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Journal of Pain Research 2022This systematic review comprehensively compared balloon kyphoplasty and vertebroplasty with respect to height restoration and pain relief. (Review)
Review
PURPOSE OF REVIEW
This systematic review comprehensively compared balloon kyphoplasty and vertebroplasty with respect to height restoration and pain relief.
RECENT FINDINGS
PRISMA guidelines were utilized to compare balloon kyphoplasty and vertebroplasty, focusing on the primary outcome of height restoration and the secondary outcomes of pain relief and functionality. A total of 33 randomized controlled trials were included; 20 reviewed balloon kyphoplasty, 7 reviewed vertebroplasty, and 6 compared vertebroplasty to balloon kyphoplasty. Both treatments restored some vertebral body height and showed benefits in pain reduction and improved patient-reported functionality.
SUMMARY
Balloon kyphoplasty and vertebroplasty are effective treatments for vertebral compression fractures and this review suggests that balloon kyphoplasty may be favored for vertebral height restoration. Further studies are needed to conclude whether balloon kyphoplasty or vertebroplasty is superior for alleviating pain.
PubMed: 35509620
DOI: 10.2147/JPR.S344191 -
Health Technology Assessment... Mar 2014Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty... (Review)
Review
Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis.
BACKGROUND
Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty (BKP) is a variation of this approach, in which an inflatable balloon tamp is placed in the collapsed vertebra prior to cement injection.
OBJECTIVES
To systematically evaluate and appraise the clinical effectiveness and cost-effectiveness of PVP and percutaneous BKP in reducing pain and disability in people with osteoporotic vertebral compression fractures (VCFs) in England and Wales.
DATA SOURCES
A systematic review was carried out. Ten databases including MEDLINE and CINAHL were searched from inception to November 2011, and supplemented by hand-searching relevant articles and contact with an expert. Studies met the inclusion criteria if they were randomised controlled trials (RCTs) including people with painful osteoporotic VCFs with a group receiving PVP or BKP. In addition, lead authors of identified RCTs were contacted for unpublished data.
REVIEW METHODS
Primary outcomes were health-related quality of life; back-specific functional status/mobility; pain/analgesic use; vertebral body height and angular deformity; incidence of new vertebral fractures and progression of treated fracture. A manufacturer provided academic-in-confidence observational data indicating that vertebral augmentation may be associated with a beneficial mortality effect, and that, potentially, BKP was more efficacious than PVP. These data were formally critiqued. A mathematical model was constructed to explore the cost-effectiveness of BKP, PVP and operative placebo with local anaesthesia (OPLA) compared with optimal pain management (OPM). Six scenario analyses were conducted that assessed combinations of assumptions on mortality (differential beneficial effects for BKP and PVP; equal beneficial effects for BKP and PVP; and no effect assumed) and derivation of utility data (either mapped from visual analogue scale pain score data produced by a network meta-analysis or using direct European Quality of Life-5 Dimensions data from the trials). Extensive sensitivity analyses were conducted on each of the six scenarios. This report contains reference to confidential information provided as part of the National Institute for Health and Care Excellence appraisal process. This information has been removed from the report and the results, discussions and conclusions of the report do not include the confidential information. These sections are clearly marked in the report.
RESULTS
A total of nine RCTs were identified and included in the review of clinical effectiveness. This body of literature was of variable quality, with the two double-blind, OPLA-controlled trials being at the least risk of bias. The most significant methodological issue among the remaining trials was lack of blinding for both study participants and outcome assessors. Broadly speaking, the literature suggests that both PVP and BKP provide substantially greater benefits than OPM in open-label trials. However, in double-blinded trials PVP was shown to have no more benefit than local anaesthetic; no trials of BKP compared with local anaesthesia have been conducted. A formal analysis of observational mortality data undertaken within this report concluded that it was not possible to say with certainty if there is a difference in mortality between patients undergoing BKP and PVP compared with OPM. Results from the cost-effectiveness analyses were varied, with all of BKP, PVP and OPLA appearing the most cost-effective treatment dependent on the assumptions made regarding mortality effects, utility, hospitalisation costs and OPLA costs.
LIMITATIONS
Data on key parameters were uncertain and/or potentially confounded, making definitive conclusions difficult to make.
CONCLUSION
For people with painful osteoporotic VCFs refractory to analgesic treatment, PVP and BKP perform significantly better in unblinded trials than OPM in terms of improving quality of life and reducing pain and disability. However, there is as yet no convincing evidence that either procedure performs better than OPLA. The uncertainty in the evidence base means that no definitive conclusion on the cost-effectiveness of PVP or BKP can be provided. Further research should focus on establishing whether or not BKP and PVP have a mortality advantage compared with OPLA and on whether or not these provide any utility gain compared with OPLA.
STUDY REGISTRATION
This study was registered as PROSPERO number CRD42011001822.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Back Pain; Bone Cements; Cost-Benefit Analysis; England; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Quality of Life; Randomized Controlled Trials as Topic; Recovery of Function; Spinal Fractures; Technology Assessment, Biomedical; Vertebroplasty
PubMed: 24650687
DOI: 10.3310/hta18170 -
World Neurosurgery Jan 2022This study was designed to help elucidate the benefits and advantages of vertebroplasty combined with zoledronic acid (ZOL) versus vertebroplasty alone, to provide... (Meta-Analysis)
Meta-Analysis
Percutaneous Vertebroplasty Combined with Zoledronic Acid in Treatment and Prevention of Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis of Comparative Studies.
OBJECTIVE
This study was designed to help elucidate the benefits and advantages of vertebroplasty combined with zoledronic acid (ZOL) versus vertebroplasty alone, to provide clinical recommendations for the treatment of osteoporotic vertebral compression fractures (OVCFs) considering the current best-available evidence.
METHODS
We comprehensively searched PubMed, Embase, Web of Science, and the Cochrane Library and performed a systematic review and cumulative meta-analysis of all randomized controlled trials and retrospective comparative studies assessing these important indexes of 2 methods using Review Manager 5.4.
RESULTS
Four randomized controlled trials and 4 retrospective studies including 2335 cases were identified. Vertebroplasty combined with ZOL was associated with benefits from decreased pain (weighted mean difference [WMD] -0.43; 95% confidence interval [CI] -0.59 to -0.27; P < 0.05), increased function (WMD -4.94; 95% CI -6.13 to -3.75; P < 0.05), increased BMD of the vertebral body(WMD 0.85; 95% CI 0.30-1.40; P < 0.05) and of the proximal femoral neck (WMD 0.14; 95% CI 0.08-0.21; P < 0.05), fewer markers of bone metabolism (N-terminal molecular fragment: WMD -4.82; 95% CI -6.08 to -3.55; P < 0.05; procollagen type I N-terminal propeptide: WMD -17.31; 95% CI -18.04 to -16.58; P < 0.05; beta collagen degradation product: WMD -0.27; 95% CI -0.35 to -0.19; P < 0.05), and lower rate of refracture (1.54% and 12.6%; odds ratio 0.17; 95% CI 0.08-0.36; P < 0.05). Patients in the vertebroplasty combined with ZOL group had greater vertebral body height (WMD 2.17; 95% CI 0.72-3.62; P < 0.05) than in the vertebroplasty group, but no differences on Cobb angle were observed (WMD -1.18; 95% CI -2.47 to 0.10; P > 0.05).
CONCLUSIONS
Vertebroplasty combined with ZOL was superior to vertebroplasty alone in terms of BMD, bone metabolism makers, refracture rate, pain and function.
Topics: Aged; Bone Density Conservation Agents; Combined Modality Therapy; Female; Fractures, Compression; Humans; Male; Middle Aged; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Spinal Fractures; Vertebroplasty; Zoledronic Acid
PubMed: 34655820
DOI: 10.1016/j.wneu.2021.09.131 -
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 -
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 -
Ontario Health Technology Assessment... 2016Untreated vertebral compression fractures can have serious clinical consequences and impose a considerable impact on patients' quality of life and on caregivers. Since... (Review)
Review
BACKGROUND
Untreated vertebral compression fractures can have serious clinical consequences and impose a considerable impact on patients' quality of life and on caregivers. Since non-surgical management of these fractures has limited effectiveness, vertebral augmentation procedures are gaining acceptance in clinical practice for pain control and fracture stabilization. The objective of this analysis was to determine the cost-effectiveness and budgetary impact of kyphoplasty or vertebroplasty compared with non-surgical management for the treatment of vertebral compression fractures in patients with cancer.
METHODS
We performed a systematic review of health economic studies to identify relevant studies that compare the cost-effectiveness of kyphoplasty or vertebroplasty with non-surgical management for the treatment of vertebral compression fractures in adults with cancer. We also performed a primary cost-effectiveness analysis to assess the clinical benefits and costs of kyphoplasty or vertebroplasty compared with non-surgical management in the same population. We developed a Markov model to forecast benefits and harms of treatments, and corresponding quality-adjusted life years and costs. Clinical data and utility data were derived from published sources, while costing data were derived using Ontario administrative sources. We performed sensitivity analyses to examine the robustness of the results. In addition, a 1-year budget impact analysis was performed using data from Ontario administrative sources. Two scenarios were explored: (a) an increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario, maintaining the current proportion of kyphoplasty versus vertebroplasty; and (b) no increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario but an increase in the proportion of kyphoplasties versus vertebroplasties.
RESULTS
The base case considered each of kyphoplasty and vertebroplasty versus non-surgical management. Kyphoplasty and vertebroplasty were associated with an incremental cost-effectiveness ratio of $33,471 and $17,870, respectively, per quality-adjusted life-year gained. The budgetary impact of funding vertebral augmentation procedures for the treatment of vertebral compression fractures in adults with cancer in Ontario was estimated at about $2.5 million in fiscal year 2014/15. More widespread use of vertebral augmentation procedures raised total expenditures under a number of scenarios, with costs increasing by $67,302 to $913,386.
CONCLUSIONS
Our findings suggest that the use of kyphoplasty or vertebroplasty in the management of vertebral compression fractures in patients with cancer may be a cost-effective strategy at commonly accepted willingness-to-pay thresholds. Nonetheless, more widespread use of kyphoplasty (and vertebroplasty to a lesser extent) would likely be associated with net increases in health care costs.
Topics: Budgets; Cost-Benefit Analysis; Fractures, Compression; Humans; Kyphoplasty; Markov Chains; Models, Economic; Neoplasms; Ontario; Quality of Life; Quality-Adjusted Life Years; Vertebroplasty
PubMed: 27293494
DOI: No ID Found -
Osteoporosis International : a Journal... Nov 2011This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise,... (Review)
Review
This consensus article reviews the various aspects of the non-pharmacological management of osteoporosis, including the effects of nutriments, physical exercise, lifestyle, fall prevention, and hip protectors. Vertebroplasty is also briefly reviewed. Non-pharmacological management of osteoporosis is a broad concept. It must be viewed as an essential part of the prevention of fractures from childhood through adulthood and the old age. The topic also includes surgical procedures for the treatment of peripheral and vertebral fractures and the post-fracture rehabilitation. The present document is the result of a consensus, based on a systematic review and a critical appraisal of the literature. Diets deficient in calcium, proteins or vitamin D impair skeletal integrity. The effect of other nutriments is less clear, although an excessive consumption of sodium, caffeine, or fibres exerts negative effects on calcium balance. The deleterious effects of tobacco, excessive alcohol consumption and a low BMI are well accepted. Physical activity is of primary importance to reach optimal peak bone mass but, if numerous studies have shown the beneficial effects of various types of exercise on bone mass, fracture data as an endpoint are scanty. Fall prevention strategies are especially efficient in the community setting, but less evidence is available about their effectiveness in preventing fall-related injuries and fractures. The efficacy of hip protectors remains controversial. This is also true for vertebroplasty and kyphoplasty. Several randomized controlled studies had reported a short-term advantage of vertebroplasty over medical treatment for pain relief, but these findings have been questioned by recent sham-controlled randomized clinical studies.
Topics: Accidental Falls; Age Factors; Bone Density; Diet; Dietary Supplements; Exercise; Exercise Therapy; Female; Humans; Kyphoplasty; Life Style; Male; Osteoporosis; Osteoporotic Fractures; Postmenopause; Protective Devices; Risk Factors; Spinal Fractures; Vertebroplasty
PubMed: 21360219
DOI: 10.1007/s00198-011-1545-x -
European Spine Journal : Official... Sep 2012To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to... (Meta-Analysis)
Meta-Analysis Review
Balloon kyphoplasty versus percutaneous vertebroplasty in treating osteoporotic vertebral compression fracture: grading the evidence through a systematic review and meta-analysis.
OBJECTIVE
To assess the safety and efficacy of balloon kyphoplasty (KP) compared with percutaneous vertebroplasty (VP) and provide recommendations for using these procedures to treat osteoporotic vertebral compression fractures (OVCF).
METHODS
A systematic search of all studies published through March 2012 was conducted using the MEDLINE, EMBASE, OVID, ScienceDirect and Cochrane CENTRAL databases. The randomized controlled trials (RCTs) and non-randomized controlled trials that compared KP to VP and provided data on safety and clinical effects were identified. Demographic characteristics, adverse events and clinical outcomes were manually extracted from all of the selected studies. The evidence quality levels and recommendations were assessed using the GRADE system.
RESULTS
Twelve studies encompassing 1,081 patients met the inclusion criteria. Subgroup meta-analyses were performed according to the study design. In the RCT subgroup, there were significant differences between the two procedures in short-term visual analog scale (VAS), long-term kyphosis angles, operative times and anterior vertebrae heights. In the cohort study subgroup, there were significant differences between the two procedures in short- and long-term VAS, short- and long-term Oswestry Disability Index (ODI), cement leakage rates, short- and long-term kyphosis angles, operative times and anterior vertebrae heights. However, there were no significant differences in long-term VAS or adjacent vertebral fracture rates in the RCT subgroup. There were no significant differences in short- or long-term VAS, short- or long-term ODI, cement leakage rates, adjacent vertebral fracture rates, short- or long-term kyphosis angles or anterior vertebrae heights in the CCT subgroup, and the adjacent vertebral fracture rates did not differ significantly in the cohort study subgroup. The overall GRADE system evidence quality was very low, which lowers our confidence in their recommendations.
CONCLUSIONS
KP and VP are both safe and effective surgical procedures for treating OVCF. KP may be superior to VP in patients with large kyphosis angles, vertebral fissures, fractures in the posterior edge of the vertebral body or significant height loss in the fractured vertebrae. Due to the poor quality of the evidence currently available, high-quality RCTs are required.
Topics: Fractures, Compression; Humans; Kyphoplasty; Minimally Invasive Surgical Procedures; Osteoporotic Fractures; Pain; Recovery of Function; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 22832872
DOI: 10.1007/s00586-012-2441-6 -
AJNR. American Journal of Neuroradiology Jan 2014Studies examining the efficacy of vertebroplasty and kyphoplasty in patients with vertebral fractures from multiple myeloma are limited. We sought to perform a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND PURPOSE
Studies examining the efficacy of vertebroplasty and kyphoplasty in patients with vertebral fractures from multiple myeloma are limited. We sought to perform a systematic review of published case studies examining changes in pain, disability, and analgesic drug use in patients with multiple myeloma who have undergone vertebral augmentation.
MATERIALS AND METHODS
We performed a pooled analysis of published case series of vertebral augmentation in patients with multiple myeloma. Twenty-three studies (9 kyphoplasty, 12 vertebroplasty, and 2 of both) with data on 923 patients were identified from a PubMed search. Quantitative outcome data included the Visual Analog Scale, the Brief Pain Inventory, the Short Form 36 Health Survey, and the Owestry Disability Index. Time periods were consolidated into 3: postoperatively ≤1 week, 1 week to 1 year, and ≥1 year. Change in analgesic use was also studied. Data were compared by using nonparametric tests and matched t tests for temporally linked data.
RESULTS
Patients achieved a decrease in pain across all consolidated time periods. Pain, as measured on a 10-point scale, decreased by 4.8 points up to 1 week, 4.6 points up to 1 year, and 4.4 points after a year (P < .001). Decrease in pain was apparent early after treatment and was sustained with time. Kyphoplasty and vertebroplasty were equally effective in reducing pain scores because differences between procedures for each time period were insignificant (P < .9 for <1 week, P < 1.0 for ≤1 year, and P < .9 for >1 year.
CONCLUSIONS
Our analysis demonstrates that vertebral augmentation is effective in patients with multiple myeloma.
Topics: Adult; Aged; Aged, 80 and over; Causality; Comorbidity; Humans; Middle Aged; Multiple Myeloma; Pain; Pain Measurement; Prevalence; PubMed; Risk Factors; Spinal Neoplasms; Treatment Outcome; Vertebroplasty
PubMed: 23868153
DOI: 10.3174/ajnr.A3622