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STUDY DESIGN Retrospective review of prospectively collected data at a single institution. OBJECTIVE To compare perioperative and clinical outcomes in morbidly obese patients who underwent minimally invasive transforaminal lumbar interbody fusion (MiTLIF). SUMMARY OF BACKGROUND DATA Obesity remains a serious public health concern. Obese patients who undergo lumbar fusion have historically thought to be at higher risk for complications and fare worse regarding quality-of-life outcomes. However, recent literature may demonstrate comparable risk and outcomes in obese patients. An increasing number of patients are categorized as morbidly obese (body mass index [BMI] ≥ 40 kg/m2). Perioperative and patient-reported outcomes (PROs) are lacking in this patient population. METHODS The authors retrospectively reviewed a prospectively collected database of all morbidly obese and non-obese patients that underwent MiTLIF between 2015 and 2018 for degenerative conditions who had minimum 1-year follow-up for outcome assessment. An inverse propensity/probability of treatment weighting was utilized to create a synthetic weighted sample in which covariates were independent of obesity designation to adjust for imbalance between groups. Generalized estimating equations (GEE) was used to estimate the association of morbid obesity and complications and 1-year PROs. RESULTS A total of 292 patients were analyzed with 234 non-obese patients and 58 morbidly obese patients. Multivariate analysis failed to demonstrate any association between morbid obesity and achieving minimal clinically important difference (MCID) for Oswestry disability index (ODI), visual analog scale (VAS), or short form-12 (SF-12) physical component score. However, morbid obesity was associated with significant decrease in odds of achieving MCID for SF-12 mental component score (P = 0.001). Increased surgery duration was significantly associated with morbid obesity (P = 0.001). Morbid obesity exhibited no statistically significant association with postoperative complications, readmission, pseudarthrosis, or adjacent segment disease (ASD). CONCLUSION Morbidly obese patients who undergo MiTLIF can achieve meaningful clinical improvement comparable to nonobese patients. Morbid obesity was associated with longer surgical times but was not associated with postoperative complications, readmission, or ASD.Level of Evidence: 3.

STUDY DESIGN Retrospective review of a multi-institutional data registry. OBJECTIVE The authors sought to determine the association between age and complications & patient-reported outcomes (PRO) in patients undergoing multilevel transforaminal interbody lumbar fusion (MTLIF). SUMMARY OF BACKGROUND DATA Elderly patients undergoing MTLIF are considered high risk. However, data on complications and PRO are lacking. Additionally, safety of multilevel lumbar fusion in the elderly remains uncertain. METHODS Patients ≥50-year-old who underwent MTLIF for degenerative lumbar spine conditions were analyzed. Ninety-day complications and PROs (baseline, 90-d, 1-y, 2-y) were queried using the MSSIC database. PROs were measured by back & leg visual analog scale (VAS), Patient-reported Outcomes Measurement Information System (PROMIS), EuroQol-5D (EQ-5D), and North American Spine Society (NASS) Patient Satisfaction Index. Univariate analyses were used to compare among elderly and complication cohorts. Generalized estimating equation (GEE) was used to identify predictors of complications and PROs. RESULTS A total of 3120 patients analyzed with 961 (31%) ≥ 70-y-o and 2159 (69%) between 50-69. A higher proportion of elderly experienced postoperative complications (P = .003) including urinary retention (P =

Retrospective analysis of prospectively collected registry data using multivariable analyses of imputed data.We sought to demonstrate that age would not be associated with complications in patients undergoing anterior cervical discectomy and fusion (ACDF).Elderly patients (≥70 yrs) undergoing ACDF are considered a higher risk for complications. However, conclusive evidence is lacking. The Michigan Spine Surgery Improvement Collaborative (MSSIC) is a quality improvement collaborative with 30 hospitals across Michigan.The study included all patients who had 1 to 4 level ACDF (September 2015-August 2019) for 90-day complications. Major and minor complications were defined using a validated classification. Multiple imputations were used to generate complete covariate datasets. Generalized estimating equation model was used to identify associations with complications using the whole cohort and elderly subgroup analyses. Bonferroni correction was used.Nine thousand one hundred thirty five patients (11.1% ≥ 70 yrs and 88.9%70 yrs) with 2266 complications were analyzed. Comparing elderly versus non-elderly, the elderly had a significantly higher rate of any complications (31.5% vs. 24.0%, P 0.001) and major complications (14.1% vs. 7.0%, P 0.001). On multivariable analysis, age was not independently associated with any complication. POD#0 ambulation and preop independent ambulation were independently associated with significantly decreased odds of any complication. In the elderly, independent preoperative ambulation was protective for any complication (odds ratio [OR] 0.53, 0.39-0.73 95% confidence interval [CI]), especially major complications (OR 0.41, 0.27-0.61 95% CI).Age was not an independent risk factor for complications in patients that underwent ACDF. In the elderly, independent preoperative ambulation was especially protective for major complications.Level of Evidence: 3.

STUDY DESIGN Retrospective analysis of prospectively collected registry data using multivariable analyses of imputed data. OBJECTIVE We sought to demonstrate that age would not be associated with complications in patients undergoing anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA Elderly patients (≥70 yrs) undergoing ACDF are considered a higher risk for complications. However, conclusive evidence is lacking. The Michigan Spine Surgery Improvement Collaborative (MSSIC) is a quality improvement collaborative with 30 hospitals across Michigan. METHODS The study included all patients who had 1 to 4 level ACDF (September 2015-August 2019) for 90-day complications. Major and minor complications were defined using a validated classification. Multiple imputations were used to generate complete covariate datasets. Generalized estimating equation model was used to identify associations with complications using the whole cohort and elderly subgroup analyses. Bonferroni correction was used. RESULTS Nine thousand one hundred thirty five patients (11.1% ≥ 70 yrs and 88.9%

Summary Background VEGF and VEGF receptor 2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer. We aimed to assess whether the addition of ramucirumab, a VEGFR-2 antagonist monoclonal antibody, to first-line chemotherapy improves outcomes in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma. Methods For this double-blind, randomised, placebo-controlled, phase 3 trial done at 126 centres in 20 countries, we recruited patients aged 18 years or older with metastatic, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function. Eligible patients were randomly assigned (1:1) with an interactive web response system to receive cisplatin (80 mg/m2, on the first day) plus capecitabine (1000 mg/m2, twice daily for 14 days), every 21 days, and either ramucirumab (8 mg/kg) or placebo on days 1 and 8, every 21 days. 5-Fluorouracil (800 mg/m2 intravenous infusion on days 1–5) was permitted in patients unable to take capecitabine. The primary endpoint was investigator-assessed progression-free survival, analysed by intention to treat in the first 508 patients. We did a sensitivity analysis of the primary endpoint, including a central review of CT scans. Overall survival was a key secondary endpoint. This study is registered with ClinicalTrials.gov, number NCT02314117. Findings Between Jan 28, 2015, and Sept 16, 2016, 645 patients were randomly assigned to receive ramucirumab plus fluoropyrimidine and cisplatin (n=326) or placebo plus fluoropyrimidine and cisplatin (n=319). Investigator-assessed progression-free survival was significantly longer in the ramucirumab group than the placebo group (hazard ratio [HR] 0·753, 95% CI 0·607–0·935, p=0·0106; median progression-free survival 5·7 months [5·5–6·5] vs 5·4 months [4·5–5·7]). A sensitivity analysis based on central independent review of the radiological images did not corroborate the investigator-assessed difference in progression-free survival (HR 0·961, 95% CI 0·768–1·203, p=0·74). There was no difference in overall survival between groups (0·962, 0·801–1·156, p=0·6757; median overall survival 11·2 months [9·9–11·9] in the ramucirumab group vs 10·7 months [9·5–11·9] in the placebo group). The most common grade 3–4 adverse events were neutropenia (85 [26%] of 323 patients in the ramucirumab group vs 85 [27%] of 315 in the placebo group), anaemia (39 [12%] vs 44 [14%]), and hypertension (32 [10%] vs 5 [2%]). The incidence of any-grade serious adverse events was 160 (50%) of 323 patients in the ramucirumab group and 149 (47%) of 315 patients in the placebo group. The most common serious adverse events were vomiting (14 [4%] in the ramucirumab group vs 21 [7%] in the placebo group) and diarrhoea (11 [3%] vs 19 [6%]). There were seven deaths in each group, either during study treatment or within 30 days of discontinuing study treatment, which were the result of treatment-related adverse events. In the ramucirumab group, these adverse events were acute kidney injury, cardiac arrest, gastric haemorrhage, peritonitis, pneumothorax, septic shock, and sudden death (n=1 of each). In the placebo group, these adverse events were cerebrovascular accident (n=1), multiple organ dysfunction syndrome (n=2), pulmonary embolism (n=2), sepsis (n=1), and small intestine perforation (n=1). Interpretation Although the primary analysis for progression-free survival was statistically significant, this outcome was not confirmed in a sensitivity analysis of progression-free survival by central independent review, and did not improve overall survival. Therefore, the addition of ramucirumab to cisplatin plus fluoropyrimidine chemotherapy is not recommended as first-line treatment for this patient population. Funding Eli Lilly and Company.

Postoperative pain control following posterior lumbar fusion continues to be challenging and often requires high doses of opioids for pain relief. The use of ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. However, recent literature suggests it may not affect fusion rates with short-term use and low doses.We sought to demonstrate noninferiority regarding fusion rates in patients who received ketorolac after undergoing minimally invasive (MIS) posterior lumbar interbody fusion. Additionally, we sought to demonstrate ketorolac's opioid-sparing effect on analgesia in the immediate postoperative period.This is a prospective, randomized, double-blinded, placebo-controlled trial. We are reporting our interim analysis.Adults with degenerative spinal conditions eligible to undergo a one to three-level MIS transforaminal lumbar interbody fusion (TLIF).Six-month and 1-year radiographic fusion as determined by Suk criteria, postoperative opioid consumption as measured by intravenous milligram morphine equivalent, length of stay, and drug-related complications. Self-reported and functional measures include validated visual analog scale, short-form 12, and Oswestry Disability Index.A double-blinded, randomized placebo-controlled, noninferiority trial of patients undergoing 1- to 3-level MIS TLIF was performed with bone morphogenetic protein (BMP). Patients were randomized to receive a 48-hour scheduled treatment of either intravenous ketorolac (15 mg every 6 hours) or saline in addition to a standardized pain regimen. The primary outcome was fusion. Secondary outcomes included 48-hour and total postoperative opioid use demonstrated as milligram morphine equivalence, pain scores, length of stay (LOS), and quality-of-life outcomes. Univariate analyses were performed. The present study provides results from a planned interim analysis.Two hundred and forty-six patients were analyzed per protocol. Patient characteristics were comparable between the groups. There was no significant difference in 1-year fusion rates between the two treatments (p=.53). The difference in proportion of solid fusion between the ketorolac and placebo groups did not reach inferiority (p=.072, 95% confidence interval, -.07 to .21). There was a significant reduction in total/48-hour mean opioid consumption (p.001) and LOS (p=.001) for the ketorolac group while demonstrating equivalent mean pain scores in 48 hours postoperative (p=.20). There was no significant difference in rates of perioperative complications.Short-term use of low-dose ketorolac in patients who have undergone MIS TLIF with BMP demonstrated noninferior fusion rates. Ketorolac safely demonstrated a significant reduction in postoperative opioid use and LOS while maintaining equivalent postoperative pain control.

BACKGROUND CONTEXT Postoperative pain control following posterior lumbar fusion continues to be challenging and often requires high doses of opioids for pain relief. The use of ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. However, recent literature suggests it may not affect fusion rates with short-term use and low doses. PURPOSE We sought to demonstrate non-inferiority regarding fusion rates in patients who received ketorolac after undergoing minimally invasive (MIS) posterior lumbar fusions. Additionally, we sought to demonstrate ketorolac's opioid-sparing effect on analgesia in the immediate postoperative period. STUDY DESIGN/SETTING This is a prospective, randomized, double-blinded, placebo-controlled trial. We are reporting our interim analysis. PATIENT SAMPLE Adults with degenerative spinal conditions eligible to undergo a 1- to 3-level minimally invasive lumbar spinal fusion. OUTCOME MEASURES Six-month and 1-year radiographic fusion as determined by Suk criteria, postoperative opioid consumption as measured by intravenous milligram morphine equivalent (MME), length of stay (LOS), and drug-related complications. Self-reported and functional measures include validated visual analog scale (VAS), short-form 12 (SF-12), and Oswestry Disability Index (ODI). METHODS A double-blinded, randomized placebo-controlled, non-inferiority trial of patients undergoing 1- to 3-level minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) was performed. Patients were randomized to receive a 48-hour scheduled treatment of either intravenous ketorolac (15mg every 6 hours) or saline in addition to a standardized pain regimen. The primary outcome was fusion. Secondary outcomes included 48-hour and total postoperative opioid use demonstrated as MME, pain scores, LOS, and quality-of-life (QoL) outcomes. Univariate and multivariate analyses were performed. The present study provides results from a planned interim analysis. RESULTS Two hundred and forty-six patients were analyzed per protocol. Patient characteristics were comparable between the groups. There was no significant difference in 1-year fusion rates between the two treatments (p=.53). The difference in proportion for solid fusion between the ketorolac and placebo groups did not reach inferiority (.072, 95% CI, -.07-.21). There was a significant reduction in total/48-hour mean opioid consumption (p CONCLUSION Short-term use of low-dose ketorolac in patients who have undergone MIS lumbar fusion demonstrated favorable results suggesting non-inferior fusion rates. Ketorolac safely demonstrated a significant reduction in postoperative opioid use and LOS while maintaining equivalent postoperative pain control. FDA DEVICE/DRUG STATUS Not applicable.

Study Design: Retrospective consecutive case series. Objective: The objective of this case series was to demonstrate the safety of a modified transfacet pedicle–sparing decompression and instrumented fusion in patients with thoracic disc herniations (TDHs). Methods: Consecutive patients undergoing operative management of TDH from July 2007 to December 2011 using a posterior unilateral modified transfacet pedicle–sparing approach were identified. All patients underwent open or minimally invasive modified transfacet pedicle–sparing discectomy and segmental instrumentation with interbody fusion, performed by four different surgeons. Pre- and postoperative visual analog scale (VAS) pain scores, Nurick grade, and American Spinal Injury Association Impairment Scale (AIS) were analyzed from a retrospective chart review. Estimated blood loss and complications were also obtained. Results: Fifty-one patients were included that had operations for TDH. Thirty-nine patients had single level decompression and 12 had multilevel decompression. The total number of levels operated on was 64. Five patients were treated with minimally invasive surgery. A herniated disc level of T11-12 (n = 17) was treated most often. One major complication of epidural hematoma occurred. Minor complications such as malpositioned hardware, postoperative hematoma, wound infection, pseudoarthrosis, and pulmonary complications occurred in a few patients. Follow-up ranged from 1 to 46 months with 1 patient lost to follow-up. From preoperative to final postoperative: mean VAS scores improved from 8.31 to 4.05, AIS in all patients remained stable or improved, and Nurick scores improved from 3 to 2.6 on average. No intraoperative or permanent neurological deficit occurred. Conclusion: In our surgical series, 51 consecutive patients underwent modified transfacet pedicle–sparing approach to TDHs and experienced improvement of functional status as well as improvement of objective pain scales with no neurological complications. The posterior unilateral modified transfacet pedicle–sparing decompression and instrumented fusion approach to the thoracic spine is a safe and reproducible procedure for the treatment of TDHs.

IntroductionKetorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery. However, the literature addressing its use in spinal fusions is highly variable in both its effectiveness and complications, such as pseudarthrosis. Recent literature postulates that ketorolac may not affect fusion rates and large randomised controlled trials are needed to demonstrate ketorolac as a safe and effective adjuvant treatment to opioids for postoperative pain control.Methods and analysisThis is a multihospital, prospective, double-blinded, randomised placebo-controlled trial. Data concerning fusion rates, postoperative opioid use, pain scores, length of stay will be recorded with the aim of demonstrating that the use of ketorolac does not decrease thoracolumbar spinal fusion rates while identifying possible adverse events related to short-term minimal effective dose compared with placebo. Additionally, this investigation aims to demonstrate a decrease in postoperative opioid use demonstrated by a decrease in morphine equivalence while showing equivalent postoperative pain control and decrease the average length of stay.Ethics and disseminationEthical approval was obtained at all participating hospitals by the institutional review board. The results of this study will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03278691.

This article presents the vision `A Concept and System Architecture for IT-Based Lifelong Learning'. The paper as a whole summarises the results of a project funded by the Ministry of Industrial Development of Sabah, Malaysia. The goal of the project was to develop a concept for IT-based Lifelong Learning including a case study based on a specific curriculum and considerations about potential business opportunities. Within the project experienced international researchers in the area of IT-based learning and training worked together in two preparation workshops and a final workshop about `IT-Based Lifelong Learning Systems' in Sabah, Malaysia, in March, 1997. The paper is based on the experiences of the authors from the International Network of Institutes for Computer Graphics (INI-GraphicsNet 2 ) in several R&D projects and has been reviewed, refined and revised by a group of local experts as well as several well renowned international experts and local/regional experts ( Appendix A ). The editors of the vision paper are J. L. Encarnacao, M. Mengel and P. R. Bono. Section 1 presents first the motivation of the paper, then international trends and the vision of an IT-based learning infrastructure integrating all parts of the society. The resulting goal, advising on how to go forward into the direction of the named vision, finalizes the Introduction. Section 2 discusses the various roles of an IT-based learning environment and identifies user needs and requirements. Section 3 proposes concepts for, and an architecture of, a learning system for IT-based lifelong learning. Section 4 focuses on the Technical Implementation of the proposed system architecture. A generic approach for IT-based lifelong learning based on a conceptual system architecture is presented. This approach distinguishes between the services and environment of such a system. Firstly, the services offered by the system are described in more detail. These services include data management, cooperation and security services that are role- and activity-independent and have to be adapted to the underlying technical resources. Then the environments, including authoring, delivery and administration environments realizing a specific functionality for a specific user role and activity, are presented. The section is completed by addressing issues for a concrete implementation including implementation guidelines and assessment criteria and an implementation strategy to reduce the technological risk is suggested. Section 5 describes a case study which will be initiated cooperatively by leading experts from the fields of visualization, multimedia, interaction and communication. This case study provides a narrow vertical section through the layers of the approach to lifelong learning both to demonstrate its effectiveness and to permit the evaluation of its efficiency. Section 6 outlines a plan for the realization of the project as a whole. A glossary and bibliography complete the main part of the paper. In Appendix B (Recommendations), Appendix C (Project References), and Appendix D (Open Issues), are presented.

The number of facilities across the country "implementing" some "flavor" of the SIGGRAPH/GSPC Core System "strawman standard" ["Status Report of the Graphic Standards Planning Committee of ACM/SIGGRAPH", Computer Graphics, Vol. II, Number 3, Fall 1977] has reached approximately fifteen. To keep the graphics community informed about the reception and usage of the Core System, we have collected descriptions of the status of each facility, as reproduced here. An Implementor's Forum will occur in November '78, which we hope will provide both significant interfacility communication and some concensus among implementors on such topics as FORTRAN '77 compatible calling sequences for Core System routines, the structure of intermediate (neutral, pseudo-, etc.) display files, and techniques and algorithms for viewing, clipping, picking, and echoing.

Several members of the American National Standards Institute (ANSI) Technical Committee X3H3 on Computer Graphics will present current issues of the standardization effort. The focus of the discussion will be the technical content of these issues. The purpose of the panel discussion is to encourage technical dialogue between X3H3 participants and interested parties outside of X3H3. To that end, the presentations will describe major areas of concern, avenues of attack, and proposed solutions.

Two status reports will be presented. The first report describes the activities of Working Group 2 (Computer Graphics) of the International Standards Organization Subcommittee on Programming Languages (ISO TC97/SC5/WG2). Actions taken in recent WG2 meetings in October, 1979, and June, 1980, will be covered. Significant proposals being examined by WG2 include GKS, a German-designed 2D graphics package derived from the SIGGRAPH GSPC Core System proposals, and Videotex, a Canadian-designed protocol text communication that includes geometrically coded picture images. The second status report describes the recent activities of the American National Standards Institute (ANSI) Technical Committee X3H3, Computer Graphics. This includes the committee status, international activities, key technical issues, and future plans.

This panel session is intended to present recent technical developments in the efforts to standardize computer graphics. Several alternative approaches to 3-D standards will be presented and contrasted. The Virtual Device Metafile will be presented, as well as a proposed binding of the GKS standard to Fortran. Presentations will be made by the following individuals: Dr. Peter Bono is the chairman of the ANSI X3H3 technical committee developing standards for Computer Graphics Programming Languages, and will present the current status of the effort to adopt 2-D GKS as an International Standard and as an American National Standard. Tom Wright will be available to respond to questions about the Programmer's Minimal Interface to Graphics (PMIG) proposal, and its current status as a new output level of the draft proposed American National Standard (dpANS) GKS. Mark Skall will present a proposed binding of GKS to the Fortran Language. Mr. Skall will also discuss progress in the field of formal specification of graphics standards and developments in the establishment of conformance/certification procedures for implementations of GKS. Theodore Reed will present the technical content of the Virtual Device Metafile (VDM) draft proposed American National Standard. Discussed will be the relationship of the VDM to GKS and to the yet to be proposed Virtual Device Interface. Specific functionality of the VDM will be discussed as will specific bindings of that functionality as a character set extension and as a binary format. David Shuey will present an overview of the Programmer's Hierarchical Interface to Graphics (PHIGS) proposal. The PHIGS proposal is intended to support hierarchical structuring of graphics data, in contrast to the Core System and GKS proposals. This type of structure addresses highly interactive graphics applications which need to modify the presentation and the relationships within graphics data. Richard Ehlers will present the attribute model of the PHIGS proposal and explore the relationship of attribute model to structured graphics data bases. Also, Mr. Ehlers will discuss the viewing and transformation implications of structured graphics data bases using examples. Gunter Enderle is a member of the West German delegation to the International Standards Organization (ISO) Working Group on Computer Graphics. Herr Enderle will be discussing ISO proposals for the extension of the GKS standard from 2-D to 3-D functionality. Several such proposals have been made, including one by DIN (the official standards making body of the German Federal Republic) and a Norwegian proposal called IDIGS. Elaine Sonderegger was a member of the ACM SIGGRAPH Graphics Standards Planning Committee, and is the ACM SIGGRAPH representative to ANSI X3H3. Ms. Sonderegger will contrast the 3-D functionality of the Core System, IDIGS, DIN proposed 3-D extensions, and PHIGS.