Citations

Study Design: Prospective randomized Food and Drug Administration investigational device exemption clinical trial. Objective: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device. Summary of Background Data: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty. Methods: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient. Results: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points (P>0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening. Conclusions: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

OBJECTIVE The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4–5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Study Design. In vitro study. Objective. The purpose of the present study was to utilize an idealized cervical spine model to determine whether the parallax effect or changes in the position of the spine relative to the x-ray generator influence intervertebral motion parameters on dynamic cervical spine radiographs. Summary of Background Data. The utility of flexion-extension radiographs in clinical practice remains in question due to poor reliability of the parameters utilized to measure motion. Materials and Methods. A cervical spine model with tantalum beads inserted into the tip of each spinous process was utilized to measure interspinous process distance (IPD) on plain radiographs. The model was then manipulated to alter the generator angle and generator distance, and the IPD was measured. The impact of individual and combined changes in these parameters on IPD was assessed. Multivariate analysis was performed to identify independent drivers of variability in IPD measurements. Results. Isolated changes in the generator distance and generator angle and combined changes in these parameters led to significant changes in the measured IPD at each intervertebral level in neutral, flexion, and extension, which, in many instances, exceeded an absolute change of >1 mm or >2 mm. Multivariate analysis revealed that generator distance and generator angle are both independent factors impacting IPD measurements that have an additive effect. Conclusions. In an idealized cervical spine model, small clinically feasible changes in spine position relative to the x-ray generator produced substantial variability in IPD measurements, with absolute changes that often exceeded established cutoffs for determining the presence of pathologic motion across a fused segment. This study further reinforces that motion assessment on dynamic radiographs is not a reliable method for determining the presence of an arthrodesis unless these sources of variability can be consistently eliminated. Level of Evidence. 3

Study Design: This was a retrospective cohort study. Objective: The present study is the first to investigate whether cervical paraspinal sarcopenia is associated with cervicothoracic sagittal alignment parameters after posterior cervical fusion (PCF). Summary of Background Data: Few studies have investigated the association between sarcopenia and postoperative outcomes after cervical spine surgery. Methods: We retrospectively reviewed patients undergoing PCF from C2–T2 at a single institution between the years 2017–2020. Two independent reviewers utilized axial cuts of T2-weighted magnetic resonance imaging sequences to perform Goutallier classification of the bilateral semispinalis cervicis (SSC) muscles. Cervical sagittal alignment parameters were compared between subgroups based upon severity of SSC sarcopenia. Results: We identified 61 patients for inclusion in this study, including 19 patients with mild SSC sarcopenia and 42 patients with moderate or severe SSC sarcopenia. The moderate-severe sarcopenia subgroup demonstrated a significantly larger change in C2–C7 sagittal vertical axis (+6.8 mm) from the 3-month to 1-year postoperative follow-up in comparison to the mild sarcopenia subgroup (−2.0 mm; P=0.02). The subgroup of patients with moderate-severe sarcopenia also demonstrated an increase in T1–T4 kyphosis (10.9–14.2, P=0.007), T1 slope (28.2–32.4, P=0.003), and C2 slope (24.1–27.3, P=0.05) from 3-month to 1-year postoperatively and a significant decrease in C1-occiput distance (6.3–4.1, P=0.002) during this same interval. Conclusions: In a uniform cohort of patients undergoing PCF from C2–T2, SSC sarcopenia was associated with worsening cervicothoracic alignment from 3-month to 1-year postoperatively.

Study Design. Retrospective cohort study. Objective. The present study is the first to assess the impact of paraspinal sarcopenia on patient-reported outcome measures (PROMs) following posterior cervical decompression and fusion (PCDF). Summary of Background Data. While the impact of sarcopenia on PROMs following lumbar spine surgery is well-established, the impact of sarcopenia on PROMs following PCDF has not been investigated. Materials and Methods. We performed a retrospective review of patients undergoing PCDF from C2 to T2 at a single institution between the years 2017 and 2020. Two independent reviewers who were blinded to the clinical outcome scores utilized axial cuts of T2-weighted magnetic resonance imaging sequences to assess fatty infiltration of the bilateral multifidus muscles at the C5–C6 level and classify patients according to the Fuchs Modification of the Goutalier grading system. PROMs were then compared between subgroups. Results. We identified 99 patients for inclusion in this study, including 28 patients with mild sarcopenia, 45 patients with moderate sarcopenia, and 26 patients with severe sarcopenia. There was no difference in any preoperative PROM between the subgroups. Mean postoperative Neck Disability Index scores were lower in the mild and moderate sarcopenia subgroups (12.8 and 13.4, respectively) than in the severe sarcopenia subgroup (21.0, P <0.001). A higher percentage of patients with severe multifidus sarcopenia reported postoperative worsening of their Neck Disability Index (10 patients, 38.5%; P =0.003), Visual Analog Scale Neck scores (7 patients, 26.9%; P =0.02), Patient-Reported Outcome Measurement Information System Physical Component Scores (10 patients, 38.5%; P =0.02), and Patient-Reported Outcome Measurement Information System Mental Component Scores (14 patients, 53.8%; P =0.02). Conclusion. Patients with more severe paraspinal sarcopenia demonstrate less improvement in neck disability and physical function postoperatively and are substantially more likely to report worsening PROMs postoperatively. Level of Evidence. 3.

OBJECTIVE The aim of this study was to analyze risk factors and avoidance techniques for proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) in the upper thoracic spine with an emphasis on bone mineral density (BMD) as estimated by Hounsfield units (HU). METHODS A retrospective chart review identified patients at least 50 years of age who underwent instrumented fusion extending from the pelvis to an upper instrumented vertebra (UIV) between T1 and T6 and had a preoperative CT, pre- and postoperative radiographs, and a minimum follow-up of 12 months. HU were measured in the UIV, the vertebral body cephalad to the UIV (UIV+1), and the L3 and L4 vertebral bodies. Numerous perioperative variables were collected, including basic demographics, smoking and steroid use, preoperative osteoporosis treatment, multiple frailty indices, use of a proximal junctional tether, UIV soft landing, preoperative dual-energy x-ray absorptiometry, spinopelvic parameters, UIV screw tip distance to the superior endplate, UIV pedicle screw/pedicle diameter ratio, lumbar lordosis distribution, and postoperative spinopelvic parameters compared with age-adjusted normal values. RESULTS Eighty-one patients were included in the study (21 men and 60 women) with a mean (SD) age of 66 years (6.9 years), BMI of 29 (5.5), and follow-up of 38 months (25 months). Spinal fusion constructs at the time of surgery extended from the pelvis to a UIV of T1 (5%), T2 (15%), T3 (25%), T4 (33%), T5 (21%), and T6 (1%). Twenty-seven patients (33%) developed PJK and/or PJF; 21 (26%) had PJK and 15 (19%) had PJF. Variables associated with PJK/PJF with p < 0.05 were included in the multivariable analysis, including HU at the UIV/UIV+1, HU at L3/L4, DXA femoral neck T-score, UIV screw tip distance to the superior endplate, UIV pedicle screw/pedicle diameter ratio, and postoperative lumbar lordosis distribution. Multivariable analysis (area under the curve = 0.77) demonstrated HU at the UIV/UIV+1 to be the only independent predictor of PJK and PJF with an OR of 0.96 (p = 0.005). Patients with < 147 HU (n = 27), 147–195 HU (n = 27), and > 195 HU (n = 27) at the UIV/UIV+1 had PJK/PJF rates of 59%, 33%, and 7%, respectively. CONCLUSIONS In patients with upper thoracic–to-pelvis spinal reconstruction, lower HU at the UIV and UIV+1 were independently associated with PJK and PJF, with an optimal cutoff of 159 HU that maximizes sensitivity and specificity.

Study Design Systematic Review and Meta-analysis Objective The purpose of this study is to synthesize recommendations for perioperative medical management of RA patients and quantify outcomes after spine surgery when compared to patients without RA. Methods A search of available literature on patients with RA and spine surgery was performed. Studies were included if they provided a direct comparison of outcomes between patients undergoing spine surgery with or without RA diagnosis. Meta-analysis was performed on operative time, estimated blood loss, hospital length of stay, overall complications, implant-related complications, reoperation, infection, pseudarthrosis, and adjacent segment disease. Results Included in the analysis were 9 studies with 703 patients with RA undergoing spine surgery and 2569 patients without RA. In RA patients compared to non-RA patients undergoing spine surgery, the relative risk of infection was 2.29 times higher (P = .036), overall complications 1.61 times higher (P < .0001), implant-related complications 3.93 times higher (P = .009), and risk of reoperation 2.45 times higher (P < .0001). Hospital length of stay was 4.6 days longer in RA patients (P < .0001). Conclusions Treatment of spinal pathology in patients with RA carries an increased risk of infection and implant-related complications. Spine-specific guidelines for perioperative management of antirheumatic medication deserve further exploration. All RA patients should be perioperatively co-managed by a rheumatologist. This review helps identify risk profiles in RA specific to spine surgery and may guide future studies seeking to medically optimize RA patients perioperatively.

Study Design: This was a multicenter retrospective cohort study. Objective: The purpose of this study was to compare the surgical and radiographic outcomes of patients undergoing posterior cervical fusion (PCF) with constructs extending from C2 to T2 to patients with constructs extending from C3 to T1. Summary of Background Data: Limited evidence exists regarding the appropriate level of proximal and distal extension of PCF constructs. Methods: A multicenter retrospective cohort study of patients who underwent PCF between 2012 and 2020 was performed. Surgical and radiographic outcomes were compared between those who had C3–T1 or C2–T2 constructs. Results: A total of 155 patients were included in the study (C2–T2: 106 patients, C3–T1: 49 patients). There were no significant differences in demographics or preoperative symptoms between cohorts. Fusion rates were significantly higher in the C2–T2 (93%) than the C3–T1 (80%, P=0.040) cohort. When comparing the C2–T2 to the C3–T1 cohort, the C3–T1 cohort had a significantly greater rate of proximal junctional failure (2% vs. 10%, P=0.006), distal junctional failure (1% vs. 20%, P<0.001) and distal screw loosening (4% vs. 15%, P=0.02). Although ∆C2–C7 sagittal vertical axis increased significantly in both cohorts (C2–T2: 6.2 mm, P=0.04; C3–T1: 8.4 mm, P<0.001), correction did not significantly differ between groups (P=0.32). The C3–T1 cohort had a significantly greater increase in ∆C2 slope (8.0 vs. 3.1 degrees, P=0.03) and ∆C0–C2 Cobb angle (6.4 vs. 1.2 degrees, P=0.04). Conclusion: In patients undergoing PCF, a C2–T2 construct demonstrated lower rates of pseudarthrosis, distal junctional failure, proximal junctional failure, and compensatory upper cervical hyperextension compared with a C3–T1 construct.

Study Design Retrospective cohort study Objective Substantial variability in both the measurement and classification of subsidence limits the strength of conclusions that can be drawn from previous studies. The purpose of this study was to precisely characterize patterns of cervical cage subsidence utilizing computed tomography (CT) scans, determine risk factors for cervical cage subsidence, and investigate the impact of subsidence on pseudarthrosis rates. Methods We performed a retrospective review of patients who underwent one- to three-levels of anterior cervical discectomy and fusion (ACDF) utilizing titanium interbodies with anterior plating between the years 2018 and 2020. Subsidence measurements were performed by two independent reviewers on CT scans obtained 6 months postoperatively. Subsidence was then classified as mild if subsidence into the inferior and superior endplate were both ≤2 mm, moderate if the worst subsidence into the inferior or superior endplate was between 2 to 4 mm, or severe if the worst subsidence into the inferior or superior endplate was ≥4 mm. Results A total of 51 patients (100 levels) were included in this study. A total of 48 levels demonstrated mild subsidence (≤2 mm), 38 demonstrated moderate subsidence (2-4 mm), and 14 demonstrated severe subsidence (≥4 mm). Risk factors for severe subsidence included male gender, multilevel constructs, greater mean vertebral height loss, increased cage height, lower Taillard index, and lower screw tip to vertebral body height ratio. Severe subsidence was not associated with an increased rate of pseudarthrosis. Conclusion Following ACDF with titanium cervical cages, subsidence is an anticipated postoperative occurrence and is not associated with an increased risk of pseudarthrosis.

Abstract BACKGROUND Low bone mineral density (BMD) on dual energy x-ray absorptiometry (DXA) is likely a risk factor for proximal junctional kyphosis (PJK) and proximal junctional failure (PJF). However, prior instrumentation and degenerative changes can preclude a lumbar BMD measurement. Hounsfield units (HU) represent an alternative method to estimate BMD via targeted measurements at the intended operative levels. OBJECTIVE To determine if patients with lower HU at the upper instrumented vertebrae (UIV) and vertebral body superior to the UIV (UIV + 1) are at greater risk for PJK and PJF. METHODS A retrospective chart review identified patients at least 50 yr of age who underwent instrumented lumbar fusion with pelvic fixation, a UIV from T10 to L2, and a preoperative computed tomography (CT) encompassing the UIV. HU were measured at the UIV, UIV + 1, and the L3-L4 vertebral bodies. RESULTS A total of 150 patients (80 women and 70 men) were included with an average age of 66 yr and average follow-up of 32 mo. Multivariable logistic regression analysis with an area under the curve (AUC) of 0.89 demonstrated HU at the UIV/UIV + 1 as the only independent predictor of PJK/PJF with an odds ratio of 0.94 ( P -value = .031) for a change in a single HU. Patients with HU at UIV/UIV + 1 of <110 (n = 35), 110 to 160 (n = 73), and >160 (n = 42) had a rate of PJK/PJF of 63%, 27%, and 12%, respectively ( P -value < .001). CONCLUSION Patients with lower HU at the UIV and UIV + 1 were significantly associated with PJK and PJF, with an optimal cutoff of 122 HU that maximizes sensitivity and specificity.