A Prospective, Multi-Center, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used during the TLIF Procedure in Patients with Lumbar Disc Disease

Objective@#: This study is to evaluate the efficacy and safety of demineralized bone matrix (DBM) gel versus DBM gel with recombinant human bone morphogenetic protein-2 (rhBMP-2) used in transforaminal lumbar interbody fusion (TLIF). @*Methods@#: This study was designed as a prospective, multi-center, double-blind method, randomized study. All randomized subjects underwent TLIF with DBM gel with rhBMP-2 group (40 patients) as an experimental group or DBM gel group (36 patients) as a control group. Post-operative observations were performed at 12, 24, and 48 weeks. The spinal fusion rate on computed tomography scans and X-rays films, Visual analog scale pain scores, Oswestry disability index and SF-36 quality of life (QOL) scores were used for the efficacy evaluation. The incidence rate of adverse device effects (ADEs) and serious adverse device effects (SADEs) were used for safety evaluation. @*Results@#: The spinal fusion rate at 12 weeks for the DBM gel with rhBMP-2 group was higher with 73.68% compared to 58.82% for the DBM gel group. The 24 and 48 weeks were 72.22% and 82.86% for the DBM gel with rhBMP-2 group and 78.79% and 78.13%, respectively, for the DBM gel group. However, there were no significant differences between two groups in the spinal fusion rate at 12, 24, and 48 weeks post-treatment (p=0.1817, p=0.5272, p=0.6247). There was no significant difference between the two groups in the incidence rate of ADEs (p=0.3836). For ADEs in the experimental group, ‘Pyrexia’ (5.00%) was the most common ADE, followed by ‘Hypesthesia’, ‘Paresthesia’, ‘Transient peripheral paralysis’, ‘Spondylitis’ and ‘Insomnia’ (2.50%, respectively). ADEs reported in control group included ‘Pyrexia’, ‘Chest discomfort’, ‘Pain’, ‘Osteoarthritis’, ‘Nephropathy toxic’, ‘Neurogenic bladder’, ‘Liver function analyses’ and ‘Urticaria’ (2.86%, respectively). There was no significant difference between the two groups in the incidence rate of SADEs (p=0.6594). For SADE in the experimental group, ‘‘Pyrexia’ and ‘Spondylitis’ were 2.50%. SADE reported in the control group included 'Chest discomfort’, ‘Osteoarthritis’ and ‘Neurogenic bladder’. All SADEs described above were resolved after medical treatment. @*Conclusion@#: This study demonstrated that the spinal fusion rates of DBM gel group and DBM gel with rhBMP-2 group were not significantly different. But, this study provides knowledge regarding the earlier postoperative effect of rhBMP-2 containing DBM gel and also supports the idea that the longer term follow-up results are essential to confirm the safety and effectiveness.

A Prospective, Multi-Center, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used during the TLIF Procedure in Patients with Lumbar Disc Disease

Objective@#: This study is to evaluate the efficacy and safety of demineralized bone matrix (DBM) gel versus DBM gel with recombinant human bone morphogenetic protein-2 (rhBMP-2) used in transforaminal lumbar interbody fusion (TLIF). @*Methods@#: This study was designed as a prospective, multi-center, double-blind method, randomized study. All randomized subjects underwent TLIF with DBM gel with rhBMP-2 group (40 patients) as an experimental group or DBM gel group (36 patients) as a control group. Post-operative observations were performed at 12, 24, and 48 weeks. The spinal fusion rate on computed tomography scans and X-rays films, Visual analog scale pain scores, Oswestry disability index and SF-36 quality of life (QOL) scores were used for the efficacy evaluation. The incidence rate of adverse device effects (ADEs) and serious adverse device effects (SADEs) were used for safety evaluation. @*Results@#: The spinal fusion rate at 12 weeks for the DBM gel with rhBMP-2 group was higher with 73.68% compared to 58.82% for the DBM gel group. The 24 and 48 weeks were 72.22% and 82.86% for the DBM gel with rhBMP-2 group and 78.79% and 78.13%, respectively, for the DBM gel group. However, there were no significant differences between two groups in the spinal fusion rate at 12, 24, and 48 weeks post-treatment (p=0.1817, p=0.5272, p=0.6247). There was no significant difference between the two groups in the incidence rate of ADEs (p=0.3836). For ADEs in the experimental group, ‘Pyrexia’ (5.00%) was the most common ADE, followed by ‘Hypesthesia’, ‘Paresthesia’, ‘Transient peripheral paralysis’, ‘Spondylitis’ and ‘Insomnia’ (2.50%, respectively). ADEs reported in control group included ‘Pyrexia’, ‘Chest discomfort’, ‘Pain’, ‘Osteoarthritis’, ‘Nephropathy toxic’, ‘Neurogenic bladder’, ‘Liver function analyses’ and ‘Urticaria’ (2.86%, respectively). There was no significant difference between the two groups in the incidence rate of SADEs (p=0.6594). For SADE in the experimental group, ‘‘Pyrexia’ and ‘Spondylitis’ were 2.50%. SADE reported in the control group included 'Chest discomfort’, ‘Osteoarthritis’ and ‘Neurogenic bladder’. All SADEs described above were resolved after medical treatment. @*Conclusion@#: This study demonstrated that the spinal fusion rates of DBM gel group and DBM gel with rhBMP-2 group were not significantly different. But, this study provides knowledge regarding the earlier postoperative effect of rhBMP-2 containing DBM gel and also supports the idea that the longer term follow-up results are essential to confirm the safety and effectiveness.

Comparison of Cervical Alignment and Clinical Outcomes in Patients with Os Odontoideum versus Non-Os Odontoideum after Atlantoaxial Fixation

OBJECTIVE: The purpose of this study was to compare the effect of atlantoaxial fixation on cervical alignment and clinical outcomes in patients with os odontoideum (OO) versus non-os odontoideum (non-OO). METHODS: A total of 119 patients who underwent atlantoaxial fixation for instability were identified between January 1998 and January 2014. Inclusion criteria included age more than 21 years and diagnosis of OO and non-OO. There were 22 OO patients, and 20 non-OO patients. Measuring the Oc–C1 Cobb angle, C1–2 Cobb angle, C2–7 Cobb angle, and C2–7 sagittal vertical axis (SVA) was assessed. Clinical outcome was assessment of suboccipital pain was determined using a visual analogue scale (VAS), and Japanese Orthopedic Association (JOA) scores were obtained in all patients pre- and postoperatively. RESULTS: The preoperative C1–2 angle in the OO group (26.02°±10.53°) was significantly higher than the non-OO group (p=0.04). After C1–2 fixation, the OO group had significantly higher kyphotic change in the C1–2 angle (ΔC1–2) (3.2°±7.3° [OO] vs. −1.46°±7.21° [non-OO]) (p=0.04), and higher decrease in postoperative C2–7 SVA (ΔC2–7 SVA) (5.64±11.56 mm [OO] vs. −0.51± 6.57 mm [non-OO]) (p=0.04). Both groups showed improvements in the health related quality of life (HRQOL) after surgery based on the VAS and JOA score (p < 0.001). CONCLUSION: After fixation, kyphotic angular change in atlantoaxial joint and decrease C2–7 SVA were marked in the OO group. Both the OO and non-OO groups improved in neurological function and outcome after surgery.

Middle Meningeal Artery Embolization in Recurrent Chronic Subdural Hematoma Combined with Arachnoid Cyst / 대한신경손상학회지

Chronic subdural hematoma (CSDH) is a collection of old blood and its breakdown products between the surface of the brain parenchyma and the outermost layer called the dura. The most common treatment option for primary CSDH is burr-hole trephination; however, the treatment method for recurrent CSDH is still widely debated. An arachnoid cyst (AC) is a sac filled with cerebrospinal fluid located between the brain or spinal cord and the arachnoid membrane, which is one of the three meninges covering the brain or spinal cord. Although it is rare, the cyst is associated with CSDH in juveniles, and the recurrence rate of CSDH increases in such cases. Much of the literature has supported the preventive role of middle meningeal artery (MMA) embolization in recurrent CSDH. We report a 13-year-old male patient with recurrent CSDH and AC where the early intervention of MMA embolization was proven effective in preventing the further recurrence of CSDH.

Clinical Analysis of Delayed Surgical Epidural Hematoma / 대한신경손상학회지

OBJECTIVE: A small epidural hematoma (EDH) that has been diagnosed to be nonsurgical by initial brain computed tomography (CT) can increase in size and need surgical removal, resulting in a poor prognosis. However, there have been few studies, which focused delayed operated EDH. Therefore, we analyzed the clinical factors to determine the predicting factors of delayed operated EDH. METHODS: Between January 2011 and January 2014, 90 patients, who were admitted due to EDH, were enrolled in this study. None of the patients were indicated for operation initially. Based on the presence of surgery, we classified the patients into a delayed-surgery group (DG) and a non-surgical group (NG). Additionally, we analyzed them according to the following: time interval between the trauma and the initial CT, gender, age, medical history, drinking, change of mean arterial pressure (MAP), volume of EDH and other traumatic brain lesion. RESULTS: Among the 90 patients, the DG was 19 patients. Compared with NG, the DG revealed increased MAP, less presence of drinking, and a short time interval (DG vs. NG: +9.684 mm Hg vs. -0.428 mm Hg, 5.26% vs. 29.58%, 1.802 hours vs. 5.707 hours, respectively, p<0.05). Analyzing the time interval with receiver operating characteristic, there was 88.2% sensitivity and 68.3% specificity at the 2.05-hour cut-off value (area under the curve=0.854). CONCLUSION: According to our results, the time interval between the trauma and the initial CT along with blood pressure change are potential predicting factors in the cases of delayed operation of EDH.