Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial.

Objective: To demonstrate the non-inferiority of the novel hemostatic agent, Hemofence® (BMI Korea Co. Ltd., Jeju Korea, thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety. Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For non-inferiority test, a 97.5% one-sided confidence interval was used; the test group was deemed non-inferior if the lower limit exceeded -10%. Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% confidence interval (-4.90%, 7.44%) confirmed the test drug's non-inferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.0000, p=0.2427, and p=0.9663, respectively). Conclusion: A novel hemostatic agent, Hemofence®, demonstrated an efficacy and safety profile comparable to that of Floseal.

Current Concepts in the Treatment of Traumatic C2 Vertebral Fracture : A Literature Review.

The integrity of the high cervical spine, the transition zone from the brainstem to the spinal cord, is crucial for survival and daily life. The region protects the enclosed neurovascular structure and allows a substantial portion of the head motion. Injuries of the high cervical spine are frequent, and the fractures of the C2 vertebra account for approximately 17-25% of acute cervical fractures. We review the two major types of C2 vertebral fractures, odontoid fracture and Hangman's fracture. For both types of fractures, favorable outcomes could be obtained if the delicately selected conservative treatment is performed. In odontoid fractures, as the most common fracture on the C2 vertebrae, anterior screw fixation is considered first for type II fractures, and C1-2 fusion is suggested when nonunion is a concern or occurs. Hangman's fractures are the second most common fracture. Many stable extension type I and II fractures can be treated with external immobilization, whereas the predominant flexion type IIA and III fractures require surgical stabilization. No result proves that either anterior or posterior surgery is superior, and the surgeon should decide on the surgical method after careful consideration according to each clinical situation. This review will briefly describe the basic principles and current treatment concepts of C2 fractures.

Gravity Line-Hip Axis Offset as a Guide for Global Alignment to Prevent Recurrent Proximal Junctional Kyphosis/Failure.

BACKGROUND AND OBJECTIVES: Proximal junctional kyphosis/failure (PJK/F) is a potentially serious complication after adult spinal deformity (ASD) corrective surgery. Recurrent PJK/F is especially troublesome, necessitating fusion extension and occasionally resulting in irreversible neurological deficits. The gravity line (GL) offers valuable insights into global sagittal balance. This study aims to examine the postoperative GL-hip axis (GL-HA) offset as a critical risk factor for recurrent PJK/F. METHODS: We retrospectively reviewed patients with ASD who had undergone revision surgery for initial PJK/F at a single academic center. Patients were categorized into 2 groups: nonrecurrent PJK/F group and recurrent PJK/F group. Demographics, surgical characteristics, preoperative and postoperative parameters of spinopelvic and global alignment, and the Scoliosis Research Society-22 scores were assessed. We examined these measures for differences and correlations with recurrent PJK/F. RESULTS: Our study included 32 patients without recurrent PJK/F and 28 patients with recurrent PJK/F. No significant differences were observed in baseline demographics, operative characteristics, or Scoliosis Research Society-22 scores before and after surgery. Importantly, using a cutoff of -52.6 mm from logistic regression, there were considerable differences and correlations with recurrent PJK/F in the postoperative GL-HA offset, leading to an odds ratio of 7.0 (95% CI: 1.94-25.25, P = .003). CONCLUSION: Postoperative GL-HA offset serves as a considerable risk factor for recurrent PJK/F in patients with ASD who have undergone revision surgery. Overcorrection, with GL-HA offset less than -5 cm, is associated with recurrent PJK/F. The instrumented spine tends to align the GL near the HA, even at the cost of proximal junction.

True Continuous Segment of Ossification of Posterior Longitudinal Ligament is Protective Against Postoperative Early Kyphosis Progression After Laminoplasty.

BACKGROUND AND OBJECTIVES: Ossification of the posterior longitudinal ligament (OPLL) is a potentially catastrophic disease. Laminoplasty (LP) is a common surgical intervention, but postoperative kyphosis progression is a major complication, for which various risk factors have been identified and used in surgical decision-making. Our focus is on the ability of OPLL with specific morphological traits, designated as the true continuous segment (TCS), to stabilize alignment and prevent postoperative kyphosis after LP. METHODS: This retrospective case-control study included patients who underwent cervical LP for OPLL treatment with a minimum 1-year follow-up. Demographic, operative, and radiographic parameters were analyzed. TCS is defined as a continuous segment of OPLL that spans the disk space more than half of the adjacent vertebral body height without crack, or OPLL segment attached to both upper and lower adjacent vertebral bodies by bridging, or obvious interbody autofusion, and is identified from preoperative computed tomography. A subgroup analysis for preoperatively lordotic patients, divided into 2 groups based on cervical alignment at the final follow-up, was conducted to identify risk factors for kyphosis progression. Difference analysis, linear regression analysis for loss of lordosis (LoL), and logistic regression analysis for kyphosis progression were used. RESULTS: A total of 84 patients were identified. Among them, 78 patients with preoperatively lordotic alignment were divided into 2 groups: those who maintained lordotic alignment (n = 60) and those who progressed to kyphosis (n = 18). Regression analyses revealed a significant protective effect of TCS count against LoL and postoperative kyphosis, with a TCS count of 3 or more conclusively preventing kyphosis (sensitivity 1.000, specificity 0.283, area under the curve 0.629). CONCLUSION: For patients with OPLL, TCS was shown to protect against the LoL after LP. Therefore, TCS should be identified and considered when planning surgical treatment for OPLL.

Surgical and Clinical Outcomes Associated With the Use of Barbed Sutures and Self-Adhering Mesh System and Polymeric Glue for Wound Closure in Multilevel or Revision Spinal Surgery: A Matched Cohort Comparative Study With Conventional Wound Closure Procedure.

OBJECTIVE: Multilevel or revisional posterior spinal surgery is prone to infection and delayed wound healing, related with the wound closure time and suture strength. Knotless barbed suture is an innovative self-locking, multianchor suture. This study aims to evaluate the safety and efficacy of the knotless barbed suture and self-adhering mesh with polymeric glue in multilevel or revisional posterior spinal surgery. METHODS: This is a single-center retrospective matched cohort study. Patients were divided into 2 groups based on the wound closure method: barbed suture group with novel wound closure, and conventional suture group with conventional wound closure, 1:1 matched by the level of surgery and sex, resulting in 120 subjects each. Total operation time and wound closure time were measured intraoperatively, and perioperative clinical outcome parameters including postoperative wound complication were investigated for the first 3 months postoperatively. The distribution of continuous variables was assessed for normality by Shapiro-Wilk test, then parametric or nonparametric tests were applied accordingly (paired t-test or Wilcoxon signed-rank test). RESULTS: Wound closure time was significantly shorter with the novel barbed suture than with conventional suture in all subgroups divided by the level of spinal surgery: 3-5, 6-9, ≥ 10 levels (p < 0.001). The 2 groups showed no significant differences in surgical complications (p = 1.000). Specially, total operation time and wound-closing time were significantly shorter in revisional subgroup. CONCLUSION: Absorbable knotless barbed suture and self-adhering mesh with polymeric glue can shorten spinal wound closure time with noninferiority in complications for multilevel or revisional spinal surgery.

Postoperative Gravity Line-Hip Axis Offset as a Substantial Risk Factor for Mechanical Failure After Adult Spinal Deformity Correction Surgery.

BACKGROUND: Mechanical failure (MF) is a serious burden for patients with adult spinal deformity (ASD) who have undergone deformity correction surgery. Surgeons have sought to understand the mechanism and prevent this problematic complication, but this goal remains to be achieved. The gravity line (GL) of the whole body is a noteworthy parameter that represents global sagittal balance, for which normative values for the axial skeleton have been studied. OBJECTIVE: To assess postoperative GL-hip axis (GL-HA) offset as a critical risk factor for MF after ASD correction surgery. METHODS: Consecutive patients who underwent initial surgery for ASD at a single academic center were retrospectively included. Demographics, operative details, preoperative and postoperative spinopelvic parameters, global sagittal balance parameters, and Scoliosis Research Society-22 score were evaluated. These variables were analyzed for differences and correlations with MF. RESULTS: Thirty-five patients without MF and 30 patients with MF were identified in the study. Two groups showed no significant differences in baseline demographics, operative characteristics, preoperative global sagittal balance parameters, or preoperative and postoperative Scoliosis Research Society-22 scores. Significant differences and correlations with MF were observed for postoperative GL-HA offset using a cutoff value of 49.3 mm from logistic regression analysis, with an odds ratio of 11.0 (95% confidence interval: 3.45-35.01, P < .0001). CONCLUSION: Postoperative GL-HA offset is a substantial risk factor for MF after ASD surgery. Surgical correction of ASD with a GL-HA offset greater than 5 cm is significantly related to MF. The GL should be located near the HA after ASD surgery.

Pediatric Spine Trauma.

Pediatric spine has growth potential with incomplete ossification, and also unique biomechanics which have important implications for trauma patients. This article intends to review various aspects of pediatric spine trauma including epidemiology, anatomy and biomechanics, and clinically relevant details of each type of injury based on the location and mechanism of injury. With the appropriate but not superfluous treatment, pediatric spine trauma patients can have better chance of recovery. Therefore, as a spine surgeon, understanding the general concept for each injury subtype together with the debate and progress in the field is inevitable.

Heavily T2-Weighted Magnetic Resonance Myelography as a Safe Cerebrospinal Fluid Leakage Detection Modality for Nontraumatic Subdural Hematoma.

OBJECTIVE: Nontraumatic subdural hematoma (SDH) is a common disease, and spinal cerebrospinal fluid (CSF) leakage is a possible etiology of unknown significance, which is commonly investigated by several invasive studies. This study demonstrates that heavily T2-weighted magnetic resonance myelography (HT2W-MRM) is a safe and clinically effective imaging modality for detecting CSF leakage in patients with nontraumatic SDH. METHODS: All patients who underwent HT2W-MRM for nontraumatic SDH workup at our institution were searched and enrolled in this study. Several parameters were measured and analyzed, including patient demographic data, initial modified Rankin Scale (mRS) score upon presentation, SDH bilaterality, hematoma thickness upon presentation, CSF leakage sites, treatment modalities, follow-up hematoma thickness, and follow-up mRS score. RESULTS: Forty patients were identified, of which 22 (55.0%) had CSF leakage at various spinal locations. Five patients (12.5%) showed no change in mRS score, whereas the remaining (87.5%) showed decreases in follow-up mRS scores. In terms of the overall hematoma thickness, four patients (10.0%) showed increased thickness, two (5.0%) showed no change, 32 (80.0%) showed decreased thickness, and two (5.0%) did not undergo follow-up imaging for hematoma thickness measurement. CONCLUSION: HT2W-MRM is not only safe but also clinically effective as a primary diagnostic imaging modality to investigate CSF leakage in patients with nontraumatic SDH. Moreover, this study suggests that CSF leakage is a common etiology for nontraumatic SDH, which warrants changes in the diagnosis and treatment strategies.

Occupational Lead Exposure and Brain Tumors: Systematic Review and Meta-Analysis.

(1) Background: Due to inconsistencies in epidemiological findings, there has been uncertainty regarding the association of lead compounds with brain tumors. We performed a meta-analysis of published case-control and cohort studies exploring lead compound exposure and brain tumor risk. (2) Methods: We searched PubMed, Embase®, and Cochrane to find eligible studies. Eighteen studies were selected for assessment of occupational exposure to lead compound and brain tumor. Pooled estimates of odds ratios (ORs) were obtained using random effects models. We assessed the differences through subgroup analysis according to tumor type, study design, measurements of exposure, and tumor outcome. Statistical tests for publication bias, heterogeneity, and sensitivity analysis were applied. (3) Results: Our systematic review and meta-analysis showed a not significant association with lead exposure and risk of benign and malignant brain tumors (pooled OR = 1.11, 95% Confidence Interval (CI): 0.95-1.29). Including only malignant brain tumors, the risk of brain tumor was significantly increased (pooled OR = 1.13, 95% CI: 1.04-1.24). (4) Conclusions: This meta-analysis provides suggestive evidence for an association between lead compound exposure and brain tumor. In future studies, it will be necessary to identify the effect of lead compounds according to the types of brain tumor.

Author Correction: Vascular tortuosity of the internal carotid artery is related to the RNF213 c.14429G > A variant in moyamoya disease.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Vascular tortuosity of the internal carotid artery is related to the RNF213 c.14429G > A variant in moyamoya disease.

Recent studies have implicated RNF213 mutations in the pathogenesis of moyamoya disease (MMD). However, the underlying mechanism of disease development is not fully elucidated. Nonetheless, a possible relationship between vascular morphology and hemodynamics related with MMD has been proposed. Here, we aimed to investigate the relationship between a variant of RNF213 and the morphology of the internal carotid artery (ICA). We enrolled bilateral MMD patients who had undergone genetic testing for RNF213. Patients were divided into mutant and wild-type groups. Six anatomy-specific three-dimensional coordinates were collected using magnetic-resonance angiography. From these, five vectors between two adjacent points and four angles between two adjacent vectors were calculated. The tortuosity was defined as the ratio between the actual and the linear length of the ICAs. Among 58 patients, 44 and 14 belonged to the mutant and wild-type groups, respectively. The tortuosity of ICAs was significantly lower in the mutant group (p = 0.010). The change in blood flow direction was more prominent in the wild-type group (p = 0.002). The tortuosity was significantly lower in MMD patients than normal controls (p < 0.001). Our results indicate that RNF213 could play a role in the lower tortuosity observed in patients with RNF213 mutation.

Resonance spectrum of a three-dimensional photonic quantum ring laser with an equilateral triangle microcavity.

We have fabricated three-dimensional (3D) photonic quantum ring lasers with an equilateral triangle microcavity. Their spectra were well explained by combining the off-normal resonance and hexagonally bounced in-plane whispering-gallery-mode condition. The angular distribution of the emission modes and their discrete wavelengths were shown to be in excellent agreement with a 3D Rayleigh Fabry-Perot model. We confirmed that the allowed modes in the equilateral triangle microcavity decrease by decreasing the length of equilateral triangle side, L, and the spectral mode spacing linearly increases with the mode index m and is inversely proportional to L2.

Current-dependent spectral blueshift in a three-dimensional photonic-quantum-ring laser.

The emission spectra of photonic-quantum-ring lasers can be explained by a three-dimensional Rayleigh-Fabry-Perot cavity resonance model. The proposed model for the emission spectral peaks fits well with the observed blueshift of the emission spectrum envelope as a function of the view angle. Furthermore, we observe that the emission spectra with the high-order mode index showed blueshift behaviors as functions of the injection current, whereas those with the low-order mode index showed redshift behaviors. These phenomena might result in lowering the effective refractive index by the carrier inhomogeneity in the active disk.