Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., 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 noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior 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% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. 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=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., 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 noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior 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% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. 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=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., 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 noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior 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% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. 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=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., 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 noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior 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% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. 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=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., 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 noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior 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% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. 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=1.000, p=0.243, and p=0.966, respectively). Conclusion A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

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.

The Korean Neurosurgical Society, with its 62 years of history, has witnessed substantial growth in the field of neurosurgery, producing over 3400 neurosurgeons, establishing 12 divisions and nine regional branches, and advancing in clinical management, diagnostic methods and academic research. Despite these developments, the regulations governing neurosurgical training and evaluation methods for training hospitals have remained largely unchanged, necessitating comprehensive revisions in response to evolving medical environments. To provide balanced participation opportunities for neurosurgery residents, the Korean Neurosurgical Society formed the Training Status Investigation Standard Change Task Force (TF team) under the Training Education Committee. This paper presents the TF team’s findings and proposals for revising training status investigation standards and evaluation criteria. Through the processes including a lot of team meetings, workshops, education programs, official communications with 12 division societies, benchmarking from other societies and analysis of encrypted data from the past 5 years for neurosurgical training hospitals, the TF team created a revised training status investigation proposal, supplemented main surgery criteria. And we applied this revised proposal to the training status investigation data collected from training hospitals in 2022 for simulation. We reduced the score for main surgeries to 10 points, introduced core competency surgery standards, allocating 5 points each for brain core competency surgery and spine and peripheral core competency surgery, for a total of 10 points. We also adjusted the major surgery score to 13 points, expanding the total surgery index score to 33 points. We introduced additional definitions for main surgeries in the areas of spine, pediatrics, and functional surgery. The equipment score was reduced from 17 to 9 points. We specified minimum requirements for resident allocation eligibility, and if a hospital meets all of these criteria, they become eligible to apply for resident allocation. We introduced a new bonus point system for hospitals performing mechanical thrombectomy or stenting and surgery for peripheral nerve diseases. The proposed revisions aim to improve the training and education of neurosurgical residents and overall neurosurgical care in Korea by creating a balanced and differentiated evaluation system for training hospitals. Further monitoring, communication, and adjustments are crucial for successful implementation.

As we get closer to super-aged society, the prevalence of senile spinal diseases is constantly increasing and the burden on individuals and society grows high. Senile spinal disease is basically degenerative in nature. Pain and physical dysfunction occur due to various complex pathologic causes. For the diagnosis and treatment of such complex diseases, it is essential to understand common senile spinal diseases such as intervertebral disc herniation and spinal stenosis. Degenerative changes in intervertebral discs are caused by a combination of aging and excessive physical load, which results in structural damages and molecular biological changes in the intervertebral discs. Spinal stenosis is a disease in which nerves and blood vessels are compressed by hypertrophied ligamentum flavum, bulged disc, and a hypertrophied facet. Ligamentum flavum hypertrophy, which is the most important etiology in spinal stenosis, occurs due to mechanical stress and a cascade of inflammation and fibrosis reactions. Drug therapy targeting these pathologic mechanisms includes non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants, and agents that improve blood circulation. Nerve blocks, which prevent these pathophysiologic conditions, are also a good treatment modality. Typical nerve block techniques include medial nerve block and epidural block. It is necessary to understand the pathophysiology of senile spinal diseases and establish an appropriate treatment strategy that suit the patient's condition.

OBJECTIVE: Delayed hinge fracture (HF) that develops after cervical open door laminoplasty can be a source of postoperative complications such as axial pain. However, risk factors related to this complication remain unclear. We performed a retrospective clinical series to determine risk factors for delayed HF following plate-only open-door cervical laminoplasty. METHODS: Patients who underwent plate-only open-door laminoplasty and had available postoperative computed tomography (CT) scans (80 patients with 270 laminae) were enrolled. Hinge status, hinge gutter location, open location, hinge width, number of screws used, operation level, and open angle were observed in the CT to determine radiographic outcome. Demographic data were collected as well. Radiographic and clinical parameters were analyzed using univariate and multivariate logistic regression analysis to determine the risk factors for HF. RESULTS: Univariate logistic regression analysis results indicated poor initial hinge status, medially placed hinge gutter, double screw fixation on the elevated lamina, upper surgical level, and wide open angle as predictors for HF (p<0.05). Initial hinge status seemed to be the most powerful risk factor for HF (p=0.000) and thus was collinear with other variables. Therefore, multivariate logistic regression analysis was performed excluding initial hinge status, and the results indicated that medially placed hinge gutter, double screw fixation on the elevated lamina, and upper surgical level were risk factors for HF after adjustment for other confounding factors. CONCLUSION: To prevent HF and to draw a successful postoperative outcome after cervical laminoplasty, surgical and clinical precautions should be considered.
Humans ; Laminoplasty* ; Logistic Models ; Postoperative Complications ; Retrospective Studies ; Risk Factors*

OBJECTIVE: To assess the clinical and radiological factors as predictors for successful outcomes in lumbar disc herniation (LDH) treatment. METHODS: Two groups of patients with single level LDH (L4–5) requiring treatment were retrospectively studied. The surgery group (SG) included 34 patients, and 30 patients who initially refused the surgery were included in the nerve blocks group (NG). A visual analogue scale (VAS) for leg and back pain and motor deficit were initially evaluated before procedures, and repeated at 1, 6, and 12 months. Radiological factors including the disc herniation length, disc herniation area, canal length-occupying ratio, and canal area-occupying ratio were measured and compared. Predicting factors of successful outcomes were determined with multivariate logistic regression analysis after the optimal cut off values were established with a receiver operating characteristic curve. RESULTS: There was no significant demographic difference between two groups. A multivariate logistic regression analysis with radiological and clinical (12 months follow-up) data revealed that the high disc herniation length with cutoff value 6.31 mm [odds ratio (OR) 2.35; confidence interval (CI) 1.21–3.98] was a predictor of successful outcomes of leg pain relief in the SG. The low disc herniation length with cutoff value 6.23 mm (OR 0.05; CI 0.003–0.89) and high baseline VAS leg (OR 12.63; CI 1.64–97.45) were identified as predictors of successful outcomes of leg pain relief in the NG. CONCLUSION: The patients with the disc herniation length larger than 6.31 mm showed successful outcomes with surgery whereas the patients with the disc herniation length less than 6.23 mm showed successful outcomes with nerve block. These results could be considered as a radiological criteria in choosing optimal treatment options for LDH.
Back Pain ; Humans ; Leg ; Logistic Models ; Nerve Block* ; Retrospective Studies ; ROC Curve