Artificial nucleus replacement - Clinical experience
Artificial nucleus replacement - Clinical experience
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DOI：
10.1097/00007632-200206150-00022
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发表时间：
2002-06-15
期刊：
影响因子：
3
通讯作者：
Ray, CD
中科院分区：
文献类型：
--
作者：
Klara, PM;Ray, CD
人工椎间盘髓核旨在帮助治疗患有退行性椎间盘疾病的患者。该器械由包裹在聚乙烯护套中的水凝胶芯组成，预期用于恢复椎间盘高度，同时允许正常活动范围。1996年首次进行了人工椎间盘髓核的临床试验，发现该装置对大多数植入的患者有效。1997-1998年的其他试验不太成功，38%的患者因器械移位需要翻修手术。随后对器械形状和手术方案进行了变更，以便于植入，从而消除了较高的器械移位率。经过这些修改，该设备的成功率大大提高。临床数据显示了极好的结果，奥斯韦斯特里和Prolo评分显著改善。总体而言，椎间盘高度测量值保持在正常生理范围内。这种人工椎间盘髓核装置目前正在加拿大进行临床试验，预计将于2001年秋季向食品和药物管理局提出IDE申请。
The prosthetic disc nucleus is designed to help treat patients suffering from degenerative disc disease. The device consists of a hydrogel core that is encased in a polyethylene jacket and is intended to restore disc height while permitting normal range of motion. Clinical trials for the prosthetic disc nucleus were first conducted in 1996, and the device was found to be effective in most of the patients that were implanted. Additional trials in 1997-1998 were less successful, with 38% of patients requiring revision surgery because of device migration. Subsequent changes were made to device shapes and to the surgical protocol to facilitate implantation, thereby eliminating the high device migration rates. Following these modifications, the success rate for the device has improved significantly. Clinical data show excellent results with marked improvements in Oswestry and Prolo scores. Overall, disc height measurements have been well maintained within normal physiologic ranges. The prosthetic disc nucleus device is currently undergoing clinical trials in Canada, and an IDE application to the Food and Drug Administration was expected in the fall, 2001.