지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2021.1
- 수록면
- 177 - 183 (7page)
이용수
초록· 키워드
오류제보하기
Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. Conclusions: Further studies such as randomized controlled trials are needed to validate the findings.
목차
등록된 정보가 없습니다.
참고문헌 (17)
참고문헌 신청
Proietti L / 2013 / Complications in lumbar spine surgery : a retrospective analysis / Indian J Orthop 47:340~345
Hartman J / 2019 / The use of Vertiflex® interspinous spacer device in patients with lumbar spinal stenosis and concurrent medical comorbidities / Cureus 11:e5374
Manufacturer and User Facility Device Experience / U.S. Food and Drug Administration
Tamura T / 2012 / Omeprazole-and esomeprazole-associated hypomagnesaemia : data mining of the public version of the FDA Adverse Event Reporting System / Int J Med Sci 9:322~326
van Puijenbroek EP / 2001 / Determinants of signal selection in a spontaneous reporting system for adverse drug reactions / Br J Clin Pharmacol 52:579~586
Hartman J / 2019 / The use of Vertiflex® interspinous spacer device in patients with lumbar spinal stenosis and concurrent medical comorbidities / Cureus 11:e5374
Manufacturer and User Facility Device Experience / U.S. Food and Drug Administration
Tamura T / 2012 / Omeprazole-and esomeprazole-associated hypomagnesaemia : data mining of the public version of the FDA Adverse Event Reporting System / Int J Med Sci 9:322~326
van Puijenbroek EP / 2001 / Determinants of signal selection in a spontaneous reporting system for adverse drug reactions / Br J Clin Pharmacol 52:579~586
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