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Trials Jun 2023Many randomized trials that aim to assess new or commonly used medical or surgical interventions have been so small that the validity of conclusions becomes questionable.
BACKGROUND
Many randomized trials that aim to assess new or commonly used medical or surgical interventions have been so small that the validity of conclusions becomes questionable.
METHODS
We illustrate the small trial problem using the power calculation of five Cochrane-reviewed studies that compared vertebroplasty versus placebo interventions. We discuss some of the reasons why the statistical admonition not to dichotomize continuous variables may not apply to the calculation of the number of patients required for trials to be meaningful.
RESULTS
Placebo-controlled vertebroplasty trials planned to recruit between 23 and 71 patients per group. Four of five studies used the standardized mean difference of a continuous pain variable (centimeters on the visual analog scale (VAS)) to plan implausibly small trials. What is needed is not a mean effect at the population level but a measure of efficacy at the patient level. Clinical practice concerns the care of individual patients that vary in many more respects than the variation around the mean of a single selected variable. The inference from trial to practice concerns the frequency of success of the experimental intervention performed one patient at a time. A comparison of the proportions of patients reaching a certain threshold is a more meaningful method that appropriately requires larger trials.
CONCLUSION
Most placebo-controlled vertebroplasty trials used comparisons of means of a continuous variable and were consequently very small. Randomized trials should instead be large enough to account for the diversity of future patients and practices. They should offer an evaluation of a clinically meaningful number of interventions performed in various contexts. Implications of this principle are not specific to placebo-controlled surgical trials. Trials designed to inform practice require a per-patient comparison of outcomes and the size of the trial should be planned accordingly.
Topics: Humans; Pain; Randomized Controlled Trials as Topic; Vertebroplasty
PubMed: 37349843
DOI: 10.1186/s13063-023-07348-3 -
Cardiovascular and Interventional... Nov 2023Vertebroplasty has emerged over the last 30 years as a common treatment for painful osteoporotic vertebral fractures. Patient selection and the time at which... (Review)
Review
Vertebroplasty has emerged over the last 30 years as a common treatment for painful osteoporotic vertebral fractures. Patient selection and the time at which vertebroplasty is offered to the patient varies between centres and regions. Vertebroplasty has been studied in comparison to placebo intervention in five blinded trials. One such trial showed more benefit from vertebroplasty than placebo when the procedure was mostly performed within 3 weeks of fracture onset. Others showed no additional benefit from vertebroplasty compared to placebo when it was performed later in the natural history of the fracture. In this review, we examine data from blinded and open label randomised studies of vertebroplasty for evidence relating specifically to the use of early vertebroplasty for patients with severely painful acute osteoporotic fractures.
Topics: Humans; Osteoporotic Fractures; Fractures, Compression; Spinal Fractures; Pain; Vertebroplasty; Treatment Outcome
PubMed: 36656324
DOI: 10.1007/s00270-022-03348-z -
Ontario Health Technology Assessment... 2016Cancers that metastasize to the spine and primary cancers such as multiple myeloma can result in vertebral compression fractures or instability. Conservative strategies,... (Review)
Review
BACKGROUND
Cancers that metastasize to the spine and primary cancers such as multiple myeloma can result in vertebral compression fractures or instability. Conservative strategies, including bed rest, bracing, and analgesic use, can be ineffective, resulting in continued pain and progressive functional disability limiting mobility and self-care. Surgery is not usually an option for cancer patients in advanced disease states because of their poor medical health or functional status and limited life expectancy. The objectives of this review were to evaluate the effectiveness and safety of percutaneous image-guided vertebral augmentation techniques, vertebroplasty and kyphoplasty, for palliation of cancer-related vertebral compression fractures.
METHODS
We performed a systematic literature search for studies on vertebral augmentation of cancer-related vertebral compression fractures published from January 1, 2000, to October 2014; abstracts were screened by a single reviewer. For those studies meeting the eligibility criteria, full-text articles were obtained. Owing to the heterogeneity of the clinical reports, we performed a narrative synthesis based on an analytical framework constructed for the type of cancer-related vertebral fractures and the diversity of the vertebral augmentation interventions.
RESULTS
The evidence review identified 3,391 citations, of which 111 clinical reports (4,235 patients) evaluated the effectiveness of vertebroplasty (78 reports, 2,545 patients) or kyphoplasty (33 reports, 1,690 patients) for patients with mixed primary spinal metastatic cancers, multiple myeloma, or hemangiomas. Overall the mean pain intensity scores often reported within 48 hours of vertebral augmentation (kyphoplasty or vertebroplasty), were significantly reduced. Analgesic use, although variably reported, usually involved parallel decreases, particularly in opioids, and mean pain-related disability scores were also significantly improved. In a randomized controlled trial comparing kyphoplasty with usual care, improvements in pain scores, pain-related disability, and health-related quality of life were significantly better in the kyphoplasty group than in the usual care group. Bone cement leakage, mostly asymptomatic, was commonly reported after vertebroplasty and kyphoplasty. Major adverse events, however, were uncommon.
CONCLUSIONS
Both vertebroplasty and kyphoplasty significantly and rapidly reduced pain intensity in cancer patients with vertebral compression fractures. The procedures also significantly decreased the need for opioid pain medication, and functional disabilities related to back and neck pain. Pain palliative improvements and low complication rates were consistent across the various cancer populations and vertebral fractures that were investigated.
Topics: Fractures, Compression; Humans; Kyphoplasty; Neoplasm Metastasis; Neoplasms; Spinal Cord Compression; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 27298655
DOI: No ID Found -
Pain Physician Nov 2017Osteoporotic vertebral compression fractures (OVCFs) are a significant cause of morbidity and mortality in the United States and worldwide, with estimates of 750,000 to... (Review)
Review
UNLABELLED
Osteoporotic vertebral compression fractures (OVCFs) are a significant cause of morbidity and mortality in the United States and worldwide, with estimates of 750,000 to 1.5 million occurring annually. As the elderly population continues to increase, the incidence of OVCFs will continue to rise, as will the morbidity and mortality associated with this condition. Vertebral augmentation (VA) was almost universally accepted as the appropriate treatment modality prior to 2 sham trials published in 2009 by the New England Journal of Medicine (NEJM). Subsequently, there is now significant controversy regarding the optimal treatment of OVCFs. Since 2009 there have been 6 prospective randomized controlled studies (PRCTs) and 2 meta-analyses on VA for the treatment of OVCFs. Five of the PRCTs and both of the meta-analyses have shown superior results with VA as compared with nonsurgical management (NSM). However, a recent health technology assessment and review article continue to over-emphasize the 2 NEJM sham trials, despite the most current literature. These are examples of inconsistent or biased data reporting with overemphasis on certain trial types and exclusion of other types of data, resulting in the reporting of conclusions that are partially representative or not representative of the complete data. As clinical investigators, we have a responsibility to limit bias and ensure that the appropriate treatment modalities are made available to vulnerable populations.The aim of this perspective analysis is to examine sources of bias in reporting and some of the publications that contain it, along with comparing the publications to the current body of published literature relevant to this topic.
KEY WORDS
Vertebral augmentation, vertebroplasty, kyphoplasty, bias, osteoporosis, compression fracture.
Topics: Humans; Osteoporotic Fractures; Publication Bias; Spinal Fractures; Spine; Vertebroplasty
PubMed: 29149153
DOI: No ID Found -
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 -
Pain Research & Management 2020Osteoporotic vertebral compression fracture (OVCF) is a common cause of pain and disability and is steadily increasing due to the growth of the elderly population. To... (Review)
Review
Osteoporotic vertebral compression fracture (OVCF) is a common cause of pain and disability and is steadily increasing due to the growth of the elderly population. To date, percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are almost universally accepted as appropriate vertebral augmentation procedures for OVCFs. There are many advantages of vertebral augmentation, such as short surgical time, performance under local anaesthesia, and rapid pain relief. However, there are certain issues regarding the utilization of these vertebral augmentations, such as loss of vertebral height, cement leakage, and adjacent vertebral refracture. Hence, the treatment for OVCF has changed in recent years. Satisfactory clinical results have been obtained worldwide after application of the OsseoFix System, the SpineJack System, radiofrequency kyphoplasty of the vertebral body, and the Kiva VCF treatment system. The following review discusses the development of the current techniques used for vertebral augmentation.
Topics: Aged; Female; Fractures, Compression; Humans; Male; Osteoporotic Fractures; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 33376566
DOI: 10.1155/2020/3947368 -
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 -
Osteoporosis International : a Journal... Dec 2021Regional variation in procedure use often reflects the uncertainty about the risks and benefit of procedures. In Switzerland, regional variation in vertebroplasty and...
UNLABELLED
Regional variation in procedure use often reflects the uncertainty about the risks and benefit of procedures. In Switzerland, regional variation in vertebroplasty and balloon kyphoplasty rates was high, although the variation declined between 2013 and 2018. Substantial parts of the variation remained unexplained, and likely signal unequal access and differing physician opinion.
PURPOSE
To assess trends and regional variation in percutaneous vertebroplasty (VP) and balloon kyphoplasty (BKP) use across Switzerland.
METHODS
We conducted a population-based analysis using patient discharge data from all Swiss acute care hospitals for 2013-2018. We calculated age/sex-standardized mean procedure rates and measures of variation across VP/BKP-specific hospital areas (HSAs). We assessed the influence of potential determinants of variation using multilevel regression models with incremental adjustment for demographics, cultural/socioeconomic, health, and supply factors.
RESULTS
We analyzed 7855 discharges with VP/BKP from 31 HSAs. The mean age/sex-standardized procedure rate increased from 16 to 20/100,000 persons from 2013 to 2018. While the variation in procedure rates across HSAs declined, the overall variation remained high (systematic component of variation from 56.8 to 6.9 from 2013 to 2018). Determinants explained 52% of the variation.
CONCLUSIONS
VP/BKP procedure rates increased and regional variation across Switzerland declined but remained at a high level. A substantial part of the regional variation remained unexplained by potential determinants of variation.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Small-Area Analysis; Spinal Fractures; Switzerland; Treatment Outcome; Vertebroplasty
PubMed: 34156489
DOI: 10.1007/s00198-021-06026-x -
Journal of Orthopaedic Surgery and... Dec 2016The aim of this meta-analysis is to examine the safety and effectiveness of unilateral percutaneous vertebroplasty (PVP) for treatment of osteoporotic vertebral... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
The aim of this meta-analysis is to examine the safety and effectiveness of unilateral percutaneous vertebroplasty (PVP) for treatment of osteoporotic vertebral compression fractures (OVCFs) compared with that of bilateral treatment.
METHODS
The multiple databases including PubMed, Springer, EMBASE, OVID, and China Journal Full-text Database were adopted to search for relevant studies in English or Chinese, and full-text articles involving comparison of unilateral and bilateral PVP surgery were reviewed. Review Manager 5.0 was adopted to estimate the effects of the results among selected articles. Forest plots, sensitivity analysis, and bias analysis for the articles included were also conducted.
RESULTS
Finally, 1043 patients were included in the 14 studies, which eventually satisfied the eligibility criteria, and unilateral and bilateral surgeries were 550 and 493, respectively. The meta-analysis suggested that there was no significant difference of VAS score, ODI score, and cement leakage rate (MD = 0.12, 95%CI [-0.03, 0.26], P = 0.11; MD = -1.28, 95%CI [-3.59, 1.04], P = 0.28; RR = 0.89, 95%CI [0.61, 1.29], P = 0.52). The surgery time of unilateral PVP is much less than that of bilateral PVP (MD = -16.67, 95%CI [-19.22, -14.12], P < 0.00001). Patients with bilateral PVP surgery have been injected more cement than patients with unilateral PVP surgery (MD = -1.55, 95%CI [-1.94, -1.16], P < 0.00001).
CONCLUSIONS
Both punctures provide excellent pain relief and improvement of life quality. We still encourage the use of the unipedicular approach as the preferred surgical technique for treatment of OVCFs due to less operation time, limited X-ray exposure, and minimal cement introduction and extravasation.
Topics: Clinical Trials as Topic; Fractures, Compression; Humans; Osteoporotic Fractures; Spinal Fractures; Vertebroplasty
PubMed: 27908277
DOI: 10.1186/s13018-016-0479-6 -
Japanese Journal of Radiology Jan 2023A narrative review regarding percutaneous vertebroplasty (PVP) for osteoporotic vertebral fracture (OVF) is provided herein, addressing the epidemic of OVF in Japan, the... (Review)
Review
A narrative review regarding percutaneous vertebroplasty (PVP) for osteoporotic vertebral fracture (OVF) is provided herein, addressing the epidemic of OVF in Japan, the latest response to the criticism of PVP for OVFs, the indications and potential risks of PVP for OVFs, and a future perspective for PVP. Each year in Japan, approximately 32,000 patients aged 55 years or older suffer from chronic low back pain for several months to several years due to a compression fracture. PVP is one of the surgical treatments for an OVF, and it is less invasive compared to the traditional open surgery. PVP is suitable for OVF patients who have difficulty walking as assessed by the modified Yokoyama's activities of daily living (ADL) scoring system, and for patients with Kummell's disease diagnosed by CT and MRI examinations. Serious adverse events related to PVP occur in 1.1-3.3% of the cases, but direct deaths from PVP are extremely rare at less than 1%. Recent studies demonstrated that OVF patients treated with PVP are less likely to die after the treatment than non-surgically treated patients, which conflicts with the Cochran reviews' conclusion not supporting PVP for OVFs. Novel robotic systems and procedure-support devices are being developed, providing a next step toward fully automated PVP procedures.
Topics: Humans; Vertebroplasty; Activities of Daily Living; Spine; Osteoporotic Fractures; Spinal Fractures; Treatment Outcome
PubMed: 35943687
DOI: 10.1007/s11604-022-01322-w