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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 -
Brain & Spine 2023Mechanical complications from spinal fusion including implant loosening or junctional failure result in poor outcomes, particularly in osteoporotic patients. While the... (Review)
Review
INTODUCTION
Mechanical complications from spinal fusion including implant loosening or junctional failure result in poor outcomes, particularly in osteoporotic patients. While the use of percutaneous vertebral augmentation with polymethylmethacrylate (PMMA) has been studied for augmentation of junctional levels to offset against kyphosis and failure, its deployment around existing loose screws or in failing surrounding bone as a salvage percutaneous procedure has been described in small case series and merits review.
RESEARCH QUESTION
How effective and safe is the use of PMMA as a salvage procedure for mechanical complications in failed spinal fusion?.
MATERIALS AND METHODS
Systematic search of online databases for clinical studies using this technique.
RESULTS
11 studies were identified, only consisting of two case reports and nine case series. Consistent improvements were observed in pre- to post-operative VAS and with sustained improvements at final follow-up. The extra- or para-pedicular approach was the most frequent access trajectory. Most studies cited difficulties with visibility on fluoroscopy, using navigation or oblique views as a solution for this.
DISCUSSION AND CONCLUSIONS
Percutaneous cementation at a failing screw-bone interface stabilises further micromotion with reductions in back pain. This rarely used technique is manifested by a low but increasing number of reported cases. The technique warrants further evaluation and is best performed within a multidisciplinary setting at a specialist centre. Notwithstanding that underlying pathology may not be addressed, awareness of this technique may allow an effective and safe salvage solution with minimal morbidity for older sicker patients.
PubMed: 37383448
DOI: 10.1016/j.bas.2023.101726 -
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 -
Pain Physician May 2023Percutaneous balloon kyphoplasty (PKP) is widely used to treat osteoporotic vertebral compression fractures (OVCFs). In addition to rapid and effective pain relief, the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Percutaneous balloon kyphoplasty (PKP) is widely used to treat osteoporotic vertebral compression fractures (OVCFs). In addition to rapid and effective pain relief, the ability to recover the lost height of fractured vertebral bodies and reduce the risk for complications are believed to be the main advantages of this procedure. However, there is no consensus on the appropriate surgical timing for PKP.
OBJECTIVES
This study systematically evaluated the relationship between the surgical timing of PKP and clinical outcomes to provide more evidence for clinicians to choose the intervention timing.
STUDY DESIGN
Systematic review and meta-analysis.
METHODS
The PubMed, Embase, Cochrane Library, and Web of Science databases were systematically searched for relevant randomized controlled trials and prospective, and retrospective cohort trials published up to November 13, 2022. All included studies explored the influence of PKP intervention timing for OVCFs. Data regarding clinical and radiographic outcomes and complications were extracted and analyzed.
RESULTS
Thirteen studies involving 930 patients with symptomatic OVCFs were included. Most patients with symptomatic OVCFs achieved rapid and effective pain relief after PKP. In comparison to delayed PKP intervention, early PKP intervention was associated with similar or better outcomes in terms of pain relief, improvement of function, restoration of vertebral height, and correction of kyphosis deformity. The meta-analysis results showed there was no significant difference in cement leakage rate between early PKP and late PKP (odds ratio [OR] = 1.60, 95% CI, 0.97-2.64, P = 0.07), whereas delayed PKP had a higher risk for adjacent vertebral fractures (AVFs) than early PKP (OR = 0.31, 95% CI: 0.13-0.76, P = 0.01).
LIMITATIONS
The number of included studies was small, and the overall quality of the evidence was very low.
CONCLUSIONS
PKP is an effective treatment for symptomatic OVCFs. Early PKP may achieve similar or better clinical and radiographic outcomes for treating OVCFs than delayed PKP. Furthermore, early PKP intervention had a lower incidence of AVFs and a similar rate of cement leakage compared with delayed PKP. Based on current evidence, early PKP intervention might be more beneficial to patients.
Topics: Humans; Kyphoplasty; Fractures, Compression; Spinal Fractures; Retrospective Studies; Prospective Studies; Osteoporotic Fractures; Treatment Outcome; Bone Cements; Pain
PubMed: 37192225
DOI: No ID Found -
World Neurosurgery Jul 2023Hidden blood loss (HBL), as a perioperative complication of percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP), affects the quality of life of older... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Hidden blood loss (HBL), as a perioperative complication of percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP), affects the quality of life of older adults with poor health status, but it is often ignored by clinical surgeons. The purpose of this study was to discuss the risk factors for perioperative HBL through meta-analysis.
METHODS
We systematically searched PubMed, Embase, Cochrane Library, Web of Science, Scopus, Google Scholar, Chinese National Knowledge Infrastructure, and Wan Fang from establishment of the database to September 2022. All eligible studies regarding risk factors for HBL after PVP or PKP were included. Heterogeneity was assessed using the χ test and I statistic percentages. If I >50% or P < 0.1, the random-effect model was used; otherwise, the fixed-effect model was used. Data were analyzed with Revman 5.4 and Stata 16.0.
RESULTS
Eleven studies involving 1506 patients were included and the average HBL of PKP and PVP was 278.57 mL and 276.12mL. The results showed that bone cement leakage (P < 0.0001), thoracic vertebra (P < 0.00001), bilateral surgical approach (P = 0.0008), ≥2 fracture segments (P < 0.00001), vertebral body height loss rate (≥1/3) (P < 0.00001), and vertebral body height restoration rate (≥1/3) (P < 0.00001) were risk factors for increased HBL. Diabetes (P = 0.12) and hypertension (P = 0.52) were not significantly associated with HBL.
CONCLUSIONS
The findings of this meta-analysis suggested that fracture level, surgical approach, number of fracture levels, cement leakage, vertebral height loss and restoration rate were significant risk factors for HBL, which had certain guiding significance for clinical surgeons to take reasonable measures to deal with this complication.
Topics: Humans; Aged; Kyphoplasty; Fractures, Compression; Spinal Fractures; Quality of Life; Osteoporotic Fractures; Treatment Outcome; Vertebroplasty; Thoracic Vertebrae; Risk Factors; Retrospective Studies; Bone Cements
PubMed: 37044206
DOI: 10.1016/j.wneu.2023.03.114