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Background Context: Mechanical complications (MC) are frequently linked to suboptimal postoperative alignment and represent a primary driver of revision surgery in the context of adult spinal deformity (ASD). However, it's worth noting that even among those deemed "well aligned," the risk of experiencing MCs persists, hinting at the potential influence of factors beyond alignment., Purpose: The aim was to assess the incidence of MCs among well-aligned patients and delving into the relevant risk factors and surgical outcomes that come into play within this specific subgroup., Study Design/setting: A retrospective analysis was conducted using data from a prospective multicenter database dedicated to ASD., Patient Sample: The study focused on patients aged 55 years or older, who had a minimum follow-up period of 2 years, and exhibited a Global Alignment and Proportion (GAP) score of 2 points or less (excluding age) within 6 weeks of their index surgery., Outcome Measures: Mechanical complications such as rod fractures, pseudarthrosis, or junctional kyphosis or failure., Methods: Patients who developed mechanical complications were identified. Comparative analyses were performed, encompassing both continuous and categorical variables. Furthermore, binary logistic regression tests were employed to pinpoint risk factors, and ROC curves were used to determine the optimal threshold values for these variables., Results: A total of 83 patients met the inclusion criteria for this study, with a mean age of 66 years. On average, they had 10 instrumented levels, and 77% of them had fusion extending to the pelvis. Additionally, 27% of the patients had undergone 3-column osteotomies (3-CO). Among them, 33 patients (40%) experienced at least 1 MC during an average follow-up period of 4 years, which included 14 cases of proximal junctional kyphosis (PJK) and 20 cases of nonunion or rod breakage. 15 patients (18%) required revision surgery specifically for MC. In univariable analyses, patients who developed MC were characterized by higher body weight, poorer baseline general health (as indicated by worse SF-36 scores), and less favorable preoperative coronal and sagittal alignment. They also had longer hospital stays, a greater number of instrumented levels, and achieved less favorable postoperative coronal and sagittal alignment. Interestingly, factors such as 3-column osteotomies, postoperative bracing, and the addition of an anterior approach did not significantly alter the risk of MC in well-aligned ASD patients. Binary regression models revealed that independent risk factors for MC included the residual coronal lumbosacral curve, the number of instrumented levels, and relative spinopelvic alignment (RSA). ROC curves identified an optimal threshold of a residual lumbosacral curve of ≤4° and RSA of ≤3°. Moreover, the rate of MCs showed a stepwise increase within the GAP-Proportioned group, with rates of 31% for GAP=0, 54% for GAP=1, and 75% for GAP=2, with RSA emerging as the most influential parameter. Lastly, patients with MC exhibited poorer functional and radiological outcomes at their last follow-up assessment., Conclusions: The rate of MCs remains elevated in sagittally "well-aligned" ASD patients that can be attributed to suboptimal residual sagittal and coronal malalignment, which in turn leads to poorer functional outcomes. This study reaffirms the multifaceted nature of MCs and underscores the significance of achieving impeccable postoperative alignment, particularly in the presence of additional risk factors such as extensive surgical correction, a high lever arm (involving instrumented vertebrae), excessive body weight, and frailty (as indicated by SF-36 scores)., Competing Interests: Declarations of competing interests One or more of the authors declare financial or professional relationships on ICMJE-TSJ disclosure forms., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Study Design: Retrospective analysis of a prospective multicenter Adult Spinal Deformity (ASD) registry., Objective: Assess whether spinal alignment deteriorates post-surgery in absence of mechanical complications and evaluate the long-term outcomes of ASD surgery over a five-year period., Summary of Background Data: ASD is prevalent among older adults, leading to significant pain and disability. Surgical intervention, although increasingly popular, is associated with complications, high costs, and uncertain long-term outcomes beyond two years. Mechanical failure and alignment loss often necessitate revision surgeries, but the natural progression of spinal alignment post-surgery without complications remains unclear., Methods: Clinical and radiological data were analyzed from surgical patients in a multicenter ASD registry who maintained alignment within the instrumented region and completed a 5-year follow-up. The study evaluated patient demographics, surgical details, radiological parameters, and quality of life (QoL) outcomes. Sub-analyses were conducted to compare patients with different initial postoperative alignments and fixation levels., Results: The study included 79 patients (83.5% women, average age 61.9 years) with a mean of 10.7 fused levels. Of these, 29.1% underwent three-column osteotomies (3CO), and 88.6% had a posterior-only approach. While 65% showed favorable alignment at 6 weeks post-surgery, there was a progressive deterioration in global sagittal alignment (Global Tilt/RSA) and thoracic kyphosis over five years (P<0.05), along with increased pelvic compensation (PT SS/RPV). These changes did not correlate with worsening Health-Related Quality of Life outcomes (P>0.05). Older age was linked to greater progression in T2-T12 kyphosis, and osteoporosis was associated with increased SVA and RPV. Optimal immediate postoperative sagittal alignment did not prevent this "aging effect.", Conclusions: ASD surgery and achieving ideal postoperative alignment do not prevent the ongoing "aging" of the non-instrumented spine. Both thoracic and global sagittal alignments deteriorate over time. Although no functional decline has been observed, the implications of these changes for surgical planning remain uncertain., Competing Interests: Conflict of Interests: The European Spine Study Group receives funding support from DePuy Synthes and Medtronic., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The long-term impact of reoperations following adult spinal deformity (ASD) surgery is still poorly understood. Our aim was to identify the relationship between unplanned reoperation and health-related quality of life (HRQoL) gain at 2 and 5 years of follow-up., Methods: We included patients enrolled in a prospective ASD database who underwent surgery ≥5 years prior to the start of the study and who had 2 years of follow-up data. Adverse events (AEs) leading to an unplanned reoperation, the time of reoperation occurrence, invasiveness (blood loss, surgical time, hospital stay), and AE resolution were assessed. HRQoL was measured with use of the Oswestry Disability Index, Scoliosis Research Society-22, and Short Form-36. Linear models controlling for baseline data and index surgery characteristics were utilized to assess the relationships between HRQoL gain at 2 and 5-year follow-up and the number and invasiveness of reoperations. The association between 5-year HRQoL gain and the time of occurrence of the unplanned reoperation and that between 5-year HRQoL gain and AE resolution were also investigated., Results: Of 361 eligible patients, 316 (87.5%) with 2-year follow-up data met the inclusion criteria and 258 (71.5%) had 5-year follow-up data. At the 2-year follow-up, 96 patients (30.4%) had a total of 165 unplanned reoperations (1.72 per patient). At the 5-year follow-up, 73 patients (28.3%) had a total of 117 unplanned reoperations (1.60 per patient). The most common cause of reoperations was mechanical complications (64.9%), followed by surgical site infections (15.7%). At the 5-year follow-up, the AE that led to reoperation was resolved in 67 patients (91.8%). Reoperation invasiveness was not associated with 5-year HRQoL scores. The number of reoperations was associated with lesser HRQoL gain at 5 years for all HRQoL measures. The mean associated reduction in HRQoL gain per unplanned reoperation was 41% (range, 19% to 66%). Reoperations resulting in no resolution of the AE or resolution with sequelae had a greater impact on 5-year follow-up HRQoL scores than reoperations resulting in resolution of the AE., Conclusions: A postoperative, unplanned reoperation following ASD surgery was associated with lesser gain in HRQoL at 5 years of follow-up. The association did not diminish over time and was affected by the number, but not the magnitude, of reoperations. Resolution of the associated AE reduced the impact of the unplanned reoperation., Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence., Competing Interests: Disclosure: This study was funded in part by DePuy Spine Synthes, Medtronic, and NuVasive research grants. The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/H872)., (Copyright © 2024 by The Journal of Bone and Joint Surgery, Incorporated.)

Objective: To determine nocebo response in ADHD, identify covariates modifying nocebo response, and study the relationship between nocebo response and drug safety., Method: Systematic review of randomized, double-blind, placebo-controlled clinical trials (RCT) investigating the efficacy and safety of pharmacological interventions for ADHD patients. The influence of covariates was studied using meta-regression., Results: A total of 105 studies with 8,743 patients in placebo arms were included. Slightly over half (55.5%) of the patients experienced adverse events (AE) while receiving placebo. Nocebo response was associated positively with age, treatment length and method for collecting AEs. Studies with the largest nocebo response showcased the greatest drug response and the best outcome for drug safety., Conclusion: Nocebo response in ADHD RCTs is remarkable, showing a positive relationship with drug response, and a negative relationship with drug safety.