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The activL® Artificial Disc: a next-generation motion-preserving implant for chronic lumbar discogenic pain

机译:activL®人工椎间盘:用于慢性腰椎间盘源性疼痛的下一代运动保持植入物

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摘要

Degeneration of the lumbar intervertebral discs is a leading cause of chronic low back pain in adults. Treatment options for patients with chronic lumbar discogenic pain unresponsive to conservative management include total disc replacement (TDR) or lumbar fusion. Until recently, only two lumbar TDRs had been approved by the US Food and Drug Administration − the Charité Artificial Disc in 2004 and the ProDisc-L Total Disc Replacement in 2006. In June 2015, a next-generation lumbar TDR received Food and Drug Administration approval − the activL® Artificial Disc (Aesculap Implant Systems). Compared to previous-generation lumbar TDRs, the activL® Artificial Disc incorporates specific design enhancements that result in a more precise anatomical match and allow a range of motion that better mimics the healthy spine. The results of mechanical and clinical studies demonstrate that the activL® Artificial Disc results in improved mechanical and clinical outcomes versus earlier-generation artificial discs and compares favorably to lumbar fusion. The purpose of this report is to describe the activL® Artificial Disc including implant characteristics, intended use, surgical technique, postoperative care, mechanical testing, and clinical experience to date.
机译:腰椎间盘退变是成人慢性腰背痛的主要原因。对保守治疗无反应的慢性腰椎间盘源性疼痛患者的治疗选择包括全椎间盘置换术(TDR)或腰椎融合术。直到最近,美国食品和药物管理局仅批准了两个腰部TDR – 2004年的Charité人工椎间盘和2006年的ProDisc-L全椎间盘置换。2015年6月,下一代腰部TDR获得了美国食品药物管理局的批准。批准-activL ®人造椎间盘(Aesculap植入系统)。与上一代腰椎TDR相比,activL ®人工椎间盘具有特定的设计增强功能,可实现更精确的解剖结构匹配并允许一系列运动,从而更好地模仿健康的脊柱。机械和临床研究的结果表明,与早期的人工椎间盘相比,activL ®人工椎间盘可改善机械和临床结果,并且与腰椎融合术相比具有优势。本报告的目的是描述activL ®人工椎间盘,包括植入物的特性,预期用途,手术技术,术后护理,机械测试和迄今为止的临床经验。

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