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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 -
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 -
European Spine Journal : Official... Oct 2023Vertebroplasty has been recently described in the literature as a potential treatment for C2 metastatic lesions. Stentoplasty may represent a safest and equally... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vertebroplasty has been recently described in the literature as a potential treatment for C2 metastatic lesions. Stentoplasty may represent a safest and equally alternative to the latter.
OBJECTIVE
To describe a novel technique, stentoplasty, as an alternative for the treatment of metastatic involvement of C2 and to assess its efficacy and safety. To systematically evaluate the pertinent literature regarding the clinical outcomes and complications of C2 vertebroplasty in patients with metastatic disease.
METHODS
A systematic review of C2 vertebroplasty, in the English language medical literature was conducted for the needs of this study. Additionally, a cohort of five patients, presenting with cervical instability (SINS > 6) and/or severe pain (VAS > 6) from metastatic involvement of C2 and treated with stentoplasty in our department is presented. Outcomes evaluated include, pain control, stability, and complications.
RESULTS
Our systematic review yielded 8 studies that met the inclusion criteria, incorporating 73 patients that underwent C2 vertebroplasty for metastatic disease. There was a reduction in VAS scores following surgery from 7.6 to 2.1. Eleven patients had complications (15%), 3 (4%) required additional stabilization and decompression, 6 (8.2%) had odynophagia and the incidence of cement leak was 31.5% (23/73). With regard to our cohort, all 5 patients presented with severe neck pain (average VAS 6.2 (2-10)) with or without instability (average SINS 10 (6-14)) and underwent C2 stentoplasty. Mean duration of the procedures was 90 min (61-145) and 2.6 mls (2-3) of cement was injected. Postoperatively VAS improved from 6.2 to 1.6 (P = 0.033). No cement leak or other complications were recorded.
CONCLUSION
A systematic review of the literature demonstrated that C2 vertebroplasty can offer significant pain improvement with a low complication rate. At the same time, this is the first study to describe stentoplasty in a small cohort of patients, as an alternative for the treatment of C2 metastatic lesions in selected cases, offering adequate pain control and improving segmental stability with a high safety profile.
Topics: Humans; Vertebroplasty; Neck Pain; Bone Cements; Pain Management; Treatment Outcome; Spinal Fractures
PubMed: 37300582
DOI: 10.1007/s00586-023-07809-y -
World Neurosurgery Dec 2014Ionizing radiation is typically used during spine surgery for localization and guidance in instrumentation placement. Minimally invasive (MI) surgical procedures are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Ionizing radiation is typically used during spine surgery for localization and guidance in instrumentation placement. Minimally invasive (MI) surgical procedures are increasingly popular and often require significantly more fluoroscopy, placing surgeons at risk for increased radiation exposure and radiation-induced complications. This study provides recommendations for minimizing risk of radiation-induced injury to spine surgeons and summarizes studies addressing radiation exposure in spine procedures.
METHODS
The PubMed database was queried for relevant articles pertaining to radiation exposure in spine surgery.
RESULTS
Discectomy, percutaneous pedicle screw placement, MI transforaminal lumbar interbody fusion, MI lateral lumbar interbody fusion, and vertebroplasty/kyphoplasty procedures were assessed. The highest radiation doses were seen with MI pedicle screw placement, MI transforaminal lumbar interbody fusion, vertebroplasty and kyphoplasty, and percutaneous endoscopic lumbar discectomy. Use of lead aprons and thyroid shields reduces effective dose by several orders of magnitude. Proper operator positioning also minimizes radiation exposure. Lead gloves decrease dose to the surgeon's hand from scatter if the hand is out of the x-ray beam most of the time. If prolonged exposure of the hand cannot be avoided, the technician should collimate the surgeon's hand out of the beam or use instruments to position the hand farther from the beam. In addition to using less fluoroscopy, pulsed fluoroscopy can decrease overall dose in a procedure.
CONCLUSIONS
Spine surgeons should reduce their exposure to radiation to minimize risk of potential long-term complications. Strategies include minimizing fluoroscopy use and dose, proper use of protective gear, and appropriate manipulation of fluoroscopic equipment.
Topics: Fluoroscopy; Humans; Minimally Invasive Surgical Procedures; Radiation Injuries; Spine
PubMed: 25088230
DOI: 10.1016/j.wneu.2014.07.041 -
Health Technology Assessment... Mar 2014Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty... (Review)
Review
Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis.
BACKGROUND
Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty (BKP) is a variation of this approach, in which an inflatable balloon tamp is placed in the collapsed vertebra prior to cement injection.
OBJECTIVES
To systematically evaluate and appraise the clinical effectiveness and cost-effectiveness of PVP and percutaneous BKP in reducing pain and disability in people with osteoporotic vertebral compression fractures (VCFs) in England and Wales.
DATA SOURCES
A systematic review was carried out. Ten databases including MEDLINE and CINAHL were searched from inception to November 2011, and supplemented by hand-searching relevant articles and contact with an expert. Studies met the inclusion criteria if they were randomised controlled trials (RCTs) including people with painful osteoporotic VCFs with a group receiving PVP or BKP. In addition, lead authors of identified RCTs were contacted for unpublished data.
REVIEW METHODS
Primary outcomes were health-related quality of life; back-specific functional status/mobility; pain/analgesic use; vertebral body height and angular deformity; incidence of new vertebral fractures and progression of treated fracture. A manufacturer provided academic-in-confidence observational data indicating that vertebral augmentation may be associated with a beneficial mortality effect, and that, potentially, BKP was more efficacious than PVP. These data were formally critiqued. A mathematical model was constructed to explore the cost-effectiveness of BKP, PVP and operative placebo with local anaesthesia (OPLA) compared with optimal pain management (OPM). Six scenario analyses were conducted that assessed combinations of assumptions on mortality (differential beneficial effects for BKP and PVP; equal beneficial effects for BKP and PVP; and no effect assumed) and derivation of utility data (either mapped from visual analogue scale pain score data produced by a network meta-analysis or using direct European Quality of Life-5 Dimensions data from the trials). Extensive sensitivity analyses were conducted on each of the six scenarios. This report contains reference to confidential information provided as part of the National Institute for Health and Care Excellence appraisal process. This information has been removed from the report and the results, discussions and conclusions of the report do not include the confidential information. These sections are clearly marked in the report.
RESULTS
A total of nine RCTs were identified and included in the review of clinical effectiveness. This body of literature was of variable quality, with the two double-blind, OPLA-controlled trials being at the least risk of bias. The most significant methodological issue among the remaining trials was lack of blinding for both study participants and outcome assessors. Broadly speaking, the literature suggests that both PVP and BKP provide substantially greater benefits than OPM in open-label trials. However, in double-blinded trials PVP was shown to have no more benefit than local anaesthetic; no trials of BKP compared with local anaesthesia have been conducted. A formal analysis of observational mortality data undertaken within this report concluded that it was not possible to say with certainty if there is a difference in mortality between patients undergoing BKP and PVP compared with OPM. Results from the cost-effectiveness analyses were varied, with all of BKP, PVP and OPLA appearing the most cost-effective treatment dependent on the assumptions made regarding mortality effects, utility, hospitalisation costs and OPLA costs.
LIMITATIONS
Data on key parameters were uncertain and/or potentially confounded, making definitive conclusions difficult to make.
CONCLUSION
For people with painful osteoporotic VCFs refractory to analgesic treatment, PVP and BKP perform significantly better in unblinded trials than OPM in terms of improving quality of life and reducing pain and disability. However, there is as yet no convincing evidence that either procedure performs better than OPLA. The uncertainty in the evidence base means that no definitive conclusion on the cost-effectiveness of PVP or BKP can be provided. Further research should focus on establishing whether or not BKP and PVP have a mortality advantage compared with OPLA and on whether or not these provide any utility gain compared with OPLA.
STUDY REGISTRATION
This study was registered as PROSPERO number CRD42011001822.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Back Pain; Bone Cements; Cost-Benefit Analysis; England; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Quality of Life; Randomized Controlled Trials as Topic; Recovery of Function; Spinal Fractures; Technology Assessment, Biomedical; Vertebroplasty
PubMed: 24650687
DOI: 10.3310/hta18170 -
Neurospine Dec 2023We aimed to comprehensively compare surgical methods for osteoporotic vertebral compression fracture (OVCF) using systematic review and network meta-analysis to...
OBJECTIVE
We aimed to comprehensively compare surgical methods for osteoporotic vertebral compression fracture (OVCF) using systematic review and network meta-analysis to understand their effectiveness and outcomes, as current research provides limited overviews.
METHODS
We followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines, preregistering our protocol with PROSPERO. We analyzed Englishpublished randomized controlled trials (RCTs) on adults with OVCFs that evaluated pain intensity or functionality using tools like visual analogue scale (VAS) or Oswestry Disability Index (ODI). Exclusions included non-RCTs, malignancy-related fractures, and certain interventions. Using the RoB 2 tool, we assessed bias and visualized results with Robvis. Our primary outcome was pain intensity, with secondary outcomes including disability, new fractures, and cement leakage. Results were synthesized using Stata/MP.
RESULTS
Thirty-four RCTs from 10 countries, totaling 4,384 patients, were analyzed. Shortterm VAS indicated kyphoplasty with facet joint injection (KIJ) as the top treatment at 87.7%, while unipedicular kyphoplasty (UKP) led to long-term at 74.9%. Short-term ODI favored vertebroplasty with facet joint injection (VIJ) at 98.4%, with kyphoplasty (KP) leading longterm at 66.0%. All surgical techniques were superior to conservative treatment. Vertebral augmentation devices reported the fewest new fractures and curved vertebroplasty had the least cement leakage. SUCRA (surface under the cumulative ranking) analyses suggested UKP and VIJ as top choices for postoperative pain relief, with VIJ excelling in postoperative disability improvement.
CONCLUSION
Our analysis evaluates 12 OVCF interventions, underscoring KIJ for short-term pain relief and VIJ and UKP for long-term efficacy. Notably, VIJ stands out in disability outcomes, emphasizing the need for comprehensive OVCF management.
PubMed: 38171285
DOI: 10.14245/ns.2346996.498 -
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 -
World Neurosurgery Jan 2022This study was designed to help elucidate the benefits and advantages of vertebroplasty combined with zoledronic acid (ZOL) versus vertebroplasty alone, to provide... (Meta-Analysis)
Meta-Analysis
Percutaneous Vertebroplasty Combined with Zoledronic Acid in Treatment and Prevention of Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis of Comparative Studies.
OBJECTIVE
This study was designed to help elucidate the benefits and advantages of vertebroplasty combined with zoledronic acid (ZOL) versus vertebroplasty alone, to provide clinical recommendations for the treatment of osteoporotic vertebral compression fractures (OVCFs) considering the current best-available evidence.
METHODS
We comprehensively searched PubMed, Embase, Web of Science, and the Cochrane Library and performed a systematic review and cumulative meta-analysis of all randomized controlled trials and retrospective comparative studies assessing these important indexes of 2 methods using Review Manager 5.4.
RESULTS
Four randomized controlled trials and 4 retrospective studies including 2335 cases were identified. Vertebroplasty combined with ZOL was associated with benefits from decreased pain (weighted mean difference [WMD] -0.43; 95% confidence interval [CI] -0.59 to -0.27; P < 0.05), increased function (WMD -4.94; 95% CI -6.13 to -3.75; P < 0.05), increased BMD of the vertebral body(WMD 0.85; 95% CI 0.30-1.40; P < 0.05) and of the proximal femoral neck (WMD 0.14; 95% CI 0.08-0.21; P < 0.05), fewer markers of bone metabolism (N-terminal molecular fragment: WMD -4.82; 95% CI -6.08 to -3.55; P < 0.05; procollagen type I N-terminal propeptide: WMD -17.31; 95% CI -18.04 to -16.58; P < 0.05; beta collagen degradation product: WMD -0.27; 95% CI -0.35 to -0.19; P < 0.05), and lower rate of refracture (1.54% and 12.6%; odds ratio 0.17; 95% CI 0.08-0.36; P < 0.05). Patients in the vertebroplasty combined with ZOL group had greater vertebral body height (WMD 2.17; 95% CI 0.72-3.62; P < 0.05) than in the vertebroplasty group, but no differences on Cobb angle were observed (WMD -1.18; 95% CI -2.47 to 0.10; P > 0.05).
CONCLUSIONS
Vertebroplasty combined with ZOL was superior to vertebroplasty alone in terms of BMD, bone metabolism makers, refracture rate, pain and function.
Topics: Aged; Bone Density Conservation Agents; Combined Modality Therapy; Female; Fractures, Compression; Humans; Male; Middle Aged; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Spinal Fractures; Vertebroplasty; Zoledronic Acid
PubMed: 34655820
DOI: 10.1016/j.wneu.2021.09.131 -
European Spine Journal : Official... May 2023The incidence of osteoporotic compression fractures (VCFs) have been rising over the past decades. Presently, vertebral cement augmentation procedures such as balloon... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The incidence of osteoporotic compression fractures (VCFs) have been rising over the past decades. Presently, vertebral cement augmentation procedures such as balloon kyphoplasty and vertebroplasty are common treatments allowing pain relief and functional recovery. However, there is controversy on whether different timeframes for cement augmentation affects clinical outcomes. Hence, this study aimed to compare pain relief and complication rates between early versus late cement augmentation.
METHODS
A comprehensive systematic review of PubMed, EMBASE, Scopus and Cochrane Library was conducted, identifying studies that compared early versus late cement augmentation for VCFs. As the definitions of "early" and "late" phases across studies are heterogenous, we established the cut-off between early and late phase as intervals to accommodate as many studies as possible for analysis. We conducted two separate analyses with different cut-off intervals and included studies that reported interventions within these respective time intervals. In analysis 1, we included studies which grouped patients into "early" and "late" group based on a cut-off time frame of 2-4 weeks. On the other hand, in analysis 2, we included studies which grouped patients into "early" and "late" groups based on a cut-off time frame of 6-8 weeks. Meta-analysis was conducted via random-effect models, comparing outcomes of interest between early and late groups.
RESULTS
Eleven studies were included. The total cohort size was 712 and 775 patients in analysis 1 and 2 respectively. Mean follow-up was 12.9 ± 3.7 months and 11 ± 0.6 months respectively. VAS change at final follow-up was significantly greater in the early group for both analyses. (MD = - 0.66, p = 0.01; and MD = - 1.18, p < 0.005 respectively). There was no significant difference in post-operative absolute VAS score, number of cement leakage, number of adjacent compression fractures and local kyphotic angle, for both analyses. Patients in both groups experienced reductions in VAS score that exceeded the minimum clinically important difference.
CONCLUSION
Both early and late timeframes for cement augmentation offered significant improvement in pain relief, with similar post-operative absolute pain score, kyphotic angle, cement leakage and adjacent vertebral fractures. Early surgery may offer substantial pain relief in patients presenting with pain as early as < 2-4 weeks of VCFs.
Topics: Humans; Fractures, Compression; Treatment Outcome; Osteoporotic Fractures; Vertebroplasty; Kyphoplasty; Spinal Fractures; Bone Cements; Pain
PubMed: 36964780
DOI: 10.1007/s00586-023-07658-9 -
Global Spine Journal Mar 2022Systematic review and meta-analysis.
STUDY DESIGN
Systematic review and meta-analysis.
OBJECTIVE
Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are minimally invasive techniques widely used for the treatment of neurologically intact osteoporotic Kümmell's disease (KD), but which treatment is preferable remains controversial. Therefore, this study aimed to shed light on this issue.
METHODS
Six databases were searched for all relevant studies based on the PRISMA guidelines. Two investigators independently conducted a quality assessment, extracted the data and performed all statistical analyses.
RESULTS
Eight studies encompassing 438 neurologically intact osteoporotic KD patients met the inclusion criteria. Compared to PVP, PKP was associated with greater improvement in the short- and long-term Cobb angle [SMD = -0.37, P = 0.007; SMD = -0.34, P = 0.012], short-term anterior vertebral height [SMD = 0.43, P = 0.003] and long-term middle vertebral height [SMD = 0.57, P = 0.012] and a lower cement leakage rate [SMD = 0.50, P = 0.003] but produced more consumption (cement injection volume, operative time, fluoroscopy times, intraoperative blood loss and operation cost). However, there were no differences between the 2 procedures in the short- and long-term VAS and ODI scores, long-term anterior vertebral height, overall complications or new vertebral fractures.
CONCLUSIONS
Both procedures are equally effective for neurologically intact KD in terms of the clinical outcomes, with the exception of a lower cement leakage risk and better radiographic improvement for PKP but greater resource consumption. Based on the evidence available, good clinical judgment should be exercised in the selection of patients for these procedures.
PubMed: 33541141
DOI: 10.1177/2192568220984129