Thomas J. Buell, Davis G. Taylor, Ching-Jen Chen, Christopher I. Shaffrey, Justin S. Smith, and Shay Bess
Thomas J. Buell, Shay Bess, Ming Xu, Frank J. Schwab, Virginie Lafage, Christopher P. Ames, Christopher I. Shaffrey, and Justin S. Smith
Proximal junctional kyphosis (PJK) is, in part, due to altered segmental biomechanics at the junction of rigid instrumented spine and relatively hypermobile non-instrumented adjacent segments. Proper application of posteriorly anchored polyethylene tethers (i.e., optimal configuration and tension) may mitigate adjacent-segment stress and help prevent PJK. The purpose of this study was to investigate the impact of different tether configurations and tensioning (preloading) on junctional range-of-motion (ROM) and other biomechanical indices for PJK in long instrumented spine constructs.
Using a validated finite element model of a T7–L5 spine segment, testing was performed on intact spine, a multilevel posterior screw-rod construct (PS construct; T11–L5) without tether, and 15 PS constructs with different tether configurations that varied according to 1) proximal tether fixation of upper instrumented vertebra +1 (UIV+1) and/or UIV+2; 2) distal tether fixation to UIV, to UIV−1, or to rods; and 3) use of a loop (single proximal fixation) or weave (UIV and/or UIV+1 fixation in addition to UIV+1 and/or UIV+2 proximal attachment) of the tether. Segmental ROM, intradiscal pressure (IDP), inter- and supraspinous ligament (ISL/SSL) forces, and screw loads were assessed under variable tether preload.
PS construct junctional ROM increased abruptly from 10% (T11–12) to 99% (T10–11) of baseline. After tethers were grouped by most cranial proximal fixation (UIV+1 vs UIV+2) and use of loop versus weave, UIV+2 Loop and/or Weave most effectively dampened junctional ROM and adjacent-segment stress. Different distal fixation and use of loop versus weave had minimal effect. The mean segmental ROM at T11–12, T10–11, and T9–10, respectively, was 6%, 40%, and 99% for UIV+1 Loop; 6%, 44%, and 99% for UIV+1 Weave; 5%, 23%, and 26% for UIV+2 Loop; and 5%, 24%, and 31% for UIV+2 Weave.
Tethers shared loads with posterior ligaments; consequently, increasing tether preload tension reduced ISL/SSL forces, but screw loads increased. Further attenuation of junctional ROM and IDP reversed above approximately 100 N tether preload, suggesting diminished benefit for biomechanical PJK prophylaxis at higher preload tensioning.
In this study, finite element analysis demonstrated UIV+2 Loop and/or Weave tether configurations most effectively mitigated adjacent-segment stress in long instrumented spine constructs. Tether preload dampened ligament forces at the expense of screw loads, and an inflection point (approximately 100 N) was demonstrated above which junctional ROM and IDP worsened (i.e., avoid over-tightening tethers). Results suggest tether configuration and tension influence PJK biomechanics and further clinical research is warranted.
Justin K. Scheer, Jessica A. Tang, Justin S. Smith, Frank L. Acosta Jr., Themistocles S. Protopsaltis, Benjamin Blondel, Shay Bess, Christopher I. Shaffrey, Vedat Deviren, Virginie Lafage, Frank Schwab, Christopher P. Ames, and the International Spine Study Group
This paper is a narrative review of normal cervical alignment, methods for quantifying alignment, and how alignment is associated with cervical deformity, myelopathy, and adjacent-segment disease (ASD), with discussions of health-related quality of life (HRQOL). Popular methods currently used to quantify cervical alignment are discussed including cervical lordosis, sagittal vertical axis, and horizontal gaze with the chin-brow to vertical angle. Cervical deformity is examined in detail as deformities localized to the cervical spine affect, and are affected by, other parameters of the spine in preserving global sagittal alignment. An evolving trend is defining cervical sagittal alignment. Evidence from a few recent studies suggests correlations between radiographic parameters in the cervical spine and HRQOL. Analysis of the cervical regional alignment with respect to overall spinal pelvic alignment is critical. The article details mechanisms by which cervical kyphotic deformity potentially leads to ASD and discusses previous studies that suggest how postoperative sagittal malalignment may promote ASD. Further clinical studies are needed to explore the relationship of cervical malalignment and the development of ASD. Sagittal alignment of the cervical spine may play a substantial role in the development of cervical myelopathy as cervical deformity can lead to spinal cord compression and cord tension. Surgical correction of cervical myelopathy should always take into consideration cervical sagittal alignment, as decompression alone may not decrease cord tension induced by kyphosis. Awareness of the development of postlaminectomy kyphosis is critical as it relates to cervical myelopathy. The future direction of cervical deformity correction should include a comprehensive approach in assessing global cervicalpelvic relationships. Just as understanding pelvic incidence as it relates to lumbar lordosis was crucial in building our knowledge of thoracolumbar deformities, T-1 incidence and cervical sagittal balance can further our understanding of cervical deformities. Other important parameters that account for the cervical-pelvic relationship are surveyed in detail, and it is recognized that all such parameters need to be validated in studies that correlate HRQOL outcomes following cervical deformity correction.
Shay Bess, Jeffrey E. Harris, Alexander W. L. Turner, Virginie LaFage, Justin S. Smith, Christopher I. Shaffrey, Frank J. Schwab, and Regis W. Haid Jr.
Proximal junctional kyphosis (PJK) remains problematic following multilevel instrumented spine surgery. Previous biomechanical studies indicate that providing less rigid fixation at the cranial aspect of a long posterior instrumented construct, via transition rods or hooks at the upper instrumented vertebra (UIV), may provide a gradual transition to normal motion and prevent PJK. The purpose of this study was to evaluate the ability of posterior anchored polyethylene tethers to distribute proximal motion segment stiffness in long instrumented spine constructs.
A finite element model of a T7–L5 spine segment was created to evaluate range of motion (ROM), intradiscal pressure, pedicle screw loads, and forces in the posterior ligament complex within and adjacent to the proximal terminus of an instrumented spine construct. Six models were tested: 1) intact spine; 2) bilateral, segmental pedicle screws (PS) at all levels from T-11 through L-5; 3) bilateral pedicle screws from T-12 to L-5 and transverse process hooks (TPH) at T-11 (the UIV); 4) pedicle screws from T-11 to L5 and 1-level tethers from T-10 to T-11 (TE-UIV+1); 5) pedicle screws from T-11 to L-5 and 2-level tethers from T-9 to T-11 (TE-UIV+2); and 6) pedicle screws and 3-level tethers from T-8 to T-11 (TE-UIV+3).
Proximal-segment range of motion (ROM) for the PS construct increased from 16% at UIV−1 to 91% at UIV. Proximal-segment ROM for the TPH construct increased from 27% at UIV−1 to 92% at UIV. Posterior tether constructs distributed ROM at the UIV and cranial adjacent segments most effectively; ROM for TE-UIV+1 was 14% of the intact model at UIV−1, 76% at UIV, and 98% at UIV+1. ROM for TE-UIV+2 was 10% at UIV−1, 51% at UIV, 69% at UIV+1, and 97% at UIV+2. ROM for TE-UIV+3 was 7% at UIV−1, 33% at UIV, 45% at UIV+1, and 64% at UIV+2. Proximal segment intradiscal pressures, pedicle screw loads, and ligament forces in the posterior ligament complex were progressively reduced with increasing number of posterior tethers used.
Finite element analysis of long instrumented spine constructs demonstrated that posterior tethers created a more gradual transition in ROM and adjacent-segment stress from the instrumented to the noninstrumented spine compared with all PS and TPH constructs. Posterior tethers may limit the biomechanical risk factor for PJK; however, further clinical research is needed to evaluate clinical efficacy.
Christopher P. Ames, Justin S. Smith, Justin K. Scheer, Shay Bess, S. Samuel Bederman, Vedat Deviren, Virginie Lafage, Frank Schwab, and Christopher I. Shaffrey
Sagittal spinal misalignment (SSM) is an established cause of pain and disability. Treating physicians must be familiar with the radiographic findings consistent with SSM. Additionally, the restoration or maintenance of physiological sagittal spinal alignment after reconstructive spinal procedures is imperative to achieve good clinical outcomes. The C-7 plumb line (sagittal vertical axis) has traditionally been used to evaluate sagittal spinal alignment; however, recent data indicate that the measurement of spinopelvic parameters provides a more comprehensive assessment of sagittal spinal alignment. In this review the authors describe the proper analysis of spinopelvic alignment for surgical planning. Online videos supplement the text to better illustrate the key concepts.
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
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).
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.
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).
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.
Spontaneous improvement of cervical alignment after correction of global sagittal balance following pedicle subtraction osteotomy
Presented at the 2012 Joint Spine Section Meeting
Justin S. Smith, Christopher I. Shaffrey, Virginie Lafage, Benjamin Blondel, Frank Schwab, Richard Hostin, Robert Hart, Brian O'Shaughnessy, Shay Bess, Serena S. Hu, Vedat Deviren, Christopher P. Ames, and International Spine Study Group
Sagittal spinopelvic malalignment is a significant cause of pain and disability in patients with adult spinal deformity. Surgical correction of spinopelvic malalignment can result in compensatory changes in spinal alignment outside of the fused spinal segments. These compensatory changes, termed reciprocal changes, have been defined for thoracic and lumbar regions but not for the cervical spine. The object of this study was to evaluate postoperative reciprocal changes within the cervical spine following lumbar pedicle subtraction osteotomy (PSO).
This was a multicenter retrospective radiographic analysis of patients from International Spine Study Group centers. Inclusion criteria were as follows: adults (>18 years old) with spinal deformity treated using lumbar PSO, a preoperative C7–S1 plumb line greater than 5 cm, and availability of pre- and postoperative full-length standing radiographs.
Seventy-five patients (60 women, mean age 59 years) were included. The lumbar PSO significantly improved sagittal alignment, including the C7–S1 plumb line, C7–T12 inclination, and pelvic tilt (p <0.001). After lumbar PSO, reciprocal changes were seen to occur in C2–7 cervical lordosis (from 30.8° to 21.6°, p <0.001), C2–7 plumb line (from 27.0 mm to 22.9 mm), and T-1 slope (from −38.9° to −30.4°, p <0.001). Ideal correction of sagittal malalignment (postoperative sagittal vertical alignment < 50 mm) was associated with the greatest relaxation of cervical hyperlordosis (−12.4° vs −5.7°, p = 0.037). A change in cervical lordosis correlated with changes in T-1 slope (r = −0.621, p <0.001), C7–T12 inclination (r = 0.418, p <0.001), T12–S1 angle (r = −0.339, p = 0.005), and C7–S1 plumb line (r = 0.289, p = 0.018). Radiographic parameters that correlated with changes in cervical lordosis on multivariate linear regression analysis included change in T-1 slope and change in C2–7 plumb line (r2 = 0.53, p <0.001).
Adults with positive sagittal spinopelvic malalignment compensate with abnormally increased cervical lordosis in an effort to maintain horizontal gaze. Surgical correction of sagittal malalignment results in improvement of the abnormal cervical hyperlordosis through reciprocal changes.
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
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.
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.
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).
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.
Kseniya Slobodyanyuk, Caroline E. Poorman, Justin S. Smith, Themistocles S. Protopsaltis, Richard Hostin, Shay Bess, Gregory M. Mundis Jr., Frank J. Schwab, and Virginie Lafage
The goal of this study was to determine the outcome and risk factors in patients with adult spinal deformity (ASD) who elected to receive nonoperative care.
In this retrospective study the authors reviewed a nonoperative branch of the International Spine Study Group database, derived from 10 sites across the US. Specific inclusion criteria included nonoperative treatment for ASD and the availability of Scoliosis Research Society (SRS)-22 scores and radiographic data at baseline (BL) and at 1-year (1Y) follow-up. Health-related quality of life measures were assessed using the SRS-22 and radiographic data. Changes in SRS-22 scores were evaluated by domain and expressed in number of minimum clinically important differences (MCIDs) gained or lost; BL and 1Y scores were also compared with age- and sex-matched normative references.
One hundred eighty-nine patients (mean age 53 years, 86% female) met inclusion criteria. Pain was the domain with the largest offset for 43% of patients, followed by the Appearance (23%), Activity (18%), and Mental (15%) domains. On average, patients improved 0.3 MCID in Pain over 1Y, without changes in Activity or Appearance. Baseline scores significantly impacted 1Y outcomes, with up to 85% of patients in the mildest category of deformity being classified as < 1 MCID of normative reference at 1Y, versus 0% of patients with the most severe initial deformity. Baseline radiographic parameters did not correlate with outcome.
Patients who received nonoperative care are significantly more disabled than age- and sex-matched normative references. The likelihood for a patient to reach SRS scores similar to the normative reference at 1Y decreases with increased BL disability. Nonoperative treatment is a viable option for certain patients with ASD, and up to 24% of patients demonstrated significant improvement over 1Y with nonoperative care.
Elizabeth L. Yanik, Michael P. Kelly, Jon D. Lurie, Christine R. Baldus, Christopher I. Shaffrey, Frank J. Schwab, Shay Bess, Lawrence G. Lenke, Adam LaBore, and Keith H. Bridwell
Adult symptomatic lumbar scoliosis (ASLS) is a common and disabling condition. The ASLS-1 was a multicenter, dual-arm study (with randomized and observational cohorts) examining operative and nonoperative care on health-related quality of life in ASLS. An aim of ASLS-1 was to determine patient and radiographic factors that modify the effect of operative treatment for ASLS.
Patients 40–80 years old with ASLS were enrolled in randomized and observational cohorts at 9 North American centers. Primary outcomes were the differences in mean change from baseline to 2-year follow-up for the SRS-22 subscore (SRS-SS) and the Oswestry Disability Index (ODI). Analyses were performed using an as-treated approach with combined cohorts. Factors examined were prespecified or determined using regression tree analysis. For each potential effect modifier, subgroups were created using clinically relevant cutoffs or via regression trees. Estimates of within-group and between-group change were compared using generalized linear mixed models. An effect modifier was defined as a treatment effect difference greater than the minimal detectable measurement difference for both SRS-SS (0.4) and ODI (7).
Two hundred eighty-six patients were enrolled and 256 (90%) completed 2-year follow-up; 171 received operative treatment and 115 received nonoperative treatment. Surgery was superior to nonoperative care for all effect subgroups considered, with the exception of those with nearly normal pelvic incidence−lumbar lordosis (PI–LL) match (≤ 11°). Male patients and patients with more (> 11°) PI–LL mismatch at baseline had greater operative treatment effects on both the SRS-SS and ODI compared to nonoperative treatment. No other radiographic subgroups were associated with treatment effects. High BMI, lower socioeconomic status, and poor mental health were not related to worse outcomes.
Numerous factors previously related to poor outcomes with surgery, such as low mental health, lower socioeconomic status, and high BMI, were not related to outcomes in ASLS in this exploratory analysis. Those patients with higher PI–LL mismatch did improve more with surgery than those with normal alignment. On average, none of the factors considered were associated with a worse outcome with operative treatment versus nonoperative treatment. These findings may guide future prospective analyses of factors related to outcomes in ASLS care.