Delamarter Rick B, Bae Hyun W, Pradhan Ben B
Spine Research Foundation, The Spine Institute at Saint John's Health Center, Suite 400, 1301 20th Street, Santa Monica, CA 90404, USA.
Orthop Clin North Am. 2005 Jul;36(3):301-13. doi: 10.1016/j.ocl.2005.03.004.
The much-awaited clinical use of lumbar artificial discs has begun in the United States. The United States Investigational Device Exemption (US IDE) clinical trial of the ProDisc-II prosthetic disc (Synthes, Paoli, PA) was recently completed, with all indications that it meets or surpasses the test of equivalence against fusion controls. This is a review of the clinical performance of the ProDisc-II artificial disc and includes an interim report from the US IDE trial at one site.
备受期待的腰椎人工椎间盘临床应用已在美国展开。ProDisc-II人工椎间盘（Synthes公司，宾夕法尼亚州波利）的美国 investigational Device Exemption（美国IDE）临床试验最近完成，所有迹象表明它达到或超过了与融合对照相比的等效性测试。本文是对ProDisc-II人工椎间盘临床性能的综述，并包括来自美国IDE试验一个站点的中期报告。
