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Global Spine Journal Mar 2022Systematic review and meta-analysis.
STUDY DESIGN
Systematic review and meta-analysis.
OBJECTIVE
Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are minimally invasive techniques widely used for the treatment of neurologically intact osteoporotic Kümmell's disease (KD), but which treatment is preferable remains controversial. Therefore, this study aimed to shed light on this issue.
METHODS
Six databases were searched for all relevant studies based on the PRISMA guidelines. Two investigators independently conducted a quality assessment, extracted the data and performed all statistical analyses.
RESULTS
Eight studies encompassing 438 neurologically intact osteoporotic KD patients met the inclusion criteria. Compared to PVP, PKP was associated with greater improvement in the short- and long-term Cobb angle [SMD = -0.37, P = 0.007; SMD = -0.34, P = 0.012], short-term anterior vertebral height [SMD = 0.43, P = 0.003] and long-term middle vertebral height [SMD = 0.57, P = 0.012] and a lower cement leakage rate [SMD = 0.50, P = 0.003] but produced more consumption (cement injection volume, operative time, fluoroscopy times, intraoperative blood loss and operation cost). However, there were no differences between the 2 procedures in the short- and long-term VAS and ODI scores, long-term anterior vertebral height, overall complications or new vertebral fractures.
CONCLUSIONS
Both procedures are equally effective for neurologically intact KD in terms of the clinical outcomes, with the exception of a lower cement leakage risk and better radiographic improvement for PKP but greater resource consumption. Based on the evidence available, good clinical judgment should be exercised in the selection of patients for these procedures.
PubMed: 33541141
DOI: 10.1177/2192568220984129 -
Diagnostics (Basel, Switzerland) Mar 2023Vertebral body metastases (VBM) are one of the most frequent sites of bone metastasis, and their adequate therapeutic management still represents an insidious challenge... (Review)
Review
Radiofrequency Ablation in Vertebral Body Metastasis with and without Percutaneous Cement Augmentation: A Systematic Review Addressing the Need for SPINE Stability Evaluation.
Vertebral body metastases (VBM) are one of the most frequent sites of bone metastasis, and their adequate therapeutic management still represents an insidious challenge for both oncologists and surgeons. A possible alternative treatment for VBM is radiofrequency ablation (RFA), a percutaneous technique in which an alternating current is delivered to the tumor lesion producing local heating and consequent necrosis. However, RFA alone could alter the biomechanics and microanatomy of the vertebral body, thus increasing the risk of post-procedure vertebral fractures and spine instability, and indeed the aim of the present study is to investigate the effects of RFA on spine stability. A systematic review according to PRISMA-P guidelines was performed, and 17 papers were selected for the systematic review. The results show how RFA is an effective, safe, and feasible alternative to conventional radiotherapy for the treatment of VBM without indication for surgery, but spine stability is a major issue in this context. Although exerting undeniable benefits on pain control and local tumor recurrence, RFA alone increases the risk of spine instability and consequent vertebral body fractures and collapses. Concomitant safe and feasible therapeutic strategies such as percutaneous vertebroplasty and kyphoplasty have shown synergic positive effects on back pain and improvement in spine stability.
PubMed: 36980472
DOI: 10.3390/diagnostics13061164 -
The Spine Journal : Official Journal of... Aug 2022Osteoporotic vertebral fractures (OVF) dramatically increase with age and are serious life altering adverse events for seniors resulting in increased rates of... (Review)
Review
BACKGROUND CONTEXT
Osteoporotic vertebral fractures (OVF) dramatically increase with age and are serious life altering adverse events for seniors resulting in increased rates of institutionalization, morbidity and mortality. Given the expanding population of the elderly and increasing prevalence of OVFs, cost-effective treatment strategies need to be considered. Percutaneous vertebral augmentation (VA) procedures such as vertebroplasty (VP) or balloon kyphoplasty (BK) are increasingly employed to treat painful vertebral fractures not responding to conservative management (CM) of bedrest and analgesia. Both VA procedures have been shown to be effective treatments for OVFs in multiple systematic reviews of randomized controlled trials. In this systematic review, analytical strategies, designs and results were compared for health economic studies evaluating cost-effectiveness of VA procedures, VP or BK for OVFs. Furthermore, assessments of quality (risk of bias) were conducted for the systematic review and the individual studies with peer-reviewed checklists recommended for cost-effectiveness studies.
PURPOSE
To provide an up-to-date systematic review of peer-reviewed studies evaluating cost-effectiveness of VA procedures, VP or KP for OVFs to support treatment and health care funding decisions.
STUDY DESIGN
This study is a systematic literature review and structured narrative synthesis.
STUDY SAMPLE
Peer reviewed health economic studies reporting cost-effectiveness for VA procedures, VP or BK for OVFs OUTCOME MEASURES: The following information extracted from the studies included: report country and year, study design, comparators, population, perspective, health valuations, costing sources and cost-effectiveness measures. For economic studies involving modeling, information was also extracted for model type, time horizon, key model drivers, and handling of uncertainty. Incremental cost-effectiveness ratio (ICER), the ratio of differences between comparator treatment groups in costs and health benefits, was considered the main cost-effectiveness measure.
METHODS
A systematic review was conducted of MEDLINE, EMBASE, CINAHL, ECONLIT, Cochrane Library and DARE databases up to the review date May 2021. Studies were reviewed for those reporting cost-effectiveness analyses on VA procedures including VP or BK for OVFs. Studies including only costs, abstracts, editorials, methodologies and reviews were not included. The selection of articles was reported in line with PRISMA guidance. A descriptive framework was developed to classify types of cost-effectiveness studies based on methodological differences and a structured narrative synthesis was used to summarize studies. Quality assessments were made with British Medical Journal checklist for individual cost-effectiveness studies and the CiCERO checklist for systematic reviews of cost-effectiveness studies.
RESULTS
In this systematic review, 520 references were identified through database searching and 501 were excluded as ineligible by titles and abstract based on prior eligibility criteria. From full-text reviews of 19 reports, ten were identified as eligible for the systematic review evaluating cost-effectiveness of VA procedures for OVFs. All references were published between 2008 and 2020. The ten cost-effectiveness studies, three for VP, three for BK and four for both VP and BK, all involved CM for OVFs as a treatment comparator. The studies involved different methods of economic analysis, modeling assumptions, cost and health valuations conducted in different health care setting over different time periods. A framework for the review outlines key features of cost-effectiveness study designs consisting of unmatched, matched, or randomized controls involving cost-effectiveness or cost-utility) analyses. Both VP and BK were cost-effective alternatives to CM for OVFs with earlier health gains and significantly shorter hospital stays. Cost-effectiveness estimates, ICERs, remained relatively stable and within willingness-to-pay thresholds under a range of sensitivity analyses. Comparisons between VP and BK were variable depending on modeling assumptions, but generally the procedures had similar health benefit gains with VP having lower acute procedural costs.
CONCLUSIONS
Both VP and BK, have been shown to be cost-effective alternatives to CM for osteoporotic vertebral fractures in diverse cost-effectiveness studies conducted in multiple health care settings. Trial-based cost-utility contributed the strongest evidence supporting cost-effectiveness determination for VP and BK for OVFs.
Topics: Aged; Cost-Benefit Analysis; Humans; Kyphoplasty; Osteoporotic Fractures; Pain; Spinal Fractures; Vertebroplasty
PubMed: 35257838
DOI: 10.1016/j.spinee.2022.02.013 -
Frontiers in Surgery 2022Percutaneous vertebroplasty (PVP), percutaneous kyphoplasty (PKP), and bone-filling mesh containers(BFC) are three viable minimally invasive techniques that have been... (Review)
Review
BACKGROUND
Percutaneous vertebroplasty (PVP), percutaneous kyphoplasty (PKP), and bone-filling mesh containers(BFC) are three viable minimally invasive techniques that have been used to treat Kümmell's disease(KD). However, there is still debate as to which is safer and more effective. This study summarized the pros and cons of the three techniques in the treatment of KD through network meta-analysis(NMA).
METHODS
All eligible published clinical control studies comparing PVP, PKP, and BFC for KD up to December 2021 were collected by online search of Cochrane Library, PubMed, Embase, CNKI, Wanfang Database, and Chinese biomedical literature database. Data were extracted after screening, and Stata 16.0 software was used to perform the network meta-analysis.
RESULTS
Four randomized controlled trials (RCTs) and 16 retrospective case-control studies (CCTs) with a total of 1114 patients were included. The NMA results showed no statistical difference between the 3 procedures in terms of improving patients' clinical symptoms. PKP was most likely to be the most effective in correcting kyphosis, while BFC was likely to be the most effective in managing the occurrence of cement leakage. No statistical differences were found in the incidence of new vertebral fractures in adjacent segments.
CONCLUSIONS
Ranking analysis showed that BFC has the highest likelihood of being the optimal procedure for the treatment of KD, based on a combined assessment of effectiveness in improving patients' symptoms and safety in the occurrence of adverse events.
PubMed: 35722530
DOI: 10.3389/fsurg.2022.893404 -
Journal of Neurointerventional Surgery Sep 2020Osteolytic lesions of the atlas (C1) are challenging to treat by vertebroplasty due to the vicinity of the vertebral artery and the spinal cord.
BACKGROUND
Osteolytic lesions of the atlas (C1) are challenging to treat by vertebroplasty due to the vicinity of the vertebral artery and the spinal cord.
OBJECTIVE
To present our experience with transoral vertebroplasty (TOV) for osteolytic lesions of the lateral mass of the atlas.
METHODS
Retrospective case series involving 15 consecutive patients (nine male, six female, mean age 63 years) who underwent TOV for the treatment of an osteolytic lesion of the lateral mass of the atlas. Among the osteolytic lesions, 10/15 (67%) were bone metastases from various cancers; 4/15 (27%) were lesions related to multiple myeloma; and one lesion (7%) was an aggressive hemangioma. All the TOVs were performed under general anesthesia and in most cases (10/15; 67%) in a hybrid angiosuite combining a C-arm flat panel and a CT scan. The remaining five patients were treated under biplane fluoroscopic guidance.
RESULTS
Vertebroplasty of the lateral mass of C1 through a transoral route was feasible in all cases. Significant pain relief was obtained in most cases (1 month average decrease in Numeric Rating Scale: 4.9±4.1). No major complication was recorded. In 7/15 cases (47%), cement leakage surrounding the C1 lateral mass was seen; none of these leakages had a significant clinical consequence. No additional spine surgery was required in any of the patients.
CONCLUSION
TOV of osteolytic lesions of the lateral mass of the atlas is feasible and seems safe and effective, providing pain relief and bone stabilization.
Topics: Adult; Aged; Aged, 80 and over; Bone Cements; Cervical Vertebrae; Cohort Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Spinal Neoplasms; Tomography, X-Ray Computed; Vertebroplasty
PubMed: 32354844
DOI: 10.1136/neurintsurg-2020-015853 -
Joint Diseases and Related Surgery Jan 2024The study aimed to compare the efficacy and safety of percutaneous kyphoplasty (PKP) and vertebral body stenting (VBS) in the treatment of osteoporotic vertebral... (Meta-Analysis)
Meta-Analysis
Comparison of clinical and radiological outcomes of vertebral body stenting versus percutaneous kyphoplasty for the treatment of osteoporotic vertebral compression fracture: A systematic review and meta-analysis.
OBJECTIVES
The study aimed to compare the efficacy and safety of percutaneous kyphoplasty (PKP) and vertebral body stenting (VBS) in the treatment of osteoporotic vertebral compression fractures (OVCFs) and evaluate the clinical efficacy, Cobb angle correction, and cement leakage associated with both methods for OVCFs.
PATIENTS AND METHODS
A systematic search was conducted in PubMed, EMBASE, Cochrane Library, Medline, China National Knowledge, and Wanfang Data for clinical studies comparing VBS with PKP for OVCF up to May 2023. The meta-analysis was performed using Review Manager 5.3, with a focus on evaluating clinical and radiologic outcomes.
RESULTS
A total of eight eligible clinical studies were included in this meta-analysis. In terms of clinical outcomes, VBS was found to have a longer surgical time compared to PKP (standard mean difference [SMD]=1.06 min; 95% confidence interval [CI]: 0.20, 1.92; p=0.02). However, VBS demonstrated comparable blood loss to PKP (SMD =0.00 mL; 95% CI: -0.45, 0.45; p=0.99). Additionally, VBS showed slight superiority in alleviating back pain as measured by the Visual Analog Scale (VAS) (SMD=-0.38; 95% CI: -0.63, -0.12; p=0.004), as well as in improving functional disability based on the Oswestry Disability Index (ODI) (SMD= -0.28; 95% CI: -0.54, -0.03; p=0.03). Radiographically, VBS achieved better Cobb angle correction compared to PKP (SMD= -1.00; 95% CI: -1.48, -0.51; p<0.0001), while there was no significant difference in cement leakage between VBS and PKP (odds ratio=0.81; 95% CI: 0.21, 3.14; p=0.76).
CONCLUSION
The findings suggest that VBS has a comparable clinical outcome to PKP based on operation time, intraoperative blood loss, VAS, and ODI. Furthermore, VBS showed slightly better maintenance of Cobb angle correction, whereas VBS did not demonstrate a significant advantage over PKP in terms of cement leakage.
Topics: Humans; Kyphoplasty; Fractures, Compression; Spinal Fractures; Vertebral Body; Osteoporotic Fractures; Bone Cements
PubMed: 38108184
DOI: 10.52312/jdrs.2023.1356 -
International Journal of Surgery... May 2022Pulmonary cement embolism (PCE) was a rare but fatal complication for percutaneous vertebral augmentation (PVA). Thus we did a systematic review and meta-analysis of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pulmonary cement embolism (PCE) was a rare but fatal complication for percutaneous vertebral augmentation (PVA). Thus we did a systematic review and meta-analysis of cohort studies to investigate the risk factors for PCE after PVA.
METHODS
We systematically searched PubMed, EMBASE, Cochrane library, Google Scholar, web of science, and ClinicalTrial.gov from the establishment of the database to September 2021. All eligible studies assessing the risk factors for PCE after PVA were incorporated. Dichotomous data was calculated by risk difference (RD) from Mantel-Haenszel method (M - H method); continuous data was analyzed by mean difference (MD) from Inverse-Variance method (I-V method). All variables were taken as measure of effect by fixed effect model. Heterogeneity, sensitivity, and publication bias analyses were also performed.
RESULTS
This study totally included 13 studies. According to the Newcastle-Ottawa Scale (NOS), 7 studies were considered as low quality, with NOS< 6. The others were of relatively high quality, with NOS≥6. 144/6251 patients (2.3%) had PCE after PVA. percutaneous vertebroplasty (PVP) (RD = 0.02, 95%CI: [0.01, 0.04], Z = 3.70, P < 0.01), thoracic vertebra (RD = 0.03, 95%CI: [0.01, 0.05], Z = 3.53, P < 0.01), higher cement volume injected per level (MD = 0.23, 95%CI: [0.05, 0.42], Z = 2.44, P = 0.01), more than three vertebrae treated per session (MD = -0.05, 95%CI: [-0.08, -0.02], Z = 3.65, P < 0.01), venous cement leakage (RD = 0.07, 95%CI: [0.03, 0.11], Z = 3.79, P < 0.01) were more likely to cause PCE.
CONCLUSION
This study showed that risk factors for PCE included PVP, thoracic vertebra, higher cement volume injected per level, more than three vertebrae treated per session, venous cement leakage. As a serious complication, PCE should be paid attention and avoided.
Topics: Bone Cements; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Pulmonary Embolism; Risk Factors; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 35452848
DOI: 10.1016/j.ijsu.2022.106632 -
BioMed Research International 2021We conducted this meta-analysis to provide better evidence of the efficacy and safety of zoledronic acid (ZA) combined with percutaneous vertebroplasty/kyphoplasty... (Meta-Analysis)
Meta-Analysis
Clinical Efficacy and Safety of Zoledronic Acid Combined with PVP/PKP in the Treatment of Osteoporotic Vertebral Compression Fracture: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
OBJECTIVE
We conducted this meta-analysis to provide better evidence of the efficacy and safety of zoledronic acid (ZA) combined with percutaneous vertebroplasty/kyphoplasty (PVP/PKP) on osteoporotic vertebral compression fracture (OVCF) and proposed a protocol for its application in clinical practice.
METHODS
All randomized controlled trials (RCTs) of ZA combined with PVP or PKP compared to individual PVP/PKP for the management of patients with OVCFs were included in this study. Electronic database searches were conducted from database inception to November 2020, including the Cochrane Library, PubMed, Web of Science, and Embase. The pooled data were analyzed using RevMan 5.3 software.
RESULTS
Seven RCTs with 929 subjects were finally included. All included studies reported visual analog scores (VAS), and no statistically significant differences were identified at follow-ups of 3 d and 1 w ( > 0.05). In contrast, significant differences were observed at the 1 mo, 3 mo, 6 mo, and 12 mo follow-ups ( < 0.05). Two trials reported the Cobb angle and vertebral body height (VBH), including 182 subjects without significant differences at the 12 mo follow-up ( > 0.05). In addition, significant differences in the bone mineral density (BMD), -isomerized C-terminal telopeptide of type I collagen (-CTX), N-terminal propeptide of type I collagen (PINP), and N-terminal molecular fragment (N-MID) levels were observed between the two groups ( < 0.05). All trials reported side effects. Significant differences in recurrent fractures, fever, flu-like symptoms, and arthralgia or myalgia were identified ( < 0.05); however, no significant difference in postoperative leakage was detected ( > 0.05).
CONCLUSION
Compared to PVP/PKP alone, an additional ZA injection had advantages of long-term analgesic effects with improved bone metabolism indexes. Moreover, combination therapy significantly prevented complications and drug reactions were well tolerated. Overall, this systematic review revealed that ZA combined with PVP/PKP was an effective, safe, and comprehensive therapy for patients with OVCFs.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Spinal Fractures; Treatment Outcome; Vertebroplasty; Zoledronic Acid
PubMed: 33928158
DOI: 10.1155/2021/6650358 -
Alternative Therapies in Health and... Jul 2022Osteoporotic vertebral compression fractures (OVCFs) are acknowledged to be common fractures, especially in the elderly population. Minimally invasive percutaneous... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIM
Osteoporotic vertebral compression fractures (OVCFs) are acknowledged to be common fractures, especially in the elderly population. Minimally invasive percutaneous methods of treatment for these fractures such as kyphoplasty (KP) and vertebroplasty (VP) have been valid and effective tools for decreasing clinical problems, which are associated with more beneficial effects compared with traditional methods such as open surgery or conservative treatment. Hence, we conducted the current meta-analysis in order to gather updated evidence for the systematic assessment of clinical and radiographic outcomes of KP compared with VP.
METHODS
We searched articles published based on the electronic databases, including PubMed, EMBASE, and Cochrane Library. Publications of studies comparing KP with VP in the treatment of OVCFs were collected. After rigorous and thorough review of study quality, we extracted the data on the basis of eligible trials, which analyzed the summary hazard ratios (HRs) of the end points of interest.
RESULTS
Our inclusion criteria involved a total of 6 studies. In total, data from 644 patients, 330 who received VP and 284 who received KP, were included in the review. There was no significant difference in either group in terms of visual analog scale (VAS) scores (MD = 0.17; 95% CI, -0.39 to 0.73; P = .56), risk of cement leakage (odds ratio [OR] = 1.31; 95% CI, 0.62 to 2.74; P = .47) or Oswestry Disability Index (ODI) scores (MD = 0.51; 95% CI, -1.87 to 2.88; P = .68). Nevertheless, the injected cement volume (MD = -0.52; 95% CI, -0.88 to -0.15; P = .005) in the VP group was linked to a markedly lower statistically significant trend compared with the KP group.
CONCLUSION
This meta-analysis evaluated acceptable efficacy levels across the involved trials. VP injected cement volume had several advantages in this meta-analysis. Yet, no significant differences were observed in terms of VAS scores, ODI scores, or cement leakage when KP was compared to VP therapy. Given the combined results of our study, the optimal treatment for patients with OVCFs should be determined by further high-quality multicenter randomized controlled trials with longer follow-up and larger sample sizes.
Topics: Aged; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 35648693
DOI: No ID Found -
BMJ Open Jul 2023Although there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is...
OBJECTIVE
Although there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is less well known. The objective of this study is to provide a systematic review of cost-effectiveness studies and policy-based willingness-to-pay (WTP) thresholds for different vertebral augmentation (VA) procedures, vertebroplasty (VP) and balloon kyphoplasty (BK), for osteoporotic vertebral fractures (OVFs).
DESIGN
A systematic review targeting cost-effectiveness studies of VA procedures for OVFs.
DATA SOURCES
Six bibliographic databases were searched from inception up to May 2021.
ELIGIBILITY CRITERIA FOR STUDY SELECTION
Studies were eligible if meeting all predefined criteria: (1) VP or BK intervention, (2) OVFs and (3) cost-effectiveness study. Articles not written in English, abstracts, editorials, reviews and those reporting only cost data were excluded.
DATA EXTRACTION AND SYNTHESIS
Information was extracted on study characteristics, cost-effective estimates, summary decisions and payer WTP thresholds. Incremental cost-effective ratio (ICER) was the main outcome measure. Studies were summarised by a structured narrative synthesis organised by comparisons with conservative management (CM). Two independent reviewers assessed the quality (risk of bias) of the systematic review and cost-effectiveness studies by peer-reviewed checklists.
RESULTS
We identified 520 references through database searching and 501 were excluded as ineligible by titles and abstract. Ten reports were identified as eligible from 19 full-text reviews. ICER for VP versus CM evaluated as cost per quality-adjusted life-year (QALY) ranged from €22 685 (*US$33 395) in Netherlands to £-2240 (*US$-3273), a cost-saving in the UK. ICERs for BK versus CM ranged from £2706 (*US$3954) in UK to kr600 000 (*US$90 910) in Sweden. ICERs were within payer WTP thresholds for a QALY based on historical benchmarks.
CONCLUSIONS
Both VP and BK were judged cost-effective alternatives to CM for OVFs in economic studies and were within WTP thresholds in multiple healthcare settings.
Topics: Humans; Cost-Benefit Analysis; Vertebroplasty; Kyphoplasty; Spinal Fractures; Outcome Assessment, Health Care; Osteoporotic Fractures
PubMed: 37491092
DOI: 10.1136/bmjopen-2022-062832