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.

Dysphagia After Anterior Cervical Spine Surgery: Pathophysiology, Diagnosis, and Management.

Anterior cervical spine surgery (ACSS) is a surgical intervention widely used for a myriad of indications including degenerative, oncologic, inflammatory, traumatic, and congenital spinal conditions. A primary concern for surgeons performing ACSS is the postoperative development of oropharyngeal dysphagia. Current literature reports a wide incidence of this complication ranging from 1 to 79%. Dysphagia after ACSS is multifactorial, with common risk factors being prolonged duration of operation, revision surgeries, multilevel surgeries, and use of recombinant human bone morphogenetic protein-2. Many technical strategies have been developed to reduce the risk of postoperative dysphagia, including the development of low-profile implants and retropharyngeal local steroid application. In this article, we review the most recent literature regarding the epidemiology and pathophysiology, diagnostic criteria, risk factors, and management of dysphagia after ACSS.

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.

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.

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.

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.

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.

Are insufficient corrections a major factor in distal junctional kyphosis? A simulated analysis of cervical deformity correction using in-construct measurements.

OBJECTIVE: The present study utilized recently developed in-construct measurements in simulations of cervical deformity surgery in order to assess undercorrection and predict distal junctional kyphosis (DJK). METHODS: A retrospective review of a database of operative cervical deformity patients was analyzed for severe DJK and mild DJK. C2-lower instrumented vertebra (LIV) sagittal angle (SA) was measured postoperatively, and the correction was simulated in the preoperative radiograph in order to match the C2-LIV by using the planning software. Linear regression analysis that used C2 pelvic angle (CPA) and pelvic tilt (PT) determined the simulated PT that matched the virtual CPA. Linear regression analysis was used to determine the C2-T1 SA, C2-T4 SA, and C2-T10 SA that corresponded to DJK of 20° and cervical sagittal vertical axis (cSVA) of 40 mm. RESULTS: Sixty-nine cervical deformity patients were included. Severe and mild DJK occurred in 11 (16%) and 22 (32%) patients, respectively; 3 (4%) required DJK revision. Simulated corrections demonstrated that severe and mild DJK patients had worse alignment compared to non-DJK patients in terms of cSVA (42.5 mm vs 33.0 mm vs 23.4 mm, p < 0.001) and C2-LIV SVA (68.9 mm vs 57.3 mm vs 36.8 mm, p < 0.001). Linear regression revealed the relationships between in-construct measures (C2-T1 SA, C2-T4 SA, and C2-T10 SA), cSVA, and change in DJK (all R > 0.57, p < 0.001). A cSVA of 40 mm corresponded to C2-T4 SA of 10.4° and C2-T10 SA of 28.0°. A DJK angle change of 10° corresponded to C2-T4 SA of 5.8° and C2-T10 SA of 20.1°. CONCLUSIONS: Simulated cervical deformity corrections demonstrated that severe DJK patients have insufficient corrections compared to patients without DJK. In-construct measures assess sagittal alignment within the fusion separate from DJK and subjacent compensation. They can be useful as intraoperative tools to gauge the adequacy of cervical deformity correction.

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.

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.

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.

Functional Alignment Within the Fusion in Adult Spinal Deformity (ASD) Improves Outcomes and Minimizes Mechanical Failures.

STUDY DESIGN: Retrospective review of an adult deformity database. OBJECTIVE: To identify pelvic incidence (PI) and age-appropriate physical function alignment targets using a component angle of T1-pelvic angle within the fusion to define correction and their relationship to proximal junctional kyphosis (PJK) and clinical outcomes. SUMMARY OF BACKGROUND DATA: In preoperative planning, a patient's PI is often utilized to determine the alignment target. In a trend toward more patient-specific planning, age-specific alignment has been shown to reduce the risk of mechanical failures. PI and age have not been analyzed with respect to defining a functional alignment. METHODS: A database of patients with operative adult spinal deformity was analyzed. Patients fused to the pelvis and upper-instrumented vertebrae above T11 were included. Alignment within the fusion correlated with clinical outcomes and PI. Short form 36-Physical Component Score (SF36-PCS) normative data and PI were used to compute functional alignment for each patient. Overcorrected, under-corrected, and functionally corrected groups were determined using T10-pelvic angle (T10PA). RESULTS: In all, 1052 patients met the inclusion criteria. T10PA correlated with SF36-PCS and PI (R=0.601). At six weeks, 40.7% were functionally corrected, 39.4% were overcorrected, and 20.9% were under-corrected. The PJK incidence rate was 13.6%. Overcorrected patients had the highest PJK rate (18.1%) compared with functionally (11.3%) and under-corrected (9.5%) patients ( P <0.05). Overcorrected patients had a trend toward more PJK revisions. All groups improved in HRQL; however, under-corrected patients had the worst 1-year SF36-PCS offset relative to normative patients of equivalent age (-8.1) versus functional (-6.1) and overcorrected (-4.5), P <0.05. CONCLUSIONS: T10PA was used to determine functional alignment, an alignment based on PI and age-appropriate physical function. Correcting patients to functional alignment produced improvements in clinical outcomes, with the lowest rates of PJK. This patient-specific approach to spinal alignment provides adult spinal deformity correction targets that can be used intraoperatively.

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.

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.

Efficacy of Varying Surgical Approaches on Achieving Optimal Alignment in Adult Spinal Deformity Surgery.

BACKGROUND: The Roussouly, SRS-Schwab, and Global Alignment and Proportion (GAP) classifications define alignment by spinal shape and deformity severity. The efficacy of different surgical approaches and techniques to successfully achieve these goals is not well understood. PURPOSE: Identify the impact of surgical approach and/or technique on meeting complex realignment goals in adult spinal deformity (ASD) corrective surgery. STUDY DESIGN/SETTING: Retrospective study. MATERIALS AND METHODS: Included patients with ASD fused to pelvis with 2-year data. Patients were categorized by: (1) Roussouly: matching current and theoretical spinal shapes, (2) improving in SRS-Schwab modifiers (0, +, ++), and (3) improving GAP proportionality by 2 years. Analysis of covariance and multivariable logistic regression analyses controlling for age, levels fused, baseline deformity, and 3-column osteotomy usage compared the effect of different surgical approaches, interbody, and osteotomy use on meeting realignment goals. RESULTS: A total of 693 patients with ASD were included. By surgical approach, 65.7% were posterior-only and 34.3% underwent anterior-posterior approach with 76% receiving an osteotomy (21.8% 3-column osteotomy). By 2 years, 34% matched Roussouly, 58% improved in GAP, 45% in SRS-Schwab pelvic tilt (PT), 62% sagittal vertical axis, and 70% pelvic incidence-lumbar lordosis. Combined approaches were most effective for improvement in PT [odds ratio (OR): 1.7 (1.1-2.5)] and GAP [OR: 2.2 (1.5-3.2)]. Specifically, anterior lumbar interbody fusion (ALIF) below L3 demonstrated higher rates of improvement versus TLIFs in Roussouly [OR: 1.7 (1.1-2.5)] and GAP [OR: 1.9 (1.3-2.7)]. Patients undergoing pedicle subtraction osteotomy at L3 or L4 were more likely to improve in PT [OR: 2.0 (1.0-5.2)] and pelvic incidence-lumbar lordosis [OR: 3.8 (1.4-9.8)]. Clinically, patients undergoing the combined approach demonstrated higher rates of meeting SCB in Oswestry Disability Index by 2 years while minimizing rates of proximal junctional failure, most often with an ALIF at L5-S1 [Oswestry Disability Index-SCB: OR: 1.4 (1.1-2.0); proximal junctional failure: OR: 0.4 (0.2-0.8)]. CONCLUSIONS: Among patients undergoing ASD realignment, optimal lumbar shape and proportion can be achieved more often with a combined approach. Although TLIFs, incorporating a 3-column osteotomy, at L3 and L4 can restore lordosis and normalize pelvic compensation, ALIFs at L5-S1 were most likely to achieve complex realignment goals with an added clinical benefit and mitigation of junctional failure.

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.

Outcomes of Surgical Treatment for Patients With Mild Scoliosis and Age-Appropriate Sagittal Alignment With Minimum 2-Year Follow-up.

OBJECTIVE: The goal of this study was to determine if patients with mild scoliosis and age-appropriate sagittal alignment have favorable outcomes following surgical correction. METHODS: Retrospective review of a prospective, multicenter adult spinal deformity database. Inclusion criteria: operative patients age ≥18 years, and preoperative pelvic tilt, mismatch between pelvic incidence and lumbar lordosis (PI-LL), and C7 sagittal vertical axis all within established age-adjusted thresholds with minimum 2-year follow-up. Health-related quality of life (HRQoL) scores: Oswestry Disability Index (ODI), 36-item Short Form health survey (SF-36), Scoliosis Research Society-22R (SRS22R), back/leg pain Numerical Rating Scale and minimum clinically important difference (MCID)/substantial clinical benefit (SCB). Two-year and preoperative HRQoL radiographic data were compared. Patients with mild scoliosis (Mild Scoli, Max coronal Cobb 10°-30°) were compared to those with larger curves (Scoli). RESULTS: One hundred fifty-one patients included from 667 operative patients (82.8% women; average age, 56.4 ± 16.2 years). Forty-two patients (27.8%) included in Mild Scoli group. Mild Scoli group had significantly worse baseline leg pain, ODI, and physical composite scores (p < 0.02). Mean 2-year maximum coronal Cobb angle was significantly improved compared to baseline (p < 0.001). All 2-year HRQoL measures were significantly improved compared to (p < 0.001) except mental composite score, SRS activity and SRS mental for the Mild Scoli group (p > 0.05). From the mild Scoli group, 36%-74% met either MCID or SCB for the HRQoL measures. Sixty-four point three percent had minimum 1 complication, 28.6% had a major complication, 35.7% had reoperation. CONCLUSION: Mild scoliosis patients with age-appropriate sagittal alignment benefit from surgical correction, decompression, and stabilization at 2 years postoperative despite having a high complication rate.

Are We Focused on the Wrong Early Postoperative Quality Metrics? Optimal Realignment Outweighs Perioperative Risk in Adult Spinal Deformity Surgery.

BACKGROUND: While reimbursement is centered on 90-day outcomes, many patients may still achieve optimal, long-term outcomes following adult spinal deformity (ASD) surgery despite transient short-term complications. OBJECTIVE: Compare long-term clinical success and cost-utility between patients achieving optimal realignment and suboptimally aligned peers. STUDY DESIGN/SETTING: Retrospective cohort study of a prospectively collected multicenter database. METHODS: ASD patients with two-year (2Y) data included. Groups were propensity score matched (PSM) for age, frailty, body mass index (BMI), Charlson Comorbidity Index (CCI), and baseline deformity. Optimal radiographic criteria are defined as meeting low deformity in all three (Scoliosis Research Society) SRS-Schwab parameters or being proportioned in Global Alignment and Proportionality (GAP). Cost-per-QALY was calculated for each time point. Multivariable logistic regression analysis and ANCOVA (analysis of covariance) adjusting for baseline disability and deformity (pelvic incidence (PI), pelvic incidence minus lumbar lordosis (PI-LL)) were used to determine the significance of surgical details, complications, clinical outcomes, and cost-utility. RESULTS: A total of 930 patients were considered. Following PSM, 253 "optimal" (O) and 253 "not optimal" (NO) patients were assessed. The O group underwent more invasive procedures and had more levels fused. Analysis of complications by two years showed that the O group suffered less overall major (38% vs. 52%, p = 0.021) and major mechanical complications (12% vs. 22%, p = 0.002), and less reoperations (23% vs. 33%, p = 0.008). Adjusted analysis revealed O patients more often met MCID (minimal clinically important difference) in SF-36 PCS, SRS-22 Pain, and Appearance. Cost-utility-adjusted analysis determined that the O group generated better cost-utility by one year and maintained lower overall cost and costs per QALY (both p < 0.001) at two years. CONCLUSIONS: Fewer late complications (mechanical and reoperations) are seen in optimally aligned patients, leading to better long-term cost-utility overall. Therefore, the current focus on avoiding short-term complications may be counterproductive, as achieving optimal surgical correction is critical for long-term success.

Economic burden of nonoperative treatment of adult spinal deformity.

OBJECTIVE: The purpose of this study was to investigate the cost utility of nonoperative treatment for adult spinal deformity (ASD). METHODS: Nonoperatively and operatively treated patients who met database criteria for ASD and in whom complete radiographic and health-related quality of life data at baseline and at 2 years were available were included. A cost analysis was completed on the PearlDiver database assessing the average cost of nonoperative treatment prior to surgical intervention based on previously published treatments (NSAIDs, narcotics, muscle relaxants, epidural steroid injections, physical therapy, and chiropractor). Utility data were calculated using the Oswestry Disability Index (ODI) converted to SF-6D with published conversion methods. Quality-adjusted life years (QALYs) used a 3% discount rate to account for residual decline in life expectancy (78.7 years). Minor and major comorbidities and complications were assessed according to the CMS.gov manual's definitions. Successful nonoperative treatment was defined as a gain in the minimum clinically importance difference (MCID) in both ODI and Scoliosis Research Society (SRS)-pain scores, and failure was defined as a loss in MCID or conversion to operative treatment. Patients with baseline ODI ≤ 20 and continued ODI of ≤ 20 at 2 years were considered nonoperative successful maintenance. The average utilization of nonoperative treatment and cost were applied to the ASD cohort. RESULTS: A total of 824 patients were included (mean age 58.24 years, 81% female, mean body mass index 27.2 kg/m2). Overall, 75.5% of patients were in the operative and 24.5% were in the nonoperative cohort. At baseline patients in the operative cohort were significantly older, had a greater body mass index, increased pelvic tilt, and increased pelvic incidence-lumbar lordosis mismatch (all p < 0.05). With respect to deformity, patients in the operative group had higher rates of severe (i.e., ++) sagittal deformity according to SRS-Schwab modifiers for pelvic tilt, sagittal vertical axis, and pelvic incidence-lumbar lordosis mismatch (p < 0.05). At 2 years, patients in the operative cohort showed significantly increased rates of a gain in MCID for physical component summary of SF-36, ODI, and SRS-activity, SRS-pain, SRS-appearance, and SRS-mental scores. Cost analysis showed the average cost of nonoperative treatment 2 years prior to surgical intervention to be $2041. Overall, at 2 years patients in the nonoperative cohort had again in ODI of 0.36, did not show a gain in QALYs, and nonoperative treatment was determined to be cost-ineffective. However, a subset of patients in this cohort underwent successful maintenance treatment and had a decrease in ODI of 1.1 and a gain in utility of 0.006 at 2 years. If utility gained for this cohort was sustained to full life expectancy, patients' cost per QALY was $18,934 compared to a cost per QALY gained of $70,690.79 for posterior-only and $48,273.49 for combined approach in patients in the operative cohort. CONCLUSIONS: Patients with ASD undergoing operative treatment at baseline had greater sagittal deformity and greater improvement in health-related quality of life postoperatively compared to patients treated nonoperatively. Additionally, patients in the nonoperative cohort overall had an increase in ODI and did not show improvement in utility gained. Patients in the nonoperative cohort who had low disability and sagittal deformity underwent successful maintenance and cost-effective treatment.