Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
نویسندگان
چکیده
منابع مشابه
Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
BACKGROUND Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. METHODS In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, w...
متن کاملNeurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc
abnormalities and degeneration in the intervertebral disc. The associated pathological entities include herniation of the nucleus pulposus, DDD, and segmental instability. In recent years, the diagnostic accuracy and description of these abnormalities have been aided by the development of water-soluble myelography, MR imaging, provocative discography, diagnostic blocks, and high-resolution CT s...
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BACKGROUND The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumbar artificial disc replacement to fusion. The results of the investigational device exemption (IDE)...
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چکیده ندارد.
15 صفحه اولFive-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial.
OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study repor...
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ژورنال
عنوان ژورنال: International Journal of Spine Surgery
سال: 2007
ISSN: 2211-4599
DOI: 10.1016/sasj-2006-0004-rr