Long-Term Loss of Alignment Following ASD Surgery in the Absence of Mechanical Complications: Aging Spine?

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.

Surgical versus conservative treatment for odontoid fractures in older people: an international prospective comparative study.

BACKGROUND: The optimal treatment for odontoid fractures in older people remains debated. Odontoid fractures are increasingly relevant to clinical practice due to ageing of the population. METHODS: An international prospective comparative study was conducted in fifteen European centres, involving patients aged ≥55 years with type II/III odontoid fractures. The surgeon and patient jointly decided on the applied treatment. Surgical and conservative treatments were compared. Primary outcomes were Neck Disability Index (NDI) improvement, fracture union and stability at 52 weeks. Secondary outcomes were Visual Analogue Scale neck pain, Likert patient-perceived recovery and EuroQol-5D-3L at 52 weeks. Subgroup analyses considered age, type II and displaced fractures. Multivariable regression analyses adjusted for age, gender and fracture characteristics. RESULTS: The study included 276 patients, of which 144 (52%) were treated surgically and 132 (48%) conservatively (mean (SD) age 77.3 (9.1) vs. 76.6 (9.7), P = 0.56). NDI improvement was largely similar between surgical and conservative treatments (mean (SE) -11 (2.4) vs. -14 (1.8), P = 0.08), as were union (86% vs. 78%, aOR 2.3, 95% CI 0.97-5.7) and stability (99% vs. 98%, aOR NA). NDI improvement did not differ between patients with union and persistent non-union (mean (SE) -13 (2.0) vs. -12 (2.8), P = 0.78). There was no difference for any of the secondary outcomes or subgroups. CONCLUSIONS: Clinical outcome and fracture healing at 52 weeks were similar between treatments. Clinical outcome and fracture union were not associated. Treatments should prioritize favourable clinical over radiological outcomes.

Spinal cord injury in high-risk complex adult spinal deformity surgery: review of incidence and outcomes from the Scoli-RISK-1 study.

STUDY DESIGN: Clinical case series. OBJECTIVE: To describe the cause, treatment and outcome of 6 cases of perioperative spinal cord injury (SCI) in high-risk adult deformity surgery. SETTING: Adult spinal deformity patients were enrolled in the multi-center Scoli-RISK-1 cohort study. METHODS: A total of 272 patients who underwent complex adult deformity surgery were enrolled in the prospective, multi-center Scoli-RISK-1 cohort study. Clinical follow up data were available up to a maximum of 2 years after index surgery. Cases of perioperative SCI were identified and an extensive case review was performed. RESULTS: Six individuals with SCI were identified from the Scoli-RISK-1 database (2.2%). Two cases occurred intraoperatively and four cases occurred postoperatively. The first case was an incomplete SCI due to a direct intraoperative insult and was treated postoperatively with Riluzole. The second SCI case was caused by a compression injury due to overcorrection of the deformity. Three cases of incomplete SCI occurred; one case of postoperative hematoma, one case of proximal junctional kyphosis (PJK) and one case of adjacent segment disc herniation. All cases of post-operative incomplete SCI were managed with revision decompression and resulted in excellent clinical recovery. One case of incomplete SCI resulted from infection and PJK. The patient's treatment was complicated by a delay in revision and the patient suffered persistent neurological deficits up to six weeks following the onset of SCI. CONCLUSION: Despite the low incidence in high-risk adult deformity surgeries, perioperative SCI can result in devastating consequences. Thus, appropriate postoperative care, follow up and timely management of SCI are essential.

Proximal junctional kyphosis after adult spinal deformity operated patients with long fusion to the pelvis. Does the type of proximal anchor matter?

PURPOSE: To assess, in a large population of Adult Spinal Deformity (ASD) patients, the true interest of varying the upper anchors as a protective measure against Proximal Junctional Kyphosis (PJK), by analyzing and comparing 2 groups of patients defined according to their proximal construct. Another objective of the study is to look for any other factors, radiological or clinical, that would affect the occurrence of the proximal failure. METHODS: Retrospective review of a prospective ASD database collected from 5 centers. Inclusion criteria were age of at least 18 years, presence of a spinal deformity with instrumentation from T12 or above to the pelvis, with minimum 2 years of follow-up. Demographic data, spinopelvic parameters, functional outcomes and complications were collected. Multiple logistic regression analysis was performed to identify the risk factors that would affect the occurrence of PJK. RESULTS: 254 patients were included. 166 in the group "screws proximally" (SP) and 88 in the group "hooks proximally" (HP). There was no difference between both groups for PJK (p = 0.967). The occurrence of PJK was rather associated with greater age and BMI, higher preoperative kyphosis, worst preoperative SRS22 and SF36 scores, greater postoperative Sagittal Vertical Axis (SVA), coronal malalignment and kyphosis. CONCLUSION: The use of proximal hooks was not effective to prevent PJK after ASD surgery, when compared to proximal screws. Worse preoperative functional outcomes and worse postoperative sagittal and also coronal malalignment were the main drivers for the occurrence of PJK regardless the type of proximal implant.

Calculation of the minimal clinically important difference in operated patients with adult spine deformity: advantages of the ROC method and significance of prevalence in threshold selection.

PURPOSE: The Minimal Clinically Important Difference (MCID) is crucial to evaluate management outcomes, but different thresholds have been obtained in different works. Part of this variability is due to measurement error and influence of the database, both essential for calculating the MCID. The aim of this study was to introduce the association of the ROC method in the anchor-based MCID calculation for ODI, SRS-22r, and SF-36, to objectively set the threshold for the anchor-based MCID in an adult spine deformity (ASD) population. METHODS: Multicentric study based on a prospective database of consecutively operated ASD patients. An anchor question was used to assess patients' quality of life after surgery. Different approaches were used to calculate the MCID and then compared: SEM (Standard Error of Measurement), MDC (Minimal Detectable Change), and anchor-based MCID with ROC method. RESULTS: 516 patients were included. Those who responded with 6 and 7 to the anchor question were considered improved. The MCID ranges obtained with the ROC method exhibited the lowest variability. Prediction error rates ranged from 31% (SRS-22r) to 41% (SF-36 MCS). The MCID ranges spanned between 12 and 15 for ODI, 0.6 and 0.73 for SRS-22r, 6.62 and 7.41 for SF-36 PCS, and between 2.69 and 5.63 for SF-36 MCS. CONCLUSION: The ROC method proposes an MCID range with error rate, and can objectively determine the threshold for distinguishing improved and non-improved patients. As the MCID correlates with the utilized database and error of measurement, each study should compute its own MCID for each PROM to allow comparison among different publications. LEVEL OF EVIDENCE: II.

Opioid Use Prior to Adult Spine Deformity Correction Surgery is Associated With Worse Pre- and Postoperative Back Pain and Prolonged Opioid Demands.

STUDY DESIGN: Prospective multicenter database post-hoc analysis. OBJECTIVES: Opioids are frequently prescribed for painful spinal conditions to provide pain relief and to allow for functional improvement, both before and after spine surgery. Amidst a current opioid epidemic, it is important for providers to understand the impact of opioid use and its relationship with patient-reported outcomes. The purpose of this study was to evaluate pre-/postoperative opioid consumption surrounding ASD and assess patient-reported pain outcomes in older patients undergoing surgery for spinal deformity. METHODS: Patients ≥60 years of age from 12 international centers undergoing spinal fusion of at least 5 levels and a minimum 2-year follow-up were included. Patient-reported outcome scores were collected using the Numeric Rating Scale for back and leg pain (NRS-B; NRS-L) at baseline and at 2 years following surgery. Opioid use, defined based on a specific question on case report forms and question 11 from the SRS-22r questionnaire, was assessed at baseline and at 2-year follow-up. RESULT: Of the 219 patients who met inclusion criteria, 179 (81.7%) had 2-year data on opioid use. The percentages of patients reporting opioid use at baseline (n = 75, 34.2%) and 2 years after surgery (n = 55, 30.7%) were similar (P = .23). However, at last follow-up 39% of baseline opioid users (Opi) were no longer taking opioids, while 14% of initial non-users (No-Opi) reported opioid use. Regional pre- and postoperative opioid use was 5.8% and 7.7% in the Asian population, 58.3% and 53.1% in the European, and 50.5% and 40.2% in North American patients, respectively. Baseline opioid users reported more preoperative back pain than the No-Opi group (7.0 vs 5.7, P = .001), while NRS-Leg pain scores were comparable (4.8 vs 4, P = .159). Similarly, at last follow-up, patients in the Opi group had greater NRS-B scores than Non-Opi patients (3.2 vs 2.3, P = .012), but no differences in NRS-Leg pain scores (2.2 vs 2.4, P = .632) were observed. CONCLUSIONS: In this study, almost one-third of surgical ASD patients were consuming opioids both pre- and postoperatively world-wide. There were marked international variations, with patients from Asia having a much lower usage rate, suggesting a cultural influence. Despite both opioid users and nonusers benefitting from surgery, preoperative opioid use was strongly associated with significantly more back pain at baseline that persisted at 2-year follow up, as well as persistent postoperative opioid needs.

Reliability of a New Digital Tool for Photographic Analysis in Quantifying Body Asymmetry in Scoliosis.

Background: Advancements in non-ionizing methods for quantifying spinal deformities are crucial for assessing and monitoring scoliosis. In this study, we analyzed the observer variability of a newly developed digital tool for quantifying body asymmetry from clinical photographs. Methods: Prospective observational multicenter study. Initially, a digital tool was developed using image analysis software, calculating quantitative measures of body asymmetry. This tool was integrated into an online platform that exports data to a database. The tool calculated 10 parameters, including angles (shoulder height, axilla height, waist height, right and left waistline angles, and their difference) and surfaces of the left and right hemitrunks (shoulders, waists, pelvises, and total). Subsequently, an online training course on the tool was conducted for twelve observers not involved in its development (six research coordinators and six spine surgeons). Finally, 15 standardized back photographs of adolescent idiopathic scoliosis patients were selected from a multicenter image bank, representing various clinical scenarios (different age, gender, curve type, BMI, and pre- and postoperative images). The 12 observers measured the photographs at two different times with a three-week interval. For the second round, the images were randomly mixed. Inter- and intra-observer variabilities of the measurements were analyzed using intraclass correlation coefficients (ICCs), and reliability was measured by the standard error of measurement (SEM). Group comparisons were made using Student's t-test. Results: The mean inter-observer ICC for the ten measurements was 0.981, the mean intra-observer ICC was 0.937, and SEM was 0.3-1.3°. The parameter with the strongest inter- and intra-observer validity was the difference in waistline angles 0.994 and 0.974, respectively, while the highest variability was found with the waist height angle 0.963 and 0.845, respectively. No test-retest differences (p > 0.05) were observed between researchers (0.948 ± 0.04) and surgeons (0.925 ± 0.05). Conclusion: We developed a new digital tool integrated into an online platform demonstrating excellent reliability and inter- and intra-observer variabilities for quantifying body asymmetry in scoliosis patients from a simple clinical photograph. The method could be used for assessing and monitoring scoliosis and body asymmetry without radiation.

Which sagittal plane assessment method is most predictive of complications after adult spinal deformity surgery?

PURPOSE: Different methods of sagittal alignment assessment compete for predicting adverse events after adult spinal deformity (ASD) surgery. We wanted to study which method provides greater benefit. METHODS: Retrospective study of 391 patients operated for ASD, with > 6 instrumented levels, fused to the pelvis, and 2 years of follow-up. Three alignment methods were analyzed 6-week postoperatively: (1) Roussouly mismatch; (2) GAP score/GAP categories; (3) T4-L1-Hip axis. Binary logistic regression generated models that best predict the following adverse events: mechanical complications (MC): in general and isolated (PJK, PJF, rod breakage); reinterventions (in general and after MC); and readmissions. ROC/AUC analysis was also implemented. In a second regression round, we added different variables that were selected on univariate analysis-demographic, surgical, and radiographic-to complete the models. RESULTS: The best predictor parameters in most models were T4-L1PA mismatch and GAP score; we could not prove a predictive ability of the Roussouly mismatch. The T4-L1PA mismatch best predicted general MC, PJK, PJK + PJF, and readmission, while the GAP score best predicted PJF and reinterventions (for MC and for any complication). However, the variance explained by these models was limited (Nagelkerke's R2 = 0.031-0.113), with odds ratios ranging from 1.070 to 1.456. ROC curves plotted an AUC between 0.57 and 0.70. Introducing additional variables (demographic, surgical, and radiographic) improved prediction in all the models (Nagelkerke's R2 = 0.082-0.329) and allowed predicting rod breakage. CONCLUSION: The T4-L1-Hip axis and GAP score show potential in predicting adverse events, surpassing the Roussouly method. Despite partial efficacy in complication anticipation, recognizing postoperative sagittal alignment as a key modifiable risk factor, the crucial need arises to integrate diverse variables, both modifiable and non-modifiable, for enhanced predictive accuracy. LEVEL OF EVIDENCE: Level IV.

What factors are associated with a better restoration of pelvic version after adult spinal deformity surgery?

INTRODUCTION: Poor restoration of pelvic version after adult spinal deformity (ASD) surgery is associated with an increased risk of mechanical complications and worse quality of life. We studied the factors linked to the improvement of postoperative pelvic version. MATERIALS AND METHODS: This is a retrospective analysis of a prospective multicenter ASD database. Selection criteria were: operated patients having preoperative severe pelvic retroversion as per GAP score (Relative Pelvic Version-RPV < - 15°); panlumbar fusions to the pelvis; 2-year follow-up. Group A comprised patients with any postoperative improvement of RPV score, and group B had no improvement. Groups were compared regarding baseline characteristics, surgical factors, and postoperative sagittal parameters. Parametric and non-parametric analyses were employed. RESULTS: 177 patients were studied, median age 67 years (61; 72.5), 83.6% female. Groups were homogeneous in baseline demographics, comorbidities, and preoperative sagittal parameters (p > 0.05). The difference in RPV improvement was 11.56º. Group A (137 patients) underwent a higher percentage of ALIF procedures (OR = 6.66; p = 0.049), and posterior osteotomies (OR = 4.96; p < 0.001) especially tricolumnar (OR = 2.31; p = 0.041). It also showed a lower percentage of TLIF procedures (OR = 0.45; p = 0.028), and posterior decompression (OR = 0.44; p = 0.024). Group A displayed better postoperative L4-S1 angle and relative lumbar lordosis (RLL), leading to improved sacral slope (and RPV), and global alignment (RSA). Group A patients had longer instrumentations (11.45 vs 10; p = 0.047) and hospitalization time (13 vs 11; p = 0.045). All postoperative sagittal parameters remained significantly better in group A through follow-up. However, differences between the groups narrowed over time. CONCLUSIONS: ALIF procedures and posterior column osteotomies improved pelvic version postoperatively, and associated better L4-S1 and lumbar lordosis restoration, indirectly improving all other sagittal parameters. However, these improvements seemed to fade during the 2-year follow-up.

Back Pain in Adolescents and Young Adults with Idiopathic Scoliosis-Identifying Factors Associated with Significant Pain-A Multivariate Logistic Regression Analysis.

(1) Background: Previous data show that patients with idiopathic scoliosis (IS) can be classified into two groups according to pain intensity. This paper aims to determine which factors can independently predict the likelihood of belonging to a high-level pain group. (2) Methods: The study used a prospective, multicenter, cross-sectional design. Two-hundred and seventy-two patients with IS (mean age 18.1 years) (females 83.5%) were included. The sample was divided into two groups. The PAIN group comprised 101 patients (37.1%) with an average NRS of 5.3. The NO-PAIN group consisted of 171 patients (62.9%) with an average NRS of 1.1. Data on various factors such as comorbidities, family history, curve magnitude, type of treatment, absenteeism, anxiety, depression, kinesiophobia, family environment, and social relationships were collected. Statistical analysis consisted of multivariate logistic regression analysis to identify independent predictors of high-level pain. (3) Results: In the final model, including modifiable and non-modifiable predictors, age (OR 1.07 (1.02-1.11)); Absenteeism (OR 3.87 (1.52-9.87)), HAD anxiety (OR 1.18 (1.09-1.29)) and an indication for surgery (OR 2.87 (1.28-6.43)) were associated with an increased risk of pain. The overall model is significant at p = 0.0001 level and correctly predicts 72.6% of the responses. (4) Conclusions: Age, an indication for surgery, anxiety, and work/school absenteeism are the variables that independently determine the risk of belonging to the high-level pain group (NRS > 3).

The Impact of Unplanned Reoperation Following Adult Spinal Deformity Surgery: A Prospective Longitudinal Cohort Study with 5-Year Follow-up.

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.

Scoliosis Research Society-22r and Ceiling Effects: Limited Capabilities for Precision-Medicine with Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Retrospective registry analysis. OBJECTIVE: To examine predictions of individual Scoliosis Research Society-22r (SRS-22r) questions one year after surgery for adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: A precision-medicine approach to AIS surgery will inform patients of the likelihood of achieving particular results from surgery, specifically individual responses to the SRS-22r questionnaire. METHODS: A multi-center AIS registry was queried for surgical AIS patients treated between 2002-2020. Preoperative data collected included standard demographic data, deformity descriptive data, and SRS-22r scores. Postoperative 1yr SRS-22r scores were modeled using ordinal logistic regression. . The highest probability was the most likely response. Model performance was examined by c-statistics, where c>.8 was considered excellent. Ceiling effects were measured by the proportion of patients reporting "5" to each question. RESULTS: 3251 patients contributed data to the study; mean age 14.4 (±2.2) yrs, female 2631 (81%), major thoracic coronal curve 53°, mean lumbar 41°. C-statistic values ranged from .6 (poor) to .8 (excellent) evidence of varied predictive capabilities. Q17 ("days off work/school", c = .84, ceiling achieved 75%) and Q15 ("financial difficulties", c = .86, ceiling achieved 82%) had the greatest predictive capabilities while Q11 ("pain medication", c=.73, ceiling achieved 67%), Q10 ("appearance", c=.72, ceiling achieved 35%), and Q19 ("attractive", c=.69, ceiling achieved 37%) performed poorly. CONCLUSION: Prediction of individual SRS-22r item responses perhaps most germane to AIS treatment was poor. Prediction of less relevant outcomes, where ceiling effects are present, was greater as the models chose "5" for all responses. These ceiling effects may limit discrimination and hamper efforts at personalized outcome predictions. LEVEL OF EVIDENCE: 3.

Primary Pelvic Anteversion: Definition, Relevance, and History After Surgery for Adult Spine Deformity.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: To identify the best definition of primary anteverted pelvis in the setting of adult spine deformity (ASD), and to investigate whether this is a pathologic setting that requires surgical correction. SUMMARY OF BACKGROUND DATA: While pelvic retroversion has been thoroughly investigated, pelvic anteversion (AP) is a far lesser discussed topic. Four different AP definitions have been proposed, and AP has been described as a normal or pathologic entity by different authors. MATERIALS AND METHODS: All patients consulting for ASD at the five participating sites were included. First, the four definitions of AP were compared with descriptive statistics (anatomic method-Pelvic Tilt <0°; Relative Pelvic Version method-RPV >5°; Roussouly method-Pelvic Incidence (PI)<50° and Sacral Slope (SS)>35°); low PT method-PT/PI <25th percentile). Second a subgroup analysis among operated AP patients with a two-year follow-up was performed. Complication rate, radiographic parameters, and clinical scores (ODI, SF-36) were compared in a multivariate analysis between patients who did and did not maintain an AP at the 2-year follow-up. RESULTS: A total of 1163 patients were available for the first analysis. The RPV method seemed to be the most appropriate to define AP in ASD patient. For the second analysis, data on 410 subjects were available, and most of them were young adults with idiopathic scoliosis that did not require pelvic fixation. AP patients who maintained an AP after ASD surgery presented comparable radiographic and clinical outcomes to the patients who presented a normoverted/retroverted pelvis after surgery. CONCLUSIONS: According to the results of the presented study, the RPV method is the most appropriate to define primary AP, which is not a pathologic condition and is most often observed in young adults with idiopathic scoliosis. Anteverted pelvis does not require direct surgical correction in this patient group.

Influence of smoking on patient-reported outcome measures (PROMs) in patients undergoing surgery for adult spinal deformity: a propensity score-matched analysis.

PURPOSE: The purpose of this study was to determine the isolated influence of smoking in patient-reported outcome measures (PROMs) for adult spinal deformity (ASD) surgery excluding known tobacco-related complications. METHODS: Retrospective analysis of a prospective multicenter ASD database. Patients operated on ASD with 2 year post-operative follow-up were included. Former smokers (non-active smokers) and patients developing mechanical or infectious complications were excluded. Changes of PROMs over time were analyzed using mixed models for repeated measures (MMRM). Propensity score matching (PSM) (1:1 ratio, caliper 0.10) was performed without replacement using optimum algorithm, tolerance ≤ 0.001, and estimated with 95% confidence interval (CI). PROMS in both groups were compared by paired t test or Wilcoxon signed-rank test. RESULTS: 692 out of 1246 surgical patients met our inclusion criteria. 153 smokers were matched with 153 non-smokers according to age, BMI, number of fused levels, and global tilt. After PSM both groups were homogeneous regarding baseline parameters, surgical data, and complications (mechanical complications and infection excluded). Smokers had worse baseline results for SRS-total, SRS-pain COMI-back, and ODI; smokers also showed worse 2-year outcomes for SRS-total, SRS-function, SRS-pain, SRS-self-image, and ODI. However, no differences between the two groups were found in the improvement from baseline to 2-year follow-up or in the timing of this improvement (MMRM). The proportion of patients reaching the minimal clinically important difference (MCID) after surgery was similar in the two groups, but the proportion of patients reaching patient acceptable symptom state (PASS) was significantly lower in smokers for SRS-Subtotal, SRS-function, and SRS-image. CONCLUSION: Even in the absence of smoking-related complications, smokers had worse PROMs at baseline and 2 years after surgery with less patients achieving PASS, but similar degrees on improvement compared to non-smokers. The proportion achieving MCID was also similar between the two cohorts.

Cost Benefit of Implementation of Risk Stratification Models for Adult Spinal Deformity Surgery.

STUDY DESIGN/SETTING: Retrospective cohort study. OBJECTIVE: Assess the extent to which defined risk factors of adverse events are drivers of cost-utility in spinal deformity (ASD) surgery. METHODS: ASD patients with 2-year (2Y) data were included. Tertiles were used to define high degrees of frailty, sagittal deformity, blood loss, and surgical time. Cost was calculated using the Pearl Diver registry and cost-utility at 2Y was compared between cohorts based on the number of risk factors present. Statistically significant differences in cost-utility by number of baseline risk factors were determined using ANOVA, followed by a generalized linear model, adjusting for clinical site and surgeon, to assess the effects of increasing risk score on overall cost-utility. RESULTS: By 2 years, 31% experienced a major complication and 23% underwent reoperation. Patients with ≤2 risk factors had significantly less major complications. Patients with 2 risk factors improved the most from baseline to 2Y in ODI. Average cost increased by $8234 per risk factor (R2 = .981). Cost-per-QALY at 2Y increased by $122,650 per risk factor (R2 = .794). Adjusted generalized linear model demonstrated a significant trend between increasing risk score and increasing cost-utility (r2 = .408, P < .001). CONCLUSIONS: The number of defined patient-specific and surgical risk factors, especially those with greater than two, were associated with increased index surgical costs and diminished cost-utility. Efforts to optimize patient physiology and minimize surgical risk would likely reduce healthcare expenditures and improve the overall cost-utility profile for ASD interventions.Level of evidence: III.

Fixed coronal malalignment (CM) in the lumbar spine independently impacts disability in adult spinal deformity (ASD) patients when considering the obeid-CM (O-CM) classification.

BACKGROUND: Postoperative flatback has been described in detail for sagittal plane considerations over the past 2 decades, and its correlations with disability are now accepted. Fixed Coronal Malalignment (CM) has been less described, and some authors report no significant association with the clinical outcome. The O-CM classification analyses CM and incorporates specific modifiers for each curve type. PURPOSE: This study evaluates the O-CM classification modifiers according to age, sagittal alignment, and patient-reported outcome measures (PROMs). Our hypothesis is that fixed CM correlates with PROMs independently from sagittal alignment and age. STUDY DESIGN: Retrospective analysis of a large adult spinal deformity (ASD) database prospectively collected. PATIENT SAMPLE: We included 747 patients from the database with long lumbar fusion (more than 3 levels), with at least two years of follow-up. Three categories of patients met the inclusion criteria (prior surgery at baseline and no revision surgery afterward, prior surgery at baseline and revision afterward, no prior surgery at baseline but fusion>3 levels and 2 years follow-up). OUTCOME MEASURES: All patients completed the Oswestry Disability Index (ODI), Short Form 36 (SF36), and Scoliosis Research Society 22 scores. METHODS: The patients were classified according to the six modifiers of the O-CM classification. Central Sacral Vertical Line (CSVL) above 2, 3, and 4 cm's impact on PROMs was analyzed. Multivariate analysis was performed on the relationship between PROMS and age, global tilt (GT), and CM modifiers. RESULTS: After multivariate analysis using age and GT as confounding factors, we found that CM independently affects PROMs starting at 2 cm offset. Disability increases linearly with CSVL. Patients classified with 2B modifiers have the worst SRS-22 total score, social life, and self-image. CONCLUSION: In a fused spine, CM independently affects disability in ASD patients. Disability increases linearly with CSVL. Despite previous reports that failed to find correlations of CM with PROMs, our study showed that fixed postoperative CM, according to O-CM classification, correlates independently from sagittal malalignment with worse PROMs. LEVEL OF EVIDENCE: III.

Adherence to the Obeid coronal malalignment classification and a residual malalignment below 20 mm can improve surgical outcomes in adult spine deformity surgery.

PURPOSE: Coronal balance is a major factor impacting the surgical outcomes in adult spinal deformity (ASD). The Obeid coronal malalignment (O-CM) classification has been proposed to improve the coronal alignment in ASD surgery. Aim of this study was to investigate whether a postoperative CM < 20 mm and adherence to the O-CM classification could improve surgical outcomes and decrease the rate of mechanical failure in a cohort of ASD patients. METHODS: Multicenter retrospective analysis of prospectively collected data on all ASD patients who underwent surgical management and had a preoperative CM > 20 mm and a 2-year follow-up. Patients were divided in two groups according to whether or not surgery had been performed in adherence to the guidelines of the O-CM classification and according to whether or not the residual CM was < 20 mm. The outcomes of interest were radiographic data, rate of mechanical complications and Patient-Reported Outcome Measures. RESULTS: At 2 years, adherence to the O-CM classification led to a lower rate of mechanical complications (40 vs. 60%). A coronal correction of the CM < 20 mm allowed for a significant improvement in SRS-22 and SF-36 scores and was associated with a 3.5 times greater odd of achieving the minimal clinical important difference for the SRS-22. CONCLUSION: Adherence to the O-CM classification could reduce the risk of mechanic complications 2 years after ASD surgery. Patients with a residual CM < 20 mm showed better functional outcomes and a 3.5 times greater odd of achieving the MCID for the SRS-22 score.

Rod angulation does not reflect sagittal curvature in adult spinal deformity surgery: comparison of lumbar lordosis and rod contouring.

STUDY DESIGN: A retrospective study. OBJECTIVE: Relationship between rod and spinal shape in the sagittal plane in adult spinal deformity (ASD) surgery. BACKGROUND: Corrective surgery for adult spinal deformity (ASD) involves the use of contoured rods to correct and modify the spinal curvatures. Adequate rod bending is crucial for achieving optimal correction. The correlation between rods and spinal shape in long constructs has not been reported previously. METHODS: We conducted a retrospective analysis of a prospective, multicenter database of patients who underwent surgery for ASD. The inclusion criteria were patients who underwent pelvic fixation and had an upper instrumented vertebra at or above T12. Pre- and post-operative standing radiographs were used to assess lumbar lordosis at the L4S1 and L1S1 levels. The angle between the tangents to the rod at the L1, L4, and S1 pedicles was calculated to determine the L4S1 and L1S1 rod lordosis. The difference between the lumbar lordosis (LL) and the rod lordosis (RL) was calculated as ΔL = LL-RL. The correlation between this difference (ΔL) and various characteristics was analyzed using descriptive and statistical methods. RESULTS: Eighty-three patients were included in the study, resulting in 166 analyzed differences (ΔL) between the rod and spinal lordosis. The values for rod lordosis were found to be both greater and lesser than those of the spine but were mostly lower. The range for total ΔL was -24 °-30.9 °, with a mean absolute ΔL of 7.8 ° for L1S1 (standard deviation (SD) = 6.0) and 9.1 ° for L4S1 (SD = 6.8). In 46% of patients, both rods had a ΔL of over 5 °, and over 60% had at least one rod with a ΔL difference of over 5 °. Factors found to be related to a higher ΔL included postoperative higher lumbar lordosis, presence of osteotomies, higher corrected degrees, older age, and thinner rods. Multivariate analysis correlated only higher postoperative L1S1 lordosis with higher ΔL. No correlation was found between a higher ΔL and sagittal imbalance. CONCLUSIONS: Variations between spinal and rod curvatures were observed despite the linear regression correlation. The shape of the rod does not seem to be predictive of the shape of the spine in the sagittal plane in ASD long-construct surgeries. Several factors, other than rod contouring, are involved in explaining the postoperative shape of the spine. The observed variation calls into question the fundamentals of the ideal rod concept.

Machine Learning for Benchmarking Adolescent Idiopathic Scoliosis Surgery Outcomes.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: The aim of this study was to design a risk-stratified benchmarking tool for adolescent idiopathic scoliosis (AIS) surgeries. SUMMARY OF BACKGROUND DATA: Machine learning (ML) is an emerging method for prediction modeling in orthopedic surgery. Benchmarking is an established method of process improvement and is an area of opportunity for ML methods. Current surgical benchmark tools often use ranks and no "gold standards" for comparisons exist. MATERIALS AND METHODS: Data from 6076 AIS surgeries were collected from a multicenter registry and divided into three datasets: encompassing surgeries performed (1) during the entire registry, (2) the past 10 years, and (3) during the last 5 years of the registry. We trained three ML regression models (baseline linear regression, gradient boosting, and eXtreme gradient boosted) on each data subset to predict each of the five outcome variables, length of stay (LOS), estimated blood loss (EBL), operative time, Scoliosis Research Society (SRS)-Pain and SRS-Self-Image. Performance was categorized as "below expected" if performing worse than one standard deviation of the mean, "as expected" if within 1 SD, and "better than expected" if better than 1 SD of the mean. RESULTS: Ensemble ML methods classified performance better than traditional regression techniques for LOS, EBL, and operative time. The best performing models for predicting LOS and EBL were trained on data collected in the last 5 years, while operative time used the entire 10-year dataset. No models were able to predict SRS-Pain or SRS-Self-Image in any useful manner. Point-precise estimates for continuous variables were subject to high average errors. CONCLUSIONS: Classification of benchmark outcomes is improved with ensemble ML techniques and may provide much needed case-adjustment for a surgeon performance program. Precise estimates of health-related quality of life scores and continuous variables were not possible, suggesting that performance classification is a better method of performance evaluation.