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.

STUDY DESIGN/METHODS:Retrospective cohort study. OBJECTIVE:To develop parameter thresholds obtainable from cervical radiographs that correlate with concomitant thoracolumbar malalignment. SUMMARY OF BACKGROUND DATA/BACKGROUND:T1 slope (T1S) is typically discussed in the context of cervical deformity and correlated with health-related quality of life outcomes. Prior research suggests that T1S is related to global alignment; however, a definition for "high" T1S has not been established. Most patients undergoing cervical surgery do not undergo full-spine imaging; therefore, obtaining a parameter associated with thoracolumbar malalignment from cervical radiographs would be beneficial. METHODS:A database of preoperative adult spinal deformity (ASD) patients was analyzed. Measures obtained from standing lateral radiographs included T1S, thoracic kyphosis (TK), sagittal vertical axis (SVA), T1-pelvic angle (TPA), pelvic tilt (PT), and pelvic incidence minus lumbar lordosis (PI-LL). Decision tree analysis was then used to determine the T1S corresponding to published thresholds for high TK (40 degrees), SVA (40 mm), TPA (25 degrees), and PT (25 degrees). Alignment between high and normal T1S patients was compared. RESULTS:Two hundred twenty-six preoperative patients were included (mean: 58±16 y 62%F). Larger T1S was correlated with greater SVA (r=0.365), TPA (r=0.302), TK (r=0.606), and PT (r=0.230) (all P<0.001). Decision tree analysis yielded a threshold of 30 degrees for high T1S, which 50% of patients had. Compared with patients with T1S <30 degrees, those with T1S >30 degrees had higher TK (41.5 vs. 25.8 degrees), SVA (78.7 vs. 33.7 mm), TPA (27.6 vs. 18.3 degrees), and PT (26.3 vs. 20.8 degrees), and PI-LL (18.2 vs. 11.7 degrees) (all P<0.05). Seventy-nine percent of patients with high T1S had high TK (T1S <30=13%), 69% had high SVA (T1S <30=38%), 66% had high TPA (T1S <30=37%), 60% had PT >25 degrees (T1S <30=42%), and 47% had PI-LL >20 degrees (T1S <30=34%) (all P<0.05). CONCLUSION/CONCLUSIONS:Higher T1S was associated with worse global alignment. T1S was most strongly associated with TK. A T1S=30 degrees corresponded to high TK, SVA, TPA, and PT thresholds. Therefore, surgeons should consider obtaining full-spine radiographs if a T1S >30 degrees is present on cervical imaging.

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.

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.

BACKGROUND CONTEXT/BACKGROUND:Correcting sagittal malalignment in adult spinal deformity (ASD) is a challenging task, often requiring complex surgical interventions like pedicle subtraction osteotomies (PSOs). Different types of three-column osteotomies (3COs), including Schwab 3, Schwab 4, Schwab 4 with interbody cages, and the "sandwich" technique, aim to optimize alignment and fusion outcomes. The role of interbody cages in enhancing fusion and segmental correction remains unclear. PURPOSE/OBJECTIVE:This study aimed to compare outcomes among these 4 3CO techniques, evaluating the impact of cage use at the osteotomy site on postoperative radiographic imaging and clinical outcomes. STUDY DESIGN/SETTING/METHODS:This is a multicenter retrospective study utilizing data from a prospective multicenter database of patients undergoing complex ASD surgery. PATIENT SAMPLE/METHODS:Ninety-seven patients who underwent 1 of 4 3CO techniques for thoracolumbar ASD correction with at least 2 years of follow-up were included. The sample consisted of 29 patients who underwent Schwab 3 osteotomy, 20 Schwab 4, 28 Schwab 4 with interbody cages, and 20 who underwent "sandwich" osteotomy. OUTCOME MEASURES/METHODS:The Scoliosis Research Society-22 revised (SRS22r) questionnaire evaluating pain, activity, appearance, mental health, and satisfaction was used to evaluate patient reported outcomes and radiographic measures including segmental lordosis and fusion rates determined by 3 blinded reviewers were used to evaluate physiologic outcomes. METHODS:This study analyzed demographic data, radiographic outcomes, patient-reported outcomes, complications, and fusion rates over a 2-year follow-up period. Fusion status was determined via serial radiographs and evaluated independently by 3 blinded reviewers. Univariate and multivariate statistical analyses were performed to assess differences among the groups and the impact of interbody cage use on outcomes. RESULTS:Patients undergoing "sandwich" osteotomy exhibited worse preoperative leg pain scores and lower SRS22r activity (p=.015), appearance (p=.007), and mental health domain scores (p=.0015). No differences in complications were found among groups (p>.05). Patients who underwent osteotomy with a cage were more likely to have had previous spine fusion (91.7% vs. 71.4%, p=.010). Additionally, these patients had lower preoperative SRS22r mental domain (2.9±1 vs. 3.5±1, p=.009), satisfaction (2.3±1 vs. 2.7±1.2, p=.034), and SRS22r total scores (2.3±0.6 vs. 2.6±0.6, p=.0026) but demonstrated the greatest improvement in the mental health domain (0.9±0.7 vs. 0.3±0.9, p=.002). Cage use was associated with a larger mean change in segmental lordosis at the osteotomy site (32.9±9.6 vs. 28.7±9.5, p=.038). Fusion rates were significantly higher in the cage group (79.2% vs. 55.1%, p=.0012). Regression analysis identified cage use as an independent predictor for fusion (odds ratio, 3.338; 95% confidence interval, 1.108-10.054, p=.032). CONCLUSIONS:Interbody cage use at the osteotomy site during 3COs for ASD correction was associated with improved fusion rates and greater segmental lordosis without increasing complication rates. Incorporating cages may provide enhanced alignment and fusion outcomes in complex ASD surgeries.

BACKGROUND/UNASSIGNED:open or minimally invasive (MIS) laminectomy using the American College of Surgeons' National Surgical Quality Improvement Program (ACS-NSQIP) database. METHODS/UNASSIGNED:Using the ACS-NSQIP database from 2017 to 2022, Current Procedural Terminology (CPT) code of 63030 or 62380 were used to filter the dataset between open/tubular retractor-based and endoscopic single-level lumbar decompression cases, respectively. Overall, as collected, the endoscopic group consisted of 336 patients and the non-endoscopic group had 55,111 patients. The groups were compared to evaluate the patient characteristics and adverse events within 30 days after their operation. Outcome measures compared were operative time, length of stay (days), adverse outcomes [superficial infection, deep infection, organ/space infection, wound dehiscence, pneumonia, unplanned intubation, pulmonary embolism, ventilator >48 hours, progressive renal insufficiency, acute renal failure, urinary tract infection, stroke/cerebrovascular accident (CVA) accident, cardiac arrest, myocardial infarction, blood transfusion, deep vein thrombosis (DVT), sepsis, and septic shock], 30-day readmission, return to operating room (OR). RESULTS/UNASSIGNED:4.8%, P=0.01), with significantly lower rate of blood transfusions (P<0.05) compared to the non-endoscopic group. CONCLUSIONS/UNASSIGNED:Patients who underwent endoscopic lumbar decompression demonstrated a significantly lower rate of total adverse events and significantly lower rate of blood transfusions compared to their counterparts. This data from the ACS-NSQIP supports the reported benefits of endoscopic technique in the current literature. As endoscopic surgery becomes more widely utilized throughout the United States, more data will become available for further studies.

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.

STUDY DESIGN/METHODS:Retrospective analysis of prospectively-collected data. OBJECTIVE:This study aims to define clinically relevant blood loss in adult spinal deformity (ASD) surgery. BACKGROUND:Current definitions of excessive blood loss following spine surgery are highly variable and may be suboptimal in predicting adverse events (AE). METHODS:Adults undergoing complex ASD surgery were included. Estimated blood loss (EBL) was extracted for investigation, and estimated blood volume loss (EBVL) was calculated by dividing EBL by the preoperative blood volume utilizing Nadler's formula. LASSO regression was performed to identify five variables from demographic and peri-operative parameters. Logistic regression was subsequently performed to generate a receiver operating characteristics (ROC) curve and estimate an optimal threshold for EBL and EBVL. Finally, the proportion of patients with AE plotted against EBL and EBVL to confirm the identified thresholds. RESULTS:In total 552 patients were included with a mean age of 60.7±15.1 years, 68% females, mean CCI was 1.0±1.6, and 22% experienced AEs. LASSO regression identified ASA score, baseline hypertension, preoperative albumin, and use of intra-operative crystalloids as the top predictors of an AE, in addition to EBL/EBVL. Logistic regression resulted in ROC curve which was used to identify a cut-off of 2.3 liters of EBL and 42% for EBVL. Patients exceeding these thresholds had AE rates of 36% (odds-ratio: 2.1, 95% CI [1.2-3.6]) and 31% (odds-ratio: 1.7, 95% CI [1.1-2.8]), compared to 21% for those below the thresholds of EBL and EBVL, respectively. CONCLUSION/CONCLUSIONS:In complex ASD surgery, intraoperative EBL of 2.3 liters and an EBVL of 42% are associated with clinically-significant AEs. These thresholds may be useful in guiding preoperative-patient-counseling, healthcare system quality initiatives, and clinical perioperative bloodloss management strategies in patients undergoing complex spine surgery. Additionally, similar methodology could be performed in other specialties to establish procedure-specific clinically-relevant bloodloss thresholds.

BACKGROUND AND OBJECTIVES/OBJECTIVE:The spectrum of patients requiring adult spinal deformity (ASD) surgery is highly variable in baseline (BL) risk such as age, frailty, and deformity severity. Although improvements have been realized in ASD surgery over the past decade, it is unknown whether these carry over to high-risk patients. We aim to determine temporal differences in outcomes at 2 years after ASD surgery in patients stratified by BL risk. METHODS:Patients ≥18 years with complete pre- (BL) and 2-year (2Y) postoperative data from 2009 to 2018 were categorized as having undergone surgery from 2009 to 2013 [early] or from 2014 to 2018 [late]. High-risk [HR] patients met ≥2 of the criteria: (1) ++ BL pelvic incidence and lumbar lordosis or SVA by Scoliosis Research Society (SRS)-Schwab criteria, (2) elderly [≥70 years], (3) severe BL frailty, (4) high Charlson comorbidity index, (5) undergoing 3-column osteotomy, and (6) fusion of >12 levels, or >7 levels for elderly patients. Demographics, clinical outcomes, radiographic alignment targets, and complication rates were assessed by time period for high-risk patients. RESULTS:Of the 725 patients included, 52% (n = 377) were identified as HR. 47% (n = 338) had surgery pre-2014 [early], and 53% (n = 387) underwent surgery in 2014 or later [late]. There was a higher proportion of HR patients in Late group (56% vs 48%). Analysis by early/late status showed no significant differences in achieving improved radiographic alignment by SRS-Schwab, age-adjusted alignment goals, or global alignment and proportion proportionality by 2Y (all P > .05). Late/HR patients had significantly less poor clinical outcomes per SRS and Oswestry Disability Index (both P < .01). Late/HR patients had fewer complications (63% vs 74%, P = .025), reoperations (17% vs 30%, P = .002), and surgical infections (0.9% vs 4.3%, P = .031). Late/HR patients had lower rates of early proximal junctional kyphosis (10% vs 17%, P = .041) and proximal junctional failure (11% vs 22%, P = .003). CONCLUSION/CONCLUSIONS:Despite operating on more high-risk patients between 2014 and 2018, surgeons effectively reduced rates of complications, mechanical failures, and reoperations, while simultaneously improving health-related quality of life.

PURPOSE/OBJECTIVE:Clinical trials have studied the effects of curve magnitude and flexibility, age, and skeletal immaturity on the outcomes of VBT. No studies have assessed the effect of Lenke curve type on the outcomes of VBT. This study compares outcomes in patients who underwent VBT with Lenke type 1, 3, 5, and 6 curves. METHODS:Single center retrospective review of patients undergoing mini-open thoracoscopic-assisted two row vertebral body tethering (2RVBT) for the correction of AIS with a minimum 2-year follow-up were included. Patients were grouped by Lenke type, which yielded 4 groups; types 1, 3, 5, or 6. Analysis included preoperative demographic parameters, as well as radiographic and clinical outcome measures. RESULTS:156 2RVBT (Lenke 1, N = 61; Lenke 3, N = 35; Lenke 5, N = 37; Lenke 6, N = 23) patients met inclusion criteria. The mean preoperative apex Cobb angle in the Lenke type 1, 3, 5, and 6 groups were 50.2 ± 9.1, 50.5 ± 10.1, 45.0 ± 8.6, and 49.0 ± 10.8, respectively. This corrected to 21.2 ± 10.2, 19.2 ± 8.5, 13.6 ± 7.2, 18.5 ± 8.3 in Lenke type 1, 3, 5, and 6 groups, respectively, demonstrating that Lenke type 5 saw greatest correction following 2RVBT. With regards to revision recommendation following tether breakage, Lenke type 3 curves were most frequently indicated for fusion, whereas Lenke type 1 curves were most frequently not indicated for revision surgery. CONCLUSION/CONCLUSIONS:Lenke type 5 curves are the most amenable to correction via 2RVBT, as evident by their lower post-operative apex Cobb angles and lowest rate of recommendation for revision to posterior spinal fusion.