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BMJ Open Jul 2023Although there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is...
OBJECTIVE
Although there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is less well known. The objective of this study is to provide a systematic review of cost-effectiveness studies and policy-based willingness-to-pay (WTP) thresholds for different vertebral augmentation (VA) procedures, vertebroplasty (VP) and balloon kyphoplasty (BK), for osteoporotic vertebral fractures (OVFs).
DESIGN
A systematic review targeting cost-effectiveness studies of VA procedures for OVFs.
DATA SOURCES
Six bibliographic databases were searched from inception up to May 2021.
ELIGIBILITY CRITERIA FOR STUDY SELECTION
Studies were eligible if meeting all predefined criteria: (1) VP or BK intervention, (2) OVFs and (3) cost-effectiveness study. Articles not written in English, abstracts, editorials, reviews and those reporting only cost data were excluded.
DATA EXTRACTION AND SYNTHESIS
Information was extracted on study characteristics, cost-effective estimates, summary decisions and payer WTP thresholds. Incremental cost-effective ratio (ICER) was the main outcome measure. Studies were summarised by a structured narrative synthesis organised by comparisons with conservative management (CM). Two independent reviewers assessed the quality (risk of bias) of the systematic review and cost-effectiveness studies by peer-reviewed checklists.
RESULTS
We identified 520 references through database searching and 501 were excluded as ineligible by titles and abstract. Ten reports were identified as eligible from 19 full-text reviews. ICER for VP versus CM evaluated as cost per quality-adjusted life-year (QALY) ranged from €22 685 (*US$33 395) in Netherlands to £-2240 (*US$-3273), a cost-saving in the UK. ICERs for BK versus CM ranged from £2706 (*US$3954) in UK to kr600 000 (*US$90 910) in Sweden. ICERs were within payer WTP thresholds for a QALY based on historical benchmarks.
CONCLUSIONS
Both VP and BK were judged cost-effective alternatives to CM for OVFs in economic studies and were within WTP thresholds in multiple healthcare settings.
Topics: Humans; Cost-Benefit Analysis; Vertebroplasty; Kyphoplasty; Spinal Fractures; Outcome Assessment, Health Care; Osteoporotic Fractures
PubMed: 37491092
DOI: 10.1136/bmjopen-2022-062832 -
Neurospine May 2024Percutaneous vertebroplasty (PVP) is currently the most common surgical procedure for unstable Kummell disease (KD), but bone cement loosening or displacement often...
OBJECTIVE
Percutaneous vertebroplasty (PVP) is currently the most common surgical procedure for unstable Kummell disease (KD), but bone cement loosening or displacement often occurs after the operation. We had been using percutaneous pediculoplasty (PPP) or a self-developed bone cement bridging screw system to avoid this severe complication. This study intends to compare the safety, advantages and disadvantages of these 2 novel surgical procedures through a 2-year follow-up evaluation.
METHODS
In accordance with the inclusion and exclusion criteria, from May 2017 to May 2021, 77 patients with single segmental unstable KD who had received the PVP-PPP combined therapy were included in the PPP group, and 42 patients with the same who had received the PVP-bone cement bridging screw system combined therapy were included in the screw group. All patients received the operation through unilateral approach. The changes in the vertebral body index (VBI), bisegmental Cobb angle, visual analogue scale (VAS) and Oswestry Disability Index (ODI) and the bone cement loosening rate and displacement rate at different follow-up time points were used to evaluate the clinical efficacy.
RESULTS
The average operation duration of the PPP group was 85.52±10.78 minutes (range, 70-115 minutes), and its average bone cement injection volume was 4.98±0.67 mL (range, 4-6 mL). The average operation duration of the screw group was 52.07±9.90 minutes (range, 36-65 minutes), and its average bone cement injection volume was 4.43±0.89 mL (range, 2.5-6 mL). Before operation, immediately after operation and at 6 months after operation, there was no significant difference in VBI or bisegmental Cobb angle between the screw group and the PPP group (p>0.05), while at 1-year and 2-year midterm postoperative evaluations, the screw group had higher VBI and bisegmental Cobb angle than the PPP group (p<0.05). Before operation, immediately after operation, at 6 months after operation and at 1 year after operation, there was no significant difference in VAS or ODI score between the screw group and the PPP group (p>0.05), while at 2 years after operation, the screw group still had higher VAS and ODI scores than the PPP group (p<0.05). No bone cement displacement occurred in both groups, but the rate of bone cement loosening was 14.29% in group PPP, and 0 in screw group (p<0.05).
CONCLUSION
This 2-year follow-up study shows that the PVP-bone cement bridging screw system combined therapy had better midterm treatment efficacy than the PVP-PPP combined therapy in patients with unstable KD, and the bone cement bridging screw system is a preferred therapy with better anti cement loosening ability.
PubMed: 38763157
DOI: 10.14245/ns.2347274.637 -
Medicinski Glasnik : Official... Feb 2024Aim Kyphoplasty and vertebroplasty are minimally invasive procedures used in bone augmentation following vertebral fractures when conservative management has failed....
Aim Kyphoplasty and vertebroplasty are minimally invasive procedures used in bone augmentation following vertebral fractures when conservative management has failed. Cement injection could leak into surrounding structures leading to post-operative sequelae, which could be symptomatic. This study compared the rate and site of cement extravasation in vertebroplasty, kyphoplasty, and a combined approach. The indications, aetiology, and factors influencing results and the effect of screws were considered. Methods A retrospective descriptive study of 171 patients was conducted between 2009 and 2021. Only 89 patients had available imaging. The site of cement extravasation was evaluated postoperatively by CT-scan and X-ray. Results There was a statistically significant difference in the prevalence of cement extravasation between kyphoplasty and vertebroplasty procedures (p=0.004). Age and gender had no significant influence on the rate of cement extravasation. Patients who underwent kyphoplasty had the lowest rate of cement extravasation (46.9%) compared to vertebroplasty (85.2%) and the combined approach (69.2%). The most common site of leakage was in perivertebral veins (37.9%). The use of screws did not indicate a greater risk of cement leak (p=0.652). Bone metastases were the aetiology with the highest cement leakage rate (27.5%). Conclusion The use of kyphoplasty alone or in conjunction with vertebroplasty decreases the risk of cement extravasation and subsequent complications compared to vertebroplasty alone. The use of pedicle screws appears to be safe and was not found to increase the risk of cement extravasation.
PubMed: 37950655
DOI: 10.17392/1626-23 -
European Review For Medical and... Sep 2023This study aimed to compare the relationship of pain relief with the amount and distribution of injected cement in kyphoplasty for osteoporotic vertebral fractures.
OBJECTIVE
This study aimed to compare the relationship of pain relief with the amount and distribution of injected cement in kyphoplasty for osteoporotic vertebral fractures.
PATIENTS AND METHODS
This cohort study was conducted on 90 patients with osteoporotic vertebral fractures who needed chronic pain medication. Patients underwent kyphoplasty balloon surgery, and polymethylmethacrylate (PMMA) or bone cement was injected into the created cavities and the volume of injected cement was recorded. After the surgery, the distribution of cement was measured using a computed tomography (CT) scan in the coronal, sagittal, and axial axes of the vertebra, and the percentage of cement distribution was evaluated using Photoshop software in these three axes, followed by the pattern of cement distribution. The cement was measured in the entire vertebra. The patients were evaluated over a period of 6 months, and the amount of pain improvement was measured by the VAS scale in 24 hours, two weeks, six weeks, and six months after surgery. In this study, the data of 90 patients with a mean age of 72.5±10.9 years were included in the study. The mean volume of cement injected was 1.2±5.8 cc, followed by the mean percentage of cement distribution (47.7±7.4%); the mean pain score before the operation (8.7±1.3), the mean pain score 24 hours after the operation (7.7±1.4), the mean pain score 2 weeks after the operation (4.8±1.3), the mean pain score 6 weeks after the operation (3.6±1.2) and the mean pain score 6 months after the operation (3.5±1.4) were evaluated after collection.
RESULTS
The pain intensity 24 hours after the operation had a significant positive correlation with the percentage of cement distribution and pain intensity before the operation. The intensity of pain 2 weeks after the operation was positively correlated with the age of the patients and the intensity of pain before the operation. The pain intensity 6 weeks after the operation was significantly correlated with the age of the patients and the pain intensity before the operation. The intensity of pain 6 months after the operation was positively linked to the age of the patients and negatively correlated with the percentage of cement distribution. The pain reduction has changed significantly in the 4 measured intervals, and during a period of 6 months, there was a significant improvement in the pain level of the patients continuously. It was found that the rate of recovery of the patient's pain has increased by increased distribution of injected cement. Although this reduction in pain during the 6-month period was not significantly related to the variables of gender, smoking, history of corticosteroid use, and the volume of injected cement.
CONCLUSIONS
The balloon kyphoplasty is a safe and successful method for treating symptomatic vertebral fractures. Kyphoplasty is associated with significant pain relief, improved quality of life, and kyphosis correction. The volume of cement injected had no effect on reducing patients' pain after the operation, but a higher percentage of cement distribution was associated with a better response in patients.
Topics: Humans; Middle Aged; Aged; Aged, 80 and over; Kyphoplasty; Bone Cements; Cohort Studies; Quality of Life; Fractures, Compression; Treatment Outcome; Spine; Spinal Fractures; Osteoporotic Fractures; Chronic Pain
PubMed: 37782170
DOI: 10.26355/eurrev_202309_33779 -
Biomechanics and Modeling in... Aug 2023The outcome of vertebroplasty is hard to predict due to its dependence on complex factors like bone cement and marrow rheologies. Cement leakage could occur if the...
The outcome of vertebroplasty is hard to predict due to its dependence on complex factors like bone cement and marrow rheologies. Cement leakage could occur if the procedure is done incorrectly, potentially causing adverse complications. A reliable simulation could predict the patient-specific outcome preoperatively and avoid the risk of cement leakage. Therefore, the aim of this work was to introduce a computationally feasible and experimentally validated model for simulating vertebroplasty. The developed model is a multiphase continuum-mechanical macro-scale model based on the Theory of Porous Media. The related governing equations were discretized using a combined finite element-finite volume approach by the so-called Box discretization. Three different rheological upscaling methods were used to compare and determine the most suitable approach for this application. For validation, a benchmark experiment was set up and simulated using the model. The influence of bone marrow and parameters like permeability, porosity, etc., was investigated to study the effect of varying conditions on vertebroplasty. The presented model could realistically simulate the injection of bone cement in porous materials when used with the correct rheological upscaling models, of which the semi-analytical averaging of the viscosity gave the best results. The marrow viscosity is identified as the crucial reference to categorize bone cements as 'high- 'or 'low-' viscosity in the context of vertebroplasty. It is confirmed that a cement with higher viscosity than the marrow ensures stable development of the injection and a proper cement interdigitation inside the vertebra.
Topics: Humans; Bone Cements; Porosity; Vertebroplasty; Spine; Computer Simulation
PubMed: 37171687
DOI: 10.1007/s10237-023-01715-4 -
Healthcare (Basel, Switzerland) Nov 2023Wound complications are commonly seen after surgeries for metastatic spine tumors. While numerous studies have pinpointed various risk factors, there is ongoing debate....
Wound complications are commonly seen after surgeries for metastatic spine tumors. While numerous studies have pinpointed various risk factors, there is ongoing debate. Therefore, this study aimed to verify various factors that are still under debate utilizing the comprehensive Korean National Health Insurance Service database. We identified and retrospectively reviewed a cohort of 3001 patients who underwent one of five surgical treatments (corpectomy, decompression and instrumentation, instrumentation only, decompression only, and vertebroplasty) for newly diagnosed spinal metastasis between 2009 and 2017. A Cox regression analysis was performed to determine the risk factors. A total of 197 cases (6.6%) of wound revision were found. Only the surgical method and Charlson comorbidity index were significantly different between the group that underwent wound revision and the group that did not. Regarding surgical methods, the adjusted hazard ratios for decompression only, corpectomy, instrumentation and decompression, and instrumentation only were 1.3, 2.2, 2.2, and 2.4, with these ratios being compared to the vertebroplasty group ( for trend = 0.02). In this regard, based on a sizable South Korean cohort, both surgical methods and medical comorbidity were found to be associated with the wound revision rate among spinal surgery patients for spinal metastasis.
PubMed: 37998455
DOI: 10.3390/healthcare11222962 -
Diagnostic and Interventional Radiology... Aug 2023This study aimed to explore the relationship between the time from percutaneous vertebral augmentation (PVA) until subsequent fracture and the risk of new symptomatic...
PURPOSE
This study aimed to explore the relationship between the time from percutaneous vertebral augmentation (PVA) until subsequent fracture and the risk of new symptomatic fractures (NSFs) in untreated vertebrae at different distances from "augmented vertebrae".
METHODS
Patients who underwent PVA for the treatment of osteoporotic vertebral compression fractures at the West China Hospital of Sichuan University from May 2014 to April 2019 were retrospectively recruited. Vertebrae not treated during PVA were stratified based on their distance from the nearest augmented vertebra and the time elapsed since PVA. Survival curves were plotted to compare the risk of NSFs in untreated vertebrae at different distances from augmented vertebrae. The Cox proportional hazards model was used to identify risk factors of NSFs in untreated vertebrae.
RESULTS
total, 162 patients with 228 NSFs (2.760 vertebrae) were analyzed. More than half of the NSFs (56.6%) occurred within the first year after PVA. Rates and hazard ratios (HRs) of NSFs were higher in vertebrae located one segment away from the augmented vertebrae (21.0%, HR: 3.99, < 0.001), two segments away (10.6%, HR: 1.97, = 0.003), or three segments away (10.5%, HR: 2.26, < 0.001) than in vertebrae located five or more segments away (3.81%, HR: 1.00). Similar results were observed regardless of whether the untreated vertebrae were located in the thoracolumbar junction. In addition to distance, other risk factors of NSFs were the thoracolumbar location of untreated vertebrae, the number of augmented vertebrae, and percutaneous vertebroplasty.
CONCLUSION
The risk of NSFs is greater for untreated vertebrae located closer to augmented vertebrae than for untreated vertebrae further away. This distance dependence occurs mainly within the three segments closest to the augmented vertebra. The risk of NSFs decreases with time after augmentation, and it is also related to the number of augmented vertebrae, the type of augmentation, and whether the untreated vertebrae are thoracolumbar or not.
PubMed: 37554659
DOI: 10.4274/dir.2023.221424 -
Scientific Reports Jun 2024The correlation between lower psoas mass and the prognosis of osteoporotic vertebral compression fractures (OVCF) is still unclear. This study aims to investigate the...
The correlation between lower psoas mass and the prognosis of osteoporotic vertebral compression fractures (OVCF) is still unclear. This study aims to investigate the impact of lower psoas mass on the prognosis of patients undergoing percutaneous vertebroplasty (PVP). One hundred and sixty-three elderly patients who underwent single-segment PVP from January 2018 to December 2021 were included. The psoas to L4 vertebral index (PLVI) via MRI were measured to assess psoas mass. Patients were divided into high PLVI (> 0.79) and low PLVI (≤ 0.79) groups based on the median PLVI in the cohort. The basic information (age, gender, body mass index (BMI) and bone mineral density (BMD)), surgical intervention-related elements (duration of operation, latency to ambulation, period of hospital stay, and surgical site), postoperative clinical outcomes (Visual Analog Scale (VAS) scores, Oswestry Disability Index (ODI) scores, Japanese Orthopaedic Association (JOA) scores), and incidence of secondary fractures) were compared. Patients showed no statistically significant differences in terms of age, gender, surgical sute, BMI, BMD and preoperative VAS, ODI, JOA scores (P > 0.05) between the two groups. However, there were significant differences in terms of latency to ambulation, period of hospital stay (P < 0.05). VAS, ODI, and JOA scores at 1, 6, and 12 months after surgery showed that the high PLVI group had significantly better outcomes than the low PLVI group (P < 0.05). Additionally, the low PLVI group had a significantly higher incidence of recurrent fracture (P < 0.05). Lower psoas mass can reduce the clinical effect of PVP in patients with osteoporotic vertebral compression fractures, and is a risk factor for recurrent vertebral fracture.
Topics: Humans; Male; Female; Aged; Vertebroplasty; Fractures, Compression; Osteoporotic Fractures; Spinal Fractures; Prognosis; Aged, 80 and over; Psoas Muscles; Treatment Outcome; Bone Density; Retrospective Studies
PubMed: 38880790
DOI: 10.1038/s41598-024-64626-z -
International Journal of Spine Surgery Oct 2023Proximal junctional kyphosis (PJK) is a common complication following long-segment thoracolumbar fusions for patients with adult spinal deformities. PJK is described as...
Proximal junctional kyphosis (PJK) is a common complication following long-segment thoracolumbar fusions for patients with adult spinal deformities. PJK is described as a progressive kyphosis at the upper instrumented vertebra or 1 or 2 segments adjacent to the instrumented vertebra. This condition can lead to proximal junction failure, which results in vertebral body fractures, screw pullouts, and neurological deficits. Revision surgery is necessary to address symptomatic PJK. Research efforts have been dedicated to elucidating risk factors and prevention strategies. It has been postulated that minimally invasive surgery (MIS) techniques may help prevent PJK because these techniques aim to preserve the soft tissue integrity at the top of the construct and maintain posterior element support. In this article, the authors define PJK, describe MIS strategies to prevent PJK, and compare PJK rates after MIS with PJK rates after open approaches for long-segment thoracolumbar fusion.
PubMed: 37460241
DOI: 10.14444/8511 -
Neurospine Dec 2023To compare unilateral extrapedicular vertebroplasty (UEV) and bilateral transpedicular vertebroplasty (BTV) by quantitatively calculating the structural changes of...
Quantitative Comparison of Vertebral Structural Changes After Percutaneous Vertebroplasty Between Unilateral Extrapedicular Approach and Bilateral Transpedicular Approach Using Voxel-Based Morphometry.
OBJECTIVE
To compare unilateral extrapedicular vertebroplasty (UEV) and bilateral transpedicular vertebroplasty (BTV) by quantitatively calculating the structural changes of fractured vertebral body after percutaneous vertebroplasty (PVP) using 3-dimensional voxel-based morphometry (VBM).
METHODS
We calculated bone cement volume (BCV); vertebral body volume (VBV); leaked intradiscal BCV; and spatial, symmetric, and even bone cement distribution (BCD) in and out of 222 vertebral bodies treated with 2 different PVPs using VBM and evaluated the incidence of subsequent vertebral compression fracture (SVCF). Statistical analyses were conducted to compare values between the 2 different PVPs.
RESULTS
Relative BCV, which is a potential risk factor for SVCF, was higher in the BTV group based on the data using VBM (0.22±0.03 vs. 0.29±0.03; p<0.001, t-test); however, the SVCF incidence between the 2 surgeries was not significantly different (UEV, 24.7%; BTV, 31%; p=0.046, chi-square test). Spatial, even, and symmetric BCD along the 3 axes was not significantly different between UEV and BTV using VBM (x, y, z-axis, p=0.893, p= 0.590, p=0.908 respectively, chi-square test).
CONCLUSION
Contrary to intuitive concerns, UEV can inject a sufficient and more optimal BCV than BTV. Additionally, it can inject bone cement spatially, symmetrically, and evenly well-distributed without an increased rate of intradiscal leakage and SVCF compared with BTV based on VBM. Therefore, UEV could be a superior alternative surgical method with similar clinical effectiveness and safety, considering the above results and the consensus that UEV is less invasive.
PubMed: 37743248
DOI: 10.14245/ns.2346536.268