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Pain Physician May 2021Percutaneous kyphoplasty (PKP) has been reported to provide a favorable analgesic effect for pain caused by osteoporotic vertebral compression fractures (OVCFs)....
BACKGROUND
Percutaneous kyphoplasty (PKP) has been reported to provide a favorable analgesic effect for pain caused by osteoporotic vertebral compression fractures (OVCFs). However, a systematic review demonstrated that pain relief was only reported for approximately 86% of kyphoplasty treatments.
OBJECTIVES
To explore whether an additional facet joint block (FJB) can minimize pain and improve the clinical outcome of PKP in patients with acute OVCFs.
STUDY DESIGN
Prospective study.
SETTING
All data were from Honghui Hospital in Xi'an.
METHODS
According to the inclusion and exclusion criteria, 194 patients were eventually included in our study; they were randomly divided into 2 groups of 97 patients each and treated with either PKP + FJB or PKP alone. Follow-up consultations were scheduled 1 day, 3 days, 1 week, 1 month, 3 months, and 1 year postoperatively; the demographic characteristics, related surgical information, and complications observed within both groups were recorded. The clinical evaluation parameters included the intraoperative satisfaction score, the Visual Analog Scale (VAS) score, and the Oswestry Disability Index (ODI).
RESULTS
A total of 171 patients (61 men and 110 women; age range: 62-85 years) completed the full postoperative follow-up schedule, with 83 patients in the PKP + FJB group and 88 in the PKP group. No significant differences were observed in the genders, ages, preoperative bone mineral density, surgical levels, or volume of cement injected between the 2 groups (P > 0.05, respectively). The average duration of the surgeries in the PKP + FJB group was slightly longer than that in the PKP group (35.5 ± 4.8 min vs. 31.8 ± 4.3 min; P = 0.038), and in terms of the clinical outcomes, the average intraoperative satisfaction score was significantly higher in the PKP + FJB group (8.6 ± 1.1 vs. 6.3 ± 1.3; P < 0.001). Compared with the preoperative data, significant improvements in the VAS scores of back pain and ODI were observed at each follow-up interval (P < 0.05, respectively). These scores were significantly higher in the PKP + FJB group than in the PKP group; however, this was only observed within the first month after the procedure.
LIMITATIONS
A single-center noncontrol study.
CONCLUSIONS
The addition of an FJB (which in our study involved a unique combination of ropivacaine, prednisolone, and vitamin B12) improved the short-term clinical outcome of PKP for acute OVCFs. The local anti-inflammatory and analgesic effects on the facet joints resulted in higher intraoperative satisfaction and lower VAS and ODI scores for the first postoperative month when compared with the PKP group.
Topics: Aged; Aged, 80 and over; Bone Cements; Female; Fractures, Compression; Humans; Kyphoplasty; Male; Middle Aged; Osteoporotic Fractures; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Spinal Fractures; Treatment Outcome; Zygapophyseal Joint
PubMed: 33988948
DOI: No ID Found -
Spine Dec 2021Systematic review and meta-analysis. (Meta-Analysis)
Meta-Analysis
STUDY DESIGN
Systematic review and meta-analysis.
OBJECTIVE
To compare the magnitude and duration of pain relief with vertebral augmentation to any other therapy for the treatment of cancer-related vertebral compression fractures through meta-analysis of randomized controlled trials.
SUMMARY OF BACKGROUND DATA
Derived from search on PubMed, EMBASE, CINAHL, Scopus, Central, Scopus, and Web of Science databases in May 2020. Studies selected were limited to randomized controlled trials comparing vertebral augmentation, either Balloon Kyphoplasty or Percutaneous Vertebroplasty (PVP) with or without additional therapy to any other intervention or placebo/sham.
METHODS
The methodological quality of each included study was assessed according to the Cochrane Collaboration's domain-based framework. Random effects model, Q test, and I2 statistics were implemented.
RESULTS
Of 180 records identified, 7 were considered relevant, and included 476 participants. The risk of bias was considered "Low" in all studies. In five of the studies, vertebral augmentation alone (either PVP or Balloon Kyphoplasty) comprised one group, while comparative treatments included nonsurgical management, Kiva implantation, PVP and radiofrequency therapy, PVP and chemotherapy, PVP and intrasomatic injection of steroid, and PVP with 125I seeds. Two studies compared PVP with an additional therapy against the standard of care. With regard to changes in pain severity, the effect sizes varied from 0.0 (95% -1.7 to 1.7) to -5.1 (95% -5.3 to -4.9). Most studies demonstrated a positive and statistically significant effect associated with PVP. Four of the seven studies demonstrated a clinically significant effect as well. Other than cement leakage, with an event rate of 0.24 (95% CI 0.11-0.44) or 24% (95% CI 11%-44%), there were no major adverse events consistently observed across multiple studies.
CONCLUSIONS
The included randomized controlled trials demonstrated an overall positive and statistically significant effect of vertebral augmentation surgeries, such as vertebroplasty and kyphoplasty, for the treatment of cancer-related vertebral compression fractures, especially when compared with nonsurgical management, radiofrequency ablation, or chemotherapy alone.Level of Evidence: 1.
Topics: Fractures, Compression; Humans; Iodine Radioisotopes; Kyphoplasty; Neoplasms; Osteoporotic Fractures; Spinal Fractures; Treatment Outcome; Vertebroplasty
PubMed: 33958537
DOI: 10.1097/BRS.0000000000004093 -
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 -
BioMed Research International 2021We conducted this meta-analysis to provide better evidence of the efficacy and safety of zoledronic acid (ZA) combined with percutaneous vertebroplasty/kyphoplasty... (Meta-Analysis)
Meta-Analysis
Clinical Efficacy and Safety of Zoledronic Acid Combined with PVP/PKP in the Treatment of Osteoporotic Vertebral Compression Fracture: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
OBJECTIVE
We conducted this meta-analysis to provide better evidence of the efficacy and safety of zoledronic acid (ZA) combined with percutaneous vertebroplasty/kyphoplasty (PVP/PKP) on osteoporotic vertebral compression fracture (OVCF) and proposed a protocol for its application in clinical practice.
METHODS
All randomized controlled trials (RCTs) of ZA combined with PVP or PKP compared to individual PVP/PKP for the management of patients with OVCFs were included in this study. Electronic database searches were conducted from database inception to November 2020, including the Cochrane Library, PubMed, Web of Science, and Embase. The pooled data were analyzed using RevMan 5.3 software.
RESULTS
Seven RCTs with 929 subjects were finally included. All included studies reported visual analog scores (VAS), and no statistically significant differences were identified at follow-ups of 3 d and 1 w ( > 0.05). In contrast, significant differences were observed at the 1 mo, 3 mo, 6 mo, and 12 mo follow-ups ( < 0.05). Two trials reported the Cobb angle and vertebral body height (VBH), including 182 subjects without significant differences at the 12 mo follow-up ( > 0.05). In addition, significant differences in the bone mineral density (BMD), -isomerized C-terminal telopeptide of type I collagen (-CTX), N-terminal propeptide of type I collagen (PINP), and N-terminal molecular fragment (N-MID) levels were observed between the two groups ( < 0.05). All trials reported side effects. Significant differences in recurrent fractures, fever, flu-like symptoms, and arthralgia or myalgia were identified ( < 0.05); however, no significant difference in postoperative leakage was detected ( > 0.05).
CONCLUSION
Compared to PVP/PKP alone, an additional ZA injection had advantages of long-term analgesic effects with improved bone metabolism indexes. Moreover, combination therapy significantly prevented complications and drug reactions were well tolerated. Overall, this systematic review revealed that ZA combined with PVP/PKP was an effective, safe, and comprehensive therapy for patients with OVCFs.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Randomized Controlled Trials as Topic; Spinal Fractures; Treatment Outcome; Vertebroplasty; Zoledronic Acid
PubMed: 33928158
DOI: 10.1155/2021/6650358 -
Medicine Apr 2021To identify the risk factors of the secondary fractures for osteoporotic vertebral compression fractures (OVCFs) after percutaneous vertebroplasty (PVP).We conducted a... (Meta-Analysis)
Meta-Analysis
To identify the risk factors of the secondary fractures for osteoporotic vertebral compression fractures (OVCFs) after percutaneous vertebroplasty (PVP).We conducted a search of relevant articles using Cochrane Library, PubMed, Medline, Science Direct, Embase, the Web of Science and other databases. The time range we retrieved from establishment of the electronic database to November 2017. Gray studies were found in the references of included literature reports. STATA version 11.0 (Stata Corporation, College Station, Texas) was used to analyze the pooled data.Fourteen studies involving 1910 patients, 395 of whom had fracture secondary to the surgery were included in this meta-analysis. The result of meta-analyses showed the risk factors of the secondary fractures for OVCFs after PVP was related to bone mineral density (BMD) [95%CI (-0.650, -0.164), SMD=-0.407, P=.001], cement leakage ((RR=0.596, 95%CI (0.444,0.798), P = .001)), and kyphosis after primary operation ((SMD=0.741, 95%CI (0.449,1.032), P = .000)), but not to gender, age, body mass index, cement volume, thoracolumbar spine, and cement injection approaches.Bone mineral density, cement leakage, and kyphosis after primary operation are the risk factors closely correlative to the secondary fracture after PVP. There have not been enough evidences to support the association between the secondary fracture and gender, age, body mass index, cement volume, thoracolumbar spine, and cement injection approaches.
Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Bone Cements; Bone Density; Clinical Trials as Topic; Female; Fractures, Compression; Humans; Kyphosis; Male; Middle Aged; Osteoporotic Fractures; Postoperative Complications; Risk Factors; Spinal Fractures; Vertebroplasty
PubMed: 33879670
DOI: 10.1097/MD.0000000000025396 -
Medicine Apr 2021The aim of this study is to investigate the clinical efficacy of zoledronic acid (ZOL) in the treatment and prevention of osteoporotic vertebral compression fractures... (Meta-Analysis)
Meta-Analysis
Clinical efficacy of zoledronic acid combined with percutaneous kyphoplasty in the prevention and treatment of osteoporotic vertebral compression fracture: A systematic review and meta-analysis.
OBJECTIVE:
The aim of this study is to investigate the clinical efficacy of zoledronic acid (ZOL) in the treatment and prevention of osteoporotic vertebral compression fractures (OVCF) after percutaneous kyphoplasty (PKP) for elderly patients.
METHODS:
The PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang, VIP, and Embase were investigated through June 2020. All randomized controlled trials (RCT) involving ZOL injections for OVCF were enrolled. Outcome indicators included the bone mineral density (BMD), Visual Analog Scale (VAS), recompression vertebral fracture (RVF), Oswestry Disability Index (ODI), and bone metabolism (Procollagen type I N-terminal propeptide [PINP] and βcross-linked C-telopeptide of type I collagen [β-CTX]), bone cement leakage. Review Manager 5.3 was used to analyze these indicators.
RESULTS:
In this study, (1).. Eight studies had met the eligibility criteria, a total of 578 participants were involved (285 and 293 in the experimental (ZOL) group and control [no ZOL] group, respectively). (2).. The BMD scores of patients with OVCF in the experimental group were significantly higher than that in the control group ( < .05). The VAS scores were significantly different between the 2 groups at the 6, 12 months follow-up ( < .05). After PKP operation, ZOL injections reduced the rate of RVF ( < .05). In the comparison of ODI scores, the experimental group improved compared with the control group ( < .05). Respectively, the bone metabolism of patients with OVCF after ZOL was better than that of patients in control group ( < .05).
CONCLUSION:
Zoledronic acid had a significant effect on the treatment and prevention of OVCF in elderly osteoporotic patients after PKP. Due to the limited quality and data, more high-quality studies are needed to confirm the results of this meta-analysis.
Topics: Bone Density Conservation Agents; Humans; Kyphoplasty; Osteoporotic Fractures; Spinal Fractures; Zoledronic Acid
PubMed: 33787604
DOI: 10.1097/MD.0000000000025215 -
Global Spine Journal Mar 2022Systematic review and meta-analysis.
STUDY DESIGN
Systematic review and meta-analysis.
OBJECTIVE
Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are minimally invasive techniques widely used for the treatment of neurologically intact osteoporotic Kümmell's disease (KD), but which treatment is preferable remains controversial. Therefore, this study aimed to shed light on this issue.
METHODS
Six databases were searched for all relevant studies based on the PRISMA guidelines. Two investigators independently conducted a quality assessment, extracted the data and performed all statistical analyses.
RESULTS
Eight studies encompassing 438 neurologically intact osteoporotic KD patients met the inclusion criteria. Compared to PVP, PKP was associated with greater improvement in the short- and long-term Cobb angle [SMD = -0.37, P = 0.007; SMD = -0.34, P = 0.012], short-term anterior vertebral height [SMD = 0.43, P = 0.003] and long-term middle vertebral height [SMD = 0.57, P = 0.012] and a lower cement leakage rate [SMD = 0.50, P = 0.003] but produced more consumption (cement injection volume, operative time, fluoroscopy times, intraoperative blood loss and operation cost). However, there were no differences between the 2 procedures in the short- and long-term VAS and ODI scores, long-term anterior vertebral height, overall complications or new vertebral fractures.
CONCLUSIONS
Both procedures are equally effective for neurologically intact KD in terms of the clinical outcomes, with the exception of a lower cement leakage risk and better radiographic improvement for PKP but greater resource consumption. Based on the evidence available, good clinical judgment should be exercised in the selection of patients for these procedures.
PubMed: 33541141
DOI: 10.1177/2192568220984129 -
The Spine Journal : Official Journal of... May 2021Correction of adult spinal deformity (ASD) by long segment instrumented spinal fusion is an increasingly common surgical intervention. However, it is associated with... (Review)
Review
Instrumentation techniques to prevent proximal junctional kyphosis and proximal junctional failure in adult spinal deformity correction-a systematic review of biomechanical studies.
BACKGROUND CONTEXT
Correction of adult spinal deformity (ASD) by long segment instrumented spinal fusion is an increasingly common surgical intervention. However, it is associated with high rates of complications and revision surgery, especially in the elderly patient population. The high construct stiffness of instrumented thoracolumbar spinal fusion has been postulated to lead to a higher incidence of proximal junctional kyphosis (PJK) and failure (PJF). Several cadaveric biomechanical studies have reported on surgical techniques to reduce the incidence of PJF/PJK. As yet, no overview has been made of these biomechanical studies.
PURPOSE
To summarize the evidence of all biomechanical studies that have assessed techniques to reduce PJK/PJF following long segment instrumented spinal fusion in the ASD patient population.
STUDY DESIGN
A systematic review.
METHODS
EMBASE and MEDLINE databases were searched for human and animal cadaveric biomechanical studies investigating the effect of various surgical techniques to reduce PJK/PJF following long segment instrumented thoracolumbar spinal fusion in the adult patient population. Studied techniques, biomechanical test methods, range of motion (ROM), intervertebral disc pressure (IDP) and other relevant outcome parameters were documented.
RESULTS
Twelve studies met the inclusion criteria. Four of these studies included non-human cadaveric material. One study investigated the prophylactic application of cement augmentation (vertebroplasty), whereas the remaining studies investigated semi-rigid junctional fixation techniques to achieve a gradual transition zone of forces at the proximal end of a fusion construct, so-called topping-off. An increased gradual transition zone in terms of ROM compared to pedicle screw constructs was demonstrated for sublaminar tethers, sublaminar tape, pretensioned suture loops, transverse hooks and laminar hooks. Furthermore, reduced IDP was found after the application of sublaminar tethers, suture loops, sublaminar tapes and laminar hooks. Finally, two-level prophylactic vertebroplasty resulted in a lower incidence of vertebral compression fractures in a flexion-compression experiment.
CONCLUSIONS
A variety of techniques, involving either posterior semi-rigid junctional fixation or the reinforcement of vertebral bodies, has been biomechanically assessed. However, the low number of studies and variation in study protocols hampers direct comparison of different techniques. Furthermore, determination of what constitutes an optimal gradual transition zone and its translation to clinical practice, would aid comparison and further development of different semi-rigid junctional fixation techniques. Even though biomechanics are extremely important in the development of PJK/PJF, patient-specific factors should always be taken into account on a case-by-case basis when considering to apply a semi-rigid junctional fixation technique.
Topics: Adult; Aged; Fractures, Compression; Humans; Kyphosis; Pedicle Screws; Retrospective Studies; Spinal Fractures; Spinal Fusion
PubMed: 33482379
DOI: 10.1016/j.spinee.2021.01.011 -
European Review For Medical and... Dec 2020The purpose of this study was to conduct a systematic review and meta-analysis analyzing the efficacy of zoledronic acid in improving outcomes with percutaneous... (Meta-Analysis)
Meta-Analysis
Efficacy of zoledronic acid with percutaneous kyphoplasty/vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a systematic review and meta-analysis.
OBJECTIVE
The purpose of this study was to conduct a systematic review and meta-analysis analyzing the efficacy of zoledronic acid in improving outcomes with percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) surgeries for osteoporotic vertebral compression fracture (OVCF).
MATERIALS AND METHODS
We electronically searched the databases of PubMed, Embase, ScienceDirect, CENTRAL, and Google Scholar up to 15th September 2020. All types of studies assessing the use of zoledronic acid with PKP/PVP surgeries were included.
RESULTS
Seven studies were included. On meta-analysis of data from five studies reporting bone mineral density (BMD) as g/cm2, we found a statistically significant increase in BMD in the zoledronic group (MD: 0.14; 95% CI: 0.07, 0.21, I2=97%; p<0.001). On pooled analysis of two studies reporting T scores, a similar result in favour of the zoledronic acid group was noted (MD: 0.60; 95% CI: 0.23, 0.98, I2=76%; p=0.002). We also found a statistically significant reduction in pain scores (MD: -1.23; 95% CI: -1.59, -0.86, I2=97%; p<0.00001), ODI scores (MD: -9.54; 95% CI: -12.76, -6.31, I2=95%; p<0.00001) and serum type I procollagen peptide (CTX) levels (MD: -0.19; 95% CI: -0.25, -0.12, I2=98%; p<0.00001) with zoledronic acid as compared to control. Our analysis also found a significantly reduced risk of further vertebral fractures in patients receiving zoledronic acid as compared to control (RR: 0.17; 95% CI: 0.07, 0.39, I2=0%; p<0.00001).
CONCLUSIONS
Our review indicates that the use of once-yearly zoledronic acid in the peri-operative period of PVP/PKP procedures for patients with OVCF leads to significant improvement of BMD, reduced pain scores, better ODI scores, and reduced incidence of further vertebral fractures. Our results have clinical significance as it encourages the use of zoledronic acid for such patients for better clinical outcomes.
Topics: Combined Modality Therapy; Humans; Osteoporotic Fractures; Treatment Outcome; Vertebroplasty; Zoledronic Acid
PubMed: 33336756
DOI: 10.26355/eurrev_202012_24030 -
European Spine Journal : Official... Sep 2021This study aims to determine whether outcomes following vertebroplasty with high viscosity cement are superior to low viscosity cement and non-inferior to kyphoplasty in... (Meta-Analysis)
Meta-Analysis Review
Comparison between vertebroplasty with high or low viscosity cement augmentation or kyphoplasty in cement leakage rate for patients with vertebral compression fracture: a systematic review and network meta-analysis.
PURPOSE
This study aims to determine whether outcomes following vertebroplasty with high viscosity cement are superior to low viscosity cement and non-inferior to kyphoplasty in the setting of vertebral compression fractures.
METHODS
We searched for randomized controlled trials and cohort studies assessing cement leakage rate in adult patients with VCFs who underwent vertebroplasty with high (HVCV) or low viscosity cement (LVCV) augmentation, or kyphoplasty (KP) in PubMed, Embase, Ovid, The Cochrane Library, and Web of Science from inception up to December 2019. Two authors extracted data and appraised risk of bias. We performed pairwise meta-analyses in R to compare differences between three treatments and network meta-analysis using frequentist random-effects models for indirect comparison. We used P-score to rate the overall certainty of evidence. The primary outcome was cement leakage rate.
RESULTS
Five RCTs and eight cohort studies with 840 patients and a total of 1280 vertebral bodies were included in the systematic review and network meta-analysis. Compared to LVCV, the relative risk for cement leakage following HVCV and KP was 0.42 (95% CI 0.28-0.61) and 0.83 (95% CI 0.40-1.68), respectively. Our pooled results suggested that HVCV (P-score = 0.99) was better than KP (P-score = 0.36) in cement leakage rate.
CONCLUSIONS
The present network meta-analysis demonstrated that HVCV may be associated with lower risk of cement leakage among patients with VCFs as compared to other augmentation techniques. Future prospective studies will validate the findings of this analysis and further elucidate the risk of symptomatic cement leakage.
Topics: Fractures, Compression; Humans; Kyphoplasty; Network Meta-Analysis; Prospective Studies; Spinal Fractures; Vertebroplasty; Viscosity
PubMed: 33185740
DOI: 10.1007/s00586-020-06636-9