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Ziad Bakouny, Nour Khalil, Joeffroy Otayek, Aren Joe Bizdikian, Fares Yared, Michel Salameh, Naji Bou Zeid, Ismat Ghanem, Khalil Kharrat, Gaby Kreichati, Renaud Lafage, Virginie Lafage and Ayman Assi

OBJECTIVE

The Ames–International Spine Study Group (ISSG) classification has recently been proposed as a tool for adult cervical deformity evaluation. This classification includes three radiographic cervical sagittal modifiers that have not been evaluated in asymptomatic adults. The aim of this study was to determine whether the sagittal radiographic modifiers described in the Ames-ISSG cervical classification are encountered in asymptomatic adults without alteration of health-related quality of life (HRQOL).

METHODS

The authors conducted a cross-sectional study of subjects with an age ≥ 18 years and no cervical or back-related complaints or history of orthopedic surgery. All subjects underwent full-body biplanar radiographs with the measurement of cervical, segmental, and global alignment and completed the SF-36 HRQOL questionnaire. Subjects were classified according to the sagittal radiographic modifiers (chin-brow vertical angle [CBVA], mismatch between T1 slope and cervical lordosis [TS-CL], and C2–7 sagittal vertical axis [cSVA]) of the Ames–ISSG classification for cervical deformity, which also includes a qualitative descriptor of cervical deformity, the modified Japanese Orthopaedic Association (mJOA) myelopathy score, and the Scoliosis Research Society (SRS)–Schwab classification for spinal deformity assessment. Characteristics of the subjects classified by the different modifier grades were compared.

RESULTS

One hundred forty-one asymptomatic subjects (ages 18–59 years, 71 females) were enrolled in the study. Twenty-seven (19.1%) and 61 (43.3%) subjects were classified as grade 1 in terms of the TS-CL and CBVA modifiers, respectively. Ninety-eight (69.5%) and 4 (2.8%) were grade 2 for these same respective modifiers. One hundred thirty-six (96.5%) subjects had at least one modifier at grade 1 or 2. There was a significant relationship between patient age and grades of TS-CL (p < 0.001, Cramer’s V [CV] = 0.32) and CBVA (p = 0.04, CV = 0.22) modifiers. The HRQOL, global alignment, and segmental alignment parameters were similar among the subjects with different modifier grades (p > 0.05).

CONCLUSIONS

The CBVA and TS-CL radiographic modifiers of the Ames-ISSG classification do not seem to be specific to subjects with cervical deformities and can occur in asymptomatic subjects without alteration in HRQOL.

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

OBJECTIVE

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

METHODS

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

RESULTS

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

CONCLUSIONS

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

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

OBJECTIVE

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

METHODS

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

RESULTS

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

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

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

CONCLUSIONS

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

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

OBJECTIVE

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

METHODS

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

RESULTS

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

CONCLUSIONS

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

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

OBJECTIVE

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

METHODS

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

RESULTS

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

CONCLUSIONS

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

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

OBJECTIVE

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

METHODS

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

RESULTS

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

CONCLUSIONS

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

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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.