Sagittal realignment: surgical restoration of the global alignment and proportion score parameters: a subgroup analysis. What are the consequences of failing to realign?

INTRODUCTION: The Global Alignment and Proportion (GAP) score incorporates three domains directly modified with surgery (relative pelvic version-RPV, relative lumbar lordosis-RLL, lumbar distribution index-LDI) and one indirectly restored (relative spinopelvic alignment-RSA). We analyzed our surgical realignment performance and the consequences of domain-specific realignment failure on mechanical complications and PROMs. MATERIALS AND METHODS: From an adult spinal deformity prospective multicenter database, we selected patients: fused to pelvis, upper instrumented vertebra at or above L1, and 2 years of follow-up. Descriptive, univariate and multivariate analyses were employed. RESULTS: The sample included 333 patients. RLL-6w showed the highest success rate (58.3% aligned), but 16.5% of patients were classified in the "Severe hypolordosis" and "Hyperlordosis" subgroups. RPV-6w was the most challenging to realign, with 51.6% moderate or severe retroversion. Regarding RSA-6w, 21.9% had severe positive malalignment. Correct alignment of RPV-6w (p = 0.025) and RSA-6w (p = 0.002) proved to be protective factors against the development of mechanical complications. Severe pelvic retroversion (p = 0.026) and severe positive malalignment (p = 0.007) were risk factors for mechanical complications. RSA-6w "Severe positive malalignment" was associated with less improvement in PROMs: ∆ODI (8.83 vs 17.2; p = 0.011), ∆SRS-22 total (0.54 vs 0.87; p = 0.007), and ∆SF-36PCS (3.47 vs 7.76; p = 0.04); MCID for ODI (37.0 vs 55.5%; p = 0.023), and SRS-22 (40.8 vs 60.1%; p = 0.015); and PASS for ODI (17.6 vs 31.7%; p = 0.047). CONCLUSIONS: RPV was the most underperformed modifiable parameter. Severe pelvic retroversion and severe positive malalignment influenced the occurrence of mechanical complications. Severe positive malalignment affected PROMs improvement.

Revision surgery following long lumbopelvic constructs for adult spinal deformity: prospective experience from two dedicated databases.

PURPOSE: Pan Lumbar Arthodesis (PLA) are often required for Adult Spinal Deformity (ASD) correction, reducing significantly the compensatory capacity in case of postoperative sagittal malalignment. Few papers have investigated outcomes and complications in this vulnerable subset of patients. The objective of this study was to assess revision surgery rate for PLA in ASD, its risk factors and impact on clinical outcomes. METHODS: Retrospective multicenter review of prospective ASD data from 7 hospitals covering Europe and Asia. ASD patients included in two prospective databases having a posterior instrumentation spanning the whole lumbar region with more than 2-years of follow-up were reviewed. Demographic, surgical, radiographic parameters and Health-Related Quality of Life (HRQoL) scores were analyzed. Univariate and multivariate regression models analyzed risk factors for revision surgery as well as surgical outcomes. Patients with Early versus Late and PJK versus Non-PJK mechanical complications were also compared. RESULTS: Out of 1359 ASD patients included in the database 589 (43%) had a PLA and 357 reached 2-years mark. They were analyzed and compared to non-PLA patients. Average age was 67 and 82% were females. 100 Patients (28.1%) needed 114 revision surgeries (75.4% for mechanical failures). Revised patients were more likely to have a nerve system disorder, higher BMI and worst immediate postoperative alignment (as measured by GAP Parameters). These risk factors were also associated with earlier mechanical complications and PJK. Deformity and HRQoL parameters were comparable at baseline. Non-revised patients had significantly better clinical outcomes at 2-years (SRS 22 scores, ODI, Back pain). Multivariate analysis could identify nerve system disorder (OR 4.8; CI 1.8-12.6; p = 0.001), postoperative sagittal alignment (GAP Score) and high BMI (OR 1.07; CI 1.01-1.13; p = 0.004) as independent risk factors for revisions. CONCLUSIONS: Revision surgery due to mechanical failures is relatively common after PLA leading to worse clinical outcomes. Prevention strategies should focus on individualized restoration of sagittal alignment and better weight control to decrease stress on these rigid constructs in non-compliant spines. Nerve system disorders independently increase revision risk in PLA. LEVEL OF EVIDENCE II: Prognosis.

Does the use of postoperative brace help preventing mechanical complications following adult deformity surgery?

PURPOSE: There is scarce information regarding the effectiveness of postoperative braces in decreasing mechanical complications and reinterventions following adult deformity surgery. METHODS: Retrospective matched cohort study from a prospective adult deformity multicenter database. We selected operated patients, fused to the pelvis, > 6 instrumented levels, and minimum 2 year follow-up. Three hundred and eighty patients were separated into two groups (Brace-3 months TLSO-vs No Brace) and then matched controlling for age, gender and frailty. We studied demographic, intraoperative, and postoperative spinopelvic parameters. Both groups were compared regarding complications and reinterventions in the first 2 postoperative years, using univariate and multivariate logistic regression analysis. RESULTS: We finally analyzed 359 matched patients, mean age of 65.3 ± 8.9 years, frailty-index (0.43 ± 0.15), and mostly females (84%). 224 patients wore a postoperative brace (B) and 135 didn't (NoB). They showed no difference in intraoperative variables and postoperative spinopelvic alignment. They differed (P < 0.05) in: Pelvic incidence (B:58° ± 13 vs NoB:54.5° ± 13); BMI (B:25.8 ± 4 vs NoB:27.4 ± 5); upper instrumented vertebra (B:81.7% T8-L1 vs NoB:72.6% T8-L1), and the use of multiple rods (B:47.3% vs NoB:18.5%). Univariate analysis showed a higher rate of mechanical complications and reinterventions when not using a brace. As well as higher NRS-back and leg pain at 6 weeks. However, multivariate analysis selected the use of multiple rods as the only independent factor protecting against mechanical complications (OR: 0.38; CI 95% 0.22-0.64) and reinterventions (OR: 0.41; CI 95% 0.216-0.783). CONCLUSION: After controlling for potential confounders, our study could not identify the protective effect of postoperative braces preventing mechanical complications and reinterventions in the first two postoperative years.

A 5-year follow-up of the effect of corrective surgery in young adults with idiopathic scoliosis.

PURPOSE: The purpose of this study was to determine mid-long-term outcomes (5 years) following surgery for young adult idiopathic scoliosis (YAdIS). METHODS: This is a retrospective review of a prospective, multicenter adult deformity database including patients operated on idiopathic scoliosis by a single posterior approach, age at surgery between 19 and 29 (considered young adults), and 5-year follow-up. Demographic, radiographic and PROMS were analyzed preoperatively, at 2 years and at final follow-up. RESULTS: Forty-two patients were included. Mean preoperative major curve angle was 59.65 ± 18.94. Main coronal curve initial correction was 56.38%, with 6% loss at 5 years. From baseline to 5 years after surgery, there was improvement in all PROMs (P < 0.004)-especially self-image-, except NRS-leg pain. This improvement was present at 6 months for all PROMs except for functional outcomes (SRS-Function and ODI) in which the improvement took place between 6 months and 2 years. In the 2- to 5-year follow-up period, no significant changes were seen in any PROMs. The percentage of patients reaching MCID from baseline at 5 years was: 75% for SRS-image, 45% for SRS-pain, 47.5% for SRS-function, 51.3% for SRS-mental, 42.5% for SRS-total and 15.4% for ODI. Patients reaching PASS at 5 years were: 88.1% for SRS-image, 81% for SRS-pain, 92.9% for SRS-function, 57.1% for SRS-mental, 88.1% for SRS-total, 92.7% for ODI and 69% for NRS pain. 11 minor and 4 major complications were identified. CONCLUSION: YAdIS surgery resulted in an early and significant improvement in PROMs, especially for self-image, significantly reaching MCID and PASS thresholds. These results were maintained during long-term (5-year) follow-up.

Validation of Adult Spinal Deformity Surgical Outcome Prediction Tools in Adult Symptomatic Lumbar Scoliosis.

STUDY DESIGN: A post hoc analysis. OBJECTIVE: Advances in machine learning (ML) have led to tools offering individualized outcome predictions for adult spinal deformity (ASD). Our objective is to examine the properties of these ASD models in a cohort of adult symptomatic lumbar scoliosis (ASLS) patients. SUMMARY OF BACKGROUND DATA: ML algorithms produce patient-specific probabilities of outcomes, including major complication (MC), reoperation (RO), and readmission (RA) in ASD. External validation of these models is needed. METHODS: Thirty-nine predictive factors (12 demographic, 9 radiographic, 4 health-related quality of life, 14 surgical) were retrieved and entered into web-based prediction models for MC, unplanned RO, and hospital RA. Calculated probabilities were compared with actual event rates. Discrimination and calibration were analyzed using receiver operative characteristic area under the curve (where 0.5=chance, 1=perfect) and calibration curves (Brier scores, where 0.25=chance, 0=perfect). Ninety-five percent confidence intervals are reported. RESULTS: A total of 169 of 187 (90%) surgical patients completed 2-year follow up. The observed rate of MCs was 41.4% with model predictions ranging from 13% to 68% (mean: 38.7%). RO was 20.7% with model predictions ranging from 9% to 54% (mean: 30.1%). Hospital RA was 17.2% with model predictions ranging from 13% to 50% (mean: 28.5%). Model classification for all three outcome measures was better than chance for all [area under the curve=MC 0.6 (0.5-0.7), RA 0.6 (0.5-0.7), RO 0.6 (0.5-0.7)]. Calibration was better than chance for all, though best for RA and RO (Brier Score=MC 0.22, RA 0.16, RO 0.17). CONCLUSIONS: ASD prediction models for MC, RA, and RO performed better than chance in a cohort of adult lumbar scoliosis patients, though the homogeneity of ASLS affected calibration and accuracy. Optimization of models require samples with the breadth of outcomes (0%-100%), supporting the need for continued data collection as personalized prediction models may improve decision-making for the patient and surgeon alike.

Association between sagittal alignment and loads at the adjacent segment in the fused spine: a combined clinical and musculoskeletal modeling study of 205 patients with adult spinal deformity.

PURPOSE: Sagittal malalignment is a risk factor for mechanical complications after surgery for adult spinal deformity (ASD). Spinal loads, modulated by sagittal alignment, may explain this relationship. The aims of this study were to investigate the relationships between: (1) postoperative changes in loads at the proximal segment and realignment, and (2) absolute postoperative loads and postoperative alignment measures. METHODS: A previously validated musculoskeletal model of the whole spine was applied to study a clinical sample of 205 patients with ASD. Based on clinical and radiographic data, pre-and postoperative patient-specific alignments were simulated to predict loads at the proximal segment adjacent to the spinal fusion. RESULTS: Weak-to-moderate associations were found between pre-to-postop changes in lumbar lordosis, LL (r = - 0.23, r = - 0.43; p < 0.001), global tilt, GT (r = 0.26, r = 0.38; p < 0.001) and the Global Alignment and Proportion score, GAP (r = 0.26, r = 0.37; p < 0.001), and changes in compressive and shear forces at the proximal segment. GAP score parameters, thoracic kyphosis measurements and the slope of upper instrumented vertebra were associated with changes in shear. In patients with T10-pelvis fusion, moderate-to-strong associations were found between postoperative sagittal alignment measures and compressive and shear loads, with GT showing the strongest correlations (r = 0.75, r = 0.73, p < 0.001). CONCLUSIONS: Spinal loads were estimated for patient-specific full spinal alignment profiles in a large cohort of patients with ASD pre-and postoperatively. Loads on the proximal segments were greater in association with sagittal malalignment and malorientation of proximal vertebra. Future work should explore whether they provide a causative mechanism explaining the associated risk of proximal junction complications.

Combined anterior-posterior versus all-posterior approaches for adult spinal deformity correction: a matched control study.

PURPOSE: Anterior approaches are gaining popularity for adult spinal deformity (ASD) surgeries especially with the introduction of hyperlordotic cages and improvement in MIS techniques. Combined Approaches provide powerful segmental sagittal correction potential and increase the surface area available for fusion in ASD surgery, both of which would improve overall. This is the first study directly comparing surgical outcomes between combined anterior-posterior approaches and all-posterior approach in a matched ASD population. METHODS: This is a retrospective matched control cohort analysis with substitution using a multicenter prospectively collected ASD data of patients with > 2 year FU. Matching criteria include: age, American Society of Anesthesiologists Score, Lumbar Cobb angle, sagittal deformity (Global tilt) and ODI. RESULTS: In total, 1024 ASD patients were available for analysis. 29 Combined Approaches patients met inclusion criteria, and only 22 could be matched (1:2 ratio). Preoperative non-matched demographical, clinical, surgical and radiological parameters were comparable between both groups. Combined approaches had longer surgeries (548 mns vs 283) with more blood loss (2850 ml vs 1471) and needed longer ICU stays (74 h vs 27). Despite added morbidity, they had comparable complication rates but with significantly less readmissions (9.1% vs 38.1%) and reoperations (18.2% vs 43.2%) at 2 years. Combined Approaches achieved more individualised and harmonious deformity correction initially. At the 2 years control, Combined Approaches patients reported better outcomes as measured by COMI and SRS scores. This trend was maintained at 3 years. CONCLUSION: Despite an increased initial surgical invasiveness, combined approaches seem to achieve more harmonious correction with superior sagittal deformity control; they need fewer revisions and have improved long-term functional outcomes when compared to all-posterior approaches for ASD deformity correction.

Surgeons' risk perception in ASD surgery: The value of objective risk assessment on decision making and patient counselling.

BACKGROUND: Surgeons often rely on their intuition, experience and published data for surgical decision making and informed consent. Literature provides average values that do not allow for individualized assessments. Accurate validated machine learning (ML) risk calculators for adult spinal deformity (ASD) patients, based on 10 year multicentric prospective data, are currently available. The objective of this study is to assess surgeon ASD risk perception and compare it to validated risk calculator estimates. METHODS: Nine ASD complete (demographics, HRQL, radiology, surgical plan) preoperative cases were distributed online to 100 surgeons from 22 countries. Surgeons were asked to determine the risk of major complications and reoperations at 72 h, 90 d and 2 years postop, using a 0-100% risk scale. The same preoperative parameters circulated to surgeons were used to obtain ML risk calculator estimates. Concordance between surgeons' responses was analyzed using intraclass correlation coefficients (ICC) (poor < 0.5/excellent > 0.85). Distance between surgeons' and risk calculator predictions was assessed using the mean index of agreement (MIA) (poor < 0.5/excellent > 0.85). RESULTS: Thirty-nine surgeons (74.4% with > 10 years' experience), from 12 countries answered the survey. Surgeons' risk perception concordance was very low and heterogeneous. ICC ranged from 0.104 (reintervention risk at 72 h) to 0.316 (reintervention risk at 2 years). Distance between calculator and surgeon prediction was very large. MIA ranged from 0.122 to 0.416. Surgeons tended to overestimate the risk of major complications and reintervention in the first 72 h and underestimated the same risks at 2 years postop. CONCLUSIONS: This study shows that expert surgeon ASD risk perception is heterogeneous and highly discordant. Available validated ML ASD risk calculators can enable surgeons to provide more accurate and objective prognosis to adjust patient expectations, in real time, at the point of care.

Ability of Visual Analogue Scale to predict Oswestry Disability Index improvement and surgical treatment decision in patients with adult spinal deformity.

Introduction: The effect of pain on HRQoL scores in ASD patients is not well studied. Disability is a major factor on decision and outcomes. On the other hand, little is known about the effect of perceived and reported pain on these parameters, especially in the elderly population. We hypothesized that baseline back and leg pain would not affect the treatment decision whereas may have a negative effect on outcomes. Research question: To determine the correlation between preoperative ODI and VAS scores; and to identify the effect of baseline VAS score on treatment decision and ODI improvement following treatment. Material and methods: In this retrospective study, patients with a follow-up duration of minimum 2 years were enrolled from a prospective multicentric ASD database. Pearson and Spearman correlation tests were used to evaluate the correlation between ODI and VAS scores; univariate binary logistic regression method was used to analyze the effect of VAS on treatment decision as well as the outcomes. Results: 1050 patients (mean age 48.2) were analyzed. Baseline ODI and back, leg pain VAS scores were significantly correlated (P â€‹< â€‹0.001). One unit increase in baseline back and leg pain VAS scores, increased the probability of improvement in ODI by 1.219 (P â€‹= â€‹0.016) and 1.182 times (P â€‹= â€‹0.029), respectively in surgically treated patients; and reduced it by 0.894 times (P â€‹= â€‹0.012) for conservatively treated patients. For patients >70 years old, one-unit increase in baseline leg pain VAS score increased the probability of deciding on surgical treatment by 1.121 times (p â€‹= â€‹0.016). Discussion and conclusions: Preoperative back and leg pain VAS scores were found to be significantly correlated with the preoperative ODI scores. Additionally, preoperative baseline back and leg pain VAS scores were useful in predicting the improvement in disability as assessed by ODI. Another important finding was that, higher baseline leg pain (but not back pain) VAS scores increased the rate of elderly patients preferring surgical treatment.

Compensatory mechanisms recruited against proximal junctional kyphosis by patients instrumented from the thoracolumbar junction to the iliac.

PURPOSE: The compensatory mechanisms recruited by un-instrumented patients against sagittal imbalance are well documented. However, there is a lack of information regarding instrumented patients. MATERIAL AND METHODS: We performed a retrospective analysis of data collected prospectively in a multicenter adult spinal deformity database. We included patients suffering PJK/PJF after (T8-L2) to iliac instrumentation with minimum two-year follow-up. We measured quantitative sagittal spinopelvic and qualitative sagittal distribution parameters in the immediate postoperative period (6w) and at the time of PJK/PJF appearance. We analyzed how these parameters changed comparing these two time points with univariate and multivariate logistic regression analyses. RESULTS: A total of 69 patients were included. Two different patterns at PJK/PJF were found: 36 patients activated compensation (defined as an increase in pelvic retroversion (ΔRPV > 5º), and 33 did not (ΔRPV < 5º). The difference in behavior relied mostly on the amount of not surgically restored pelvic rotation at 6w (OR: 0.6; CI95%: 0.4-9.2; P = 0.017). Non-compensators had less rotation reserve (PTx100/PI = 33.9% vs 47.8%;P < 0.001) associated with worse 6w relative pelvic version and lower lumbar arc restoration, worse 6w relative sagittal alignment and GAP-score, compared with compensators (P < 0.001). Compensators' response was based on pelvic retroversion, causing lower lumbar arc decrease, lumbar apex caudal migration, and upper lumbar arc posterior inclination. Despite compensation, a thoracic kyphosis increase in both upper and lower arches gradually evolved into a PJK/PJF. Non-compensators did not react to PJK/PJF, which forced them into kyphosis from the lumbar apex and extending cranially, mainly throughout the upper thoracic arc. CONCLUSIONS: In patients fused from the TL junction to the iliac, those having greater postoperative pelvic rotation reserve showed greater capacity to recruit compensatory mechanisms against PJK/PJF.

The Effect of Discharging Patients with Low Hemoglobin Levels on Hospital Readmission and Quality of Life after Adult Spinal Deformity Surgery.

STUDY DESIGN: Retrospective cohort. PURPOSE: This study aims to evaluate the impact of anemia on functional outcomes, health-related quality of life (HRQoL), and early hospital readmission (EHR) rates after adult spinal deformity (ASD) surgery at the time of discharge from the hospital. OVERVIEW OF LITERATURE: Concerns with risks of transfusion, insufficient evidence for its benefits, and the possibility of associated adverse outcomes have led to restrictive transfusion practices. Therefore, patients are discharged according to patient blood management programs that are implemented in hospitals nationwide to reduce unnecessary blood transfusions. However, not many comprehensive kinds of studies exist on the effect of postoperative anemia on functional life and complications. METHODS: Anemia severity was defined following the 2011 World Health Organization guidelines. All patients had HRQoL tests as well as complete blood counts pre- and postoperatively. EHR is the admission within 30 days of discharge and was used as the dependent parameter. RESULTS: This study comprised 225 surgically treated ASD patients with a median age of 62.0 years, predominantly women (80%). Of the 225 patients, 82, 137, and six had mild, moderate, and severe anemia at the time of discharge, respectively. Seventeen of the patients (mild [11, 64.7%]; moderate [5, 29.4%]; severe [1, 5.9%]) were readmitted within 30 days. The mean hemoglobin values were higher in readmitted patients (p=0.071). Infection was the leading cause of readmission (n=12), but a low hemoglobin level was not observed in any of these patients at the time of discharge. Except for Scoliosis Research Society-22 questionnaire, HRQoL improvements did not reach statistical significance in early readmitted patients in the first year after surgery. CONCLUSIONS: The results of this study demonstrated that the occurrence and the severity of postoperative anemia are not associated with EHR in surgically treated patients with ASD. The findings of the current research suggested that clinical awareness of the parameters other than postoperative anemia may be crucial. Thus, improvements in HRQoL scores were poor in early readmitted patients 1 year after surgery.

Quality metrics in adult spinal deformity surgery over the last decade: a combined analysis of the largest prospective multicenter data sets.

OBJECTIVE: The reported rate of complications and cost of adult spinal deformity (ASD) surgery, associated with an exponential increase in the number of surgeries, cause alarm among healthcare payers and providers worldwide. The authors conjointly analyzed the largest prospective available ASD data sets to define trends in quality-of-care indicators (complications, reinterventions, and health-related quality of life [HRQOL] outcomes) since 2010. METHODS: This is an observational prospective longitudinal cohort study. Patients underwent surgery between January 2010 and December 2016, with > 2 years of follow-up data. Demographic, surgical, radiological, and HRQOL (i.e., Oswestry Disability Index, SF-36, Scoliosis Research Society-22r) data obtained preoperatively and at 3, 6, 12, and 24 months after surgery were evaluated. Trends and changes in indicators were analyzed using local regression (i.e., locally estimated scatterplot smoothing [LOESS]) and adjusted odds ratio (OR). RESULTS: Of the 2286 patients included in the 2 registries, 1520 underwent surgery between 2010 and 2016. A total of 1151 (75.7%) patients who were treated surgically at 23 centers in 5 countries met inclusion criteria. Patient recruitment increased progressively (2010-2011 vs 2015-2016: OR 1.64, p < 0.01), whereas baseline clinical characteristics (age, American Society of Anesthesiologists class, HRQOL scores, sagittal deformity) did not change. Since 2010 there has been a sustained reduction in major and minor postoperative complications observed at 90 days (major: OR 0.59; minor: OR 0.65; p < 0.01); at 1 year (major: OR 0.52; minor: 0.75; p < 0.01); and at 2 years of follow-up (major: OR 0.4; minor: 0.80; p < 0.01) as well as in the 2-year reintervention rate (OR 0.41, p < 0.01). Simultaneously, there has been a slight improvement in the correction of sagittal deformity (i.e., pelvic incidence-lumbar lordosis mismatch: OR 1.11, p = 0.19) and a greater gain in quality of life (i.e., Oswestry Disability Index 26% vs 40%, p = 0.02; Scoliosis Research Society-22r, self-image domain OR 1.16, p = 0.13), and these are associated with a progressive reduction of surgical aggressiveness (number of fused segments: OR 0.81, p < 0.01; percent pelvic fixation: OR 0.66, p < 0.01; percent 3-column osteotomies: OR 0.63, p < 0.01). CONCLUSIONS: The best available data show a robust global improvement in quality metrics in ASD surgery over the last decade. Surgical complications and reoperations have been reduced by half, while improvement in disability increased and correction rates were maintained, in patients with similar baseline characteristics.

State-of-the-art reviews predictive modeling in adult spinal deformity: applications of advanced analytics.

Adult spinal deformity (ASD) is a complex and heterogeneous disease that can severely impact patients' lives. While it is clear that surgical correction can achieve significant improvement of spinopelvic parameters and quality of life measures in adults with spinal deformity, there remains a high risk of complication associated with surgical approaches to adult deformity. Over the past decade, utilization of surgical correction for ASD has increased dramatically as deformity correction techniques have become more refined and widely adopted. Along with this increase in surgical utilization, there has been a massive undertaking by spine surgeons to develop more robust models to predict postoperative outcomes in an effort to mitigate the relatively high complication rates. A large part of this revolution within spine surgery has been the gradual adoption of predictive analytics harnessing artificial intelligence through the use of machine learning algorithms. The development of predictive models to accurately prognosticate patient outcomes following ASD surgery represents a dramatic improvement over prior statistical models which are better suited for finding associations between variables than for their predictive utility. Machine learning models, which offer the ability to make more accurate and reproducible predictions, provide surgeons with a wide array of practical applications from augmenting clinical decision making to more wide-spread public health implications. The inclusion of these advanced computational techniques in spine practices will be paramount for improving the care of patients, by empowering both patients and surgeons to more specifically tailor clinical decisions to address individual health profiles and needs.

The dynamics of satisfaction in surgical and non-surgical adult spinal deformity patients.

PURPOSE: For adult spinal deformity (ASD) patients receiving operative (op) and non-operative (non-op) treatment, the relationship between HRQoL measures, complications and self-reported satisfaction remains unclear. The objective of this analysis is to study nonlinear association dynamics between ASD patient satisfaction, HRQoL, and complications over a two-year follow-up period. METHODS: From a prospective multicenter international adult spinal deformity database, all patients with 2-year follow-up data on satisfaction (21st question of SRS-22r) were identified and included. A total of 12 LOESS (local polynomial fit) regressions were performed between patient satisfaction (SRS22 item 21) and HRQoL measures (ODI, SF36PCS and SRS22 subtotal) interacting with surgery at baseline, 6 months and 1 and 2 years of follow-up. RESULTS: A total of 856 patients (527 op and 329 non-op) were included. At baseline, satisfaction was lower for patients scheduled for surgery even when HRQL was similar to those elected for conservative treatment. The nonlinear correlations showed that for similar PROMs, op patients reached higher satisfaction levels during follow-up, especially at six months. In fact, at six months operated patients with a deterioration of their initial PROMs had some improvement in their satisfaction, which could not be further observed at the end of follow-up. CONCLUSIONS: Satisfaction does not correlate well with other PROMs, and it might be subject to other external factors not directly related to treatment. Even if patient satisfaction is important in evaluating well-being and patient's experience with medical care, it should not be considered as an isolated proxy to measure quality of treatment.

Variation of Minimum Clinically Important Difference by Age, Gender, Baseline Disability, and Change of Direction in Adult Spinal Deformity Population: Is It a Constant Value?

BACKGROUND: The minimum clinically important difference (MCID), an important concept to evaluate the effectiveness of treatments, might not be a single "magical" constant for any given health-related quality of life (HRQoL) scale. Thus, we analyzed the effects of various factors on MCIDs for several HRQoL measures in an adult spinal deformity population. METHODS: Surgical and nonsurgical patients from a multicenter adult spinal deformity database who had completed pretreatment and 1-year follow-up questionnaires (Core Outcome Measures Index [COMI], Oswestry Disability Index [ODI], Medical Outcomes Study 36-item short-form questionnaire, 22-item Scoliosis Research Society Outcomes questionnaire, and an anchor question of "back health"-related change during the previous year) were evaluated. The MCIDs for each HRQoL measure were calculated using an anchor-based method and latent class analysis for the overall population and subpopulations stratified by age, gender, and baseline scores (ODI and COMI) separately for patients with positive versus negative perceptions of change. RESULTS: Patients with a baseline ODI score of <20, 20-40, and >40 had an MCID of 2.24, 11.35, and 26.57, respectively. Similarly, patients with a baseline COMI score of <2.75, 2.8-5.4, and >5.4 had an MCID of 0.59, 1.38, and 3.67 respectively. The overall MCID thresholds for deterioration and improvement were 0.27 and 2.62 for COMI, 2.23 and 14.31 for ODI, and 0.01 and 0.71 for 22-item Scoliosis Research Society Outcomes questionnaire, respectively. CONCLUSIONS: The results from the present study have demonstrated that MCIDs change in accordance with the baseline scores and direction of change but not by age or gender. The MCID, in its current state, should be considered a concept rather than a constant.

Adult Congenital Spine Deformity: Clinical Features and Motivations for Surgical Treatment.

BACKGROUND: There is scarce information available about adult congenital spine deformity (ACSD) in the literature, especially its impact after the pediatric age. The aim was to define ACSD characteristics and to establish the drivers for surgical intervention. METHODS: Cross-sectional study of data collected in an adult deformity multicenter database. Only ACSD patients were included. Demographic and radiographic data, as well as patient-reported outcome measures, were assessed. Conservatively (C) vs surgically (S) treated patients were compared using Student t test, χ², and Mann-Whitney U test. RESULTS: Fifty-two patients were included. They were young adults (x = 37.7 years), mostly female (71%). Among them, 60% had single hemivertebrae (HV), 35% had multiple HV, and 5% had segmentation defects. Also, 75% had mainly coronal deformity (Cobb 62.5° ± 29.6) and 25% had sagittal deformity.Mean Oswestry Disability Index (ODI) was 29.6% ± 17 and mean Scoliosis Research Society 22-item survey (SRS-22) total score was 3.2 ± 0.8. Of note, mean SRS-22 self-image score was 2.8 ± 0.9 and 36-item Short Form Health Survey (SF-36) physical function score was 40.9 ± 11.Thirty patients were treated conservatively (C), whereas 22 patients underwent surgery (S). No differences were found regarding age, type or location of the deformity, comorbidities, or radiographic parameters. Operated patients had worse Core Outcome Measurement Index (COMI) back scores (C: 3.8 ± 2.4 vs S: 6.7 ± 2.4; P = 0.004); worse SRS-22 self-image (C: 3 ± 0.9 vs S: 2.5 ± 0.9; P = 0.047), and SRS-22 total scores (C: 3.4 ± 0.8 vs S: 2.9 ± 0.7; P = 0.01); worse SF-36 physical component summary (C: 43.3 ± 10.8 vs S: 36.7 ± 10.4; P = 0.048); and worse SF-36 physical role, function, and social function. CONCLUSION: Adult congenital deformity patients were mainly female young adults, with formation defects (HV), worried about their image and presenting some degree of functional impairment and pain. These symptoms were the essential drivers for surgery, rather than the radiographic deformity itself. CLINICAL RELEVANCE: One of the few studies describing the characteristics and clinical concerns of patients with congenital spinal deformities. LEVEL OF EVIDENCE: 3.

Decision Analysis in Quest of the Ideal Treatment in Adult Spinal Deformity Adjusted for Minimum Clinically Important Difference.

BACKGROUND: Surgery appears to yield better results in adult spinal deformity treatment when fixed minimum clinically important difference values are used to define success. Our objective was to analyze utilities and improvement provided by surgical versus nonsurgical treatment at 2 years using Oswestry Disability Index with treatment-specific minimum clinically important difference values. METHODS: From a multicenter database including 1452 patients, 698 with 2 years of follow-up were analyzed. Mean age of patients was 50.95 ± 19.44 years; 580 patients were women, and 118 were men. The surgical group comprised 369 patients, and the nonsurgical group comprised 329 patients. The surgical group was subcategorized into no complications (192 patients), minor complications (97 patients) and major complications (80 patients) groups to analyze the effect of complications on results. Minimum clinically important differences using Oswestry Disability Index were 14.31, 14.96, and 2.48 for overall, surgical, and nonsurgical groups. Utilities were calculated by visual analog scale mapping. RESULTS: Surgical treatment provided higher utility (0.583) than nonsurgical treatment (0.549) that was sensitive to complications, being 0.634, 0.564, and 0.497 in no, minor, and major complications. Probabilities of improvement, unchanged, and deterioration were 38.3%, 39.2%, and 22.5% for surgical treatment and 39.4%, 10.5%, and 50.1% for nonsurgical treatment. Improvement in the surgical group was also sensitive to complications with rates of 40.1%, 39.3%, and 33.3%. CONCLUSIONS: Our results suggest that surgical treatment has less disease burden and less chance of deterioration, but equal chances for improvement at 2 years of follow-up. As it appears to be a better modality in the absence of complications, future efforts need be directed to decreasing the complication rates.

Effect of lumbar pedicle subtraction osteotomy level on lordosis distribution and shape.

PURPOSE: Little is known about the qualitative results (postoperative upper/lower lumbar arches distribution and lumbar apex or inflection point positioning) of lumbar pedicle subtraction osteotomies (L-PSO) depending on the level of L-PSO. METHODS: We conducted a retrospective analysis of prospectively collected data of adult deformity patients undergoing single-level L-PSO. We analyzed several variables in preoperative and postoperative sagittal radiographs: L-PSO level, Roussouly classification (R-type), inflection point (InfP), lumbar apex (LApex), spinopelvic parameters, lordosis distribution index (LDI = L4-S1/L1-S1), and number of levels in the lordosis (NVL). Comparisons between PSO levels were performed to determine lordosis distribution and sagittal shape using ANOVA test and Chi-squared statistics. RESULTS: A total of 126 patients were included in this study. L5-PSO mainly increased the lower lumbar arch, thereby increasing LDI. L4 increased upper/lower arches similarly. PSOs at and above L3 increased the upper lumbar arch, thereby decreasing LDI (P < 0.001). L4-PSO added 1 vertebra into the lordosis (NVL = + 1.2 ± 2.2). PSOs above L3 added 2 vertebrae into the lordosis (NVL = + 2.3 ± 1.4). Overall P = 0.007. PSOs above L4 shifted the LApex cranially in 70% of the cases (mean 1.12 levels) and the InfP in 85% of the cases (mean 2.4 levels). L5-PSO shifted the LApex caudally in 70% of the cases (mean - 1.1 levels) and the InfP in 50% of the cases (mean - 1.6 levels). Overall P < 0.006. The L-PSO level was not associated with a specific Roussouly-type P > 0.05. CONCLUSIONS: The level of L-PSO influenced upper/lower lumbar arches distribution, and lumbar apex and inflection point positioning. The correct level should be chosen based on the individual assessment of each patient.

Ideal sagittal profile restoration and ideal lumbar apex positioning play an important role in postoperative mechanical complications after a lumbar PSO.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: To determine the influence of postoperative ideal lordosis distribution and ideal sagittal harmony on mechanical complications in patients undergoing one-level lumbar pedicle subtraction osteotomy (L-PSO). Many variables have been associated with mechanical complications after L-PSO. However, the impact of restoring the ideal inflexion point, lumbar apex, and sagittal shape is still underexplored. METHODS: Analyzed risk factors were: age and patient-related variables, PSO level, interbody cages, rod material/diameter, number of rods, upper instrumented vertebra, lower instrumented vertebra, PI-LL mismatch, global tilt (GT), postoperative level of lumbar apex (LApex), postoperative level of inflexion point (InfxP), and postoperative type of Roussouly sagittal profile (R-type). These last variables were compared to ideal (based on pelvic incidence). Univariate and multivariate analyses were performed to identify risks for mechanical complications with a minimum 2-year follow-up. RESULTS: A total of 87 patients were included. Mean follow-up was 4.5 ± 1.7 years. 40.2% of the patients suffered postoperative mechanical complications (7 PJK, 4 PJF, 18 pseudoarthrosis/rod breakage, 6 screw pullout). Mean time for complications was 584 ± 416 days from surgery. Univariate analysis showed that age (63 vs 57 years; P = 0.04), BMI (28.1 vs 25.9; P = 0.024), preoperative-GT (50.7° vs 38.7°; P < 0.001), postoperative-GT (28.9° vs 23.4°; P = 0.018), postoperative LApex location mismatched from ideal (77.8% vs 22.2%; P = 0.036), and postoperative R-type mismatched from ideal (67.6% vs 22.6%; P < 0.001) were significantly related to mechanical complications. The independent factors selected by multivariate analysis were: postoperative R-type mismatched from ideal OR 11.3 (95% CI 3.9-32.6; P < 0.001), age OR 1.05 (95% CI 1-1.1; P = 0.03), and LApex matching OR 0.5 (95% CI 0.27-0.97; P = 0.04). The further the LApex was from its ideal position, the higher the risk of mechanical complications (P = 0.036). CONCLUSIONS: Over other multiple suspected risk factors, proper lumbar apex position and ideal sagittal shape restoration played an important role in postoperative mechanical complications after L-PSO. LEVEL OF EVIDENCE: III.