Mundis, Gregory M.

Background: The purpose of this study was to determine whether placement of triangular titanium implants (TTI) suprajacent to S2-alar-iliac (S2AI) pelvic fixation screws during multilevel spinal fusion surgery for adult spine deformity reduces pelvic fixation failures. Methods: This prospective, multicenter, international, partially blinded randomized clinical trial included 222 patients scheduled for multilevel spinal fusion surgery with S2AI-based pelvic fixation. In the S2AI+TTI group, the mean age was 64.9 years, 54.1% were female, 3.7% were Hispanic, 5.5% were African American, and 1.8% were Asian. In the S2AI-alone group, the mean age was 64.8 years, 58.4% were female, 3.5% were Hispanic, 7.1% were African American, and 0.9% were Asian. Subjects were randomized to pelvic fixation using S2AI screws alone versus S2AI+TTI. Scheduled follow-up included a 24-month full-spine radiograph and a high-resolution computed tomography (CT) scan, which was independently interpreted. Results: The primary composite radiographic end point (S2AI screw breakage, lucency, or pullout, or posterior spinal rod breakage distal to S1) occurred less frequently in the S2AI+TTI group than in the S2AI-alone group (11.0% versus 20.4%, p = 0.0415). Except for rod-screw dissociation and rod fracture distal to S1, all components of the primary composite end point occurred less frequently in the S2AI+TTI group. TTI placement did not affect sagittal or coronal spinal alignment parameters. The rate of rod fracture throughout the spinal construct was slightly higher in the S2AI+TTI group (9.2% versus 5.3%) but the difference was not significant (p = 0.197). Conclusions: Placement of TTI suprajacent to S2AI screws reduced the rate of pelvic fixation failure in patients undergoing multilevel spinal fusion with pelvic fixation. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

OBJECTIVE The aim of this study was to determine predictors of the minimum clinically important difference (MCID) in the Neck Disability Index (NDI) following cervical spinal deformity surgery. METHODS A retrospective review was performed of a prospective, multicenter adult cervical spinal deformity database. All patients had baseline and 1-year NDI scores. Patients met MCID with an improvement of NDI by 7 points between baseline and 1 year, as previously established. Baseline demographics, comorbidities, and both baseline and 1-year spinopelvic parameters were evaluated for statistical significance in a univariate logistic regression analysis. Significant variables, in addition to baseline NDI, were analyzed in a multivariable logistic regression model by backward selection with Akaike information criterion minimization. RESULTS A total of 122 patients were included with a median age of 62 (IQR 56, 69) years; 62% of patients were female. Of the 122 patients, 72 (59%) achieved NDI MCID at 1 year. Predictors of achieving MCID on univariate analysis included a lower Charlson Comorbidity Index (CCI) total score (OR 0.70, p = 0.03), depression as a comorbidity (OR 2.9, p = 0.02), lower C2 tilt at the 1-year follow-up (OR 0.92, p = 0.02), and a greater difference between 1-year postoperative C2–7 sagittal vertical axis (SVA) and preoperative C2–7 SVA (OR 0.98, p = 0.0495). On multivariable logistic regression analysis, predictors of achieving MCID included a lower CCI (OR 0.62, p = 0.03), depression as a comorbidity (OR 3.1, p = 0.059), a greater change in C2–7 SVA at the 1-year follow-up compared with baseline (OR 0.97, p = 0.055), and baseline NDI (OR 1.02, p = 0.24) with an area under the curve of 0.74. CONCLUSIONS The best-fit multivariable model included higher baseline NDI, a greater change in C2–7 SVA, patient-reported baseline depression, and lower CCI as important factors in predicting NDI MCID.

OBJECTIVE Correction of mild flexible cervical deformity (CD) via the posterior approach has been described with and without the use of posterior osteotomies (POs), despite a lack of clarity regarding their necessity or risks. The purpose of this study was to determine whether the use of POs when correcting mild flexible CD leads to improved clinical or radiographic outcomes, as well as defining the relative risks in utilizing them. METHODS A prospective multicenter registry of operative CD patients was analyzed. Inclusion criteria were cervical kyphosis > 10°, cervical scoliosis > 10°, cervical sagittal vertical axis (cSVA) > 4 cm, or chin-brow vertical angle > 25°. Mild deformity was defined by a cSVA of 3–5 cm and/or kyphosis < 15°. Flexibility was defined by a C2–7 angular change > 5° on preoperative flexion/extension radiographs. Patients who received a posterior column osteotomy (PCO) (Ames grades 1 and 2) were compared with patients who did not undergo a PCO (noPCO) as well as those who underwent a three-column osteotomy (3CO) (Ames grades 3–6). RESULTS Ninety-five patients (33 PCO, 49 noPCO, 13 3CO) met the inclusion criteria. Both the number of levels fused (9.2 vs 7.7, p = 0.001) and the estimated blood loss (EBL) (1027 vs 486 mL, p = 0.012) were higher in the PCO cohort. Patients in the noPCO group were more likely to have a cervical apex of kyphosis (71.1%, p = 0.046), while those undergoing 3COs were more likely to have a thoracic apex (58.3%, p = 0.005). Preoperative cSVA (PCO vs noPCO: 45.4 vs 37.9 cm, p = 0.084), T1 slope (32.5° vs 29.6°, p = 0.376), C2–7 lordosis (−8.9° vs −9.2°, p = 0.942), and modified Japanese Orthopaedic Association (mJOA) score (13.4 vs 13.5, p = 0.854) were similar; however, both Neck Disability Index (NDI) (55.6 vs 42, p = 0.002) and numeric rating scale (NRS) neck (7.2 vs 5.8, p = 0.028) scores were higher in the PCO group before surgery. When adjusting for the use of an anterior approach, there was no significant difference in 1-year postoperative cSVA (35.7 and 35.6 cm, respectively; p = 0.969), C2–7 lordosis (13.7° and 10.1°, respectively; p = 0.393), and patient-reported outcome measures (NRS, NDI, and mJOA) between the PCO and noPCO groups. Two-year radiographic outcomes were largely similar, except for C2 slope, which was higher in the PCO group (29.1° vs 18°, p = 0.026). The overall complication rates progressively increased with more complex osteotomy use (noPCO 68.8% vs PCO 71.9% vs 3CO 75%) but did not reach significance (p = 0.063). CONCLUSIONS The use of POs for mild flexible adult CD may not be necessary to achieve desirable radiographic correction. They are associated with greater EBL and fusion burden. Further studies are needed to fully delineate the risks of adverse events for various types of osteotomies.

Study Design Cadaveric study. Objectives The purpose of this study was to compare a novel, integrated 3D navigational system (NAV) and conventional fluoroscopy in the accuracy, efficiency, and radiation exposure of thoracolumbar percutaneous pedicle screw (PPS) placement. Methods Twelve skeletally mature cadaveric specimens were obtained for twelve individual surgeons. Each participant placed bilateral PS at 11 segments, from T8 to S1. Prior to insertion, surgeons were randomized to the sequence of techniques and the side (left or right). Following placement, a CT scan of the spine was obtained for each cadaver, and an independent reviewer assessed the accuracy of screw placement using the Gertzbein grading system. Outcome metrics of interest included a comparison of breach incidence/severity, screw placement time, total procedure time, and radiation exposure between the techniques. Bivariate statistics were employed to compare outcomes at each level. Results A total of 262 screws (131 using each technique) were placed. The incidence of cortical breaches was significantly lower with NAV compared to FG (9% vs 18%; P = .048). Of breaches with NAV, 25% were graded as moderate or severe compared to 39% in the FG subgroup ( P = .034). Median time for screw placement was significantly lower with NAV (2.7 vs 4.1 min/screw; P = .012), exclusive of registration time. Cumulative radiation exposure to the surgeon was significantly lower for NAV-guided placement (9.4 vs 134 μGy, P = .02). Conclusions The use of NAV significantly decreased the incidence of cortical breaches, the severity of screw breeches, screw placement time, and radiation exposure to the surgeon when compared to traditional FG.

OBJECTIVE Intraoperative neuromonitoring (IONM) has become commonplace in assessing neurological integrity during lateral approaches to lumbar interbody fusion surgeries. Neuromonitoring is designed to aid surgeons in identifying the potential for intraoperative nerve injury and reducing associated postoperative complications. However, standardized protocols for neuromonitoring have not been provided, and outcomes are not well described. The purpose of this study was to provide a standardized protocol for IONM, and to describe clinical outcomes in a cohort of individuals who underwent lateral lumbar interbody fusion (LLIF) surgery. METHODS A retrospective review of 169 consecutive patients who underwent LLIF surgery at a single institution from October 2014 to October 2016 was performed. Patient characteristics, intraoperative details, clinical outcomes, and postoperative deficits (PODs) were compared between patients who did and did not trigger IONM alerts, and between patients who did and did not demonstrate a POD. A protocol for IONM decision-making was generated based on these observations. RESULTS Most patients (91.7%) underwent surgery for a degenerative spine condition. Twenty-three patients (13.6%) triggered neuromonitoring alerts, and 16 patients (9.5%) demonstrated a POD. Leg pain, back pain, and disability improved significantly (p < 0.045), and 2 patients had both motor and sensory deficits at the 12-week postoperative time point. Patients with a POD demonstrated greater operating room time (p = 0.034) and a greater number of interbody fusion levels (p = 0.015) but were less likely to have triggered a neuromonitoring alert (p = 0.04). There was no association between retractor time and POD (p = 0.98). When an IONM protocol was followed, individuals who experienced a POD were less likely to trigger an alert than those who did not experience a POD (p = 0.04). CONCLUSIONS This study provides a protocol algorithm for IONM alert responses in patients undergoing LLIF surgery. PODs are most associated with multilevel fusion, and patients with alerts had a low rate of persistent deficit. Future research is needed to validate these findings using a more rigorous comparative study design.

Background and Objectives: Mitigating post-operative complications is a key metric of success following interbody fusion. LLIF is associated with a unique complication profile when compared to other approaches, and while numerous studies have attempted to report the incidence of post-operative complications, there is currently no consensus regarding their definitions or reporting structure. The aim of this study was to standardize the classification of complications specific to lateral lumbar interbody fusion (LLIF). Materials and Methods: A search algorithm was employed to identify all the articles that described complications following LLIF. A modified Delphi technique was then used to perform three rounds of consensus among twenty-six anonymized experts across seven countries. Published complications were classified as major, minor, or non-complications using a 60% agreement threshold for consensus. Results: A total of 23 articles were extracted, describing 52 individual complications associated with LLIF. In Round 1, forty-one of the fifty-two events were identified as a complication, while seven were considered to be approach-related occurrences. In Round 2, 36 of the 41 events with complication consensus were classified as major or minor. In Round 3, forty-nine of the fifty-two events were ultimately classified into major or minor complications with consensus, while three events remained without agreement. Vascular injuries, long-term neurologic deficits, and return to the operating room for various etiologies were identified as important consensus complications following LLIF. Non-union did not reach significance and was not classified as a complication. Conclusions: These data provide the first, systematic classification scheme of complications following LLIF. These findings may improve the consistency in the future reporting and analysis of surgical outcomes following LLIF.