Browsing by Author "Lenke, Lawrence G"
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Item Open Access A Radiographic Analysis of Lumbar Fusion Status and Instrumentation Failure After Complex Adult Spinal Deformity Surgery With Spinopelvic Fixation: Two-Year Follow-up From the Scoli-Risk-1 Prospective Database.(Clinical spine surgery, 2020-12) Shimizu, Takayoshi; Lenke, Lawrence G; Cerpa, Meghan; Beauchamp, Eduardo C; Carreon, Leah Y; Shaffrey, Christopher I; Cheung, Kenneth MC; Fehlings, Michael GStudy design
A retrospective review of prospectively collected data.Objective
The objective of this study was to investigate the fusion status of the lumbar spine and lumbosacral junction at 2 years postoperatively after complex adult spinal deformity (ASD) surgery.Summary of background data
Achieving fusion is crucial for maintaining optimal alignment in ASD surgery. However, prospective data assessing fusion status using large patient populations are lacking in this patient population.Materials and methods
Postoperative radiographs of 162 patients from the Scoli-Risk-1 database, who underwent complex ASD surgery with fusion to the sacrum, were evaluated by 3 independent spine surgeons at 6-week, 6-month, and 2-year follow-up. The fusion rate of the lumbar spine segments at a 2-year follow-up was determined by using previously published radiographic grading criteria. We also assessed the prevalence of instrumentation failures.Results
The interrater reliabilities for grading the fusion status were overall fair at each level evaluated (Fleiss κ, 0.337-0.439). Overall, 70.3% (114/162) demonstrated the solid fusion of the entire lumbar spine at a 2-year follow-up. The fusion rates of each segment were L1/L2: 87.0%, L2/L3: 82.0%, L3/L4: 83.9%, L4/L5: 89.5%, and L5/S1: 89.5%. Pedicle screw loosening was the most frequent implant failure throughout the observation period (9.2%, 11.6%, and 11.0% at 6-wk, 6-mo, and 2-y follow-up, respectively). No rod breakage was observed at 6 weeks, increasing to 9.8% at 2-year follow-up. The prevalence of postoperative proximal junctional kyphosis was 5.5% at 6 weeks, showing no difference at 2 years postoperative.Conclusions
In this series of complex ASD surgeries often requiring 3-column osteotomies, 70.3% showed solid fusion of the entire lumbar spine, including the lumbosacral junction. The lumbosacral segments showed a relatively high fusion rate at a 2-year follow-up likely due to the frequent use of anterior column support and graft. The prevalence of rod breakage increased as follow-up proceeded to 9.8%, which was most commonly observed at the lumbosacral junction.Level of evidence
Level IV.Item Open Access Adult Cervical Deformity Patients Have Higher Baseline Frailty, Disability, and Comorbidities Compared With Complex Adult Thoracolumbar Deformity Patients: A Comparative Cohort Study of 616 Patients.(Global spine journal, 2023-11) Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Ben-Israel, David; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter; Gum, Jeffrey L; Kebaish, Khal; Mullin, Jeffrey P; Eastlack, Robert; Daniels, Alan; Soroceanu, Alex; Mundis, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Burton, Douglas; Ames, Christopher P; Bess, Shay; International Spine Study GroupStudy design
Multicenter comparative cohort.Objective
Studies have shown markedly higher rates of complications and all-cause mortality following surgery for adult cervical deformity (ACD) compared with adult thoracolumbar deformity (ATLD), though the reasons for these differences remain unclear. Our objectives were to compare baseline frailty, disability, and comorbidities between ACD and complex ATLD patients undergoing surgery.Methods
Two multicenter prospective adult spinal deformity registries were queried, one ATLD and one ACD. Baseline clinical and frailty measures were compared between the cohorts.Results
616 patients were identified (107 ACD and 509 ATLD). These groups had similar mean age (64.6 vs 60.8 years, respectively, P = .07). ACD patients were less likely to be women (51.9% vs 69.5%, P < .001) and had greater Charlson Comorbidity Index (1.5 vs .9, P < .001) and ASA grade (2.7 vs 2.4, P < .001). ACD patients had worse VR-12 Physical Component Score (PCS, 25.7 vs 29.9, P < .001) and PROMIS Physical Function Score (33.3 vs 35.3, P = .031). All frailty measures were significantly worse for ACD patients, including hand dynamometer (44.6 vs 55.6 lbs, P < .001), CSHA Clinical Frailty Score (CFS, 4.0 vs 3.2, P < .001), and Edmonton Frailty Scale (EFS, 5.15 vs 3.21, P < .001). Greater proportions of ACD patients were frail (22.9% vs 5.7%) or vulnerable (15.6% vs 10.9%) based on EFS (P < .001).Conclusions
Compared with ATLD patients, ACD patients had worse baseline characteristics on all measures assessed (comorbidities/disability/frailty). These differences may help account for greater risk of complications and all-cause mortality previously observed in ACD patients and facilitate strategies for better preoperative optimization.Item Open Access An Analysis of the Incidence and Outcomes of Major Versus Minor Neurological Decline After Complex Adult Spinal Deformity Surgery: A Subanalysis of Scoli-RISK-1 Study.(Spine, 2018-07) Kato, So; Fehlings, Michael G; Lewis, Stephen J; Lenke, Lawrence G; Shaffrey, Christopher I; Cheung, Kenneth MC; Carreon, Leah Y; Dekutoski, Mark B; Schwab, Frank J; Boachie-Adjei, Oheneba; Kebaish, Khaled M; Ames, Christopher P; Qiu, Yong; Matsuyama, Yukihiro; Dahl, Benny T; Mehdian, Hossein; Pellisé, Ferran; Berven, Sigurd HStudy design
A subanalysis from a prospective, multicenter, international cohort study in 15 sites (Scoli-RISK-1).Objective
To report detailed information regarding the severity of neurological decline related to complex adult spine deformity (ASD) surgery and to examine outcomes based on severity.Summary of background data
Postoperative neurological decline after ASD surgeries can occur due to nerve root(s) or spinal cord dysfunction. The impact of decline and the pattern of recovery may be related to the anatomic location and the severity of the injury.Methods
An investigation of 272 prospectively enrolled complex ASD surgical patients with neurological status measured by American Spinal Injury Association Lower Extremity Motor Scores (LEMS) was undertaken. Postoperative neurological decline was categorized into "major" (≥5 points loss) versus "minor" (<5 points loss) deficits. Timing and extent of recovery in LEMS were investigated for each group.Results
Among the 265 patients with LEMS available at discharge, 61 patients (23%) had neurological decline, with 20 (33%) experiencing major decline. Of note, 90% of the patients with major decline had deficits in three or more myotomes. Full recovery was seen in 24% at 6 weeks and increased to 65% at 6 months. However, 34% continued to experience some neurological decline at 24 months, with 6% demonstrating no improvement. Of 41 patients (67%) with minor decline, 73% had deficits in one or two myotomes. Full recovery was seen in 49% at 6 weeks and increased to 70% at 6 months. Of note, 26% had persistence of some neurological deficit at 24 months, with 18% demonstrating no recovery.Conclusion
In patients undergoing complex ASD correction, a rate of postoperative neurological decline of 23% was noted with 33% of these being "major." Although most patients showed substantial recovery by 6 months, approximately one-third continued to experience neurological dysfunction.Level of evidence
2.Item Open Access An international consensus on the appropriate evaluation and treatment for adults with spinal deformity.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2018-03) Berven, Sigurd H; Kamper, Steven J; Germscheid, Niccole M; Dahl, Benny; Shaffrey, Christopher I; Lenke, Lawrence G; Lewis, Stephen J; Cheung, Kenneth M; Alanay, Ahmet; Ito, Manabu; Polly, David W; Qiu, Yong; de Kleuver, Marinus; AOSpine Knowledge Forum DeformityPurpose
Evaluation and surgical management for adult spinal deformity (ASD) patients varies between health care providers. The purpose of this study is to identify appropriateness of specific approaches and management strategies for the treatment of ASD.Methods
From January to July 2015, the AOSpine Knowledge Deformity Forum performed a modified Delphi survey where 53 experienced deformity surgeons from 24 countries, rated the appropriateness of management strategies for multiple ASD clinical scenarios. Four rounds were performed: three surveys and a face-to-face meeting. Consensus was achieved with ≥70% agreement.Results
Appropriate surgical goals are improvement of function, pain, and neural symptoms. Appropriate preoperative patient evaluation includes recording information on history and comorbidities, and radiographic workup, including long standing films and MRI for all patients. Preoperative pulmonary and cardiac testing and DEXA scan is appropriate for at-risk patients. Intraoperatively, appropriate surgical strategies include long fusions with deformity correction for patients with large deformity and sagittal imbalance, and pelvic fixation for multilevel fusions with large curves, sagittal imbalance, and osteoporosis. Decompression alone is inappropriate in patients with large curves, sagittal imbalance, and progressive deformity. It is inappropriate to fuse to L5 in patients with symptomatic disk degeneration at L5-S1.Conclusions
These results provide guidance for informed decision-making in the evaluation and management of ASD. Appropriate care for ASD, a very diverse spectrum of disease, must be responsive to patient preference and values, and considerations of the care provider, and the healthcare system. A monolithic approach to care should be avoided.Item Open Access Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?(Journal of neurosurgery. Spine, 2024-03) Mullin, Jeffrey P; Soliman, Mohamed AR; Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter G; Gum, Jeffrey L; Kebaish, Khaled; Eastlack, Robert K; Daniels, Alan H; Soroceanu, Alex; Mundis, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish C; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Bess, Shay; Ames, Christopher P; Burton, DouglasObjective
Complex spinal deformity surgeries may involve significant blood loss. The use of antifibrinolytic agents such as tranexamic acid (TXA) has been proven to reduce perioperative blood loss. However, for patients with a history of thromboembolic events, there is concern of increased risk when TXA is used during these surgeries. This study aimed to assess whether TXA use in patients undergoing complex spinal deformity correction surgeries increases the risk of thromboembolic complications based on preexisting thromboembolic risk factors.Methods
Data were analyzed for adult patients who received TXA during surgical correction for spinal deformity at 21 North American centers between August 2018 and October 2022. Patients with preexisting thromboembolic events and other risk factors (history of deep venous thrombosis [DVT], pulmonary embolism [PE], myocardial infarction [MI], stroke, peripheral vascular disease, or cancer) were identified. Thromboembolic complication rates were assessed during the postoperative 90 days. Univariate and multivariate analyses were performed to assess thromboembolic outcomes in high-risk and low-risk patients who received intravenous TXA.Results
Among 411 consecutive patients who underwent complex spinal deformity surgery and received TXA intraoperatively, 130 (31.6%) were considered high-risk patients. There was no significant difference in thromboembolic complications between patients with and those without preexisting thromboembolic risk factors in univariate analysis (high-risk group vs low-risk group: 8.5% vs 2.8%, p = 0.45). Specifically, there were no significant differences between groups regarding the 90-day postoperative rates of DVT (high-risk group vs low-risk group: 1.5% vs 1.4%, p = 0.98), PE (2.3% vs 1.8%, p = 0.71), acute MI (1.5% vs 0%, p = 0.19), or stroke (0.8% vs 1.1%, p > 0.99). On multivariate analysis, high-risk status was not a significant independent predictor for any of the thromboembolic complications.Conclusions
Administration of intravenous TXA during the correction procedure did not change rates of thromboembolic events, acute MI, or stroke in this cohort of adult spinal deformity surgery patients.Item Open Access Analysis of tranexamic acid usage in adult spinal deformity patients with relative contraindications: does it increase the risk of complications?(JOURNAL OF NEUROSURGERY-SPINE, 2024) Mullin, Jeffrey P; Soliman, Mohamed AR; Smith, Justin S; Kelly, Michael P; Buell, Thomas J; Diebo, Bassel; Scheer, Justin K; Line, Breton; Lafage, Virginie; Lafage, Renaud; Klineberg, Eric; Kim, Han Jo; Passias, Peter G; Gum, Jeffrey L; Kebaish, Khaled; Eastlack, Robert K; Daniels, Alan H; Soroceanu, Alex; Mundis, Gregory; Hostin, Richard; Protopsaltis, Themistocles S; Hamilton, D Kojo; Gupta, Munish C; Lewis, Stephen J; Schwab, Frank J; Lenke, Lawrence G; Shaffrey, Christopher I; Bess, Shay; Ames, Christopher P; Burton, DouglasItem Open Access Antibiotic Use in Adult Spine Deformity Surgery: Results From the AO Spine Surveillance of the Management of Patients With Adult Spine Deformity.(Global spine journal, 2023-09) Rocos, Brett; Kato, So; Lewis, Stephen J; Shaffrey, Christopher I; Lenke, Lawrence G; AO spine knowledge forum deformityStudy design
Cross-sectional international survey with literature review.Objectives
To evaluate the evidence for these strategies and to understand the current trends in prophylactic antibiotic use during ASD surgery through an international survey.Methods
An online survey was conducted among international AO Spine members regarding the peri-operative management of patients with ASD. The details of perioperative systemic and topical antibiotic use were solicited. Descriptive data were summarized for the responding surgeons who perform at least 10 long-segment fusions of >5 levels extending to the pelvis annually.Results
The literature supports the use of prophylactic antibiotic effective against gram positive organisms. The use of topical vancomycin remains debated, and there is limited evidence for topical tobramycin use. A total of 116 responses were received. 74 (64%) surgeons use topical vancomycin, most usually deep to the fascia only 45 (61%). The most usual dose used is 1-2 g. 4 (3%) surgeons use topical tobramycin deep to fascia. Following surgery, 90 (78%) surgeons use prophylactic cephalosporin with 3 (3%) using cloxacillin, 5 (4%) using ciprofloxacin and 9 (8%) using vancomycin and 6 (5%) using clindamycin either in addition or alone.Conclusions
The present survey identifies a trend towards systemic and topical antibiotic prophylaxis primarily targeted at gram positive pathogens. The use of topical tobramycin, proposedly effective against gram negative infections, remains uncommon. There is a lack of consensus in the selection of perioperative antibiotic prophylaxis, thus a prospective study of the rates of infection with each strategy would be useful to inform guidelines.Item Open Access Are Higher Global Alignment and Proportion Scores Associated With Increased Risks of Mechanical Complications After Adult Spinal Deformity Surgery? An External Validation.(Clinical orthopaedics and related research, 2021-02) Kwan, Kenny Yat Hong; Lenke, Lawrence G; Shaffrey, Christopher I; Carreon, Leah Y; Dahl, Benny T; Fehlings, Michael G; Ames, Christopher P; Boachie-Adjei, Oheneba; Dekutoski, Mark B; Kebaish, Khaled M; Lewis, Stephen J; Matsuyama, Yukihiro; Mehdian, Hossein; Qiu, Yong; Schwab, Frank J; Cheung, Kenneth Man Chee; AO Spine Knowledge Forum DeformityBackground
The Global Alignment and Proportion (GAP) score, based on pelvic incidence-based proportional parameters, was recently developed to predict mechanical complications after surgery for spinal deformities in adults. However, this score has not been validated in an independent external dataset.Questions/purposes
After adult spinal deformity surgery, is a higher GAP score associated with (1) an increased risk of mechanical complications, defined as rod fractures, implant-related complications, proximal or distal junctional kyphosis or failure; (2) a higher likelihood of undergoing revision surgery to treat a mechanical complication; and (3) is a lower (more proportioned) GAP score category associated with better validated outcomes scores using the Oswestry Disability Index (ODI), Scoliosis Research Society-22 (SRS-22) and the Short Form-36 questionnaires?Methods
A total of 272 patients who had undergone corrective surgeries for complex spinal deformities were enrolled in the Scoli-RISK-1 prospective trial. Patients were included in this secondary analysis if they fulfilled the original inclusion criteria by Yilgor et al. From the original 272 patients, 14% (39) did not satisfy the radiographic inclusion criteria, the GAP score could not be calculated in 14% (37), and 24% (64) did not have radiographic assessment at postoperative 2 years, leaving 59% (159) for analysis in this review of data from the original trial. A total of 159 patients were included in this study,with a mean age of 58 ± 14 years at the time of surgery. Most patients were female (72%, 115 of 159), the mean number of levels involved in surgery was 12 ± 4, and three-column osteotomy was performed in 76% (120 of 159) of patients. The GAP score was calculated using parameters from early postoperative radiographs (between 3 and 12 weeks) including pelvic incidence, sacral slope, lumbar lordosis, lower arc lordosis and global tilt, which were independently obtained from a computer software based on centralized patient radiographs. The GAP score was categorized as proportional (scores of 0 to 2), moderately disproportional (scores of 3 to 6), or severely disproportional (scores higher than 7 to 13). Receiver operating characteristic area under curve (AUC) was used to assess associations between GAP score and risk of mechanical complications and risk of revision surgery. An AUC of 0.5 to 0.7 was classified as "no or low associative power", 0.7 to 0.9 as "moderate" and greater than 0.9 as "high". We analyzed differences in validated outcome scores between the GAP categories using Wilcoxon rank sum test.Results
At a minimum of 2 years' follow-up, a higher GAP score was not associated with increased risks of mechanical complications (AUC = 0.60 [95% CI 0.50 to 0.70]). A higher GAP score was not associated with a higher likelihood of undergoing a revision surgery to treat a mechanical complication (AUC = 0.66 [95% 0.53 to 0.78]). However, a moderately disproportioned GAP score category was associated with better SF-36 physical component summary score (36 ± 10 versus 40 ± 11; p = 0.047), better SF-36 mental component summary score (46 ± 13 versus 51 ± 12; p = 0.01), better SRS-22 total score (3.4 ± 0.8 versus 3.7 ± 0.7, p = 0.02) and better ODI score (35 ± 21 versus 25 ± 20; p = 0.003) than severely disproportioned GAP score category.Conclusion
Based on the findings of this external validation study, we found that alignment targets based on the GAP score alone were not associated with increased risks of mechanical complications and mechanical revisions in patients with complex adult spinal disorders. Parameters not included in the original GAP score needed to be considered to reduce the likelihood of mechanical complications.Level of evidence
Level III, diagnostic study.Item Open Access Are Minimally Invasive Spine Surgeons or Classical Open Spine Surgeons More Consistent with Their Treatment of Adult Spinal Deformity?(World neurosurgery, 2022-09) Uribe, Juan S; Koffie, Robert M; Wang, Michael Y; Mundis, Gregory M; Kanter, Adam S; Eastlack, Robert K; Anand, Neel; Park, Paul; Smith, Justin S; Burton, Douglas C; Chou, Dean; Kelly, Michael P; Kim, Han Jo; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank J; Lenke, Lawrence G; Mummaneni, Praveen VObjective
Spine surgeons have a heuristic sense of how to surgically restore alignment and address adult spinal deformity (ASD) symptoms, but consensus on the extent of treatment remains unclear. We sought to determine the variability of surgical approaches in treating ASD.Methods
Sixteen spine surgeons were surveyed on treatment approaches in 10 select ASD cases. We repeated the survey with the same surgeons 4 weeks later, with cases ordered differently. We examined the variability in length of construct, use of interbody spacers, osteotomies, and pelvic fixation frequency.Results
Treatment approaches for each case varied by surgeon, with some surgeons opting for long fusion constructs in cases for which others offered no surgery. There was no consensus among surgeons on the number of levels fused, interbody spacer use, or anterior/posterior osteotomies. Intersurgeon and intrasurgeon variability was 48% (kappa = 0.31) and 59% (kappa = 0.44) for surgeons performing minimally invasive surgery (MIS) versus 37% (kappa = 0.21) and 47% (kappa = 0.30) for those performing open surgery. In the second-round survey, 8 of 15 (53%) surgeons substantially changed the construct length, number of interbody spacers, and osteotomies in at least half the cases they previously reviewed. Surgeons performing MIS versus open surgery were less likely to extend constructs to the pelvis (42.5% vs. 67.5%; P = 0.02), but construct length was not correlated with whether a surgeon performed MIS or open surgery.Conclusions
Spinal deformity surgeons lack consensus on the optimal surgical approach for treating ASD. Classifying surgeons as performing MIS or open surgery does not mitigate this variability.Item Open Access Baseline Patient-Reported Outcomes Correlate Weakly With Radiographic Parameters: A Multicenter, Prospective NIH Adult Symptomatic Lumbar Scoliosis Study of 286 Patients.(Spine, 2016-11) Chapman, Todd M; Baldus, Christine R; Lurie, Jon D; Glassman, Steven D; Schwab, Frank J; Shaffrey, Christopher I; Lafage, Virginie; Boachie-Adjei, Oheneba; Kim, Han J; Smith, Justin S; Crawford, Charles H; Lenke, Lawrence G; Buchowski, Jacob M; Edwards, Charles; Koski, Tyler; Parent, Stefan; Lewis, Stephen; Kang, Daniel G; McClendon, Jamal; Metz, Lionel; Zebala, Lukas P; Kelly, Michael P; Spratt, Kevin F; Bridwell, Keith HStudy design
Prospective, cross-sectional study.Objective
The aim of the study was to determine which radiographic parameters drive patient-reported outcomes (PROs) in primary presentation adult symptomatic lumbar scoliosis (ASLS).Summary of background data
Previous literature suggests correlations between PROs and sagittal plane deformity (sagittal vertical axis [SVA], pelvic incidence-lumbar lordosis [PI-LL] mismatch, pelvic tilt [PT]). Prior work included revision and primary adult spinal deformity patients. The present study addresses only primary presentation ASLS.Methods
Prospective baseline data were analyzed on 286 patients enrolled in an NIH RO1 clinical trial by nine centers from 2010 to 2014.Inclusion criteria
40 to 80 years old, lumbar Cobb (LC) 30° or higher and Scoliosis Research Society-23 score 4.0 or less in Pain, Function or Self-Image domains, or Oswestry Disability Index (ODI) 20 or higher. Patients were primary presentation (no prior spinal deformity surgery) and had complete baseline data: standing coronal/sagittal 36" radiographs and PROs (ODI, Scoliosis Research Society-23, Short Form-12). Correlation coefficients were calculated to evaluate relations between radiographic parameters and PROs for the study population and a subset of patients with ODI 40 or higher. Analysis of variance was used to identify differences in PROs for radiographic modifier groups.Results
Mean age was 60.3 years. Mean spinopelvic parameters were: LL = -39.2°; SVA = 3.1 cm; sacral slope = 32.5°; PT = 23.9°; PI-LL mismatch = 16.8°. Only weak correlations (0.2-0.4) were identified between population sacral slope, SVA and SVA modifiers, and SRS function. SVA and SVA modifiers were weakly associated with ODI. Although there were more correlations in subset analysis of high-symptom patients, all were weak. Analysis of variance identified significant differences in ODI reported by SVA modifier groups.Conclusion
In primary presentation patients with ASLS and a subset of "high-symptom" patients (ODI ≥ 40), only weak associations between baseline PROs and radiographic parameters were identified. For this patient population, these results suggest regional radiographic parameters (LC, LL, PT, PI-LL mismatch) are not drivers of PROs and cannot be used to extrapolate effect on patient-perceived pathology.Level of evidence
2.Item Open Access Can unsupervised cluster analysis identify patterns of complex adult spinal deformity with distinct perioperative outcomes?(Journal of neurosurgery. Spine, 2023-05) Lafage, Renaud; Fourman, Mitchell S; Smith, Justin S; Bess, Shay; Shaffrey, Christopher I; Kim, Han Jo; Kebaish, Khaled M; Burton, Douglas C; Hostin, Richard; Passias, Peter G; Protopsaltis, Themistocles S; Daniels, Alan H; Klineberg, Eric O; Gupta, Munish C; Kelly, Michael P; Lenke, Lawrence G; Schwab, Frank J; Lafage, Virginie; International Spine Study GroupObjective
The objective of this study was to use an unsupervised cluster approach to identify patterns of operative adult spinal deformity (ASD) and compare the perioperative outcomes of these groups.Methods
A multicenter data set included patients with complex surgical ASD, including those with severe deformities, significant surgical complexity, or advanced age who underwent a multilevel fusion. An unsupervised cluster analysis allowing for 10% outliers was used to identify different deformity patterns. The perioperative outcomes of these clusters were then compared using ANOVA, Kruskal-Wallis, and chi-square tests, with p values < 0.05 considered significant.Results
Two hundred eighty-six patients were classified into four clusters of deformity patterns: hyper-thoracic kyphosis (hyper-TK), severe coronal, severe sagittal, and moderate sagittal. Hyper-TK patients had the lowest disability (mean Oswestry Disability Index [ODI] 32.9 ± 17.1) and pain scores (median numeric rating scale [NRS] back score 6, leg score 1). The severe coronal cluster had moderate functional impairment (mean physical component score 34.4 ± 12.3) and pain (median NRS back score 7, leg score 4) scores. The severe sagittal cluster had the highest levels of disability (mean ODI 49.3 ± 15.6) and low appearance scores (mean 2.3 ± 0.7). The moderate cluster (mean 68.8 ± 7.8 years) had the highest pain interference subscores on the Patient-Reported Outcomes Measurement Information System (mean 65.2 ± 5.8). Overall 30-day adverse events were equivalent among the four groups. Fusion to the pelvis was most common in the moderate sagittal (89.4%) and severe sagittal (97.5%) clusters. The severe coronal cluster had more osteotomies per case (median 11, IQR 6.5-14) and a higher rate of 30-day implant-related complications (5.5%). The severe sagittal and hyper-TK clusters had more three-column osteotomies (43% and 32.3%, respectively). Hyper-TK patients had shorter hospital stays.Conclusions
This cohort of patients with complex ASD surgeries contained four natural clusters of deformity, each with distinct perioperative outcomes.Item Open Access Changes in radiographic and clinical outcomes with primary treatment adult spinal deformity surgeries from two years to three- to five-years follow-up.(Spine, 2010-09) Bridwell, Keith H; Baldus, Christine; Berven, Sigurd; Edwards, Charles; Glassman, Steven; Hamill, Christopher; Horton, William; Lenke, Lawrence G; Ondra, Stephen; Schwab, Frank; Shaffrey, Christopher; Wootten, DavidStudy design
Retrospective analysis of data entered prospectively into a multicenter database-clinical and radiographic outcomes assessment.Objective
Our hypothesis is that between the 2-year and the 3- to 5-year points surgically treated adult spinal deformity patients will show significant reduction in outcomes by Scoliosis Research Society (SRS), Oswestry Disability Index (ODI), and numerical rating scale back and leg pain scores and will show increasing thoracic kyphosis, loss of lumbar lordosis, and loss of coronal and sagittal balance.Summary of background data
Most analyses of primary presentation adult spinal deformity surgery assess 2-year follow-up. However, it is established that in some patients unfavorable events occur between the 2-year and 5-year points.Methods
The cohort of 113 patients entered into a multicenter database with complete preoperative, 2-year, and 3- to 5-year data. All patients who had adult spinal deformity and surgical treatment represented their first reconstruction. Diagnoses were scoliosis (82.5%), kyphosis (10%), and scoliosis and kyphosis combined (7.5%). Outcome measures and basic radiographic parameters (curve size, thoracic and lumbar sagittal plane, coronal and sagittal balance) were assessed at those 3 time intervals. Complications (pseudarthrosis/implant failure, infection, and junctional deformities) were assessed at the 2-year and the 3- to 5-year (mean, 3.76 years) points. RESULTS.: The mean major curve Cobb angle (preoperative, 57°; 2-year, 29°; 3-5 year, 26°); thoracic kyphosis T5 to T12 (30°, 31°, 32°) and lumbar lordosis T12 to sacrum (48°, 49°, 51°) did not change from the 2-year to ultimate follow-up. Likewise, coronal and sagittal balance parameters were the same at 2-year and ultimate follow-up. SRS total scores and modified ODI were similar at the 2 year and final follow-up (SRS: 3.89-3.88; ODI: 19-18). Preoperative SRS total score was 3.17. Six patients demonstrated complications at the 2-year point and additional 9 patients demonstrated complications at the 3- to 5-year point. Those 9 patients with complications at ultimate follow-up demonstrated significant deterioration in their ODI and SRS scores when compared with the patients who did not have complications at ultimate follow-up.Conclusion
Contrary to our hypothesis, we could not establish deterioration in mean radiographic or clinical outcomes between the 2-year and 3- to 5-year follow-up points when analyzing the group as a whole. However, for the 9 patients who experienced complications between 3- and 5-year follow-up, their outcomes were significantly worse than for the other 104 patients.One should not anticipate an overall radiographic and clinical deterioration of the outcomes of surgically treated primary presentation adult spinal deformity patients in this studied time interval. However, close to 10% of patients will experience a new complication at the 3- to 5-year point, most commonly implant failure/nonunion and/or junctional kyphosis, which will negatively effect the patient-reported outcome.Item Open Access Clinical outcomes and proximal junctional failure in adult spinal deformity patients corrected to normative alignment versus functional alignment.(Journal of neurosurgery. Spine, 2023-07) Protopsaltis, Themistocles S; Ani, Fares; Soroceanu, Alexandra; Lafage, Renaud; Kim, Han Jo; Balouch, Eaman; Norris, Zoe; Smith, Justin S; Daniels, Alan H; Klineberg, Eric O; Ames, Christopher P; Hart, Robert; Bess, Shay; Shaffrey, Christopher I; Schwab, Frank J; Lenke, Lawrence G; Lafage, Virginie; Gupta, Munish CObjective
The objective of this study was to explore the rate of proximal junctional failure (PJF) and functional outcomes of normative alignment goals compared with alignment targets based on age-appropriate physical function.Methods
Baseline relationships between age, pelvic incidence (PI), and a component of the T1 pelvic angle (TPA) within the fusion were analyzed in adult spinal deformity (ASD) patients and compared with those of asymptomatic patients. Linear regression modeling was used to determine alignment based on PI and age in asymptomatic patients (normative alignment), and in ASD patients, alignment corresponding to age-appropriate functional status (functional alignment). A cohort of 288 ASD patients was split into two groups based on whether the patient was closer to their normative or functional alignment goal at their 6-week postoperative radiographic follow-up. The rates of proximal junctional kyphosis (PJK) and PJF were determined for each cohort.Results
In the 288 ASD patients included in this pre- to postoperative analysis, there was no difference in baseline alignment or health-related quality of life (HRQOL) between the normative alignment and functional alignment groups. At 6 weeks, patients with normative alignment had a smaller TPA (4.45° vs 14.1°) and PI minus lumbar lordosis (-7.24° vs 7.4°) (both p < 0.0001) and higher PJK (40% vs 27.2%, p = 0.03) and PJF (17% vs 6.8%, p = 0.008) rates than patients with functional alignment.Conclusions
Correction in ASD patients to normative alignment resulted in higher rates of PJK and PJF without improvements in HRQOL. Correction in ASD patients to functional alignment that mirrors the physical function of their age-matched asymptomatic peers is recommended.Item Open Access Complications associated with surgical treatment of traumatic spinal fractures: a review of the scoliosis research society morbidity and mortality database.(World neurosurgery, 2014-05) Williams, Brian J; Smith, Justin S; Saulle, Dwight; Ames, Christopher P; Lenke, Lawrence G; Broadstone, Paul A; Vaccaro, Alexander R; Polly, David W; Shaffrey, Christopher IObjective
Traumatic spinal fracture is a common indication for surgery, with an associated high incidence of perioperative complications. The literature provides a wide range in the incidence of complications. We seek to assess the perioperative morbidity and mortality of surgery for traumatic spinal fractures and to identify predictors of their occurrence.Methods
We performed a retrospective analysis of all traumatic spinal fracture cases submitted by members of the Scoliosis Research Society from 2004 to 2007.Results
A total of 108,478 cases were submitted from 2004 through 2007, with 6,706 (6.2%) performed for treatment of traumatic fracture. Twenty-two percent of patients had preoperative neurological deficits. Intraoperative neuromonitoring was used in 58% of cases. The overall incidence of complications was 6.9%. The perioperative mortality was 0.5%. There were 59 (0.9%) new postoperative neurological deficits. Multivariate analysis demonstrated preoperative neurological deficit (P = .001; odds ratio [OR] 1.449, 95% confidence interval [CI] [1.156 to 1.817]) and fusion (P =.001; OR 1.12, 95% CI [1.072 to 1.168]) as predictors of complications and use of intraoperative neuromonitoring (P = .016; OR 1.949, 95% CI [1.13 to 3.361]), and preoperative neurological deficit (P < .001; OR 2.964, 95% CI [1.667 to 5.271]) as predictors of new postoperative neurological deficits (P < .001).Conclusions
Overall, surgery for the treatment of spinal fractures was performed with relatively low incidences of perioperative complications (6.9%) and mortality (0.5%). These data may prove useful for patient counseling and ongoing efforts to improve the safety of operative care for patients with spinal fracture.Item Open Access Contemporary utilization of three-column osteotomy techniques in a prospective complex spinal deformity multicenter database: implications on full-body alignment and perioperative course.(Spine deformity, 2024-06) Williamson, Tyler K; Mir, Jamshaid M; Smith, Justin S; Lafage, Virginie; Lafage, Renaud; Line, Breton; Diebo, Bassel G; Daniels, Alan H; Gum, Jeffrey L; Hamilton, D Kojo; Scheer, Justin K; Eastlack, Robert; Demetriades, Andreas K; Kebaish, Khaled M; Lewis, Stephen; Lenke, Lawrence G; Hostin, Richard A; Gupta, Munish C; Kim, Han Jo; Ames, Christopher P; Burton, Douglas C; Shaffrey, Christopher I; Klineberg, Eric O; Bess, Shay; Passias, Peter G; International Spine Study GroupBackground
Research has focused on the increased correction from a three-column osteotomy (3CO) during adult spinal deformity (ASD) surgery. However, an in-depth analysis on the performance of a 3CO in a cohort of complex spinal deformity cases has not been described.Study design/setting
This is a retrospective study on a prospectively enrolled, complex ASD database.Purpose
This study aimed to determine if three-column osteotomies demonstrate superior benefit in correction of complex sagittal deformity at the cost of increased perioperative complications.Methods
Surgical complex adult spinal deformity patients were included and grouped into thoracolumbar 3COs compared to those who did not have a 3CO (No 3CO) (remaining cohort). Rigid deformity was defined as ΔLL less than 33% from standing to supine. Severe deformity was defined as global (SVA > 70 mm) or C7-PL > 70 mm, or lumbopelvic (PI-LL > 30°). Means comparison tests assessed correction by 3CO grade/location. Multivariate analysis controlling for baseline deformity evaluated outcomes up to six weeks compared to No 3CO.Results
648 patients were included (Mean age 61 ± 14.6 years, BMI 27.55 ± 5.8 kg/m2, levels fused: 12.6 ± 3.8). 126 underwent 3CO, a 20% higher usage than historical cohorts. 3COs were older, frail, and more likely to undergo revision (OR 5.2, 95% CI [2.6-10.6]; p < .001). 3COs were more likely to present with both severe global/lumbopelvic deformity (OR 4), 62.4% being rigid. 3COs had greater use of secondary rods (OR 4st) and incurred 4 times greater risk for: massive blood loss (> 3500 mL), longer LOS, SICU admission, perioperative wound and spine-related complications, and neurologic complications when performed below L3. 3COs had similar HRQL benefit, but higher perioperative opioid use. Mean segmental correction increased by grade (G3-21; G4-24; G5-27) and was 4 × greater than low-grade osteotomies, especially below L3 (OR 12). 3COs achieved 2 × greater spinopelvic correction. Higher grades properly distributed lordosis 50% of the time except L5. Pelvic compensation and non-response were relieved more often with increasing grade, with greater correction in all lower extremity parameters (p < .01). Due to the increased rate of complications, 3COs trended toward higher perioperative cost ($42,806 vs. $40,046, p = .086).Conclusion
Three-column osteotomy usage in contemporary complex spinal deformities is generally limited to more disabled individuals undergoing the most severe sagittal and coronal realignment procedures. While there is an increased perioperative cost and prolongation of length of stay with usage, these techniques represent the most powerful realignment techniques available with a dramatic impact on normalization at operative levels and reciprocal changes.Item Open Access Defining rates and causes of mortality associated with spine surgery: comparison of 2 data collection approaches through the Scoliosis Research Society.(Spine, 2014-04) Shaffrey, Ellen; Smith, Justin S; Lenke, Lawrence G; Polly, David W; Chen, Ching-Jen; Coe, Jeffrey D; Broadstone, Paul A; Glassman, Steven D; Vaccaro, Alexander R; Ames, Christopher P; Shaffrey, Christopher IStudy design
Retrospective review of prospectively collected databases.Objective
To compare 2 approaches for assessment of mortality associated with spine surgery.Summary of background data
The Scoliosis Research Society collects morbidity and mortality data from its members. Previously, this included details for all spine cases and all complications. To reduce time burden and improve compliance, collection was changed to focus on a few major complications (death, neurological deficit, and blindness) for specific deformity diagnoses (scoliosis, spondylolisthesis, and kyphosis) and only for cases with complications.Methods
Data were extracted from the Scoliosis Research Society from 2004-2007 (detailed system) and 2009-2011 (simplified system). As an anchor for comparison, mortality rates were compared between the systems.Results
Between 2009 and 2011, the number of deformity cases reported were 87,162, with 131 deaths (1.50/1000 cases). The mean age of these 131 patients was 50, mean American Society of Anesthesiologists grade was 2.8, 10% were smokers, and 18% had diabetes. Rates of death (per 1000 cases) were: idiopathic scoliosis (0.4), congenital scoliosis (1.3), neuromuscular scoliosis (3.6), other scoliosis (3.1), spondylolisthesis (0.6), and kyphosis (4.7). Common causes of mortality included respiratory (48), cardiac (32), sepsis (12), organ failure (9), and blood loss (7). Compared with the detailed system, the simplified system had greater surgeon compliance (79% vs. 62%, P < 0.001), greater number of deformity cases per reporting surgeon per year (139 vs. 90, P < 0.001), and modest but significantly lower mortality rates (1.50 vs. 1.80/1000 cases; P < 0.001). Causes of death were comparable between the 2 systems.Conclusion
On the basis of the simplified collection system, the rate of mortality for spinal deformity surgery was 1.50 per 1000 cases. Compared with the detailed system, the simplified system had significantly improved compliance and similar mortality rates. Although the simplified system is limited by less data collected, it achieves better compliance and may prove effective, especially if supplemented with focused data collection modules.Item Open Access Degenerative Spinal Deformity.(Neurosurgery, 2015-10) Ailon, Tamir; Smith, Justin S; Shaffrey, Christopher I; Lenke, Lawrence G; Brodke, Darrel; Harrop, James S; Fehlings, Michael; Ames, Christopher PDegenerative spinal deformity afflicts a significant portion of the elderly and is increasing in prevalence. Recent evidence has revealed sagittal plane malalignment to be a key driver of pain and disability in this population and has led to a significant shift toward a more evidence-based management paradigm. In this narrative review, we review the recent literature on the epidemiology, evaluation, management, and outcomes of degenerative adult spinal deformity (ASD). ASD is increasing in prevalence in North America due to an aging population and demographic shifts. It results from cumulative degenerative changes focused in the intervertebral discs and facet joints that occur asymmetrically to produce deformity. Deformity correction focuses on restoration of global alignment, especially in the sagittal plane, and decompression of the neural elements. General realignment goals have been established, including sagittal vertical axis <50 mm, pelvic tilt <22°, and lumbopelvic mismatch <±9°; however, these should be tailored to the patient. Operative management, in carefully selected patients, yields satisfactory outcomes that appear to be superior to nonoperative strategies. ASD is characterized by malalignment in the sagittal and/or coronal plane and, in adults, presents with pain and disability. Nonoperative management is recommended for patients with mild, nonprogressive symptoms; however, evidence of its efficacy is limited. Surgery aims to restore global spinal alignment, decompress neural elements, and achieve fusion with minimal complications. The surgical approach should balance the desired correction with the increased risk of more aggressive maneuvers. In well-selected patients, surgery yields excellent outcomes.Item Open Access Development and Validation of a Multidomain Surgical Complication Classification System for Adult Spinal Deformity.(Spine, 2021-02) Klineberg, Eric O; Wick, Joseph B; Lafage, Renaud; Lafage, Virginie; Pellise, Ferran; Haddad, Sleiman; Yilgor, Caglar; Núñez-Pereira, Susana; Gupta, Munish; Smith, Justin S; Shaffrey, Christopher; Schwab, Frank; Ames, Christopher; Bess, Shay; Lewis, Stephen; Lenke, Lawrence G; Berven, Sigurd; International Spine Study GroupStudy design
Prospective analysis of example cases.Objective
The aim of this study was to analyze the accuracy and repeatability of a new comprehensive classification system for capturing complications data in adult spinal deformity.Summary of background data
Complications are common in adult spinal deformity surgery. However, no consensus exists on the definition or classification of complications in adult spinal deformity surgery. The lack of consensus significantly limits understanding of complications' effects on outcomes in surgery for adult spinal deformity.Methods
Using a Delphi method, members of the International Spine Study Group, AO Spine, and the European Spine Study Group collaborated to develop an adult spinal deformity classification system. The multidomain classification system accounts for medical complications (cancer, cardiopulmonary, central nervous system, gastrointestinal, infectious, musculoskeletal, renal) and surgical complications (implant complications, radiographic complications, neurologic events, intraoperative events, and wound complications). Seventeen individuals ("event readers"), including spine surgeons, trainees, and research coordinators, used the new classification system two separate times to analyze complications in ten example cases. The accuracy and repeatability of the classification system were subsequently calculated based on the providers' responses for the example cases.Results
The 10 example cases included 22 complications. Nearly 95% of complications were captured by >95% of the event readers. The system demonstrated good repeatability of 86.9% between the first and second set of responses provided by event readers.Conclusion
The ISSG-AO Multi-Domain Spinal Deformity Complication Classification System for Adult Spinal Deformity demonstrated good accuracy and repeatability among both surgeons and research coordinators in capturing complications in adult spinal deformity surgery. The ISSG-AO system may be applied to help better understand the impact of complications on outcomes and costs in adult spinal deformity surgery.Level of Evidence: 5.Item Open Access Effect modifiers for patient-reported outcomes in operatively and nonoperatively treated patients with adult symptomatic lumbar scoliosis: a combined analysis of randomized and observational cohorts.(Journal of neurosurgery. Spine, 2020-03) Yanik, Elizabeth L; Kelly, Michael P; Lurie, Jon D; Baldus, Christine R; Shaffrey, Christopher I; Schwab, Frank J; Bess, Shay; Lenke, Lawrence G; LaBore, Adam; Bridwell, Keith HOBJECTIVE:Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS. METHODS:Patients 40-80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7). RESULTS:Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence-lumbar lordosis (PI-LL) match (≤ 11°). Male patients and patients with more (> 11°) PI-LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes. CONCLUSIONS:Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI-LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.Item Open Access Effect of Serious Adverse Events on Health-related Quality of Life Measures Following Surgery for Adult Symptomatic Lumbar Scoliosis.(Spine, 2019-09) Smith, Justin S; Shaffrey, Christopher I; Kelly, Michael P; Yanik, Elizabeth L; Lurie, Jon D; Baldus, Christine R; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Bridwell, Keith HStudy design
Secondary analysis of prospective multicenter cohort.Objective
To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).Summary of background data
Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.Methods
The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.Results
Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).Conclusion
Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.Level of evidence
2.