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World Neurosurgery Aug 2022Vertebral compression fractures are the most common fragility fractures affecting osteoporotic patients. This study evaluated volume trends and outcomes across...
BACKGROUND
Vertebral compression fractures are the most common fragility fractures affecting osteoporotic patients. This study evaluated volume trends and outcomes across specialties performing cement augmentation procedures.
METHODS
Patients were identified using Current Procedural Terminology codes for vertebroplasty or kyphoplasty from 2010 to 2019. Patients were grouped by surgical providers (orthopedic surgery and neurological surgery) or nonsurgical providers (anesthesia, pain medicine, radiology, and physical medicine and rehabilitation). Outcomes recorded included reoperation rates and postoperative complications occurring within 30 days. Logistic regression was employed to account for potential confounding variables, and odds ratios were obtained.
RESULTS
Inclusion criteria were met by 80,864 patients who received cement augmentation. Surgeon specialists performed 51.7% of all procedures. Of procedures carried out by nonsurgeon specialists, radiologists performed the most. Despite a stable number of procedures performed over the period, the percentage of procedures performed by surgeons decreased from 58.8% to 49.9% (P < 0.001). Patients with procedures performed by surgeons experienced lower odds of reoperation at 30 days (P < 0.001) and 1 year (P < 0.001), but 5-year and overall rates were not significant (P > 0.05). Surgical patients had lower odds of acute kidney injury (P < 0.004) and pulmonary embolism (odds ratio = 0.62, P < 0.001), yet increased odds of surgical site infection (P < 0.001).
CONCLUSIONS
Kyphoplasties and vertebroplasties are increasingly performed by nonsurgeon specialists. Although early reoperation rates are higher for nonsurgeon specialists, 5-year and overall reoperation rates were similar. Differing complication rates may relate to patient selection rather than operative technique and can be investigated with future studies.
Topics: Bone Cements; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures; Surgeons; Treatment Outcome; Vertebroplasty
PubMed: 35552034
DOI: 10.1016/j.wneu.2022.05.004 -
Pain Physician 2015Percutaneous vertebroplasty (PVP) and percutaneous balloon kyphoplasty (PKP) can increase bone strength as well as alleviate the pain caused by vertebral compression... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Percutaneous vertebroplasty (PVP) and percutaneous balloon kyphoplasty (PKP) can increase bone strength as well as alleviate the pain caused by vertebral compression fractures (VCFs), and both procedures rely on polymethyl methacrylate (PMMA) cement injected into the fractured vertebra for mechanical stabilization of the VCFs. However, there is debate over which of these 2 surgical procedures can give better short-term and long-term outcomes. A lot of studies and meta-analysis were designed to assess the advantages and drawbacks of PKP and PVP in the treatment of VCFs, but most of them didn't consider the effect of VCF levels on the treatment outcome, which can influence the results.
OBJECTIVE
To assess the safety and efficacy of PKP compared to PVP in the treatment of single level osteoporotic vertebral compression fractures (OVCF).
STUDY DESIGN
Studies with the following criteria were included: patients with VCFs due to osteoporosis; PKP comparing PVP; study design, RCT or prospective or retrospective comparative studies. Furthermore, the studies which reported at least one of the following outcomes: subjective pain perception, quality of life evaluation, incidence of new adjacent vertebral fracture, bone cement leakage, and post-operative kyphotic angle. Articles were excluded in our meta-analysis if they had a neoplastic etiology (i.e., metastasis or myeloma), infection, neural compression, traumatic fracture, neurological deficit, spinal stenosis, severe degenerative diseases of the spine, previous surgery at the involved vertebral body, and PKP or PVP with other invasive or semi-invasive intervention treatment.
SETTING
University hospital.
METHODS
A systematic search of all articles published through May 2014 was performed by Medline, EMASE, OVID, and other databases. All the articles that compared PKP with PVP on single level OVCF were identified. The evidence quality levels of the selected articles were evaluated by Grade system. Data about the clinical outcomes and complications were extracted and analyzed.
RESULTS
Eight studies, encompassing 845 patients, met the inclusion criteria. Overall, the results indicated that there were significant differences between the 2 groups in the short-term visual analog scale (VAS) scores, the long-term Oswestry Disability Index (ODI), short- and long-term kyphosis angle, the kyphosis angle improvement, the injected cement, and the cement leakage rates. However, there were no significant differences in the long-term VAS scores, the short-term ODI scores, the short- and long-term SF-36 scores, or the adjacent-level fracture rates.
LIMITATIONS
Statistical efficacy can be improved by more studies, low evidence based non-RCT articles are likely to induce various types of bias, no accurate definition of short-term and long-term outcome time points.
CONCLUSION
PKP and PVP are both safe and effective surgical procedures in treating OVCF. PKP has a similar long-term pain relief, function outcome (short-term ODI scores, short-and long-term SF-36 scores), and new adjacent VCFs in comparison to PVP. PKP is superior to PVP for the injected cement volume, the short-term pain relief, the improvement of short- and long-term kyphotic angle, and lower cement leakage rate. However, PKP has a longer operation time and higher material cost than PVP. To confirm this evaluation, a large multi-center randomized controlled trial (RCT) should be conducted.
Topics: Fractures, Compression; Humans; Kyphoplasty; Minimally Invasive Surgical Procedures; Pain Management; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 26000665
DOI: No ID Found -
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 -
AJNR. American Journal of Neuroradiology Oct 2018
Topics: Humans; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures; Spine; Vertebroplasty
PubMed: 30213814
DOI: 10.3174/ajnr.A5781 -
The Spine Journal : Official Journal of... Jun 2019Percutaneous vertebroplasty (PVP) and kyphoplasty (KP) are minimally invasive treatment options for vertebral compression fractures (VCFs) due to malignancy.
BACKGROUND CONTEXT
Percutaneous vertebroplasty (PVP) and kyphoplasty (KP) are minimally invasive treatment options for vertebral compression fractures (VCFs) due to malignancy.
PURPOSE
To perform a systematic review evaluating the effectiveness and safety of vertebral augmentation for malignant VCFs.
STUDY DESIGN
Systematic review.
STUDY SAMPLE
Studies on PVP or KP for VCFs in patients with malignant spinal lesions.
OUTCOME MEASURES
Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), Karnofsky Performance Score (KPS), and complications were extracted from eligible studies.
METHODS
Using Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, studies published between January 1, 2000 and January 3, 2018 were identified by combining the results of a report by Health Quality Ontario with an updated literature search.
RESULTS
The review identified two randomized controlled trials, 16 prospective studies, 44 retrospective studies, and 25 case series for a patient sample size of 3,426. At the earliest follow-up, pain improved from 7.48 to 3.00 with PVP, and from 7.05 to 2.96 with KP. ODI improved from 74.68 to 17.73 with PVP, and from 66.02 to 34.73 with KP. KPS improved from 66.99 to 80.28. Cement leakage was seen in 37.9% and 13.6% of patients treated with PVP and KP, respectively. Symptomatic complications (N = 43) were rare.
CONCLUSIONS
This review showed clinically relevant improvements in pain, ODI, and KPS in patients with VCFs due to malignancy treated with either PVP or KP. Cement leakage is common, but rarely symptomatic. Percutaneous vertebroplasty and KP are safe and effective palliative procedures for painful VCFs in patients with malignant spinal lesions.
Topics: Bone Cements; Clinical Studies as Topic; Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Palliative Care; Postoperative Complications; Spinal Fractures; Vertebroplasty
PubMed: 30822527
DOI: 10.1016/j.spinee.2019.02.012 -
Vertebroplasty: about sense and nonsense of uncontrolled "controlled randomized prospective trials".European Spine Journal : Official... Sep 2009
Topics: Data Interpretation, Statistical; Fractures, Compression; Humans; Kyphosis; Peer Review, Research; Randomized Controlled Trials as Topic; Registries; Reproducibility of Results; Sample Size; Selection Bias; Societies, Medical; Spinal Fractures; Vertebroplasty
PubMed: 19756780
DOI: 10.1007/s00586-009-1164-9 -
Neuro-Chirurgie Jan 2023Randomized trials (RCTs) should include a sufficient number of patients to reduce the risk that the observed outcome is a result of chance rather than from a truly...
OBJECTIVES
Randomized trials (RCTs) should include a sufficient number of patients to reduce the risk that the observed outcome is a result of chance rather than from a truly different treatment effect. Trials must be even larger to claim an absence of treatment effect in a placebo-controlled trial. To estimate the size of the trial and maximize power, it is often suggested to use a comparison between the means of a continuous variable.
METHODS
We examine the RCTs that have compared vertebroplasty and placebo for patients with osteoporotic fractures. Most trials compared the means of a continuous pain score to yield implausibly small trials, as small as 24 patients per group.
RESULTS
The minimally significant difference between groups has no precise clinical meaning for patients when it is based on a comparison of means of pain scores. A comparison of the proportions of patients reaching a per-patient outcome measure of treatment success is much more pertinent if the trial is to inform the care of future patients. The resulting trials will admittedly need to be larger, but they will be much less likely to fall prey to the 'evidence of absence' fallacy. Furthermore, trial size should also take into consideration harder clinical outcome measures, such as death and disability.
CONCLUSION
When the goal of a trial is to inform outcome-based medical care, comparing the proportions of patients reaching a clinically pertinent outcome is more appropriate than comparing the means of a continuous variable.
Topics: Humans; Fractures, Compression; Osteoporotic Fractures; Pain; Pain Measurement; Quality of Life; Randomized Controlled Trials as Topic; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 36621210
DOI: 10.1016/j.neuchi.2022.101402 -
The Medical Journal of Australia Mar 2010Our recent editorial in the Journal presents an accurate summary of our two randomised trials of vertebroplasty, which found no benefit of vertebroplasty over placebo.... (Review)
Review
Our recent editorial in the Journal presents an accurate summary of our two randomised trials of vertebroplasty, which found no benefit of vertebroplasty over placebo. Participants in both trials are representative of patients seen in clinical practice and who would qualify for government-subsidised funding of vertebroplasty in Australia. Clinical experience and previous published literature are likely to have overestimated the treatment benefit of vertebroplasty for many reasons. This is why randomised placebo-controlled trials are required to determine the efficacy of treatment interventions, particularly when the condition being treated is self-limiting and the primary end point is improvement of symptoms. Based on the best evidence currently available, the routine use of vertebroplasty outside of the research setting for painful osteoporotic vertebral fractures appears unjustified.
Topics: Australia; Humans; Osteoporosis; Outcome Assessment, Health Care; Patient Selection; Periodicals as Topic; Randomized Controlled Trials as Topic; Reproducibility of Results; Selection Bias; Spinal Fractures; Vertebroplasty
PubMed: 20230352
DOI: 10.5694/j.1326-5377.2010.tb03534.x -
Journal of Neurointerventional Surgery May 2021
Topics: Fractures, Compression; Humans; Kyphoplasty; Spinal Fractures; Treatment Outcome; United States; Vertebroplasty
PubMed: 33479034
DOI: 10.1136/neurintsurg-2020-017147 -
Der Orthopade Jul 2010
Topics: Bone Cements; Humans; Laminectomy; Spinal Fractures; Vertebroplasty
PubMed: 20521140
DOI: 10.1007/s00132-010-1598-0