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European Spine Journal : Official... Sep 2021This study aims to determine whether outcomes following vertebroplasty with high viscosity cement are superior to low viscosity cement and non-inferior to kyphoplasty in... (Meta-Analysis)
Meta-Analysis Review
Comparison between vertebroplasty with high or low viscosity cement augmentation or kyphoplasty in cement leakage rate for patients with vertebral compression fracture: a systematic review and network meta-analysis.
PURPOSE
This study aims to determine whether outcomes following vertebroplasty with high viscosity cement are superior to low viscosity cement and non-inferior to kyphoplasty in the setting of vertebral compression fractures.
METHODS
We searched for randomized controlled trials and cohort studies assessing cement leakage rate in adult patients with VCFs who underwent vertebroplasty with high (HVCV) or low viscosity cement (LVCV) augmentation, or kyphoplasty (KP) in PubMed, Embase, Ovid, The Cochrane Library, and Web of Science from inception up to December 2019. Two authors extracted data and appraised risk of bias. We performed pairwise meta-analyses in R to compare differences between three treatments and network meta-analysis using frequentist random-effects models for indirect comparison. We used P-score to rate the overall certainty of evidence. The primary outcome was cement leakage rate.
RESULTS
Five RCTs and eight cohort studies with 840 patients and a total of 1280 vertebral bodies were included in the systematic review and network meta-analysis. Compared to LVCV, the relative risk for cement leakage following HVCV and KP was 0.42 (95% CI 0.28-0.61) and 0.83 (95% CI 0.40-1.68), respectively. Our pooled results suggested that HVCV (P-score = 0.99) was better than KP (P-score = 0.36) in cement leakage rate.
CONCLUSIONS
The present network meta-analysis demonstrated that HVCV may be associated with lower risk of cement leakage among patients with VCFs as compared to other augmentation techniques. Future prospective studies will validate the findings of this analysis and further elucidate the risk of symptomatic cement leakage.
Topics: Fractures, Compression; Humans; Kyphoplasty; Network Meta-Analysis; Prospective Studies; Spinal Fractures; Vertebroplasty; Viscosity
PubMed: 33185740
DOI: 10.1007/s00586-020-06636-9 -
Fukuoka Igaku Zasshi = Hukuoka Acta... Sep 2007
Review
Topics: Bone Cements; Contraindications; Diagnostic Imaging; Fractures, Compression; Humans; Osteoporosis; Polymethyl Methacrylate; Spinal Fractures; Vertebroplasty
PubMed: 17974077
DOI: No ID Found -
Maturitas May 2012After more than two decades the treatment effect of cement augmentation of osteoporotic vertebral compression fractures (VCF) has now been questioned by two blinded... (Comparative Study)
Comparative Study Review
Vertebroplasty and kyphoplasty--a systematic review of cement augmentation techniques for osteoporotic vertebral compression fractures compared to standard medical therapy.
After more than two decades the treatment effect of cement augmentation of osteoporotic vertebral compression fractures (VCF) has now been questioned by two blinded randomised placebo-controlled trials. Thus many practitioners are uncertain on the recommendation for cement augmentation techniques in elderly patients with osteoporotic VCF. This systematic review analyses randomised controlled trials on vertebroplasty and kyphoplasty to provide an overview on the current evidence. From an electronic database research 8 studies could be identified meeting our inclusion criteria of osteoporotic VCF in elderly (age>60 years), treatment with vertebroplasty or kyphoplasty, controlled with placebo or standard medical therapy, quality of life, function, or pain as primary parameter, and randomisation. Only two studies were properly blinded using a sham-operation as control. The other studies were using a non-surgical treatment control group. Further possible bias may be caused by manufacturer involvement in financing of three published RCT. There is level Ib evidence that vertebroplasty is no better than placebo, which is conflicting with the available level IIb evidence that there is a positive short-term effect of cement augmentation compared to standard medical therapy with regard to QoL, function and pain. Kyphoplasty is not superior to vertebroplasty with regard to pain, but with regard to VCF reduction (evidence level IIb). Kyphoplasty is probably not cost-effective (evidence level IIb), and vertebroplasty has not more than short-term cost-effectiveness (evidence level IV). Vertebroplasty and kyphoplasty cannot be recommended as standard treatment for osteoporotic VCF. Ongoing sham-controlled trials may provide further evidence in this regard.
Topics: Bone Cements; Fractures, Compression; Humans; Kyphoplasty; Osteoporosis; Osteoporotic Fractures; Spinal Fractures; Standard of Care; Vertebroplasty
PubMed: 22425141
DOI: 10.1016/j.maturitas.2012.02.010 -
Orthopaedic Surgery Oct 2023This systematic review and meta-analysis is aimed to provide higher quality evidence regarding the efficacy and safety between PCVP and PVP/KP in OVCFs. We searched the... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis is aimed to provide higher quality evidence regarding the efficacy and safety between PCVP and PVP/KP in OVCFs. We searched the Cochrane Library, PubMed, Web of Science, and Embase databases for all randomized controlled trials (RCTs) and observational studies (cohort or case-control studies) that compare PCVP to PVP/KP for OVCFs. The Cochrane Collaboration's Risk of Bias Tool and Newcastle-Ottawa Scale (NOS) were used to evaluate the quality of the RCTs and non-RCTs, respectively. Meta-analysis was performed using RevMan 5.4 software. A total of seven articles consisting of 562 patients with 593 diseased vertebral bodies were included. Statistically significant differences were found in the postoperative visual analog scale (VAS) at 1 day (MD = -0.11; 95% CI: [-0.21 to -0.01], p = 0.03), but not at 3 months (MD = -0.21; 95% CI: [-0.41-0.00], p = 0.05) or 6 months (MD = 0.03; 95% CI: [-0.13-0.20], p = 0.70). There was no statistically significant difference in postoperative Oswestry disability index (ODI) at 1 day (MD = -0.28; 95% CI: [-0.62-0.05], p = 0.10), 3 months (MD = -1.52; 95% CI: [-3.11-0.07], p = 0.06), or 6 months (MD = 0.18; 95% CI: [-0.13-0.48], p = 0.25). Additionally, there were no statistically significant differences in Cobb angle (MD = 0.30; 95% CI: [-1.69-2.30], p = 0.77) or anterior vertebral body height (SMD = -0.01; 95% CI: [-0.26-0.23], p = 0.92) after surgery. Statistically significant differences were found in surgical time (MD = -8.60; 95% CI: [-13.75 to -3.45], p = 0.001), cement infusion volume (MD = -0.82; 95% CI: [-1.50 to -0.14], P = 0.02), and dose of fluoroscopy (SMD = -1.22; 95% CI: [-1.84 to -0.60], p = 0.0001) between curved and noncurved techniques, especially compared to bilateral PVP. Moreover, cement leakage showed statistically significant difference (OR = 0.40; 95% CI: [0.27-0.60], p < 0.0001). Compared with PVP/KP, PCVP is superior for pain relief at short-term follow-up. Additionally, PCVP has the advantages of significantly lower surgical time, radiation exposure, bone cement infusion volume, and cement leakage incidence compared to bilateral PVP, while no statistically significant difference is found when compared with unilateral PVP or PKP. In terms of quality of life and radiologic outcomes, the effects of PCVP and PVP/KP are not significantly different. Overall, this meta-analysis reveals that PCVP was an effective and safe therapy for patients with OVCFs.
Topics: Humans; Fractures, Compression; Vertebroplasty; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures; Bone Cements; Treatment Outcome
PubMed: 37497571
DOI: 10.1111/os.13800 -
The Spine Journal : Official Journal of... Dec 2013Percutaneous augmentation with bone cement is a widely accepted modality of treatment for thoracic and lumbar vertebral osteoporotic fractures. Infection after... (Review)
Review
BACKGROUND CONTEXT
Percutaneous augmentation with bone cement is a widely accepted modality of treatment for thoracic and lumbar vertebral osteoporotic fractures. Infection after vertebroplasty or kyphoplasty is a serious, yet, rarely reported complication.
PURPOSE
To present a case series with a long-term follow-up of spinal infection after vertebroplasty/kyphoplasty with analysis of preoperative condition, risk factors, diagnostic findings, time before reoperation, causative organism, treatment, and outcome.
STUDY DESIGN
A retrospective, uncontrolled clinical case series in a single institution.
PATIENT SAMPLE
Between January 1997 and June 2012, 1,307 patients underwent percutaneous vertebroplasty or kyphoplasty. Six cases had postoperative infection (0.46%) and three additional cases were referred from other institutions for salvage treatment.
OUTCOME MEASURES
Perioperative assessment included visual analog scale, clinical, laboratory, and imaging findings, and activities of daily living at the end of the follow-up.
METHODS
Nine patients were included: six females and three males (mean age 73.8 years). Comorbidities were found in all patients. Kyphoplasty had been done in five patients and vertebroplasty in four.
RESULTS
The interval between augmentation and revision surgery ranged from 10 to 395 days with a mean of 118.4 days. Three cases with early infection presented within 1 month. Infection parameters were high in all patients at readmission. All patients were treated surgically except one case who died before the planned revision surgery. In all cases, debridement and corpectomy were done through anterior approaches combined with posterior instrumentation. The most common causative organism was Staphylococcus aureus in three cases. Mean follow-up period after the revision surgery was 26.68 months, excluding two patients who died early in the follow-up (within 4 months). This amounts to a mortality rate of 33.3% perioperatively. At the end of follow-up, two patients had unrestricted activities and one patient required a walker. Of three paraparetic patients, two improved functionally and could walk unassisted and one improved but still used a wheelchair.
CONCLUSIONS
Although vertebroplasty and kyphoplasty are minimally invasive interventions, postoperative infection can develop into life-threatening complications. This should be accounted for, in decision making in the elderly age group most commonly affected by osteoporotic fractures and especially in suspicious and high-risk immune-compromised patients.
Topics: Aged; Aged, 80 and over; Comorbidity; Female; Humans; Infections; Kyphoplasty; Male; Middle Aged; Postoperative Complications; Risk Factors; Vertebroplasty
PubMed: 23880354
DOI: 10.1016/j.spinee.2013.05.053 -
Neuro-Chirurgie Jan 2023To better understand the explanatory-pragmatic distinction in the design and interpretation of randomized controlled trials (RCTs). (Review)
Review
OBJECTIVES
To better understand the explanatory-pragmatic distinction in the design and interpretation of randomized controlled trials (RCTs).
METHODS
We review the explanatory-pragmatic distinction in clinical trial design. We use the PRECIS-2 tool to evaluate the trial design of selected RCTs on percutaneous vertebroplasty for osteoporotic vertebral compression fractures. We discuss difficulties in the selection of criteria and in the construction of PRECIS diagrams. We also examine how inconsistency in the selection of various items of trial design can cause confusion in the interpretation of results.
RESULTS
The selection of criteria and the scoring of multiple PRECIS domains were subjective and thus debatable. The pragmascope patterns of various vertebroplasty trials were heterogeneous. Many trials had both pragmatic and explanatory components. Some placebo-controlled trial goals seem to have been explanatory, but their design actually included enough pragmatic items such that the meaning of negative trial results remains ambiguous.
CONCLUSION
The results of a trial cannot be interpreted without understanding the various design choices made along the explanatory-pragmatic spectrum.
Topics: Humans; Randomized Controlled Trials as Topic; Research Design; Vertebroplasty; Fractures, Compression; Spinal Fractures
PubMed: 36566693
DOI: 10.1016/j.neuchi.2022.101403 -
Journal of Vascular and Interventional... Feb 2014
Review
Topics: Evidence-Based Medicine; Fractures, Compression; Humans; Patient Selection; Quality Improvement; Quality Indicators, Health Care; Radiography, Interventional; Radiology, Interventional; Risk Assessment; Risk Factors; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 24238815
DOI: 10.1016/j.jvir.2013.09.004 -
Neuro-Chirurgie Jan 2023
Topics: Humans; Research Design; Vertebroplasty; Spinal Fractures
PubMed: 36608448
DOI: 10.1016/j.neuchi.2022.101400 -
Pain Medicine (Malden, Mass.) Nov 2010
Topics: Fractures, Compression; Humans; Randomized Controlled Trials as Topic; Spinal Fractures; Vertebroplasty
PubMed: 21044252
DOI: 10.1111/j.1526-4637.2010.00984.x -
Pain Physician 2017Because of an aging population,osteoporotic vertebral fractures are becoming more frequent.Conservative therapy was considered the gold standard for treating... (Meta-Analysis)
Meta-Analysis Review
Does Percutaneous Vertebroplasty or Balloon Kyphoplasty for Osteoporotic Vertebral Compression Fractures Increase the Incidence of New Vertebral Fractures? A Meta-Analysis.
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 are widely 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 or a 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 two 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.
Topics: Controlled Clinical Trials as Topic; Fractures, Compression; Humans; Incidence; Kyphoplasty; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 28072794
DOI: No ID Found