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Michael P. Kelly, Michael A. Kallen, Christopher I. Shaffrey, Justin S. Smith, Douglas C. Burton, Christopher P. Ames, Virginie Lafage, Frank J. Schwab, Han Jo Kim, Eric O. Klineberg, Shay Bess and the International Spine Study Group

OBJECTIVE

After using PROsetta Stone crosswalk tables to calculate Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores, the authors sought to examine 1) correlations with Scoliosis Research Society–22r (SRS-22r) scores, 2) responsiveness to change, and 3) the relationship between baseline scores and 2-year follow-up scores in adult spinal deformity (ASD).

METHODS

PROsetta Stone crosswalk tables were used to converted SF-36 scores to PROMIS scores for pain and physical function in a cohort of ASD patients with 2-year follow-up. Spearman correlations were used to evaluate the relationship of PROMIS scores with SRS-22r scores. Effect size (ES) and adjusted standardized response mean (aSRM) were used to assess responsiveness to change. Linear regression was used to evaluate the association between baseline scores and 2-year follow-up scores.

RESULTS

In total, 425 (425/625, 68%) patients met inclusion criteria. Strong correlations (all |r| > 0.7, p < 0.001) were found between baseline and 2-year PROMIS values and corresponding SRS-22r domain scores. PROMIS-PI showed a large ES (1.09) and aSRM (0.88), indicating good responsiveness to change. PROMIS-PF showed a moderate ES (0.52) and moderate aSRM (0.69), indicating a moderate responsiveness to change. Patients with greater baseline pain complaints were associated with greater pain improvement at 2 years for both SRS-22r Pain (B = 0.39, p < 0.001) and PROMIS-PI (B = 0.45, p < 0.001). Higher functional scores at baseline were associated with greater average improvements in both SRS-22r Activity (B = 0.62, p < 0.001) and PROMIS-PF (B = 0.40, p < 0.001).

CONCLUSIONS

The authors found strong correlations between the SRS-22r Pain and Activity domains with corresponding PROMIS-PI and -PF scores. Pain measurements showed similar and strong ES and aSRM while the function measurements showed similar, moderate ES and aSRM at 2-year follow-up. These data support further exploration of the use of PROMIS–computer adaptive test instruments in ASD.

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Ajay Niranjan, Wendy Fellows, William Stauffer, Edward A. Burton, Chang-Sook Hong, L. Dade Lunsford, Douglas Kondziolka, Joseph C. Glorioso and Glenn T. Gobbel

Object

Authors of previous studies have reported that adult transplanted neural progenitor cells (NPCs) are suitable for brain cell replacement or gene delivery. In this study, the authors evaluated survival and integration of adult rat–derived NPCs after transplantation and explored the potential impact on transplant survival of various mechanical and biological factors of clinical importance.

Methods

Adult female Fischer 344 rats were used both as a source and recipient of transplanted NPCs. Both 9L and RG2 rat glioma cells were used to generate in vivo brain tumor models. On the 5th day after tumor implantation, NPCs expressing green fluorescent protein (GFP) were administered either intravenously (3.5 × 107 cells) or by stereotactic injection (1 × 104–1 × 106 cells) into normal or tumor-bearing brain. The authors evaluated the effect of delivery method (sharp compared with blunt needles, normal compared with zero-volume needles, phosphate-buffered saline compared with medium as vehicle), delivery sites (intravenous compared with intratumoral compared with intraparenchymal), and pretreatment with an immunosuppressive agent (cyclosporin) or brain irradiation (20–40 Gy) on survival and integration of transplanted NPCs.

Results

Very few cells survived when less than 105 cells were transplanted. When 105 cells or more were transplanted, only previously administered brain irradiation significantly affected survival and integration of NPCs. Although GFP-containing NPCs could be readily detected 1 day after injection, few cells survived 4 days to 1 week unless preceded by whole-brain radiation (20 or 40 Gy in a single fraction), which increased the number of GFP-containing NPCs within the tissue more than fivefold.

Conclusions

he authors' findings indicate that most NPCs, including those from a syngeneic autologous source, do not survive at the site of implantation, but that brain irradiation can facilitate subsequent survival in both normal and tumor-bearing brain. An understanding of the mechanisms of this effect could lead to improved survival and clinical utility of transplanted NPCs.

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Frank J. Schwab, Ashish Patel, Christopher I. Shaffrey, Justin S. Smith, Jean-Pierre Farcy, Oheneba Boachie-Adjei, Richard A. Hostin, Robert A. Hart, Behrooz A. Akbarnia, Douglas C. Burton, Shay Bess and Virginie Lafage

Object

Pedicle subtraction osteotomy (PSO) is a surgical procedure that is frequently performed on patients with sagittal spinopelvic malalignment. Although it allows for substantial spinopelvic realignment, suboptimal realignment outcomes have been reported in up to 33% of patients. The authors' objective in the present study was to identify differences in radiographic profiles and surgical procedures between patients achieving successful versus failed spinopelvic realignment following PSO.

Methods

This study is a multicenter retrospective consecutive PSO case series. The authors evaluated 99 cases involving patients who underwent PSO for sagittal spinopelvic malalignment. Because precise cutoffs of acceptable residual postoperative sagittal vertical axis (SVA) values have not been well defined, comparisons were focused between patient groups with a postoperative SVA that could be clearly considered either a success or a failure. Only cases in which the patients had a postoperative SVA of less than 50 mm (successful PSO realignment) or more than 100 mm (failed PSO realignment) were included in the analysis. Radiographic measures and PSO parameters were compared between successful and failed PSO realignments.

Results

Seventy-nine patients met the inclusion criteria. Successful realignment was achieved in 61 patients (77%), while realignment failed in 18 (23%). Patients with failed realignment had larger preoperative SVA (mean 217.9 vs 106.7 mm, p < 0.01), larger pelvic tilt (mean 36.9° vs 30.7°, p < 0.01), larger pelvic incidence (mean 64.2° vs 53.7°, p < 0.01), and greater lumbar lordosis–pelvic incidence mismatch (−47.1° vs −30.9°, p < 0.01) compared with those in whom realignment was successful. Failed and successful realignments were similar regarding the vertebral level of the PSO, the median size of wedge resection 22.0° (interquartile range 16.5°−28.5°), and the numerical changes in pre- and postoperative spinopelvic parameters (p > 0.05).

Conclusions

Patients with failed PSO realignments had significantly larger preoperative spinopelvic deformity than patients in whom realignment was successful. Despite their apparent need for greater correction, the patients in the failed realignment group only received the same amount of correction as those in the successfully realigned patients. A single-level standard PSO may not achieve optimal outcome in patients with high preoperative spinopelvic sagittal malalignment. Patients with large spinopelvic deformities should receive larger osteotomies or additional corrective procedures beyond PSOs to avoid undercorrection.

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Alex Soroceanu, Douglas C. Burton, Bassel Georges Diebo, Justin S. Smith, Richard Hostin, Christopher I. Shaffrey, Oheneba Boachie-Adjei, Gregory M. Mundis Jr., Christopher Ames, Thomas J. Errico, Shay Bess, Munish C. Gupta, Robert A. Hart, Frank J. Schwab, Virginie Lafage and International Spine Study Group

OBJECT

Adult spinal deformity (ASD) surgery is known for its high complication rate. This study examined the impact of obesity on complication rates, infection, and patient-reported outcomes in patients undergoing surgery for ASD.

METHODS

This study was a retrospective review of a multicenter prospective database of patients with ASD who were treated surgically. Patients with available 2-year follow-up data were included. Obesity was defined as having a body mass index (BMI) ≥ 30 kg/m2. Data collected included complications (total, minor, major, implant-related, radiographic, infection, revision surgery, and neurological injury), estimated blood loss (EBL), operating room (OR) time, length of stay (LOS), and patient-reported questionnaires (Oswestry Disability Index [ODI], Short Form-36 [SF-36], and Scoliosis Research Society [SRS]) at baseline and at 6 weeks, 1 year, and 2 years postoperatively. The impact of obesity was studied using multivariate modeling, accounting for confounders.

RESULTS

Of 241 patients who satisfied inclusion criteria, 175 patients were nonobese and 66 were obese. Regression models showed that obese patients had a higher overall incidence of major complications (IRR 1.54, p = 0.02) and wound infections (odds ratio 4.88, p = 0.02). Obesity did not increase the number of minor complications (p = 0.62), radiographic complications (p = 0.62), neurological complications (p = 0.861), or need for revision surgery (p = 0.846). Obesity was not significantly correlated with OR time (p = 0.23), LOS (p = 0.9), or EBL (p = 0.98). Both groups experienced significant improvement overtime, as measured on the ODI (p = 0.0001), SF-36 (p = 0.0001), and SRS (p = 0.0001) questionnaires. However, the overall magnitude of improvement was less for obese patients (ODI, p = 0.0035; SF-36, p = 0.0012; SRS, p = 0.022). Obese patients also had a lower rate of improvement over time (SRS, p = 0.0085; ODI, p = 0.0001; SF-36, p = 0.0001).

CONCLUSIONS

This study revealed that obese patients have an increased risk of complications following ASD correction. Despite these increased complications, obese patients do benefit from surgical intervention; however, their improvement in health-related quality of life (HRQL) is less than that of nonobese patients.

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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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Dana L. Cruz, Ethan W. Ayres, Matthew A. Spiegel, Louis M. Day, Robert A. Hart, Christopher P. Ames, Douglas C. Burton, Justin S. Smith, Christopher I. Shaffrey, Frank J. Schwab, Thomas J. Errico, Shay Bess, Virginie Lafage and Themistocles S. Protopsaltis

OBJECTIVE

Neck and back pain are highly prevalent conditions that account for major disability. The Neck Disability Index (NDI) and Oswestry Disability Index (ODI) are the two most common functional status measures for neck and back pain. However, no single instrument exists to evaluate patients with concurrent neck and back pain. The recently developed Total Disability Index (TDI) combines overlapping elements from the ODI and NDI with the unique items from each. This study aimed to prospectively validate the TDI in patients with spinal deformity, back pain, and/or neck pain.

METHODS

This study is a retrospective review of prospectively collected data from a single center. The 14-item TDI, derived from ODI and NDI domains, was administered to consecutive patients presenting to a spine practice. Patients were assessed using the ODI, NDI, and EQ-5D. Validation of internal consistency, test-retest reproducibility, and validity of reconstructed NDI and ODI scores derived from TDI were assessed.

RESULTS

A total of 252 patients (mean age 55 years, 56% female) completed initial assessments (back pain, n = 115; neck pain, n = 52; back and neck pain, n = 55; spinal deformity, n = 55; and no pain/deformity, n = 29). Of these patients, 155 completed retests within 14 days. Patients represented a wide range of disability (mean ODI score: 36.3 ± 21.6; NDI score: 30.8 ± 21.8; and TDI score: 34.1 ± 20.0). TDI demonstrated excellent internal consistency (Cronbach’s alpha = 0.922) and test-retest reliability (intraclass correlation coefficient = 0.96). Differences between actual and reconstructed scores were not clinically significant. Subanalyses demonstrated TDI’s ability to quantify the degree of disability due to back or neck pain in patients complaining of pain in both regions.

CONCLUSIONS

The TDI is a valid and reliable disability measure in patients with back and/or neck pain and can capture each spine region’s contribution to total disability. The TDI could be a valuable method for total spine assessment in a clinical setting, and its completion is less time consuming than that for both the ODI and NDI.

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Justin K. Scheer, Justin S. Smith, Frank Schwab, Virginie Lafage, Christopher I. Shaffrey, Shay Bess, Alan H. Daniels, Robert A. Hart, Themistocles S. Protopsaltis, Gregory M. Mundis Jr., Daniel M. Sciubba, Tamir Ailon, Douglas C. Burton, Eric Klineberg, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

The operative management of patients with adult spinal deformity (ASD) has a high complication rate and it remains unknown whether baseline patient characteristics and surgical variables can predict early complications (intraoperative and perioperative [within 6 weeks]). The development of an accurate preoperative predictive model can aid in patient counseling, shared decision making, and improved surgical planning. The purpose of this study was to develop a model based on baseline demographic, radiographic, and surgical factors that can predict if patients will sustain an intraoperative or perioperative major complication.

METHODS

This study was a retrospective analysis of a prospective, multicenter ASD database. The inclusion criteria were age ≥ 18 years and the presence of ASD. In total, 45 variables were used in the initial training of the model including demographic data, comorbidities, modifiable surgical variables, baseline health-related quality of life, and coronal and sagittal radiographic parameters. Patients were grouped as either having at least 1 major intraoperative or perioperative complication (COMP group) or not (NOCOMP group). An ensemble of decision trees was constructed utilizing the C5.0 algorithm with 5 different bootstrapped models. Internal validation was accomplished via a 70/30 data split for training and testing each model, respectively. Overall accuracy, the area under the receiver operating characteristic (AUROC) curve, and predictor importance were calculated.

RESULTS

Five hundred fifty-seven patients were included: 409 (73.4%) in the NOCOMP group, and 148 (26.6%) in the COMP group. The overall model accuracy was 87.6% correct with an AUROC curve of 0.89 indicating a very good model fit. Twenty variables were determined to be the top predictors (importance ≥ 0.90 as determined by the model) and included (in decreasing importance): age, leg pain, Oswestry Disability Index, number of decompression levels, number of interbody fusion levels, Physical Component Summary of the SF-36, Scoliosis Research Society (SRS)–Schwab coronal curve type, Charlson Comorbidity Index, SRS activity, T-1 pelvic angle, American Society of Anesthesiologists grade, presence of osteoporosis, pelvic tilt, sagittal vertical axis, primary versus revision surgery, SRS pain, SRS total, use of bone morphogenetic protein, use of iliac crest graft, and pelvic incidence–lumbar lordosis mismatch.

CONCLUSIONS

A successful model (87% accuracy, 0.89 AUROC curve) was built predicting major intraoperative or perioperative complications following ASD surgery. This model can provide the foundation toward improved education and point-of-care decision making for patients undergoing ASD surgery.

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Joshua Bakhsheshian, Justin K. Scheer, Jeffrey L. Gum, Richard Hostin, Virginie Lafage, Shay Bess, Themistocles S. Protopsaltis, Douglas C. Burton, Malla Kate Keefe, Robert A. Hart, Gregory M. Mundis Jr., Christopher I. Shaffrey, Frank Schwab, Justin S. Smith, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

Mental disease burden can have a significant impact on levels of disability and health-related quality of life (HRQOL) measures. Therefore, the authors investigated the significance of mental health status in adults with spinal deformity and poor physical function.

METHODS

A retrospective analysis of a prospective multicenter database of 365 adult spinal deformity (ASD) patients who had undergone surgical treatment was performed. Health-related QOL variables were examined preoperatively and at the 2-year postoperative follow-up. Patients were grouped by their 36-Item Short Form Health Survey mental component summary (MCS) and physical component summary (PCS) scores. Both groups had PCS scores ≤ 25th percentile for matched norms; however, the low mental health (LMH) group consisted of patients with an MCS score ≤ 25th percentile, and the high mental health (HMH) group included patients with an MCS score ≥ 75th percentile.

RESULTS

Of the 264 patients (72.3%) with a 2-year follow-up, 104 (28.5%) met the inclusion criteria for LMH and 40 patients (11.0%) met those for HMH. The LMH group had a significantly higher overall rate of comorbidities, specifically leg weakness, depression, hypertension, and self-reported neurological and psychiatric disease processes, and were more likely to be unemployed as compared with the HMH group (p < 0.05 for all). The 2 groups had similar 2-year postoperative improvements in HRQOL (p > 0.05) except for the greater improvements in the MCS and the Scoliosis Research Society-22r questionnaire (SRS-22r) mental domain (p < 0.05) in the LMH group and greater improvements in PCS and SRS-22r satisfaction and back pain domains (p < 0.05) in the HMH group. The LMH group had a higher rate of reaching a minimal clinically important difference (MCID) on the SRS-22r mental domain (p < 0.01), and the HMH group had a higher rate of reaching an MCID on the PCS and SRS-22r activity domain (p < 0.05). On multivariable logistic regression, having LMH was a significant independent predictor of failure to reach an MCID on the PCS (p < 0.05). At the 2-year postoperative follow-up, 14 LMH patients (15.1%) were categorized as HMH. Two LMH patients (2.2%), and 3 HMH patients (7.7%) transitioned to a PCS score ≥ 75th percentile for age- and sex-matched US norms (p < 0.01).

CONCLUSIONS

While patients with poor mental and physical health, according to their MCS and PCS scores, have higher medical comorbidity and unemployment rates, they still demonstrate significant improvements in HRQOL measurements postoperatively. Both LMH and HMH patient groups demonstrated similar improvements in most HRQOL domains, except that the LMH patients had difficulties in obtaining improvements in the PCS domain.

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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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Christopher P. Ames, Justin S. Smith, Justin K. Scheer, Christopher I. Shaffrey, Virginie Lafage, Vedat Deviren, Bertrand Moal, Themistocles Protopsaltis, Praveen V. Mummaneni, Gregory M. Mundis Jr., Richard Hostin, Eric Klineberg, Douglas C. Burton, Robert Hart, Shay Bess, Frank J. Schwab and the International Spine Study Group

Object

Cervical spine osteotomies are powerful techniques to correct rigid cervical spine deformity. Many variations exist, however, and there is no current standardized system with which to describe and classify cervical osteotomies. This complicates the ability to compare outcomes across procedures and studies. The authors' objective was to establish a universal nomenclature for cervical spine osteotomies to provide a common language among spine surgeons.

Methods

A proposed nomenclature with 7 anatomical grades of increasing extent of bone/soft tissue resection and destabilization was designed. The highest grade of resection is termed the major osteotomy, and an approach modifier is used to denote the surgical approach(es), including anterior (A), posterior (P), anterior-posterior (AP), posterior-anterior (PA), anterior-posterior-anterior (APA), and posterior-anterior-posterior (PAP). For cases in which multiple grades of osteotomies were performed, the highest grade is termed the major osteotomy, and lower-grade osteotomies are termed minor osteotomies. The nomenclature was evaluated by 11 reviewers through 25 different radiographic clinical cases. The review was performed twice, separated by a minimum 1-week interval. Reliability was assessed using Fleiss kappa coefficients.

Results

The average intrarater reliability was classified as “almost perfect agreement” for the major osteotomy (0.89 [range 0.60–1.00]) and approach modifier (0.99 [0.95–1.00]); it was classified as “moderate agreement” for the minor osteotomy (0.73 [range 0.41–1.00]). The average interrater reliability for the 2 readings was the following: major osteotomy, 0.87 (“almost perfect agreement”); approach modifier, 0.99 (“almost perfect agreement”); and minor osteotomy, 0.55 (“moderate agreement”). Analysis of only major osteotomy plus approach modifier yielded a classification that was “almost perfect” with an average intrarater reliability of 0.90 (0.63–1.00) and an interrater reliability of 0.88 and 0.86 for the two reviews.

Conclusions

The proposed cervical spine osteotomy nomenclature provides the surgeon with a simple, standard description of the various cervical osteotomies. The reliability analysis demonstrated that this system is consistent and directly applicable. Future work will evaluate the relationship between this system and health-related quality of life metrics.