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"Jang-Bo Lee"

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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
Neurospine. 2024;21(3):1004-1013.   Published online April 4, 2024
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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
Neurospine. 2024;21(3):1004-1013.   Published online April 4, 2024
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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.

Citations

Citations to this article as recorded by  Crossref logo
  • Beyond Side Effect: Immuno-Ethical Risk Analysis of Animal-Derived Ingredients in Pharmaceuticals
    Yedi Herdiana, Dolih Gozali, Norisca Putriana, Muchtaridi Muchtaridi, Shaharum Shamsuddin, Ferry Sofian
    Risk Management and Healthcare Policy.2026; Volume 19: 1.     CrossRef
  • Hemostasis in Endoscopic Spine Surgery
    Ting Ting Feng, Woo-Keun Kwon, Ji Min Ling, Thomas Choo Heng Tan
    Journal of Minimally Invasive Spine Surgery and Technique.2025; 10(Suppl 1): S20.     CrossRef
  • Opportunities and challenges of adhesive hemostatic hydrogels in spinal surgery
    Qianli Gao, Chi Zhang, Rong Xu, Yifeng Shi, Yang Luo, Bin Yu, Dongdong Xia
    BME Horizon.2025;[Epub]     CrossRef
  • 8,318 View
  • 263 Download
  • 3 Web of Science
  • 3 Crossref

Case Report

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A Rare Case of Malignant Lymphoma Occurred at Spinal Epidural Space: A Case Report
Korean J Spine. 2015;12(3):177-180.   Published online September 30, 2015
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A Rare Case of Malignant Lymphoma Occurred at Spinal Epidural Space: A Case Report
Korean J Spine. 2015;12(3):177-180.   Published online September 30, 2015
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The sacral spinal epidural space is an uncommon site for primary malignant lymphomas, presenting with symptoms associated with cauda equina compression. Especially, lumbo-sacral epidural lymphoma has been reported to be very rare. We present a rare case of 29-year-old male with sacral spinal epidural malignant lymphoma. The patient complained of tingling sensation in his buttocks that was radiating to his calf. The neurological examination was normal. Magnetic resonance imaging (MRI) with contrast showed a well-defined extradural mass lesion at the mid L5 to mid S2 level. The lesion was iso- to hypointense on T1 and T2 weighted images and showed homogenous enhancement and a focal enhancement in the L5 vertebral body on post-contrast images. The patient underwent a L5-S2 laminectomy and subtotal excision of the lesion. Intra-operatively, the lesion was extradural and not densely adherent to the dura; the lesion was friable, not firm, fleshy, brownish and hypervascular. The histologic diagnosis was grade 2 non-Hodgkin's follicular lymphoma. Even though the primary spinal epidural non-Hodgkin's lymphoma is a very rare disease, clinicians should take it into consideration in the differential diagnosis of patients with spinal epidural tumor.

Citations

Citations to this article as recorded by  Crossref logo
  • Primary Spinal Epidural Low-grade B-cell Lymphoma: Masquerading as a Case of Spinal Cord Compression
    K. P. Sreehari, Anand P. Nair, Tinu Ravi Abraham, Mark Mohan Mathew
    Neurology India Case Report.2025; 1(1): 30.     CrossRef
  • Surgical Intervention for Primary B-cell Lymphoma of the Spine
    Julian L. Gendreau, Neal Patel, Nolan J. Brown, Seung Jin Lee, Ronald Sahyouni, Andrew K. Chan, William E. Clifton, Selby Chen
    Clinical Spine Surgery.2024; 37(7): 296.     CrossRef
  • Spinal Meningeal Mass Lesion
    Jessica D. White, Michelle J. Clarke, Jonas Paludo, Andrew L. Feldman, Ugur T. Sener
    The Neurologist.2024; 29(2): 122.     CrossRef
  • Aggressive B-Cell Lymphoma with Metastatic Spinal Cord Compression: Treat the Patient, Not the Disease
    Leonid L. Yavorkovsky
    Oncology Research and Treatment.2024; 47(6): 287.     CrossRef
  • Low-grade B-cell lymphomas in the spinal epidural space: A case series and review of the literature
    Sandra Leskinen, Hamza Khilji, Faina Ablyazova, Avraham Zlochower, Manju Harshan, A. Gabriella Wernicke, Morana Vojnic, Randy S. D'Amico
    Current Problems in Cancer: Case Reports.2023; 12: 100269.     CrossRef
  • A Conservative Approach to the Treatment of a Rare Case of Cervical Spine Double Expressor Diffuse Large B-cell Lymphoma: A Case Report
    Wesley Chen, Busha Hika, Caitlyn J Smith, Timothy J Parrett, Fassil B Mesfin
    Cureus.2022;[Epub]     CrossRef
  • Primary Spinal Epidural Diffuse Large B-cell Lymphoma: Case Report and Literature Review
    Prarthna V Bhardwaj, Annie Abraham, Sunitha Alluri
    Cureus.2022;[Epub]     CrossRef
  • Primary spinal Non-Hodgkin Lymphoma presenting as impending cauda equina syndrome: A case report
    Prashant Adhikari, Sulochana Khadka, Pradeep Raj Regmi, Anjan Shrestha, Bhaskar Raj Panta, Sandeep Bhandari, Emre Acaroglu
    Annals of Medicine and Surgery.2022; 83: 104696.     CrossRef
  • Use of a nano-hydroxyapatite/polyamide composite in anterior cervical subtotal corpectomy and fusion
    Xiaojiang Li, Xudong Zhang, Shanshan Dong, Haijun Li, Chunlan Wang, Dalong Liu, Jingbin Feng, Xiangyang Leng
    Materials Express.2021; 11(9): 1491.     CrossRef
  • Primary Spinal Epidural Non-Hodgkin’s Lymphoma: A Case Report
    ​​​​​​​Kristianne A Payad, Dax Ronald Librado
    Philippine Journal of Internal Medicine.2019; 57(3): 167.     CrossRef
  • A case report of primary central nervous system lymphoma with intestinal obstruction as the initial symptom
    Xiaoke Li, Shuo Qi, Yuntao Jiao, Jing Gao, Hongbo Du
    Medicine.2018; 97(10): e0080.     CrossRef
  • Primary spinal intradural extramedullary lymphoma: A novel management strategy
    Angelique Sao-Mai Do, Gabriel A. Smith, Jonathan Pace, Alia Hdeib, Manish K. Kasliwal
    Journal of Clinical Neuroscience.2017; 35: 122.     CrossRef
  • Diagnostic challenge in a patient with primary bilateral Dumbbell-shaped lumbar non-Hodgkin’s lymphoma
    D. Adam, Gina Burduşa, D. Iftimie, Ioana Hornea, Camelia Dobrea, Sorina Nicoleta Badelita
    Romanian Neurosurgery.2016; 30(2): 168.     CrossRef
  • 11,461 View
  • 120 Download
  • 13 Crossref

Clinical Article

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Preliminary Experiences of the Combined Midline-Splitting French Door Laminoplasty with Polyether Ether Ketone (PEEK) Plate for Cervical Spondylosis and OPLL
Korean J Spine. 2015;12(2):48-54.   Published online June 30, 2015
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Preliminary Experiences of the Combined Midline-Splitting French Door Laminoplasty with Polyether Ether Ketone (PEEK) Plate for Cervical Spondylosis and OPLL
Korean J Spine. 2015;12(2):48-54.   Published online June 30, 2015
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Objective

The purpose of this study was to evaluate the safety and efficacy of cervical midline-splitting French-door laminoplasty with a polyether ether ketone (PEEK) plate. The authors retrospectively analyzed the results of patients with cervical laminoplasty miniplate (MAXPACER®) without bone grafts in multilevel cervical stenosis.

Methods

Fifteen patients (13 males and 2 females, mean age 50.0 years (range 35-72)) with multilevel cervical stenosis (ossification of the posterior longitudinal ligament and cervical spondylotic myelopathy) underwent a combined surgery of midline-splitting French-door laminoplasty with or without mini plate. All 15 patients were followed for at least 12 months (mean follow-up 13.3 months) after surgery, and a retrospective review of the clinical, radiological and surgical data was conducted.

Results

The radiographic results showed a significant increase over the postoperative period in anterior-posterior diameter (9.4±2.2 cm to 16.2±1.1 cm), open angles in cervical lamina (46.5±16.0° to 77.2±13.1°), and sectional volume of cervical central canal (100.5±0.7 cm2 to 146.5±4.9 cm2) (p<0.001). The sagittal alignment of the cervical spine was well preserved (31.7±10.0° to 31.2±7.6°, p=0.877) during the follow-up period. The clinical results were successful, and there were no significant intraoperative complications except for screw displacement in two cases. The mini plate constructs did not fail during the 12 month follow-up period, and the decompression was maintained.

Conclusion

Despite the small cohort and short follow-up duration, the present study demonstrated that combined cervical expansive laminoplasty using the mini plate is an effective treatment for multilevel cervical stenosis.

Citations

Citations to this article as recorded by  Crossref logo
  • Clip-plate versus suture-anchor in double-door laminoplasty for degenerative cervical myelopathy: Protocol for a multicenter, non-inferiority, randomized controlled trial
    Kentaro Yamada, Kenichiro Sakai, Takashi Hirai, Kazuyuki Fukushima, Takuya Takahashi, Yu Matsukura, Satoru Egawa, Hiroaki Onuma, Motonori Hashimoto, Akihiro Hirakawa, Yoshiyasu Arai, Toshitaka Yoshii, Koji Akeda
    PLOS One.2026; 21(4): e0339103.     CrossRef
  • 12,382 View
  • 98 Download
  • 1 Crossref

Case Report

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Unusual Fatal Infections after Anterior Cervical Spine Surgeries
Korean J Spine. 2012;9(3):304-308.   Published online September 30, 2012
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Unusual Fatal Infections after Anterior Cervical Spine Surgeries
Korean J Spine. 2012;9(3):304-308.   Published online September 30, 2012
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We report two cases of cervical spinal epidural abscess (SEA), which are related to anterior cervical surgeries. The first case reveals a late postoperative infection without any predisposing factor. The second case reveals combined complication of infection and instrument failure (artificial disc). Both two cases manifested ascending infections that are unusual courses of anterior cervical infections. The abscess extended upwards and, finally, caused life threatening bacterial meningitis. We suggest aggressive surgical interventions with anti-bacterial therapies in such cases.

Citations

Citations to this article as recorded by  Crossref logo
  • Pneumorrhachis of Infectious Origin in a Patient with Advanced HIV and Uncontrolled Diabetes: A Case Report and Review of the Literature
    Thenell Van der Westhuizen, Abdullah E Laher
    Cureus.2026;[Epub]     CrossRef
  • Early Postoperative Infections of the Sub-Axial Cervical Spine: A Case Series and a Review of Literature
    Aditya Raj, Sudhir Kumar Srivastava, Karthik Ramachandran, Ajoy Prasad Shetty, Amitava Biswas, Bharat Dave
    Indian Spine Journal.2026; 9(2): 226.     CrossRef
  • Treatment Modalities for Spinal Epidural Abscess: A Systematic Review and Introducing a Novel Minimally Invasive Approach
    Seyed Hadi Aghili, Saeed Safari, Iman Chehregani Rad, Mehri Farhang Ranjbar, Ali Majidi
    Journal of Emergency Practice and Trauma.2026; 11(1): 47.     CrossRef
  • Lethal necrotising mediastinitis: A rare but critical complication of post-cervical disc arthroplasty
    Faizal Soehadak, Teddy Wardhana, Lukas Widhiyanto
    Scripta Medica.2025; 56(6): 871.     CrossRef
  • Not Your Typical Sore Throat–A Case Report on Delayed Complications From Cervical Spinal Surgery
    Emma Ivanauskas, Kerin A. Jones
    Annals of Emergency Medicine.2024; 83(1): 68.     CrossRef
  • Presentation and management of infection in total disc replacement: A review
    Hannah Spece, Armen Khachatryan, Frank M. Phillips, Todd H. Lanman, Gunnar B.J. Andersson, Grant E. Garrigues, Hyun Bae, Joshua J. Jacobs, Steven M. Kurtz
    North American Spine Society Journal (NASSJ).2024; 18: 100320.     CrossRef
  • A case of spinal cord transection for an intramedullary abscess containing gas
    Koji Matsumoto, Hirokatsu Sawada, Sosuke Saito, Kazuma Hirata, Ryo Ozaki, Sumie Ohni, Haruna Nishimaki, Kazuyoshi Nakanishi
    Journal of Orthopaedic Science.2023; 28(6): 1570.     CrossRef
  • Late Retropharyngeal and Parapharyngeal Abscess in Patients with a History of Anterior Cervical Discectomy and Fusion
    Louis Bivona, Adrian Williamson, Sanford E. Emery, William A. Stokes
    Annals of Otology, Rhinology & Laryngology.2023; 132(3): 294.     CrossRef
  • Delayed surgical site infection 2 years after cervical disk arthroplasty. Case report and literature review
    Aleix Rosselló, Jose Luis Sanmillán, Luis López-Obarrio, Iván Pelegrín, Andreu Gabarrós, Oscar Godino
    Neurocirugía.2019; 30(2): 81.     CrossRef
  • Pneumorachis from the cervical to the sacral spinal canal with spinal epidural abscess by gas gangrene
    Tomoki Matsuo, Atsushi Tanji, Koichi Tateyama, Yuhei Yoda, Yusaku Kamata, Tadahisa Urabe
    Journal of Orthopaedic Surgery.2019;[Epub]     CrossRef
  • Emergency 1-stage anterior approach for cervical spine infection complicated by epidural abscess
    Haoxi Li, Zhaoxiong Chen, Zhiyao Yong, Xinhua Li, Yufeng Huang, Desheng Wu
    Medicine.2017; 96(26): e7301.     CrossRef
  • Surgical site infections following operative management of cervical spondylotic myelopathy: prevalence, predictors of occurence, and influence on peri-operative outcomes
    C. M. Jalai, N. Worley, G. W. Poorman, D. L. Cruz, S. Vira, P. G. Passias
    European Spine Journal.2016; 25(6): 1891.     CrossRef
  • Deep-wound and organ-space infection after surgery for degenerative spine disease: an analysis from 2006 to 2012
    Rafael De la Garza-Ramos, Nicholas B. Abt, Panagiotis Kerezoudis, Brandon A. McCutcheon, Ali Bydon, Ziya Gokaslan, Mohamad Bydon
    Neurological Research.2016; 38(2): 117.     CrossRef
  • Rapidly Progressive Gas-containing Lumbar Spinal Epidural Abscess
    Jin Hyuk Bang, Keun-Tae Cho
    Korean Journal of Spine.2015; 12(3): 139.     CrossRef
  • 11,444 View
  • 106 Download
  • 14 Crossref