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Emmanuelle Ferrero, Barthelemy Liabaud, Vincent Challier, Renaud Lafage, Bassel G. Diebo, Shaleen Vira, Shian Liu, Jean Marc Vital, Brice Ilharreborde, Themistocles S. Protopsaltis, Thomas J. Errico, Frank J. Schwab, and Virginie Lafage

OBJECT

Previous forceplate studies analyzing the impact of sagittal-plane spinal deformity on pelvic parameters have demonstrated the compensatory mechanisms of pelvis translation in addition to rotation. However, the mechanisms recruited for this pelvic rotation were not assessed. This study aims to analyze the relationship between spinopelvic and lower-extremity parameters and clarify the role of pelvic translation.

METHODS

This is a retrospective study of patients with spinal deformity and full-body EOS images. Patients with only stenosis or low-back pain were excluded. Patients were grouped according to T-1 spinopelvic inclination (T1SPi): sagittal forward (forward, > 0.5°), neutral (−6.3° to 0.5°), or backward (< −6.3°). Pelvic translation was quantified by pelvic shift (sagittal offset between the posterosuperior corner of the sacrum and anterior cortex of the distal tibia), hip extension was measured using the sacrofemoral angle (SFA; the angle formed by the middle of the sacral endplate and the bicoxofemoral axis and the line between the bicoxofemoral axis and the femoral axis), and chin-brow vertical angle (CBVA). Univariate and multivariate analyses were used to compare the parameters and correlation with the Oswestry Disability Index (ODI).

RESULTS

In total, 336 patients (71% female; mean age 57 years; mean body mass index 27 kg/m2) had mean T1SPi values of −8.8°, −3.5°, and 5.9° in the backward, neutral, and forward groups, respectively. There were significant differences in the lower-extremity and spinopelvic parameters between T1SPi groups. The backward group had a normal lumbar lordosis (LL), negative SVA and pelvic shift, and the largest hip extension. Forward patients had a small LL and an increased SVA, with a large pelvic shift creating compensatory knee flexion. Significant correlations existed between lower-limb parameter and pelvic shift, pelvic tilt, T-1 pelvic angle, T1SPi, and sagittal vertical axis (0.3 < r < 0.8; p < 0.001). ODI was significantly correlated with knee flexion and pelvic shift.

CONCLUSIONS

This is the first study to describe full-body alignment in a large population of patients with spinal pathologies. Furthermore, patients categorized based on T1SPi were found to have significant differences in the pelvic shift and lower-limb compensatory mechanisms. Correlations between lower-limb angles, pelvic shift, and ODI were identified. These differences in compensatory mechanisms should be considered when evaluating and planning surgical intervention for adult patients with spinal deformity.

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Shian Liu, Renaud Lafage, Justin S. Smith, Themistocles S. Protopsaltis, Virginie C. Lafage, Vincent Challier, Christopher I. Shaffrey, Kris Radcliff, Paul M. Arnold, Jens R. Chapman, Frank J. Schwab, Eric M. Massicotte, S. Tim Yoon, Michael G. Fehlings, and Christopher P. Ames

OBJECT

Cervical stenosis is a defining feature of cervical spondylotic myelopathy (CSM). Matsunaga et al. proposed that elements of stenosis are both static and dynamic, where the dynamic elements magnify the canal deformation of the static state. For the current study, the authors hypothesized that dynamic changes may be associated with myelopathy severity and neck disability. This goal of this study was to present novel methods of dynamic motion analysis in CSM.

METHODS

A post hoc analysis was performed of a prospective, multicenter database of patients with CSM from the AOSpine North American study. One hundred ten patients (34%) met inclusion criteria, which were symptomatic CSM, age over 18 years, baseline flexion/extension radiographs, and health-related quality of life (HRQOL) questionnaires (modified Japanese Orthopaedic Association [mJOA] score, Neck Disability Index [NDI], the 36-Item Short Form Health Survey Physical Component Score [SF-36 PCS], and Nurick grade). The mean age was 56.9 ± 12 years, and 42% of patients were women (n = 46). Correlations with HRQOL measures were analyzed for regional (cervical lordosis and cervical sagittal vertical axis) and focal parameters (kyphosis and spondylolisthesis between adjacent vertebrae) in flexion and extension. Baseline dynamic parameters (flexion/extension cone relative to a fixed C-7, center of rotation [COR], and range of motion arc relative to the COR) were also analyzed for correlations with HRQOL measures.

RESULTS

At baseline, the mean HRQOL measures demonstrated disability and the mean radiographic parameters demonstrated sagittal malalignment. Among regional parameters, there was a significant correlation between decreased neck flexion (increased C2–7 angle in flexion) and worse Nurick grade (R = 0.189, p = 0.048), with no significant correlations in extension. Focal parameters, including increased C-7 sagittal translation overT-1 (slip), were significantly correlated with greater myelopathy severity (mJOA score, Flexion R = −0.377, p = 0.003; mJOA score, Extension R = −0.261, p = 0.027). Sagittal slip at C-2 and C-4 also correlated with worse HRQOL measures. Reduced flexion/extension motion cones, a more posterior COR, and smaller range of motion correlated with worse general health SF-36 PCS and Nurick grade.

CONCLUSIONS

Dynamic motion analysis may play an important role in understanding CSM. Focal parameters demonstrated a significant correlation with worse HRQOL measures, especially increased C-7 sagittal slip in flexion and extension. Novel methods of motion analysis demonstrating reduced motion cones correlated with worse myelopathy grades. More posterior COR and smaller range of motion were both correlated with worse general health scores (SF-36 PCS and Nurick grade). To our knowledge, this is the first study to demonstrate correlation of dynamic motion and listhesis with disability and myelopathy in CSM.

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Amit Jain, Hamid Hassanzadeh, Varun Puvanesarajah, Eric O. Klineberg, Daniel M. Sciubba, Michael P. Kelly, D. Kojo Hamilton, Virginie Lafage, Aaron J. Buckland, Peter G. Passias, Themistocles S. Protopsaltis, Renaud Lafage, Justin S. Smith, Christopher I. Shaffrey, Khaled M. Kebaish, and the International Spine Study Group

OBJECTIVE

Using 2 complication-reporting methods, the authors investigated the incidence of major medical complications and mortality in elderly patients after surgery for adult spinal deformity (ASD) during a 2-year follow-up period.

METHODS

The authors queried a multicenter, prospective, surgeon-maintained database (SMD) to identify patients 65 years or older who underwent surgical correction of ASD from 2008 through 2014 and had a minimum 2 years of follow-up (n = 153). They also queried a Centers for Medicare & Medicaid Services claims database (MCD) for patients 65 years or older who underwent fusion of 8 or more vertebral levels from 2005 through 2012 (n = 3366). They calculated cumulative rates of the following complications during the first 6 weeks after surgery: cerebrovascular accident, congestive heart failure, deep venous thrombosis, myocardial infarction, pneumonia, and pulmonary embolism. Significance was set at p < 0.05.

RESULTS

During the perioperative period, rates of major medical complications were 5.9% for pneumonia, 4.1% for deep venous thrombosis, 3.2% for pulmonary embolism, 2.1% for cerebrovascular accident, 1.8% for myocardial infarction, and 1.0% for congestive heart failure. Mortality rates were 0.9% at 6 weeks and 1.8% at 2 years. When comparing the SMD with the MCD, there were no significant differences in the perioperative rates of major medical complications except pneumonia. Furthermore, there were no significant intergroup differences in the mortality rates at 6 weeks or 2 years. The SMD provided greater detail with respect to deformity characteristics and surgical variables than the MCD.

CONCLUSIONS

The incidence of most major medical complications in the elderly after surgery for ASD was similar between the SMD and the MCD and ranged from 1% for congestive heart failure to 5.9% for pneumonia. These complications data can be valuable for preoperative patient counseling and informed consent.

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

OBJECTIVE

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

METHODS

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

RESULTS

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

CONCLUSIONS

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

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

OBJECTIVE

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

METHODS

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

RESULTS

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

CONCLUSIONS

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

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Themistocles S. Protopsaltis, Nicholas Stekas, Justin S. Smith, Alexandra Soroceanu, Renaud Lafage, Alan H. Daniels, Han Jo Kim, Peter G. Passias, Gregory M. Mundis Jr., Eric O. Klineberg, D. Kojo Hamilton, Munish Gupta, Virginie Lafage, Robert A. Hart, Frank Schwab, Douglas C. Burton, Shay Bess, Christopher I. Shaffrey, and Christopher P. Ames

OBJECTIVE

Cervical deformity (CD) patients have severe disability and poor health status. However, little is known about how patients with rigid CD compare with those with flexible CD. The main objectives of this study were to 1) assess whether patients with rigid CD have worse baseline alignment and therefore require more aggressive surgical corrections and 2) determine whether patients with rigid CD have similar postoperative outcomes as those with flexible CD.

METHODS

This is a retrospective review of a prospective, multicenter CD database. Rigid CD was defined as cervical lordosis (CL) change < 10° between flexion and extension radiographs, and flexible CD was defined as a CL change ≥ 10°. Patients with rigid CD were compared with those with flexible CD in terms of cervical alignment and health-related quality of life (HRQOL) at baseline and at multiple postoperative time points. The patients were also compared in terms of surgical and intraoperative factors such as operative time, blood loss, and number of levels fused.

RESULTS

A total of 127 patients met inclusion criteria (32 with rigid and 95 with flexible CD, 63.4% of whom were females; mean age 60.8 years; mean BMI 27.4); 47.2% of cases were revisions. Rigid CD was associated with worse preoperative alignment in terms of T1 slope minus CL, T1 slope, C2–7 sagittal vertical axis (cSVA), and C2 slope (C2S; all p < 0.05). Postoperatively, patients with rigid CD had an increased mean C2S (29.1° vs 22.2°) at 3 months and increased cSVA (47.1 mm vs 37.5 mm) at 1 year (p < 0.05) compared with those with flexible CD. Patients with rigid CD had more posterior levels fused (9.5 vs 6.3), fewer anterior levels fused (1 vs 2.0), greater blood loss (1036.7 mL vs 698.5 mL), more 3-column osteotomies (40.6% vs 12.6%), greater total osteotomy grade (6.5 vs 4.5), and mean osteotomy grade per level (3.3 vs 2.1) (p < 0.05 for all). There were no significant differences in baseline HRQOL scores, the rate of distal junctional kyphosis, or major/minor complications between patients with rigid and flexible CD. Both rigid and flexible CD patients reported significant improvements from baseline to 1 year according to the numeric rating scale for the neck (−2.4 and −2.7, respectively), Neck Disability Index (−8.4 and −13.3, respectively), modified Japanese Orthopaedic Association score (0.1 and 0.6), and EQ-5D (0.01 and 0.05) (p < 0.05). However, HRQOL changes from baseline to 1 year did not differ between rigid and flexible CD patients.

CONCLUSIONS

Patients with rigid CD have worse baseline cervical malalignment compared with those with flexible CD but do not significantly differ in terms of baseline disability. Rigid CD was associated with more invasive surgery and more aggressive corrections, resulting in increased operative time and blood loss. Despite more extensive surgeries, rigid CD patients had equivalent improvements in HRQOL compared with flexible CD patients. This study quantifies the importance of analyzing flexion-extension images, creating a prognostic tool for surgeons planning CD correction, and counseling patients who are considering CD surgery.

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Justin S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames, and the International Spine Study Group

OBJECTIVE

Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications.

METHODS

As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years.

RESULTS

Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury).

CONCLUSIONS

This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

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Thomas J. Buell, Justin S. Smith, Christopher I. Shaffrey, Han Jo Kim, Eric O. Klineberg, Virginie Lafage, Renaud Lafage, Themistocles S. Protopsaltis, Peter G. Passias, Gregory M. Mundis Jr., Robert K. Eastlack, Vedat Deviren, Michael P. Kelly, Alan H. Daniels, Jeffrey L. Gum, Alex Soroceanu, D. Kojo Hamilton, Munish C. Gupta, Douglas C. Burton, Richard A. Hostin, Khaled M. Kebaish, Robert A. Hart, Frank J. Schwab, Shay Bess, Christopher P. Ames, and the International Spine Study Group (ISSG)

OBJECTIVE

The impact of global coronal malalignment (GCM; C7 plumb line–midsacral offset) on adult spinal deformity (ASD) treatment outcomes is unclear. Here, the authors’ primary objective was to assess surgical outcomes and complications in patients with severe GCM, with a secondary aim of investigating potential surgical target coronal thresholds for optimal outcomes.

METHODS

This is a retrospective analysis of a prospective multicenter database. Operative patients with severe GCM (≥ 1 SD above the mean) and a minimum 2-year follow-up were identified. Demographic, surgical, radiographic, health-related quality of life (HRQOL), and complications data were analyzed.

RESULTS

Of 691 potentially eligible operative patients (mean GCM 4 ± 3 cm), 80 met the criteria for severe GCM ≥ 7 cm. Of these, 62 (78%; mean age 63.7 ± 10.7 years, 81% women) had a minimum 2-year follow-up (mean follow-up 3.3 ± 1.1 years). The mean ASD–Frailty Index was 3.9 ± 1.5 (frail), 50% had undergone prior fusion, and 81% had concurrent severe sagittal spinopelvic deformity with GCM and C7–S1 sagittal vertical axis (SVA) positively correlated (r = 0.313, p = 0.015). Surgical characteristics included posterior-only (58%) versus anterior-posterior (42%) approach, mean fusion of 13.2 ± 3.8 levels, iliac fixation (90%), 3-column osteotomy (36%), operative duration of 8.3 ± 3.0 hours, and estimated blood loss of 2.3 ± 1.7 L. Final alignment and HRQOL significantly improved (p < 0.01): GCM, 11 to 4 cm; maximum coronal Cobb angle, 43° to 20°; SVA, 13 to 4 cm; pelvic tilt, 29° to 23°; pelvic incidence–lumbar lordosis mismatch, 31° to 5°; Oswestry Disability Index, 51 to 37; physical component summary of SF-36 (PCS), 29 to 37; 22-Item Scoliosis Research Society Patient Questionnaire (SRS-22r) Total, 2.6 to 3.5; and numeric rating scale score for back and leg pain, 7 to 4 and 5 to 3, respectively. Residual GCM ≥ 3 cm was associated with worse SRS-22r Appearance (p = 0.04) and SRS-22r Satisfaction (p = 0.02). The minimal clinically important difference and/or substantial clinical benefit (MCID/SCB) was met in 43%–83% (highest for SRS-22r Appearance [MCID 83%] and PCS [SCB 53%]). The severity of baseline GCM (≥ 2 SD above the mean) significantly impacted postoperative SRS-22r Satisfaction and MCID/SCB improvement for PCS. No significant partial correlations were demonstrated between GCM or SVA correction and HRQOL improvement. There were 89 total complications (34 minor and 55 major), 45 (73%) patients with ≥ 1 complication (most commonly rod fracture [19%] and proximal junctional kyphosis [PJK; 18%]), and 34 reoperations in 22 (35%) patients (most commonly for rod fracture and PJK).

CONCLUSIONS

Study results demonstrated that ASD surgery in patients with substantial GCM was associated with significant radiographic and HRQOL improvement despite high complication rates. MCID improvement was highest for SRS-22r Appearance/Self-Image. A residual GCM ≥ 3 cm was associated with a worse outcome, suggesting a potential coronal realignment target threshold to assist surgical planning.