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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 -
Journal of Orthopaedic Surgery and... Mar 2022Percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) have been widely used to treat osteoporotic vertebral compression fractures (OVCF), but the risk of vertebral... (Meta-Analysis)
Meta-Analysis Review
Risk factors of vertebral re-fracture after PVP or PKP for osteoporotic vertebral compression fractures, especially in Eastern Asia: a systematic review and meta-analysis.
OBJECTIVE
Percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) have been widely used to treat osteoporotic vertebral compression fractures (OVCF), but the risk of vertebral re-fracture after PVP/PKP remains controversial. This study aims to investigate the incidence and risk factors of vertebral re-fracture after PVP/PKP.
METHODS
Relevant literatures published up to November 2021 were collected from PubMed, Embase and Web of Science. A meta-analysis was performed to extract data associated with risk factors of SVCF following the PRISMA guidelines. Also, pooled odds ratio (OR) or weighted mean difference (WMD) with 95% confidence interval (CI) was calculated.
RESULTS
A total of 23 studies, encompassing 9372 patients with OVCF, met the inclusion criteria. 1255 patients (13.39%) suffered re-fracture after PVP/PKP surgery. A total of 22 studies were from Eastern Asia and only 1 study was from Europe. Female sex (OR = 1.34, 95%CI 1.09-1.64, P = 0.006), older age (WMD = 2.04, 95%CI 0.84-3.24, P = 0.001), lower bone mineral density (BMD, WMD = - 0.38, 95%CI - 0.49-0.26, P < 0.001) and bone cement leakages (OR = 2.05, 95% CI 1.40-3.00, P < 0.001) increased the risk of SVCF. The results of subgroup analysis showed the occurrence of re-fracture was significantly associated with gender (P = 0.002), age (P = 0.001) and BMD (P < 0.001) in Eastern Asia. Compared with the unfractured group, anterior-to-posterior vertebral body height ratio (AP ratio, WMD = 0.06, 95%CI 0.00-0.12, P = 0.037) and visual analog scale score (VAS, WMD = 0.62, 95%CI 0.09-1.15, P = 0.022) were higher in the refracture group, and kyphotic angle correction ratio (Cobb ratio, WMD = - 0.72, 95%CI - 1.26-0.18, P = 0.008) was smaller in Eastern Asia. In addition, anti-osteoporosis treatment (OR = 0.40, 95% CI 0.27-0.60, P < 0.001) could be a protective factor.
CONCLUSION
The main factors associated with re-fracture after PVP/PKP are sex, age, bone mineral density, AP ratio, Cobb ratio, VAS score, bone cement leakage and anti-osteoporosis treatment, especially in Eastern Asia.
Topics: Bone Cements; Female; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Reoperation; Risk Factors; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 35279177
DOI: 10.1186/s13018-022-03038-z -
Spine Aug 2006Systematic literature review. (Review)
Review
STUDY DESIGN
Systematic literature review.
OBJECTIVE
To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures.
SUMMARY OF BACKGROUND DATA
Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures.
METHODS
This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed.
RESULTS
A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees ) and for a subset of patients using vertebroplasty (average 6.6 degrees ). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture.
CONCLUSIONS
The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.
Topics: Humans; Incidence; Kyphosis; Orthopedic Procedures; Palliative Care; Spinal Fractures; Spine; Treatment Outcome
PubMed: 16924218
DOI: 10.1097/01.brs.0000229254.89952.6b -
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 -
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 -
Pain Physician May 2023Percutaneous balloon kyphoplasty (PKP) is widely used to treat osteoporotic vertebral compression fractures (OVCFs). In addition to rapid and effective pain relief, the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Percutaneous balloon kyphoplasty (PKP) is widely used to treat osteoporotic vertebral compression fractures (OVCFs). In addition to rapid and effective pain relief, the ability to recover the lost height of fractured vertebral bodies and reduce the risk for complications are believed to be the main advantages of this procedure. However, there is no consensus on the appropriate surgical timing for PKP.
OBJECTIVES
This study systematically evaluated the relationship between the surgical timing of PKP and clinical outcomes to provide more evidence for clinicians to choose the intervention timing.
STUDY DESIGN
Systematic review and meta-analysis.
METHODS
The PubMed, Embase, Cochrane Library, and Web of Science databases were systematically searched for relevant randomized controlled trials and prospective, and retrospective cohort trials published up to November 13, 2022. All included studies explored the influence of PKP intervention timing for OVCFs. Data regarding clinical and radiographic outcomes and complications were extracted and analyzed.
RESULTS
Thirteen studies involving 930 patients with symptomatic OVCFs were included. Most patients with symptomatic OVCFs achieved rapid and effective pain relief after PKP. In comparison to delayed PKP intervention, early PKP intervention was associated with similar or better outcomes in terms of pain relief, improvement of function, restoration of vertebral height, and correction of kyphosis deformity. The meta-analysis results showed there was no significant difference in cement leakage rate between early PKP and late PKP (odds ratio [OR] = 1.60, 95% CI, 0.97-2.64, P = 0.07), whereas delayed PKP had a higher risk for adjacent vertebral fractures (AVFs) than early PKP (OR = 0.31, 95% CI: 0.13-0.76, P = 0.01).
LIMITATIONS
The number of included studies was small, and the overall quality of the evidence was very low.
CONCLUSIONS
PKP is an effective treatment for symptomatic OVCFs. Early PKP may achieve similar or better clinical and radiographic outcomes for treating OVCFs than delayed PKP. Furthermore, early PKP intervention had a lower incidence of AVFs and a similar rate of cement leakage compared with delayed PKP. Based on current evidence, early PKP intervention might be more beneficial to patients.
Topics: Humans; Kyphoplasty; Fractures, Compression; Spinal Fractures; Retrospective Studies; Prospective Studies; Osteoporotic Fractures; Treatment Outcome; Bone Cements; Pain
PubMed: 37192225
DOI: No ID Found -
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 -
PloS One 2015Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic... (Review)
Review
CONTEXT
Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.
OBJECTIVE
To assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.
DATA SOURCES
A systematic review of articles in English or French listed in the MEDLINE, PASCAL, COCHRANE and National Health Service Economic Evaluation databases, with limits on publication date (up to the date of the review, March 2014).
STUDY SELECTION
We included only economic evaluations of vertebroplasty or kyphoplasty. Editorial and methodological articles were excluded.
DATA EXTRACTION
Data were extracted from articles by two authors working independently and using two analysis grids to measure the quality of economic evaluations.
DATA SYNTHESIS
Twenty-one studies met our inclusion criteria. All were published between 2008 and 2014. Eighteen (86%) were full economic evaluations. Cost-effectiveness analysis (CEA) was the most frequent type of economic evaluation, and was present in 11 (52%) studies. Only three CEAs complied fully with the British Medical Journal checklist. The quality of the data sources used in the 21 studies was high, but the CEAs conforming to methodological guidelines did not use high-quality data sources for all components of the analysis.
CONCLUSIONS
This systematic review shows that the level of evidence in economic evaluations of vertebroplasty and kyphoplasty is low, despite the recent publication of a large number of studies. This finding highlights the challenges to be faced to improve the quality of economic evaluations of medical devices.
Topics: Cost-Benefit Analysis; Equipment and Supplies; Humans; Kyphoplasty; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Vertebroplasty
PubMed: 26661078
DOI: 10.1371/journal.pone.0144892 -
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 -
European Spine Journal : Official... Sep 2012To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of... (Comparative Study)
Comparative Study Review
PURPOSE
To determine if differences in safety or efficacy exist between balloon kyphoplasty (BKP), vertebroplasty (VP) and non-surgical management (NSM) for the treatment of osteoporotic vertebral compression fractures (VCFs).
METHODS
As of February 1, 2011, a PubMed search (key words: kyphoplasty, vertebroplasty) resulted in 1,587 articles out of which 27 met basic selection criteria (prospective multiple-arm studies with cohorts of ≥ 20 patients). This systematic review adheres to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines.
RESULTS
Pain reduction in both BKP (-5.07/10 points, P < 0.01) and VP (-4.55/10, P < 0.01) was superior to that for NSM (-2.17/10), while no difference was found between BKP/VP (P = 0.35). Subsequent fractures occurred more frequently in the NSM group (22 %) compared with VP (11 %, P = 0.04) and BKP (11 %, P = 0.01). BKP resulted in greater kyphosis reduction than VP (4.8º vs. 1.7°, P < 0.01). Quality of life (QOL) improvement showed superiority of BKP over VP (P = 0.04), along with a trend for disability improvement (P = 0.08). Cement extravasation was less frequent in the BKP (P = 0.01). Surgical intervention within the first 7 weeks yielded greater pain reduction than VCFs treated later.
CONCLUSIONS
BKP/VP provided greater pain relief and fewer subsequent fractures than NSM in osteoporotic VCFs. BKP is marginally favored over VP in disability improvement, and significantly favored in QOL improvement. BKP had a lower risk of cement extravasation and resulted in greater kyphosis correction. Despite this analysis being restricted to Level I and II studies, significant heterogeneity suggests that the current literature is delivering inconsistent messages and further trials are needed to delineate confounding variables.
Topics: Controlled Clinical Trials as Topic; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Pain; Spinal Fractures; Vertebroplasty
PubMed: 22543412
DOI: 10.1007/s00586-012-2314-z