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Ferran Pellisé, Miquel Serra-Burriel, Justin S. Smith, Sleiman Haddad, Michael P. Kelly, Alba Vila-Casademunt, Francisco Javier Sánchez Pérez-Grueso, Shay Bess, Jeffrey L. Gum, Douglas C. Burton, Emre Acaroğlu, Frank Kleinstück, Virginie Lafage, Ibrahim Obeid, Frank Schwab, Christopher I. Shaffrey, Ahmet Alanay, Christopher Ames, the International Spine Study Group and the European Spine Study Group

OBJECTIVE

Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO).

METHODS

Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis.

RESULTS

The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%–75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs.

CONCLUSIONS

The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.

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The comprehensive anatomical spinal osteotomy and anterior column realignment classification

Presented at the 2018 AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves

Juan S. Uribe, Frank Schwab, Gregory M. Mundis Jr., David S. Xu, Jacob Januszewski, Adam S. Kanter, David O. Okonkwo, Serena S. Hu, Deviren Vedat, Robert Eastlack, Pedro Berjano and Praveen V. Mummaneni

OBJECTIVE

Spinal osteotomies and anterior column realignment (ACR) are procedures that allow preservation or restoration of spine lordosis. Variations of these techniques enable different degrees of segmental, regional, and global sagittal realignment. The authors propose a comprehensive anatomical classification system for ACR and its variants based on the level of technical complexity and invasiveness. This serves as a common language and platform to standardize clinical and radiographic outcomes for the utilization of ACR.

METHODS

The proposed classification is based on 6 anatomical grades of ACR, including anterior longitudinal ligament (ALL) release, with varying degrees of posterior column release or osteotomies. Additionally, a surgical approach (anterior, lateral, or posterior) was added. Reliability of the classification was evaluated by an analysis of 16 clinical cases, rated twice by 14 different spine surgeons, and calculation of Fleiss kappa coefficients.

RESULTS

The 6 grades of ACR are as follows: grade A, ALL release with hyperlordotic cage, intact posterior elements; grade 1 (ACR + Schwab grade 1), additional resection of the inferior facet and joint capsule; grade 2 (ACR + Schwab grade 2), additional resection of both superior and inferior facets, interspinous ligament, ligamentum flavum, lamina, and spinous process; grade 3 (ACR + Schwab grade 3), additional adjacent-level 3-column osteotomy including pedicle subtraction osteotomy; grade 4 (ACR + Schwab grade 4), 2-level distal 3-column osteotomy including pedicle subtraction osteotomy and disc space resection; and grade 5 (ACR + Schwab grade 5), complete or partial removal of a vertebral body and both adjacent discs with or without posterior element resection. Intraobserver and interobserver reliability were 97% and 98%, respectively, across the 14-reviewer cohort.

CONCLUSIONS

The proposed anatomical realignment classification provides a consistent description of the various posterior and anterior column release/osteotomies. This reliability study confirmed that the classification is consistent and reproducible across a diverse group of spine surgeons.

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Justin K. Scheer, Taemin Oh, Justin S. Smith, Christopher I. Shaffrey, Alan H. Daniels, Daniel M. Sciubba, D. Kojo Hamilton, Themistocles S. Protopsaltis, Peter G. Passias, Robert A. Hart, Douglas C. Burton, Shay Bess, Renaud Lafage, Virginie Lafage, Frank Schwab, Eric O. Klineberg, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Pseudarthrosis can occur following adult spinal deformity (ASD) surgery and can lead to instrumentation failure, recurrent pain, and ultimately revision surgery. In addition, it is one of the most expensive complications of ASD surgery. Risk factors contributing to pseudarthrosis in ASD have been described; however, a preoperative model predicting the development of pseudarthrosis does not exist. The goal of this study was to create a preoperative predictive model for pseudarthrosis based on demographic, radiographic, and surgical factors.

METHODS

A retrospective review of a prospectively maintained, multicenter ASD database was conducted. Study inclusion criteria consisted of adult patients (age ≥ 18 years) with spinal deformity and surgery for the ASD. From among 82 variables assessed, 21 were used for model building after applying collinearity testing, redundancy, and univariable predictor importance ≥ 0.90. Variables included demographic data along with comorbidities, modifiable surgical variables, baseline coronal and sagittal radiographic parameters, and baseline scores for health-related quality of life measures. Patients groups were determined according to their Lenke radiographic fusion type at the 2-year follow-up: bilateral or unilateral fusion (union) or pseudarthrosis (nonunion). A decision tree was constructed, and internal validation was accomplished via bootstrapped training and testing data sets. Accuracy and the area under the receiver operating characteristic curve (AUC) were calculated to evaluate the model.

RESULTS

A total of 336 patients were included in the study (nonunion: 105, union: 231). The model was 91.3% accurate with an AUC of 0.94. From 82 initial variables, the top 21 covered a wide range of areas including preoperative alignment, comorbidities, patient demographics, and surgical use of graft material.

CONCLUSIONS

A model for predicting the development of pseudarthrosis at the 2-year follow-up was successfully created. This model is the first of its kind for complex predictive analytics in the development of pseudarthrosis for patients with ASD undergoing surgical correction and can aid in clinical decision-making for potential preventative strategies.

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Michael Akbar, Haidara Almansour, Renaud Lafage, Bassel G. Diebo, Bernd Wiedenhöfer, Frank Schwab, Virginie Lafage and Wojciech Pepke

OBJECTIVE

The goal of this study was to investigate the impact of thoracic and lumbar alignment on cervical alignment in patients with adolescent idiopathic scoliosis (AIS).

METHODS

Eighty-one patients with AIS who had a Cobb angle > 40° and full-length spine radiographs were included. Radiographs were analyzed using dedicated software to measure pelvic parameters (sacral slope [SS], pelvic incidence [PI], pelvic tilt [PT]); regional parameters (C1 slope, C0–C2 angle, chin-brow vertical angle [CBVA], slope of line of sight [SLS], McRae slope, McGregor slope [MGS], C2–7 [cervical lordosis; CL], C2–7 sagittal vertical axis [SVA], C2–T3, C2–T3 SVA, C2–T1 Harrison measurement [C2–T1 Ha], T1 slope, thoracic kyphosis [TK], lumbar lordosis [LL], and PI-LL mismatch); and global parameters (SVA). Patients were stratified by their lumbar alignment into hyperlordotic (LL > 59.7°) and normolordotic (LL 39.3° to 59.7°) groups and also, based on their thoracic alignment, into hypokyphotic (TK < −33.1°) and normokyphotic (TK −33.1° to −54.9°) groups. Finally, they were grouped based on their global alignment into either an anterior-aligned group or a posterior-aligned group.

RESULTS

The lumbar hyperlordotic group, in comparison to the normolordotic group, had a significantly larger LL, SS, PI (all p < 0.001), and TK (p = 0.014) and a significantly smaller PI-LL mismatch (p = 0.001). Lumbar lordosis had no influence on local cervical parameters.

The thoracic hypokyphotic group had a significantly larger PI-LL mismatch (p < 0.002) and smaller T1 slope (p < 0.001), and was significantly more posteriorly aligned than the normokyphotic group (−15.02 ± 8.04 vs 13.54 ± 6.17 [mean ± SEM], p = 0.006). The patients with hypokyphotic AIS had a kyphotic cervical spine (cervical kyphosis [CK]) (p < 0.001). Furthermore, a posterior-aligned cervical spine in terms of C2–7 SVA (p < 0.006) and C2–T3 SVA (p < 0.001) was observed in the thoracic hypokyphotic group.

Comparing patients in terms of global alignment, the posterior-aligned group had a significantly smaller T1 slope (p < 0.001), without any difference in terms of pelvic, lumbar, and thoracic parameters when compared to the anterior-aligned group. The posterior-aligned group also had a CK (−9.20 ± 1.91 vs 5.21 ± 2.95 [mean ± SEM], p < 0.001) and a more posterior-aligned cervical spine, as measured by C2–7 SVA (p = 0.003) and C2–T3 SVA (p < 0.001).

CONCLUSIONS

Alignment of the cervical spine is closely related to thoracic curvature and global alignment. In patients with AIS, a hypokyphotic thoracic alignment or posterior global alignment was associated with a global cervical kyphosis. Interestingly, upper cervical and cranial parameters were not statistically different in all investigated groups, meaning that the upper cervical spine was not recruited for compensation in order to maintain a horizontal gaze.

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Renaud Lafage, Ibrahim Obeid, Barthelemy Liabaud, Shay Bess, Douglas Burton, Justin S. Smith, Cyrus Jalai, Richard Hostin, Christopher I. Shaffrey, Christopher Ames, Han Jo Kim, Eric Klineberg, Frank Schwab, Virginie Lafage and the International Spine Study Group

OBJECTIVE

The surgical correction of adult spinal deformity (ASD) often involves modifying lumbar lordosis (LL) to restore ideal sagittal alignment. However, corrections that include large changes in LL increase the risk for development of proximal junctional kyphosis (PJK). Little is known about the impact of cranial versus caudal correction in the lumbar spine on the occurrence of PJK. The goal of this study was to investigate the impact of the location of the correction on acute PJK development.

METHODS

This study was a retrospective review of a prospective multicenter database. Surgically treated ASD patients with early follow-up evaluations (6 weeks) and fusions of the full lumbosacral spine were included. Radiographic parameters analyzed included the classic spinopelvic parameters (pelvic incidence [PI], pelvic tilt [PT], PI−LL, and sagittal vertical axis [SVA]) and segmental correction. Using Glattes’ criteria, patients were stratified into PJK and noPJK groups and propensity matched by age and regional lumbar correction (ΔPI−LL). Radiographic parameters and segmental correction were compared between PJK and noPJK patients using independent t-tests.

RESULTS

After propensity matching, 312 of 483 patients were included in the analysis (mean age 64 years, 76% women, 40% with PJK). There were no significant differences between PJK and noPJK patients at baseline or postoperatively, or between changes in alignment, with the exception of thoracic kyphosis (TK) and ΔTK. PJK patients had a decrease in segmental lordosis at L4-L5-S1 (−0.6° vs 1.6°, p = 0.025), and larger increases in segmental correction at cranial levels L1-L2-L3 (9.9° vs 7.1°), T12-L1-L2 (7.3° vs 5.4°), and T11-T12-L1 (2.9° vs 0.7°) (all p < 0.05).

CONCLUSIONS

Although achievement of an optimal sagittal alignment is the goal of realignment surgery, dramatic lumbar corrections appear to increase the risk of PJK. This study was the first to demonstrate that patients who developed PJK underwent kyphotic changes in the L4–S1 segments while restoring LL at more cranial levels (T12–L3). These findings suggest that restoring lordosis at lower lumbar levels may result in a decreased risk of developing PJK.

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Blake N. Staub, Renaud Lafage, Han Jo Kim, Christopher I. Shaffrey, Gregory M. Mundis Jr., Richard Hostin, Douglas Burton, Lawrence Lenke, Munish C. Gupta, Christopher Ames, Eric Klineberg, Shay Bess, Frank Schwab, Virginie Lafage and the International Spine Study Group

OBJECTIVE

Numerous studies have attempted to delineate the normative value for T1S−CL (T1 slope minus cervical lordosis) as a marker for both cervical deformity and a goal for correction similar to how PI-LL (pelvic incidence–lumbar lordosis) mismatch informs decision making in thoracolumbar adult spinal deformity (ASD). The goal of this study was to define the relationship between T1 slope (T1S) and cervical lordosis (CL).

METHODS

This is a retrospective review of a prospective database. Surgical ASD cases were initially analyzed. Analysis across the sagittal parameters was performed. Linear regression analysis based on T1S was used to provide a clinically applicable equation to predict CL. Findings were validated using the postoperative alignment of the ASD patients. Further validation was then performed using a second, normative database. The range of normal alignment associated with horizontal gaze was derived from a multilinear regression on data from asymptomatic patients.

RESULTS

A total of 103 patients (mean age 54.7 years) were included. Analysis revealed a strong correlation between T1S and C0–7 lordosis (r = 0.886), C2–7 lordosis (r = 0.815), and C0–2 lordosis (r = 0.732). There was no significant correlation between T1S and T1S−CL. Linear regression analysis revealed that T1S−CL assumed a constant value of 16.5° (R2 = 0.664, standard error 2°). These findings were validated on the postoperative imaging (mean absolute error [MAE] 5.9°). The equation was then applied to the normative database (MAE 6.7° controlling for McGregor slope [MGS] between −5° and 15°). A multilinear regression between C2–7, T1S, and MGS demonstrated a range of T1S−CL between 14.5° and 26.5° was necessary to maintain horizontal gaze.

CONCLUSIONS

Normative CL can be predicted via the formula CL = T1S − 16.5° ± 2°. This implies a threshold of deformity and aids in providing a goal for surgical correction. Just as pelvic incidence (PI) can be used to determine the ideal LL, T1S can be used to predict ideal CL. This formula also implies that a kyphotic cervical alignment is to be expected for individuals with a T1S < 16.5°.

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David B. Bumpass, Lawrence G. Lenke, Jeffrey L. Gum, Christopher I. Shaffrey, Justin S. Smith, Christopher P. Ames, Shay Bess, Brian J. Neuman, Eric Klineberg, Gregory M. Mundis Jr., Frank Schwab, Virginie Lafage, Han Jo Kim, Douglas C. Burton, Khaled M. Kebaish, Richard Hostin, Renaud Lafage, Michael P. Kelly and for the International Spine Study Group

OBJECTIVE

Adolescent spine deformity studies have shown that male patients require longer surgery and have greater estimated blood loss (EBL) and complications compared with female patients. No studies exist to support this relationship in adult spinal deformity (ASD). The purpose of this study was to investigate associations between sex and complications, deformity correction, and health-related quality of life (HRQOL) in patients with ASD. It was hypothesized that male ASD patients would have greater EBL, longer surgery, and more complications than female ASD patients.

METHODS

A multicenter ASD cohort was retrospectively queried for patients who underwent primary posterior-only instrumented fusions with a minimum of 5 levels fused. The minimum follow-up was 2 years. Primary outcomes were EBL, operative time, intra-, peri-, and postoperative complications, radiographic correction, and HRQOL outcomes (Oswestry Disability Index, SF-36, and Scoliosis Research Society-22r Questionnaire). Poisson multivariate regression was used to control for age, comorbidities, and levels fused.

RESULTS

Ninety male and 319 female patients met the inclusion criteria. Male patients had significantly greater mean EBL (2373 ml vs 1829 ml, p = 0.01). The mean operative time, transfusion requirements, and final radiographic measurements did not differ between sexes. Similarly, changes in HRQOL showed no significant differences. Finally, there were no sex differences in the incidence of complications (total, major, or minor) at any time point after controlling for age, body mass index, comorbidities, and levels fused.

CONCLUSIONS

Despite higher EBL, male ASD patients did not experience more complications or require less deformity correction at the 2-year follow-up. HRQOL scores similarly showed no sex differences. These findings differ from adolescent deformity studies, and surgeons can counsel patients that sex is unlikely to influence the outcomes and complication rates of primary all-posterior ASD surgery.

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Taemin Oh, Justin K. Scheer, Justin S. Smith, Richard Hostin, Chessie Robinson, Jeffrey L. Gum, Frank Schwab, Robert A. Hart, Virginie Lafage, Douglas C. Burton, Shay Bess, Themistocles Protopsaltis, Eric O. Klineberg, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Patients with adult spinal deformity (ASD) experience significant quality of life improvements after surgery. Treatment, however, is expensive and complication rates are high. Predictive analytics has the potential to use many variables to make accurate predictions in large data sets. A validated minimum clinically important difference (MCID) model has the potential to assist in patient selection, thereby improving outcomes and, potentially, cost-effectiveness.

METHODS

The present study was a retrospective analysis of a multiinstitutional database of patients with ASD. Inclusion criteria were as follows: age ≥ 18 years, radiographic evidence of ASD, 2-year follow-up, and preoperative Oswestry Disability Index (ODI) > 15. Forty-six variables were used for model training: demographic data, radiographic parameters, surgical variables, and results on the health-related quality of life questionnaire. Patients were grouped as reaching a 2-year ODI MCID (+MCID) or not (−MCID). An ensemble of 5 different bootstrapped decision trees was constructed using the C5.0 algorithm. Internal validation was performed via 70:30 data split for training/testing. Model accuracy and area under the curve (AUC) were calculated. The mean quality-adjusted life years (QALYs) and QALYs gained at 2 years were calculated and discounted at 3.5% per year. The QALYs were compared between patients in the +MCID and –MCID groups.

RESULTS

A total of 234 patients met inclusion criteria (+MCID 129, −MCID 105). Sixty-nine patients (29.5%) were included for model testing. Predicted versus actual results were 50 versus 40 for +MCID and 19 versus 29 for −MCID (i.e., 10 patients were misclassified). Model accuracy was 85.5%, with 0.96 AUC. Predicted results showed that patients in the +MCID group had significantly greater 2-year mean QALYs (p = 0.0057) and QALYs gained (p = 0.0002).

CONCLUSIONS

A successful model with 85.5% accuracy and 0.96 AUC was constructed to predict which patients would reach ODI MCID. The patients in the +MCID group had significantly higher mean 2-year QALYs and QALYs gained. This study provides proof of concept for using predictive modeling techniques to optimize patient selection in complex spine surgery.

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Justin S. Smith, Christopher I. Shaffrey, Eric Klineberg, Virginie Lafage, Frank Schwab, Renaud Lafage, Han Jo Kim, Richard Hostin, Gregory M. Mundis Jr., Munish Gupta, Barthelemy Liabaud, Justin K. Scheer, Bassel G. Diebo, Themistocles S. Protopsaltis, Michael P. Kelly, Vedat Deviren, Robert Hart, Doug Burton, Shay Bess and Christopher P. Ames

OBJECTIVE

Although 3-column osteotomy (3CO) can provide powerful alignment correction in adult spinal deformity (ASD), these procedures are complex and associated with high complication rates. The authors' objective was to assess complications associated with ASD surgery that included 3CO based on a prospectively collected multicenter database.

METHODS

This study is a retrospective review of a prospectively collected multicenter consecutive case registry. ASD patients treated with 3CO and eligible for 2-year follow-up were identified from a prospectively collected multicenter ASD database. Early (≤ 6 weeks after surgery) and delayed (> 6 weeks after surgery) complications were collected using standardized forms and on-site coordinators.

RESULTS

Of 106 ASD patients treated with 3CO, 82 (77%; 68 treated with pedicle subtraction osteotomy [PSO] and 14 treated with vertebral column resection [VCR]) had 2-year follow-up (76% women, mean age 60.7 years, previous spine fusion in 80%). The mean number of posterior fusion levels was 12.9, and 17% also had an anterior fusion. A total of 76 early (44 minor, 32 major) and 66 delayed (13 minor, 53 major) complications were reported, with 41 patients (50.0%) and 45 patients (54.9%) affected, respectively. Overall, 64 patients (78.0%) had at least 1 complication, and 50 (61.0%) had at least 1 major complication. The most common complications were rod breakage (31.7%), dural tear (20.7%), radiculopathy (9.8%), motor deficit (9.8%), proximal junctional kyphosis (PJK, 9.8%), pleural effusion (8.5%), and deep wound infection (7.3%). Compared with patients who did not experience early or delayed complications, those who had these complications did not differ significantly with regard to age, sex, body mass index, Charlson Comorbidity Index, American Society of Anesthesiologists score, smoking status, history of previous spine surgery or spine fusion, or whether the 3CO performed was a PSO or VCR (p ≥ 0.06). Twenty-seven (33%) patients had 1–11 reoperations (total of 44 reoperations). The most common indications for reoperation were rod breakage (n = 14), deep wound infection (n = 15), and PJK (n = 6). The 24 patients who did not achieve 2-year follow-up had a mean of 0.85 years of follow-up, and the types of early and delayed complications encountered in these 24 patients were comparable to those encountered in the patients that achieved 2-year follow-up.

CONCLUSIONS

Among 82 ASD patients treated with 3CO, 64 (78.0%) had at least 1 early or delayed complication (57 minor, 85 major). The most common complications were instrumentation failure, dural tear, new neurological deficit, PJK, pleural effusion, and deep wound infection. None of the assessed demographic or surgical parameters were significantly associated with the occurrence of complications. These data may prove useful for surgical planning, patient counseling, and efforts to improve the safety and cost-effectiveness of these procedures.

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Michael P. Kelly, Lawrence G. Lenke, Jakub Godzik, Ferran Pellise, Christopher I. Shaffrey, Justin S. Smith, Stephen J. Lewis, Christopher P. Ames, Leah Y. Carreon, Michael G. Fehlings, Frank Schwab and Adam L. Shimer

OBJECTIVE

The authors conducted a study to compare neurological deficit rates associated with complex adult spinal deformity (ASD) surgery when recorded in retrospective and prospective studies. Retrospective studies may underreport neurological deficits due to selection, detection, and recall biases. Prospective studies are expensive and more difficult to perform, but they likely provide more accurate estimates of new neurological deficit rates.

METHODS

New neurological deficits were recorded in a prospective study of complex ASD surgeries (pSR1) with a defined outcomes measure (decrement in American Spinal Injury Association lower-extremity motor score) for neurological deficits. Using identical inclusion criteria and a subset of participating surgeons, a retrospective study was created (rSR1) and neurological deficit rates were collected. Continuous variables were compared with the Student t-test, with correction for multiple comparisons. Neurological deficit rates were compared using the Mantel-Haenszel method for standardized risks. Statistical significance for the primary outcome measure was p < 0.05.

RESULTS

Overall, 272 patients were enrolled in pSR1 and 207 patients were enrolled in rSR1. Inclusion criteria, defining complex spinal deformities, and exclusion criteria were identical. Sagittal Cobb measurements were higher in pSR1, although sagittal alignment was similar. Preoperative neurological deficit rates were similar in the groups. Three-column osteotomies were more common in pSR1, particularly vertebral column resection. New neurological deficits were more common in pSR1 (pSR1 17.3% [95% CI 12.6–22.2] and rSR1 9.0% [95% CI 5.0–13.0]; p = 0.01). The majority of deficits in both studies were at the nerve root level, and the distribution of level of injury was similar.

CONCLUSIONS

New neurological deficit rates were nearly twice as high in the prospective study than the retrospective study with identical inclusion criteria. These findings validate concerns regarding retrospective cohort studies and confirm the need for and value of carefully designed prospective, observational cohort studies in ASD.