Restoring L4-S1 Lordosis Shape in Severe Sagittal Deformity: Impact of Correction Techniques on Alignment and Complication Profile.

BACKGROUND CONTEXT: Severe sagittal plane deformity with loss of L4-S1 lordosis is disabling and can be improved through various surgical techniques. However, data is limited on the differing ability of anterior lumbar interbody fusion (ALIF), pedicle subtraction osteotomy (PSO), and transforaminal lumbar interbody fusion (TLIF) to achieve alignment goals in severely malaligned patients. PURPOSE: To examine surgical techniques aimed at restoring L4-S1 lordosis in severe adult spinal deformity (ASD). DESIGN: Retrospective review of prospectively collected data. PATIENT SAMPLE: A total of 96 patients who underwent ALIF, PSO, and TLIF were included in this study. OUTCOME MEASURES: The following data were observed for all cases: patient demographics, spinopelvic parameters, complications, and PROMs. METHODS: Severe ASD patients with preoperative PI-LL >20°, L4-S1 lordosis <30°, and full body radiographs and patient-reported outcome measures (PROMs) at baseline and six-week postoperative visit were included. Patients were grouped into ALIF (1-2 level ALIF at L4-S1), PSO (L4/L5 PSO), and TLIF (1-2 level TLIF at L4-S1). Comparative analyses were performed on demographics, radiographic spinopelvic parameters, complications, and PROMs. RESULTS: Among the 96 included patients, 40 underwent ALIF, 27 underwent PSO, and 29 underwent TLIF. At baseline, cohorts had comparable age, sex, race, Edmonton frailty scores and radiographic spinopelvic parameters (p>0.05). However, PSO was performed more often in revision cases (p<0.001). Following surgery, L4-S1 lordosis correction (p=0.001) was comparable among ALIF and PSO patients and caudal lordotic apex migration (p=0.044) was highest among ALIF patients. PSO patients had higher intraoperative estimated blood loss (p<0.001) and motor deficits (p=0.049), and in-hospital ICU admission (p=0.022) and blood products given (p=0.004) but were otherwise comparable in terms of length of stay, blood transfusion given, and postoperative admission to rehab. Likewise, 90-day postoperative complication profiles and six-week PROMs were comparable as well. CONCLUSIONS: ALIF can restore L4-S1 sagittal alignment as powerfully as PSO, with fewer intra-operative and in-hospital complications. When feasible, ALIF is a suitable alternative to PSO and likely superior to TLIF for correcting L4-S1 lordosis among patients with severe sagittal malalignment.

Contemporary utilization of three-column osteotomy techniques in a prospective complex spinal deformity multicenter database: implications on full-body alignment and perioperative course.

BACKGROUND: Research has focused on the increased correction from a three-column osteotomy (3CO) during adult spinal deformity (ASD) surgery. However, an in-depth analysis on the performance of a 3CO in a cohort of complex spinal deformity cases has not been described. STUDY DESIGN/SETTING: This is a retrospective study on a prospectively enrolled, complex ASD database. PURPOSE: This study aimed to determine if three-column osteotomies demonstrate superior benefit in correction of complex sagittal deformity at the cost of increased perioperative complications. METHODS: Surgical complex adult spinal deformity patients were included and grouped into thoracolumbar 3COs compared to those who did not have a 3CO (No 3CO) (remaining cohort). Rigid deformity was defined as ΔLL less than 33% from standing to supine. Severe deformity was defined as global (SVA > 70 mm) or C7-PL > 70 mm, or lumbopelvic (PI-LL > 30°). Means comparison tests assessed correction by 3CO grade/location. Multivariate analysis controlling for baseline deformity evaluated outcomes up to six weeks compared to No 3CO. RESULTS: 648 patients were included (Mean age 61 ± 14.6 years, BMI 27.55 ± 5.8 kg/m2, levels fused: 12.6 ± 3.8). 126 underwent 3CO, a 20% higher usage than historical cohorts. 3COs were older, frail, and more likely to undergo revision (OR 5.2, 95% CI [2.6-10.6]; p < .001). 3COs were more likely to present with both severe global/lumbopelvic deformity (OR 4), 62.4% being rigid. 3COs had greater use of secondary rods (OR 4st) and incurred 4 times greater risk for: massive blood loss (> 3500 mL), longer LOS, SICU admission, perioperative wound and spine-related complications, and neurologic complications when performed below L3. 3COs had similar HRQL benefit, but higher perioperative opioid use. Mean segmental correction increased by grade (G3-21; G4-24; G5-27) and was 4 × greater than low-grade osteotomies, especially below L3 (OR 12). 3COs achieved 2 × greater spinopelvic correction. Higher grades properly distributed lordosis 50% of the time except L5. Pelvic compensation and non-response were relieved more often with increasing grade, with greater correction in all lower extremity parameters (p < .01). Due to the increased rate of complications, 3COs trended toward higher perioperative cost ($42,806 vs. $40,046, p = .086). CONCLUSION: Three-column osteotomy usage in contemporary complex spinal deformities is generally limited to more disabled individuals undergoing the most severe sagittal and coronal realignment procedures. While there is an increased perioperative cost and prolongation of length of stay with usage, these techniques represent the most powerful realignment techniques available with a dramatic impact on normalization at operative levels and reciprocal changes.

The Incremental Clinical Benefit of Adding Layers of Complexity to the Planning and Execution of Adult Spinal Deformity Corrective Surgery.

BACKGROUND AND OBJECTIVES: For patients with surgical adult spinal deformity (ASD), our understanding of alignment has evolved, especially in the last 20 years. Determination of optimal restoration of alignment and spinal shape has been increasingly studied, yet the assessment of how these alignment schematics have incrementally added benefit to outcomes remains to be evaluated. METHODS: Patients with ASD with baseline and 2-year were included, classified by 4 alignment measures: Scoliosis Research Society (SRS)-Schwab, Age-Adjusted, Roussouly, and Global Alignment and Proportion (GAP). The incremental benefits of alignment schemas were assessed in chronological order as our understanding of optimal alignment progressed. Alignment was considered improved from baseline based on SRS-Schwab 0 or decrease in severity, Age-Adjusted ideal match, Roussouly current (based on sacral slope) matching theoretical (pelvic incidence-based), and decrease in proportion. Patients separated into 4 first improving in SRS-Schwab at 2-year, second Schwab improvement and matching Age-Adjusted, third two prior with Roussouly, and fourth improvement in all four. Comparison was accomplished with means comparison tests and χ2 analyses. RESULTS: Sevenhundredthirty-two. patients met inclusion. SRS-Schwab BL: pelvic incidence-lumbar lordosis mismatch (++:32.9%), sagittal vertical axis (++: 23%), pelvic tilt (++:24.6%). 640 (87.4%) met criteria for first, 517 (70.6%) second, 176 (24%) third, and 55 (7.5%) fourth. The addition of Roussouly (third) resulted in lower rates of mechanical complications and proximal junctional kyphosis (48.3%) and higher rates of meeting minimal clinically important difference (MCID) for physical component summary and SRS-Mental (P < .05) compared with the second. Fourth compared with the third had higher rates of MCID for ODI (44.2% vs third: 28.3%, P = .011) and SRS-Appearance (70.6% vs 44.8%, P < .001). Mechanical complications and proximal junctional kyphosis were lower with the addition of Roussouly (P = .024), while the addition of GAP had higher rates of meeting MCID for SRS-22 Appearance (P = .002) and Oswestry Disability Index (P = .085). CONCLUSION: Our evaluation of the incremental benefit that alignment schemas have provided in ASD corrective surgery suggests that the addition of Roussouly provided the greatest reduction in mechanical complications, while the incorporation of GAP provided the most significant improvement in patient-reported outcomes.

Revision Strategy for Proximal Junctional Failure: Combined Effect of Proximal Extension and Focal Correction.

STUDY DESIGN: Retrospective review of a prospectively-collected multicenter database. OBJECTIVES: The objective of this study was to determine optimal strategies in terms of focal angular correction and length of proximal extension during revision for PJF. METHODS: 134 patients requiring proximal extension for PJF were analyzed in this study. The correlation between amount of proximal junctional angle (PJA) reduction and recurrence of proximal junctional kyphosis (PJK) and/or PJF was investigated. Following stratification by the degree of PJK correction and the numbers of levels extended proximally, rates of radiographic PJK (PJA >28° & ΔPJA >22°), and recurrent surgery for PJF were reported. RESULTS: Before revision, mean PJA was 27.6° ± 14.6°. Mean number of levels extended was 6.0 ± 3.3. Average PJA reduction was 18.8° ± 18.9°. A correlation between the degree of PJA reduction and rate of recurrent PJK was observed (r = -.222). Recurrent radiographic PJK (0%) and clinical PJF (4.5%) were rare in patients undergoing extension ≥8 levels, regardless of angular correction. Patients with small reductions (<5°) and small extensions (<4 levels) experienced moderate rates of recurrent PJK (19.1%) and PJF (9.5%). Patients with large reductions (>30°) and extensions <8 levels had the highest rate of recurrent PJK (31.8%) and PJF (16.0%). CONCLUSION: While the degree of focal PJK correction must be determined by the treating surgeon based upon clinical goals, recurrent PJK may be minimized by limiting reduction to <30°. If larger PJA correction is required, more extensive proximal fusion constructs may mitigate recurrent PJK/PJF rates.

Impact of Self-Reported Loss of Balance and Gait Disturbance on Outcomes following Adult Spinal Deformity Surgery.

Background: The objective of this study was to evaluate if imbalance influences complication rates, radiological outcomes, and patient-reported outcomes (PROMs) following adult spinal deformity (ASD) surgery. Methods: ASD patients with baseline and 2-year radiographic and PROMs were included. Patients were grouped according to whether they answered yes or no to a recent history of pre-operative loss of balance. The groups were propensity-matched by age, pelvic incidence-lumbar lordosis (PI-LL), and surgical invasiveness score. Results: In total, 212 patients were examined (106 in each group). Patients with gait imbalance had worse baseline PROM measures, including Oswestry disability index (45.2 vs. 36.6), SF-36 mental component score (44 vs. 51.8), and SF-36 physical component score (p < 0.001 for all). After 2 years, patients with gait imbalance had less pelvic tilt correction (-1.2 vs. -3.6°, p = 0.039) for a comparable PI-LL correction (-11.9 vs. -15.1°, p = 0.144). Gait imbalance patients had higher rates of radiographic proximal junctional kyphosis (PJK) (26.4% vs. 14.2%) and implant-related complications (47.2% vs. 34.0%). After controlling for age, baseline sagittal parameters, PI-LL correction, and comorbidities, patients with imbalance had 2.2-times-increased odds of PJK after 2 years. Conclusions: Patients with a self-reported loss of balance/unsteady gait have significantly worse PROMs and higher risk of PJK.

Benchmark Values for Construct Survival and Complications by Type of ASD Surgery.

OBJECTIVE: Provide benchmarks for the rates of complications by type of surgery performed. STUDY DESIGN: Prospective multicenter database. BACKGROUND: We have previously examined overall construct survival and complication rates for ASD surgery. However, the relationship between type of surgery and construct survival warrants more detailed assessment. METHODS: Eight surgical scenarios were defined based on the levels treated, previous fusion status (primary [P] vs. revision [R]), and 3-column osteotomy use [3CO]: Short Lumbar fusion, LT-Pelvis with 5-12 levels treated (P, R or 3CO), UT-Pelvis with  13 levels treated (P, R or 3CO), and Thoracic to Lumbar fusion without pelvic fixation, representing 92.4% of the case in the cohort. Complication rates for each type were calculated and Kaplan Meier curves with multivariate Cox regression analysis was used to evaluate the effect of the case characteristics on construct survival rate, while controlling for patient profile. RESULTS: 1073 of 1494 patients eligible for 2-year follow-up (71.8%) were captured. Survival curves for major complications (with or without reoperation), while controlling for demographics differed significantly among surgical types (P<0.001). Fusion procedures short of the pelvis had the best survival rate, while UT-Pelvis with 3CO had the worst survival rate. Longer fusions and more invasive operations were associated with lower 2-year complication-free survival, however there were no significant associations between type of surgery and renal, cardiac, infection, wound, gastrointestinal, pulmonary, implant malposition or neurologic complications (all P>0.5). CONCLUSION: This study suggests that there is an inherent increased risk of complication for some types of ASD surgery independent of patient profile. The results of this paper can be used to produce a surgery-adjusted benchmark for ASD surgery with regard to complications and survival. Such a tool can have very impactful applications for surgical decision making and more informed patient counseling.

Stronger association of objective physical metrics with baseline patient-reported outcome measures than preoperative standing sagittal parameters for adult spinal deformity patients.

OBJECTIVE: Sagittal alignment measured on standing radiography remains a fundamental component of surgical planning for adult spinal deformity (ASD). However, the relationship between classic sagittal alignment parameters and objective metrics, such as walking time (WT) and grip strength (GS), remains unknown. The objective of this work was to determine if ASD patients with worse baseline sagittal malalignment have worse objective physical metrics and if those metrics have a stronger relationship to patient-reported outcome metrics (PROMs) than standing alignment. METHODS: The authors conducted a retrospective review of a multicenter ASD cohort. ASD patients underwent baseline testing with the timed up-and-go 6-m walk test (seconds) and for GS (pounds). Baseline PROMs were surveyed, including Oswestry Disability Index (ODI), Patient-Reported Outcomes Measurement Information System (PROMIS), Scoliosis Research Society (SRS)-22r, and Veterans RAND 12 (VR-12) scores. Standard spinopelvic measurements were obtained (sagittal vertical axis [SVA], pelvic tilt [PT], and mismatch between pelvic incidence and lumbar lordosis [PI-LL], and SRS-Schwab ASD classification). Univariate and multivariable linear regression modeling was performed to interrogate associations between objective physical metrics, sagittal parameters, and PROMs. RESULTS: In total, 494 patients were included, with mean ± SD age 61 ± 14 years, and 68% were female. Average WT was 11.2 ± 6.1 seconds and average GS was 56.6 ± 24.9 lbs. With increasing PT, PI-LL, and SVA quartiles, WT significantly increased (p < 0.05). SRS-Schwab type N patients demonstrated a significantly longer average WT (12.5 ± 6.2 seconds), and type T patients had a significantly shorter WT time (7.9 ± 2.7 seconds, p = 0.03). With increasing PT quartiles, GS significantly decreased (p < 0.05). SRS-Schwab type T patients had a significantly higher average GS (68.8 ± 27.8 lbs), and type L patients had a significantly lower average GS (51.6 ± 20.4 lbs, p = 0.03). In the frailty-adjusted multivariable linear regression analyses, WT was more strongly associated with PROMs than sagittal parameters. GS was more strongly associated with ODI and PROMIS Physical Function scores. CONCLUSIONS: The authors observed that increasing baseline sagittal malalignment is associated with slower WT, and possibly weaker GS, in ASD patients. WT has a stronger relationship to PROMs than standing alignment parameters. Objective physical metrics likely offer added value to standard spinopelvic measurements in ASD evaluation and surgical planning.

Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?

OBJECTIVE: Complex spinal deformity surgeries may involve significant blood loss. The use of antifibrinolytic agents such as tranexamic acid (TXA) has been proven to reduce perioperative blood loss. However, for patients with a history of thromboembolic events, there is concern of increased risk when TXA is used during these surgeries. This study aimed to assess whether TXA use in patients undergoing complex spinal deformity correction surgeries increases the risk of thromboembolic complications based on preexisting thromboembolic risk factors. METHODS: Data were analyzed for adult patients who received TXA during surgical correction for spinal deformity at 21 North American centers between August 2018 and October 2022. Patients with preexisting thromboembolic events and other risk factors (history of deep venous thrombosis [DVT], pulmonary embolism [PE], myocardial infarction [MI], stroke, peripheral vascular disease, or cancer) were identified. Thromboembolic complication rates were assessed during the postoperative 90 days. Univariate and multivariate analyses were performed to assess thromboembolic outcomes in high-risk and low-risk patients who received intravenous TXA. RESULTS: Among 411 consecutive patients who underwent complex spinal deformity surgery and received TXA intraoperatively, 130 (31.6%) were considered high-risk patients. There was no significant difference in thromboembolic complications between patients with and those without preexisting thromboembolic risk factors in univariate analysis (high-risk group vs low-risk group: 8.5% vs 2.8%, p = 0.45). Specifically, there were no significant differences between groups regarding the 90-day postoperative rates of DVT (high-risk group vs low-risk group: 1.5% vs 1.4%, p = 0.98), PE (2.3% vs 1.8%, p = 0.71), acute MI (1.5% vs 0%, p = 0.19), or stroke (0.8% vs 1.1%, p > 0.99). On multivariate analysis, high-risk status was not a significant independent predictor for any of the thromboembolic complications. CONCLUSIONS: Administration of intravenous TXA during the correction procedure did not change rates of thromboembolic events, acute MI, or stroke in this cohort of adult spinal deformity surgery patients.

Tailored Yoga Intervention for Postlumbar Spine Surgical Pain Management: A Feasibility Study.

Introduction: Severe pain, anxiety, and high opioid use are common following lumbar spine surgery (LSS). Yoga helps to reduce pain and anxiety, but it has not been considered for postsurgical care. The authors developed and tested the feasibility of a tailored yoga program designed for individuals undergoing LSS and explored clinical feasibility of yoga intervention on measures of pain, function, psychological status, and opioid use. Methods: Individuals scheduled for LSS were randomized into yoga versus control groups presurgery. Participants in the yoga group received tailored yoga sessions plus usual care, whereas participants in the control group received usual care only during the hospital stay post-LSS. In-person daily yoga sessions were individually presented and performed in the participant's hospital room. Feasibility was assessed by recruitment and retention rates, rate of yoga session completion, tolerance to yoga intervention, and ability to carry out planned assessment. Exploratory clinical outcomes included pain, psychological measures, Timed-Up-and-Go test, gait distance, and opioid use, during the hospital stay post-LSS. Results: Forty-one participants were enrolled, of which 30 completed. There were no dropouts. Planned assessments were completed within 45 min, suggesting no excessive burden on participants. Baseline variables were similar across both groups. The majority of participants participated in yoga intervention on the day of surgery or one day after surgery with acceptance rate of 100%. Participants showed good tolerance to yoga intervention on 0-4 tolerance scale and by their reports of exploratory clinical outcomes. Conclusion: This study indicates feasibility for a modified yoga program for postoperative care following LSS due to participant tolerance and retention. The results provide preliminary framework for future confirmatory studies that can assess the potential benefits of yoga in reducing pain, catastrophizing behavior, and opioid use and improving function. A modified yoga program focusing on diaphragmatic breathing, relaxation, and core isometric contraction exercises can be an important adjunct intervention for patients undergoing LSS. CTR Number: This trial was registered in UMIN CTR (https://rctportal.niph.go.jp/en/) with registration number: UMIN000032595.

Factors Associated with the Maintenance of Cost-Effectiveness at 5 Years in Adult Spinal Deformity Corrective Surgery.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To evaluate factors associated with the long-term durability of cost-effectiveness (CE) in ASD patients. BACKGROUND: A substantial increase in costs associated with the surgical treatment for adult spinal deformity (ASD) has given precedence to scrutinize the value and utility it provides. METHODS: We included 327 operative ASD patients with 5-year (5 Y) follow-up. Published methods were used to determine costs based on CMS.gov definitions and were based on the average DRG reimbursement rates. Utility was calculated using quality-adjusted life-years (QALY) utilizing the Oswestry Disability Index (ODI) converted to Short-Form Six-Dimension (SF-6D), with a 3% discount applied for its decline with life expectancy. The CE threshold of $150,000 was used for primary analysis. RESULTS: Major and minor complication rates were 11% and 47% respectively, with 26% undergoing reoperation by 5 Y. The mean cost associated with surgery was $91,095±$47,003, with a utility gain of 0.091±0.086 at 1Y, QALY gained at 2 Y of 0.171±0.183, and at 5 Y of 0.42±0.43. The cost per QALY at 2 Y was $414,885, which decreased to $142,058 at 5 Y.With the threshold of $150,000 for CE, 19% met CE at 2 Y and 56% at 5 Y. In those in which revision was avoided, 87% met cumulative CE till life expectancy. Controlling analysis depicted higher baseline CCI and pelvic tilt (PT) to be the strongest predictors for not maintaining durable CE to 5 Y (CCI OR: 1.821 [1.159-2.862], P=0.009) (PT OR: 1.079 [1.007-1.155], P=0.030). CONCLUSIONS: Most patients achieved cost-effectiveness after four years postoperatively, with 56% meeting at five years postoperatively. When revision was avoided, 87% of patients met cumulative cost-effectiveness till life expectancy. Mechanical complications were predictive of failure to achieve cost-effectiveness at 2 Y, while comorbidity burden and medical complications were at 5 Y.

Machine learning clustering of adult spinal deformity patients identifies four prognostic phenotypes: a multicenter prospective cohort analysis with single surgeon external validation.

BACKGROUND CONTEXT: Among adult spinal deformity (ASD) patients, heterogeneity in patient pathology, surgical expectations, baseline impairments, and frailty complicates comparisons in clinical outcomes and research. This study aims to qualitatively segment ASD patients using machine learning-based clustering on a large, multicenter, prospectively gathered ASD cohort. PURPOSE: To qualitatively segment adult spinal deformity patients using machine learning-based clustering on a large, multicenter, prospectively gathered cohort. STUDY DESIGN/SETTING: Machine learning algorithm using patients from a prospective multicenter study and a validation cohort from a retrospective single center, single surgeon cohort with complete 2-year follow up. PATIENT SAMPLE: About 805 ASD patients; 563 patients from a prospective multicenter study and 242 from a single center to be used as a validation cohort. OUTCOME MEASURES: To validate and extend the Ames-ISSG/ESSG classification using machine learning-based clustering analysis on a large, complex, multicenter, prospectively gathered ASD cohort. METHODS: We analyzed a training cohort of 563 ASD patients from a prospective multicenter study and a validation cohort of 242 ASD patients from a retrospective single center/surgeon cohort with complete two-year patient-reported outcomes (PROs) and clinical/radiographic follow-up. Using k-means clustering, a machine learning algorithm, we clustered patients based on baseline PROs, Edmonton frailty, age, surgical history, and overall health. Baseline differences in clusters identified using the training cohort were assessed using Chi-Squared and ANOVA with pairwise comparisons. To evaluate the classification system's ability to discern postoperative trajectories, a second machine learning algorithm assigned the single-center/surgeon patients to the same 4 clusters, and we compared the clusters' two-year PROs and clinical outcomes. RESULTS: K-means clustering revealed four distinct phenotypes from the multicenter training cohort based on age, frailty, and mental health: Old/Frail/Content (OFC, 27.7%), Old/Frail/Distressed (OFD, 33.2%), Old/Resilient/Content (ORC, 27.2%), and Young/Resilient/Content (YRC, 11.9%). OFC and OFD clusters had the highest frailty scores (OFC: 3.76, OFD: 4.72) and a higher proportion of patients with prior thoracolumbar fusion (OFC: 47.4%, OFD: 49.2%). ORC and YRC clusters exhibited lower frailty scores and fewest patients with prior thoracolumbar procedures (ORC: 2.10, 36.6%; YRC: 0.84, 19.4%). OFC had 69.9% of patients with global sagittal deformity and the highest T1PA (29.0), while YRC had 70.2% exhibiting coronal deformity, the highest mean coronal Cobb Angle (54.0), and the lowest T1PA (11.9). OFD and ORC had similar alignment phenotypes with intermediate values for Coronal Cobb Angle (OFD: 33.7; ORC: 40.0) and T1PA (OFD: 24.9; ORC: 24.6) between OFC (worst sagittal alignment) and YRC (worst coronal alignment). In the single surgeon validation cohort, the OFC cluster experienced the greatest increase in SRS Function scores (1.34 points, 95%CI 1.01-1.67) compared to OFD (0.5 points, 95%CI 0.245-0.755), ORC (0.7 points, 95%CI 0.415-0.985), and YRC (0.24 points, 95%CI -0.024-0.504) clusters. OFD cluster patients improved the least over 2 years. Multivariable Cox regression analysis demonstrated that the OFD cohort had significantly worse reoperation outcomes compared to other clusters (HR: 3.303, 95%CI: 1.085-8.390). CONCLUSION: Machine-learning clustering found four different ASD patient qualitative phenotypes, defined by their age, frailty, physical functioning, and mental health upon presentation, which primarily determines their ability to improve their PROs following surgery. This reaffirms that these qualitative measures must be assessed in addition to the radiographic variables when counseling ASD patients regarding their expected surgical outcomes.

Complication Rates Following Adult Spinal Deformity Surgery: Evaluation of the Category of Complication and Chronology.

OBJECTIVE: Provide benchmarks for the rates of complications by type and timing. STUDY DESIGN: Prospective multicenter database. BACKGROUND: Complication rates following adult spinal deformity (ASD) surgery have been previously reported. However, the interplay between timing and complication type warrants further analysis. METHODS: The data for this study were sourced from a prospective, multicenter ASD database. Date and type of complication were collected and classified into three severity groups (minor, major, major leading to reoperation). Only complications occurring before the 2-year visit were retained for analysis. RESULTS: Of the 1260 patients eligible for 2-year follow-up, 997 (79.1%) achieved 2-year follow-up. The overall complication rate was 67.4% (N=672). 247 patients (24.8%) experienced at least one complication on the day of surgery (including intra-operatively), 359 (36.0%) between post-op day 1 and 6 weeks post-op, 271 (27.2%) between 6 weeks and 1 one -year post-op, and finally 162 (16.3%) between 1 year and 2 years post-op. Using Kaplan-Meier survival analysis, the rate of remaining complication-free was estimated at different time points for different severities and types of complications. Stratification by type of complication demonstrated that most of the medical complications occurred within the first 60 days. Surgical complications presented over two distinct timeframes. Operative complications, incision-related complications, and infections occurred early (within 60 d), while implant-related and radiographic complications occurred at a constant rate over the 2-year follow-up period. Neurologic complications had the highest occurrence within the first 60 days but continued to increase up to the 2-year visit. CONCLUSION: Only one-third of ASD patients remained complication-free by 2 years, and 2 out of 10 patients had a complication requiring a reoperation or revision. Estimation of timing and type of complication associated with surgical treatment may prove useful for more meaningful patient counseling and aid in assessing the cost-effectiveness of treatment.

Impact of Hip and Knee Osteoarthritis on Full Body Sagittal Alignment and Compensation for Sagittal Spinal Deformity.

STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To investigate the effect of lower extremity osteoarthritis on sagittal alignment and compensatory mechanisms in adult spinal deformity (ASD). BACKGROUND: Spine, hip, and knee pathologies often overlap in ASD patients. Limited data exists on how lower extremity osteoarthritis impacts sagittal alignment and compensatory mechanisms in ASD. PATIENTS AND METHODS: In total, 527 preoperative ASD patients with full body radiographs were included. Patients were grouped by Kellgren-Lawrence grade of bilateral hips and knees and stratified by quartile of T1-Pelvic Angle (T1PA) severity into low-, mid-, high-, and severe-T1PA. Full-body alignment and compensation were compared across quartiles. Regression analysis examined the incremental impact of hip and knee osteoarthritis severity on compensation. RESULTS: The mean T1PA for low-, mid-, high-, and severe-T1PA groups was 7.3°, 19.5°, 27.8°, and 41.6°, respectively. Mid-T1PA patients with severe hip osteoarthritis had an increased sagittal vertical axis and global sagittal alignment ( P <0.001). Increasing hip osteoarthritis severity resulted in decreased pelvic tilt ( P =0.001) and sacrofemoral angle ( P <0.001), but increased knee flexion ( P =0.012). Regression analysis revealed that with increasing T1PA, pelvic tilt correlated inversely with hip osteoarthritis and positively with knee osteoarthritis ( r2 =0.812). Hip osteoarthritis decreased compensation through sacrofemoral angle (ß-coefficient=-0.206). Knee and hip osteoarthritis contributed to greater knee flexion (ß-coefficients=0.215, 0.101; respectively). For pelvic shift, only hip osteoarthritis significantly contributed to the model (ß-coefficient=0.100). CONCLUSIONS: For the same magnitude of spinal deformity, increased hip osteoarthritis severity was associated with worse truncal and full body alignment with posterior translation of the pelvis. Patients with severe hip and knee osteoarthritis exhibited decreased hip extension and pelvic tilt but increased knee flexion. This examines sagittal alignment and compensation in ASD patients with hip and knee arthritis and may help delineate whether hip and knee flexion is due to spinal deformity compensation or lower extremity osteoarthritis.

Development of a modified frailty index for adult spinal deformities independent of functional changes following surgical correction: a true baseline risk assessment tool.

PURPOSE: To develop a simplified, modified frailty index for adult spinal deformity (ASD) patients dependent on objective clinical factors. METHODS: ASD patients with baseline (BL) and 2-year (2Y) follow-up were included. Factors with the largest R2 value derived from multivariate forward stepwise regression were including in the modified ASD-FI (clin-ASD-FI). Factors included in the clin-ASD-FI were regressed against mortality, extended length of hospital stay (LOS, > 8 days), revisions, major complications and weights for the clin-ASD-FI were calculated via Beta/Sullivan. Total clin-ASD-FI score was created with a score from 0 to 1. Linear regression correlated clin-ASD-FI with ASD-FI scores and published cutoffs for the ASD-FI were used to create the new frailty cutoffs: not frail (NF: < 0.11), frail (F: 0.11-0.21) and severely frail (SF: > 0.21). Binary logistic regression assessed odds of complication or reop for frail patients. RESULTS: Five hundred thirty-one ASD patients (59.5 yrs, 79.5% F) were included. The final model had a R2 of 0.681, and significant factors were: < 18.5 or > 30 BMI (weight: 0.0625 out of 1), cardiac disease (0.125), disability employment status (0.3125), diabetes mellitus (0.0625), hypertension (0.0625), osteoporosis (0.125), blood clot (0.1875), and bowel incontinence (0.0625). These factors calculated the score from 0 to 1, with a mean cohort score of 0.13 ± 0.14. Breakdown by clin-ASD-FI score: 51.8% NF, 28.1% F, 20.2% SF. Increasing frailty severity was associated with longer LOS (NF: 7.0, F: 8.3, SF: 9.2 days; P < 0.001). Frailty independently predicted occurrence of any complication (OR: 9.357 [2.20-39.76], P = 0.002) and reop (OR: 2.79 [0.662-11.72], P = 0.162). CONCLUSIONS: Utilizing an existing ASD frailty index, we proposed a modified version eliminating the patient-reported components. This index is a true assessment of physiologic status, and represents a superior risk factor assessment compared to other tools for both primary and revision spinal deformity surgery as a result of its immutability with surgery, lack of subjectivity, and ease of use.

Predictors of pelvic tilt normalization: a multicenter study on the impact of regional and lower-extremity compensation on pelvic alignment after complex adult spinal deformity surgery.

OBJECTIVE: The objective was to determine the degree of regional decompensation to pelvic tilt (PT) normalization after complex adult spinal deformity (ASD) surgery. METHODS: Operative ASD patients with 1 year of PT measurements were included. Patients with normalized PT at baseline were excluded. Predicted PT was compared to actual PT, tested for change from baseline, and then compared against age-adjusted, Scoliosis Research Society-Schwab, and global alignment and proportion (GAP) scores. Lower-extremity (LE) parameters included the cranial-hip-sacrum angle, cranial-knee-sacrum angle, and cranial-ankle-sacrum angle. LE compensation was set as the 1-year upper tertile compared with intraoperative baseline. Univariate analyses were used to compare normalized and nonnormalized data against alignment outcomes. Multivariable logistic regression analyses were used to develop a model consisting of significant predictors for normalization related to regional compensation. RESULTS: In total, 156 patients met the inclusion criteria (mean ± SD age 64.6 ± 9.1 years, BMI 27.9 ± 5.6 kg/m2, Charlson Comorbidity Index 1.9 ± 1.6). Patients with normalized PT were more likely to have overcorrected pelvic incidence minus lumbar lordosis and sagittal vertical axis at 6 weeks (p < 0.05). GAP score at 6 weeks was greater for patients with nonnormalized PT (0.6 vs 1.3, p = 0.08). At baseline, 58.5% of patients had compensation in the thoracic and cervical regions. Postoperatively, compensation was maintained by 42% with no change after matching in age-adjusted or GAP score. The patients with nonnormalized PT had increased rates of thoracic and cervical compensation (p < 0.05). Compensation in thoracic kyphosis differed between patients with normalized PT at 6 weeks and those with normalized PT at 1 year (69% vs 35%, p < 0.05). Those who compensated had increased rates of implant complications by 1 year (OR [95% CI] 2.08 [1.32-6.56], p < 0.05). Cervical compensation was maintained at 6 weeks and 1 year (56% vs 43%, p = 0.12), with no difference in implant complications (OR 1.31 [95% CI -2.34 to 1.03], p = 0.09). For the lower extremities at baseline, 61% were compensating. Matching age-adjusted alignment did not eliminate compensation at any joint (all p > 0.05). Patients with nonnormalized PT had higher rates of LE compensation across joints (all p < 0.01). Overall, patients with normalized PT at 1 year had the greatest odds of resolving LE compensation (OR 9.6, p < 0.001). Patients with normalized PT at 1 year had lower rates of implant failure (8.9% vs 19.5%, p < 0.05), rod breakage (1.3% vs 13.8%, p < 0.05), and pseudarthrosis (0% vs 4.6%, p < 0.05) compared with patients with nonnormalized PT. The complication rate was significantly lower for patients with normalized PT at 1 year (56.7% vs 66.1%, p = 0.02), despite comparable health-related quality of life scores. CONCLUSIONS: Patients with PT normalization had greater rates of resolution in thoracic and LE compensation, leading to lower rates of complications by 1 year. Thus, consideration of both the lower extremities and thoracic regions in surgical planning is vital to preventing adverse outcomes and maintaining pelvic alignment.

Lumbar Lordosis Redistribution and Segmental Correction in Adult Spinal Deformity (ASD): Does it Matter?

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: Evaluate the impact of correcting to normative segmental lordosis values on post-operative outcomes. BACKGROUND: Restoring lumbar lordosis magnitude is crucial in adult spinal deformity surgery, but the optimal location and segmental distribution remains unclear. METHODS: Patients were grouped based on offset to normative segmental lordosis values, extracted from recent publications. Matched patients were within 10% of the cohort's mean offset, less than or over 10% were under- and over-corrected. Surgical technique, PROMs, and surgical complications were compared across groups at baseline and 2-year. RESULTS: 510 patients with an average age of 64.6, mean CCI 2.08, and average follow-up of 25 months. L4-5 was least likely to be matched (19.1%), while L4-S1 was the most likely (24.3%). More patients were overcorrected at proximal levels (T10-L2; Undercorrected, U: 32.2% vs. Matched, M: 21.7% vs. Overcorrected, O: 46.1%) and undercorrected at distal levels (L4-S1: U: 39.0% vs. M: 24.3% vs. O: 36.8%). Postoperative ODI was comparable across correction groups at all spinal levels except at L4-S1 and T10-L2/L4-S1, where overcorrected patients and matched were better than undercorrected (U: 32.1 vs. M: 25.4 vs. O: 26.5, P=0.005; U: 36.2 vs. M: 24.2 vs. O: 26.8, P=0.001; respectively). Patients overcorrected at T10-L2 experienced higher rates of proximal junctional failure (PJF) (U: 16.0% vs. M: 15.6% vs. O: 32.8%, P<0.001) and had greater posterior inclination of the upper instrumented vertebra (UIV) (U: -9.2±9.4° vs. M: -9.6±9.1° vs. O: -12.2±10.0°, P<0.001), whereas undercorrection at these levels led to higher rates of revision for implant failure (U: 14.2% vs. M: 7.3% vs. O: 6.4%, P=0.025). CONCLUSIONS: Patients undergoing fusion for adult spinal deformity suffer higher rates of PJF with overcorrection and increased rates of implant failure with undercorrection based on normative segmental lordosis. LEVEL OF EVIDENCE: IV.

Persistent Lower Extremity Compensation for Sagittal Imbalance After Surgical Correction of Complex Adult Spinal Deformity: A Radiographic Analysis of Early Impact.

BACKGROUND AND OBJECTIVES: Achieving spinopelvic realignment during adult spinal deformity (ASD) surgery does not always produce ideal outcomes. Little is known whether compensation in lower extremities (LEs) plays a role in this disassociation. The objective is to analyze lower extremity compensation after complex ASD surgery, its effect on outcomes, and whether correction can alleviate these mechanisms. METHODS: We included patients with complex ASD with 6-week data. LE parameters were as follows: sacrofemoral angle, knee flexion angle, and ankle flexion angle. Each parameter was ranked, and upper tertile was deemed compensation. Patients compensating and not compensating postoperatively were propensity score matched for body mass index, frailty, and T1 pelvic angle. Linear regression assessed correlation between LE parameters and baseline deformity, demographics, and surgical details. Multivariate analysis controlling for baseline deformity and history of total knee/hip arthroplasty evaluated outcomes. RESULTS: Two hundred and ten patients (age: 61.3 ± 14.1 years, body mass index: 27.4 ± 5.8 kg/m2, Charlson Comorbidity Index: 1.1 ± 1.6, 72% female, 22% previous total joint arthroplasty, 24% osteoporosis, levels fused: 13.1 ± 3.8) were included. At baseline, 59% were compensating in LE: 32% at hips, 39% knees, and 36% ankles. After correction, 61% were compensating at least one joint. Patients undercorrected postoperatively were less likely to relieve LE compensation (odds ratio: 0.2, P = .037). Patients compensating in LE were more often undercorrected in age-adjusted pelvic tilt, pelvic incidence, lumbar lordosis, and T1 pelvic angle and disproportioned in Global Alignment and Proportion (P < .05). Patients matched in sagittal age-adjusted score at 6 weeks but compensating in LE were more likely to develop proximal junctional kyphosis (odds ratio: 4.1, P = .009) and proximal junctional failure (8% vs 0%, P = .035) than those sagittal age-adjusted score-matched and not compensating in LE. CONCLUSION: Perioperative lower extremity compensation was a product of undercorrecting complex ASD. Even in age-adjusted realignment, compensation was associated with global undercorrection and junctional failure. Consideration of lower extremities during planning is vital to avoid adverse outcomes in perioperative course after complex ASD surgery.

Determining the best vertebra for measuring pelvic incidence and spinopelvic parameters in adult spinal deformity patients with transitional anatomy.

OBJECTIVE: The aim of this study was to determine if spinal deformity patients with L5 sacralization should have pelvic incidence (PI) and other spinopelvic parameters measured from the L5 or S1 endplate. METHODS: This study was a multicenter retrospective comparative cohort study comprising a large database of adult spinal deformity (ASD) patients and a database of asymptomatic individuals. Linear regression modeling was used to determine normative T1 pelvic angle (TPA) and PI - lumbar lordosis (LL) mismatch (PI-LL) based on PI and age in a database of asymptomatic subjects. In an ASD database, patients with radiographic evidence of L5 sacralization had the PI, LL, and TPA measured from the superior endplate of S1 and then also from L5. The differences in TPA and PI-LL from normative were calculated in the sacralization cohort relative to L5 and S1 and correlated to the Oswestry Disability Index (ODI). Patients were grouped based on the Scoliosis Research Society (SRS)-Schwab PI-LL modifier (0, +, or ++) using the L5 PI-LL and S1 PI-LL. Baseline ODI and SF-36 Physical Component Summary (PCS) scores were compared across and within groups. RESULTS: Among 1179 ASD patients, 276 (23.4%) had transitional anatomy, 176 with sacralized L5 (14.9%) and 100 (8.48%) with lumbarization of S1. The 176 patients with sacralized L5 were analyzed. When measured using the L5 superior endplate, pelvic parameters were significantly smaller than those measured relative to S1 (PI: 24.5° ± 11.0° vs 55.7° ± 12.0°, p = 0.001;TPA: 11.2° ± 12.0° vs 20.3° ± 12.5°, p = 0.001; and PI-LL: 0.67° ± 21.1° vs 11.4° ± 20.8°, p = 0.001). When measured from S1, 76 (43%), 45 (25.6%), and 55 (31.3%) patients had SRS-Schwab PI-LL modifiers of 0, +, and ++, respectively, compared with 124 (70.5%), 22 (12.5%), and 30 (17.0%), respectively, when measured from L5. There were significant differences in ODI and PCS scores as the SRS-Schwab grade increased regardless of L5 or S1 measurement. The L5 group had lower PCS functional scores for SRS-Schwab modifiers 0 and ++ relative to same grades in the S1 group. Offset from normative TPA (0.5° ± 11.1° vs 9.6° ± 10.8°, p = 0.001) and PI-LL (4.5° ± 20.4° vs 15.2° ± 19.3°, p = 0.001) were smaller when measuring from L5. Moreover, S1 measurements were more correlated with health status by ODI (TPA offset from normative: S1, R = 0.326 vs L5, R = 0.285; PI-LL offset from normative: S1, R = 0.318 vs L5, R = 0.274). CONCLUSIONS: Measuring the PI and spinopelvic parameters at L5 in sacralized anatomy results in underestimating spinal deformity and is less correlated with health-related quality of life. Surgeons may consider measuring PI and spinopelvic parameters relative to S1 rather than at L5 in patients with a sacralized L5.

The Case for Operative Efficiency in Adult Spinal Deformity Surgery: Impact of Operative Time on Complications, Length of Stay, Alignment, Fusion Rates, and Patient-Reported Outcomes.

STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To analyze the impact of operative room (OR) time in adult spinal deformity (ASD) surgery on patient outcomes. BACKGROUND: It is currently unknown if OR time in ASD patients matched for deformity severity and surgical invasiveness is associated with patient outcomes. MATERIALS AND METHODS: ASD patients with baseline and two-year postoperative radiographic and patient-reported outcome measures (PROM) data, undergoing a posterior-only approach for long fusion (>L1-Ilium) were included. Patients were grouped into short OR time (<40th percentile: <359 min) and long OR time (>60th percentile: >421 min). Groups were matched by age, baseline deformity severity, and surgical invasiveness. Demographics, radiographic, PROM data, fusion rate, and complications were compared between groups at baseline and two years follow-up. RESULTS: In total, 270 patients were included for analysis: the mean OR time was 286 minutes in the short OR group versus 510 minutes in the long OR group ( P <0.001). Age, gender, percent of revision cases, surgical invasiveness, pelvic incidence minus lumbar lordosis, sagittal vertical axis, and pelvic tilt were comparable between groups ( P >0.05). Short OR had a slightly lower body mass index than the short OR group ( P <0.001) and decompression was more prevalent in the long OR time ( P =0.042). Patients in the long group had greater hospital length of stay ( P =0.02); blood loss ( P <0.001); proportion requiring intensive care unit ( P =0.003); higher minor complication rate ( P =0.001); with no significant differences for major complications or revision procedures ( P >0.5). Both groups had comparable radiographic fusion rates ( P =0.152) and achieved improvement in sagittal alignment measures, Oswestry disability index, and Short Form-36 ( P <0.001). CONCLUSION: Shorter OR time for ASD correction is associated with a lower minor complication rate, a lower estimated blood loss, fewer intensive care unit admissions, and a shorter hospital length of stay without sacrificing alignment correction or PROMs. Maximizing operative efficiency by minimizing OR time in ASD surgery has the potential to benefit patients, surgeons, and hospital systems.

Patient-specific Cervical Deformity Corrections With Consideration of Associated Risk: Establishment of Risk Benefit Thresholds for Invasiveness Based on Deformity and Frailty Severity.

STUDY DESIGN/SETTING: This was a retrospective cohort study. BACKGROUND: Little is known of the intersection between surgical invasiveness, cervical deformity (CD) severity, and frailty. OBJECTIVE: The aim of this study was to investigate the outcomes of CD surgery by invasiveness, frailty status, and baseline magnitude of deformity. METHODS: This study included CD patients with 1-year follow-up. Patients stratified in high deformity if severe in the following criteria: T1 slope minus cervical lordosis, McGregor's slope, C2-C7, C2-T3, and C2 slope. Frailty scores categorized patients into not frail and frail. Patients are categorized by frailty and deformity (not frail/low deformity; not frail/high deformity; frail/low deformity; frail/high deformity). Logistic regression assessed increasing invasiveness and outcomes [distal junctional failure (DJF), reoperation]. Within frailty/deformity groups, decision tree analysis assessed thresholds for an invasiveness cutoff above which experiencing a reoperation, DJF or not achieving Good Clinical Outcome was more likely. RESULTS: A total of 115 patients were included. Frailty/deformity groups: 27% not frail/low deformity, 27% not frail/high deformity, 23.5% frail/low deformity, and 22.5% frail/high deformity. Logistic regression analysis found increasing invasiveness and occurrence of DJF [odds ratio (OR): 1.03, 95% CI: 1.01-1.05, P =0.002], and invasiveness increased with deformity severity ( P <0.05). Not frail/low deformity patients more often met Optimal Outcome with an invasiveness index <63 (OR: 27.2, 95% CI: 2.7-272.8, P =0.005). An invasiveness index <54 for the frail/low deformity group led to a higher likelihood of meeting the Optimal Outcome (OR: 9.6, 95% CI: 1.5-62.2, P =0.018). For the frail/high deformity group, patients with a score <63 had a higher likelihood of achieving Optimal Outcome (OR: 4.8, 95% CI: 1.1-25.8, P =0.033). There was no significant cutoff of invasiveness for the not frail/high deformity group. CONCLUSIONS: Our study correlated increased invasiveness in CD surgery to the risk of DJF, reoperation, and poor clinical success. The thresholds derived for deformity severity and frailty may enable surgeons to individualize the invasiveness of their procedures during surgical planning to account for the heightened risk of adverse events and minimize unfavorable outcomes.