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.

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.

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.

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.

Left-digit bias in surgical decision-making for lumbar spinal stenosis.

BACKGROUND CONTEXT: Left-digit bias is a behavioral heuristic or cognitive "shortcut" in which the leftmost digit of a number, such as patient age, disproportionately influences surgical decisions. PURPOSE: To determine if left-digit bias in patient age influences the decision to perform arthrodesis with instrumentation vs decompression in lumbar spinal stenosis (LSS). DESIGN: Retrospective cohort. PATIENT SAMPLE: Patients with an ICD-10 diagnosis of lumbar stenosis or spondylolisthesis identified in the 2017-2021 National Surgical Quality Improvement Program (NSQIP) database. OUTCOME MEASURES: The primary outcome was the percent of patients who underwent arthrodesis with instrumentation (AwI). Matched age group comparisons without left-digit differences (ie, 76/77 vs 78/79, 80/81 vs 82/83, etc.) were performed to isolate the effect of the heuristic. Secondary outcomes including peri-operative events and complications were also compared within AwI and decompression cohorts. METHODS: Using CPT codes, procedures were classified as either AwI or decompression. Patients were grouped into 6 cohorts based on 2-year age windows (74/75, 76/77, 78/79, 80/81, 82/83, 84/85). The cohorts were propensity matched with neighboring age groups based on the presence of spondylolisthesis, demographics, and comorbidities. The primary comparison was between those aged 78/79 vs 80/81. RESULTS: After matching, the primary cohort consisted of two groups of 1,550 patients (aged 78/79 and 80/81). Patients aged 80/81 were less likely to undergo AwI than patients aged 78/79 (23.5% vs 27.2%, p=.021). AwI procedures occurred at similar rates between age groups with the same left digit. Within the decompression and AwI cohorts, there were no differences in secondary outcomes between patients aged 78/79 and 80/81. CONCLUSIONS: LSS patients aged 80/81 are less likely to undergo AwI than patients aged 78/79, regardless of comorbidities. This was not seen when comparing patients with similar left digits in age. Until objective measures of physiologic capacity are established, left-digit bias may influence clinical decisions.

Trends in Indications and Contraindications for Cervical Disk Arthroplasty from 2009 to 2019.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: Assess trends of indications and contraindications for the use of Cervical Disk Arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: As spine surgeons become more familiar with CDA, there have been expansions in indications. METHODS: The Medicare Provider Analysis and Review Limited Data Sets for 2009, 2014, and 2019 were utilized. Patients undergoing elective CDA were included. Diagnosis for index surgery and "contraindications" as defined by original CDA Investigative Device Exemption (IDE) criteria were assessed. Variables were identified by the International Classification of Diseases (ICD)-9 or ICD-10 diagnosis and procedural codes. RESULTS: A total of 1067 elective CDA patients were included. There were 230 patients in 2009, 300 patients in 2014, and 537 patients in 2019. The proportion of patients aged >65 increased from 35% to 51% (P<0.001). Incidence of CDA for radiculopathy increased from 57% to 69% (P<0.001), myelopathy increased from 23% to 78% (P<0.001), and spondylosis without radiculopathy or myelopathy decreased from 19% to 3% (P<0.001). There were increased incidences of ankylosing spondylitis (0.4% to 2.8%, P=0.007), long-term steroid use (1% to 2%, P=0.039), morbid obesity (2% to 6%, P=0.019), and osteoporosis (1% to 5%, P=0.014). The incidence of hybrid CDA and anterior cervical discectomy and fusion (ACDF) decreased from 28% to 23% (P=0.007). CONCLUSION: From 2009 to 2019, the number of CDA performed in older patients increased. An increase in the use of CDA for the treatment of myelopathy and radiculopathy and a decrease in the treatment of isolated cervical spondylosis was observed. The proportion of CDA performed in patients with original IDE trial "contraindications" increased. Further research into the efficacy of CDA for patients with contraindications is warranted.

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.

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.

Randomized Trial of Augmented Pelvic Fixation in Patients Undergoing Thoracolumbar Fusion for Adult Spine Deformity: Initial Results from a Multicenter Randomized Trial.

BACKGROUND: The optimal configuration for spinopelvic fixation during multilevel spine fusion surgery for adult spine deformity remains unclear. Postoperative sacroiliac (SI) joint pain, S2AI screw loosening and implant breakage could be related to continued motion of the SI joint with use of only a single point of fixation across the SI joint. METHODS: Prospective, international, multicenter randomized controlled trial of 222 patients with adult spine deformity scheduled for multilevel (4 or more levels) spine fusion surgery with pelvic fixation. Subjects were randomized to sacroalar (S2) iliac (S2AI) screws alone for pelvic fixation or S2AI + triangular titanium implants placed cephalad to S2AI screws. Quad rod techniques were not allowed or used. Baseline spinal deformity measures were read by an independent radiologist. Site-reported perioperative adverse events were reviewed by a clinical events committee. Quality of life questionnaires and other clinical outcomes are in process with planned 2-year follow-up. RESULTS: One hundred thirteen participants were assigned to S2AI and 109 to S2AI + titanium triangular implants (TTI). 35/222 (16%) of all subjects had a history of SI joint pain or were diagnosed with SI joint pain during preoperative workup. Three-month follow-up was available in all but 4 subjects. TTI placement was successful in 106 of 109 (98%) subjects assigned to TTI. In 2 cases, TTI could not be placed due to anatomical considerations. Three TTI ventral iliac breaches were observed, all of which were managed non-surgically. One TTI subject had a transverse sacral fracture and 1 TTI subject had malposition of the implant requiring removal. CONCLUSIONS: SI joint pain is common in patients with adult spinal deformity who are candidates for multilevel spine fusion surgery. Concurrent placement of TTI parallel to S2AI screws during multilevel spine fusion surgery is feasible and safe. Further follow-up will help to determine the clinical value of this approach to augment pelvic fixation.

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.

Reliability of Vertebral Pelvic Angles in Assessment of Spinal Alignment.

STUDY DESIGN: Reliability analysis. OBJECTIVES: Vertebral pelvic angles (VPA) are gaining popularity given their ability to describe the shape of the spine. Understanding the reliability and minimal detectable change (MDC) is necessary to determine how these measurement tools should be used in the manual assessment of spine radiographs. Our aim is to assess intra- and interobserver intraclass correlation coefficients (ICC) and the MDC in the use of VPA for assessing alignment in adult spinal deformity (ASD). METHODS: Three independent examiners blindly measured T1, T4, T9, L1, and L4PA twice in ASD patients with a 4-week window after the initial measurements. Patients who had undergone hip or shoulder arthroplasty, fused or transitional vertebrae, or whose hip joints were not visible on radiographs were excluded. Power analysis calculated a minimum sample size of 19. Both intra- and interobserver ICC and MDC, which denotes the smallest detectable change in a true value with 95% confidence, were calculated. RESULTS: Out of the 193 patients, 39 were ultimately included in the study, and 390 measurements were performed by 3 raters. Intraobserver ICC values ranged from .90 to .99. The interobserver ICC was .97, .97, .96, .95, and .92, and the MDC was 5.3°, 5.1°, 4.8°, 4.9°, and 4.1° for T1, T4, T9, L1, and L4PA, respectively. CONCLUSION: All VPAs showed excellent intra- and interobserver reliability, however, the MDC is relatively high compared to typical ranges for VPA values. Therefore, surgeons must be aware that substantial alignment changes may not be detected by a single VPA.

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.

Decisional regret following corrective adult spinal deformity surgery: a single institution study of incidence and risk factors.

PURPOSE: To assess the characteristics and risk factors for decisional regret following corrective adult spinal deformity (ASD) surgery at our hospital. METHODS: This is a retrospective cohort study of a single-surgeon ASD database. Adult patients (> 40 years) who underwent ASD surgery from May 2016 to December 2020 with minimum 2-year follow-up were included (posterior-only, ≥ 4 levels fused to the pelvis) (n = 120). Ottawa decision regret questionnaires, a validated and reliable 5-item Likert scale, were sent to patients postoperatively. Regret scores were defined as (1) low regret: 0-39 (2) medium to high regret: 40-100. Risk factors for medium or high decisional regret were identified using multivariate models. RESULTS: Ninety patients were successfully contacted and 77 patients consented to participate. Nonparticipants were older, had a higher incidence of anxiety, and higher ASA class. There were 7 patients that reported medium or high decisional regret (9%). Ninety percentage of patients believed that surgery was the right decision, 86% believed that surgery was a wise choice, and 87% would do it again. 8% of patients regretted the surgery and 14% believed that surgery did them harm. 88% of patients felt better after surgery. On multivariate analysis, revision fusion surgery was independently associated with an increased risk of medium or high decisional regret (adjusted odds ratio: 6.000, 95% confidence interval: 1.074-33.534, p = 0.041). CONCLUSIONS: At our institution, we found a 9% incidence of decisional regret. Revision fusion was associated with increased decisional regret. Estimates for decisional regret should be based on single-institution experiences given differences in patient populations.

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.

Revision-Free Loss of Sagittal Correction Greater Than Three Years After Adult Spinal Deformity Surgery: Who and Why?

STUDY DESIGN: Multicenter retrospective cohort study. OBJECTIVE: To investigate risk factors for loss of correction within the instrumented lumbar spine after adult spinal deformity surgery. SUMMARY OF BACKGROUND DATA: The sustainability of adult spinal deformity surgery remains a health care challenge. Malalignment is a major reason for revision surgery. PATIENTS AND METHODS: A total of 321 patients who underwent fusion of the lumbar spine (≥5 levels, LIV pelvis) with a revision-free follow-up of ≥3 years were identified. Patients were stratified by a change in pelvic incidence-lumbar lordosis from 6 weeks to 3 years postoperative as "maintained" versus "loss" >5°. Those with instrumentation failure (broken rod, screw pullout, etc .) were excluded before comparisons. Demographics, surgical data, and radiographic alignment were compared. Repeated measure analysis of variance was performed to evaluate the maintenance of the correction for L1-L4 and L4-S1. Multivariate logistic regression was conducted to identify independent surgical predictors of correction loss. RESULTS: The cohort had a mean age of 64 years, a mean Body Mass Index of 28 kg/m 2 , and 80% females. Eighty-two patients (25.5%) lost >5° of pelvic incidence-lumbar lordosis correction (mean loss 10±5°). After the exclusion of patients with instrumentation failure, 52 losses were compared with 222 maintained. Demographics, osteotomies, 3CO, interbody fusion, use of bone morphogenetic protein, rod material, rod diameter, and fusion length were not significantly different. L1-S1 screw orientation angle was 1.3 ± 4.1 from early postoperative to 3 years ( P = 0.031), but not appreciably different at L4-S1 (-0.1 ± 2.9 P = 0.97). Lack of a supplemental rod (odds ratio: 4.0, P = 0.005) and fusion length (odds ratio 2.2, P = 0.004) were associated with loss of correction. CONCLUSIONS: Approximately, a quarter of revision-free patients lose an average of 10° of their 6-week correction by 3 years. Lordosis is lost proximally through the instrumentation ( i.e. tulip/shank angle shifts and/or rod bending). The use of supplemental rods and avoiding sagittal overcorrection may help mitigate this loss.

Trans-sacral interbody fixation in long fusions to the sacrum for adult spinal deformity: complications and fusion rates at minimum two years follow-up.

PURPOSE: This study aims to investigate the fusion rate and complications associated with trans-sacral interbody fusion (TSIF) in long fusions to the sacrum for adult spinal deformity (ASD) over a two year follow-up period. Potential predictor variables associated with pseudarthrosis were also examined. METHODS: A retrospective clinical review was conducted on a consecutive series of ASD patients who underwent long fusions to the sacrum, with TSIF performed as a same-day or staged procedure. Patient demographics, bone mineral density, operative details, perioperative and late complications, and fusion rates were reviewed. Univariate analysis was used to identify the risk factors associated with pseudarthrosis. RESULTS: The study included 43 patients with an average age of 55.3 ± 8.9 years. The perioperative complication rate was 28%, with 12% of the complications directly related to TSIF. The late complication rate was 33%, with 16% related to TSIF. The most common complications were pseudarthrosis (14%) and postoperative ileus (7%). The overall radiographic fusion rate at two years was 86%. Univariate analysis revealed that revision surgery was significantly associated with pseudarthrosis (p = 0.027). Over the follow-up period, patients who underwent TSIF during long posterior fusions to the sacrum showed improvement in overall SRS scores, ODI scores, and SF-36 physical health and mental health (p < 0.05). CONCLUSION: TSIF is a relatively safe and minimally invasive method for achieving interbody fusion at the lumbosacral junction in the treatment of ASD, with acceptable fusion rates and a low complication rate. However, TSIF is not recommended for revision reconstruction in ASD.

Intravenous Ketorolac Substantially Reduces Opioid Use and Length of Stay After Lumbar Fusion: A Randomized Controlled Trial.

STUDY DESIGN: A randomized, double-blinded, placebo-controlled trial. OBJECTIVE: To examine the effect of intravenous ketorolac (IV-K) on hospital opioid use compared with IV-placebo (IV-P) and IV acetaminophen (IV-A). SUMMARY OF BACKGROUND DATA: Controlling postoperative pain while minimizing opioid use after lumbar spinal fusion is an important area of study. PATIENTS AND METHODS: Patients aged 18 to 75 years undergoing 1 to 2 level lumbar fusions between April 2016 and December 2019 were included. Patients with chronic opioid use, smokers, and those on systemic glucocorticoids or contraindications to study medications were excluded. A block randomization scheme was used, and study personnel, hospital staff, and subjects were blinded to the assignment. Patients were randomized postoperatively. The IV-K group received 15 mg (age > 65) or 30 mg (age < 65) every six hours (q6h) for 48 hours, IV-A received 1000 mg q6h, and IV-P received normal saline q6h for 48 hours. Demographic and surgical details, opioid use in morphine milliequivalents, opioid-related adverse events, and length of stay (LOS) were recorded. The primary outcome was in-hospital opioid use up to 72 hours. RESULTS: A total of 171 patients were included (58 IV-K, 55 IV-A, and 58 IV-P) in the intent-to-treat (ITT) analysis, with a mean age of 57.1 years. The IV-K group had lower opioid use at 72 hours (173 ± 157 mg) versus IV-A (255 ± 179 mg) and IV-P (299 ± 179 mg; P = 0.000). In terms of opiate use, IV-K was superior to IV-A ( P = 0.025) and IV-P ( P = 0.000) on ITT analysis, although on per-protocol analysis, the difference with IV-A did not reach significance ( P = 0.063). When compared with IV-P, IV-K patients reported significantly lower worst ( P = 0.004), best ( P = 0.001), average ( P = 0.001), and current pain ( P = 0.002) on postoperative day 1, and significantly shorter LOS ( P = 0.009) on ITT analysis. There were no differences in opioid-related adverse events, drain output, clinical outcomes, transfusion rates, or fusion rates. CONCLUSIONS: By reducing opioid use, improving pain control on postoperative day 1, and decreasing LOS without increases in complications or pseudarthrosis, IV-K may be an important component of "enhanced recovery after surgery" protocols.

Postoperative Discharge to Acute Rehabilitation or Skilled Nursing Facility Compared With Home Does Not Reduce Hospital Readmissions, Return to Surgery, or Improve Outcomes Following Adult Spine Deformity Surgery.

STUDY DESIGN: Retrospective review of a prospective multicenter adult spinal deformity (ASD) study. OBJECTIVE: The aim of this study was to evaluate 30-day readmissions, 90-day return to surgery, postoperative complications, and patient-reported outcomes (PROs) for matched ASD patients receiving nonhome discharge (NON), including acute rehabilitation (REHAB), and skilled nursing facility (SNF), or home (HOME) discharge following ASD surgery. SUMMARY OF BACKGROUND DATA: Postoperative disposition following ASD surgery frequently involves nonhome discharge. Little data exists for longer term outcomes for ASD patients receiving nonhome discharge versus patients discharged to home. MATERIALS AND METHODS: Surgically treated ASD patients prospectively enrolled into a multicenter study were assessed for NON or HOME disposition following hospital discharge. NON was further divided into REHAB or SNF. Propensity score matching was used to match for patient age, frailty, spine deformity, levels fused, and osteotomies performed at surgery. Thirty-day hospital readmissions, 90-day return to surgery, postoperative complications, and 1-year and minimum 2-year postoperative PROs were evaluated. RESULTS: A total of 241 of 374 patients were eligible for the study. NON patients were identified and matched to HOME patients. Following matching, 158 patients remained for evaluation; NON and HOME had similar preoperative age, frailty, spine deformity magnitude, surgery performed, and duration of hospital stay ( P >0.05). Thirty-day readmissions, 90-day return to surgery, and postoperative complications were similar for NON versus HOME and similar for REHAB (N=64) versus SNF (N=42) versus HOME ( P >0.05). At 1-year and minimum 2-year follow-up, HOME demonstrated similar to better PRO scores including Oswestry Disability Index, Short-Form 36v2 questionnaire Mental Component Score and Physical Component Score, and Scoliosis Research Society scores versus NON, REHAB, and SNF ( P <0.05). CONCLUSIONS: Acute needs must be considered following ASD surgery, however, matched analysis comparing 30-day hospital readmissions, 90-day return to surgery, postoperative complications, and PROs demonstrated minimal benefit for NON, REHAB, or SNF versus HOME at 1- and 2-year follow-up, questioning the risk and cost/benefits of routine use of nonhome discharge. LEVEL OF EVIDENCE: Level III-prognostic.