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Hiroyuki Yoshihara, Peter G. Passias and Thomas J. Errico

Object

Lateral mass screws (LMS) have been used extensively with a low complication rate in the subaxial spine. Recently, cervical pedicle screws (CPS) have been introduced, and are thought to provide more optimal stabilization of the subaxial spine in certain circumstances. However, because of the concern for neurovascular injury, the routine use of CPS in this location remains controversial. Despite this controversy, however, there are no articles directly comparing screw-related complications of each procedure in the subaxial cervical spine. The purpose of this study was to evaluate screw-related complications of LMS and CPS in the subaxial cervical spine.

Methods

A PubMed/MEDLINE and Cochrane Collaboration Library search was executed, using the key words “lateral mass screw” and “cervical pedicle screw.” Clinical studies evaluating surgical procedures of the subaxial cervical spine in which either LMS or CPS were used and complications were reported were included. Studies in which the number of patients who had subaxial cervical spine surgery and the number of screws placed from C-3 to C-7 could not be specified were excluded. Data on screw-related complications of each study were recorded and compared.

Results

Ten studies of LMS and 12 studies of CPS were included in the analysis. Vertebral artery injuries were slightly but statistically significantly higher with the use of CPS relative to LMS in the subaxial cervical spine. Although the use of LMS was associated with a higher rate of screw loosening, screw pullout, loss of reduction, pseudarthrosis, and revision surgery, this finding was not statistically significant.

Conclusions

Based on the available literature, it appears that perioperative neurological and late biomechanical complication rates, including pseudarthrosis, are similarly low for both LMS and CPS techniques. In contrast, vertebral artery injuries, although statistically significantly more common when using CPS, are extremely rare with both techniques, which may justify their nonroutine use in select cases. Given the paucity of well-designed studies available, this recommendation may be a reflection of deficiencies in the available studies. Surgeons using either technique should have intimate knowledge of cervical anatomy and an adequate preoperative evaluation for each patient, with the final selection based on individual case requirements and anatomical limitations.

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Reginald Davis, Joshua D. Auerbach, Hyun Bae and Thomas J. Errico

Object

Posterolateral spinal fusion (PSF) has long been the standard of care for degenerative spondylolisthesis, but less invasive, motion-preserving alternatives have been proposed to reduce the complications associated with fusion while still providing neural decompression and stabilization. The object of the current study is to evaluate the safety and efficacy of coflex Interlaminar Stabilization compared with PSF to treat low-grade spondylolisthesis with spinal stenosis.

Methods

This is a prospective, randomized, multicenter FDA investigational device exemption (IDE) trial comparing coflex Interlaminar Stabilization with laminectomy and PSF. A total of 322 patients from 21 sites in the US were enrolled between 2006 and 2008 for the IDE trial. The current study evaluated only the subset of patients from this overall cohort with Grade 1 spondylolisthesis (99 in the coflex group and 51 in the fusion group). Subjects were randomized 2:1 to receive decompression and coflex interlaminar stabilization or decompression and posterolateral spinal fusion with spinal instrumentation. Data collected included perioperative outcomes, Oswestry Disability Index (ODI), back and worse leg visual analog scale (VAS) scores, 12-Item Short Form Health Survey, Zurich Claudication Questionnaire (ZCQ), and radiographic outcomes at a minimum of 2 years. The FDA criteria for overall device success required the following to be met: 15-point reduction in ODI, no reoperations, no major device-related complications, and no postoperative epidural injections.

Results

At a minimum of 2 years, patient follow-up was 94.9% and 94.1% in the coflex and fusion control groups, respectively. There were no group differences at baseline for any demographic, clinical, or radiographic parameter. The average age was 63 years in the coflex cohort and 65 years in the fusion cohort. Coflex subjects experienced significantly shorter operative times (p < 0.0001), less estimated blood loss (p < 0.0001), and shorter length of stay (p < 0.0001) than fusion controls. Both groups experienced significant improvements from baseline at 2 years in ODI, VAS back, VAS leg, and ZCQ, with no significant group differences, with the exception of significantly greater ZCQ satisfaction with coflex at 2 years. FDA overall success was achieved in 62.8% of coflex subjects (59 of 94) and 62.5% of fusion controls (30 of 48) (p = 1.000). The reoperation rate was higher in the coflex cohort (14 [14.1%] of 99) compared with fusion (3 [5.9%] of 51, p = 0.18), although this difference was not statistically significant. Fusion was associated with significantly greater angulation and translation at the superior and inferior adjacent levels compared with baseline, while coflex showed no significant radiographic changes at the operative or index levels.

Conclusions

Low-grade spondylolisthesis was effectively stabilized by coflex and led to similar clinical outcomes, with improved perioperative outcomes, compared with PSF at 2 years. Reoperation rates, however, were higher in the coflex cohort. Patients in the fusion cohort experienced significantly increased superior and inferior level angulation and translation, while those in the coflex cohort experienced no significant adjacent or index level radiographic changes from baseline. Coflex Interlaminar Stabilization is a less invasive, safe, and equally efficacious clinical solution to PSF to treat low-grade spondylolisthesis, and it appears to reduce stresses at the adjacent levels. Clinical trial registration no.: NCT00534235 (ClinicalTrials.gov).

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John K. Houten, Nicholas H. Post, Joseph W. Dryer and Thomas J. Errico

Object

Although transforaminal lumbar interbody fusion (TLIF) is an increasingly popular surgical technique, there are a limited number of studies in which investigators have stratified outcome data with respect to surgical indications or documented radiographically proven and clinical results with respect to disc space height (DSH). The authors conducted a study to evaluate the long-term outcomes after TLIF with respect to surgical indication and radiographic/neuroimaging results.

Methods

Thirty-three consecutive TLIF-treated patients underwent follow-up investigation for a mean of 37 months. Isthmic spondylolysis was present in eight patients, recurrent disc herniation in 14, and degenerative disc disease (DDD) in 11. The operative technique involved the placement of interbody structural allograft, pedicle screw instrumentation, and morcellized autograft in the anterior interbody space and the contralateral intertransverse gutter. Surgery was performed at L4–5 in 16 patients, L5–S1 in 14, L3–4 in two, and both L4–5 and L5–S1 in one patient.

Preoperative symptoms were back pain (in 91% of cases), leg pain (in 94%), sensory loss (in 67%), and motor deficits (in 30%). Postoperatively, back pain was improved in 67% of the patients, unchanged in 27%, and worsened in 7%. Leg pain improved in 80% of patients, was unchanged in 10%, and worsened in 10%. Outcome, as measured using the Prolo Functional and Economic Scales, improved from a score of 4.9 to 7. In patients with spondylolysis and recurrent disc herniation outcomes were better than in those with DDD only. There was no correlation of outcome with symptom duration, patient age, or level of surgery. In an independent review of pre- and late postoperative radiographs no significant differences in lordosis angles, Cobb angles, or DSHs were found. Fusion occurred in all cases.

Conclusions

The TLIF procedure was associated with good clinical outcomes and a high fusion rate but no change in the DSH. Patients who present with spondylolysis and recurrent herniations experience better outcome than those with degenerative disease alone.

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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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Michael G. Fehlings, Paul R. Cooper and Thomas J. Errico

✓ Although posterior plates are increasingly used to manage cervical spinal instability, long-term follow-up evaluation of patients with a critical analysis of efficacy and complications has not been reported. The authors have retrospectively analyzed the outcome in 44 consecutive patients (37 males and seven females, age range 16 to 80 years) treated with posterior cervical plates. The indications for instrumentation were instability due to trauma in 42 cases, tumor in one, and infection in one. In four patients the follow-up period was limited to 3, 5, 11, and 16 months. Two patients died of chronic medical problems 4 and 9 months after treatment. The remaining 38 patients were followed from 2 to 6 years (mean 46 months). One motion segment was stabilized in 23 patients using two-hole plates; two motion segments were stabilized in the other 21 patients using three-hole plates. In the majority of patients (37 cases), supplemental bone grafting was not used. Patients were immobilized postoperatively in a Philadelphia collar. Solid arthrodesis was achieved in 39 (93%) of 42 patients. Three patients required revision of the cervical plating: in one patient with a C-5 burst fracture, two-hole plates were applied at C5–6 and progressive kyphosis mandated anterior fusion; the second patient required posterior wiring due to screw pull-out resulting from a technical error in screw insertion; the third patient, who refused to wear an orthosis postoperatively, also developed screw pull-out. In two patients who went on to spinal fusion, there was an increase in sagittal kyphosis (6° and 8°) without clinical sequelae. Screw loosening was noted in five patients, involving eight (3.8%) of the 210 lateral mass screws; this complication resulted in instrumentation failure or increased kyphosis in three cases. There were two superficial infections.

This analysis indicates that posterior cervical plating is highly effective; at long-term follow-up review the cervical spine was successfully stabilized in 93% of cases. Plate failure was related to faulty screw placement, failure to include sufficient motion segments, and noncompliance with postoperative orthoses. Halo vest immobilization was unnecessary and supplemental bone grafting was generally not required for recent trauma.

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M. Burhan Janjua, Jared C. Tishelman, Dennis Vasquez-Montes, Max Vaynrub, Thomas J. Errico, Aaron J. Buckland and Themistocles Protopsaltis

Sitting radiographs are a valuable tool to consider the thoracic compensatory mechanism in patients who are candidates for thoracolumbar correction surgery.

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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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Ian McCarthy, Michael O'Brien, Christopher Ames, Chessie Robinson, Thomas Errico, David W. Polly Jr. and Richard Hostin

Object

Incremental cost-effectiveness analysis is critical to the efficient allocation of health care resources; however, the incremental cost-effectiveness ratio (ICER) of surgical versus nonsurgical treatment for adult spinal deformity (ASD) has eluded the literature, due in part to inherent empirical difficulties when comparing surgical and nonsurgical patients. Using observed preoperative health-related quality of life (HRQOL) for patients who later underwent surgery, this study builds a statistical model to predict hypothetical quality-adjusted life years (QALYs) without surgical treatment. The analysis compares predicted QALYs to observed postoperative QALYs and forms the resulting ICER.

Methods

This was a single-center (Baylor Scoliosis Center) retrospective analysis of consecutive patients undergoing primary surgery for ASD. Total costs (expressed in 2010 dollars) incurred by the hospital for each episode of surgical care were collected from administrative data and QALYs were calculated from the 6-dimensional Short-Form Health Survey, each discounted at 3.5% per year. Regression analysis was used to predict hypothetical QALYs without surgery based on preoperative longitudinal data for 124 crossover surgical patients with similar diagnoses, baseline HRQOL, age, and sex compared with the surgical cohort. Results were projected through 10-year follow-up, and the cost-effectiveness acceptability curve (CEAC) was estimated using nonparametric bootstrap methods.

Results

Three-year follow-up was available for 120 (66%) of 181 eligible patients, who were predominantly female (89%) with average age of 50. With discounting, total costs averaged $125,407, including readmissions, with average QALYs of 1.93 at 3-year follow-up. Average QALYs without surgery were predicted to be 1.6 after 3 years. At 3- and 5-year follow-up, the ICER was $375,000 and $198,000, respectively. Projecting through 10-year follow-up, the ICER was $80,000. The 10-year CEAC revealed a 40% probability that the ICER was $80,000 or less, a 90% probability that the ICER was $90,000 or less, and a 100% probability that the ICER was less than $100,000.

Conclusions

Based on the WHO's suggested upper threshold for cost-effectiveness (3 times per capita GDP, or $140,000 in 2010 dollars), the analysis reveals that surgical treatment for ASD is cost-effective after a 10-year period based on predicted deterioration in HRQOL without surgery. The ICER well exceeds the WHO threshold at earlier follow-up intervals, highlighting the importance of the durability of surgical treatment in assessing the value of surgical intervention. Due to the study's methodology, the results are dependent on the predicted deterioration in HRQOL without surgery. As such, the results may not extend to patients whose HRQOL would remain steady without surgery. Future research should therefore pursue a direct comparison of QALYs for surgical and nonsurgical patients to better understand the cost-effectiveness of surgery for the average ASD patient.

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Bassel G. Diebo, Jonathan H. Oren, Vincent Challier, Renaud Lafage, Emmanuelle Ferrero, Shian Liu, Shaleen Vira, Matthew Adam Spiegel, Bradley Yates Harris, Barthelemy Liabaud, Jensen K. Henry, Thomas J. Errico, Frank J. Schwab and Virginie Lafage

OBJECTIVE

Sagittal malalignment requires higher energy expenditure to maintain an erect posture. Because the clinical impact of sagittal alignment is affected by both the severity of the deformity and recruitment of compensatory mechanisms, it is important to investigate new parameters that reflect both disability level and compensatory mechanisms for all patients. This study investigated the clinical relevance of the global sagittal axis (GSA), a novel measure to evaluate the standing axis of the human body.

METHODS

This is a retrospective review of patients who underwent full-body radiographs and completed health-related quality of life (HRQOL) questionnaires: Oswestry Disability Index (ODI), Scoliosis Research Society–22, EuroQol-5D (EQ-5D), and the visual analog scale for back and leg pain. The GSA was defined as the angle formed by a line from the midpoint of the femoral condyles to the center of C-7, and a line from the midpoint between the femoral condyles to the posterior superior corner of the S-1 sacral endplate. After evaluating the correlation of GSA/HRQOL with sagittal parameters, linear regression models were generated to investigate how ODI and GSA related to radiographic parameters (T-1 pelvic angle, pelvic retroversion, knee flexion, and pelvic posterior translation).

RESULTS

One hundred forty-three patients (mean age 44 years) were included. The GSA correlated significantly with all HRQOL (up to r = 0.6 with EQ-5D) and radiographic parameters (up to r = 0.962 with sagittal vertical axis). Regression between ODI and sagittal radiographic parameters identified the GSA as an independent predictor (r = 0.517, r2 = 0.267; p < 0.001). Analysis of standardized coefficients revealed that when controlling for deformity, the GSA increased with a concurrent decrease in pelvic retroversion (−0.837) and increases in knee flexion (+0.287) and pelvic posterior translation (+0.193).

CONCLUSIONS

The GSA is a simple, novel measure to assess the standing axis of the human body in the sagittal plane. The GSA correlated highly with spinopelvic and lower-extremities sagittal parameters and exhibited remarkable correlations with HRQOL, which exceeded other commonly used parameters.

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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.