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Maturitas May 2012After more than two decades the treatment effect of cement augmentation of osteoporotic vertebral compression fractures (VCF) has now been questioned by two blinded... (Comparative Study)
Comparative Study Review
Vertebroplasty and kyphoplasty--a systematic review of cement augmentation techniques for osteoporotic vertebral compression fractures compared to standard medical therapy.
After more than two decades the treatment effect of cement augmentation of osteoporotic vertebral compression fractures (VCF) has now been questioned by two blinded randomised placebo-controlled trials. Thus many practitioners are uncertain on the recommendation for cement augmentation techniques in elderly patients with osteoporotic VCF. This systematic review analyses randomised controlled trials on vertebroplasty and kyphoplasty to provide an overview on the current evidence. From an electronic database research 8 studies could be identified meeting our inclusion criteria of osteoporotic VCF in elderly (age>60 years), treatment with vertebroplasty or kyphoplasty, controlled with placebo or standard medical therapy, quality of life, function, or pain as primary parameter, and randomisation. Only two studies were properly blinded using a sham-operation as control. The other studies were using a non-surgical treatment control group. Further possible bias may be caused by manufacturer involvement in financing of three published RCT. There is level Ib evidence that vertebroplasty is no better than placebo, which is conflicting with the available level IIb evidence that there is a positive short-term effect of cement augmentation compared to standard medical therapy with regard to QoL, function and pain. Kyphoplasty is not superior to vertebroplasty with regard to pain, but with regard to VCF reduction (evidence level IIb). Kyphoplasty is probably not cost-effective (evidence level IIb), and vertebroplasty has not more than short-term cost-effectiveness (evidence level IV). Vertebroplasty and kyphoplasty cannot be recommended as standard treatment for osteoporotic VCF. Ongoing sham-controlled trials may provide further evidence in this regard.
Topics: Bone Cements; Fractures, Compression; Humans; Kyphoplasty; Osteoporosis; Osteoporotic Fractures; Spinal Fractures; Standard of Care; Vertebroplasty
PubMed: 22425141
DOI: 10.1016/j.maturitas.2012.02.010 -
The Canadian Journal of Neurological... Sep 2019Clinical trials with percutaneous vertebral augmentation (PVA) for intractable pain from vertebral compression fractures (VCF) have shown variable results. Variation in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Clinical trials with percutaneous vertebral augmentation (PVA) for intractable pain from vertebral compression fractures (VCF) have shown variable results. Variation in the outcomes may be related to poor patient selection on imaging.
OBJECTIVE
To assess if PVA augmentation for osteoporotic VCF results in better improvement in pain when patients were selected based on clinical examination plus imaging vs clinical examination only.
RESULTS
A systematic review and meta-analysis were performed. PubMed, Embase and Cochrane Library databases were searched from 2000 to May 2018. Two reviewers independently screened and extracted data to identify randomised control trials (RCTs) on PVA for osteoporotic VCF and assessed the risk of bias. Standard systematic review and meta-analysis methods were advocated by the Cochrane Collaboration and PRISMA Statement. A total of 12 RCTs with 1110 participants met the inclusion criteria. Eight of the 10 studies (938 participants) that used imaging to confirm oedema in the target vertebral bodies showed PVA (compared to nonsurgical treatment) was effective in reducing pain (immediate term: mean difference (MD) of -1.89; 95% confidence interval -1.93 to -1.85, p < 0.001; short term: MD of -1.68; 95% CI -1.82 to -1.54, p < 0.001; intermediate term: MD of -2.04; 95% CI -2.15 to -1.94, p < 0.001 and long term: MD of -1.88; 95% CI -1.95 to -1.80, p < 0.001).
CONCLUSIONS
RCTs using imaging to confirm marrow oedema in the index vertebra showed an improved size effect compared to RCTs using no imaging. This benefit was observed in the immediate, short, intermediate and long term.
Topics: Fractures, Compression; Humans; Magnetic Resonance Imaging; Osteoporotic Fractures; Pain, Intractable; Randomized Controlled Trials as Topic; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 31232247
DOI: 10.1017/cjn.2019.236 -
European Spine Journal : Official... Apr 2024Osteoporotic vertebral compression fractures affect a large number of elderly people and cause significant issues with pain and mobility. Percutaneous vertebroplasty... (Review)
Review
BACKGROUND
Osteoporotic vertebral compression fractures affect a large number of elderly people and cause significant issues with pain and mobility. Percutaneous vertebroplasty (PVP) and kyphoplasty (PKP) are employed to treat those who remain symptomatic, with comparable clinical outcomes. Although PVP is faster and less expensive, concerns around cement-leakage complications make PKP perceptively safer.
METHODS
By means of systematic review, we sought to ascertain whether PVP did carry a higher risk of cement-leakage and associated symptomatic complications (neural compromise, pulmonary embolism and need for emergency decompression surgery).
RESULTS
Our search of 138 articles returned six studies after shortlisting and manual review: three randomised-controlled trials, and three retrospective comparative studies which met our criteria and directly compared cement-leakage rates and complications between the two treatments. 532 PVPs and 493 PKPs recorded 213 (39.3%) and 143 (28.9%) leaks, respectively (p < 0.0005). Of these, no leaks resulted in any of the aforementioned leak-related complications. No meta-analysis was performed due to heterogeneity of the data.
CONCLUSIONS
We therefore concluded that whilst PVP does result in more cement leaks, this does not appear to be clinically significant. Further studies would add weight to this conclusion, and cost-effectiveness should be assessed to restore confidence in PVP.
LEVEL OF EVIDENCE
Level III Evidence.
Topics: Humans; Aged; Kyphoplasty; Fractures, Compression; Retrospective Studies; Clinical Relevance; Spinal Fractures; Osteoporotic Fractures; Treatment Outcome; Vertebroplasty; Bone Cements
PubMed: 37999769
DOI: 10.1007/s00586-023-08026-3 -
Vertebroplasty and kyphoplasty for cervical spine metastases: a systematic review and meta-analysis.International Journal of Spine Surgery 2016Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of...
BACKGROUND
Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of these procedures are performed in the thoracolumbar spine, and there is limited data on outcomes after VP/KP for cervical metastases. The purpose of this article is to evaluate the safety and efficacy of VP and KP for treating pain in patients with cervical spine metastases.
METHODS
A systematic review of the literature was conducted using the PubMed and Medline databases. Only studies that reported five or more patients treated with VP/KP in the cervical spine were included. Levels of evidence and grades of recommendation were established based on the Oxford Centre for Evidence-Based Medicine guidelines. Data was pooled to perform a meta-analysis for pain relief and complication rates.
RESULTS
Six studies (all level 4 studies) met the inclusion criteria, representing 120 patients undergoing VP/KP at 135 vertebrae; the most common addressed level was C2 in 83 cases. The average volume of injected cement was 2.5 ± 0.5 milliliters at each vertebra. There were 22 asymptomatic cement leaks (16%; 95% CI, 9.8% - 22.2%) most commonly occurring in the paraspinal soft tissue. There were 5 complications (4%; 95% CI, 0.5% - 7.5%): 3 cases of mild odynophagia, 1 case of occipital neuralgia secondary to leak, and 1 case of stroke secondary to cement embolism. Pain relief was achieved in 89% of cases (range: 80 - 100%). The calculated average pain score decreased significantly from 7.6 ± 0.9 before surgery to 1.9 ± 0.8 at last evaluation (p=0.006).
CONCLUSION
Although the calculated complication rate after VP/KP in the cervical spine is low (4%) and the reported pain relief rate is approximately 89%, there is lack of high-quality evidence supporting this. Future randomized controlled trials are needed.
PubMed: 26913227
DOI: 10.14444/3007 -
Annals of Saudi Medicine 2016Both kyphoplasty (KP) and vertebroplasty (VP) are effective for patients with osteoporotic vertebral compression fracture (OVCF), but which approach might be more... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Both kyphoplasty (KP) and vertebroplasty (VP) are effective for patients with osteoporotic vertebral compression fracture (OVCF), but which approach might be more effective remains unclear, so we decided to update earlier systematic reviews.
OBJECTIVE
Review and analyze studies published as of August 2015 that compared clinical outcomes and complications of KP versus VP.
DESIGN
Systematic review and meta-analysis.
SEARCH METHOD
Published reports up to August 2015 were found in PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL).
SELECTION CRITERIA
Randomized controlled trials (RCTs) and prospective and retrospective cohort stud.ies comparing KP and VP in patients with OVCF.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the studies and extracted data.
RESULTS
Thirty-two studies involving 3274 patients fulfilled the inclusion criteria. There were significant differences between the two groups in short- and long-term postoperative changes in measures of pain intensity and dysfunction (P < .01), in anterior and middle height (P < .01), kyphotic angle (P < .01), and time to injury, but not in posterior height (P=.178). There were no significant differences in the rate of postoperative fractures including adjacent and total fractures, but cement leakage to the intraspinal space was greater in the VP group (P=.035). KP surgery took longer and required a greater volume of injected cement.
CONCLUSIONS
KR resulted in better pain relief, improvements in Oswestry dysfunction and radiographic outcomes with less cement leakage, but further RCTs are needed to verify this conclusion.
LIMITATIONS
Only four RCTs with a certain of risk of bias. Most studies were observational.
Topics: Bone Cements; Disability Evaluation; Fractures, Compression; Humans; Kyphoplasty; Operative Time; Osteoporotic Fractures; Pain Measurement; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 27236387
DOI: 10.5144/0256-4947.2016.165 -
Journal of Neurosurgery. Spine Apr 2021Percutaneous vertebroplasty (PV) and balloon kyphoplasty (BK) are two minimally invasive techniques used to treat mechanical pain secondary to spinal compression... (Review)
Review
OBJECTIVE
Percutaneous vertebroplasty (PV) and balloon kyphoplasty (BK) are two minimally invasive techniques used to treat mechanical pain secondary to spinal compression fractures. A concern for both procedures is the radiation exposure incurred by both operators and patients. The authors conducted a systematic review of the available literature to examine differences in interventionalist radiation exposure between PV and BK and differences in patient radiation exposure between PV and BK.
METHODS
The authors conducted a search of the PubMed, Ovid Medline, Cochrane Reviews, Embase, and Web of Science databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Full-text articles in English describing one of the primary endpoints in ≥ 5 unique patients treated with PV or BK of the mobile spine were included. Estimates of mean operative time, radiation exposure, and fluoroscopy duration were reported as weighted averages. Additionally, annual occupational dose limits provided by the United States Nuclear Regulatory Commission (USNRC) were used to determine the number needed to harm (NNH).
RESULTS
The meta-analysis included 27 articles. For PV, the mean fluoroscopy times were 4.9 ± 3.3 minutes per level without protective measures and 5.2 ± 3.4 minutes with protective measures. The mean operator radiation exposures per level in mrem were 4.6 ± 5.4 at the eye, 7.8 ± 8.7 at the neck, 22.7 ± 62.4 at the torso, and 49.2 ± 62.2 at the hand without protective equipment and 0.3 ± 0.1 at the torso and 95.5 ± 162.5 at the hand with protection. The mean fluoroscopy times per level for BK were 6.1 ± 2.5 minutes without protective measures and 6.0 ± 3.2 minutes with such measures. The mean exposures were 31.3 ± 39.3, 19.7 ± 4.6, 31.8 ± 34.2, and 174.4 ± 117.3 mrem at the eye, neck, torso, and hand, respectively, without protection, and 1, 9.2 ± 26.2, and 187.7 ± 100.4 mrem at the neck, torso, and hand, respectively, with protective equipment. For protected procedures, radiation to the hand was the limiting factor and the NNH estimates were 524 ± 891 and 266 ± 142 for PV and BK, respectively. Patient exposure as measured by flank-mounted dosimeters, entrance skin dose, and dose area product demonstrated lower exposure with PV than BK (p < 0.01).
CONCLUSIONS
Operator radiation exposure is significantly decreased by the use of protective equipment. Radiation exposure to both the operator and patient is lower for PV than BK. NNH estimates suggest that radiation to the hand limits the number of procedures an operator can safely perform. In particular, radiation to the hand limits PV to 524 and BK to 266 procedures per year before surpassing the threshold set by the USNRC.
PubMed: 33930867
DOI: 10.3171/2020.9.SPINE201525 -
World Neurosurgery May 2023Augmented reality (AR) and virtual reality (VR) implementation in spinal surgery has expanded rapidly over the past decade. This systematic review summarizes the use of... (Review)
Review
BACKGROUND
Augmented reality (AR) and virtual reality (VR) implementation in spinal surgery has expanded rapidly over the past decade. This systematic review summarizes the use of AR/VR technology in surgical education, preoperative planning, and intraoperative guidance.
METHODS
A search query for AR/VR technology in spine surgery was conducted through PubMed, Embase, and Scopus. After exclusions, 48 studies were included. Included studies were then grouped into relevant subsections. Categorization into subsections yielded 12 surgical training studies, 5 preoperative planning, 24 intraoperative usage, and 10 radiation exposure.
RESULTS
VR-assisted training significantly reduced penetration rates or increased accuracy rates compared to lecture-based groups in 5 studies. Preoperative VR planning significantly influenced surgical recommendations and reduced radiation exposure, operating time, and estimated blood loss. For 3 patient studies, AR-assisted pedicle screw placement accuracy ranged from 95.77% to 100% using the Gertzbein grading scale. Head-mounted display was the most common interface used intraoperatively followed by AR microscope and projector. AR/VR also had applications in tumor resection, vertebroplasty, bone biopsy, and rod bending. Four studies reported significantly reduced radiation exposure in AR group compared to fluoroscopy group.
CONCLUSIONS
AR/VR technologies have the potential to usher in a paradigm shift in spine surgery. However, the current evidence indicates there is still a need for 1) defined quality and technical requirements for AR/VR devices, 2) more intraoperative studies that explore usage outside of pedicle screw placement, and 3) technological advancements to overcome registration errors via the development of an automatic registration method.
Topics: Humans; Augmented Reality; Surgery, Computer-Assisted; Neurosurgical Procedures; Virtual Reality; Pedicle Screws
PubMed: 36812986
DOI: 10.1016/j.wneu.2023.02.068 -
Journal of Spinal Disorders & Techniques Jun 2013Literature review and meta-analysis. (Meta-Analysis)
Meta-Analysis Review
STUDY DESIGN
Literature review and meta-analysis.
OBJECTIVE
To perform a systematic review and meta-analysis of risk factors for new osteoporotic vertebral compression fracture (VCF) after vertebroplasty.
SUMMARY OF BACKGROUND DATA
New osteoporotic VCF is one of the serious complications of vertebroplasty, and it is important to investigate the risk factors for such VCFs. The risk factors for new VCFs reported so far remain controversial because of limited data and lack of uniform measurements and evaluation.
METHODS
We searched the electronic database of PubMed for case-control studies about the risk of new osteoporotic VCFs after vertebroplasty.
RESULTS
A total of 116 studies were identified, of which 16 studies including 559 cases and 1736 controls met the inclusion criteria. The significant risk factors for new VCFs were low bone mineral density [BMD; standardized mean difference (SMD), -0.73; 95% confidence interval (CI), -1.26 to -0.20], low body mass index (BMI; SMD, -0.30; 95% CI, -0.51 to -0.10), and intradiscal cement leakage [odds ratio (OR), 2.13; 95% CI, 1.40-2.36]. The significant risk factors for new VCFs adjacent to the treated VCF were low BMD (SMD, -0.43; 95% CI, -0.76 to -0.09), low BMI (SMD, -0.52; 95% CI, -0.81 to -0.22), and intradiscal cement leakage (OR, 2.61; 95% CI, 1.63-4.17). Low BMD, low BMI, intradiscal cement leakage, cement volume, surgical approach, age, sex, and thoracolumbar junction fracture were all not significant risk factors for new VCFs away from the original VCF. Only one study reported dynamic characteristics as risk factors for new VCFs.
CONCLUSIONS
The results of this meta-analysis strongly suggested that patients with low BMD, low BMI, and intradiscal cement leakage were at high risk for new VCFs after vertebroplasty, and risk-reduction options should be considered for such patients.
Topics: Age Distribution; Body Mass Index; Bone Density; Causality; Comorbidity; Female; Fractures, Compression; Humans; Male; Osteoporotic Fractures; Postoperative Complications; Prevalence; Risk Factors; Sex Distribution; Spinal Fractures; Vertebroplasty
PubMed: 23027362
DOI: 10.1097/BSD.0b013e31827412a5 -
Spine Nov 2006Systematic review and meta-regression. (Comparative Study)
Comparative Study Review
STUDY DESIGN
Systematic review and meta-regression.
OBJECTIVES
To compare the efficacy and safety of balloon kyphoplasty and vertebroplasty for the treatment of vertebral compression fractures, and to examine the prognostic factors that predict outcome.
SUMMARY OF BACKGROUND DATA
A previous systematic review of vertebroplasty by Levine et al in 2000 identified seven case series studies and no controlled studies.
METHODS
A number of electronic databases were searched through March 1, 2004. Citation searches of included studies were undertaken and contact was made with experts in the field. No language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression.
RESULTS
The following studies were included: balloon kyphoplasty (three nonrandomized comparative studies against conventional medical therapy and 13 case series), vertebroplasty (one nonrandomized comparative study against conventional medical care and 57 cases series), balloon kyphoplasty versus vertebroplasty (one nonrandomized comparative study). The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. At this time, there is no good quality direct comparative evidence of balloon kyphoplasty versus vertebroplasty. From indirect comparison of case series evidence, the procedures appear to provide similar gains in pain relief while for balloon kyphoplasty there is better documentation of gains in patient functionality and quality of life. The level of cement leakage and number of reported adverse events (pulmonary emboli and neurologic injury) in balloon kyphoplasty was significantly lower than for vertebroplasty. These findings were confirmed by meta-regression analysis.
CONCLUSIONS
There is Level III evidence to support balloon kyphoplasty and vertebroplasty as effective therapies in the management of patients with symptomatic osteoporotic vertebral compression fractures refractory to conventional medical therapy. Although there was a good ratio of benefit to harm for both procedures, balloon kyphoplasty appears to offer the better adverse event profile. These conclusions need to be updated on the basis of the findings of ongoing randomized controlled trials.
Topics: Aged; Bone Cements; Catheterization; Female; Fractures, Compression; Humans; Injections; Kyphosis; Male; Middle Aged; Minimally Invasive Surgical Procedures; Orthopedic Procedures; Palliative Care; Polymethyl Methacrylate; Safety; Spinal Fractures; Treatment Outcome
PubMed: 17077747
DOI: 10.1097/01.brs.0000244639.71656.7d