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Max Vaynrub, Brandon P. Hirsch, Jared Tishelman, Dennis Vasquez-Montes, Aaron J. Buckland, Thomas J. Errico, and Themistocles S. Protopsaltis

OBJECTIVE

Verifying the adequacy of surgical correction of adult spinal sagittal deformity (SSD) leads to improved postoperative alignment and clinical outcomes. Traditionally, surgeons relied on intraoperative measurements of lumbar lordosis (LL) correction. However, T-1 pelvic angle (TPA) and its component angles more reliably predict postoperative alignment. While TPA is readily measured on standing radiographs, intraoperative radiographs offer poor resolution of the bicoxofemoral axis. A method to recreate this radiographic landmark by extrapolating preoperative measurements has been described. The authors aimed to assess the reliability of measurements of global spinal alignment obtained via geometrical reconstitution of the bicoxofemoral axis on prone intraoperative radiographs.

METHODS

A retrospective review was performed. Twenty sets of preoperative standing full-length and intraoperative prone 36-inch lateral radiographs were analyzed. Pelvic incidence (PI) and sacral to bicoxofemoral axis distance (SBFD) were recorded on preoperative films. A perpendicular line was drawn on the intraoperative radiograph from the midpoint of the sacral endplate. This was used as one limb of the PI, and the second limb was digitally drawn at an angle that reproduced the preoperatively obtained PI, extending for a distance that matched the preoperative SBFD. This final point marked the obscured bicoxofemoral axis. These landmarks were used to measure the L-1, T-9, T-4, and T-1 pelvic angles (LPA, T9PA, T4PA, and TPA, respectively) and LL. Two spine fellows and 2 attending spine surgeons made independent measurements and repeated the process in 1 month. Mixed-model 2-way intraclass correlation coefficient (ICC) and Cronbach’s α values were calculated to assess interobserver, intraobserver, and scale reliability.

RESULTS

Interobserver reliability was excellent for preoperative PI and intraoperative LPA, T9PA, and T4PA (ICC = 0.88, 0.84, 0.84, and 0.93, respectively), good for intraoperative TPA (ICC = 0.68), and fair for preoperative SBFD (ICC = 0.60) and intraoperative LL (ICC = 0.50). Cronbach’s α was ≥ 0.80 for all measurements. Measuring PI on preoperative standing images had excellent intraobserver reliability for all raters (ICC = 0.89, range 0.80–0.93). All raters but one showed excellent reliability for measuring the SBFD. Reliability for measuring prone LL was good for all raters (ICC = 0.71, range 0.64–0.76). The LPA demonstrated good to excellent reliability for each rater (ICC = 0.76, range 0.65–0.81). The thoracic pelvic angles tended to be more reliable at more distal vertebrae (T9PA ICC = 0.71, range 0.49–0.81; T4PA ICC = 0.62, range 0.43–0.83; TPA ICC = 0.56, range 0.31–0.86).

CONCLUSIONS

Intraoperative assessment of global spinal alignment with TPA and component angles is more reliable than intraoperative measurements of LL. Reconstruction of preoperatively measured PI and SBFD on intraoperative radiographs effectively overcomes poor visualization of the bicoxofemoral axis. This method is easily adopted and produces accurate and reliable prone intraoperative measures of global spinal alignment.

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Jared C. Tishelman, Dennis Vasquez-Montes, David S. Jevotovsky, Nicholas Stekas, Michael J. Moses, Raj J. Karia, Thomas Errico, Aaron J. Buckland, and Themistocles S. Protopsaltis

OBJECTIVE

The Patient-Reported Outcomes Measurement Information System (PROMIS) has become increasingly popular due to computer adaptive testing methodology. This study aims to validate the association between PROMIS and legacy outcome metrics and compare PROMIS to legacy metrics in terms of ceiling and floor effects and questionnaire burden.

METHODS

A retrospective review of an outcomes database was performed at a single institution from December 2016 to April 2017. Inclusion criteria were age > 18 years and a chief complaint of back pain or neck pain. The PROMIS computer adaptive testing Pain Interference, Physical Function (PF), and Pain Intensity domains; Oswestry Disability Index (ODI); Neck Disability Index (NDI); and visual analog scale (VAS) back, VAS leg, VAS neck, and VAS arm were completed in random order. PROMIS was compared to legacy metrics in terms of the average number of questions needed to complete each questionnaire and the score distributions in the lower and higher bounds of scores.

RESULTS

A total of 494 patients with back pain and 130 patients with neck pain were included. For back pain, ODI showed a strong correlation with PROMIS-PF (R = −0.749, p < 0.001), Pain Intensity (R = 0.709, p < 0.001), and Pain Interference (R = 0.790, p < 0.001) domains. Additionally, the PROMIS Pain Intensity domain correlated to both VAS back and neck pain (R = 0.642, p < 0.001 for both). PROMIS-PF took significantly fewer questions to complete compared to the ODI (4.123 vs 9.906, p < 0.001). When assessing for instrument sensitivity, neither survey presented a significant ceiling and floor effect in the back pain population (ODI: 0.40% and 2.63%; PROMIS-PF: 0.60% and 1.41%). In the neck pain cohort, NDI showed a strong correlation with PROMIS-PF (R = 0.771, p < 0.001). Additionally, PROMIS Pain Intensity correlated to VAS neck (R = 0.642, p < 0.001). The mean number of questions required to complete the questionnaire was much lower for PROMIS-PF compared to NDI (4.417 vs 10, p < 0.001). There were no significant differences found in terms of ceiling and floor effects for neck complaints (NDI: 2.3% and 6.92%; PROMIS-PF: 0.00% and 5.38%) or back complaints (ODI: 0.40% and 2.63%; PROMIS-PF: 1.41% and 0.60%).

CONCLUSIONS

PROMIS correlates strongly with traditional disability measures in patients with back pain and neck pain. For both back and neck pain, the PROMIS-PF required patients to answer significantly fewer questions to achieve similar granularity. There were no significant differences in ceiling and floor effects for NDI or ODI when compared with the PROMIS-PF instrument.

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Devon J. Ryan, Nicholas D. Stekas, Ethan W. Ayres, Mohamed A. Moawad, Eaman Balouch, Dennis Vasquez-Montes, Charla R. Fischer, Aaron J. Buckland, Thomas J. Errico, and Themistocles S. Protopsaltis

OBJECTIVE

The goal of this study was to reliably predict sagittal and coronal spinal alignment with clinical photographs by using markers placed at easily localized anatomical landmarks.

METHODS

A consecutive series of patients with adult spinal deformity were enrolled from a single center. Full-length standing radiographs were obtained at the baseline visit. Clinical photographs were taken with reflective markers placed overlying C2, S1, the greater trochanter, and each posterior-superior iliac spine. Sagittal radiographic parameters were C2 pelvic angle (CPA), T1 pelvic angle (TPA), and pelvic tilt. Coronal radiographic parameters were pelvic obliquity and T1 coronal tilt. Linear regressions were performed to evaluate the relationship between radiographic parameters and their photographic “equivalents.” The data were reanalyzed after stratifying the cohort into low–body mass index (BMI) (< 30) and high-BMI (≥ 30) groups. Interobserver and intraobserver reliability was assessed for clinical measures via intraclass correlation coefficients (ICCs).

RESULTS

A total of 38 patients were enrolled (mean age 61 years, mean BMI 27.4 kg/m2, 63% female). All regression models were significant, but sagittal parameters were more closely correlated to photographic parameters than coronal measurements. TPA and CPA had the strongest associations with their photographic equivalents (both r2 = 0.59, p < 0.001). Radiographic and clinical parameters tended to be more strongly correlated in the low-BMI group. Clinical measures of TPA and CPA had high intraobserver reliability (all ICC > 0.99, p < 0.001) and interobserver reliability (both ICC > 0.99, p < 0.001).

CONCLUSIONS

The photographic measures of spinal deformity developed in this study were highly correlated with their radiographic counterparts and had high inter- and intraobserver reliability. Clinical photography can not only reduce radiation exposure in patients with adult spinal deformity, but also be used to assess deformity when full-spine radiographs are unavailable.

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Emmanuelle Ferrero, Barthelemy Liabaud, Vincent Challier, Renaud Lafage, Bassel G. Diebo, Shaleen Vira, Shian Liu, Jean Marc Vital, Brice Ilharreborde, Themistocles S. Protopsaltis, Thomas J. Errico, Frank J. Schwab, and Virginie Lafage

OBJECT

Previous forceplate studies analyzing the impact of sagittal-plane spinal deformity on pelvic parameters have demonstrated the compensatory mechanisms of pelvis translation in addition to rotation. However, the mechanisms recruited for this pelvic rotation were not assessed. This study aims to analyze the relationship between spinopelvic and lower-extremity parameters and clarify the role of pelvic translation.

METHODS

This is a retrospective study of patients with spinal deformity and full-body EOS images. Patients with only stenosis or low-back pain were excluded. Patients were grouped according to T-1 spinopelvic inclination (T1SPi): sagittal forward (forward, > 0.5°), neutral (−6.3° to 0.5°), or backward (< −6.3°). Pelvic translation was quantified by pelvic shift (sagittal offset between the posterosuperior corner of the sacrum and anterior cortex of the distal tibia), hip extension was measured using the sacrofemoral angle (SFA; the angle formed by the middle of the sacral endplate and the bicoxofemoral axis and the line between the bicoxofemoral axis and the femoral axis), and chin-brow vertical angle (CBVA). Univariate and multivariate analyses were used to compare the parameters and correlation with the Oswestry Disability Index (ODI).

RESULTS

In total, 336 patients (71% female; mean age 57 years; mean body mass index 27 kg/m2) had mean T1SPi values of −8.8°, −3.5°, and 5.9° in the backward, neutral, and forward groups, respectively. There were significant differences in the lower-extremity and spinopelvic parameters between T1SPi groups. The backward group had a normal lumbar lordosis (LL), negative SVA and pelvic shift, and the largest hip extension. Forward patients had a small LL and an increased SVA, with a large pelvic shift creating compensatory knee flexion. Significant correlations existed between lower-limb parameter and pelvic shift, pelvic tilt, T-1 pelvic angle, T1SPi, and sagittal vertical axis (0.3 < r < 0.8; p < 0.001). ODI was significantly correlated with knee flexion and pelvic shift.

CONCLUSIONS

This is the first study to describe full-body alignment in a large population of patients with spinal pathologies. Furthermore, patients categorized based on T1SPi were found to have significant differences in the pelvic shift and lower-limb compensatory mechanisms. Correlations between lower-limb angles, pelvic shift, and ODI were identified. These differences in compensatory mechanisms should be considered when evaluating and planning surgical intervention for adult patients with spinal deformity.

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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 S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames, and the International Spine Study Group

OBJECTIVE

Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications.

METHODS

As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years.

RESULTS

Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury).

CONCLUSIONS

This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.