Wigfield C C, Nelson R J
Department of Neurosurgery, Frenchay Hospital, Bristol, United Kingdom.
Spine (Phila Pa 1976). 2001 Mar 15;26(6):687-94. doi: 10.1097/00007632-200103150-00027.
A review of the literature concerning the use of interbody fusion devices and materials in anterior cervical surgery.
To examine the evidence supporting the use of interbody fusion devices as an alternative to autologous bone after anterior cervical discectomy.
Concerns over the morbidity associated with harvesting autologous bone and the risk of transmissible infectious from allografts and xenografts have prompted the search for alternative methods of achieving interbody fusion. Several of these methods have been associated with an unacceptable rate of complications. The clinical and health economic implications of the widespread introduction of interbody fusion devices in the absence of sound evidence cannot be ignored.
A systematic review of the literature relating to cervical interbody fusion was undertaken. Studies were assessed critically with respect to their methodology, results, and conclusions.
Thirty-two clinical studies and 10 laboratory studies were analyzed. Methodologic weaknesses were identified in the majority. Only four clinical reports were either randomized or blinded or involved independent assessment of their outcomes. Fewer than half of the studies included a valid statistical analysis. Radiologic evidence of fusion was limited in many cases. There was little evidence that nonautologous fusion devices offered a reduction in the length of hospital stay. Autologous bone was as effective as, or superior to, many other fusion devices. The early results of some new fusion techniques used alone or in combination showed promise.
There is limited evidence supporting the use of a cervical interbody fusion device in place of autologous bone. There is a need to standardize the testing of implants with good quality laboratory work preceding clinical use. Certain devices including cages, some forms of hydroxyapatite, and bone morphogenic proteins merit further study.
对有关颈椎前路手术中椎间融合器及材料应用的文献进行综述。
探讨支持使用椎间融合器替代颈椎前路椎间盘切除术后自体骨的证据。
对自体骨采集相关发病率以及同种异体移植物和异种移植物传播感染风险的担忧促使人们寻找实现椎间融合的替代方法。其中一些方法与不可接受的并发症发生率相关。在缺乏充分证据的情况下广泛引入椎间融合器对临床和卫生经济学的影响不容忽视。
对与颈椎椎间融合相关的文献进行系统综述。从方法学、结果和结论方面对研究进行严格评估。
分析了32项临床研究和10项实验室研究。多数研究存在方法学缺陷。只有4份临床报告是随机或盲法的，或涉及对其结果的独立评估。不到一半的研究进行了有效的统计分析。在许多病例中，融合的影像学证据有限。几乎没有证据表明非自体融合器能缩短住院时间。自体骨与许多其他融合器一样有效或更优。一些单独或联合使用的新融合技术的早期结果显示出前景。
支持使用颈椎椎间融合器替代自体骨的证据有限。在临床使用前，需要通过高质量的实验室工作对植入物测试进行标准化。某些装置，包括椎间融合器、某些形式的羟基磷灰石和骨形态发生蛋白值得进一步研究。
