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International Orthopaedics Jan 2018Poly(methyl methacrylate) (PMMA) cement is widely used for percutaneous kyphoplasty and vertebroplasty (PKP and PVP) but possesses formidable shortcomings due to...
PURPOSE
Poly(methyl methacrylate) (PMMA) cement is widely used for percutaneous kyphoplasty and vertebroplasty (PKP and PVP) but possesses formidable shortcomings due to non-degradability. Here, a biodegradable replacement is developed.
METHODS
Calcium phosphate cement (CPC) was redesigned by incorporating starch and BaSO (new cement named as CPB). The biomechanical, biocompatibility, osseointegrative and handling properties of CPB were systematically evaluated in vitro and in vivo by the models of osteoporotic sheep vertebra, rat subcutaneous implantation and rat femoral defect.
RESULTS
CPB revealed appropriate injectability and setting ability for PKP and PVP. More importantly, its biomechanical strengths measured by in vitro and in vivo models were not less than that of PMMA, while its biodegradability and osseointegrative capacities were significantly enhanced compared to PMMA.
CONCLUSIONS
CPB is injectable, biomechanically robust, biodegradable and osseointegrative, demonstrating revolutionary potential for the application in PKP and PVP.
Topics: Absorbable Implants; Animals; Biomechanical Phenomena; Bone Cements; Calcium Phosphates; Femur; Fractures, Compression; Humans; Kyphoplasty; Male; Osseointegration; Osteoporosis; Polymethyl Methacrylate; Rats; Rats, Sprague-Dawley; Sheep; Spinal Fractures; Spine; Vertebroplasty
PubMed: 29116357
DOI: 10.1007/s00264-017-3674-0 -
World Neurosurgery May 2022Patients who experience vertebral compression fractures are vulnerable to subsequent vertebral compression fractures (SVCFs). The purpose of this nationwide...
OBJECTIVE
Patients who experience vertebral compression fractures are vulnerable to subsequent vertebral compression fractures (SVCFs). The purpose of this nationwide population-based study was to determine the age-specific cumulative incidence and factors associated with SVCFs in South Korea.
METHODS
Diagnostic codes, medical costs, and comorbid diseases in patients who had a vertebral compression fracture in 2011 and 2012 were collected from the National Health Insurance Service database of South Korea from 2007 to 2018. Demographic data, mortality rate, medical cost, and frequency of vertebroplasty or kyphoplasty were compared between patients with an initial fracture (IF) and those with a subsequent fracture (SF).
RESULTS
The cumulative incidence of SVCFs over 4 years was 24.4% and increased rapidly within a few months after the IF. In 2011, SVCFs occurred in 17,004 patients, and the incidence rate per 100,000 people was 113.6 (84.9 in men vs. 138.5 in women). The odds ratio (OR) of SVCFs in units of 10 years was the highest in women in their 60s, at 2.89. However, in men in their 70s, the OR was the highest, at 2.51. The rates of vertebroplasty or kyphoplasty, medical expenses, and mortality rate were significantly higher in the SF group than in the IF group (P < 0.01).
CONCLUSIONS
The age-specific cumulative incidence of SVCFs per 100,000 people was 113.6. SVCFs were more frequent among women, the elderly, and patients who underwent vertebroplasty or kyphoplasty. Women in their 60s or above and men in their 70s or above were at highest risk.
Topics: Aged; Female; Fractures, Compression; Humans; Incidence; Kyphoplasty; Male; Osteoporotic Fractures; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 35077893
DOI: 10.1016/j.wneu.2022.01.064 -
Medicine Aug 2022This study aimed to analyze the most influential publications on vertebral augmentation for treating osteoporotic vertebral compression fracture. The Web of Science... (Review)
Review
This study aimed to analyze the most influential publications on vertebral augmentation for treating osteoporotic vertebral compression fracture. The Web of Science database was searched using the key words "percutaneous vertebroplasty," "percutaneous kyphoplasty," "balloon kyphoplasty," "vertebroplasty," "kyphoplasty," and "vertebral augmentation." The top 100 publications were arranged by citations per year and descriptively and visually analyzed. The top 100 publications were cited 25,482 times, with an average of 14.4 citations per paper per year. The corresponding authors of the publications represented 17 nations, with most authors being American (46 authors). Thirty-two journals were involved, with SPINE issuing the most publications (24 papers of the 100). Clinical research (73 of the 100 papers) outnumbered basic studies (14 papers) and systematic reviews (13 papers), and the most publications were published between 2000 and 2004. Co-citation analysis of the key words indicated that the top 5 focus areas were "complication," "balloon kyphoplasty," "vertebral compression fracture," "biomechanics," and "calcium phosphate cement." The top 3 keywords with the strongest citation bursts were "compression fracture," "cement," and "balloon kyphoplasty." The keywords with persistent strong citation bursts are "balloon kyphoplasty" and "augmentation." There are still contrary opinions about vertebral augmentation; new research should be conducted with more deliberate design and longer follow-up.
Topics: Bone Cements; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 35945791
DOI: 10.1097/MD.0000000000030023 -
Journal of the American College of... Aug 2017Vertebral fractures have a substantial impact on the health and quality of life of elderly individuals as one of the most common complications of osteoporosis. Vertebral...
PURPOSE
Vertebral fractures have a substantial impact on the health and quality of life of elderly individuals as one of the most common complications of osteoporosis. Vertebral augmentation procedures including vertebroplasty and kyphoplasty have been supported as means of reducing pain and mitigating disability associated with these fractures. However, use of vertebroplasty is debated, with negative randomized controlled trials published in 2009 and divergent clinical guidelines. The effect of changing evidence and guidelines on different practitioners' utilization of both kyphoplasty and vertebroplasty in the years after these developments and publication of data supporting their use is poorly understood.
METHODS
Using national aggregate Medicare claims data from 2002 through 2014, vertebroplasty and kyphoplasty procedures were identified by provider type. Changes in utilization by procedure type and provider were studied.
RESULTS
Total vertebroplasty billing increased 101.6% from 2001 (18,911) through 2008 (38,123). Total kyphoplasty billing frequency increased 17.2% from 2006 (54,329) through 2008 (63,684). Vertebroplasty billing decreased 60.9% from 2008 through 2014 to its lowest value (14,898). Kyphoplasty billing decreased 8.4% from 2008 (63,684) through 2010 (58,346), but then increased 7.6% from 2010 to 2013 (62,804).
CONCLUSIONS
Vertebroplasty billing decreased substantially beginning in 2009 and continued to decrease through 2014 despite publication of more favorable studies in 2010 to 2012, suggesting studies published in 2009 and AAOS guidelines in 2010 may have had a persistent negative effect. Kyphoplasty did not decrease as substantially and increased in more recent years, suggesting a clinical practice response to favorable studies published during this period.
Topics: Aged; Humans; Kyphoplasty; Medicare; Practice Guidelines as Topic; Quality of Life; Randomized Controlled Trials as Topic; Spinal Fractures; United States; Vertebroplasty
PubMed: 28778222
DOI: 10.1016/j.jacr.2017.04.026 -
European Journal of Orthopaedic Surgery... Dec 2020Metastatic spinal lesions are diseases that impair the quality of life and require early diagnosis and treatment. The count of spinal metastasis patients rises day by...
BACKGROUND
Metastatic spinal lesions are diseases that impair the quality of life and require early diagnosis and treatment. The count of spinal metastasis patients rises day by day. Increased life expectancy has increased the incidence of cancer, making metastases more observable. The aim of our study was to investigate how the quality of life is affected in the patient group with vertebral fracture due to spinal metastases of multiple myeloma and undergoing vertebroplasty and kyphoplasty.
MATERIALS AND METHODS
Forty-two patients with fracture due to spinal metastasis and adequate follow-up between the years of 2011 and 2018 were included in the study. Patients were listed according to their primary malignancy and metastases. The effect of vertebroplasty and kyphoplasty was investigated by evaluating preoperative and postoperative VAS and Oswestry Disability Index scores. All patients' radiographic kyphosis angle, compression ratio and wedging index were calculated before operation and after operation.
RESULTS
A total of 76 vertebrae were operated in 42 patients. Significant differences were found in the comparison of preoperative and postoperative quality of life according to VAS and Oswestry Disability Index scores in the patients undergoing vertebroplasty, kyphoplasty or both procedures after spinal metastases (VAS; p = 0.0001, ODI; p = 0.002/0.0001). There were statistically significant differences in preoperative local kyphosis angle, compression ratio and wedging index and post-op local kyphosis angle, compression ratio and wedging index (p = 0.001).
CONCLUSION
Vertebroplasty and kyphoplasty, minimally invasive procedures performed after spinal metastases, improve the quality of life of the patients.
Topics: Fractures, Compression; Humans; Kyphoplasty; Lumbar Vertebrae; Multiple Myeloma; Osteoporotic Fractures; Pain Measurement; Quality of Life; Spinal Fractures; Spinal Neoplasms; Treatment Outcome; Vertebroplasty
PubMed: 32591912
DOI: 10.1007/s00590-020-02721-3 -
Clinical Spine Surgery Jul 2022A meta-analysis. (Meta-Analysis)
Meta-Analysis
STUDY DESIGN
A meta-analysis.
OBJECTIVE
The aim is to compare the efficacy of percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) in treating Kümmell's disease (KD) without neurological deficits.
SUMMARY OF BACKGROUND DATA
PVP and PKP are routine methods for the treatment of KD without neurological deficits; however, whether PVP or PKP is superior is a matter of debate.
MATERIALS AND METHODS
According to the Cochrane Handbook for Systematic Reviews of Interventions, PubMed, Embase, the Cochrane Library, and Web of Knowledge were searched for eligible randomized controlled trials or cohort studies. Two authors independently collected data and assessed the methodologic quality of the included studies. Intraoperative and postoperative clinical outcomes, cement leakage, refracture rate, and the costs during hospitalization were evaluated.
RESULTS
Five observational studies comparing 119 PVP and 128 PKP patients were included in qualitative and quantitative reviews. All of the included s studies had evidence of good quality, as assessed by the Newcastle-Ottawa scale. On the basis of meta-analysis the operation time [weighted mean difference: -10.65; 95% confidence interval (95% CI): -11.94 to -9.35; P <0.00001] and hospitalization cost (weighted mean difference: -2.38; 95% CI: -2.87 to -1.89; P <0.00001) were less for PVP, while the cement leakage rate was lower for PKP (odds ratio: 3.03; 95% CI: 1.58-5.82; P <0.001). Together, the data indicated that the differences in cement volume, visual analog scale score, Oswestry disability index score, Cobb angle, anterior vertebral height, and refracture rate were not significantly different.
CONCLUSION
The findings of this study suggest that PVP and PKP are safe and effective for the treatment of KD. PVP required less operative time and was more affordable, but PKP was superior given the lower cement leakage rate. Additional high-quality randomized controlled trials designed to support these findings are warranted.
Topics: Bone Cements; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Retrospective Studies; Spinal Fractures; Spondylosis; Systematic Reviews as Topic; Treatment Outcome; Vertebroplasty
PubMed: 34694259
DOI: 10.1097/BSD.0000000000001269 -
Orthopaedic Surgery Aug 2020To explore the effect of bone cement distribution, cement leakage, and clinical outcomes with side-opening cannula for bone cement injection in percutaneous... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To explore the effect of bone cement distribution, cement leakage, and clinical outcomes with side-opening cannula for bone cement injection in percutaneous vertebroplasty (PVP) in treatment of Kummell disease.
METHODS
A prospective study of patients with Kummell disease undergoing PVP was conducted from April 2012 to September 2017. In total, 43 patients (11 males, 32 females) with Kummell disease who received bilateral PVP were included in the study. The patients were divided into front-opening cannulas (FOC) group with front-opening cannulas and side-opening cannulas (SOC) group with side-opening cannulas. All patients were followed up for 6 months. The patient general information such as gender, age, bone density, compression ratio, operative time, and location of fracture vertebrae were recorded. Visual analogue scale (VAS), Oswestry Disability Index (ODI), bone cement distribution, radiation exposure time, bone cement leakage rate and vertebral height, and kyphosis angle were measured and compared for two groups before surgery, 1 day and 6 months after surgery.
RESULTS
A total of 43 patients were enrolled, including 11 males and 32 females, aged 61-84 years. The bone density (T value) was 2.5 ± 0.6 in FOC group and 2.4 ± 0.6 in SOC group (P > 0.05). The compression ratio and operative time were 36.1% ± 13.0%, 39.3 ± 7.9 min in FOC group and 35.2% ± 13.7%, 40.0 ± 10.7 min in SOC group (P > 0.05). There was no significance between FOC and SOC groups in the location of fracture vertebrae. All patients underwent at least 6 months of follow-up. At 6 months postoperatively, the VAS and ODI were significantly higher in the FOC group (3.0 ± 0.8, 35.7% ± 2.1%) than in the SOC group (1.3 ± 0.4, 18.6% ± 2.4%) (P < 0.05). The cement leakage rate of the SOC group was 4.8%, which was lower than that of the FOC group (31.8%, P < 0.05), and the bone cement distribution ratio was higher than that of the FOC group (63.1% ± 7.9% vs 40.5% ± 8.6%, P < 0.05). At 6 months after operation, the height of the anterior and posterior vertebral bodies of the patients in the SOC group restored better than the FOC group (anterior SOC: FOC 5.1 ± 0.5 mm vs 4.5 ± 0.5 mm; posterior SOC: FOC 0.6 ± 0.1 mm vs 0.3 ± 0.1 mm, P < 0.05), and the kyphosis correction was more obvious than patients in FOC group (SOC: FOC 8.5° ± 1.4° vs 4.6° ± 0.8°, P < 0.05).
CONCLUSION
Percutaneous vertebroplasty with side-opening cannula is safe and effective in avoiding bone cement leakage, improving bone cement distribution, and restoring vertebral height.
Topics: Aged; Aged, 80 and over; Disability Evaluation; Female; Fractures, Compression; Humans; Male; Middle Aged; Minimally Invasive Surgical Procedures; Osteoporotic Fractures; Pain Measurement; Prospective Studies; Spinal Fractures; Vertebroplasty
PubMed: 32638545
DOI: 10.1111/os.12730 -
Pain Physician 2017Because of an aging population,osteoporotic vertebral fractures are becoming more frequent.Conservative therapy was considered the gold standard for treating... (Meta-Analysis)
Meta-Analysis Review
Does Percutaneous Vertebroplasty or Balloon Kyphoplasty for Osteoporotic Vertebral Compression Fractures Increase the Incidence of New Vertebral Fractures? A Meta-Analysis.
BACKGROUND
Because of an aging population,osteoporotic vertebral fractures are becoming more frequent.Conservative therapy was considered the gold standard for treating osteoporotic vertebral compression fractures (OVCFs) in the past. Percutaneous vertebroplasty (PVP) or balloon kyphoplasty (BKP) as minimally invasive techniques are new treatments that are widely used for painful OVCFs. However, an increase in new vertebral compression fractures at non-treated levels following augmentation is of concern. There is no convincing evidence that new fractures are inevitable after augmentation compared to after conservative treatment, and it is still unclear whether further fractures are the consequence of augmentation or a result of the natural progression of osteoporosis.
OBJECTIVE
The objective of this study was to evaluate the new-level fracture risk after PVP or BKP compared with conservative (non-operative) treatment and to determine the dominant risk factor associated with new OVCFs.
STUDY DESIGN
A meta-analysis of comparative studies was performed to evaluate the incidence of new vertebral fractures between vertebral augmentation, such as vertebroplasty and kyphoplasty, and no operation.
SETTING
The PubMed, ISI Web of Science, ELSEVIER ScienceDirect, and Cochrane Library databases and abstracts published in annual proceedings were systematically searched.In addition, we also retrieved data from references when titles met our inclusion criteria.
METHODS
Detailed searches of a number of online databases comparing operative and non-operative groups were performed. We included randomized controlled trials,clinical controlled trials,and prospective clinical studies to provide available data. All studies were reviewed by two reviewers independently, and all the references that met our inclusion criteria were searched for additional trials, using the guidelines set by the QUOROM (Quality of Reporting of Meta-analysis) statement.
RESULTS
We evaluated 12 studies encompassing 1,328 patients in total, including 768 who underwent operation with polymethylmethacrylateand 560 who received non-operative treatments. For new-level vertebral fractures, our meta-analysis found no significant difference between the 2 methods, including total new fractures (P = 0.55) and adjacent fractures (P = 0.5). For pre-existing vertebral fractures, there was no significant difference between the 2 groups (operative and non-operative groups) (P = 0.24). Additionally,there was no significant difference in bone mineral density, both in the lumbar (P = 0 .13) and femoral neck regions (P = 0.37), between the 2 interventions.
LIMITATION
All studies we screened were published online except for unpublished articles. Moreover, only a few data sources could be extracted from the published studies.There were only 5 randomized clinical trials and 7 prospective studies that met our inclusion criteria.
CONCLUSION
Vertebral augmentation techniques, such as vertebroplasty and kyphoplasty, have been widely used to treat osteoporotic vertebral fractures in order to alleviate back pain and correct the deformity, and it has been frequently reported that many new vertebral fractures occurred after this operation. Our analysis did not reveal evidence of an increased risk of fracture of vertebral bodies, especially those adjacent to the treated vertebrae, following augmentation with either method compared with conservative treatment.Key words: Vertebroplasty, kyphoplasty, new osteoporotic compression vertebral fracture, meta-analysis.
Topics: Controlled Clinical Trials as Topic; Fractures, Compression; Humans; Incidence; Kyphoplasty; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 28072794
DOI: No ID Found -
Current Pain and Headache Reports Apr 2020To review the utilization patterns of vertebral augmentation procedures in the US Medicare population from 2004 to 2017 surrounding concurrent developments in the... (Comparative Study)
Comparative Study Review
PURPOSE OF REVIEW
To review the utilization patterns of vertebral augmentation procedures in the US Medicare population from 2004 to 2017 surrounding concurrent developments in the literature and the enactment of the Affordable Care Act (ACA).
RECENT FINDINGS
The analysis of vertebroplasty and kyphoplasty utilization patterns was carried out using specialty utilization data from the Centers for Medicare and Medicaid Services Database. Of note, over the period of time between 2009 and 2017, the number of people aged 65 or older showed a 3.2% rate of annual increase, and the number of Medicare beneficiaries increased by 27.6% with a 3.1% rate of annual increase. Concurrently, vertebroplasty utilization decreased 72.8% (annual decline of 15% per 100,000 Medicare beneficiaries), and balloon kyphoplasty utilization decreased 19% (annual decline of 2.6% per 100,000 Medicare beneficiaries). This translates to a 38.3% decrease in vertebroplasty and balloon kyphoplasty utilization (annual decline of 5.9% per 100,000 Medicare beneficiaries) from 2009 to 2017. By contrast, from 2004 to 2009, there was a total 188% increase in vertebroplasty and balloon kyphoplasty utilization (annual increase rate of 23.6% per 100,000 Medicare beneficiaries). The majority of vertebroplasty procedures were done by radiologists, and the majority of kyphoplasties were done by aggregate groups of spine surgeons. These results illustrate a significant decline in vertebral augmentation procedures in the fee-for-service Medicare population between 2004 and 2017, with dramatic decreases following the publication of two 2009 trials that failed to demonstrate benefit of vertebroplasty over sham and the enactment of the ACA.
Topics: Fractures, Compression; Humans; Medicare; Patient Protection and Affordable Care Act; Randomized Controlled Trials as Topic; Spinal Fractures; United States; Vertebroplasty
PubMed: 32291587
DOI: 10.1007/s11916-020-00850-2 -
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