Characteristics of Spinal Morphology According to the "Current" and "Theoretical" Roussouly Classification Systems in a Diverse, Asymptomatic Cohort: Multi-Ethnic Alignment Normative Study (MEANS).

STUDY DESIGN: Cross-sectional cohort study. OBJECTIVE: To classify spinal morphology using the "current" and "theoretical" Roussouly systems and assess sagittal alignment in an asymptomatic cohort. METHODS: 467 asymptomatic volunteers were recruited from 5 countries. Radiographic parameters were measured via the EOS imaging system. "Current" and "theoretical" Roussouly classification was assigned with sagittal whole spine imaging using sacral slope (SS), pelvic incidence (PI), and the lumbar apex. One-way analysis of variance (ANOVA) was performed to compare subject characteristics across Roussouly types, followed by post hoc Bonferroni correction. RESULTS: Volunteers were categorized into 4 groups (Types 1-4) and 1 subgroup (Type 3 AP) using the "current" and "theoretical" Roussouly systems. The mean PI in "current" Roussouly groups was 40.8° (Type 1), 43.6° (Type 2), 52.4° (Type 3), 62.4° (Type 4), and 43.7° (Type 3AP). The mean PI in "theoretical" Roussouly groups was 36.5° (Type 1), 39.1°(Type 2), 52.5° (Type 3), 67.3° (Type 4), and 51.0° (Type 3AP). The difference in PI between "current" and "theoretical" Roussouly types was significant for Type 1 (P = .02), Type 2 (P < .001), Type 4 (P < .001), and Type 3AP (P < .001). 34.7% of subjects had a "current" Roussouly type different from the "theoretical" type. Type 3 theoretical shape had the most frequent mismatch, constituting 61.1% of the mismatched subjects. 51.5% of mismatched Type 3 become "current" Type 4. CONCLUSION: The distribution of Roussouly types differs depending on whether the "current" or "theoretical" classification are employed. A sizeable proportion of volunteers exhibited current and theoretical type mismatch, highlighting the need to interpret sagittal alignment cautiously when utilizing the Roussouly system.

Polyetheretherketone Polymer Transpedicular Vertebral System to Treat Vertebral Compression Fracture: A Multicentre Pilot Study of Feasibility and Safety.

OBJECTIVES: To prospectively evaluate the feasibility and safety of a polyetheretherketone (PEEK) polymer transpedicular vertebral system to treat vertebral compression fracture (VCF). METHODS: Nine consecutive patients (4 men and 5 women; median age 59 [interquartile range: 58-64 years]) were included. The procedure duration, length of hospital stay, and complications were reported. Visual analog scale (VAS) and the Oswestry disability index (ODI) for pain and disability were assessed before and at 2, 6, and 12-month after the procedure. RESULTS: The procedure was technically feasible in all patients. The median procedural time was 64 minutes [45-94]. Only minor adverse events were reported (5 clinically asymptomatic cement leakages) but no severe complications. No post procedural adjacent fracture was reported during follow-up (median: 193 days [147-279]). The median VAS score decreased from 55 mm [50-70] before the procedure to 25 mm [5-30] at 2-month (P = .0003) and 30 mm [15-40] at 6-month follow-up (P = .14). The median ODI decreased from 23% [19-26] before the procedure to 12% [10-14] at 2-month (P = .03) and 12% [9-20] at 6-month follow-up (P = .47). CONCLUSIONS: Percutaneous transpedicular fixation of VCF by PEEK implants appears feasible and safe.

Characteristics of Spinal Morphology according to the Global Alignment and Proportion (GAP) Score in a Diverse, Asymptomatic Cohort: Multi-Ethnic Alignment Normative Study.

STUDY DESIGN: Multi-Ethnic Alignment Normative Study (MEANS) cohort: prospective, cross-sectional, multi-center. OBJECTIVE: To analyze the distribution of GAP scores in the MEANS cohort and compare the spinal shape via stratification by GAP alignment category, age, and country. SUMMARY OF BACKGROUND DATA: The GAP score has been used to categorize spinal morphology and prognosticate adult spinal deformity surgical outcomes and mechanical complications. We analyzed a large, multiethnic, asymptomatic cohort to assess the distribution of GAP scores. METHODS: 467 healthy volunteers without spinal disorders were recruited in 5 countries. Sagittal radiographic parameters were measured via the EOS imaging system. The GAP total and constituent factor scores were calculated for each patient. Kruskal-Wallis rank sum test was performed to compare variables across groups, followed by post hoc Games Howell test. Fisher's exact test was used to compare categorical variables. The significance level was set to P<0.05. RESULTS: In the MEANS cohort, 13.7% (64/467) of volunteers were≥60 years old, and 86.3% (403/467) were<60 years old. 76.9% (359/467) was proportioned, 19.5% (91/467) was moderately disproportioned, and 3.6% (17/467) was severely disproportioned. There was no significant difference in the frequency of proportioned, moderately, or severely disproportioned GAP between subjects from different countries (P=0.060). Those with severely disproportioned GAP alignment were on average 14.5 years older (P=0.016), had 23.1° lower magnitude lumbar lordosis (LL) (P<0.001), 14.2° higher pelvic tilt (P<0.001), 13.3° lower sacral slope (P<0.001), 24.1° higher pelvic-incidence (PI)-LL mismatch (P<0.001), 18.2° higher global tilt (P<0.001) than those with proportioned GAP; thoracic kyphosis and PI were not significantly different (P>0.05). CONCLUSION: The GAP system applies to a large, multi-ethnic, asymptomatic cohort. Spinal alignment should be considered on a spectrum, as 19.5% of the asymptomatic volunteers were classified as moderately disproportioned and 3.6% severely disproportioned. Radiographic malalignment does not always indicate symptoms or pathology. LEVEL OF EVIDENCE: 3.

The Importance of Pelvic Obliquity in Assessing Spinal Coronal Alignment: Normative Values, Demographic, and Radiographic Correlations.

STUDY DESIGN: Prospective, cross-sectional study. OBJECTIVE: In a geographically diverse population of asymptomatic volunteers, we sought to report the incidence of pelvic obliquity (PO), establish normative values of PO across patient factors, and assess the correlation of PO with radiographic parameters. SUMMARY OF BACKGROUND DATA: PO is defined as the misalignment of the pelvis and can be assessed through several anatomic landmarks. Significant PO, whether caused by leg-length discrepancy or not, can lead to coronal malalignment which causes severe pain and disability. Significant emphasis has been placed on achieving appropriate sagittal alignment in recent decades; however, a greater understanding of coronal alignment is needed, and PO is a crucial aspect of evaluating the coronal plane in adult spinal deformity patients. METHODS: Asymptomatic adult volunteers, ages 18-80 years, enrolled patients from 5 countries (France, Japan, Singapore, Tunisia, and the United States) in the "multiethnic alignment normative study" cohort (IRB 201812144). The included volunteers had no known spinal disorder(s), no significant neck or back pain (Visual Analog Scale: ≤2; Oswestry Disability Index: ≤20), and no abnormal alignment (Cobb ≤20°). PO was measured in the frontal plane as the distance between the highest points of each acetabulum, calculated along the vertical axis in millimeters (mm). The incidence of PO was defined as PO ≥10 mm. Kruskal-Wallis, Wilcoxon rank-sum, Pearson correlation, and linear regression were used. RESULTS: A total of 467 patients were included, and PO values by age, sex, body mass index, and country were provided. The overall incidence of PO ≥10 mm was 4.3%, and a nonsignificant trend toward increased PO with age was seen ( P = 0.077). No significant differences were seen in PO between sex, ethnicity, or body mass index groups. No significant correlation existed between PO and other commonly used coronal radiographic measurements. CONCLUSION: PO ≥10 mm occurred in 4.3% of asymptomatic volunteers. Despite the importance of recognizing PO in preventing coronal malalignment, PO did not seem to be associated with other radiographic and demographic information, which underscores the importance of intentionally assessing for any PO before surgery. These results in an asymptomatic population provide a foundation for studying PO in patients with spinal pathology.

The Thoracolumbar Inflection Point in a Population of Asymptomatic Volunteers: A Multi-Ethnic Alignment Normative Study Cohort Study.

STUDY DESIGN: Prospective cohort study. OBJECTIVES: To show population variance in the Inflection Point (IP) and its role in defining maximum Thoracic Kyphosis (TK) and Lumbar Lordosis (LL). METHODS: 468 asymptomatic adult volunteers were included in the Multi-Ethnic Normative Alignment Study (MEANS). To find parameters correlating with IP, the vertebrae and discs were numbered such that C7 was 0, T1 was 1, with T1-T2 disc being 1.5, etc. Statistical analysis was performed by a correlation matrix for IP and the 9 other selected parameters along with linear regressions. RESULTS: The overall mean IP was 12.44 approximately corresponding to T12-L1 disc with the median being 12.50, range was T8-L4. The cohort was then stratified by sex and ethnicity, but there was no significant difference in IP between groups. IP in younger subjects was 13 (L1), compared to 12.5 (T12-L1 disc) in older subjects (P < .05). IP was moderately correlated with the TK apex (r = .66). No strong correlation was found between IP and LL magnitude or apex, TK magnitude, sacral slope, or Pelvic Incidence (PI). In terms of other sagittal parameters, PI and LL demonstrated a significant positive correlation. PI and TK did not have a strong association. CONCLUSIONS: The mean IP was at the T12-L1 disc, however IP ranged from T8 to L4. Older subjects tended to have a relatively more cephalad IP. No radiographic variable was found to be a strong predictor of the IP. TK apex was found to have a moderate correlation.

Racial differences in whole-body sagittal alignment between Asians and Caucasians based on international multicenter data.

PURPOSE: To examine inherent differences adjusted for age and clinical score in whole-body sagittal (WBS) alignment involving the lower extremities between Asians and Caucasians, and to determine the relationship between age and WBS parameters by race and sex. METHODS: A total of 317 individuals consisting of 206 Asians and 111 Caucasians participated. WBS parameters including C2-7 lordotic angle, lower lumbar lordosis (lower LL, L4-S), pelvic incidence (PI), pelvic thickness, knee flexion (KF), sagittal vertical axis (SVA), and T1 pelvic angle (TPA) were evaluated radiologically. Propensity score-matching adjustments for age and the Oswestry Disability Index scores for comparative analysis between the two race cohorts and correlation analysis between age and WBS parameters for all subjects by race and sex were conducted. RESULTS: The comparative analysis included 136 subjects (age: Asians 41.1 ± 13.5, Caucasians 42.3 ± 16.2 years, p = 0.936). Racial differences in WBS parameters were observed in C2-7 lordotic angle (-1.8 ± 12.3 vs. 6.3 ± 12.2 degrees, p = 0.001), and lower LL (34.0 ± 6.6 vs. 38.0 ± 6.1 degrees, p < .001). In correlation analysis with age, moderate or more significant correlations with age were found in KF for all groups, and in SVA and TPA for females of both racial groups. Age-related changes in pelvic parameters of PI and pelvic thickness were more significant in Caucasian females. CONCLUSION: Analysis of the correlation between age and WBS parameters suggested that age-related WBS changes vary between races and should be considered during corrective spinal surgery.

Morphological description of sagittal lumbar spinal alignment using curve magnitude, span, and apex-the multiethnic alignment normative study (MEANS).

BACKGROUND CONTEXT: Current definition of lumbar lordosis uses the L1-S1 angle. Prevailing classification of sagittal spinal morphology, derived from a young adult population, classifies the spine into four subtypes defined by their sacral slope (SS) and curve morphology. PURPOSE: To describe physiological sagittal alignment of the lumbar spine across age groups using three main parameters that dictate the lumbar curve: angular magnitude, span, and apex. STUDY DESIGN: A large, multicenter, cross-sectional radiographic comparison study. PATIENT SAMPLE: Four hundred sixty-eight healthy, asymptomatic subjects aged 18 to 80 years from five countries (184 males, 284 females; 98 France, 119 Japan, 79 Singapore, 80 Tunisia, 92 USA, mean age 40.61±14.99 years). OUTCOME MEASURES: Sagittal lumbar profile subtypes clustered based on lumbar curve angular magnitude (ie, Cobb angle of the lumbar lordosis), span, and apex, and described by sagittal radiographic parameters. METHODS: Subjects underwent whole-body low-dose EOS stereoradiographs. Comparisons between conventional L1-S1 lumbar lordosis (cLL) and true lumbar lordosis (tLL, defined by the inflection-S1 angle) were conducted. Using the K-means clustering algorithm, lumbar curve angular magnitude, span and apex were used to classify sagittal spinal morphology into subtypes, stratified across age groups. Further univariate and multivariate analyses were conducted to compare radiographic parameters across subtypes, and identify predictors for the lumbar curve's angular magnitude, span and apex. RESULTS: Mean cLL was -57.27±11.37°, and tLL was -62.62±10.76°. Using tLL, instead of cLL, to describe sagittal spinal morphology, we found significant differences in terms of angular magnitude of the lumbar curve, the median thoracolumbar inflection vertebral level and pelvic incidence-lumbar lordosis mismatch Multivariate analysis found a larger SS, more positive T9 tilt, and more kyphotic T4-T12 predictive for a more lordotic tLL, while a larger overhang distance predicted for a less lordotic tLL (p-values<.001). In addition, a larger T9 tilt, less lordotic L1-L5 and smaller PT were predictors of a more caudal thoracolumbar inflection and lumbar apical vertebral levels (p-values<.001). Sagittal lumbar profiles of subjects age<30 years, 30≤age<60 years and age≥60 years, could be classified into 4, 6, and 3 subtypes, respectively. CONCLUSIONS: Sagittal lumbar profile subtypes vary across age groups, with more homogenous morphologies at the extremes of ages. Improved understanding of the morphological evolution of sagittal spinal profiles with age in asymptomatic individuals will help guide future individualized surgical treatment.

Sagittal spinal alignment varies with an individual's race: results of the multi-ethnic alignment normative study (MEANS).

PURPOSE: Assess normative values of sagittal spinal and lower extremity alignment in asymptomatic volunteers of three difference races. METHODS: Asymptomatic volunteers between the ages of 18-80 years were enrolled prospectively and then analyzed retrospectively from six different centers. Volunteers included reported no significant neck or back pain, nor any known spinal disorder(s). All volunteers underwent a standing full-body or full-spine low dose stereoradiograph. Volunteers were grouped into three main races; Asian (A), Arabo-Bèrbère (B), and Caucasian (C). The Asian volunteers included in this study were from Japan and Singapore. RESULTS: There were statistical differences in the Age, ODI, and BMI of the volunteers from the three different races. Asian volunteers had the lowest age (A: 36.7, B: 45.5, C: 42.0) and BMI (A: 22.1, B: 27.1, C: 27.3). Pelvic morphology including pelvic incidence (A: 51.0, B: 52.0, C: 52.5, p = 0.37), pelvic tilt (A: 11.9, B: 12.3, C: 12.9, p = 0.44), and sacral slope (A: 39.1, B: 39.7, C: 39.6, p = 0.77) were similar amongst the 3 races. Regional spinal alignment was different between the groups. Thoracic Kyphosis (A: 32.9, B: 43.3, C: 40.0, p < 0.0001) and Lumbar lordosis (A: - 54.2, B: - 60.4, C: - 59.6, p < 0.0001) were lower in Asians compared to Caucasian and Arabo-Bèrbère volunteers despite having similar pelvic incidence. CONCLUSION: Volunteers in the Asian group had lower lumbar lordosis and thoracic kyphosis when compared to the Arabo-Bèrbère and Caucasian groups while all groups had similar pelvic morphology. Thoracic Kyphosis had no correlation with Pelvic Incidence, while Lumbar Lordosis correlated well with both Thoracic Kyphosis and Pelvic Incidence. Thoracic kyphosis may be an independent variable in establishing adequate lumbar lordosis and varies based on an individual's race.

A novel device with pedicular anchorage provides better biomechanical properties than balloon kyphoplasty for the treatment of vertebral compression fractures.

PURPOSE: To compare the biomechanical behavior of vertebrae with vertebral compression fractures (VCF) treated by a novel system with pedicular anchorage (dowelplasty) versus balloon kyphoplasty. METHODS: Four cadaveric spines (T12-L5) were harvested, cleaned from soft tissues, and separated into vertebrae. Axial compressive loads were applied to each vertebra until a VCF was generated. Half of the vertebrae (n = 11) were instrumented using the "dowelplasty" system, consisting of a hollow titanium dowel anchored into the pedicle, through which a cannulated titanium nail is inserted and locked and through which cement is injected. The other half (n = 11) were instrumented using balloon kyphoplasty. Axial compressive loads were re-applied to each vertebra until fracture. Fracture load and fracture energy were calculated from load-displacement data for the pre- and post-treatment states. RESULTS: Compared to balloon kyphoplasty, dowelplasty granted greater net change in fracture load (373N; 95%CI,-331-1076N) and fracture energy (755Nmm; 95%CI,-563-2072Nmm). A sensitivity analysis was performed without L4 and L5 vertebrae from the dowelplasty group, since the length of the cannulated nails was too short for these vertebrae: compared to balloon kyphoplasty, dowelplasty granted an even greater net change in fracture load (680N; 95%CI,-96-1457N) and fracture energy (1274Nmm; 95%CI,-233-2781Nmm). CONCLUSION: Treating VCFs with dowelplasty grants increased fracture load and fracture energy compared to the pre-treatment state. Furthermore, dowelplasty grants greater improvement in fracture load and fracture energy compared to balloon kyphoplasty, which suggests that dowelplasty may be a good alternative for the treatment of VCF. LEVEL OF EVIDENCE: level IV.

Comparison of Cobb angle measurements for scoliosis assessment using different imaging modalities: a systematic review.

Purpose: To report accuracy, repeatability, and agreement of Cobb angle measurements on radiographs and/or stereo-radiographs (EOS) compared against one another or against other imaging modalities. Methods: This review follows Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. A literature search was conducted on 21 July 2021 using Medline, Embase, and Cochrane. Two researchers independently performed title/abstract/full-text screening and data extraction. Studies were eligible if they reported Cobb angles, and/or their repeatability and agreement, measured on radiographs and/or EOS compared against one another or against other imaging modalities. Results: Of the 2993 records identified, 845 were duplicates and 2212 were excluded during title/abstract/full-text screening. Two more relevant studies were identified from references of eligible studies, leaving 14 studies for inclusion. Two studies compared Cobb angles from EOS vs CT, while 12 compared radiographs vs other imaging modalities: EOS, CT, MRI, digital fluoroscopy, or dual-energy x-ray absorptiometry. Angles from standing radiographs tended to be higher than those from supine MRI and CT, and angles from standing EOS tended to be higher than those from supine or prone CT. Correlations across modalities were strong (R = 0.78-0.97). Inter-observer agreement was excellent for all studies (ICC = 0.77-1.00), except one (ICC = 0.13 radiographs and ICC = 0.68 for MRI). Conclusion: Differences of up to 11º were found when comparing Cobb angles across combinations of imaging modalities and patient positions. It is not possible, however, to determine whether the differences observed are due to the change of modality, position, or both. Therefore, clinicians should be careful when utilizing the thresholds for standing radiographs across other modalities and positions for diagnosis and assessment of scoliosis.

Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.

BACKGROUND: Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. METHODS: In this multicenter, site-level, randomized, double-blind trial, patients aged 18-85 years received a single dose of SA4Ag or placebo 10-60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. RESULTS: Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. CONCLUSIONS: In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165.

Variation in Lumbar Shape and Lordosis in a Large Asymptomatic Population: A MEANS Study.

STUDY DESIGN: Prospective, cross-sectional cohort study. OBJECTIVE: To determine the relationship between lumbar shape and sagittal parameters. SUMMARY OF BACKGROUND DATA: Understanding the lumbar shape is vital for deformity surgery. Normative sagittal parameters and spine shape remain unstudied in large, multiethnic, asymptomatic cohorts. MATERIALS AND METHODS: A prospective, cross-sectional cohort of 468 asymptomatic volunteers between 18 and 80 years was enrolled across 5 countries. Demographic data and radiographic parameters such as pelvic incidence (PI) were collected. Pearson correlation test and linear regression were used to find the relationship between lumbar lordosis (LL) and other parameters. One-way analysis of variance and Welch 2-sample t test were performed to compare lumbar shape across such categories as PI and lumbar apex followed by post hoc Bonferroni correction if needed. RESULTS: PI was moderately correlated with proximal lumbar lordosis (pLL) ( r = -0.54) and weakly correlated with distal lumbar lordosis (dLL) ( r = -0.16). Thoracic kyphosis (T1-T12) was moderately correlated with pLL ( r = -0.35) and dLL ( r = -0.29). dLL was moderately correlated with LL ( r = 0.64). 2.6% (12/468) of subjects had lumbar apex at L2, 40.2% (188/468) at L3, 56.6% at L4 (265/468), and 0.6% (3/468) at other levels. Mean PI was different between volunteers with the apex at L3 and L4. A lower mean PI was associated with the apex at L4 (49.0°), whereas a higher mean PI was associated with the apex at L3 (55.8°). The mean PI-LL mismatch for volunteers was -5.4° with a range from -35° to 39.7°. PI-LL mismatch increased from a mean of -10.1° in volunteers with low PI to a mean of 2.2° in volunteers with high PI. Age was not correlated with LL ( P = 0.84). CONCLUSIONS: In asymptomatic adult volunteers, pLL showed a moderate correlation with PI and increased with PI, whereas dLL showed a weak correlation. The lumbar apex migrated proximally with increasing PI. Segmental lordosis and apex position instead of solely global lordosis should be emphasized. LEVEL OF EVIDENCE: Level III.

The age-specific normative values of standing whole-body sagittal alignment parameters in healthy adults: based on international multicenter data.

PURPOSE: To investigate the age-specific normative values of whole-body sagittal alignment (WBSA) including global balance parameters in healthy adults and to clarify the correlations among parameters based on the data from three international multicenter. METHODS: Three hundred and seventeen healthy subjects (range: 20-84 y.o., mean: 43.8 ± 14.7 y.o.) were included and underwent whole-body biplanar X-ray imaging system. Spinopelvic parameters and knee flexion (KF), the center of acoustic meatus (CAM)-hip axis (HA), and C2 dentiform apophyse (OD)-HA, the cranial center (Cr)-HA were evaluated radiologically. Sub-analysis for correlation analysis between age and parameters and among parameters was performed to investigate age-specific change and compensatory mechanisms. RESULTS: For age-related change, C2-7 angle (r = .326 for male/.355 for female), KF (r = .427/.429), and SVA (r = .234/.507) increased with age in both male and female group. For global parameters related to the center of the gravity, correlations with age were not significant (r = .120/.161 for OD-HA, r = .163/.275 for Cr-HA, r = .149/.262 for CAM-HA). Knee flexion (KF) has correlation with global parameters (i.e., SVA, OD-HA, Cr-HA, CAM-HA) and does not have correlations with local spinopelvic alignment. CONCLUSION: While several local alignment changes with age were found, changes in global parameters related to the center of gravity were kept relatively mild by the chain of compensation mechanisms including the lower limbs. We showed the normative values for a comprehensive WBSA in standing posture from large international healthy subjects' database.

Do Age-Related Variations Of Sagittal Alignment Rely On SpinoPelvic Organization? An Observational Study Of 1540 Subjects.

STUDY DESIGN: Descriptive radiographic analysis of a prospective multi-center database. OBJECTIVE: This study aims to provide normative values of spinopelvic parameters and their correlations according to age and pelvic incidence (PI) of subjects without spinal deformity. METHODS: After Institutional Review Board (IRB) approval, 1540 full spine radiographs were analyzed. Subjects were divided into 3 groups of PI: low PI < 45°, intermediate PI 45-60°, high PI > 60°, and then stratified by age (20-34, 35-49, 50-64, > 65 Y.O). Pelvic and spinal parameters were measured. Statistical analysis between parameters was performed using Bayesian inference and correlation. RESULTS: Mean age was 53.5 years (845 females, 695 males, range 20-93 years).In low PI group, lumbar lordosis (LL) decrease was mainly observed in the 2 younger age groups.In medium and high PI groups, loss of lordosis was linear during aging and occurred mainly on the distal arch of lordosis. Moderate PI group had a stable lordosis apex and thoracolumbar inflection point. High PI group had a stable thoracolumbar inflection point and a more distal lordosis apex in elderly subjects.For all subjects, kyphosis and pelvic tilt (PT) increased with age.There was a constant chain of correlation between PI and age groups. Proximal lumbar lordosis (PLL) was correlated with kyphosis and sagittal vertical axis (SVA C7), while the distal lumbar lordosis (DLL) was correlated with PI and PT. CONCLUSION: This study provides a detailed repository of sagittal spinopelvic parameters normative values with detailed analysis of segmental kyphosis and lordosis distribution according to gender, age, and PI.

Team management in complex posterior spinal surgery allows blood loss limitation.

PURPOSE: The objective is to analyse peri-operative blood loss (BL) and hidden blood loss (HBL) rates in spinal deformity complex cases surgery, with a focus on the strategies to prevent major bleeding. METHODS: We retrospectively analysed surgical and anaesthesiologic data of patients who had been operated for adolescent idiopathic scoliosis (AIS) or adult spinal deformities (ASD) with a minimum of five levels fused. A statistical comparison among AIS, ASD without a pedicle subtraction osteotomy (PSO) (ASD-PSO( -)) and ASD with PSO (ASD-PSO( +)) procedures was performed with a view to identifying patient- and/or surgical-related factors affecting peri-operative BL and HBL. RESULTS: One-hundred patients were included with a mean 9.9 ± 2.8 fused vertebrae and a mean 264.2 ± 68.3 minutes operative time (OT) (28.3 ± 9 min per level). The mean perioperative BL was 641.2 ± 313.8 ml (68.9 ± 39.5 ml per level) and the mean HBL was 556.6 ± 381.8 ml (60.6 ± 42.8 ml per level), with the latter accounting for 51.5% of the estimated blood loss (EBL). On multivariate regression analysis, a longer OT (p < 0.05; OR 3.38) and performing a PSO (p < 0.05; OR 3.37) were related to higher peri-operative BL, while older age (p < 0.05; OR 2.48) and higher BMI (p < 0.05; OR 2.15) were associated to a more significant post-operative HBL. CONCLUSION: With the correct use of modern technologies and patient management, BL in major spinal deformity surgery can be dramatically reduced. Nevertheless, it should be kept in mind that 50% of patients estimated losses are hidden and not directly controllable. Knowing the per-level BL allows anticipating global losses and, possibly, the need of allogenic transfusions.

Can Lumbopelvic Parameters Be Used to Predict Thoracic Kyphosis at all Ages? A National Cross-Sectional Study.

STUDY DESIGN: National cross-sectional study. BACKGROUND: Thoracic kyphosis (TK) is related to sagittal parameters as pelvic tilt (PT), lumbar lordosis (LL) and pelvic incidence (PI). The equation TK =2 (PT+LL-PI) was validated for adolescents.Objective: to investigate if this equation correctly predicts TK regardless of age. METHODS: Sagittal alignment parameters were assessed on full spine radiographs of 2599 individuals without spine pathology (1488 females, 1111 males). Calculated TK (CTK) = 2 (PT+LL-PI) and measured TK (MTK) were compared by calculating the gap and using a linear regression between both parameters. Subgroup analyses were performed for gender, age, TK groups (≤20°, 21°-40°, 41°-60°, >60°), and PI groups (<45°, 45°-60°, >60°). RESULTS: Average values in the total population were: MTK 45.0°, CTK 36.9°. Average TK gap was 8.1°, 5.2° in females (intercept 11.7, slope .61) and 11.9° in males (intercept 7.1, slope .58). The mean gap was 3.6° for 15-34 years, 5.7° under 15 years and it increased progressively after 35 years with a maximum of 19.9° over 80 years. The gap also increased with the amount of MTK: -3.5° for TK<20° up to 17.3° for TK >60°. Differences in gaps were minor between PI groups. The intercept was smallest and slopes >.6 for PI <45° and TK ≤20°. CONCLUSION: The formula TK=2 (PT+LL-PI) yielded moderate accuracy for adolescents and young adults, but did not fit for over 35 years and under 15. The amount and variance in TK increased in elderly subjects, which made the formula less accurate.

Computed Tomography Intraoperative Navigation in Spinal Surgery: Assessment of Patient Radiation Exposure in Current Practices.

BACKGROUND: Patient radiation exposure associated with the use of computed tomography (CT) navigation during spinal surgeries was widely compared with other intraoperative imaging techniques. The aim of this study is to explore the use of navigation with regard to current spinal surgery practices and the technical limitations of such imaging systems. METHODS: Dosimetric data from 101 patients who underwent intraoperative, CT-navigated spine surgery were retrospectively collected. The study population was divided into 3 groups according to the primary surgical indication. The number of CT image acquisitions per patient, the field length, and the time of exposure per acquisition during a single surgery were compared as well as the radiation dose emitted to patients. RESULTS: Dose-length products (DLP) per acquisition were 678.52, 656.8, and 649.36 mGy·cm with no significant difference for spinal deformity (SD), degenerative disease (DD), and vertebral fracture (VF) procedures, respectively. Analyzing the number of CT image acquisitions per patient revealed that repeated intraoperative scans were often performed for patients who were suffering from an SD due to technical limitations of the navigation. As a consequence, the cumulative dose was higher in the SD group (DLP total = 1175 mGy·cm) than in the DD (DLP total = 762.74 mGy·cm) and VF (DLP total = 649.36 mGy·cm) groups. CONCLUSIONS: CT navigation is an efficient intraoperative imaging technique that reduces the rate of surgical complications, but its technical limitations lead to an increased risk of patient radiation exposure, especially for complex surgeries where multiple scanning acquisitions are needed. CLINICAL RELEVANCE: To avoid patient's overexposure, spine surgeons should minimize the number of intraoperative acquisitions while considering the complexity of the surgery and the limitations of the guidance system. The use of dual guidance systems has also to be considered according to the benefit-risk balance between patient's outcomes and radiation dose exposure.

Can artificial intelligence support or even replace physicians in measuring sagittal balance? A validation study on preoperative and postoperative full spine images of 170 patients.

PURPOSE: Sagittal balance (SB) plays an important role in the surgical treatment of spinal disorders. The aim of this research study is to provide a detailed evaluation of a new, fully automated algorithm based on artificial intelligence (AI) for the determination of SB parameters on a large number of patients with and without instrumentation. METHODS: Pre- and postoperative sagittal full body radiographs of 170 patients were measured by two human raters, twice by one rater and by the AI algorithm which determined: pelvic incidence, pelvic tilt, sacral slope, L1-S1 lordosis, T4-T12 thoracic kyphosis (TK) and the spino-sacral angle (SSA). To evaluate the agreement between human raters and AI, the mean error (95% confidence interval (CI)), standard deviation and an intra- and inter-rater reliability was conducted using intra-class correlation (ICC) coefficients. RESULTS: ICC values for the assessment of the intra- (range: 0.88-0.97) and inter-rater (0.86-0.97) reliability of human raters are excellent. The algorithm is able to determine all parameters in 95% of all pre- and in 91% of all postoperative images with excellent ICC values (PreOP-range: 0.83-0.91, PostOP: 0.72-0.89). Mean errors are smallest for the SSA (PreOP: -0.1° (95%-CI: -0.9°-0.6°); PostOP: -0.5° (-1.4°-0.4°)) and largest for TK (7.0° (6.1°-7.8°); 7.1° (6.1°-8.1°)). CONCLUSION: A new, fully automated algorithm that determines SB parameters has excellent reliability and agreement with human raters, particularly on preoperative full spine images. The presented solution will relieve physicians from time-consuming routine work of measuring SB parameters and allow the analysis of large databases efficiently.

Age and Gender Based Spinopelvic and Regional Spinal Alignment in Asymptomatic Adult Volunteers: Results of the Multi-Ethnic Alignment Normative Study (MEANS).

BACKGROUND: Spinal alignment can have a significant impact on a patient's overall quality of life. Predicting the ideal sagittal spinal alignment of a specific individual is still a difficult task. The Multi-Ethnic Alignment Normative Study (MEANS) investigated skeletal alignment, including the spine and lower extremities, of the largest multi-ethnic cohort of asymptomatic adult volunteers. In this analysis, the authors aim to assess normative values of spinopelvic parameters and the regional cervical, thoracic, and lumbar spinal alignment in asymptomatic volunteers stratified by age and sex. MATERIALS AND METHODS: Asymptomatic volunteers between ages 18 and 80 years were enrolled prospectively from centers in France, Japan, Singapore, Tunisia, and the United States. Volunteers included reported no significant neck or back pain (Visual Analog Scale ≤2), nor any known spinal disorder(s). All volunteers underwent a standing full-body or full-spine low-dose stereoradiograph. RESULTS: MEANS consisted of 468 volunteers with a mean age of 40.4±14.8 years. Mean cervical lordosis from C2 to C7 was -0.4±12.7°. The T1-slope averaged 23.0±7.9° and showed strong correlation ( r =0.87) with the C7-slope mean of 19.8±8.6°. Thoracic kyphosis (TK) from T4 to T12 showed a mean of 37.4±10.9°. Average L1-S1 lumbar lordosis (LL) was -57.4±11.3°. The mean pelvic incidence (PI) measured 52.0±10.7° and pelvic tilt was 12.5±7.3°. Sacral slope averaged 39.5±8.2°. The average PI-LL was -5.4±10.7°. Approximately 60% of volunteers met the PI-LL criteria within ±10°, 8.3% were ≥10°, while 32.1% were ≤-10°. LL showed moderate correlation with PI ( r =0.53) and TK ( r =0.50), while there was no correlation between TK and PI. Multiple linear regression including PI, TK, and age resulted in the following equation LL=14.6+0.57 (PI)+0.57 (TK)-0.2 (age) ( r =0.75). CONCLUSIONS: LL did not change with increasing age in asymptomatic volunteers. However, TK did increase with age leading to an increase in T1-slope and a compensatory increase in cervical lordosis. TK did not correlate with PI and was an independent variable in the prediction of LL. LEVEL OF EVIDENCE: Level II-prospective cohort study.