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The Spine Journal : Official Journal of... Oct 2020In 2010, the American Academy of Orthopedic Surgeons published guidelines strongly recommending against the use of vertebroplasty following the publication of randomized... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND CONTEXT
In 2010, the American Academy of Orthopedic Surgeons published guidelines strongly recommending against the use of vertebroplasty following the publication of randomized control trials that failed to show significant improvement in pain. Vertebroplasty has remained controversial since those findings.
PURPOSE
To study and provide an update on utilization of vertebroplasty and kyphoplasty procedures among Medicare beneficiaries by physician specialty and practice setting following publication of recommendations against vertebroplasty in 2010.
STUDY DESIGN/SETTING
This study uses Medicare Part B Physician/Supplier Procedure Summary Master File (PSPSMF) for the years 2010 to 2018 to determine trends in volume and reimbursement by physician specialty and practice setting.
PATIENT SAMPLE
All vertebral augmentation procedures with a physician reimbursement claims approved by Medicare Part B from 2010 to 2018.
OUTCOME MEASURES
This study analyzes trends in volume and physician payment of vertebroplasty and kyphoplasty procedures by physician specialty for the time period 2010 to 2018.
METHODS
Claims from the Medicare Part B PSPSMF for the years 2010 to 2018 were extracted using the Current Procedural Terminology codes for vertebroplasty and kyphoplasty. Total volumes, payment amounts (professional component), and trends were analyzed by physician specialty.
RESULTS
Between 2010 and 2018, the total volume of vertebroplasties decreased by 61.2% (29,995 to 11,654), whereas the volume of kyphoplasties increased modestly by 14.4% (59,691 to 68,294). Radiologists performed an increasing share of both procedures over this time period, from 68.5% to 75.1% for vertebroplasties and 28.9% to 37.1% for kyphoplasties. Total payment for vertebroplasties decreased by 74.3% from $14.8 million in 2010 to $3.8 million in 2018; whereas it increased by 235.3% for kyphoplasty procedures from $26.7 million to $89.7 million. This is driven in large part by a 6,833% increase in office based kyphoplasties which bill at the higher nonfacility rate that incorporates overhead, staff, and equipment.
CONCLUSIONS
Previous studies have demonstrated mixed evidence for benefits of vertebroplasty procedures and decreasing volumes over time. Data show continued downtrend in vertebroplasty and increased utilization of kyphoplasty among Medicare beneficiaries. In addition, the growing number of kyphoplasties correlated with a sharp rise in volume and increased reimbursement for office-based procedures. Radiologists have been performing an increasing share of both procedures.
Topics: Aged; Current Procedural Terminology; Fractures, Compression; Humans; Kyphoplasty; Medicare; Physicians; Spinal Fractures; United States; Vertebroplasty
PubMed: 32417502
DOI: 10.1016/j.spinee.2020.05.002 -
Medicine Dec 2021The objective of this study was to compare the efficacy of lateral and bilateral percutaneous vertebroplasty (PVP) in treating osteoporotic vertebral compression...
Comparison of the effectiveness and safety of unilateral and bilateral percutaneous vertebroplasty for osteoporotic vertebral compression fractures: A protocol for systematic review and meta-analysis.
BACKGROUND
The objective of this study was to compare the efficacy of lateral and bilateral percutaneous vertebroplasty (PVP) in treating osteoporotic vertebral compression fractures (OVCFs).
METHODS
A comprehensive literature search was performed using PubMed, Cochrane Library, EMBASE, CMB, CNKI, Wanfang, and VIP databases between January 2014 and December 2020. The clinical efficacy of the 2 approaches was evaluated by comparing perioperative outcomes (operation time, X-ray exposure time, volume of injected cement), clinical outcomes (degree of vertebral height restoration, improvement of Cobb angle, visual analogue scale score, and Oswestry Disability Index scores), and operation-related complications (rate of cement leakage, adjacent vertebral fracture rate, and nerve root stimulation). Data were analyzed using RevMan 5.3.3 and Stata 15.1.
RESULTS
A total of 237 related articles were retrieved, and 17 randomized controlled trials were included. Meta-analysis results showed that compared to bilateral PVP, unilateral PVP led to decreased operation times (mean difference [MD] = -15.24, 95% confidence interval [CI]: [-17.77, -12.70], P < .05), decreased X-ray exposure time (MD-8.94, 95% CI[-12.08,-5.80]; P < .01), decreased volumes of injected cement (MD-1.57, 95% CI[-2.00,-1.14]; P < .05), and lower incidence of cement leakage (risk ratio [RR] = 0.6,95% CL[0.48,0.77], P < .01). Patients that underwent unilateral PVP experienced more effective pain relief at the last follow-up (MD-0.09, 95% CI [-0.15,-0.03];P=.006 < .05) and had a low degree of vertebral height restoration (MD-0.38, 95% CL [-0.71, -0.06]; P=.02 < .05). However, no differences in adjacent vertebral fractures (RR 1.19, 95% CI [0.78,1.82]; P = .41 > .01), nerve root stimulation (RR 1.98, 95% CI [0.22, 17.90]; P = .54 > .01), improvement of Cobb angle (MD = -0.18, 95% CI [-0.49, 0.13], P = .26 > .01), and improvement of ODI score (MD = 0.22, 95% CI[-0.37, 0.80], P > .05) were found between the 2 approaches.
CONCLUSIONS
Although both unilateral and bilateral PVP can improve the quality of life of this patient population by managing pain effectively, unilateral PVP offers more benefits, including shorter operation time and less fluoroscopy, and should be recommended in clinical practice for OVCFs.
Topics: Bone Cements; Fractures, Compression; Humans; Meta-Analysis as Topic; Osteoporotic Fractures; Pain; Quality of Life; Spinal Fractures; Systematic Reviews as Topic; Treatment Outcome; Vertebroplasty
PubMed: 34941201
DOI: 10.1097/MD.0000000000028453 -
Osteoporosis International : a Journal... Apr 2015We reviewed all peer-reviewed papers analysing the cost-effectiveness of vertebroplasty and balloon kyphoplasty for osteoporotic vertebral compression fractures. In... (Review)
Review
We reviewed all peer-reviewed papers analysing the cost-effectiveness of vertebroplasty and balloon kyphoplasty for osteoporotic vertebral compression fractures. In general, the procedures appear to be cost effective but are very dependent upon model input details. Better data, rather than new models, are needed to answer outstanding questions. Vertebral augmentation procedures (VAPs), including vertebroplasty (VP) and balloon kyphoplasty (BKP), seek to stabilise fractured vertebral bodies and reduce pain. The aim of this paper is to review current literature on the cost-effectiveness of VAPs as well as to discuss the challenges for economic evaluation in this research area. A systematic literature search was conducted to identify existing published studies on the cost-effectiveness of VAPs in patients with osteoporosis. Only peer-reviewed published articles that fulfilled the criteria of being regarded as full economic evaluations including both morbidity and mortality in the outcome measure in the form of quality-adjusted life years (QALYs) were included. The search identified 949 studies, of which four (0.4 %) were identified as relevant with one study added later. The reviewed studies differed widely in terms of study design, modelling framework and data used, yielding different results and conclusions regarding the cost-effectiveness of VAPs. Three out of five studies indicated in the base case results that VAPs were cost effective compared to non-surgical management (NSM). The five main factors that drove the variations in the cost-effectiveness between the studies were time horizon, quality of life effect of treatment, offset time of the treatment effect, reduced number of bed days associated with VAPs and mortality benefit with treatment. The cost-effectiveness of VAPs is uncertain. In answering the remaining questions, new cost-effectiveness analysis will yield limited benefit. Rather, studies that can reduce the uncertainty in the underlying data, especially regarding the long-term clinical outcomes of VAPs, should be conducted.
Topics: Cost-Benefit Analysis; Fractures, Compression; Health Care Costs; Humans; Kyphoplasty; Osteoporotic Fractures; Quality of Life; Spinal Fractures; Vertebroplasty
PubMed: 25381046
DOI: 10.1007/s00198-014-2953-5 -
The American Journal of the Medical... May 2015
Topics: Aged; Asymptomatic Diseases; Bone Cements; Humans; Lumbar Vertebrae; Male; Postoperative Complications; Pulmonary Embolism; Radiography; Spinal Fractures; Vertebroplasty
PubMed: 24534786
DOI: 10.1097/MAJ.0000000000000211 -
Disease Markers 2022To investigate the clinical application of bone filling mesh container vertebroplasty in osteoporotic vertebral compression fractures (OVCFs).
OBJECTIVE
To investigate the clinical application of bone filling mesh container vertebroplasty in osteoporotic vertebral compression fractures (OVCFs).
METHODS
Patients with OVCF from October 2018 to April 2020 were selected. Patients in the control and study groups underwent percutaneous kyphoplasty (PKP) and bone filling mesh container vertebroplasty, respectively. The Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA), visual analog scale (VAS) scores before and after surgery, and the incidence of complications were compared between the two groups.
RESULTS
The operation time and fluoroscopy time of the study group were significantly lower than those of the control group ( < 0.05). There was no significant difference in the injection volume of bone cement between the study group and the control group ( > 0.05). There was no significant difference in Cobb angle between the two groups. Three months after the operation, the height of the anterior edge increased and the Cobb angle decreased in the two groups ( < 0.05), but there was no significant difference in the height of the anterior edge and the Cobb angle between the two groups ( > 0.05). The JOA scores increased, while the ODI and VAS scores decreased in both groups after surgery ( < 0.05). There was no significant difference in the total effective rate between the study group (96.15%) and the control group (92.31%) ( > 0.05). The incidence of complications in the study group (3.85%) was significantly lower than that in the control group (15.38%) ( < 0.05).
CONCLUSIONS
For the treatment of OVCFs, bone filling mesh container vertebroplasty is comparable to PKP in terms of functional recovery, but it can safely reduce operative time, fluoroscopy time, and complication rates.
Topics: Fractures, Compression; Humans; Osteoporotic Fractures; Spinal Fractures; Surgical Mesh; Treatment Outcome; Vertebroplasty
PubMed: 35958282
DOI: 10.1155/2022/5029679 -
Clinical Neurology and Neurosurgery Nov 2018Despite vertebral fractures being a common occurrence in elderly osteoporotic individuals, literature remains scant with regards to 30-day outcomes following vertebral...
OBJECTIVES
Despite vertebral fractures being a common occurrence in elderly osteoporotic individuals, literature remains scant with regards to 30-day outcomes following vertebral augmentation for these injuries. We studied a national database of elderly osteoporotic patients who underwent vertebroplasty and kyphoplasty.
PATIENTS AND METHODS
The 2012-2014 ACS-NSQIP database was queried using CPT codes for vertebroplasty (22520, 22521 and 22522) and kyphoplasty (22523, 22524 and 22525). Patients undergoing concurrent spinal fusion and/or laminectomies/laminotomies/laminoplasties were removed from the study. Patients with missing data were also excluded from the study.
RESULTS
Following inclusion/exclusion criteria, a total of 2433 patients were included in the study out of which 242(9.9%) underwent vertebroplasty and 2191(90.1%) underwent kyphoplasty. Following adjusted analysis, having a dependent functional health status pre-operatively (OR 1.78; p = 0.010), pre-operative sepsis/SIRS (OR 2.52; p = 0.009), history of COPD (OR 1.62; p = 0.025), disseminated cancer (OR 1.94; p = 0.028), pre-operative wound infection (OR 3.47; p = 0.003) and inpatient admission status (OR 3.22; p < 0.001) were independent predictors of having any complication within 30-days of the procedure. Significant independent risk factors for 30-day mortality were functional health status prior to surgery (OR 2.92; p = 0.002), pre-operative dialysis use (OR 11.74; p = 0.003), Disseminated cancer (OR 7.09; p < 0.001), chronic steroid use (OR 3.59; p < 0.001), and inpatient admission status (OR 4.95; p < 0.001).
CONCLUSION
Vertebroplasty/Kyphoplasty is associated with significant adverse outcomes. Providers can utilize these data to better pre-operatively filter high-risk patients and tailor an appropriate peri-operative medical optimization program to enhance care to lower the risk of complications, readmissions and mortality from this procedure.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Female; Humans; Kyphoplasty; Male; Middle Aged; Mortality; Patient Readmission; Retrospective Studies; Spinal Fractures; Time Factors; Treatment Outcome; Vertebroplasty; Young Adult
PubMed: 30236639
DOI: 10.1016/j.clineuro.2018.08.014 -
Neuro-Chirurgie Jan 2023
Topics: Humans; Research Design; Vertebroplasty; Spinal Fractures
PubMed: 36608448
DOI: 10.1016/j.neuchi.2022.101400 -
Spine Jul 2017Retrospective cohort study.
STUDY DESIGN
Retrospective cohort study.
OBJECTIVE
Analyze efficacy of vertebroplasty and its affect on return to work (RTW) in a workers' compensation (WC) population SUMMARY OF BACKGROUND DATA.: Vertebroplasty remains a controversial treatment modality for vertebral compression fractures (VCFs). No studies have analyzed use of vertebroplasty in the clinically distinct WC population.
METHODS
A total of 371 Ohio WC subjects were identified who sustained VCFs and were treated with either vertebroplasty or conservative medical therapy between 1993 and 2013 using Current Procedural Terminology procedural and International Classification of Diseases, Ninth Revision diagnosis codes. Subjects with a prior smoking history, prior thoracolumbar surgery or comorbidities, or underwent decompression and/or fusion within 3 months after injury were excluded. Forty-six subjects had undergone vertebroplasty within 1 year of injury and were therefore included in the vertebroplasty group. The remaining 325 subjects received spinal orthosis and formed the control group. The primary outcomes were whether subjects returned to work at early and late time points. Early RTW was defined as returning to work within 3 months and remaining at work for more than 6 months of the following year. Late RTW was defined as returning to work within 2 years and remaining at work for more than 6 months of the following year. Secondary outcomes included opioid use, all-cause mortality, and additional VCFs.
RESULTS
Approximately 37% (17/46) of vertebroplasty group made an early RTW, compared with 35.4% (115/325) of control group (P = 0.835). Regarding late RTW, only 54.3% (25/46) of vertebroplasty group made a sustainable RTW, compared with 70.8% (230/325) of subjects in control group (P = 0.025). In addition, the vertebroplasty group was associated with significantly higher postoperative opioid use.
CONCLUSION
Vertebroplasty may not be an effective treatment modality for VCFs in the WC population when RTW is the primary goal.
LEVEL OF EVIDENCE
3.
Topics: Cohort Studies; Female; Humans; Lumbar Vertebrae; Male; Middle Aged; Population Surveillance; Retrospective Studies; Return to Work; Spinal Fractures; Thoracic Vertebrae; Vertebroplasty; Workers' Compensation
PubMed: 27922573
DOI: 10.1097/BRS.0000000000002008 -
Clinical Spine Surgery Jun 2018The spine is the most common site of bone metastases. Vertebroplasty (VP) and kyphoplasty (KP) have been proposed as potential minimally invasive therapeutic options for...
INTRODUCTION
The spine is the most common site of bone metastases. Vertebroplasty (VP) and kyphoplasty (KP) have been proposed as potential minimally invasive therapeutic options for metastatic spinal lesion (MSL) pain. However, the efficacy of VP and KP on MSL pain is currently unclear.
OBJECTIVE
The aim of this study was to assess the effects of VP and KP compared with each other, usual care, or other treatments on pain, disability, and quality of life following MSL.
METHODS
We included randomized controlled trials and prospective nonrandomized controlled clinical trials assessing VP or KP for the treatment of pain following MSL without cord compression. We searched MEDLINE, EMBASE, PubMed, and CENTRAL.
RESULTS
The literature search revealed 387 citations. Of these, 9 trials met all eligibility criteria and were included in the qualitative analysis. In total, there were 622 patients enrolled in the trials and of them 432 were in the surgical treatment group (92 received KP, 97 received VP, 134 received VP and chemotherapy, 68 received VP and radiotherapy, and 41 received Kiva implant) and 190 were in the nonsurgical treatment group (83 received chemotherapy, 46 received radiotherapy, and 61 received other treatment). Using the grading of recommendations assessment, development and evaluation approach, pain (low-quality evidence) and functional scores (very low-quality evidence) improved more with VP plus chemotherapy than with chemotherapy alone (pain: mean difference, -3.01; 95% confidence interval, -3.21 to -2.80; functional score: mean difference, 15.46; 95% confidence interval, 13.58-17.34). KP seemed to lead to significantly greater improvement in pain, disability, and health-related quality of life (HRQoL) compared with nonsurgical management. VP plus Iodine-125 seemed to lead to significantly greater improvement in pain and disability in comparison with VP alone. VP plus radiochemotherapy resulted in better pain relief and HRQoL postoperatively in comparison with routine radiochemotherapy. There was low-quality evidence to prove that surgical treatment significantly decreases pain, and improves functional score and HRQoL following MSL in comparison with nonsurgical management.
CONCLUSION
On the basis of the analysis of currently published trial data, it is unclear whether VP for MSL provides benefits over KP.
LEVEL OF EVIDENCE
Level 2.
Topics: Clinical Trials as Topic; Humans; Kyphoplasty; Prospective Studies; Quality of Life; Spinal Neoplasms; Vertebroplasty
PubMed: 29283901
DOI: 10.1097/BSD.0000000000000601 -
European Journal of Trauma and... Feb 2017The need for spinal instrumented fusion in osteoporotic patients is rising. In this review, we try to give an overview of the current spectrum of pedicle screw... (Review)
Review
PURPOSE
The need for spinal instrumented fusion in osteoporotic patients is rising. In this review, we try to give an overview of the current spectrum of pedicle screw augmentation techniques, safety aspects and indications.
METHODS
Review of literature and discussion of indications, limitations and technical aspects.
RESULTS
Various studies have shown higher failure rates in osteoporotic patients, most probably due to reduced bone quality and a poor bone-screw interface. Augmentation of pedicle screws with bone cement, such as polymethylmethacrylate or calcium based cements, is one valid option to enhance fixation if required.
CONCLUSIONS
Crucial factors for success in the use of augmented screws are careful patient selection, a proper technique and choice of the ideal cement augmentation option.
Topics: Bone Cements; Decompression, Surgical; Fracture Fixation, Internal; Humans; Osteoporotic Fractures; Pedicle Screws; Polymethyl Methacrylate; Spinal Fractures; Spinal Fusion; Vertebroplasty
PubMed: 27995283
DOI: 10.1007/s00068-016-0750-x