Representativeness of the American Spine Registry: a comparison of patient characteristics with the National Inpatient Sample.

OBJECTIVE: The American Spine Registry (ASR) is a collaborative effort between the American Academy of Orthopaedic Surgeons and the American Association of Neurological Surgeons. The goal of this study was to evaluate how representative the ASR is of the national practice with spinal procedures, as recorded in the National Inpatient Sample (NIS). METHODS: The authors queried the NIS and the ASR for cervical and lumbar arthrodesis cases performed during 2017-2019. International Classification of Diseases, 10th Revision and Current Procedural Terminology codes were used to identify patients undergoing cervical and lumbar procedures. The two groups were compared for the overall proportion of cervical and lumbar procedures, age distribution, sex, surgical approach features, race, and hospital volume. Outcomes available in the ASR, such as patient-reported outcomes and reoperations, were not analyzed due to nonavailability in the NIS. The representativeness of the ASR compared to the NIS was assessed via Cohen's d effect sizes, and absolute standardized mean differences (SMDs) of < 0.2 were considered trivial, whereas > 0.5 were considered moderately large. RESULTS: A total of 24,800 arthrodesis procedures were identified in the ASR for the period between January 1, 2017, and December 31, 2019. During the same time period, 1,305,360 cases were recorded in the NIS. Cervical fusions comprised 35.9% of the ASR cohort (8911 cases) and 36.0% of the NIS cohort (469,287 cases). The two databases presented trivial differences in terms of patient age and sex for all years of interest across both cervical and lumbar arthrodeses (SMD < 0.2). Trivial differences were also noted in the distribution of open versus percutaneous procedures of the cervical and lumbar spine (SMD < 0.2). Among lumbar cases, anterior approaches were more common in the ASR than in the NIS (32.1% vs 22.3%, SMD = 0.22), but the discrepancy among cervical cases in the two databases was trivial (SMD = 0.03). Small differences were illustrated in terms of race, with SMDs < 0.5, and a more significant discrepancy was identified in the geographic distribution of participating sites (SMDs of 0.7 and 0.74 for cervical and lumbar cases, respectively). For both of these measures, SMDs in 2019 were smaller than those in 2018 and 2017. CONCLUSIONS: The ASR and NIS databases presented a very high similarity in proportions of cervical and lumbar spine surgeries, as well as similar distributions of age and sex, and distribution of open versus endoscopic approach. Slight discrepancies in anterior versus posterior approach among lumbar cases and patient race, and more significant discrepancies in geographic representation were also identified, yet decreasing trends in differences suggested the improving representativeness of the ASR over the course of time and its progressive growth. These conclusions are important to underline the external validity of quality investigations and research conclusions to be drawn from analyses in which the ASR is used.

Predictive Analytics for Determining Extended Operative Time in Corrective Adult Spinal Deformity Surgery.

BACKGROUND: More sophisticated surgical techniques for correcting adult spinal deformity (ASD) have increased operative times, adding to physiologic stress on patients and increased complication incidence. This study aims to determine factors associated with operative time using a statistical learning algorithm. METHODS: Retrospective review of a prospective multicenter database containing 837 patients undergoing long spinal fusions for ASD. Conditional inference decision trees identified factors associated with skin-to-skin operative time and cutoff points at which factors have a global effect. A conditional variable-importance table was constructed based on a nonreplacement sampling set of 2000 conditional inference trees. Means comparison for the top 15 variables at their respective significant cutoffs indicated effect sizes. RESULTS: Included: 544 surgical ASD patients (mean age: 58.0 years; fusion length 11.3 levels; operative time: 378 minutes). The strongest predictor for operative time was institution/surgeon. Center/surgeons, grouped by decision tree hierarchy, a and b were, on average, 2 hours faster than center/surgeons c-f, who were 43 minutes faster than centers g-j, all P < 0.001. The next most important predictors were, in order, approach (combined vs posterior increases time by 139 minutes, P < 0.001), levels fused (<4 vs 5-9 increased time by 68 minutes, P < 0.050; 5-9 vs < 10 increased time by 47 minutes, P < 0.001), age (age <50 years increases time by 57 minutes, P < 0.001), and patient frailty (score <1.54 increases time by 65 minutes, P < 0.001). Surgical techniques, such as three-column osteotomies (35 minutes), interbody device (45 minutes), and decompression (48 minutes), also increased operative time. Both minor and major complications correlated with <66 minutes of increased operative time. Increased operative time also correlated with increased hospital length of stay (LOS), increased estimated intraoperative blood loss (EBL), and inferior 2-year Oswestry Disability Index (ODI) scores. CONCLUSIONS: Procedure location and specific surgeon are the most important factors determining operative time, accounting for operative time increases <2 hours. Surgical approach and number of levels fused were also associated with longer operative times, respectively. Extended operative time correlated with longer LOS, higher EBL, and inferior 2-y ODI outcomes. CLINICAL RELEVANCE: We further identified the poor outcomes associated with extended operative time during surgical correction of ASD, and attributed the useful predictors of time spent in the operating room, including site, surgeon, surgical approach, and the number of levels fused.

Are the Arbeitsgemeinschaft Für Osteosynthesefragen (AO) Principles for Long Bone Fractures Applicable to 3-Column Osteotomy to Reduce Rod Fracture Rates?

OBJECTIVE: The aim was to determine whether applying Arbeitsgemeinschaft für Osteosynthesefragen (AO) principles for external fixation of long bone fracture to patients with a 3-column osteotomy (3CO) would be associated with reduced rod fracture (RF) rates. SUMMARY OF BACKGROUND DATA: AO dictate principles to follow when fixating long bone fractures: (1) decrease bone-rod distance; (2) increase the number of connecting rods; (3) increase the diameter of rods; (4) increase the working length of screws; (5) use multiaxial fixation. We hypothesized that applying these principles to patients undergoing a 3CO reduces the rate of RF. METHODS: Patients were categorized as having RF versus no rod fracture (non-RF). Details on location and type of instrumentation were collected. Dedicated software was used to calculate the distance between osteotomy site and adjacent pedicle screws, angle between screws and the distance between the osteotomy site and rod. Classic sagittal spinopelvic parameters were evaluated. RESULTS: The study included 170 patients (34=RF, 136=non-RF). There was no difference in age (P=0.224), sagittal vertical axis correction (P=0.287), or lumbar lordosis correction (P=0.36). There was no difference in number of screws cephalad (P=0.62) or caudal (P=0.31) to 3CO site. There was a lower rate of RF for patients with >2 rods versus 2 rods (P<0.001). Patients with multiplanar rod fixation had a lower rod fracture rate (P=0.01). For patients with only 2 rods (N=68), the non-RF cohort had adjacent screws that trended to have less angulation to each other (P=0.06) and adjacent screws that had a larger working length (P=0.03). CONCLUSIONS: A portion of AO principles can be applied to 3CO to reduce RF rates. Placing more rods around a 3CO site, placing rods in multiple planes, and placing adjacent screws with a larger working length around the 3CO site is associated with lower RF rates.

Examination of Adult Spinal Deformity Patients Undergoing Surgery with Implanted Spinal Cord Stimulators and Intrathecal Pumps.

STUDY DESIGN: Retrospective cohort study of a prospectively collected multi-center database of adult spinal deformity (ASD) patients. OBJECTIVE: We hypothesized that patients undergoing ASD surgery with and without previous spinal cord stimulators (SCS)/ intrathecal medication pumps (ITP) would exhibit increased complication rates but comparable improvement in health-related quality of life. SUMMARY OF BACKGROUND DATA: ASD patients sometimes seek pain management with SCS or ITP before spinal deformity correction. Few studies have examined outcomes in this patient population. METHODS: Patients undergoing ASD surgery and eligible for 2-year follow-up were included. Preoperative radiographs were reviewed for the presence of SCS/ITP. Outcomes included complications, Oswestry Disability Index (ODI), Short Form-36 Mental Component Score, and SRS-22r. Propensity score matching was utilized. RESULTS: In total, of 1034 eligible ASD patients, a propensity score-matched cohort of 60 patients (30 with SCS/ITP, 30 controls) was developed. SCS/ITP were removed intraoperatively in most patients (56.7%, n = 17). The overall complication rate was 80.0% versus 76.7% for SCS/ITP versus control (P > 0.2), with similarly nonsignificant differences for intraoperative and infection complications (all P > 0.2). ODI was significantly higher among patients with SCS/ITP at baseline (59.2 vs. 47.6, P = 0.0057) and at 2-year follow-up (44.4 vs. 27.7, P = 0.0295). The magnitude of improvement, however, did not significantly differ (P = 0.45). Similar results were observed for SRS-22r pain domain. Satisfaction did not differ between groups at either baseline or follow-up (P > 0.2). No significant difference was observed in the proportion of patients with SCS/ITP versus control reaching minimal clinically important difference in ODI (47.6% vs. 60.9%, P = 0.38). Narcotic usage was more common among patients with SCS/ITP at both baseline and follow-up (P < 0.05). CONCLUSION: ASD patients undergoing surgery with SCS/ITP exhibited worse preoperative and postoperative ODI and SRS-22r pain domain; however, the mean improvement in outcome scores was not significantly different from patients without stimulators or pumps. No significant differences in complications were observed between patients with versus without SCS/ITP.Level of Evidence: 3.

Adult Spinal Deformity Surgery Is Associated with Increased Productivity and Decreased Absenteeism From Work and School.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: We hypothesized that adult spinal deformity (ASD) surgery would be associated with improved work- and school-related productivity, as well as decreased rates of absenteeism. SUMMARY OF BACKGROUND DATA: ASD patients experience markedly decreased health-related quality of life along many dimensions. METHODS: Only patients eligible for 2-year follow-up were included, and those with a history of previous spinal fusion were excluded. The primary outcome measures in this study were Scoliosis Research Society-22r score (SRS-22r) questions 9 and 17. A repeated measures mixed linear regression was used to analyze responses over time among patients managed operatively (OP) versus nonoperatively (NON-OP). RESULTS: In total, 1188 patients were analyzed. 66.6% were managed operatively. At baseline, the mean percentage of activity at work/school was 56.4% (standard deviation [SD] 35.4%), and the mean days off from work/school over the past 90 days was 1.6 (SD 1.8). Patients undergoing ASD surgery exhibited an 18.1% absolute increase in work/school productivity at 2-year follow-up versus baseline (P < 0.0001), while no significant change was observed for the nonoperative cohort (P > 0.5). Similarly, the OP cohort experienced 1.1 fewer absent days over the past 90 days at 2 years versus baseline (P < 0.0001), while the NON-OP cohort showed no such difference (P > 0.3). These differences were largely preserved after stratifying by baseline employment status, age group, sagittal vertical axis (SVA), pelvic incidence minus lumbar lordosis (PI-LL), and deformity curve type. CONCLUSION: ASD patients managed operatively exhibited an average increase in work/school productivity of 18.1% and decreased absenteeism of 1.1 per 90 days at 2-year follow-up, while patients managed nonoperatively did not exhibit change from baseline. Given the age distribution of patients in this study, these findings should be interpreted as pertaining primarily to obligations at work or within the home. Further study of the direct and indirect economic benefits of ASD surgery to patients is warranted.Level of Evidence: 3.

Lateral Thoracolumbar Listhesis as an Independent Predictor of Disability in Adult Scoliosis Patients: Multivariable Assessment Before and After Surgical Realignment.

BACKGROUND: Lateral (ie, coronal) vertebral listhesis may contribute to disability in adult scoliosis patients. OBJECTIVE: To assess for a correlation between lateral listhesis and disability among patients with adult scoliosis. METHODS: This was a retrospective multi-center analysis of prospectively collected data. Patients eligible for a minimum of 2-yr follow-up and with coronal plane deformity (defined as maximum Cobb angle ≥20º) were included (n = 724). Outcome measures were Oswestry Disability Index (ODI) and leg pain numeric scale rating. Lateral thoracolumbar listhesis was measured as the maximum vertebral listhesis as a percent of the superior endplate across T1-L5 levels. Linear and logistic regression was utilized, as appropriate. Multivariable analyses adjusted for demographics, comorbidities, surgical invasiveness, maximum Cobb angle, and T1-PA. Minimally clinically important difference (MCID) in ODI was defined as 12.8. RESULTS: In total, 724 adult patients were assessed. The mean baseline maximum lateral thoracolumbar listhesis was 18.3% (standard deviation 9.7%). The optimal statistical grouping for lateral listhesis was empirically determined to be none/mild (<6.7%), moderate (6.7-15.4%), and severe (≥15.4%). In multivariable analysis, listhesis of moderate and severe vs none/mild was associated with worse baseline ODI (none/mild = 33.7; moderate = 41.6; severe = 43.9; P < .001 for both comparisons) and leg pain NSR (none/mild = 2.9, moderate = 4.0, severe = 5.1, P < .05). Resolution of severe lateral listhesis to none/mild was independently associated with increased likelihood of reaching MCID in ODI at 2 yr postoperatively (odds ratio 2.1 95% confidence interval 1.2-3.7, P = .0097). CONCLUSION: Lateral thoracolumbar listhesis is associated with worse baseline disability among adult scoliosis patients. Resolution of severe lateral listhesis following deformity correction was independently associated with increased likelihood of reaching MCID in ODI at 2-yr follow-up.

Artificial intelligence clustering of adult spinal deformity sagittal plane morphology predicts surgical characteristics, alignment, and outcomes.

PURPOSE: AI algorithms have shown promise in medical image analysis. Previous studies of ASD clusters have analyzed alignment metrics-this study sought to complement these efforts by analyzing images of sagittal anatomical spinopelvic landmarks. We hypothesized that an AI algorithm would cluster preoperative lateral radiographs into groups with distinct morphology. METHODS: This was a retrospective review of a multicenter, prospectively collected database of adult spinal deformity. A total of 915 patients with adult spinal deformity and preoperative lateral radiographs were included. A 2 × 3, self-organizing map-a form of artificial neural network frequently employed in unsupervised classification tasks-was developed. The mean spine shape was plotted for each of the six clusters. Alignment, surgical characteristics, and outcomes were compared. RESULTS: Qualitatively, clusters C and D exhibited only mild sagittal plane deformity. Clusters B, E, and F, however, exhibited marked positive sagittal balance and loss of lumbar lordosis. Cluster A had mixed characteristics, likely representing compensated deformity. Patients in clusters B, E, and F disproportionately underwent 3-CO. PJK and PJF were particularly prevalent among clusters A and E. Among clusters B and F, patients who experienced PJK had significantly greater positive sagittal balance than those who did not. CONCLUSIONS: This study clustered preoperative lateral radiographs of ASD patients into groups with highly distinct overall spinal morphology and association with sagittal alignment parameters, baseline HRQOL, and surgical characteristics. The relationship between SVA and PJK differed by cluster. This study represents significant progress toward incorporation of computer vision into clinically relevant classification systems in adult spinal deformity. LEVEL OF EVIDENCE IV: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

A Comparison of Three Different Positioning Techniques on Surgical Corrections and Postoperative Alignment in Cervical Spinal Deformity (CD) Surgery.

STUDY DESIGN: Retrospective review of a prospective multicenter cervical deformity database. OBJECTIVE: To examine the differences in sagittal alignment correction between three positioning methods in cervical spinal deformity surgery (CD). SUMMARY OF BACKGROUND DATA: Surgical correction for CD is technically demanding and various techniques are utilized to achieve sagittal alignment objectives. The effect of different patient positioning techniques on sagittal alignment correction following CD remains unknown. METHODS: Patients with sagittal deformity who underwent a posterior approach (with and without anterior approach) with an upper instrumented vertebra of C6 or above. Patients with Grade 5, 6, or 7 osteotomies were excluded. Positioning groups were Mayfield skull clamp, bivector traction, and halo ring. Preoperative lower surgical sagittal curve (C2-C7), C2-C7 sagittal vertical axis (cSVA), cervical scoliosis, T1 slope minus cervical lordosis (TS-CL), T1 slope (T1S), chin-brow vertebral angle (CBVA), C2-T3 curve, and C2-T3 SVA was assessed and compared with postoperative radiographs. Segmental changes were analyzed using the Fergusson method. RESULTS: Eighty patients (58% female) with a mean age of 60.6 ±â€Š10.5 years (range, 31-83) were included. The mean postoperative C2-C7 lordosis was 7.8°â€Š±â€Š14 and C2-C7 SVA was 34.1 mm ±â€Š15. There were overall significant changes in cervical alignment across the entire cohort, with improvements in T1 slope (P < 0.001), C2-C7 (P < 0.001), TS-CL (P < 0.001), and cSVA (P = 0.006). There were no differences postoperatively of any radiographic parameter between positioning groups (P > 0.05). The majority of segmental lordotic correction was achieved at C4-5-6 (mean 6.9°â€Š±â€Š11). Additionally, patients who had bivector traction applied had had significantly more segmental correction at C7-T1-T2 compared with Mayfield and halo traction (4.2° vs. 0.3° vs. -1.7° respectively, P < 0.027). CONCLUSION: Postoperative cervical sagittal correction or alignment was not affected by patient position. The majority of segmental correction occurred at C4-5-6 across all positioning methods, while bivector traction had the largest corrective ability at the cervicothoracic junction.Level of Evidence: 4.

The spino-pelvic ratio: a novel global sagittal parameter associated with clinical outcomes in adult spinal deformity patients.

PURPOSE: Analysis of interactions of spinal alignment metrics may uncover novel alignment parameters, similar to PI-LL. This study utilized a data-driven approach to hypothesis generation by testing all possible division interactions between spinal alignment parameters. METHODS: This study was a retrospective cohort analysis. In total, 1439 patients with baseline ODI were included for hypothesis generation. In total, 666 patients had 2-year postoperative follow-up and were included for validation. All possible combinations of division interactions between baseline metrics were assessed with linear regression against baseline ODI. RESULTS: From 247 raw alignment metrics, 32,398 division interactions were considered in hypothesis generation. Conceptually, the TPA divided by PI is a measure of the relative alignment of the line connecting T1 to the femoral head and the line perpendicular to the sacral endplate. The mean TPA/PI was 0.41 at baseline and 0.30 at 2 years postoperatively. Higher TPA/PI was associated with worse baseline ODI (p < 0.0001). The change in ODI at 2 years was linearly associated with the change in TPA/PI (p = 0.0172). The optimal statistical grouping of TPA/PI was low/normal (≤ 0.2), medium (0.2-0.4), and high (> 0.4). The R-squared for ODI against categorical TPA/PI alone (0.154) was directionally higher than that for each of the individual Schwab modifiers (SVA: 0.138, PI-LL 0.111, PT 0.057). CONCLUSION: This study utilized a data-driven approach for hypothesis generation and identified the spino-pelvic ratio (TPA divided by PI) as a promising measure of sagittal spinal alignment among ASD patients. Patients with SPR > 0.2 exhibited inferior ODI scores. LEVEL OF EVIDENCE: III.

Prospective multicenter assessment of complication rates associated with adult cervical deformity surgery in 133 patients with minimum 1-year follow-up.

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.

Artificial Intelligence Models Predict Operative Versus Nonoperative Management of Patients with Adult Spinal Deformity with 86% Accuracy.

OBJECTIVE: Patients with ASD show complex and highly variable disease. The decision to manage patients operatively is largely subjective and varies based on surgeon training and experience. We sought to develop models capable of accurately discriminating between patients receiving operative versus nonoperative treatment based only on baseline radiographic and clinical data at enrollment. METHODS: This study was a retrospective analysis of a multicenter consecutive cohort of patients with ASD. A total of 1503 patients were included, divided in a 70:30 split for training and testing. Patients receiving operative treatment were defined as those undergoing surgery up to 1 year after their baseline visit. Potential predictors included available demographics, past medical history, patient-reported outcome measures, and premeasured radiographic parameters from anteroposterior and lateral films. In total, 321 potential predictors were included. Random forest, elastic net regression, logistic regression, and support vector machines (SVMs) with radial and linear kernels were trained. RESULTS: Of patients in the training and testing sets, 69.0% (n = 727) and 69.1% (n = 311), respectively, received operative management. On evaluation with the testing dataset, performance for SVM linear (area under the curve =0.910), elastic net (0.913), and SVM radial (0.914) models was excellent, and the logistic regression (0.896) and random forest (0.830) models performed very well for predicting operative management of patients with ASD. The SVM linear model showed 86% accuracy. CONCLUSIONS: This study developed models showing excellent discrimination (area under the curve >0.9) between patients receiving operative versus nonoperative management, based solely on baseline study enrollment values. Future investigations may evaluate the implementation of such models for decision support in the clinical setting.

Sexual Dysfunction Secondary to Lumbar Stiffness in Adult Spinal Deformity Patients Before and After Long-Segment Spinal Fusion.

OBJECTIVE: Sexual function is an important factor contributing to quality of life. Adult spinal deformity (ASD) patients may have sexual limitations due to lumbar spinal stiffness that may be affected by long-segment fusion. METHODS: This study utilized a multicenter, prospectively defined, consecutive cohort of ASD patients. The primary outcome in this study was the Lumbar Stiffness Disability Index (LSDI) question 10: "Choose the statement that best describes the effect of low back stiffness on your ability to engage in sexual intercourse". RESULTS: In total, 368 patients were included in this study, including 76 men and 292 women, of which 80.7% (n = 293) underwent 9 or more level fusion and 74.4% (n = 270) had pelvic fixation. Baseline LSDI sexual function scores averaged 1.7 (SD 1.3), which improved to 1.3 (SD 1.2) at 2-year follow-up (P = 0.0008). After adjusting for confounding factors, worse LSDI sexual function score was strongly associated with worse Oswestry Disability Index, Scoliosis Research Society-22r total, and SF-36 Physical Component Summary and Mental Component Summary scores at both baseline and 2-year follow-up (p<0.05 for all comparisons). Predictors of poorer baseline sexual function included older age, increased SVA, and increased back pain (p<0.05 for all comparisons). Predictors of improvement in sexual function at 2-year follow-up included sagittal vertical axis improvement (P = 0.0032) and decreased postoperative back pain (P < 0.0001). CONCLUSIONS: This study found that sexual dysfunction scores due to lumbar stiffness significantly improved after surgery for ASD. Additionally, lumbar stiffness-related sexual dysfunction is strongly related to overall outcome measured by Oswestry Disability Index and Scoliosis Research Society-22r total score, highlighting the importance of sexual health on overall outcome in ASD patients.

Assessment of Patient Outcomes and Proximal Junctional Failure Rate of Patients with Adult Spinal Deformity Undergoing Caudal Extension of Previous Spinal Fusion.

OBJECTIVE: This case series examined patients undergoing caudal extension of prior fusion without alteration of the prior upper instrumented vertebra (UIV) to assess patient outcomes and rates of proximal junctional kyphosis (PJK)/proximal junctional failure (PJF). METHODS: Patients eligible for 2-year minimum follow-up undergoing caudal extension of prior fusion with unchanged UIVs were identified. These patients were evaluated for PJK/PJF, and patient reported outcomes were recorded. RESULTS: In total, 40 patients were included. Mean follow-up duration was 2.2 ± 0.3 years. Patients in this cohort had poor preoperative sagittal alignment (pelvic incidence minus lumbar lordosis [PI-LL] 26.7°, T1 pelvic angle [TPA] 29.0°, sagittal vertical axis [SVA] 93.4 mm) and achieved substantial sagittal correction (ΔSVA -62.2 mm, ΔPI-LL -19.8°, ΔTPA -11.1°) after caudal extension surgery. At final follow-up, there was a 0% rate of PJF among patients undergoing caudal extension of previous fusion without creation of a new UIV, but 27.5% of patients experienced PJK. Patients experienced significant improvement in both the Oswestry Disability Index and Scoliosis Research Society-22r total score at 2 years postoperatively (P < 0.05). In total, 7.5% (n = 3) of patients underwent further revision, at an average of 1.1 ± 0.54 years after the surgery with unaltered UIV. All 3 of these patients underwent revision for rod fracture with no revisions for PJK/PJF. CONCLUSIONS: Patients undergoing caudal extension of previous fusions for sagittal alignment correction have high rates of clinical success, low revision surgery rates, and very low rates of PJF. Minimizing repetitive tissue trauma at the UIV may result in decreased PJF risk because the PJF rate in this cohort of patients with unaltered UIV is below historical PJF rates of patients undergoing sagittal balance correction.

Intraoperative alignment goals for distinctive sagittal morphotypes of severe cervical deformity to achieve optimal improvements in health-related quality of life measures.

BACKGROUND CONTEXT: Patients with severe cervical deformity (CD) often have profound deficits in numerous activities of daily living. The association between health status and postoperative radiographic goals is difficult to quantify. PURPOSE: We aimed to investigate the radiographic characteristics of patients who achieved optimal health related quality of life scores following surgery for CD. STUDY DESIGN: We performed a retrospective review of a prospectively collected database of patients with spinal deformity. PATIENT SAMPLE: One hundred and fifty-three patients with cervical deformity OUTCOME MEASURES: Common health-related quality of life scores (HRQOLs) measurements were taken for patients treated operatively for cervical deformity including neck disability index (NDI), modified Japanese Orthopaedic Association scale (mJOA) for myelopathy and numeric rating scale for neck pain (NRS-neck), METHODS: Surgical patients with severe CD were isolated based upon a previously presented discriminant analysis which outlined a combination of preoperative cervical sagittal vertical axis (cSVA), T1 slope, maximum focal kyphosis in extension, C2 slope in extension, and number of kyphotic levels in extension. Those with available preoperative and 1-year postoperative HRQL data were included. Based on a previous study, patients were grouped into three distinct sagittal morphotypes of CD: focal deformity (FD), flat neck (FN = large TS-CL and lack of compensation), or cervicothoracic (CT). Postoperative outcomes were defined as "good" if a patient had ≥2 of the three following criteria (1) NDI <20 or meeting MCID, (2) mild myelopathy (mJOA≥14), and (3) NRS-Neck ≤5 or improved by ≥2 points from baseline. Within each distinct deformity group, patients with good outcomes were compared to those with poor outcomes (ie, not meeting the criteria for good) for differences in demographics, HRQOL scores, and alignment, via Chi-squared or student's t tests. RESULTS: Overall, 83 of 153 patients met the criteria of severe CD and 40 patients had complete 1-year follow-up of clinical/radiographic data. Patient breakdown by deformity pattern was: CT (N=13), FN (N=17), and FD (N=17), with 7 patients meeting criteria for both FD and FN deformities. Within the FD cohort, maximal focal kyphosis (ie, kyphosis at one level) was better corrected in patients with a "good" outcome (p=.03). In the FN cohort, patients with "good" outcomes presented preoperatively with worse horizontal gaze (McGregor Slope 21° vs. 6°, p=.061) and cSVA (72 mm vs. 60 mm, p=.030). "Good" outcome FN patients showed significantly greater postop correction of horizontal gaze (-25° vs. -5°, p=.031). In the CT cohort, patients with "good" outcomes had superior global alignment both pre- (SVA: -17 mm vs. 108 mm, p<.001) and postoperatively (50 mm vs. 145 mm, p=.001). CT patients with "good" outcomes also had better postop cervical alignment (cSVA 35 mm vs. 49 mm, p=.030), and less kyphotic segments during extension (p=.011). In the FD cohort, there were no differences between "good" and "poor" outcomes patients in preoperative alignment; however, "good" outcome patients showed superior changes in postoperative focal kyphosis (-2° vs. 5°, p=.030). Within all three deformity pattern categories, there were no differences between "good" and "poor" outcome patients with respect to demographics or surgical parameters (levels fused, surgical approach, decompression, osteotomy, all p>.050). CONCLUSIONS: The results of this study show each CD patient's unique deformity must be carefully examined in order to determine the appropriate alignment goals to achieve optimal HRQOLs. In particular, the recognition of the sagittal morphotype can help assist surgeons to aim for specific alignment goals for CT, FN and FD. Distinct deformity specific intra-operative goals include obtaining proper sagittal global/cervical alignment for cervicothoracic patients, correcting maximal focal kyphosis in focal deformity patients, and correcting horizontal gaze for flatneck patients.

Younger Patients Are Differentially Affected by Stiffness-Related Disability Following Adult Spinal Deformity Surgery.

OBJECTIVE: The Lumbar Stiffness Disability Index (LSDI) assesses impact of lumbar stiffness on activities of daily living. We hypothesized that patients <60 years old would perceive greater lumbar stiffness-related functional limitation following fusion for adult spinal deformity. METHODS: Patients completed the LSDI and Scoliosis Research Society 22 Questionnaire, Revised (SRS-22r) preoperatively and at 2 years postoperatively. The primary independent variable was patient age <60 versus ≥60. Multivariable regression analyses were used. RESULTS: Analysis included 267 patients. Patients <60 years old (51.3%) and ≥60 years old (48.7%) were evenly represented. In bivariable analysis, patients age <60 exhibited lower LSDI at baseline versus patients age ≥60 (25.7 vs. 35.5, ß -9.8, P < 0.0001), but a directionally smaller difference at 2 years (26.4 vs. 32.3, ß -5.8, P = 0.0147). LSDI was associated with lower SRS-22r total score among both age groups at baseline and 2 years (all P < 0.0001); the association was stronger among patients age <60 versus ≥60 at 2 years. LSDI was associated with SRS-22r satisfaction scores at 2 years among patients age <60 (P < 0.0001), but not patients age ≥60 (P = 0.2250). The difference in SRS-22r satisfaction per unit LSDI between patients <60 years old and ≥60 years old was significant (P = 0.0021). CONCLUSIONS: Among patients with adult spinal deformity managed operatively, higher LSDI was associated with inferior SRS-22r total score and satisfaction at 2 years postoperatively. The association between increased LSDI and worse patient-reported outcome measures was greater among patients age <60 versus ≥60. Preoperative counseling is needed for patients age <60 undergoing adult spinal deformity surgery regarding effects that lumbar stiffness may have on postoperative function and satisfaction.

Comparison of Best Versus Worst Clinical Outcomes for Adult Cervical Deformity Surgery.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Factors that predict outcomes for adult cervical spine deformity (ACSD) have not been well defined. To compare ACSD patients with best versus worst outcomes. METHODS: This study was based on a prospective, multicenter observational ACSD cohort. Best versus worst outcomes were compared based on Neck Disability Index (NDI), Neck Pain Numeric Rating Scale (NP-NRS), and modified Japanese Orthopaedic Association (mJOA) scores. RESULTS: Of 111 patients, 80 (72%) had minimum 1-year follow-up. For NDI, compared with best outcome patients (n = 28), worst outcome patients (n = 32) were more likely to have had a major complication (P = .004) and to have undergone a posterior-only procedure (P = .039), had greater Charlson Comorbidity Index (P = .009), and had worse postoperative C7-S1 sagittal vertical axis (SVA; P = .027). For NP-NRS, compared with best outcome patients (n = 26), worst outcome patients (n = 18) were younger (P = .045), had worse baseline NP-NRS (P = .034), and were more likely to have had a minor complication (P = .030). For the mJOA, compared with best outcome patients (n = 16), worst outcome patients (n = 18) were more likely to have had a major complication (P = .007) and to have a better baseline mJOA (P = .030). Multivariate models for NDI included posterior-only surgery (P = .006), major complication (P = .002), and postoperative C7-S1 SVA (P = .012); models for NP-NRS included baseline NP-NRS (P = .009), age (P = .017), and posterior-only surgery (P = .038); and models for mJOA included major complication (P = .008). CONCLUSIONS: Factors distinguishing best and worst ACSD surgery outcomes included patient, surgical, and radiographic factors. These findings suggest areas that may warrant greater awareness to optimize patient counseling and outcomes.

Rod Fracture After Apparently Solid Radiographic Fusion in Adult Spinal Deformity Patients.

BACKGROUND: Rod fracture occurs with delayed fusion or pseudarthrosis after adult spinal deformity (ASD) surgery. Rod fracture after apparent radiographic fusion has not been previously investigated. METHODS: Patients with ASD in a multicenter database were assessed for radiographic fusion by a committee of 3 spinal deformity surgeons. Fusions were rated as bilaterally fused (A), unilaterally fused (B), partially fused (C), or not fused (D). Patients with grade A or B fusion and 2-year follow-up were included. Patients with radiographic fusion were evaluated for subsequent rod fracture. Adjusted analyses were conducted with multiple logistic regression, using backwards-variable selection to a threshold of P < 0.2, to assess for associated factors. RESULTS: Of 402 patients with radiographically apparent solid fusion, 9.5% (38) subsequently suffered a broken rod. On multivariate analysis, greater rates of rod fracture were seen among patients of age group 60-69 years (vs. 18-49), body mass index 30-34 and 35+ (vs. <25), stainless-steel rods (vs. titanium), patients with rods ≤5.5 mm (vs. 6.35 mm), and patients with Charlson score 0 (vs. 3+). Of the 38 patients with rod fractures, 18 (47.4%) presented with worsened pain, and 8 (21.1%) required revision at minimum 2-year follow-up. CONCLUSIONS: Rod fracture occurred in 9.5% of patients with apparently solid radiographic fusion after ASD surgery. Advanced age, obesity, small diameter rods (5.5 mm), osteotomy, and lower comorbidity burden were significantly associated with rod fracture. Nearly one-half of these patients noted worsening pain, and 21.1% required revision surgery. Instrumentation failure may occur and may be symptomatic even in the setting of apparent fusion on plain radiographs.

Center variation in episode-of-care costs for adult spinal deformity surgery: results from a prospective, multicenter database.

BACKGROUND CONTEXT: Adult spinal deformity (ASD) surgery is associated with significant resource utilization, costing more than $958 million in charges for Medicare patients and more than $1.7 billion in charges for managed care population in the last decade. Given the recent move toward bundled payment models, it is important to understand the various care components a patient receives over the course of a defined clinical episode, its associated cost, and the proportion of cost for each component toward the bundled payment. PURPOSE: To examine the degree and determinants of variation in inpatient episode-of-care (EOC) cost, resource utilization, and patient-reported outcomes for patients undergoing ASD surgery across four spine deformity centers in the United States. STUDY DESIGN/SETTING: Retrospective analysis of prospective, multicenter database. PATIENT SAMPLE: Consecutive patients enrolled in an ASD database from four spinal deformity centers. OUTCOME MEASURES: Total in-patient EOC costs and Short Form (SF)-6D. METHODS: The study used a multicenter database of 210 consecutively enrolled operative patients from 2008 to 2013 at four participating centers in the United States. Demographic, surgical, and direct cost data, expressed in 2013 dollars, for the entire inpatient EOC were obtained from administrative databases from the respective hospitals. Mixed models and multivariable linear regression were used to evaluate the impact of center on total costs adjusting for patient characteristics, length of stay (LOS), and surgical factors. RESULTS: A total of 126 patients with complete baseline and 2-year follow-up data were included. The percentages of patients from each center were 36.5%, 7.1%, 24.6%, and 31.7%. Overall, the mean patient age was 58.4±12.6 years, 86% were women, and 94% were Caucasian. The proportion of total cost variation explained by the center at which the patient was treated was 17%. After adjusting for patient, LOS, and surgical factors the cost variation reduced to 4%. In multivariable analysis, each additional level fused increased total cost variation by $2,500, whereas recombinant human bone morphogenetic protein-2 (BMP) use and posterior-only surgical approach lowered total EOC costs by $10,500 and $9,400, respectively. No significant difference was observed in 2-year quality-adjusted life year across centers. CONCLUSIONS: Total EOC costs for ASD surgery varied significantly by center. Levels fused, BMP use, and surgical approach were the primary drivers of cost variation across centers. Differences in resource utilization had no impact on 2-year quality-adjusted life year improvement across centers.

Prospective Multicenter Assessment of All-Cause Mortality Following Surgery for Adult Cervical Deformity.

BACKGROUND: Surgical treatments for adult cervical spinal deformity (ACSD) are often complex and have high complication rates. OBJECTIVE: To assess all-cause mortality following ACSD surgery. METHODS: ACSD patients presenting for surgical treatment were identified from a prospectively collected multicenter database. Clinical and surgical parameters and all-cause mortality were assessed. RESULTS: Of 123 ACSD patients, 120 (98%) had complete baseline data (mean age, 60.6 yr). The mean number of comorbidities per patient was 1.80, and 80% had at least 1 comorbidity. Surgical approaches included anterior only (15.8%), posterior only (50.0%), and combined anterior/posterior (34.2%). The mean number of vertebral levels fused was 8.0 (standard deviation [SD] = 4.5), and 23.3% had a 3-column osteotomy. Death was reported for 11 (9.2%) patients at a mean of 1.1 yr (SD = 0.76 yr; range = 7 d to 2 yr). Mean follow-up for living patients was 1.2 yr (SD = 0.64 yr). Causes of death included myocardial infarction (n = 2), pneumonia/cardiopulmonary failure (n = 2), sepsis (n = 1), obstructive sleep apnea/narcotics (n = 1), subsequently diagnosed amyotrophic lateral sclerosis (n = 1), burn injury related to home supplemental oxygen (n = 1), and unknown (n = 3). Deceased patients did not significantly differ from alive patients based on demographic, clinical, or surgical parameters assessed, except for a higher major complication rate (excluding mortality; 63.6% vs 22.0%, P = .006). CONCLUSION: All-cause mortality at a mean of 1.2 yr following surgery for ACSD was 9.2% in this prospective multicenter series. Causes of death were reflective of the overall high level of comorbidities. These findings may prove useful for treatment decision making and patient counseling in the context of the substantial impact of ACSD.

After 9 Years of 3-Column Osteotomies, Are We Doing Better? Performance Curve Analysis of 573 Surgeries With 2-Year Follow-up.

BACKGROUND: In spinal deformity treatment, the increased utilization of 3-column (3CO) osteotomies reflects greater comfort and better training among surgeons. This study aims to evaluate the longitudinal performance and adverse events (complications or revisions) for a multicenter group following a decade of 3CO. OBJECTIVE: To investigate if performance of 3CO surgeries improves with years of practice. METHODS: Patients who underwent 3CO for spinal deformity with intra/postoperative and revision data collected up to 2 yr were included. Patients were chronologically divided into 4 even groups. Demographics, baseline deformity/correction, and surgical metrics were compared using Student t-test. Postoperative and revision rates were compared using Chi-square analysis. RESULTS: Five hundred seventy-three patients were stratified into: G1 (n = 143, 2004-2008), G2 (n = 142, 2008-2009), G3 (n = 144, 2009-2010), G4 (n = 144 2010-2013). The most recent patients were more disabled by Oswestry disability index (G4 = 49.2 vs G1 = 38.3, P = .001), and received a larger osteotomy resection (G4 = 26° vs G1 = 20°, P = .011) than the earliest group. There was a decrease in revision rate (45%, 35%, 33%, 30%, P = .039), notably in revisions for pseudarthrosis (16.7% G1 vs 6.9% G4, P = .007). Major complication rates also decreased (57%, 50%, 46%, 39%, P = .023) as did excessive blood loss (>4 L, 27.2 vs 16.7%, P = .023) and bladder/bowel deficit (4.2% vs 0.7% P = .002). Successful outcomes (no complications or revision) significantly increased (P = .001). CONCLUSION: Over 9 yr, 3COs are being performed on an increasingly disabled population while gaining a greater correction at the osteotomy site. Revisions and complication rate decreased while success rate improved during the 2-yr follow-up period.