1.A Morphologically Atypical Case of Atlantoaxial Rotatory Subluxation.
Daisuke UMEBAYASHI ; Masahito HARA ; Yusuke NISHIMURA ; Toshihiko WAKABAYASHI
Journal of Korean Neurosurgical Society 2014;55(5):284-288
A rare case of atlantoaxial rotatory subluxation occurred after pediatric cervical spine surgery performed to remove a dumbbell-shaped meningioma at the level of the C1/C2 vertebrae. This case is classified as a post-surgical atlantoaxial rotatory subluxation, but has a very rare morphology that has not previously been reported. Although there are several reports about post-surgical atlantoaxial rotatory subluxation, an important point of this case is that it might be directly related to the spinal cord surgery in C1/C2 level. On day 6 after surgery, the patient presented with the Cock Robin position, and a computed tomography scan revealed a normal type of atlantoaxial rotatory subluxation. Manual reduction was performed followed by external fixation with a neck collar. About 7 months after the first surgery, the subluxation became severe, irreducible, and assumed an atypical form where the anterior tubercle of C1 migrated to a cranial position, and the posterior tubercle of C1 and the occipital bone leaned in a caudal direction. The pathogenic process suggested deformity of the occipital condyle and bilateral C2 superior facets with atlantooccipital subluxation. A second operation for reduction and fixation was performed, and the subluxation was stabilized by posterior fixation. We encountered an unusual case of a refractory subluxation that was associated with an atypical deformity of the upper spine. The case was successfully managed by posterior fixation.
Congenital Abnormalities
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Humans
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Meningioma
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Neck
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Occipital Bone
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Songbirds
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Spinal Cord
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Spine
2.Biomechanical Analysis of a Pedicle Screw-Rod System with a Novel Cross-Link Configuration.
Yasuhiro NAKAJIMA ; Masahito HARA ; Daisuke UMEBAYASHI ; Shoichi HAIMOTO ; Yu YAMAMOTO ; Yusuke NISHIMURA ; Toshihiko WAKABAYASHI
Asian Spine Journal 2016;10(6):993-999
STUDY DESIGN: The strength effects of a pedicle screw-rod system supplemented with a novel cross-link configuration were biomechanically evaluated in porcine spines. PURPOSE: To assess the biomechanical differences between a conventional cross-link pedicle screw-rod system versus a novel cross-link instrumentation, and to determine the effect of the cross-links. OVERVIEW OF LITERATURE: Transverse cross-link systems affect torsional rigidity, but are thought to have little impact on the sagittal motion of spinal constructs. We tested the strength effects in pullout and flexion-compression tests of novel cross-link pedicle screw constructs using porcine thoracic and lumbar vertebrae. METHODS: Five matched thoracic and lumbar vertebral segments from 15 porcine spines were instrumented with 5.0-mm pedicle screws, which were then connected with 6.0-mm rods after partial corpectomy in the middle vertebral body. The forces required for construct failure in pullout and flexion-compression tests were examined in a randomized manner for three different cross-link configurations: un-cross-link control, conventional cross-link, and cross-link passing through the base of the spinous process. Statistical comparisons of strength data were analyzed using Student's t-tests. RESULTS: The spinous process group required a significantly greater pullout force for construct failure than the control group (p=0.036). No difference was found between the control and cross-link groups, or the cross-link and spinous process groups in pullout testing. In flexion-compression testing, the spinous processes group required significantly greater forces for construct failure than the control and cross-link groups (p<0.001 and p=0.003, respectively). However, there was no difference between the control and cross-link groups. CONCLUSIONS: A novel cross-link configuration that features cross-link devices passing through the base of the spinous processes increased the mechanical resistance in pullout and flexion-compression testing compared to un-cross-link constructs. This configuration provided more resistance to middle-column damage under flexion-compression testing than conventional cross-link configuration.
Lumbar Vertebrae
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Pedicle Screws
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Spinal Fusion
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Spine
3.Recommendations for Conducting Post-Marketing Database Study in Japan Based on the Critical Appraisal of Published Articles from Overseas Real-World Data (RWD) Analyses
Shinichi MATSUDA ; Nobuyuki FUKADA ; Masahito OISHI ; Hiroaki OKA ; Ryousuke HARA ; Ai KOJIMA ; Shun NAKANO ; Katsuaki MOTOYOSHI ; Shigeki IGARASHI ; Yuko SASAKI ; Natsuko KAMEYAMA ; Kazuhiro KUBOTA
Japanese Journal of Pharmacoepidemiology 2021;26(1):41-54
Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan; however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.