Surgical and clinical results with the PDN® prosthetic disc-nucleus device
Surgical and clinical results with the PDN® prosthetic disc-nucleus device
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DOI：
10.1007/s00586-002-0424-8
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发表时间：
2002-10-01
影响因子：
2.8
通讯作者：
Schönmayr, R
中科院分区：
文献类型：
--
作者：
Bertagnoli, R;Schönmayr, R
PDN假体椎间盘-髓核器械已在临床试验和商业销售中使用了6年。已收集并分析了该器械的手术和临床数据，以帮助确定植入物的强度和局限性。已发现器械的形状是预测手术成功的重要因素，楔形和矩形器械最稳定。患者的椎间盘尺寸也至关重要。数据表明，椎间盘高度小于5 mm的患者应排除手术。此外，椎间盘终板的前后（AP）直径必须为37 mm或更大，以便在椎间盘内正确放置两个器械-AP直径较小的患者应仅接受单个器械。体重和患者总体重也是手术成功的良好预测因素。如果患者的体重指数为30或更高，则患者不应接受植入物。与PDN植入物相关的并发症包括一些患者的器械移位和终板重塑。这种终板重塑通常是轻微的，并且是对载荷分布变化的反应。在少数病例中，椎间盘高度丢失导致更明显的重塑。为了最大限度地减少终板重塑，PDN水凝胶经过重新配制变得更软，可以吸收80%重量的水。在对器械设计和患者选择进行变更后，并引入ALPA（前外侧经腰肌入路）技术植入器械，手术成功率增加，同时翻修手术数量减少。从1999年到2001年植入的患者的当前手术成功率为88%。临床结果也非常令人鼓舞，奥斯韦斯特里和视觉模拟量表疼痛水平显著降低，椎间盘高度也显示出改善和稳定。
The PDN prosthetic disc-nucleus device has been in use for 6 years, both in clinical trials and through commercial sale. Surgical and clinical data for the device have been collected and analyzed to help determine the strengths and limitations of the implant. The shape of the device has been found to be an important element in predicting surgical success, with wedge and rectangular devices being the most stable. The patient's disc dimensions are also critically important. Data indicate that patients with a disc height of less than 5 rum should be excluded from surgery. Moreover, the anterior-posterior (AP) diameter of the disc endplates must be 37 mm or more in order to properly situate two devices within the disc - patients with a smaller AP diameter should receive only a single device. Body mass and overall patient weight are also good predictors of surgical success. If the patient's body mass index is 30 or greater, then the patient should not receive the implants. Complications related to the PDN implant have included migration of the device and endplate remodeling in some patients. This endplate remodeling has usually been mild, and has occurred in response to the change in load distribution. In a few cases there has been more pronounced remodeling with a loss of disc height. To minimize endplate remodeling, the PDN hydrogel has been reformulated to be softer, absorbing 80% of its weight in water. Subsequent to implementing changes in device design and patient selection, and with the introduction of the ALPA (Anterior-Lateral transPsoatic Approach) technique for implanting the devices, there has been an increase in surgical success with a concomitant reduction in the number of revision surgeries. The current surgical success rate for patients implanted from 1999 through 2001 is 88%. Clinical results are also very encouraging, with marked decreases in Oswestry and visual analog scale pain levels, and disc height also shows improvement and stabilization.