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O. Wayne Houser, Burton M. Onofrio, Gary M. Miller, W. Neath Folger, Patsy L. Smith, and Douglas A. Kallman

✓ The surgical and computerized tomographic myelography (CTM) features of 134 stenotic foraminal canals were correlated retrospectively in 95 patients. The myelographic site of stenosis was the entrance to the foraminal canal in 70 cases (52%) and the canal itself in 37 (28%); the site was not identified definitively in 27 (20%). At the entrance to the foraminal canal, encroachment on the adjacent nerve root was by a cartilaginous cap in 10 cases (8%), a bony osteophyte in 17 (13%), a synovial cyst in one (1%), and a combination of a bony and cartilaginous osteophyte in 42 (31%). The diagnostic features of stenosis within the foraminal canal were more variable. Small bone spurs arising from the uncovertebral process encroached on the anterior aspect of the foramen in 29 instances (22%), accompanied in all cases by either a congenitally narrow canal (in 16) or a diffuse osteophytically narrowed canal (in 13); osteophytes arising from the superior facet in eight instances (6%) were larger and encroached on the posterior aspect of the foramen. Diagnosis on the basis of CTM is difficult because stenosis was readily evident as a bone spur in only 13% of cases, could not be distinguished from prolapsed disc in 39%, had to be differentiated from a congenitally narrow foraminal canal in 27%, and was frankly missed in 20% of the instances of stenosis.

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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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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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Virginie Lafage, Neil J. Bharucha, Frank Schwab, Robert A. Hart, Douglas Burton, Oheneba Boachie-Adjei, Justin S. Smith, Richard Hostin, Christopher Shaffrey, Munish Gupta, Behrooz A. Akbarnia, and Shay Bess

Object

Sagittal spinopelvic imbalance is a major contributor to pain and disability for patients with adult spinal deformity (ASD). Preoperative planning is essential for pedicle subtraction osteotomy (PSO) candidates; however, current methods are often inaccurate because no formula to date predicts both postoperative sagittal balance and pelvic alignment. The authors of this study aimed to evaluate the accuracy of 2 novel formulas in predicting postoperative spinopelvic alignment after PSO.

Methods

This study is a multicenter retrospective consecutive PSO case series. Adults with spinal deformity (> 21 years old) who were treated with a single-level lumbar PSO for sagittal imbalance were evaluated. All patients underwent preoperative and a minimum of 6-month postoperative radiography. Two novel formulas were used to predict the postoperative spinopelvic alignment. The results predicted by the formulas were then compared with the actual postoperative radiographic values, and the formulas' ability to identify successful (sagittal vertical axis [SVA] ≤ 50 mm and pelvic tilt [PT] ≤ 25°) and unsuccessful (SVA > 50 mm or PT > 25°) outcomes was evaluated.

Results

Ninety-nine patients met inclusion criteria. The median absolute error between the predicted and actual PT was 4.1° (interquartile range 2.0°–6.4°). The median absolute error between the predicted and actual SVA was 27 mm (interquartile range 11–47 mm). Forty-one of 54 patients with a formula that predicted a successful outcome had a successful outcome as shown by radiography (positive predictive value = 0.76). Forty-four of 45 patients with a formula that predicted an unsuccessful outcome had an unsuccessful outcome as shown by radiography (negative predictive value = 0.98).

Conclusions

The spinopelvic alignment formulas were accurate when predicting unsuccessful outcomes but less reliable when predicting successful outcomes. The preoperative surgical plan should be altered if an unsuccessful result is predicted. However, even after obtaining a predicted successful outcome, surgeons should ensure that the predicted values are not too close to unsuccessful values and should identify other variables that may affect alignment. In the near future, it is anticipated that the use of these formulas will lead to better surgical planning and improved outcomes for patients with complex ASD.

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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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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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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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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.

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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.