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Justin K. Scheer, Jessica A. Tang, Justin S. Smith, Eric Klineberg, Robert A. Hart, Gregory M. Mundis Jr., Douglas C. Burton, Richard Hostin, Michael F. O'Brien, Shay Bess, Khaled M. Kebaish, Vedat Deviren, Virginie Lafage, Frank Schwab, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

Object

Complications and reoperation for surgery to correct adult spinal deformity are not infrequent, and many studies have analyzed the rates and factors that influence the likelihood of reoperation. However, there is a need for more comprehensive analyses of reoperation in adult spinal deformity surgery from a global standpoint, particularly focusing on the 1st year following operation and considering radiographic parameters and the effects of reoperation on health-related quality of life (HRQOL). This study attempts to determine the prevalence of reoperation following surgery for adult spinal deformity, assess the indications for these reoperations, evaluate for a relation between specific radiographic parameters and the need for reoperation, and determine the potential impact of reoperation on HRQOL measures.

Methods

A retrospective review was conducted of a prospective, multicenter, adult spinal deformity database collected through the International Spine Study Group. Data collected included age, body mass index, sex, date of surgery, information regarding complications, reoperation dates, length of stay, and operation time. The radiographic parameters assessed were total number of levels instrumented, total number of interbody fusions, C-7 sagittal vertical axis, uppermost instrumented vertebra (UIV) location, and presence of 3-column osteotomies. The HRQOL assessment included Oswestry Disability Index (ODI), 36-Item Short Form Health Survey physical component and mental component summary, and SRS-22 scores. Smoking history, Charlson Comorbidity Index scores, and American Society of Anesthesiologists Physical Status classification grades were also collected and assessed for correlation with risk of early reoperation. Various statistical tests were performed for evaluation of specific factors listed above, and the level of significance was set at p < 0.05.

Results

Fifty-nine (17%) of a total of 352 patients required reoperation. Forty-four (12.5%) of the reoperations occurred within 1 year after the initial surgery, including 17 reoperations (5%) within 30 days.

Two hundred sixty-eight patients had a minimum of 1 year of follow-up. Fifty-three (20%) of these patients had a 3-column osteotomy, and 10 (19%) of these 53 required reoperation within 1 year of the initial procedure. However, 3-column osteotomy was not predictive of reoperation within 1 year, p = 0.5476). There were no significant differences between groups with regard to the distribution of UIV, and UIV did not have a significant effect on reoperation rates. Patients needing reoperation within 1 year had worse ODI and SRS-22 scores measured at 1-year follow-up than patients not requiring operation.

Conclusions

Analysis of data from a large multicenter adult spinal deformity database shows an overall 17% reoperation rate, with a 19% reoperation rate for patients treated with 3-column osteotomy and a 16% reoperation rate for patients not treated with 3-column osteotomy. The most common indications for reoperation included instrumentation complications and radiographic failure. Reoperation significantly affected HRQOL outcomes at 1-year follow-up. The need for reoperation may be minimized by carefully considering spinal alignment, termination of fixation, and type of surgical procedure (presence of osteotomy). Precautions should be taken to avoid malposition or instrumentation (rod) failure.

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Christopher P. Ames, Justin S. Smith, Robert Eastlack, Donald J. Blaskiewicz, Christopher I. Shaffrey, Frank Schwab, Shay Bess, Han Jo Kim, Gregory M. Mundis Jr., Eric Klineberg, Munish Gupta, Michael O’Brien, Richard Hostin, Justin K. Scheer, Themistocles S. Protopsaltis, Kai-Ming G. Fu, Robert Hart, Todd J. Albert, K. Daniel Riew, Michael G. Fehlings, Vedat Deviren, Virginie Lafage and International Spine Study Group

OBJECT

Despite the complexity of cervical spine deformity (CSD) and its significant impact on patient quality of life, there exists no comprehensive classification system. The objective of this study was to develop a novel classification system based on a modified Delphi approach and to characterize the intra- and interobserver reliability of this classification.

METHODS

Based on an extensive literature review and a modified Delphi approach with an expert panel, a CSD classification system was generated. The classification system included a deformity descriptor and 5 modifiers that incorporated sagittal, regional, and global spinopelvic alignment and neurological status. The descriptors included: “C,” “CT,” and “T” for primary cervical kyphotic deformities with an apex in the cervical spine, cervicothoracic junction, or thoracic spine, respectively; “S” for primary coronal deformity with a coronal Cobb angle ≥ 15°; and “CVJ” for primary craniovertebral junction deformity. The modifiers included C2–7 sagittal vertical axis (SVA), horizontal gaze (chin-brow to vertical angle [CBVA]), T1 slope (TS) minus C2–7 lordosis (TS–CL), myelopathy (modified Japanese Orthopaedic Association [mJOA] scale score), and the Scoliosis Research Society (SRS)-Schwab classification for thoracolumbar deformity. Application of the classification system requires the following: 1) full-length standing posteroanterior (PA) and lateral spine radiographs that include the cervical spine and femoral heads; 2) standing PA and lateral cervical spine radiographs; 3) completed and scored mJOA questionnaire; and 4) a clinical photograph or radiograph that includes the skull for measurement of the CBVA. A series of 10 CSD cases, broadly representative of the classification system, were selected and sufficient radiographic and clinical history to enable classification were assembled. A panel of spinal deformity surgeons was queried to classify each case twice, with a minimum of 1 intervening week. Inter- and intrarater reliability measures were based on calculations of Fleiss k coefficient values.

RESULTS

Twenty spinal deformity surgeons participated in this study. Interrater reliability (Fleiss k coefficients) for the deformity descriptor rounds 1 and 2 were 0.489 and 0.280, respectively, and mean intrarater reliability was 0.584. For the modifiers, including the SRS-Schwab components, the interrater (round 1/round 2) and intrarater reliabilities (Fleiss k coefficients) were: C2–7 SVA (0.338/0.412, 0.584), horizontal gaze (0.779/0.430, 0.768), TS-CL (0.721/0.567, 0.720), myelopathy (0.602/0.477, 0.746), SRS-Schwab curve type (0.590/0.433, 0.564), pelvic incidence-lumbar lordosis (0.554/0.386, 0.826), pelvic tilt (0.714/0.627, 0.633), and C7-S1 SVA (0.071/0.064, 0.233), respectively. The parameter with the poorest reliability was the C7–S1 SVA, which may have resulted from differences in interpretation of positive and negative measurements.

CONCLUSIONS

The proposed classification provides a mechanism to assess CSD within the framework of global spinopelvic malalignment and clinically relevant parameters. The intra- and interobserver reliabilities suggest moderate agreement and serve as the basis for subsequent improvement and study of the proposed classification.

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Alexander A. Theologis, Tamir Ailon, Justin K. Scheer, Justin S. Smith, Christopher I. Shaffrey, Shay Bess, Munish Gupta, Eric O. Klineberg, Khaled Kebaish, Frank Schwab, Virginie Lafage, Douglas Burton, Robert Hart, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

The objective of this study was to isolate whether the effect of a baseline clinical history of depression on outcome is independent of associated physical disability and to evaluate which mental health screening tool has the most utility in determining 2-year clinical outcomes after adult spinal deformity (ASD) surgery.

METHODS

Consecutively enrolled patients with ASD in a prospective, multicenter ASD database who underwent surgical intervention with a minimum 2-year follow-up were retrospectively reviewed. A subset of patients who completed the Distress and Risk Assessment Method (DRAM) was also analyzed. The effects of categorical baseline depression and DRAM classification on the Oswestry Disability Index (ODI), SF-36, and Scoliosis Research Society questionnaire (SRS-22r) were assessed using univariate and multivariate linear regression analyses. The probability of achieving ≥ 1 minimal clinically important difference (MCID) on the ODI based on the DRAM’s Modified Somatic Perceptions Questionnaire (MSPQ) score was estimated.

RESULTS

Of 267 patients, 66 (24.7%) had self-reported preoperative depression. Patients with baseline depression had significantly more preoperative back pain, greater BMI and Charlson Comorbidity Indices, higher ODIs, and lower SRS-22r and SF-36 Physical/Mental Component Summary (PCS/MCS) scores compared with those without self-reported baseline depression. They also had more severe regional and global sagittal malalignment. After adjusting for these differences, preoperative depression did not impact 2-year ODI, PCS/MCS, or SRS-22r totals (p > 0.05). Compared with those in the “normal” DRAM category, “distressed somatics” (n = 11) had higher ODI (+23.5 points), lower PCS (−10.9), SRS-22r activity (−0.9), and SRS-22r total (−0.8) scores (p ≤ 0.01), while “distressed depressives” (n = 25) had lower PCS (−8.4) and SRS-22r total (−0.5) scores (p < 0.05). After adjusting for important covariates, each additional point on the baseline MSPQ was associated with a 0.8-point increase in 2-year ODI (p = 0.03). The probability of improving by at least 1 MCID in 2-year ODI ranged from 77% to 21% for MSPQ scores 0–20, respectively.

CONCLUSIONS

A baseline clinical history of depression does not correlate with worse 2-year outcomes after ASD surgery after adjusting for baseline differences in comorbidities, health-related quality of life, and spinal deformity severity. Conversely, DRAM improved risk stratification of patient subgroups predisposed to achieving suboptimal surgical outcomes. The DRAM’s MSPQ was more predictive than MCS and SRS mental domain for 2-year outcomes and may be a valuable tool for surgical screening.

Free access

Taemin Oh, Justin K. Scheer, Justin S. Smith, Richard Hostin, Chessie Robinson, Jeffrey L. Gum, Frank Schwab, Robert A. Hart, Virginie Lafage, Douglas C. Burton, Shay Bess, Themistocles Protopsaltis, Eric O. Klineberg, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Patients with adult spinal deformity (ASD) experience significant quality of life improvements after surgery. Treatment, however, is expensive and complication rates are high. Predictive analytics has the potential to use many variables to make accurate predictions in large data sets. A validated minimum clinically important difference (MCID) model has the potential to assist in patient selection, thereby improving outcomes and, potentially, cost-effectiveness.

METHODS

The present study was a retrospective analysis of a multiinstitutional database of patients with ASD. Inclusion criteria were as follows: age ≥ 18 years, radiographic evidence of ASD, 2-year follow-up, and preoperative Oswestry Disability Index (ODI) > 15. Forty-six variables were used for model training: demographic data, radiographic parameters, surgical variables, and results on the health-related quality of life questionnaire. Patients were grouped as reaching a 2-year ODI MCID (+MCID) or not (−MCID). An ensemble of 5 different bootstrapped decision trees was constructed using the C5.0 algorithm. Internal validation was performed via 70:30 data split for training/testing. Model accuracy and area under the curve (AUC) were calculated. The mean quality-adjusted life years (QALYs) and QALYs gained at 2 years were calculated and discounted at 3.5% per year. The QALYs were compared between patients in the +MCID and –MCID groups.

RESULTS

A total of 234 patients met inclusion criteria (+MCID 129, −MCID 105). Sixty-nine patients (29.5%) were included for model testing. Predicted versus actual results were 50 versus 40 for +MCID and 19 versus 29 for −MCID (i.e., 10 patients were misclassified). Model accuracy was 85.5%, with 0.96 AUC. Predicted results showed that patients in the +MCID group had significantly greater 2-year mean QALYs (p = 0.0057) and QALYs gained (p = 0.0002).

CONCLUSIONS

A successful model with 85.5% accuracy and 0.96 AUC was constructed to predict which patients would reach ODI MCID. The patients in the +MCID group had significantly higher mean 2-year QALYs and QALYs gained. This study provides proof of concept for using predictive modeling techniques to optimize patient selection in complex spine surgery.

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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.