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Radiolucent Carbon Fiber-Reinforced Implants for Treatment of Spinal Tumors-Clinical, Radiographic, and Dosimetric Considerations.
Takayanagi, A, Siddiqi, I, Ghanchi, H, Lischalk, J, Vrionis, F, Ratliff, J, Bilsky, M, Hariri, OR
World neurosurgery. 2021;:61-70
Abstract
The management of spine tumors is multimodal and personalized to each individual patient. Patients often require radiation therapy after surgical fixation. Although titanium implants are used most commonly, they produce significant artifact, leading to decreased confidence in target-volume coverage and normal tissue sparing. Carbon-based materials have been found to have minimal effects on dose perturbation in postoperative radiation therapy and have shown biostability and biocompatibility that are comparable to titanium implants. Using the PubMed and Web of Sciences databases, we conducted a systematic review of carbon-based screw and rod fixation systems in the treatment of spinal tumors. We reviewed clinical studies regarding safety of spine fixation with carbon fiber-reinforced (CFR) implants and biomechanical studies, as well as radiation and dosimetric studies. The radiolucency of CFR-polyether ether ketone implants has the potential to benefit patients with spine tumor. Clinical studies have shown no increase in complications with implementation of CFR-polyether ether ketone implants, and these devices seem to have sufficient stiffness and pullout strength. However, further trials are necessary to determine if there is a clinically significant impact on local tumor control.
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Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial.
Ghogawala, Z, Terrin, N, Dunbar, MR, Breeze, JL, Freund, KM, Kanter, AS, Mummaneni, PV, Bisson, EF, Barker, FG, Schwartz, JS, et al
JAMA. 2021;(10):942-951
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Abstract
IMPORTANCE Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results. OBJECTIVE To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020. INTERVENTIONS Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. MAIN OUTCOMES AND MEASURES The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1- and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score. RESULTS Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, -2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%). CONCLUSIONS AND RELEVANCE Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02076113.
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Pharmacologic considerations in patients with osteoporosis undergoing lumbar interbody fusion: A systematic review.
Soldozy, S, Sarathy, D, Skaff, A, Montgomery, SR, Young, S, Desai, B, Sokolowski, JD, Buchholz, AL, Shaffrey, ME, Syed, HR
Clinical neurology and neurosurgery. 2020;:106030
Abstract
OBJECTIVE As the ageing population continues to grow, the incidence of osteoporosis continues to rise. Patients with osteoporosis are often managed pharmacologically. It is unclear the impact of these medications on osteoporotic patients requiring lumbar interbody fusion, and whether differences exist with respect to patient outcomes among the different medication classes that are often employed. In this systematic review, the authors examine studies evaluating the impact of pharmacologic therapy on osteoporotic patients undergoing lumbar interbody fusion. METHODS Using PubMed and MEDLINE databases, the authors conducted a systematic literature review for studies published between 1986 and 2020 following PRISMA guidelines. RESULTS A total of 12 articles were ultimately selected. Studies assessing bisphosphonate usage, parathyroid hormone analogues, vitamin D, or combination therapies and their impact on lumbar interbody fusion were included. CONCLUSIONS The evidence regarding bisphosphonate therapy and improved fusion rates with reduced incidence of complications is inconsistent. While some studies suggest bisphosphonates to confer added benefit, other studies suggest no such improvements despite reduction in bone turnover biomarkers. Teriparatide, on the other hand, consistently demonstrated improved fusion rates and may reduce screw loosening events. In comparison studies against bisphosphonates, teriparatide demonstrates greater potential. A single study reported vitamin D3 to increase fusion rates, although more studies are needed to validate this finding. It is important to note that these benefits are only demonstrated in single-level fusion, with multi-level fusions not being significantly enhanced by teriparatide therapy. Combination therapy with denosumab further augment fusion rates. Further prospective randomized controlled trials are necessary before standardized recommendations regarding pharmacological intervention in patients undergoing LIF can be made.
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Oxygen Embolism and Pneumocephalus After Hydrogen Peroxide Application During Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgery: A Case Report and Literature Review.
Zou, P, Yang, JS, Wang, XF, Wei, JM, Guo, H, Zhang, B, Zhang, F, Chu, L, Hao, DJ, Zhao, YT
World neurosurgery. 2020;:201-204
Abstract
BACKGROUND Hydrogen peroxide (H2O2) solution is commonly used to irrigate wounds because of its hemostatic and antiseptic properties. Previous studies suggest that H2O2 can result in toxicity to keratinocytes and fibroblasts, but complications after H2O2 application, including oxygen embolism, which is one of the most severe, have rarely been reported. CASE DESCRIPTION A 40-year-old woman was diagnosed with L4-5 lumbar spinal stenosis and subsequently underwent minimally invasive transforaminal lumbar interbody fusion treatment at another hospital. Hypotension, hypoxia, and a decrease in end-tidal carbon dioxide pressure occurred immediately after H2O2 irrigation. After the operation, she was able to be extubated but remained comatose. Postoperative computed tomography scan revealed intracranial air trapping in the right frontal lobe and multiple cerebral infarction foci. CONCLUSIONS When using a knee-prone surgical position or in cases of dural laceration, the application of undiluted H2O2 solution should be avoided, especially in a surgical wound within a closed cavity. When hypotension, hypoxia, and a decrease in end-tidal carbon dioxide pressure occur immediately after H2O2 irrigation, oxygen embolism should be strongly suspected.
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Correlation Between Different Interbody Grafts and Pseudarthrosis After Anterior Cervical Discectomy and Fusion Compared with Control Group: Systematic Review.
Iunes, EA, Barletta, EA, Barba Belsuzarri, TA, Onishi, FJ, Cavalheiro, S, Joaquim, AF
World neurosurgery. 2020;:272-279
Abstract
BACKGROUND Cervical spine degenerative disease is one of the main causes of myelopathy. Anterior cervical discectomy and fusion (ACDF) is the most common surgical procedure used to treat cervical myelopathy. Therefore, it is important to study pseudarthrosis rates after ACDF and correlate them with the graft used. METHODS We performed a systematic review to evaluate the relationship between pseudarthrosis after ACDF and the interbody graft used. RESULTS A total of 3732 patients were evaluated in 46 studies. The mean age of the included patients was 51.5 ± 4.18 years (range, 42-59.6 years). ACDF is most often perforemd as single-level surgery and the level most impaired is C5-C6. The use of titanium cages, zero profile, recombinant human bone morphogenetic protein 2, and carbon cages was seen as a protective factor for pseudarthrosis compared with the autograft group (control group); with an odds ratio of 0.29, 0.51, 0.03, and 0.3, respectively; the results were statistically relevant. The use of polyetheretherketone, poly(methyl methacrylate), and trabecular metal was a risk factor for development of pseudarthrosis compared with the control group, with an odds ratio of 1.7, 8.7, and 6.8, respectively; the results were statistically relevant. Radiologic follow-up was an important factor for the pseudarthrosis rate; paradoxically, a short follow-up (<1 year) had lower rates of pseudarthrosis and follow-up >2 years increased the chance of finding pseudarthrosis. CONCLUSIONS Different types of grafts lead to a significant difference in pseudarthrosis rates. Follow-up time is also an important factor that affects the rate of pseudarthrosis after ACDF.
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A novel scoliosis instrumentation using special superelastic nickel-titanium shape memory rods: a biomechanical analysis using a calibrated computer model and data from a clinical trial.
Wang, X, Yeung, K, Cheung, JPY, Lau, JY, Qi, W, Cheung, KM, Aubin, CE
Spine deformity. 2020;(3):369-379
Abstract
STUDY DESIGN Biomechanical analysis of scoliosis instrumentation using superelastic Nickel-titanium shape memory (SNT) rods. OBJECTIVE To compare SNT with conventional Titanium (Ti) and Cobalt-chrome (Co-Cr) rods. A clinical trial has documented comparable efficacy between two adolescent idiopathic scoliosis (AIS) cohorts instrumented using SNT versus conventional Ti rods. The shape memory and superelasticity of the SNT rod are thought to allow easy rod insertion, progressive curve correction, and correction from spinal tissue relaxation, but study is yet to be done to assess the effects of the shape memory and superelasticity. METHODS Instrumentations of AIS patients from the clinical trial were computationally simulated using SNT, Ti and Co-Cr rods (5.5 or 6 mm; 30°, 50° or 60° sagittal contouring angles; 0°, 25° or 50° coronal over-contouring angles). Curve correction, its improvement from stress relaxation in the spine, and loads in the instrumentation constructs were computed and compared. RESULTS The simulated main thoracic Cobb angles (MT) and thoracic kyphosis with the SNT rods were 4°-7° higher and 1°-2° lower than the Ti and Co-Cr rods, respectively. Bone-implant forces with Ti and Co-Cr rods were higher than the SNT rods by 84% and 130% at 18 °C and 35% and 65% at 37 °C, respectively (p < 0.001). Further corrections of the MT from the simulated stress relaxation in the spine were 4°-8° with the SNT rods versus 2°-5° with the Ti and Co-Cr rods (p < 0.001). CONCLUSION This study concurs with clinical observation that the SNT rods are easier to insert and can result in similar correction to the conventional rods. The SNT rods allow significantly lower bone-implant forces and have the ability to take advantage of post-instrumentation correction as the tissues relax.
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Radiographic and clinical outcomes of silicate-substituted calcium phosphate (SiCaP) bone grafts in spinal fusion: Systematic review and meta-analysis.
Cottrill, E, Premananthan, C, Pennington, Z, Ehresman, J, Theodore, N, Sciubba, DM, Witham, T
Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia. 2020;:353-366
Abstract
Pseudarthrosis continues to affect a nontrivial proportion of spine fusion patients. Given its ties to poorer patient outcomes and high reoperation rates, there remains great interest in interventions aimed at reducing the rates of nonunion. Recently, silicate-substituted calcium phosphate (SiCaP) bone grafts have been suggested to improve fusion rates, yet there exists no systematic review of the body of evidence for SiCaP grafts. Here, we present the first such review along with a meta-analysis of the effect of SiCaP bone grafts on fusion rates. Using the PubMed, Embase, and Web of Science databases, we queried the English-language literature for all studies examining the effect of SiCaPs on spinal fusion. Primary endpoints were: 1) radiographic fusion rate at last follow-up and 2) postoperative improvements in Visual Analog Scale (VAS) pain scores and Oswestry Disability Index (ODI) at last follow-up. Meta-analyses were performed for each endpoint using random effects. Ten articles (694 patients treated with SiCaP bone grafts) were included. Among SiCaP-treated patients, 93% achieved radiographic fusion (range: 79-100%), with comparable rates across subgroups. Meta-analysis of the three randomized controlled trials demonstrated no difference in fusion rates between SiCaP-treated patients and patients receiving grafts with recombinant human bone morphogenetic protein-2 (rhBMP-2) (OR: 1.11; p = 0.83). Patients treated with SiCaP bone grafts experienced significant improvements in VAS back pain (-3.3 points), VAS leg pain (-4.8 points), and ODI (-31.6 points) by last follow-up (p < 0.001 for each). Additional high-quality research is needed to evaluate the relative cost-effectiveness of SiCaP bone grafts in spinal fusion.
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Structural Allograft versus Polyetheretherketone Implants in Patients Undergoing Spinal Fusion Surgery: A Systematic Review and Meta-Analysis.
Fatima, N, Massaad, E, Shankar, GM, Shin, JH
World neurosurgery. 2020;:101-109
Abstract
OBJECTIVE Interbody spacers have been successfully used in spinal fusion procedures with the aim to restore disc height, provide stability, and promote bone fusion. The authors evaluated the efficacy of structural body allograft versus polyetheretherketone (PEEK) implants in patients undergoing spinal fusion surgery. METHODS A systematic review of electronic databases was conducted using different Medical Subject Headings terms from January 1970 to August 2019. Pooled and subgroup analyses were performed using random-effects and fixed-effects models based on I2 heterogeneity. RESULTS The analysis included 6640 patients (structural allograft 64% and PEEK cage 36%) from 7 comparative studies. There were no statistically significant differences in age (P = 0.27), sex (P = 0.31), body mass index (P = 0.82), and smoking status (P = 0.27) between the 2 groups. Overall, the mean follow-up was 12.9 ± 1.5 months. Pooled meta-analysis revealed that patients with structural allograft had 2.59-fold higher likelihood of fusion compared with patients with PEEK cages (odds ratio [OR] 2.59, 95% confidence interval [CI] 1.02-6.57, P = 0.05) at last follow-up evaluation. Patients with structural allograft had 61% less likelihood of pseudarthrosis (OR 0.39, 95% CI 0.15-0.98, P = 0.05) and 74% lower incidence of reoperation compared with patients with PEEK implants (OR 0.26, 95% CI 0.09-0.79, P = 0.02). Our results suggest that patients with structural allografts had a higher subsidence rate compared with patients with PEEK implants, but this was statistically insignificant (OR 1.07, 95% CI 0.45-2.53, P = 0.89). CONCLUSIONS Our results corroborate that structural allografts are highly effective in promoting bony fusion compared with PEEK implants in patients undergoing spinal fusion surgery.
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Radiological diagnostic accuracy study comparing Lenke, Bridwell, BSF, and CT-HU fusion grading scales for minimally invasive lumbar interbody fusion spine surgery and its correlation to clinical outcome.
Soriano Sánchez, JA, Soriano Solís, S, Soto García, ME, Soriano Solís, HA, Torres, BYA, Romero Rangel, JAI
Medicine. 2020;(21):e19979
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Abstract
Prospective randomized double-blinded diagnostic accuracy study about radiological grading of fusion after minimally invasive lumbar interbody fusion procedures (MI-LIFP).To determinate the intra and the inter-observer correlation between different radiological lumbar interbody fusion grading scales (RLIFGS) in patients undergoing MI-LIFP and their correlation to clinical outcome.Besides technological improvements in medical diagnosis and the many existing RLIFGS, surgical exploration continues to be the gold-standard to assess fusion in patients with radiological pseudarthrosis, with little if any research on the relationship between RLIFGS and clinical outcome.We collected data from patients undergoing MI-LIFP procedures operated by a single surgeon from 2009 to 2017, which had follow-up and CT-scan control greater than 12 months, whose clinical registers specified lumbar and radicular visual analogue scale (L and R-VAS) and Oswestry Disability Index (ODI) score preoperatively and at the end of follow-up. Interbody fusion levels were coded for blinded evaluation by three different minimally invasive spine (MIS) surgeons, using Lenke, Bridwell, BSF (Brantigan, Steffe, Fraser), and CT-HU RLIFGS. We established fusion criteria, as described in their original papers. Another independent spine surgeon blindly evaluated successful clinical outcome (SCO), defined as a significant improvement in 2 of 3 of the following issues: L-VAS, R-VAS, or ODI score at follow-up; otherwise, rated as clinical pseudarthrosis. Radiological and clinical data was coded and statistically analyzed using Student T-Test, Pearson P-Test, and ANOVA with statistical package for the social sciences 21 by another blinded researcher, positive and negative predictive values were also calculated for each RLFGS.We found a significant clinical improvement with a moderate intra-observer correlation between scales and no inter-observer or clinical correlation, with no sub-group statistically significant differences.This paper represents the first study about the diagnostic accuracy of RLFGS, we concluded that their diagnostic accuracy is pretty low to determine fusion or pseudoarthrosis based on its low correlation to clinical outcome, we recommend surgeons rely on clinical findings to decide whether a patient has clinical fusion or pseudoarthrosis based on successful clinical outcome.
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Application of polyetheretherketone cages through minimally invasive oblique retroperitoneal approach for the treatment of lumbar polymicrobial spondylodiscitis: A STROBE-compliant retrospective study with 7 cases.
Luo, W, Zhu, Y, Zhao, ZH, Ou, YS
Medicine. 2020;(17):e18594
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Despite the plethora of evidence in support of the use of structural osseous autograft in lumbar spondylodiscitis, attention has recently been turned to the addition of synthetic materials such as polyetheretherketone (PEEK) to restore anterior vertebral column support.From January 2015 to April 2017, 7 patients with lumbar polymicrobial spondylodiscitis were surgically treated with a minimally invasive oblique retroperitoneal approach to the infected focus. The patients underwent a standard lateral minimally invasive oblique retroperitoneal approach using direct lateral interbody fusion system. The PEEK cages were loaded with autologous bone graft. All the patients underwent posterior fixation with percutaneous pedicle screw instrumentation. Lumbar function was measured using Oswestry Disability Index, and pain was measured with visual analog scale. Fusion and subsidence were also recorded.The study included 5 female and 2 male patients. The median age was 58.9 years. The duration of follow-up was 31.8 ± 6.1 months (range: 24-47). All patients recovered from the infection without relapse within 24-month follow-up. Visual analog scale significantly declined from 7.57 ± 0.53 before surgery to 1.57 ± 0.53 at 12-month follow-up. Mean Oswestry Disability Index decreased from 72.14 ± 6.82 before surgery to 22.28 ± 2.13 after surgery. All patients had solid fusion at 2-year follow-up. Fusion occurred at 6 to 15 months (mean 9.8 months).The specific use of PEEK cages in lumbar polymicrobial spondylodiscitis suggests reliable outcome in terms of clinical and imaging outcomes in our limited cases.