Prosthetic disc nucleus (PDN) replacement for lumbar disc herniation - Preliminary report with six months' follow-up

Prosthetic disc nucleus (PDN) replacement for lumbar disc herniation - Preliminary report with six months' follow-up
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DOI:
10.1097/00024720-200308000-00004
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发表时间:
2003-08-01
影响因子:
--
通讯作者:
Jiang, JM
Jiang, JM
中科院分区:
医学3区
文献类型:
--
作者:
Jin, DD;Qu, DB;Jiang, JM

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进行了一项临床随访研究,以评估腰椎间盘髓核置换术的临床和功能。目的是评估人工椎间盘髓核(PDN)治疗腰椎间盘突出症的临床疗效。 PDN 旨在治疗患有椎间盘突出和/或退变的患者。 PDN的临床试验于1996年首次进行,结果表明PDN装置对大多数植入的患者有效。这些研究是针对植入了一对设备的患者进行的。主要的复杂性是设备迁移。因此,设计了基于单个PDN装置植入的后续研究来评估其临床效果。 2002年3月至2002年12月,45例腰椎间盘突出症患者植入1台PDN装置。30例(66.7%)患者接受了为期6个月的临床、功能和影像学随访检查。通过仔细审查所有患者的图表、手术记录、术前和术后放射线照片、磁共振图像和随访记录来进行独立分析。植入后,很大一部分患者的疼痛得到缓解。疼痛强度、步行距离、腰椎活动度、神经无力、Oswestry 和 Prolo 评分以及椎间盘高度均有改善。 PDN植入后工作状态没有变化。与术前相比,椎间盘增加了19.7%(P < 0.001)。在任何患者中均未发现装置移位、故障和脱位。少数患者出现短暂低烧等轻微并发症。临床上首选单一PDN,可以有效增加腰椎间盘突出症患者的椎间盘高度。然而,PDN植入的长期随访仍需研究。
A clinical follow-up study was performed to evaluate lumbar disc nucleus replacement clinically and functionally. The objective was to assess the clinical efficacy of the prosthetic disc nucleus (PDN) for treatment of lumbar disc herniation. The PDN was designed to treat patients suffering from disc herniation and/or degeneration. Clinical trials for PDN were first conducted in 1996, and the results showed that the PDN device was effective in most of the patients who were implanted. These studies had been carried out with patients who were implanted with a pair of the devices. The main complication was device migration. Therefore, a follow-up study based on a single PDN device implantation was designed to evaluate its clinical result. Forty-five patients with lumbar disc herniation were implanted with one PDN device from March 2002 to December 2002. Thirty (66.7%) patients came to the clinical, functional, and radiographic 6-month follow-up examinations. Independent analysis was performed by careful review of the charts, operative notes, preoperative and postoperative radiographs, magnetic resonance images, and follow-up records of all patients. After implantation, significant proportions of patients experienced pain relief. Improvements were noted in pain intensity, walking distance, lumbar mobility, neurologic weakness, Oswestry and Prolo scores, and intervertebral disc height. No difference in work status after PDN implantation could be detected. Compared with the preoperative height, the interverilebral disc had gained 19.7% (P < 0.001). Device migration, failure, and dislocation were not noticed in any patient. A few patients had minor complications such as transient low-grade fever. Clinically, a single PDN is preferred and can effectively increase the height of the intervertebral disc in patients with lumbar disc herniation. However, long-term follow-up of PDN implantation needs to be studied.