A randomized prospective study of an anterior cervical interbody fusion device with a minimum of 2 years of follow-up results
A randomized prospective study of an anterior cervical interbody fusion device with a minimum of 2 years of follow-up results
复制标题
DOI：
10.3171/spi.2000.93.2.0222
复制
发表时间：
2000-10-01
影响因子：
4.1
通讯作者：
Hacker, RJ
中科院分区：
文献类型：
--
作者：
Hacker, RJ
Object.尽管技术上的变化，固有的问题仍然存在，目前的方法，颈椎前路融合。本研究旨在确定使用试验器械进行颈椎前路融合术治疗退行性颈椎间盘疾病是否安全有效，以及该器械是否优于现有技术。作为美国食品药品监督管理局器械研究的一部分，54例因单节段或两节段颈椎退行性椎间盘疾病导致的神经根病伴或不伴轻度脊髓病的患者被随机分组。显微手术椎间盘切除术后，对照组接受髂嵴植骨融合术治疗;实验研究组接受椎间融合器插入和局部自体植骨置入。所有患者均接受至少2年的术后随访，实验组和对照组的优良率分别为97%和88%。所有接受单节段椎间融合器置入的患者均实现了牢固融合，两组中均超过90%的患者在一个或两个节段实现了牢固融合。对照组中有31%的患者报告了慢性供区疼痛。在这项研究中，使用椎间融合器避免了供体部位的发病率，自体移植物的放置获得了很高的良好或优秀结果。椎间融合器似乎安全有效，其使用有助于避免当前颈椎前路融合技术中的一些固有问题。
Object. Despite variations in technique, inherent problems persist with current approaches to anterior cervical fusion. This study was performed to determine whether anterior cervical fusion performed using an investigational device was safe and effective in the treatment of degenerative cervical disc disorders and whether this device offered advantages over current techniques.Methods. Fifty-four patients with radiculopathy with or without mild myelopathy due to one- or two-level cervical degenerative disc disease were randomized as part of a Food and Drug Administration device study. Following microsurgical discectomy, the control group was treated with iliac crest graft fusion; the experimental study group underwent insertion of an interspace cage and placement of a local autograft. All patients received postoperative follow-up care for at least 2 years.Good or excellent results were found in approximately 97% of the experimental group and 88% of the control group. A solid fusion was achieved in all patients who underwent one-level cage placement, and a solid fusion at one or both levels was achieved in over 90% of both groups. Chronic donor site pain was reported by 31% of the control group.Conclusions. in this study, the use of an interbody fusion cage avoided donor site morbidity and placement of autograft achieved a high rate of good or excellent results. Interbody fusion cages appear safe and effective, and their use helps to avoid some of the inherent problems in performing current anterior cervical fusion techniques.