The Impact of Posterior Intervertebral Osteophytes on Patient-Reported Outcome Measures After L5-S1 Anterior Lumbar Interbody Fusion and Transforaminal Lumbar Interbody Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: (1) To develop a reliable grading system to assess the severity of posterior intervertebral osteophytes and (2) to investigate the impact of posterior intervertebral osteophytes on clinical outcomes after L5-S1 decompression and fusion through anterior lumbar interbody fusion (ALIF) and minimally-invasive transforaminal lumbar interbody fusion (MIS-TLIF). BACKGROUND: There is limited evidence regarding the clinical implications of posterior lumbar vertebral body osteophytes for ALIF and MIS-TLIF surgeries and there are no established grading systems that define the severity of these posterior lumbar intervertebral osteophytes. PATIENTS AND METHODS: A retrospective analysis of patients undergoing L5-S1 ALIF or MIS-TLIF was performed. Preoperative and postoperative patient-reported outcome measures of the Oswestry Disability Index (ODI) and leg Visual Analog Scale (VAS) at 2-week, 6-week, 12-week, and 6-month follow-up time points were assessed. Minimal clinically important difference (MCID) for ODI of 14.9 and VAS leg of 2.8 were utilized. Osteophyte grade was based on the ratio of osteophyte length to foraminal width. "High-grade" osteophytes were defined as a maximal osteophyte length >50% of the total foraminal width. RESULTS: A total of 70 consecutive patients (32 ALIF and 38 MIS-TLIF) were included in the study. There were no significant differences between the two cohorts in patient-reported outcome measures or achievement of MCID for Leg VAS or ODI preoperatively or at any follow-ups. On multivariate analysis, neither the surgical approach nor the presence of high-grade foraminal osteophytes was associated with leg VAS or ODI scores at any follow-up time point. In addition, neither the surgical approach nor the presence of high-grade foraminal osteophytes was associated with the achievement of MCID for leg VAS or ODI at 6 months. CONCLUSION: ALIF and MIS-TLIF are both valid options for treating degenerative spine conditions and lumbar radiculopathy, even in the presence of high-grade osteophytes that significantly occupy the intervertebral foramen. LEVEL OF EVIDENCE: 3.

Postoperative Radiculitis After L5-S1 Anterior Lumbar Interbody Fusion.

STUDY DESIGN: Retrospective chart review. OBJECTIVE: This study aimed to examine postoperative radiculitis after isolated L5-S1 anterior lumbar interbody fusion (ALIF), determine which factors contribute to its development, and investigate the comparative outcomes of patients with versus without postoperative radiculitis. SUMMARY OF BACKGROUND DATA: Both standalone and traditionalALIF are common and safe lumbar spine fusion techniques. Although optimal safety and effectiveness are achieved through appropriate patient selection, postoperative radiculitis after L5-S1 ALIF is a potential complication that seems to be the least predictable in the absence of iatrogenic injury. PATIENTS AND METHODS: All adult patients (18-80 yr) with preoperative radiculopathies who underwent L5-S1 ALIF by 9 board-certified spine surgeons at a single academic institution from January 2016 to December 2021 with a minimum of 3 months follow-up were included. Patient records were assessed for data on clinical characteristics and patient-reported outcome scores (patient-reported outcome measures). All patient records were evaluated to determine whether postoperative radiculitis developed. Radiographic measurements using x-rays were completed using all available pre and postoperative imaging. Multivariable logistic regressions were performed utilizing radiculitis as the dependent variable and various independent predictor variables. RESULTS: One hundred forty patients were included, 48 (34%) patients developed postoperative radiculitis, with symptom onset and resolution occurring at 14.5 and 83 days, respectively. The two groups had no differences in preoperative or postoperative radiographic parameters. Multivariable regression showed 3 independent predictors of postoperative radiculitis: methylprednisolone use [OR: 6.032; (95% CI: 1.670-25.568)], increased implant height [OR: 1.509; (95% CI: 1.189-1.960)], and no posterior fixation [OR: 2.973; (95% CI: 1.353-0.806)]. CONCLUSIONS: Of the 34% of patients who developed postoperative radiculitis after L5-S1 ALIF, it resolved on average within 3 months of surgery. These findings may help reduce the risk of undue short-term morbidity after isolated L5-S1 ALIF by informing preoperative counseling and intraoperative decision-making.

Poor muscle health and low preoperative ODI are independent predictors for slower achievement of MCID after minimally invasive decompression.

BACKGROUND CONTEXT: Although some previous studies have analyzed predictors of nonimprovement, most of these have focused on demographic and clinical variables and have not accounted for radiological predictors. In addition, while several studies have examined the degree of improvement after decompression, there is less data on the rate of improvement. PURPOSE: To identify the risk factors and predictors (both radiological and nonradiological) for slower as well as nonachievement of minimal clinically important difference (MCID) after minimally invasive decompression. DESIGN: Retrospective cohort. PATIENT SAMPLE: Patients who underwent minimally invasive decompression for degenerative lumbar spine conditions and had a minimum of 1-year follow up were included. Patients with preoperative Oswestry Disability Index (ODI) <20 were excluded. OUTCOME MEASURE: MCID achievement in ODI (cut off 12.8). METHODS: Patients were stratified into two groups (achieved MCID, did not achieve MCID) at two timepoints (early ≤3 months, late ≥6 months). Nonradiological (age, gender, BMI, comorbidities, anxiety, depression, number of levels operated, preoperative ODI, preoperative back pain) and radiological (MRI - Schizas grading for stenosis, dural sac cross-sectional area, Pfirrmann grading for disc degeneration, psoas cross-sectional area and Goutallier grading, facet cyst/effusion; X-ray - spondylolisthesis, lumbar lordosis, spinopelvic parameters) variables were assessed with comparative analysis to identify risk factors and with multiple regression models to identify predictors for slower achievement of MCID (MCID not achieved by ≤3 months) and nonachievement of MCID (MCID not achieved at ≥6 months). RESULTS: A total of 338 patients were included. At ≤3 months, patients who did not achieve MCID had significantly lower preoperative ODI (40.1 vs 48.1, p<0.001) and worse psoas Goutallier grading (p=.048). At ≥6 months, patients who did not achieve MCID had significantly lower preoperative ODI (38 vs 47.5, p<.001), higher age (68 vs 63 years, p=.007), worse average L1-S1 Pfirrmann grading (3.5 vs 3.2, p=.035), and higher rate of pre-existing spondylolisthesis at the operated level (p=.047). When these and other probable risk factors were put into a regression model, low preoperative ODI (p=.002) and poor Goutallier grading (p=.042) at the early timepoint and low preoperative ODI (p<.001) at the late timepoint came out as independent predictors for MCID nonachievement. CONCLUSION: After minimally invasive decompression, low preoperative ODI and poor muscle health are risk factors and predictors for slower achievement of MCID. For nonachievement of MCID, low preoperative ODI, higher age, greater disc degeneration, and spondylolisthesis are risk factors and low preoperative ODI is the only independent predictor.

Predictors of Subsidence and its Clinical Impact After Expandable Cage Insertion in Minimally Invasive Transforaminal Interbody Fusion.

STUDY DESIGN: Retrospective review of prospectively collected multisurgeon data. OBJECTIVE: Examine the rate, clinical impact, and predictors of subsidence after expandable minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) cage. SUMMARY OF BACKGROUND DATA: Expandable cage technology has been adopted in MI-TLIF to reduce the risks and optimize outcomes. Although subsidence is of particular concern when using expandable technology as the force required to expand the cage can weaken the endplates, its rates, predictors, and outcomes lack evidence. MATERIALS AND METHODS: Patients who underwent 1 or 2-level MI-TLIF using expandable cages for degenerative lumbar conditions and had a follow-up of >1 year were included. Preoperative and immediate, early, and late postoperative radiographs were reviewed. Subsidence was determined if the average anterior/posterior disc height decreased by >25% compared with the immediate postoperative value. Patient-reported outcomes were collected and analyzed for differences at the early (<6 mo) and late (>6 mo) time points. Fusion was assessed by 1-year postoperative computed tomography. RESULTS: One hundred forty-eight patients were included (mean age, 61 yr, 86% 1-level, 14% 2-level). Twenty-two (14.9%) demonstrated subsidence. Although statistically not significant, patients with subsidence were older, had lower bone mineral density, and had higher body mass index and comorbidity burden. Operative time was significantly higher ( P = 0.02) and implant width was lower ( P < 0.01) for subsided patients. Visual analog scale-leg was significantly lower for subsided patients compared with nonsubsided patients at a >6 months time point. Long-term (>6 mo) patient-acceptable symptom state achievement rate was lower for subsided patients (53% vs . 77%), although statistically not significant ( P = 0.065). No differences existed in complication, reoperation, or fusion rates. CONCLUSIONS: Of the patients, 14.9% experienced subsidence predicted by narrower implants. Although subsidence did not have a significant impact on most patient-reported outcome measures and complication, reoperation, or fusion rates, patients had lower visual analog scale-leg and patient-acceptable symptom state achievement rates at the >6-month time point. LEVEL OF EVIDENCE: Level 4.

HBcAg produced in transgenic tobacco triggers Th1 and Th2 response when intramuscularly delivered.

Hepatitis B core Antigen (HBcAg) assembled into Capsid-Like Particles (CLPs) is investigated as a therapeutic vaccine in treatment of chronic hepatitis B (CHB) and in diagnostic tests or as a carrier for various epitopes. While the expression of HBcAg has been thoroughly clarified in E. coli and yeast, it has also been investigated in other expression systems. Stably transformed tobacco expressed HBcAg at a level of 110-250µg/g fresh weight, therefore in view of its large leaf biomass it offers a production platform comparable with transient expression systems regarding the final yield of HBcAg. Several extraction and purification methods were tested and finally the antigen was purified up to 43% using sucrose density gradient centrifugation. The purified HBcAg retained its antigenicity, as confirmed by ELISA and western blot, while maintaining its CLP-structure as observed in TEM. In mice HBcAg intramuscularly delivered at 2×10µg triggered a significant response (serum anti-HBc titre around 150,000), being statistically equivalent to that induced by the reference antigen. Among anti-HBc IgG isotypes, IgG2a and then IgG1 were increasing during immune response. However IgG2b and IgG3 were also induced, especially in mice immunised with the plant-derived antigen. Analysis of the isotype profile indicates mainly Th1 polarisation, but completed with Th2 response. Obtained results indicate a considerable potential of plant-derived HBcAg as a therapeutic vaccine, since a mixed immune response with a stronger Th1 component is particularly required for treatment of CHB.