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ObjectiveAlthough short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.MethodsThe ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22.ResultsThe 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD.ConclusionsThe significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.

Objective: Malalignment following cervical spine deformity (CSD) surgery can negatively impact outcomes and increase complications. Despite the growing ability to plan alignment, it remains unclear whether preoperative goals are achieved with surgery. The objective of this study was to assess how good surgeons are at achieving their preoperative goal alignment following CSD surgery., Methods: Adult patients with CSD were prospectively enrolled into a multicenter registry. Surgeons documented alignment goals prior to surgery, including C2-7 sagittal vertical axis (SVA), C2-7 sagittal Cobb angle, T1 slope minus cervical lordosis (TS-CL), and C7-S1 SVA. Goals were compared with achieved alignment, and the offsets (achieved goal) were calculated. General linear models were created for offset magnitude for each alignment parameter, controlling for baseline deformity and surgical factors., Results: The 88 enrolled patients had a mean age of 63.6 ± 13.0 years. The mean number of anterior and posterior instrumented levels was 3.5 ± 1.0 and 10.6 ± 4.5, respectively. Surgeons failed to achieve their preoperative alignment goals by an average of 17.2 (range 0.1-75.4) mm for C2-7 SVA, 10.3° (range 0.1°-45.5°) for C2-7 sagittal Cobb angle, 15.6° (range 0.0°-42.9°) for TS-CL, and 34.2 (range 0.3-113.7) mm for C7-S1 SVA. The sagittal alignment parameters with the highest rate of extreme outliers were TS-CL and C7-S1 SVA, with 32.2% exceeding 20° and 60.8% exceeding 20 mm from goal alignment, respectively. After controlling for baseline deformity and operative parameters, the only factor associated with achieving targeted alignment for C2-7 sagittal Cobb angle was greater baseline thoracic kyphosis (TK; B = -0.148, 95% CI -0.288 to -0.007, p = 0.040), and for TS-CL, the only associated factor was lower baseline TS-CL (B = 0.187, 95% CI 0.027-0.347, p = 0.022). Both lower TK and greater TS-CL may reflect increased baseline deformity through greater thoracic compensation and increased TS-CL mismatch, respectively. No significant associations were identified for C2-7 SVA and C7-S1 SVA., Conclusions: Surgeons failed to achieve their preoperative alignment goals by an average of 17.2 mm for C2-7 SVA, 10.3° for C2-7 sagittal Cobb angle, 15.6° for TS-CL, and 34.2 mm for C7-S1 SVA. The few factors identified that were associated with offset between goal and achieved alignment suggest that achievement of goal alignment was most challenging for more severe deformities. Further advancements are needed to enable more consistent translation of preoperative alignment goals into the operating room for adult CSD correction. Clinical trial registration no.: NCT01588054 (ClinicalTrials.gov).

Objective: The objective of this study was to identify baseline patient and surgical factors predictive of optimal outcomes in staged versus same-day combined-approach surgery., Methods: Adult spinal deformity (ASD) patients with baseline and perioperative (by 6 weeks) data were stratified based on single-stage (same-day) or multistage (staged) surgery, excluding planned multiple hospitalizations. Means comparison analyses were used to assess baseline demographic, radiographic, and surgical differences between cohorts. Backstep logistic regression and conditional inference tree analysis were used to identify variable thresholds associated with study-specific definitions of an optimal outcome in each cohort, defined as no intraoperative or surgery-related in-hospital adverse event., Results: There were 439 patients with complex ASD in the dataset (mean age 64.0 ± 9.3 years, 68% female, mean BMI 28.7 ± 5.5 kg/m2). Overall, 58.8% of patients were in the same-day group, while 41.2% were in the staged group. Demographically, cohorts were not significantly different (p > 0.05), but staged patients were more frail per total Edmonton Frail Scale score (p = 0.043). Staged patients also reported greater numeric rating scale scores for back pain than same-day patients (p = 0.002). Cohorts were comparable in magnitude of planned correction of C7-S1 sagittal vertical axis, pelvic incidence-lumbar lordosis (PI-LL) mismatch, and T4-12 kyphosis (all p > 0.05). Controlling for baseline age, frailty, and number of levels fused, staged patients reported significantly higher PROMIS Discretionary Social Activities scores by 6 weeks (p = 0.029). Radiographic outcomes by 6 weeks were comparable between cohorts, in terms of both magnitude of change from baseline and overall result (all p > 0.05). Same-day patients were significantly more likely to experience in-hospital complications (p = 0.013). When considering frailty thresholds for staging, only a Charlson Comorbidity Index ≤ 1.0 was associated with optimal outcome in same-day patients, while Edmonton Frail Scale score ≥ 7 (p = 0.036), ≥ 9 levels fused (p = 0.016), and baseline PI-LL mismatch ≥ 15.3° (p = 0.028) were associated with optimal outcome for staged patients. Yet, staging alone was not significantly associated with an optimal outcome perioperatively (p = 0.056)., Conclusions: While staged and same-day combined-approach surgeries yield comparable radiographic and patient-reported outcomes, certain subsets of complex ASD patients may benefit from staged surgery despite the invariably increased hospital length of stay. Individuals with increased frailty, moderate to severe PI-LL mismatch, and increased anticipated number of levels fused may experience a lower risk of perioperative adverse events if they undergo a staged procedure. Clinical trial registration no.: NCT04194138 (ClinicalTrials.gov).

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.

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.

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.

In this review, the value of patient-reported outcome measures, immersive technology, and patient review systems is discussed, and these strategies are presented as ways to enhance both the research and clinical aspects of a practice. The value of a research team and open access research databases is also discussed. Establishing a research program does not need elaborate resources to sustain efforts. The aforementioned simple yet effective strategies can enhance the clinical and research experience for surgeons in both academic and private practice settings.

Objective: Deterioration of global coronal alignment (GCA) may be associated with worse outcomes after adult spinal deformity (ASD) surgery. The impact of fusion length and upper instrumented vertebra (UIV) selection on patients with this complication is unclear. The authors' objective was to compare outcomes between long sacropelvic fusion with upper-thoracic (UT) UIV and those with lower-thoracic (LT) UIV in patients with worsening GCA ≥ 1 cm., Methods: This was a retrospective analysis of a prospective multicenter database of consecutive ASD patients. Index operations involved instrumented fusion from sacropelvis to thoracic spine. Global coronal deterioration was defined as worsening GCA ≥ 1 cm from preoperation to 2-year follow-up., Results: Of 875 potentially eligible patients, 560 (64%) had complete 2-year follow-up data, of which 144 (25.7%) demonstrated worse GCA at 2-year postoperative follow-up (35.4% of UT patients vs 64.6% of LT patients). At baseline, UT patients were younger (61.6 ± 9.9 vs 64.5 ± 8.6 years, p = 0.008), a greater percentage of UT patients had osteoporosis (35.3% vs 16.1%, p = 0.009), and UT patients had worse scoliosis (51.9° ± 22.5° vs 32.5° ± 16.3°, p < 0.001). Index operations were comparable, except UT patients had longer fusions (16.4 ± 0.9 vs 9.7 ± 1.2 levels, p < 0.001) and operative duration (8.6 ± 3.2 vs 7.6 ± 3.0 hours, p = 0.023). At 2-year follow-up, global coronal deterioration averaged 2.7 ± 1.4 cm (1.9 to 4.6 cm, p < 0.001), scoliosis improved (39.3° ± 20.8° to 18.0° ± 14.8°, p < 0.001), and sagittal spinopelvic alignment improved significantly in all patients. UT patients maintained smaller positive C7 sagittal vertical axis (2.7 ± 5.7 vs 4.7 ± 5.7 cm, p = 0.014). Postoperative 2-year health-related quality of life (HRQL) significantly improved from baseline for all patients. HRQL comparisons demonstrated that UT patients had worse Scoliosis Research Society-22r (SRS-22r) Activity (3.2 ± 1.0 vs 3.6 ± 0.8, p = 0.040) and SRS-22r Satisfaction (3.9 ± 1.1 vs 4.3 ± 0.8, p = 0.021) scores. Also, fewer UT patients improved by ≥ 1 minimal clinically important difference in numerical rating scale scores for leg pain (41.3% vs 62.7%, p = 0.020). Comparable percentages of UT and LT patients had complications (208 total, including 53 reoperations, 77 major complications, and 78 minor complications), but the percentage of reoperated patients was higher among UT patients (35.3% vs 18.3%, p = 0.023). UT patients had higher reoperation rates of rod fracture (13.7% vs 2.2%, p = 0.006) and pseudarthrosis (7.8% vs 1.1%, p = 0.006) but not proximal junctional kyphosis (9.8% vs 8.6%, p = 0.810)., Conclusions: In ASD patients with worse 2-year GCA after long sacropelvic fusion, UT UIV was associated with worse 2-year HRQL compared with LT UIV. This may suggest that residual global coronal malalignment is clinically less tolerated in ASD patients with longer fusion to the proximal thoracic spine. These results may inform operative planning and improve patient counseling.

Objective: Few studies have compared fractional curve correction after long fusion between transforaminal lumbar interbody fusion (TLIF) and anterior lumbar interbody fusion (ALIF) for adult symptomatic thoracolumbar/lumbar scoliosis (ASLS). The objective of this study was to compare fractional correction, health-related quality of life (HRQL), and complications associated with L4-S1 TLIF versus those of ALIF as an operative treatment of ASLS., Methods: The authors retrospectively analyzed a prospective multicenter adult spinal deformity database. Inclusion required a fractional curve ≥ 10°, a thoracolumbar/lumbar curve ≥ 30°, index TLIF or ALIF performed at L4-5 and/or L5-S1, and a minimum 2-year follow-up. TLIF and ALIF patients were propensity matched according to the number and type of interbody fusion at L4-S1., Results: Of 135 potentially eligible consecutive patients, 106 (78.5%) achieved the minimum 2-year follow-up (mean ± SD age 60.6 ± 9.3 years, 85% women, 44.3% underwent TLIF, and 55.7% underwent ALIF). Index operations had mean ± SD 12.2 ± 3.6 posterior levels, 86.6% of patients underwent iliac fixation, 67.0% underwent TLIF/ALIF at L4-5, and 84.0% underwent TLIF/ALIF at L5-S1. Compared with TLIF patients, ALIF patients had greater cage height (10.9 ± 2.1 mm for TLIF patients vs 14.5 ± 3.0 mm for ALIF patients, p = 0.001) and lordosis (6.3° ± 1.6° for TLIF patients vs 17.0° ± 9.9° for ALIF patients, p = 0.001) and longer operative duration (6.7 ± 1.5 hours for TLIF patients vs 8.9 ± 2.5 hours for ALIF patients, p < 0.001). In all patients, final alignment improved significantly in terms of the fractional curve (20.2° ± 7.0° to 6.9° ± 5.2°), maximum coronal Cobb angle (55.0° ± 14.8° to 23.9° ± 14.3°), C7 sagittal vertical axis (5.1 ± 6.2 cm to 2.3 ± 5.4 cm), pelvic tilt (24.6° ± 8.1° to 22.7° ± 9.5°), and lumbar lordosis (32.3° ± 18.8° to 51.4° ± 14.1°) (all p < 0.05). Matched analysis demonstrated comparable fractional correction (-13.6° ± 6.7° for TLIF patients vs -13.6° ± 8.1° for ALIF patients, p = 0.982). In all patients, final HRQL improved significantly in terms of Oswestry Disability Index (ODI) score (42.4 ± 16.3 to 24.2 ± 19.9), physical component summary (PCS) score of the 36-item Short-Form Health Survey (32.6 ± 9.3 to 41.3 ± 11.7), and Scoliosis Research Society-22r score (2.9 ± 0.6 to 3.7 ± 0.7) (all p < 0.05). Matched analysis demonstrated worse ODI (30.9 ± 21.1 for TLIF patients vs 17.9 ± 17.1 for ALIF patients, p = 0.017) and PCS (38.3 ± 12.0 for TLIF patients vs 45.3 ± 10.1 for ALIF patients, p = 0.020) scores for TLIF patients at the last follow-up (despite no differences in these parameters at baseline). The rates of total complications were similar (76.6% for TLIF patients vs 71.2% for ALIF patients, p = 0.530), but significantly more TLIF patients had rod fracture (28.6% of TLIF patients vs 7.1% of ALIF patients, p = 0.036). Multiple regression analysis demonstrated that a 1-mm increase in L4-5 TLIF cage height led to a 2.2° reduction in L4 coronal tilt (p = 0.011), and a 1° increase in L5-S1 ALIF cage lordosis led to a 0.4° increase in L5-S1 segmental lordosis (p = 0.045)., Conclusions: Operative treatment of ASLS with L4-S1 TLIF versus ALIF demonstrated comparable mean fractional curve correction (66.7% vs 64.8%), despite use of significantly larger, more lordotic ALIF cages. TLIF cage height had a significant impact on leveling L4 coronal tilt, whereas ALIF cage lordosis had a significant impact on restoration of lumbosacral lordosis. The advantages of TLIF may include reduced operative duration and hospitalization; however, associated HRQL was inferior and more rod fractures were detected in the TLIF patients included in this study.

Objective: Rod fracture (RF) after adult spinal deformity (ASD) surgery is reported in approximately 6.8%-33% of patients and is associated with loss of deformity correction and higher reoperation rates. The authors' objective was to determine the effect of accessory supplemental rod (ASR) placement on postoperative occurrence of primary RF after ASD surgery., Methods: This retrospective analysis examined patients who underwent ASD surgery between 2014 and 2017 by the senior authors. Inclusion criteria were age > 18 years, ≥ 5 instrumented levels including sacropelvic fixation, and diagnosis of ASD, which was defined as the presence of pelvic tilt ≥ 25°, sagittal vertical axis ≥ 5 cm, thoracic kyphosis ≥ 60°, coronal Cobb angle ≥ 20°, or pelvic incidence to lumbar lordosis mismatch ≥ 10°. The primary focus was patients with a minimum 2-year follow-up., Results: Of 148 patients who otherwise met the inclusion criteria, 114 (77.0%) achieved minimum 2-year follow-up and were included (68.4% were women, mean age 67.9 years, average body mass index 30.4 kg/m2). Sixty-two (54.4%) patients were treated with traditional dual-rod construct (DRC), and 52 (45.6%) were treated with ASR. Overall, the mean number of levels fused was 11.7, 79.8% of patients underwent Smith-Petersen osteotomy (SPO), 19.3% underwent pedicle subtraction osteotomy (PSO), and 66.7% underwent transforaminal lumbar interbody fusion (TLIF). Significantly more patients in the DRC cohort underwent SPO (88.7% of the DRC cohort vs 69.2% of the ASR cohort, p = 0.010) and TLIF (77.4% of the DRC cohort vs 53.8% of the ASR cohort, p = 0.0001). Patients treated with ASR had greater baseline sagittal malalignment (12.0 vs 8.6 cm, p = 0.014) than patients treated with DRC, and more patients in the ASR cohort underwent PSO (40.3% vs 1.6%, p < 0.0001). Among the 114 patients who completed follow-up, postoperative occurrence of RF was reported in 16 (14.0%) patients, with mean ± SD time to RF of 27.5 ± 11.8 months. There was significantly greater occurrence of RF among patients who underwent DRC compared with those who underwent ASR (21.0% vs 5.8%, p = 0.012) at comparable mean follow-up (38.4 vs 34.9 months, p = 0.072). Multivariate analysis demonstrated that ASR had a significant protective effect against RF (OR 0.231, 95% CI 0.051-0.770, p = 0.029)., Conclusions: This study demonstrated a statistically significant decrease in the occurrence of RF among ASD patients treated with ASR, despite greater baseline deformity and higher rate of PSO. These findings suggest that ASR placement may provide benefit to patients who undergo ASD surgery.

Objective: The impact of global coronal malalignment (GCM; C7 plumb line-midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors' primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes., Methods: This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed., Results: Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD-Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7-S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence-lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%-83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK)., Conclusions: Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.

Objective: Anterior cervical discectomy and fusion (ACDF) is a safe and effective intervention to treat cervical spine pathology. Although these were originally performed as single-level procedures, multilevel ACDF has been performed for patients with extensive degenerative disc disease. To date, there is a paucity of data regarding outcomes related to ACDFs of 3 or more levels. The purpose of this study was to compare surgical outcomes of 3- and 4-level ACDF procedures., Methods: The authors performed a retrospective chart review of patients who underwent 3- and 4-level ACDF at the University of Virginia Health System between January 2010 and December 2017. In patients meeting the inclusion/exclusion criteria, demographics, fusion rates, time to fusion, and reoperation rates were evaluated. Fusion was determined by < 1 mm of change in interspinous distance between individual fused vertebrae on lateral flexion/extension radiographs and lack of radiolucency between the grafts and vertebral bodies. Any procedure requiring a surgical revision was considered a failure., Results: Sixty-six patients (47 with 3-level and 19 with 4-level ACDFs) met the inclusion/exclusion criteria of having at least one lateral flexion/extension radiograph series ≥ 12 months after surgery. Seventy percent of 3-level patients and 68% of 4-level patients had ≥ 24 months of follow-up. Ninety-four percent of 3-level patients and 100% of 4-level patients achieved radiographic fusion for at least 1 surgical level. Eighty-eight percent and 82% of 3- and 4-level patients achieved fusion at C3-4; 85% and 89% of 3- and 4-level patients achieved fusion at C4-5; 68% and 89% of 3- and 4-level patients achieved fusion at C5-6; 44% and 42% of 3- and 4-level patients achieved fusion at C6-7; and no patients achieved fusion at C7-T1. Time to fusion was not significantly different between levels. Revision was required in 6.4% of patients with 3-level and in 16% of patients with 4-level ACDF. The mean time to revision was 46.2 and 45.4 months for 3- and 4-level ACDF, respectively. The most common reason for revision was worsening of initial symptoms., Conclusions: The authors' experience with long-segment anterior cervical fusions shows their fusion rates exceeding most of the reported fusion rates for similar procedures in the literature, with rates similar to those reported for short-segment ACDFs. Three-level and 4-level ACDF procedures are viable options for cervical spine pathology, and the authors' analysis demonstrates an equivalent rate of fusion and time to fusion between 3- and 4-level surgeries.

Objective: Although surgical treatment can provide significant improvement of symptomatic adult cervical spine deformity (ACSD), few reports have focused on the associated complications. The objective of this study was to assess complication rates at a minimum 1-year follow-up based on a prospective multicenter series of ACSD patients treated surgically., Methods: A prospective multicenter database of consecutive operative ACSD patients was reviewed for perioperative (< 30 days), early (30-90 days), and delayed (> 90 days) complications with a minimum 1-year follow-up. Enrollment required at least 1 of the following: cervical kyphosis > 10°, cervical scoliosis > 10°, C2-7 sagittal vertical axis > 4 cm, or chin-brow vertical angle > 25°., Results: Of 167 patients, 133 (80%, mean age 62 years, 62% women) had a minimum 1-year follow-up (mean 1.8 years). The most common diagnoses were degenerative (45%) and iatrogenic (17%) kyphosis. Almost 40% of patients were active or past smokers, 17% had osteoporosis, and 84% had at least 1 comorbidity. The mean baseline Neck Disability Index and modified Japanese Orthopaedic Association scores were 47 and 13.6, respectively. Surgical approaches were anterior-only (18%), posterior-only (47%), and combined (35%). A total of 132 complications were reported (54 minor and 78 major), and 74 (56%) patients had at least 1 complication. The most common complications included dysphagia (11%), distal junctional kyphosis (9%), respiratory failure (6%), deep wound infection (6%), new nerve root motor deficit (5%), and new sensory deficit (5%). A total of 4 deaths occurred that were potentially related to surgery, 2 prior to 1-year follow-up (1 cardiopulmonary and 1 due to obstructive sleep apnea and narcotic use) and 2 beyond 1-year follow-up (both cardiopulmonary and associated with revision procedures). Twenty-six reoperations were performed in 23 (17%) patients, with the most common indications of deep wound infection (n = 8), DJK (n = 7), and neurological deficit (n = 6). Although anterior-only procedures had a trend toward lower overall (42%) and major (21%) complications, rates were not significantly different from posterior-only (57% and 33%, respectively) or combined (61% and 37%, respectively) approaches (p = 0.29 and p = 0.38, respectively)., Conclusions: This report provides benchmark rates for ACSD surgery complications at a minimum 1-year (mean 1.8 years) follow-up. The marked health and functional impact of ACSD, the frail population it affects, and the high rates of surgical complications necessitate a careful risk-benefit assessment when contemplating surgery. Collectively, these findings provide benchmarks for complication rates and may prove useful for patient counseling and efforts to improve the safety of care.

Objective: Sacral insufficiency fracture after lumbosacral (LS) arthrodesis is an uncommon complication. The objective of this study was to report the authors' operative experience managing this complication, review pertinent literature, and propose a treatment algorithm., Methods: The authors analyzed consecutive adult patients treated at their institution from 2009 to 2018. Patients who underwent surgery for sacral insufficiency fractures after posterior instrumented LS arthrodesis were included. PubMed was queried to identify relevant articles detailing management of this complication., Results: Nine patients with a minimum 6-month follow-up were included (mean age 73 ± 6 years, BMI 30 ± 6 kg/m2, 56% women, mean follow-up 35 months, range 8-96 months). Six patients had osteopenia/osteoporosis (mean dual energy x-ray absorptiometry hip T-score -1.6 ± 0.5) and 3 received treatment. Index LS arthrodesis was performed for spinal stenosis (n = 6), proximal junctional kyphosis (n = 2), degenerative scoliosis (n = 1), and high-grade spondylolisthesis (n = 1). Presenting symptoms of back/leg pain (n = 9) or lower extremity weakness (n = 3) most commonly occurred within 4 weeks of index LS arthrodesis, which prompted CT for fracture diagnosis at a mean of 6 weeks postoperatively. All sacral fractures were adjacent or involved S1 screws and traversed the spinal canal (Denis zone III). H-, U-, or T-type sacral fracture morphology was identified in 7 patients. Most fractures (n = 8) were Roy-Camille type II (anterior displacement with kyphosis). All patients underwent lumbopelvic fixation via a posterior-only approach; mean operative duration and blood loss were 3.3 hours and 850 ml, respectively. Bilateral dual iliac screws were utilized in 8 patients. Back/leg pain and weakness improved postoperatively. Mean sacral fracture anterolisthesis and kyphotic angulation improved (from 8 mm/11° to 4 mm/5°, respectively) and all fractures were healed on radiographic follow-up (mean duration 29 months, range 8-90 months). Two patients underwent revision for rod fractures at 1 and 2 years postoperatively. A literature review found 17 studies describing 87 cases; potential risk factors were osteoporosis, longer fusions, high pelvic incidence (PI), and postoperative PI-to-lumbar lordosis (LL) mismatch., Conclusions: A high index of suspicion is needed to diagnose sacral insufficiency fracture after LS arthrodesis. A trial of conservative management is reasonable for select patients; potential surgical indications include refractory pain, neurological deficit, fracture nonunion with anterolisthesis or kyphotic angulation, L5-S1 pseudarthrosis, and spinopelvic malalignment. Lumbopelvic fixation with iliac screws may be effective salvage treatment to allow fracture healing and symptom improvement. High-risk patients may benefit from prophylactic lumbopelvic fixation at the time of index LS arthrodesis.

Objective: Prior reports have demonstrated the efficacy of surgical correction for adult lumbar scoliosis. Many of these reports focused on mild to moderate scoliosis. The authors' objective was to report their experience and to assess outcomes and complications after deformity correction for severe adult scoliosis., Methods: The authors retrospectively analyzed consecutive adult scoliosis patients with major thoracolumbar/lumbar (TL/L) curves ≥ 75° who underwent deformity correction at their institution. Those eligible with a minimum 2 years of follow-up were included. Demographic, surgical, coronal and sagittal plane radiographic measurements, and health-related quality of life (HRQL) scores were analyzed., Results: Among 26 potentially eligible patients, 22 (85%) had a minimum 2 years of follow-up (range 24-89 months) and were included in the study (mean age 57 ± 11 years; 91% women). The cohort comprised 16 (73%), 4 (18%), and 2 (9%) patients with adult idiopathic scoliosis, de novo degenerative scoliosis, and iatrogenic scoliosis, respectively. The surgical approach was posterior-only and multistage anterior-posterior in 18 (82%) and 4 (18%) patients, respectively. Three-column osteotomy was performed in 5 (23%) patients. Transforaminal and anterior lumbar interbody fusion were performed in 14 (64%) and 4 (18%) patients, respectively. All patients had sacropelvic fixation with uppermost instrumented vertebra in the lower thoracic spine (46% [10/22]) versus upper thoracic spine (55% [12/22]). The mean fusion length was 14 ± 3 levels. Preoperative major TL/L and lumbosacral fractional (L4-S1) curves were corrected from 83° ± 8° to 28° ± 13° (p < 0.001) and 34° ± 8° to 13° ± 6° (p < 0.001), respectively. Global coronal and sagittal balance significantly improved from 5 ± 4 cm to 1 ± 1 cm (p = 0.001) and 9 ± 8 cm to 2 ± 3 cm (p < 0.001), respectively. Pelvic tilt significantly improved from 33° ± 9° to 23° ± 10° (p < 0.001). Significant improvement in HRQL measures included the following: Scoliosis Research Society (SRS) pain score (p = 0.009), SRS appearance score (p = 0.004), and SF-12/SF-36 physical component summary (PCS) score (p = 0.026). Transient and persistent neurological deficits occurred in 8 (36%) and 2 (9%) patients, respectively. Rod fracture/pseudarthrosis occurred in 6 (27%) patients (supplemental rods were utilized more recently in 23%). Revisions were performed in 7 (32%) patients., Conclusions: In this single-center surgical series for severe adult scoliosis (major curves ≥ 75°), a posterior-only or multistage anterior-posterior approach provided major curve correction of 66% and significant improvements in global coronal and sagittal spinopelvic alignment. Significant improvements were also demonstrated in HRQL measures (SRS pain, SRS appearance, and SF-12/SF-36 PCS). Complications and revisions were comparable to those of other reports involving less severe scoliosis. The results of this study warrant future prospective multicenter studies to further delineate outcomes and complication risks for severe adult scoliosis correction.

Objective: Proximal junctional kyphosis (PJK) is, in part, due to altered segmental biomechanics at the junction of rigid instrumented spine and relatively hypermobile non-instrumented adjacent segments. Proper application of posteriorly anchored polyethylene tethers (i.e., optimal configuration and tension) may mitigate adjacent-segment stress and help prevent PJK. The purpose of this study was to investigate the impact of different tether configurations and tensioning (preloading) on junctional range-of-motion (ROM) and other biomechanical indices for PJK in long instrumented spine constructs., Methods: Using a validated finite element model of a T7-L5 spine segment, testing was performed on intact spine, a multilevel posterior screw-rod construct (PS construct; T11-L5) without tether, and 15 PS constructs with different tether configurations that varied according to 1) proximal tether fixation of upper instrumented vertebra +1 (UIV+1) and/or UIV+2; 2) distal tether fixation to UIV, to UIV-1, or to rods; and 3) use of a loop (single proximal fixation) or weave (UIV and/or UIV+1 fixation in addition to UIV+1 and/or UIV+2 proximal attachment) of the tether. Segmental ROM, intradiscal pressure (IDP), inter- and supraspinous ligament (ISL/SSL) forces, and screw loads were assessed under variable tether preload., Results: PS construct junctional ROM increased abruptly from 10% (T11-12) to 99% (T10-11) of baseline. After tethers were grouped by most cranial proximal fixation (UIV+1 vs UIV+2) and use of loop versus weave, UIV+2 Loop and/or Weave most effectively dampened junctional ROM and adjacent-segment stress. Different distal fixation and use of loop versus weave had minimal effect. The mean segmental ROM at T11-12, T10-11, and T9-10, respectively, was 6%, 40%, and 99% for UIV+1 Loop; 6%, 44%, and 99% for UIV+1 Weave; 5%, 23%, and 26% for UIV+2 Loop; and 5%, 24%, and 31% for UIV+2 Weave.Tethers shared loads with posterior ligaments; consequently, increasing tether preload tension reduced ISL/SSL forces, but screw loads increased. Further attenuation of junctional ROM and IDP reversed above approximately 100 N tether preload, suggesting diminished benefit for biomechanical PJK prophylaxis at higher preload tensioning., Conclusions: In this study, finite element analysis demonstrated UIV+2 Loop and/or Weave tether configurations most effectively mitigated adjacent-segment stress in long instrumented spine constructs. Tether preload dampened ligament forces at the expense of screw loads, and an inflection point (approximately 100 N) was demonstrated above which junctional ROM and IDP worsened (i.e., avoid over-tightening tethers). Results suggest tether configuration and tension influence PJK biomechanics and further clinical research is warranted.

Objective: Recent literature describing complications associated with spinopelvic fixation with iliac screws in adult patients has been limited but has suggested high complication rates. The authors' objective was to report their experience with iliac screw fixation in a large series of patients with a 2-year minimum follow-up., Methods: Of 327 adult patients undergoing spinopelvic fixation with iliac screws at the authors' institution between 2010 and 2015, 260 met the study inclusion criteria (age ≥ 18 years, first-time iliac screw placement, and 2-year minimum follow-up). Patients with active spinal infection were excluded. All iliac screws were placed via a posterior midline approach using fluoroscopic guidance. Iliac screw heads were deeply recessed into the posterior superior iliac spine. Clinical and radiographic data were obtained and analyzed., Results: Twenty patients (7.7%) had iliac screw-related complication, which included fracture (12, 4.6%) and/or screw loosening (9, 3.5%). No patients had iliac screw head prominence that required revision surgery or resulted in pain, wound dehiscence, or poor cosmesis. Eleven patients (4.2%) had rod or connector fracture below S1. Overall, 23 patients (8.8%) had L5-S1 pseudarthrosis. Four patients (1.5%) had fracture of the S1 screw. Seven patients (2.7%) had wound dehiscence (unrelated to the iliac screw head) or infection. The rate of reoperation (excluding proximal junctional kyphosis) was 17.7%. On univariate analysis, an iliac screw-related complication rate was significantly associated with revision fusion (70.0% vs 41.2%, p = 0.013), a greater number of instrumented vertebrae (mean 12.6 vs 10.3, p = 0.014), and greater postoperative pelvic tilt (mean 27.7° vs 23.2°, p = 0.04). Lumbosacral junction-related complications were associated with a greater mean number of instrumented vertebrae (12.6 vs 10.3, p = 0.014). Reoperation was associated with a younger mean age at surgery (61.8 vs 65.8 years, p = 0.014), a greater mean number of instrumented vertebrae (12.2 vs 10.2, p = 0.001), and longer clinical and radiological mean follow-up duration (55.8 vs 44.5 months, p < 0.001; 55.8 vs 44.6 months, p < 0.001, respectively). On multivariate analysis, reoperation was associated with longer clinical follow-up (p < 0.001)., Conclusions: Previous studies on iliac screw fixation have reported very high rates of complications and reoperation (as high as 53.6%). In this large, single-center series of adult patients, iliac screws were an effective method of spinopelvic fixation that had high rates of lumbosacral fusion and far lower complication rates than previously reported. Collectively, these findings argue that iliac screw fixation should remain a favored technique for spinopelvic fixation.

Tranexamic acid (TXA) is an antifibrinolytic agent with demonstrated efficacy in reducing blood loss when administered systemically. However, in patients with contraindications to systemic or intravenous TXA, topical TXA (tTXA) has been shown to reduce perioperative blood loss, with some studies suggesting equivalence compared to systemic TXA. However, these studies have been conducted in healthy cohorts without contraindications to systemic TXA. In the surgical management of adult spinal deformity (ASD), comorbid disease is commonly encountered and may preclude use of systemic TXA. In this subset of patients with ASD who have contraindications for systemic TXA, use of tTXA has not been reported.The primary objective of this study was to conduct a systematic review on the use of tTXA in spine surgery and to present the authors' initial experience with tTXA as a novel hemostatic technique for 2 patients with medically complex ASD. Both patients had contraindications to systemic TXA use and underwent high-risk, long-segment fusion operations for correction of ASD. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to obtain studies related to spine surgery and tTXA from the National Institutes of Health PubMed (www.pubmed.gov) database. Criteria for final selection included a demonstration of quantitative data regarding operative or postoperative blood loss with the use of tTXA, and selection criteria were met by 6 articles.Topical TXA may offer a potential therapeutic role in reducing intra- and postoperative blood loss following long-segment spinal fusion surgeries, particularly for medically complex patients with contraindications to systemic TXA. It is reasonable to consider the use of tTXA as a salvage technique in complex high-risk patients with contraindications to systemic TXA, although further research is needed to delineate safety, magnitude of benefit, and optimization of dosing.

OBJECTIVEFixed sagittal spinal malalignment is a common problem in adult spinal deformity (ASD). Various three-column osteotomy techniques, including the extended pedicle subtraction osteotomy (ePSO), may correct global and regional malalignment in this patient population. In contrast to the number of reports on traditional PSO (Schwab grade 3 osteotomy), there is limited literature on the outcomes of ePSO (Schwab grade 4 osteotomy) in ASD surgery. The objective of this retrospective study was to provide focused investigation of radiographic outcomes and complications of single-level lumbar ePSO for ASD patients with fixed sagittal malalignment.METHODSConsecutive ASD patients in whom sagittal malalignment had been treated with single-level lumbar ePSO at the authors' institution between 2010 and 2015 were analyzed, and those with a minimum 2-year follow-up were included in the study. Radiographic analyses included assessments of segmental lordosis through the ePSO site (sagittal Cobb angle measured from the superior endplate of the vertebra above and inferior endplate of the vertebra below the ePSO), lumbar lordosis (LL), pelvic tilt (PT), pelvic incidence and LL mismatch, thoracic kyphosis (TK), and sagittal vertical axis (SVA) on standing long-cassette radiographs. Complications were analyzed for the entire group.RESULTSAmong 71 potentially eligible patients, 55 (77%) had a minimum 2-year follow-up and were included in the study. Overall, the average postoperative increases in ePSO segmental lordosis and overall LL were 41° ± 14° (range 7°-69°, p < 0.001) and 38° ± 11° (range 9°-58°, p < 0.001), respectively. The average SVA improvement was 13 ± 7 cm (range of correction: -33.6 to 3.4 cm, p < 0.001). These measurements were maintained when comparing early postoperative to last follow-up values, respectively (mean follow-up 52 months, range 26-97 months): ePSO segmental lordosis, 34° vs 33°, p = 0.270; LL, 47.3° vs 46.7°, p = 0.339; and SVA, 4 vs 5 cm, p = 0.330. Rod fracture (RF) at the ePSO site occurred in 18.2% (10/55) of patients, and pseudarthrosis (PA) at the ePSO site was confirmed by CT imaging or during rod revision surgery in 14.5% (8/55) of patients. Accessory supplemental rods across the ePSO site, a more recently employed technique, significantly reduced the occurrence of RF or PA on univariate (p = 0.004) and multivariable (OR 0.062, 95% CI 0.007-0.553, p = 0.013) analyses; this effect approached statistical significance on Kaplan-Meier analysis (p = 0.053, log-rank test). Interbody cage placement at the ePSO site resulted in greater ePSO segmental lordosis correction (45° vs 35°, p = 0.007) without significant change in RF or PA (p = 0.304). Transient and persistent motor deficits occurred in 14.5% (8/55) and 1.8% (1/55) of patients, respectively.CONCLUSIONSExtended PSO is an effective technique to correct fixed sagittal malalignment for ASD. In comparison to traditional PSO techniques, ePSO may allow greater focal correction with comparable complication rates, especially with interbody cage placement at the ePSO site and the use of accessory supplemental rods.