospectively and divided into two groups (group A: PV, group B: PV + IBPSF). According to the guidelines of the German Society for Orthopaedics and Trauma (DGOU), OF 4 consists of 3 fracture types. The clinical and radiographic assessments were observed preoperatively, postoperatively, and during follow-up.
RESULTS
The patients were followed for an average of 60.50 ± 15.20 months (group A) and 58.20 ± 17.60 months (group B) without significant differences. No significant differences were found in BMD, BMI and cement volume between the two groups, but differences were found for operation time, blood loss, and hospitalization time. The VAS and ODI scores improved better significantly at the final follow-up in group B but not in group A. Compared with the preoperative values, the postoperative kyphosis angle and loss of fractured segment height significantly improved, but the difference between the groups was significant after 3 months postoperatively. The loss of angular correction and fractured segment height in group A were greater than those in group B. A total of 15 cases of cement leakage were observed in group A and 8 cases in group B, and no complications or revision surgeries were observed in either group. Thirteen new fractures occurred (11 in group A and 2 in group B), which was significant.
CONCLUSION
PV with IBPSF could provide effective restoration and maintenance of fractured segment height and segment alignment as well as a lower rate of complications of OF 4 in OVCFs.
Topics: Aged; Aged, 80 and over; Bone Cements; Cohort Studies; Female; Fracture Fixation, Internal; Fractures, Compression; Humans; Kyphosis; Male; Middle Aged; Operative Time; Osteoporotic Fractures; Pedicle Screws; Postoperative Period; Reoperation; Retrospective Studies; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 31771582
DOI: 10.1186/s12893-019-0646-x -
Medicine Oct 2021Osteoporosis is a common condition that affects bones. Osteoporotic vertebral compression fracture (OVCF) is a highly prevalent complication related to osteoporosis....
BACKGROUND
Osteoporosis is a common condition that affects bones. Osteoporotic vertebral compression fracture (OVCF) is a highly prevalent complication related to osteoporosis. Each year, OVCF affects nearly 700,000 individuals. Nowadays, there are many surgical methods to treat OVCF, and each has distinct advantages. Among them, the efficacy and safeness of vertebroplasty are yet to be established. The present article will systematically ascertain the effectiveness and security of using vertebroplasty to treat OVCF.
METHODS
All articles related to the research topic published from establishment to July 2021 will be retrieved from the following e-databases Medline, Cochrane library, PubMed database, China National of Knowledge Infrastructure, Web of Science, Embase database, and WanFang database. The collected articles will be related to the use of vertebroplasty to treat OVCF. All included articles will adhere to the standards, and will be screened by 2 independent authors. After extracting the data in the article, Review Manager 5.3 software will be used for data analysis.
RESULTS
This study will assess the efficacy and safety of using vertebroplasty to treat OVCF by pooling the results of each study.
CONCLUSION
Our findings will present strong evidence to help determine whether vertebroplasty therapy is efficient and safe for OVCF patients.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Research Design; Spinal Fractures; Vertebroplasty; Meta-Analysis as Topic; Systematic Review as Topic
PubMed: 34678868
DOI: 10.1097/MD.0000000000027408