Faculty Bibliography

STUDY DESIGN/METHODS:A national prospective cervical spine surgery registry was developed to archive radiographic studies, patient-reported outcome measures (PROMs), and surgical implant data to assess long-term safety. OBJECTIVE:To describe the design, development, funding, and implementation of a cervical spine data registry for 1000 patients with myelopathy and radiculopathy. SUMMARY OF BACKGROUND DATA/BACKGROUND:While surgery for cervical radiculopathy and myelopathy is safe and effective, there is significant practice variation among spine surgeons. While randomized clinical trials (RCTs) can provide high-quality comparative effectiveness data, RCTs lack the ability to evaluate the safety and effectiveness of various surgical procedures and implants among heterogenous real-world patient populations. The CSRS Registry was designed to collect patient demographics, outcomes, radiographic imaging, surgical approach, and implant data for the purpose of conducting high-quality research. METHODS:Patients with cervical myelopathy or radiculopathy were enrolled in the CSRS National Registry. De-identified patient data, validated PROMs, radiographic data, and implant data were collected from multiple clinical sites across the United States. RESULTS:One thousand patients [mean age, 58 y; 456 (46%) women] were enrolled, with 31% follow-up at 1 year. Five hundred ninety-two patients were diagnosed with radiculopathy, 252 with myelopathy, and 156 with radiculopathy and myelopathy. Patients had significant improvements in their PROMs after surgery. At 1 year, the mean NDI score improved from 37.2 to 20.9 (P<0.001). The mean self-reported P-mJOA score at baseline was 14.2 and improved to 15.2 by 1 year (P<0.001). Baseline CSDI score was 23.6 and improved with a 1-year decrease to an average score of 13.6 (P<0.001). There was significant improvement in PROMIS-10 Physical Health score from 41.0 to 45.9 (n=311; P<0.001) at 1-year follow-up. CONCLUSIONS:The CSRS Registry has successfully collected clinical outcomes data that is being leveraged for comparative effectiveness research and evaluations of the long-term safety and effectiveness of spinal implants.

BACKGROUND AND OBJECTIVES/OBJECTIVE:The concept of upper cervical (C0-C2) extension reserve (ER) capacity, ER relaxation, and their impact on outcomes following surgical correction of adult cervical deformity (ACD) has not been extensively studied. We aimed to evaluate the impact of upper cervical ER on postoperative disability and outcomes. METHODS:Patients with ACD, from a retrospective cohort study of a prospectively collected multicenter database, undergoing subaxial cervical fusion with 2-year (2Y) follow-up data were included. ER was defined as: ΔC0-C2 sagittal Cobb angle between neutral and extension. Relaxation of ER was defined as the ER mean in those that met all ideal thresholds in radiographic parameters for Passias et al CD modifiers. We used multivariable logistic regression to adjust for confounding, with conditional inference tree approaches used to determine thresholds that affect postoperative ER resolution on patient-reported outcomes. RESULTS:A total of 108 patients with ACD met inclusion. Preoperative C0-C2 ER was 8.7° ± 9.0°, and at last follow-up was 10.3° ± 11.1°. Preoperatively 29% of the cohort had adequate ER, whereas 60% had improved ER postoperatively, with 50% achieving adequate ER by 2Y. Lower ER correlated with greater CD (P < .05). Preoperatively, greater ER had lower Neck Disability Index (P < .001). Controlled analysis found improved ER to have a greater likelihood of achieving Neck Disability Index minimum clinically important difference (odds ratio 6.94, [1.378-34.961], P = .019). In those with inadequate ER at baseline, the preoperative C2-C7 of < -18° and T1 slope-cervical Lordosis mismatch of >59° for T1 slope-cervical Lordosis mismatch was predictive of ER resolution. In those with preoperative C2-C7 >-18°, a T1PA of >13° was predictive of postoperative return of ER (all P < .05). Surgical correction of C2-C7 by > 16° from baseline was found to be predictive of ER return. CONCLUSION/CONCLUSIONS:Increased preoperative use of the C0-C2 ER in CD was associated with worse baseline regional and global alignment and adversely affected health-related measures. Most of the patients had ER relaxation postoperatively. In those who didn't, however, there was a decreased likelihood of achieving satisfactory outcomes.

This review analyzes enabling technology in Adult Spinal Deformity (ASD), with a focus on optimizing safety and teaching. The prevalence of ASD is rising, and recent technological advancements can empower surgeons to improve outcomes for ASD patients but also each comes with specific challenges. The paper highlights opportunities and potential obstacles in effective technology integration and assesses key enabling technologies, including surgical planning software, machine leaning, three-dimensional printing, augmented and virtual reality, patient-specific instrumentation as well as navigation and robotics.

BACKGROUND AND OBJECTIVES/OBJECTIVE:To investigate the cost-effectiveness and impact of prophylactic techniques on the development of proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) in the context of postoperative alignment. METHODS:Adult spinal deformity patients with fusion to pelvis and 2-year data were included. Patients receiving PJK prophylaxis (hook, tether, cement, minimally-invasive surgery approach) were compared to those who did not. These cohorts were further stratified into "Matched" and "Unmatched" groups based on achievement of age-adjusted alignment criteria. Costs were calculated using the Diagnosis-Related Group costs accounting for PJK prophylaxis, postoperative complications, outpatient health care encounters, revisions, and medical-related readmissions. Quality-adjusted life years were calculated using Short Form-36 converted to Short-Form Six-Dimension (SF-6D) and used an annual 3% discount rate. Multivariate analysis controlling for age, sex, levels fused, and baseline deformity severity assessed outcomes of developing PJK/PJF if matched and/or with use of PJK prophylaxis. RESULTS:A total of 738 adult spinal deformity patients met inclusion criteria (age: 63.9 ± 9.9, body mass index: 28.5 ± 5.7, Charlson comorbidity index: 2.0 ± 1.7). Multivariate analysis revealed patients corrected to age-adjusted criteria postoperatively had lower rates of developing PJK or PJF (odds ratio [OR]: 0.4, [0.2-0.8]; P = .011) with the use of prophylaxis. Among those unmatched in T1 pelvic angle, pelvic incidence lumbar lordosis mismatch, and pelvic tilt, prophylaxis reduced the likelihood of developing PJK (OR: 0.5, [0.3-0.9]; P = .023) and PJF (OR: 0.1, [0.03-0.5]; P = .004). Analysis of covariance analysis revealed patients matched in age-adjusted alignment had better cost-utility at 2 years compared with those without prophylaxis ($361 539.25 vs $419 919.43; P < .001). Patients unmatched in age-adjusted criteria also generated better cost ($88 348.61 vs $101 318.07; P = .005) and cost-utility ($450 190.80 vs $564 108.86; P < .001) with use of prophylaxis. CONCLUSION/CONCLUSIONS:Despite additional surgical cost, the optimization of radiographic realignment in conjunction with prophylaxis of the proximal junction appeared to be a more cost-effective strategy, primarily because of the minimization of reoperations secondary to mechanical failure. Even among those not achieving optimal alignment, junctional prophylactic measures were shown to improve cost efficiency.

BACKGROUND:Changing from standing to sitting positions requires rotation of the femur from an almost vertical plane to the horizontal plane. Osteoarthritis of the hip limits hip extension, resulting in less ability to recruit spinopelvic tilt (SPT) while standing and requiring increased SPT while sitting to compensate for the loss of hip range of motion. To date, the effect of total hip arthroplasty (THA) on spinopelvic sitting and standing mechanics has not been reported, particularly in the setting of patients with coexistent sagittal plane spinal deformity. METHODS:A retrospective review was performed of patients ≥18 years of age undergoing unilateral THA for hip osteoarthritis with sitting and standing radiographs made before and after THA. Alignment was analyzed at baseline and follow-up after THA in both standing and sitting positions in a relaxed posture with the fingers resting on top of the clavicles. Patients were grouped according to the presence or absence of sagittal plane deformity preoperatively into 3 groups: no sagittal plane deformity (normal), thoracolumbar (TL) deformity (pelvic incidence-lumbar lordosis [PI-LL] mismatch > 10° and/or T1-pelvic angle [TPA] > 20°), or apparent deformity (PI-LL ≤ 10° and TPA ≤ 20°, but sagittal vertical axis [SVA] > 50 mm). RESULTS:In this study, 192 patients were assessed: 64 had TL deformity, 39 had apparent deformity, and 89 had normal alignment. Overall, patients demonstrated a reduction in standing SVA (45 to 34.1 mm; p < 0.001) and an increase in SPT (14.6° to 15.7°; p = 0.03) after THA. There was a greater change in standing SVA (p < 0.001) among patients with apparent deformity (-29.0 mm) compared with patients with normal alignment (0.9 mm) and patients with TL deformity (-16.3 mm). Those with apparent deformity also experienced the greatest difference (p = 0.03) in postural SPT change (moving from standing to sitting) (-10.1°) from before to after THA when compared with those with normal alignment (-3.6°) and TL deformity (-1.2°). The difference in postural SVA change from before to after THA was also greatest (p < 0.001) in those with apparent deformity (32.1 mm) compared with those with normal alignment (6.5 mm) and TL deformity (17.3 mm). CONCLUSIONS:Postural changes in spinopelvic alignment vary after THA depending on the presence of TL deformity or apparent deformity due to hip flexion contracture. Patients with apparent deformity had larger changes in standing and sitting alignment than patients with TL deformity or patients with normal alignment. The assessment of global sagittal alignment findings can be used to predict the likelihood of improvement in sagittal alignment after THA. LEVEL OF EVIDENCE/METHODS:Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

PURPOSE/OBJECTIVE:Robotic-assisted spine surgery (RASS) has increased in prevalence over recent years, and while much work has been done to analyze differences in outcomes when compared to the freehand technique, little has been done to characterize the potential pitfalls associated with using robotics. This study's goal was to leverage expert opinion to develop a classification system of potential sources of error that may be encountered when using robotics in spine surgery. This not only provides practitioners, particularly those in the early stages of robotic adoption, with insight into possible sources of error but also provides the community at large with a more standardized language through which to communicate. METHODS:The Delphi method, which is a validated system of developing consensus, was utilized. The method employed an iterative presentation of classification categories that were then edited, removed, or elaborated upon during several rounds of discussion. Voting took place to accept or reject the individual classification categories with consensus defined as ≥ 80% agreement. RESULTS:After a three-round iterative survey and video conference Delphi process, followed by an in-person meeting at the Safety in Spine Surgery Summit, consensus was achieved on a classification system that includes four key types of potential sources of error in RASS as well as a list of the most commonly identified sources within each category. Initial sources of error that were considered included: cannula skidding/skive, penetration, screw misplacement, registration failure, and frame shift. After completion of the Delphi process, the final classification included four major types of pitfalls including: Reference/Navigation, Patient Factors, Technique, and Equipment Factors (available at https://safetyinspinesurgery.com/ ). CONCLUSION/CONCLUSIONS:This work provides expert insight into potential sources of error in the setting of robotic spine surgery. The working group established four discrete categories while providing a standardized language to unify communication.

PURPOSE/OBJECTIVE:To determine if iatrogenic posterior translation (UIV SPi) at the upper instrumented vertebrae (UIV) is associated with increased mechanical complications and secondarily to generate and validate a UIV SPi threshold for increased complications. METHODS:Two patient databases were utilized: one for generating a UIV SPi threshold and another for validation. Patients with a UIV between T8-L1 and a LIV at ilium were included. A receiver operating curve (ROC) curve analyses was performed to generate a threshold that predicted proximal junctional complications. This UIV SPi angle (-16.0°) was rounded to -15.0° for practical clinical use and validated in a separate cohort. Patients were stratified as above (most translated, MT) or below (least translated, LT) the threshold for comparative demographic and outcomes analyses. RESULTS:Generation of the threshold on 192 patients (122 LT, 70 MT) revealed that the MT group had higher absolute postoperative UIV SVA (MT=-56.1 ± 23.1 mm vs. LT=-10.4 ± 31.8 mm, p < 0.001), higher PT (25.7° vs. 19.3°, p < 0.001), and 2.8-5.8 times greater odds of postoperative proximal junctional complications at 2-years (p < 0.05). Validation on 135 patients (95 LT, 40 MT) revealed that the MT group had 11.7 times greater odds of radiographic PJK and had 4.5 times greater odds of all-cause reoperations (p < 0.05). CONCLUSION/CONCLUSIONS:Patients with UIV posterior translation, despite similar PI-LL and T1PA, exhibit a high PT and experience higher odds of proximal junctional complications. Our findings support limiting the UIV SPi to < 15° of posterior translation to mitigate postoperative mechanical complications. LEVEL OF EVIDENCE/METHODS:IV.

STUDY DESIGN/METHODS:Retrospective analysis of retrospectively collected data. OBJECTIVE:To determine the effects of preoperative nonsteroidal anti-inflammatory drug (NSAID) use on estimated blood loss (EBL) and postoperative drain output in TLIF procedures. SUMMARY OF BACKGROUND DATA/BACKGROUND:Current standards of care recommend patients prescribed NSAIDs for chronic lower back pain discontinue NSAIDs at least 1 week before spine fusion surgery. The literature surrounding the effects of preoperative NSAID use is unclear, however, with dissonant findings regarding postoperative blood loss and complications. METHODS:A retrospective case review was performed on 429 cases of 1-level or 2-level TLIF, with patient NSAID use recorded within 3 days of surgery, at a single institution. Linear and logistic regressions were used to assess associations between NSAID use, patient and surgical characteristics, EBL, and drain output. RESULTS:NSAID use was significantly positively associated with drain output (P=0.03), with an approximate increase of 21±9.7 mL/day but no significant association with any postoperative complications (P=0.77). Drain output also had significant, independent positive associations with patient age (P=0.007), male sex (P<0.001), and a number of levels fused (P<0.001), and significant negative associations with robot-assisted (P<0.001) and minimally invasive (P=0.04) procedures. No significant association was detected between NSAID use and EBL (P=0.21), though EBL had significant positive associations with operative time (P<0.001) and levels fused (P<0.001), and multiple NSAIDs had a significant positive association with EBL (P<0.001). CONCLUSIONS:NSAID use had a statistically significant, but small, effect on drain output and no detectable effect on postoperative complications within 3 days of TLIF procedures, suggesting most patients can safely continue NSAID use up until their date of surgery. Future studies should further delineate the effects of preoperative NSAID use, such that a more refined risk profile could be developed from patient and surgical characteristics and NSAID use information.

INTRODUCTION/BACKGROUND:With the rapid increase in the use of robotic-assisted spine surgery (RASS), reports describing complications have inevitably emerged. This study builds on previous work done to identify, characterize, and classify potential sources of error in spine surgery performed with enabling technology in the operating room. The goal of this study is to leverage expert opinion to develop a set of best practice guidelines that can be employed to minimize complications and optimize patient safety, specifically as it relates to RASS. METHODS:After assembling a group of attending spine surgeons experienced in the use of RASS across the country, formal consensus regarding the best practices was developed using the Delphi method and nominal group technique. After a review of the relevant literature and evidence, an initial survey of study group members (n=12) helped frame potential areas for investigation. Statements were subsequently edited, removed, or elaborated upon during four iterative rounds of live discussion with the opportunity for panelists to propose new guidelines at any point in the process. Respondents were able to suggest modifications and refine the statements until consensus, defined as ≥ 80% agreement, was achieved. RESULTS:After a three-round iterative survey and video conference Delphi process, followed by an in-person meeting at the Summit for Safety in Spine Surgery, consensus was achieved on 27 best practice guideline statements. This BPG had the key focus areas of 1) general protocols, 2) screw planning/execution, 3) optimization of surgical technique, and 4) areas for robotic improvement. (available at https://safetyinspinesurgery.com/ ). CONCLUSION/CONCLUSIONS:This work provides expert insight into the best practices for minimizing errors in RASS with the presentation of 27 recommendations that can serve to reduce practice variability, optimize safety, and guide future research.

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