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World Neurosurgery Jan 2024Percutaneous curved vertebroplasty (PCVP), a modified traditional unilateral percutaneous vertebroplasty (UPVP) technique, is increasingly being used to treat... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Percutaneous curved vertebroplasty (PCVP), a modified traditional unilateral percutaneous vertebroplasty (UPVP) technique, is increasingly being used to treat osteoporotic vertebral compression fractures (OVCFs); however, its advantages remain controversial. This meta-analysis was conducted to determine whether PCVP is superior to traditional UPVP in treating OVCFs.
METHODS
Six databases were searched for studies comparing the clinical efficacy of PCVP and UPVP in treating patients with OVCFs published until March 2023. After study selection, data extraction, and risk of bias evaluation, a meta-analysis was conducted. The study protocol was registered in the PROSPERO platform (registration number: CRD42023417190).
RESULTS
Eight studies (6 randomized controlled trials and 2 cohort studies) were eligible for the final analysis. The pooled results revealed no between-group differences in operation time (P = 0.85), intraoperative fluoroscopy (P = 0.58), or postoperative short-term visual analog scale scores (P = 0.15). However, PCVP was associated with more injected cement (P = 0.003), a lower cement leakage rate (P = 0.006), and a lower final follow-up visual analog scale score (P < 0.0001).
CONCLUSIONS
PCVP was superior to UPVP in terms of reducing the bone cement leakage rate and providing long-term pain relief. Further trials with larger sample sizes and longer follow-up periods are required to verify these findings owing to the potential risk of bias.
Topics: Humans; Spinal Fractures; Fractures, Compression; Vertebroplasty; Spine; Kyphoplasty; Bone Cements; Treatment Outcome; Osteoporotic Fractures; Retrospective Studies
PubMed: 37839572
DOI: 10.1016/j.wneu.2023.10.035 -
The Journal of the American Academy of... Nov 2023The purpose of this study was to determine the stability of statistical findings among sham surgery randomized controlled trials (RCTs) in orthopaedic surgery using...
OBJECTIVES
The purpose of this study was to determine the stability of statistical findings among sham surgery randomized controlled trials (RCTs) in orthopaedic surgery using fragility analysis.
METHODS
PubMed systematic review was conducted to include studies reporting dichotomous outcomes pertaining to sham surgery. The final review included eight RCTs involving only partial meniscectomies and vertebroplasties from 2009 to 2020. With a fixed sample size with dichotomous outcome measures (events versus non-events), the Total Fragility Index (TFI), which is composed of the fragility index (FI) and reverse fragility index (RFI), was calculated by altering the ratio of events to non-events in an iterative fashion until results were reversed from significant to nonsignificant findings (FI) or vice versa (RFI). The TFI, FI, and RFI were divided by their sample sizes to obtain the respective total fragility quotient, fragility quotient (FQ), and reverse fragility quotient. Median fragility indices and quotients were reported for all studies.
RESULTS
The eight RCTs included 50 dichotomous outcomes involving either partial meniscectomies or vertebroplasties, with a median TFI and total fragility quotient of 5 [interquartile range (IQR) 4 to 6] and 0.035 (IQR 0.028 to 0.048), respectively, indicating that a median of five total patients or 3.5 per 100 patients would need to experience a different outcome to reverse significant or insignificant findings for each of the eight trials. Among the 8 statistically significant ( P < 0.05) outcome events (16%), the respective FI and FQ were 2 (IQR 1 to 5) and 0.018 (IQR 0.010 to 0.044). Among the 42 statistically insignificant outcome events (84%), the respective RFI and reverse fragility quotient were 5 (IQR 4 to 6) and 0.04 (IQR 0.034 to 0.048). The median number of patients lost to follow-up was 1.5 (IQR 0.5 to 2).
CONCLUSION
The unstable findings in partial meniscectomy and vertebroplasty sham surgical RCTs undermine their study conclusions and recommendations. We recommend using fragility analysis in future sham surgical RCTs to contextualize statistical findings.
LEVEL OF EVIDENCE
Level IV; Systematic Review.
PubMed: 37678845
DOI: 10.5435/JAAOS-D-23-00245 -
Journal of Robotic Surgery Dec 2023Percutaneous vertebral augmentation (PVA), which includes percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP). Robot-assisted (RA) and... (Meta-Analysis)
Meta-Analysis Review
Percutaneous vertebral augmentation (PVA), which includes percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP). Robot-assisted (RA) and fluoroscopy-assisted (FA) are important methods for treating osteoporotic vertebral compression fractures (OVCFs), though it is still unclear which is superior. This analysis aimed to compare the efficacy and safety of RA and FA. PubMed, Web of Science, Cochrane Library, and China National Knowledge Infrastructure were systematically searched, the outcomes included surgical parameters (leakage rate, operation time, number of fluoroscopic, injection volume, inclination angle), and clinical indexes (hospital stays, Visual Analog Scale (VAS), Oswestry Disability Index (ODI), Cobb angle, the midline height of vertebral). Thirteen articles involving 1094 patients were included. RA group produced better results than the FA group in the leakage rate (OR = 0.27; 95% CI 0.17-0.42; P < 0.00001), number of fluoroscopic (WMD = - 13.88; 95% CI - 18.47 to - 9.30; P < 0.00001), inclination angle (WMD = 5.02; 95% CI 4.42-5.61; P < 0.00001), hospital stays (WMD = - 0.32; 95% CI - 0.58 to - 0.05; P = 0.02), VAS within 3 days (WMD = - 0.19; 95% CI - 0.26 to - 0.12; P < 0.00001), Cobb angle within 3 days (WMD = - 1.35; 95% CI - 2.56 to - 0.14; P = 0.003) and Cobb angle after 1 month (WMD = - 1.02; 95% CI - 1.84 to - 0.20; P = 0.01). But no significant differences in operation time, injection volume, ODI, the midline height of vertebral, and VAS score after 1 month. Our analysis found that the RA group had lower cement leakage rates, number of fluoroscopic and hospital stays, a larger inclination angle, better short-term pain improvement, and Cobb angle improvement. It is worth acknowledging that robotic-assisted surgery holds promise for the development of spine surgery. The study was registered in the PROSPERO (CRD42023393497).
Topics: Humans; Kyphoplasty; Fractures, Compression; Spinal Fractures; Robotic Surgical Procedures; Robotics; Treatment Outcome; Osteoporotic Fractures; Retrospective Studies
PubMed: 37632602
DOI: 10.1007/s11701-023-01700-0 -
Orthopaedic Surgery Oct 2023This systematic review and meta-analysis is aimed to provide higher quality evidence regarding the efficacy and safety between PCVP and PVP/KP in OVCFs. We searched the... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis is aimed to provide higher quality evidence regarding the efficacy and safety between PCVP and PVP/KP in OVCFs. We searched the Cochrane Library, PubMed, Web of Science, and Embase databases for all randomized controlled trials (RCTs) and observational studies (cohort or case-control studies) that compare PCVP to PVP/KP for OVCFs. The Cochrane Collaboration's Risk of Bias Tool and Newcastle-Ottawa Scale (NOS) were used to evaluate the quality of the RCTs and non-RCTs, respectively. Meta-analysis was performed using RevMan 5.4 software. A total of seven articles consisting of 562 patients with 593 diseased vertebral bodies were included. Statistically significant differences were found in the postoperative visual analog scale (VAS) at 1 day (MD = -0.11; 95% CI: [-0.21 to -0.01], p = 0.03), but not at 3 months (MD = -0.21; 95% CI: [-0.41-0.00], p = 0.05) or 6 months (MD = 0.03; 95% CI: [-0.13-0.20], p = 0.70). There was no statistically significant difference in postoperative Oswestry disability index (ODI) at 1 day (MD = -0.28; 95% CI: [-0.62-0.05], p = 0.10), 3 months (MD = -1.52; 95% CI: [-3.11-0.07], p = 0.06), or 6 months (MD = 0.18; 95% CI: [-0.13-0.48], p = 0.25). Additionally, there were no statistically significant differences in Cobb angle (MD = 0.30; 95% CI: [-1.69-2.30], p = 0.77) or anterior vertebral body height (SMD = -0.01; 95% CI: [-0.26-0.23], p = 0.92) after surgery. Statistically significant differences were found in surgical time (MD = -8.60; 95% CI: [-13.75 to -3.45], p = 0.001), cement infusion volume (MD = -0.82; 95% CI: [-1.50 to -0.14], P = 0.02), and dose of fluoroscopy (SMD = -1.22; 95% CI: [-1.84 to -0.60], p = 0.0001) between curved and noncurved techniques, especially compared to bilateral PVP. Moreover, cement leakage showed statistically significant difference (OR = 0.40; 95% CI: [0.27-0.60], p < 0.0001). Compared with PVP/KP, PCVP is superior for pain relief at short-term follow-up. Additionally, PCVP has the advantages of significantly lower surgical time, radiation exposure, bone cement infusion volume, and cement leakage incidence compared to bilateral PVP, while no statistically significant difference is found when compared with unilateral PVP or PKP. In terms of quality of life and radiologic outcomes, the effects of PCVP and PVP/KP are not significantly different. Overall, this meta-analysis reveals that PCVP was an effective and safe therapy for patients with OVCFs.
Topics: Humans; Fractures, Compression; Vertebroplasty; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures; Bone Cements; Treatment Outcome
PubMed: 37497571
DOI: 10.1111/os.13800 -
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 -
European Spine Journal : Official... Oct 2023Vertebroplasty has been recently described in the literature as a potential treatment for C2 metastatic lesions. Stentoplasty may represent a safest and equally... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vertebroplasty has been recently described in the literature as a potential treatment for C2 metastatic lesions. Stentoplasty may represent a safest and equally alternative to the latter.
OBJECTIVE
To describe a novel technique, stentoplasty, as an alternative for the treatment of metastatic involvement of C2 and to assess its efficacy and safety. To systematically evaluate the pertinent literature regarding the clinical outcomes and complications of C2 vertebroplasty in patients with metastatic disease.
METHODS
A systematic review of C2 vertebroplasty, in the English language medical literature was conducted for the needs of this study. Additionally, a cohort of five patients, presenting with cervical instability (SINS > 6) and/or severe pain (VAS > 6) from metastatic involvement of C2 and treated with stentoplasty in our department is presented. Outcomes evaluated include, pain control, stability, and complications.
RESULTS
Our systematic review yielded 8 studies that met the inclusion criteria, incorporating 73 patients that underwent C2 vertebroplasty for metastatic disease. There was a reduction in VAS scores following surgery from 7.6 to 2.1. Eleven patients had complications (15%), 3 (4%) required additional stabilization and decompression, 6 (8.2%) had odynophagia and the incidence of cement leak was 31.5% (23/73). With regard to our cohort, all 5 patients presented with severe neck pain (average VAS 6.2 (2-10)) with or without instability (average SINS 10 (6-14)) and underwent C2 stentoplasty. Mean duration of the procedures was 90 min (61-145) and 2.6 mls (2-3) of cement was injected. Postoperatively VAS improved from 6.2 to 1.6 (P = 0.033). No cement leak or other complications were recorded.
CONCLUSION
A systematic review of the literature demonstrated that C2 vertebroplasty can offer significant pain improvement with a low complication rate. At the same time, this is the first study to describe stentoplasty in a small cohort of patients, as an alternative for the treatment of C2 metastatic lesions in selected cases, offering adequate pain control and improving segmental stability with a high safety profile.
Topics: Humans; Vertebroplasty; Neck Pain; Bone Cements; Pain Management; Treatment Outcome; Spinal Fractures
PubMed: 37300582
DOI: 10.1007/s00586-023-07809-y -
Journal of Orthopaedic Research :... Dec 2023This meta-analysis investigated the effects of exercise on Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores following vertebroplasty or kyphoplasty... (Meta-Analysis)
Meta-Analysis
This meta-analysis investigated the effects of exercise on Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores following vertebroplasty or kyphoplasty in osteoporotic fractures. A literature search of PubMed, EMBASE (Elsevier), CiNAHL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Scopus, and Web of Science was conducted from database inception to October 6, 2022. Eligible studies reported osteoporosis patients over 18 years of age with a diagnosis of at least one vertebral fracture via radiography or clinical assessment. This review was registered in PROSPERO (ID: CRD42022340791). Ten studies met the eligibility criteria (n = 889). VAS scores at baseline were 7.75 (95% CI: 7.54, 7.97, I = 76.11%). Following initiation of exercise, VAS scores at the endpoint of 12 months were 1.91 (95% CI: 1.53, 2.29, I = 92.69%). ODI scores at baseline were 68.66 (95% CI: 56.19, 81.13, I = 85%). Following initiation of exercise, ODI scores at the endpoint of 12 months were 21.20 (95% CI: 14.52, 27.87, I = 99.30). A two-arm analysis demonstrated improved VAS and ODI for the exercise group compared to non-exercise control at 6 months (MD = -0.70, 95% CI: -1.08, -0.32, I = 87% and MD = -6.48, 95% CI: -7.52, -5.44, I = 46%, respectively) and 12 months (MD = -0.88, 95% CI: -1.27, -0.49, I = 85% and MD = -9.62, 95% CI: -13.24, -5.99, I = 93%). Refracture was the only adverse event reported and occurred almost twice as frequently in the non-exercise group than in the exercise group. Exercise rehabilitation post vertebral augmentation is associated with improved pain and functionality, particularly after 6 months of exposure, and may reduce refracture rate.
Topics: Humans; Adolescent; Adult; Fractures, Compression; Treatment Outcome; Spine; Kyphoplasty; Vertebroplasty; Spinal Fractures; Osteoporotic Fractures
PubMed: 37203781
DOI: 10.1002/jor.25631 -
Zeitschrift Fur Orthopadie Und... Dec 2023To summarize the literature and compare the advantages and disadvantages of the unilateral transverse process-pedicle approach (UTPA) and conventional transpedicular... (Meta-Analysis)
Meta-Analysis
PURPOSE
To summarize the literature and compare the advantages and disadvantages of the unilateral transverse process-pedicle approach (UTPA) and conventional transpedicular approach (CTPA) vertebral augmentation in the treatment of osteoporotic vertebral compression fractures (OVCF).
METHODS
A single researcher performed a systematic literature review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Online scientific databases were searched in September 2021 for English- and Chinese-language publications. A series of comparative studies were included, with UTPA as the main intervention and CTPA as the comparison indicator. A meta-analysis was performed for studies that reported clinical outcome indicators. The χ was used to study heterogeneity between trials, and the I statistic was calculated to estimate variation across studies.
RESULTS
A total of eight studies were included for meta-analysis, all of which were observational studies with mixed bias risk. There were 613 subjects in the UTPA group and 488 subjects in the CTPA group. The results of the meta-analysis showed that there was no difference between the UTPA group and the CTPA group in terms of visual analogue scale scores (p = 0.31), Oswestry Disability Index scores (p = 0.50), correction of kyphosis angle (p = 0.65), and the amount of bone cement (p = 0.13), but the UTPA group had a shorter operative time (p < 0.001), bone cement leakage rates (p = 0.02), and fluoroscopy times than the CTPA group (p < 0.001). Partial analysis results had a high risk of bias, and the most common source of bias was that there was high heterogeneity between studies, and the sensitivity can only be reduced by a random effect model, and some studies (four items) did not clearly describe the confounders that they controlled.
CONCLUSION
The limited evidence obtained in this study proves that the new puncture method does not have more advantages than the traditional technique, so it is no longer meaningful to continue to obsess over the impact of the puncture method on surgical outcome.
Topics: Humans; Kyphoplasty; Spinal Fractures; Fractures, Compression; Bone Cements; Spine; Vertebroplasty; Osteoporotic Fractures; Treatment Outcome; Retrospective Studies
PubMed: 35378564
DOI: 10.1055/a-1785-5698