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Journal of Bone and Mineral Research :... Jun 2017We aimed to study the clinical and imaging characteristics of patients sustaining vertebral fractures after denosumab discontinuation. For this purpose, we conducted a... (Meta-Analysis)
Meta-Analysis Review
We aimed to study the clinical and imaging characteristics of patients sustaining vertebral fractures after denosumab discontinuation. For this purpose, we conducted a computerized advanced literature search that identified 13 published cases, and we additionally included another 11 new cases from our centers. Twenty-four postmenopausal women with vertebral fracture(s) after denosumab discontinuation, experiencing 112 fractures in total, were analyzed. The mean number of fractures per patient was 4.7. The most commonly affected vertebrae were T12 and L1. All fractures occurred 8 to 16 months after the last denosumab injection. Eighty-three percent of the patients were treatment naïve, whereas 33% had prevalent vertebral fractures. Five (23%) patients were on concurrent aromatase inhibitor treatment. When patients were divided according to treatment duration with an arbitrary cut-off of 2 years, those with ≤2 years of denosumab treatment had fewer fractures compared with those with >2 years (mean ± SEM fractures 3.2 ± 0.7 versus 5.2 ± 1.4, p = 0.055). Vertebroplasty was used in 5 patients, resulting in additional clinical vertebral fractures in all cases. We conclude that vertebral fracture(s) after denosumab discontinuation are in the majority of patients multiples, and they occur a few months after the effect of the last dose is depleted. Therefore, patients should not delay or omit denosumab doses. Fractures are typically osteoporotic, located at the lower thoracic and the upper lumbar spine. Vertebroplasty is an unsuccessful treatment strategy for such patients. © 2017 American Society for Bone and Mineral Research.
Topics: Aged; Aged, 80 and over; Denosumab; Humans; Middle Aged; Spinal Fractures; Withholding Treatment
PubMed: 28240371
DOI: 10.1002/jbmr.3110 -
International Journal of Surgery... Apr 2017To date, there has been ongoing debate over whether intravertebral vacuum cleft (IVC) has the effect of therapeutic efficacy in percutaneous vertebral augmentation (PVA)... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
To date, there has been ongoing debate over whether intravertebral vacuum cleft (IVC) has the effect of therapeutic efficacy in percutaneous vertebral augmentation (PVA) for the treatment of osteoporotic vertebral compression fractures (OVCFs).
OBJECTIVE
The aim of this meta-analysis was to calculate a pooled estimate of the IVCs on the effect of therapeutic efficacy of PVA for the treatment of OVCFs.
METHODS
A systematic electronic literature search was performed using the following databases: PubMed, Embase and Cochrane Library; the databases were searched from the earliest available records up to June 2016. Pooled risk ratio (RR) or a mean difference (MD) with 95% confidence interval (CI) was calculated using random- or fixed-effects models. The RevMan 5.2 was used to analyze the data.
RESULTS
In the immediate postoperative period, pooled results showed that vertebral height and VAS scores of the IVC patients were significantly lower than those of the non-IVC patients. However, pooled results showed there was no significant difference in kyphotic angle and ODI indices between the two groups. At final follow-up period, significant difference was observed in all the radiological and clinical parameters for the IVC patients with compared to the non-IVC patients in our pooled results. Pooled results showed significant difference with respect to the rate of cement leakage between the two groups.
CONCLUSION
The IVCs had an important effect of therapeutic efficacy in PVA for the treatment OVCFs. Therefore, we strongly recommend its strict observation and follow-up for the IVCs patients.
Topics: Aged; Bone Cements; Female; Fractures, Compression; Humans; Male; Middle Aged; Osteoporotic Fractures; Postoperative Period; Radiography; Spinal Fractures; Treatment Outcome; Vacuum; Vertebroplasty
PubMed: 28216390
DOI: 10.1016/j.ijsu.2017.02.019 -
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 -
Pain Physician 2016Kyphoplasty has been proven to be an efficient method to relieve patient suffering from osteoporotic vertebral compression fractures (OVCFs). Because of its... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Kyphoplasty has been proven to be an efficient method to relieve patient suffering from osteoporotic vertebral compression fractures (OVCFs). Because of its technological superiority, unilateral kyphoplasty consumes less operative time and bone cement than traditional bilateral kyphoplasty. However, there is controversy about which method is most efficient in the treatment of OVCFs. Thus, an overall analysis should be performed to shed light on the facts corroborating both procedures.
OBJECTIVE
To evaluate the safety and efficacy of unipedicular kyphoplasty versus bipedicular kyphoplasty in treating OVCFs.
STUDY DESIGN
Inclusion criteria were randomized controlled trials focusing on comparing unilateral versus bilateral balloon kyphoplasty in treatment of OVCFs. The exclusion criteria contained infection, neoplastic etiology, traumatic fracture, neural compression, neurological deficit, spinal stenosis, previous surgery at the involved vertebral body, long-term use of steroids, and kyphoplasty with other invasive or semi-invasive intervention treatment. Retrospective studies, reviews, technology introductions, and biochemical trials were also excluded.
SETTINGS
The PubMed MEDLINE, Cochrane Library, Web of Science, and EMBASE were systematic searched. Only randomized controlled trials published up to June 2015 comparing unilateral kyphoplasty with bilateral kyphoplasty in treatment of OVCFs were identified.
METHODS
Two researchers independently screeded the works for inclusion and data extraction. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used to assess the methodological quality and evidence synthesis.
RESULTS
Six articles with 563 patients were enrolled in this study. Results showed that the unilateral approach required less surgical time (MD, -23.19; 95% CI, [-27.08, -19.31]; P < 0.00001) and cement consumption (MD, -2.07; 95% CI, [-2.23, -1.91]; P < 0.00001), as well as a reduced cement leakage ratio (RR, 0.59; 95% CI, [0.35, 0.99]; P < 0.05) and improved short-term general health (MD, 1.48; 95% CI, [0.02, 2.93], P < 0.05). No significant difference was found in the visual analog scale score (short-term and long-term), Oswestry Disability Index score (mid-term and long-term) kyphotic angle reduction, restoration rate of anterior vertebral height, vertebral height loss rate, postoperative adjacent-level fractures, or in other assessments of 36-Item Short Form Health Survey parameters (short-term and long-term).
LIMITATIONS
Only 6 studies were included, so that the sample size was still relatively small and publication bias could not be revealed in this study. Observation time of some data was inconsistent. All of these problems could influence the reliability of the results.
CONCLUSION
Both unilateral kyphoplasty and bilateral kyphoplasty are safe and effective treatments for OVCFs. However, when operative time, cement volume, cement leakage, short-term general health, radiation dose, and hospitalization costs are taken into consideration, unilateral kyphoplasty may be the better choice. Yet, more high-quality RCTs with long-term follow-up are still required to make the final conclusion.Key words: Kyphoplasty, unilateral approach, bilateral approach, osteoporotic vertebral compression fractures, meta-analysis.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Reproducibility of Results; Retrospective Studies; Spinal Fractures; Treatment Outcome
PubMed: 27906934
DOI: No ID Found -
International Journal of Surgery... Dec 2016The aim of the present study was to evaluate whether vertebral augmentation technology increases the occurrence of adjacent vertebral fractures in patients with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The aim of the present study was to evaluate whether vertebral augmentation technology increases the occurrence of adjacent vertebral fractures in patients with osteoporotic vertebral compression fractures (OVCFs).
MATERIALS AND METHODS
Databases, including MEDLINE, EMBASE and Cochrane library, were retrieved via PRISMA covering 1987 to 2015. The number of patients who suffered from adjacent secondary vertebral fractures was calculated. A meta-analysis, using indexes of odds ratios (OR) and 95% confidence intervals (95% CI), was conducted with STATA software. Subgroup investigations were conducted according to the operation methods and the duration of observation. Sensitivity analysis and publication bias were also evaluated.
RESULTS
Ten randomized controlled trials (RCTs) met our inclusion criteria. Our results indicated there was no statistically significant difference in the occurrence rate of adjacent vertebral fractures between manipulation of vertebral augmentation and non-surgical treatment (OR = 0.89, 95% CI = 0.58-1.37). Neither subgroup investigations based on selection of operation nor duration of follow-up time showed marked differences. A sensitivity analysis did not identify specific trails seriously deflected. No obvious publication bias was identified.
CONCLUSION
Despite various limitations in the present study, our data demonstrated that using vertebral augmentation was not related to increasing incidence of subsequent adjacent vertebral fractures.
Topics: Fractures, Compression; Humans; Incidence; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Spinal Fractures; Vertebroplasty
PubMed: 27871806
DOI: 10.1016/j.ijsu.2016.11.082 -
Global Spine Journal Aug 2016Review of the literature. (Review)
Review
STUDY DESIGN
Review of the literature.
OBJECTIVE
Surgery and cement augmentation procedures are effective palliative treatment of symptomatic spinal metastases. Our objective is to systematically review the literature to describe the survival, prognostic factors, and clinical outcomes of surgery and cement augmentation procedures for breast cancer metastases to the spine.
METHODS
We performed a literature review using PubMed to identify articles that reported outcomes and/or prognostic factors of the breast cancer patient population with spinal metastases treated with any surgical technique since 1990.
RESULTS
The median postoperative survival for metastatic breast cancer was 21.7 months (8.2 to 36 months), the mean rate of any pain improvement was 92.9% (76 to 100%), the mean rate of neurologic improvement was 63.8% (53 to 100%), the mean rate of neurologic decline was 4.1% (0 to 8%), and the local tumor control rate was 92.6% (89 to 100%). Kyphoplasty studies reported a high rate of pain control in selected patients. Negative prognostic variables included hormonal (estrogen and progesterone) and human epidermal growth factor receptor 2 (HER2) receptor refractory tumor status, high degree of axillary lymph node involvement, and short disease-free interval (DFI). All other clinical or prognostic parameters were of low or insufficient strength.
CONCLUSION
With respect to clinical outcomes, surgery consistently yielded neurologic improvements in patients presenting with a deficit with a minimal risk of worsening; however, negative prognostic factors associated with shorter survival following surgery include estrogen receptor/progesterone receptor negativity, HER2 negativity, and a short DFI.
PubMed: 27433433
DOI: 10.1055/s-0035-1564807 -
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 -
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 -
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 -
Vertebroplasty and kyphoplasty for cervical spine metastases: a systematic review and meta-analysis.International Journal of Spine Surgery 2016Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of...
BACKGROUND
Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of these procedures are performed in the thoracolumbar spine, and there is limited data on outcomes after VP/KP for cervical metastases. The purpose of this article is to evaluate the safety and efficacy of VP and KP for treating pain in patients with cervical spine metastases.
METHODS
A systematic review of the literature was conducted using the PubMed and Medline databases. Only studies that reported five or more patients treated with VP/KP in the cervical spine were included. Levels of evidence and grades of recommendation were established based on the Oxford Centre for Evidence-Based Medicine guidelines. Data was pooled to perform a meta-analysis for pain relief and complication rates.
RESULTS
Six studies (all level 4 studies) met the inclusion criteria, representing 120 patients undergoing VP/KP at 135 vertebrae; the most common addressed level was C2 in 83 cases. The average volume of injected cement was 2.5 ± 0.5 milliliters at each vertebra. There were 22 asymptomatic cement leaks (16%; 95% CI, 9.8% - 22.2%) most commonly occurring in the paraspinal soft tissue. There were 5 complications (4%; 95% CI, 0.5% - 7.5%): 3 cases of mild odynophagia, 1 case of occipital neuralgia secondary to leak, and 1 case of stroke secondary to cement embolism. Pain relief was achieved in 89% of cases (range: 80 - 100%). The calculated average pain score decreased significantly from 7.6 ± 0.9 before surgery to 1.9 ± 0.8 at last evaluation (p=0.006).
CONCLUSION
Although the calculated complication rate after VP/KP in the cervical spine is low (4%) and the reported pain relief rate is approximately 89%, there is lack of high-quality evidence supporting this. Future randomized controlled trials are needed.
PubMed: 26913227
DOI: 10.14444/3007