-
The Cochrane Database of Systematic... Nov 2018Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice.
OBJECTIVES
To update the available evidence of the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures.
SEARCH METHODS
We updated the search of CENTRAL, MEDLINE and Embase and trial registries to 15 November 2017.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials (RCTs) of adults with painful osteoporotic vertebral fractures, comparing vertebroplasty with placebo (sham), usual care, or another intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events.
DATA COLLECTION AND ANALYSIS
We used standard methodologic procedures expected by Cochrane.
MAIN RESULTS
Twenty-one trials were included: five compared vertebroplasty with placebo (541 randomised participants), eight with usual care (1136 randomised participants), seven with kyphoplasty (968 randomised participants) and one compared vertebroplasty with facet joint glucocorticoid injection (217 randomised participants). Trial size varied from 46 to 404 participants, most participants were female, mean age ranged between 62.6 and 81 years, and mean symptom duration varied from a week to more than six months.Four placebo-controlled trials were at low risk of bias and one was possibly susceptible to performance and detection bias. Other trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding.Compared with placebo, high- to moderate-quality evidence from five trials indicates that vertebroplasty provides no clinically important benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success at one month. Evidence for quality of life and treatment success was downgraded due to possible imprecision. Evidence was not downgraded for potential publication bias as only one placebo-controlled trial remains unreported. Mean pain (on a scale zero to 10, higher scores indicate more pain) was five points with placebo and 0.7 points better (0.3 better to 1.2 better) with vertebroplasty, an absolute pain reduction of 7% (3% better to 12% better, minimal clinical important difference is 15%) and relative reduction of 10% (4% better to 17% better) (five trials, 535 participants). Mean disability measured by the Roland-Morris Disability Questionnaire (scale range zero to 23, higher scores indicate worse disability) was 14.2 points in the placebo group and 1.5 points better (0.4 better to 2.6 better) in the vertebroplasty group, absolute improvement 7% (2% to 11% better), relative improvement 9% better (2% to 15% better) (four trials, 472 participants).Disease-specific quality of life measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (scale zero to 100, higher scores indicating worse quality of life) was 62 points in the placebo group and 2.3 points better (1.4 points worse to 6.7 points better), an absolute imrovement of 2% (1% worse to 6% better); relative improvement 4% better (2% worse to 10% better) (three trials, 351 participants). Overall quality of life (European Quality of Life (EQ5D), zero = death to 1 = perfect health, higher scores indicate greater quality of life) was 0.38 points in the placebo group and 0.05 points better (0.01 better to 0.09 better) in the vertebroplasty group, absolute improvement: 5% (1% to 9% better), relative improvement: 18% (4% to 32% better) (three trials, 285 participants). In one trial (78 participants), 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; 95% CI 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute difference: 9% more reported success (11% fewer to 29% more); relative change: 40% more reported success (33% fewer to 195% more).Low-quality evidence (downgraded due to imprecision and potential for bias from the usual-care controlled trials) indicates uncertainty around the risk estimates of harms with vertebroplasty. The incidence of new symptomatic vertebral fractures (from six trials) was 48/418 (95 per 1000; range 34 to 264)) in the vertebroplasty group compared with 31/422 (73 per 1000) in the control group; RR 1.29 (95% CI 0.46 to 3.62)). The incidence of other serious adverse events (five trials) was 16/408 (34 per 1000, range 18 to 62) in the vertebroplasty group compared with 23/413 (56 per 1000) in the control group; RR 0.61 (95% CI 0.33 to 1.10). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses indicate that the effects did not differ according to duration of pain (acute versus subacute). Including data from the eight trials that compared vertebroplasty with usual care in a sensitivity analyses altered the primary results, with all combined analyses displaying considerable heterogeneity.
AUTHORS' CONCLUSIONS
We found high- to moderate-quality evidence that vertebroplasty has no important benefit in terms of pain, disability, quality of life or treatment success in the treatment of acute or subacute osteoporotic vertebral fractures in routine practice when compared with a sham procedure. Results were consistent across the studies irrespective of the average duration of pain.Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the high- to moderate-quality evidence that shows no important benefit of vertebroplasty and its potential for harm.
Topics: Aged; Aged, 80 and over; Bone Cements; Female; Fractures, Compression; Glucocorticoids; Humans; Male; Middle Aged; Osteoporotic Fractures; Pain Measurement; Pain, Postoperative; Quality of Life; Randomized Controlled Trials as Topic; Spinal Fractures; Vertebroplasty
PubMed: 30399208
DOI: 10.1002/14651858.CD006349.pub4 -
Journal of Orthopaedic Surgery and... Oct 2018This meta-analysis was aimed to explore the overall safety and efficacy of balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
This meta-analysis was aimed to explore the overall safety and efficacy of balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression fracture (OVCF) based on qualified studies.
METHODS
By searching multiple databases and sources, including PubMed, Cochrane, and Embase by the index words updated to January 2018, qualified studies were identified and relevant literature sources were also searched. The qualified studies included randomized controlled trials, prospective or retrospective comparative studies, and cohort studies. The meta-analysis was performed including mean difference (MD) or relative risk (RR) and 95% confidence interval (95% CI) to analyze the main outcomes.
RESULTS
A total of 16 studies were included in the meta-analysis to explore the safety and efficacy of kyphoplasty versus vertebroplasty for the treatment of OVCF. The results indicated that kyphoplasty significantly decreased the kyphotic wedge angle (SMD, 0.98; 95% CI 0.40-1.57), increased the postoperative vertebral body height (SMD, - 1.27; 95% CI - 1.86 to - 0.67), and decreased the risk of cement leakage (RR, 0.62; 95% CI 0.47-0.80) in comparison with vertebroplasty. However, there was no statistical difference in visual analog scale (VAS) scores (WMD, 0.04; 95% CI - 0.28-0.36) and Oswestry Disability Index (ODI) scores (WMD, - 1.30; 95% CI - 3.34-0.74) between the two groups.
CONCLUSIONS
Kyphoplasty contributes especially to decreasing the mean difference of kyphotic wedge angle and risk of cement leakage and increasing the vertebral body height when compared with vertebroplasty. But radiographic differences did not significantly influence the clinical results (no significant difference was observed in VAS scores and ODI scores between the two groups); thus, kyphoplasty and vertebroplasty are equally effective in the clinical outcomes of OVCF. In addition, more high-quality multi-center RCTs with a larger sample size and longer follow-up are warranted to confirm the current findings.
Topics: Bone Cements; Extravasation of Diagnostic and Therapeutic Materials; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Postoperative Complications; Spinal Fractures; Vertebroplasty
PubMed: 30348192
DOI: 10.1186/s13018-018-0952-5 -
Medicine Oct 2018Because of aging of population, osteoporotic vertebral compression fracture (OVCF) appears an increasing incidence rate. Conservative therapy (CT) and balloon... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Because of aging of population, osteoporotic vertebral compression fracture (OVCF) appears an increasing incidence rate. Conservative therapy (CT) and balloon kyphoplasty (BKP) have been used to treat OVCFs. However, an increase in new vertebral compression fractures at nontreated levels following BKP is of concern. It is still not clear whether new fractures were a result of BKP and the purpose of this meta-analysis was to evaluate the new fractures risk after BKP compared with CT.
METHODS
An exhaustive literature search of PubMed, EMBASE, and the Cochrane Library was conducted to identify randomized controlled trials and prospective nonrandomized controlled study that compared BKP with CT for patients suffering OVCF. A random-effect model was used. Results were reported as standardized mean difference or risk ratio with 95% confidence interval.
RESULTS
Twelve studies were included and there was no significant difference in total new fractures (P = .33) and adjacent fractures (P = .83) between 2 treatments. Subgroup analyses did not demonstrate significant differences in follow-up period, mean age, anti-osteoporosis therapy, and the proportion of women.
CONCLUSION
Our systematic review revealed that an increased risk of fracture of vertebral bodies was not associated with BKP compared with CT.
Topics: Clinical Trials as Topic; Conservative Treatment; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures
PubMed: 30290650
DOI: 10.1097/MD.0000000000012666 -
Pain Physician Sep 2018Metastatic spinal lesions are difficult-to-treat entities that are most commonly associated with pain and severely reduced health-related quality of life (HRQoL). Within...
BACKGROUND
Metastatic spinal lesions are difficult-to-treat entities that are most commonly associated with pain and severely reduced health-related quality of life (HRQoL). Within the last 5 to 10 years, radiofrequency ablation (RFA) has emerged as an option in the palliative treatment of vertebral metastases.
OBJECTIVES
Our review aims to evaluate the clinical effectiveness and safety of RFA, mostly in combination with vertebroplasty, in patients with painful vertebral metastases.
STUDY DESIGN
The design of this study is a systematic review.
METHODS
We conducted a systematic literature search and a manual search of 5 databases in December 2016. The review applied a methodological framework based on the HTA Core Model®. Data on each selected outcome category were synthesized according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scheme. Risk of bias was assessed using the Institute of Health Economics (IHE) Risk of Bias checklist for case series.
RESULTS
We identified 299 citations. After applying the inclusion criteria, a total of 9 studies (4 prospective and 5 retrospective studies) were determined to be eligible. These studies included a total of 583 patients with vertebral metastases who were treated with RFA and, in most cases, received an additional vertebroplasty treatment (n = 437). The studies were categorized as having a moderate to high risk of bias. The strength of evidence was found to be "very low" for safety outcomes and could not be assessed for efficacy outcomes. Current evidence suggests that RFA leads to significant pain reduction. Furthermore, no major complications occurred when using RFA.
LIMITATIONS
A major concern is the low number of included patients and heterogeneity of study characteristics in most of the studies. The low number of patients also impeded comparison of the effectiveness of RFA alone to RFA in combination with vertebroplasty.
CONCLUSION
According to the available evidence, RFA may be safe and effective, especially for patients with painful vertebral metastases who show contraindications or unresponsiveness to conventional therapies (e.g., radiation) or for those who are at risk of tumor progression.
KEY WORDS
Radiofrequency ablation, vertebral metastases, metastatic spinal lesions, pain, clinical effectiveness, safety, palliative pain treatment.
Topics: Cancer Pain; Humans; Pain Management; Palliative Care; Quality of Life; Radiofrequency Ablation; Spinal Neoplasms; Treatment Outcome
PubMed: 30282388
DOI: No ID Found -
Medicine Aug 2018Unilateral and bilateral percutaneous balloon kyphoplasty (PKP) are 2 main approaches for the treatment of patients with osteoporotic vertebral compression fractures... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Unilateral and bilateral percutaneous balloon kyphoplasty (PKP) are 2 main approaches for the treatment of patients with osteoporotic vertebral compression fractures (OVCFs). Numerous published systematic reviews and meta-analyses evaluating the effectiveness of 2 approaches remain inconclusive. In order to propose a significant principle to make decisions for comparing clinical safety and efficacy of unilateral versus bilateral PKP for treating OVCFs patients based on the currently best available evidence, a systematic review of overlapping meta-analysis was conducted.
METHODS
Three electronic databases, Pubmed/Medline, Embase2 and the Cochrance Library, were searched systematically to retrieve and identify all eligible systematic reviews and meta-analyses comparing unilateral and bilateral PKP for the treatment of patients with OVCFs. Only systematic reviews or meta-analyses with an exclusively pooled analysis of randomized controlled trials (RCTs) met the minimum eligibility criteria in this investigation. The Oxford Levels of Evidence, Jadad algorithm and Assessment of Multiple Systematic Reviews (AMSTAR) instrument were adopted for evaluation of the methodological quality for each included literature to select currently best available evidence.
RESULTS
Screening determined that out of 2159, 9 meta-analyses with level II or III of evidence met the inclusion criteria in the systematic review of overlapping meta-analyses. The multiple systematic reviews scores ranged from 8 to 9 with a mean of 8.55 (median 8.5). According to the search process and selection strategies of the Jadad algorithm, a meta-analysis by Feng et al with the best available evidence (12 RCTs and an AMSTAR score of 9) demonstrated that unilateral and bilateral PKP are both nice choices for the treatment of patients with OVCFs, and no significant differences were revealed in clinical scores, radiological outcomes, and quality of life with long-term follow-up. However, compared with bilateral PKP, unilateral PKP produced a shorter surgery time, smaller dosage of cement, lower risk of cement leakage, and relieved a higher degree of intractable pain at short-term follow-up after surgery.
CONCLUSION
Unilateral percutaneous balloon kyphoplasty is more advantageous and superior to bilateral percutaneous kyphoplasty, and should be considered an effective option for the treatment of patients with osteoporotic vertebral compression fractures.
Topics: Aged; Bone Cements; Female; Fractures, Compression; Humans; Kyphoplasty; Male; Operative Time; Osteoporotic Fractures; Spinal Fractures; Treatment Outcome
PubMed: 30113502
DOI: 10.1097/MD.0000000000011968 -
Pain Physician Jul 2018Several meta-analyses have been performed to compare unilateral percutaneous kyphoplasty (PKP) and bilateral PKP in the treatment of osteoporotic vertebral compression... (Meta-Analysis)
Meta-Analysis
Is Unilateral Percutaneous Kyphoplasty Superior to Bilateral Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures? Evidence from a Systematic Review of Discordant Meta-Analyses.
BACKGROUND
Several meta-analyses have been performed to compare unilateral percutaneous kyphoplasty (PKP) and bilateral PKP in the treatment of osteoporotic vertebral compression fractures (OVCFs), but inconsistencies in the results have led to questions as to which technique is preferable.
OBJECTIVE
This study was designed to clarify the benefits and disadvantages of unilateral PKP versus bilateral PKP as found in numerous discordant meta-analyses and thereby present surgical treatment recommendations for OVCFs considering the current best evidence.
STUDY DESIGN
Systematic review/Meta-analysis.
METHODS
Meta-analyses on unilateral and bilateral PKP for OVCFs were included by searching Pubmed, Embase, and Cochrane library. Meta-analysis quality was assessed using Oxford Levels of Evidence and Assessment of Multiple Systematic Reviews (AMSTAR). The Jadad decision algorithm was used to identify the best evidence.
RESULTS
Eight eligible meta-analyses were included, 7 of which were Level-II evidence and one was Level-III evidence. The AMSTAR scores varied from 7 to 8. The Jadad decision algorithm suggested that the best meta-analysis should be selected depending upon publication characteristics and methodology of primary studies, language restrictions, and whether data analysis was performed on individual patients. The best available evidence indicated that both unilateral and bilateral PKP could receive similar good clinical and radiological outcomes. However, without increasing the risk of complications, unilateral PKP required shorter surgical time and less cement volume, offering better pain relief and quality of life at post-operative short term follow-ups.
LIMITATIONS
Primary studies had defects in their methodologies.
CONCLUSIONS
Unilateral PKP appears to be superior to bilateral PKP in the treatment of OVCFs.
KEY WORDS
Osteoporotic vertebral compression fractures, percutaneous kyphoplasty, meta-analysis.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Quality of Life; Spinal Fractures; Treatment Outcome
PubMed: 30045590
DOI: No ID Found -
Pain Physician May 2018An increasing number of studies have been conducted to apply unilateral balloon kyphoplasty in the treatment of ostroporotic vertebral compression fractures (OVCFs).... (Meta-Analysis)
Meta-Analysis
BACKGROUND
An increasing number of studies have been conducted to apply unilateral balloon kyphoplasty in the treatment of ostroporotic vertebral compression fractures (OVCFs). However, the efficacy and safety of unilateral kyphoplasty and whether a unilateral or a bilateral approach is superior is controversial.
OBJECTIVES
The purpose of this study was to evaluate the role of unilateral balloon kyphoplasty and use meta-analysis to compare the efficacy and safety of unilateral and bilateral kyphoplasty in patients with OVCFs.
STUDY DESIGN
A systematic literature search was conducted from 1970 to April 2017 using Medline database and the Cochrane Central Register of Controlled Trials. Articles were limited to those published in English. Randomized controlled trials and nonrandomized comparative studies were also included.
SETTING
The following search terms were used: "osteoporotic vertebral compression fractures," or "OVCF," and "unilateral kyphoplasty," or "unipedicular approach," or "single balloon kyphoplasty," or "one balloon kyphoplasty." A comprehensive search of reference lists of retrieved articles and previous published reviews was also performed to ensure inclusion of all possible studies.
METHODS
All potential articles were independently reviewed by 2 investigators for inclusion into the final analysis. MINORS score was used for nonrandomized studies, and Detsky quality index was applied for prospective randomized controlled trials. Systematic review and meta-analysis was performed for the included studies.
RESULTS
After unilateral balloon kyphoplasty the mean postoperative visual analog score (VAS) was from 1.74 to 4.77, mean postoperative kyphotic angle was from 5.9º to 11.22º, and complications involving cement leaks was from 6.8 to 21.9% or adjacent level fractures was from 0 to 5.6%). Unilateral kyphoplasty had significantly lower operative time, and less bone cement volume; however, the postoperative VAS, Oswestry Disability Index (ODI), vertebral height restoration rate, and cement leakage and adjacent vertebral fracture rate, were similar to bilateral kyphoplasty.
LIMITATIONS
Only 6 randomized controlled trials and 3 retrospective comparative studies were selected for analysis. Heterogeneity was detected among the studies when we pooled the outcomes.
CONCLUSIONS
Based on the available evidence, the clinical and radiological results of unilateral balloon kyphoplasty were as good as those of bilateral balloon kyphoplasty for the treatment of OVCFs. And unilateral kyphoplasty had advantages in terms of operation time, radiation exposure, and cost.
KEY WORDS
Unilateral balloon kyphoplasty, bilateral balloon kyphoplasty, osteoporotic vertebral compression fractures, complications of balloon kyphoplasty, meta-analysis.
Topics: Aged; Female; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Prospective Studies; Retrospective Studies; Spinal Fractures; Treatment Outcome
PubMed: 29871365
DOI: No ID Found -
The Cochrane Database of Systematic... Apr 2018Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Percutaneous vertebroplasty remains widely used to treat osteoporotic vertebral fractures although our 2015 Cochrane review did not support its role in routine practice.
OBJECTIVES
To update the available evidence of the benefits and harms of vertebroplasty for treatment of osteoporotic vertebral fractures.
SEARCH METHODS
We updated the search of CENTRAL, MEDLINE and Embase and trial registries to 15 November 2017.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials (RCTs) of adults with painful osteoporotic vertebral fractures, comparing vertebroplasty with placebo (sham), usual care, or another intervention. As it is least prone to bias, vertebroplasty compared with placebo was the primary comparison. Major outcomes were mean overall pain, disability, disease-specific and overall health-related quality of life, patient-reported treatment success, new symptomatic vertebral fractures and number of other serious adverse events.
DATA COLLECTION AND ANALYSIS
We used standard methodologic procedures expected by Cochrane.
MAIN RESULTS
Twenty-one trials were included: five compared vertebroplasty with placebo (541 randomised participants), eight with usual care (1136 randomised participants), seven with kyphoplasty (968 randomised participants) and one compared vertebroplasty with facet joint glucocorticoid injection (217 randomised participants). Trial size varied from 46 to 404 participants, most participants were female, mean age ranged between 62.6 and 81 years, and mean symptom duration varied from a week to more than six months.Three placebo-controlled trials were at low risk of bias and two were possibly susceptible to performance and detection bias. Other trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding.Compared with placebo, high- to moderate-quality evidence from five trials (one with incomplete data reported) indicates that vertebroplasty provides no clinically important benefits with respect to pain, disability, disease-specific or overall quality of life or treatment success at one month. Evidence for quality of life and treatment success was downgraded due to possible imprecision. Evidence was not downgraded for potential publication bias as only one placebo-controlled trial remains unreported. Mean pain (on a scale zero to 10, higher scores indicate more pain) was five points with placebo and 0.6 points better (0.2 better to 1 better) with vertebroplasty, an absolute pain reduction of 6% (2% better to 10% better, minimal clinical important difference is 15%) and relative reduction of 9% (3% better to14% better) (five trials, 535 participants). Mean disability measured by the Roland-Morris Disability Questionnaire (scale range zero to 23, higher scores indicate worse disability) was 14.2 points in the placebo group and 1.7 points better (0.3 better to 3.1 better) in the vertebroplasty group, absolute improvement 7% (1% to 14% better), relative improvement 10% better (3% to 18% better) (three trials, 296 participants).Disease-specific quality of life measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (scale zero to 100, higher scores indicating worse quality of life) was 62 points in the placebo group and 2.75 points (3.53 worse to 9.02 better) in the vertebroplasty group, absolute change: 3% better (4% worse to 9% better), relative change: 5% better (6% worse to 15% better (two trials, 175 participants). Overall quality of life (European Quality of Life (EQ5D), zero = death to 1 = perfect health, higher scores indicate greater quality of life) was 0.38 points in the placebo group and 0.05 points better (0.01 better to 0.09 better) in the vertebroplasty group, absolute improvement: 5% (1% to 9% better), relative improvement: 18% (4% to 32% better) (three trials, 285 participants). In one trial (78 participants), 9/40 (or 225 per 1000) people perceived that treatment was successful in the placebo group compared with 12/38 (or 315 per 1000; 95% CI 150 to 664) in the vertebroplasty group, RR 1.40 (95% CI 0.67 to 2.95), absolute difference: 9% more reported success (11% fewer to 29% more); relative change: 40% more reported success (33% fewer to 195% more).Moderate-quality evidence (low number of events) from seven trials (four placebo, three usual care, 1020 participants), up to 24 months follow-up, indicates we are uncertain whether vertebroplasty increases the risk of new symptomatic vertebral fractures (70/509 (or 130 per 1000; range 60 to 247) observed in the vertebroplasty group compared with 59/511 (120 per 1000) in the control group; RR 1.08 (95% CI 0.62 to 1.87)).Similarly, moderate-quality evidence (low number of events) from five trials (three placebo, two usual care, 821 participants), indicates uncertainty around the risk of other serious adverse events (18/408 or 76 per 1000, range 6 to 156) in the vertebroplasty group compared with 26/413 (or 106 per 1000) in the control group; RR 0.64 (95% CI 0.36 to 1.12). Notably, serious adverse events reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury and respiratory failure.Our subgroup analyses indicate that the effects did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks. Including data from the eight trials that compared vertebroplasty with usual care in a sensitivity analyses altered the primary results, with all combined analyses displaying considerable heterogeneity.
AUTHORS' CONCLUSIONS
Based upon high- to moderate-quality evidence, our updated review does not support a role for vertebroplasty for treating acute or subacute osteoporotic vertebral fractures in routine practice. We found no demonstrable clinically important benefits compared with placebo (sham procedure) and subgroup analyses indicated that the results did not differ according to duration of pain ≤ 6 weeks versus > 6 weeks.Sensitivity analyses confirmed that open trials comparing vertebroplasty with usual care are likely to have overestimated any benefit of vertebroplasty. Correcting for these biases would likely drive any benefits observed with vertebroplasty towards the null, in keeping with findings from the placebo-controlled trials.Numerous serious adverse events have been observed following vertebroplasty. However due to the small number of events, we cannot be certain about whether or not vertebroplasty results in a clinically important increased risk of new symptomatic vertebral fractures and/or other serious adverse events. Patients should be informed about both the high- to moderate-quality evidence that shows no important benefit of vertebroplasty and its potential for harm.
Topics: Aged; Aged, 80 and over; Bone Cements; Female; Fractures, Compression; Glucocorticoids; Humans; Male; Middle Aged; Osteoporotic Fractures; Pain Measurement; Pain, Postoperative; Quality of Life; Randomized Controlled Trials as Topic; Spinal Fractures; Vertebroplasty
PubMed: 29618171
DOI: 10.1002/14651858.CD006349.pub3 -
Medicine Mar 2018High-viscosity cement (HVC) has been gradually applied in percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP). Although HVC has been reported to reduce... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
High-viscosity cement (HVC) has been gradually applied in percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP). Although HVC has been reported to reduce cement leakage, different opinions exist. To assess the complications of HVC in cement leakage in the treatment of vertebral compression fractures and to evaluate the clinical effect of HVC compared with low-viscosity cement (LVC).
METHODS
EMBASE, PubMed, Science Direct, Google Scholar and Cochrane Library databases were comprehensively searched from their inception to August 2017. Two researchers independently searched for articles and reviewed all retrieved studies. Forest plots were used to illustrate the results. The Q-test and I statistic were employed to evaluate between-study heterogeneity. Potential publication bias was assessed by funnel plot.
RESULTS
HVC reduced the occurrence of cement leakage (risk ratio (RR) = 0.38, 95% confidence interval (CI) = 0.29 to 0.51, P < 0.00001), especially in the disc space (RR = 0.45, 95% CI = 0.45 to 0.80, P = 0.007) and the vein (RR = 0.54, 95% CI = 0.35 to 0.85, P = 0.008) but not in the intraspinal space (RR = 0.48, 95% CI = 0.19 to 1.23, P = 0.13) or the paravertebral area (RR = 0.63, 95% CI = 0.32 to 1.22, P = 0.17). No significant differences in the visual analogue scale (VAS), Oswestry Disability Index (ODI), injected cement volume or adjacent vertebral fracture were noted between HVC and LVC (P > 0.05).
CONCLUSION
Compared with LVC, HVC results in a reduced incidence of cement leakage for the treatment of vertebral compression fractures, especially in the disc space and vein but not in the intraspinal space or the paravertebral area. In addition, HVC yields the same satisfactory clinical effect as LVC.
Topics: Bone Cements; Fractures, Compression; Humans; Spinal Fractures; Viscosity
PubMed: 29561435
DOI: 10.1097/MD.0000000000010184 -
Acta Orthopaedica Et Traumatologica... Jul 2017The aim of this study was to compare the unilateral and bilateral approaches in treating osteoporotic vertebral compression fractures. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The aim of this study was to compare the unilateral and bilateral approaches in treating osteoporotic vertebral compression fractures.
METHODS
Based on the principles and methods of the Cochrane systematic reviews, the records of the Cochrane Library, PubMed, Web of Science, Chinese Bio-medicine database, China Journal Full-text Database, VIP database, and Wanfang database were reviewed until October 2014. The randomized controlled trials on unilateral and bilateral approaches to percutaneous vertebroplasty (PVP)/percutaneous kyphoplasty (PKP) for osteoporotic vertebral compression fractures were included. The risk of bias of included trials was assessed based on the Cochrane Handbook for Systematic Reviews of Interventions Version. The RevMan Software 5.0 was used for meta-analysis.
RESULTS
Fifteen randomized controlled trials with a total of 850 patients were included. Risk of bias in the included studies was inevitable. There was no statistically significant difference in visual analog scale, vertebral height, kyphotic angular, and quality of life. The main operative complications were bone cement leakage and adjacent vertebral fracture, without difference between the two groups.
CONCLUSIONS
In view of the current evidence, there is insufficient evidence to show any difference between the unilateral and bilateral approaches in both the PVP and PKP treatment in osteoporotic vertebral compression fractures.
LEVEL OF EVIDENCE
Level I, Therapeutic study.
Topics: Comparative Effectiveness Research; Fractures, Compression; Humans; Kyphoplasty; Kyphosis; Osteoporotic Fractures; Spinal Fractures; Vertebroplasty
PubMed: 28647158
DOI: 10.1016/j.aott.2017.05.006