Simmons J W, Andersson G B, Russell G S, Hadjipavlou A G
Alamo Bone & Joint Clinic, San Antonio, Texas 78229, USA.
J Spinal Disord. 1998 Oct;11(5):367-74.
The objective of this research was to determine the efficacy and safety of an experimental instrumentation device designed for transpedicular spinal fixation by evaluating fusion rates and clinical pain and function scores; to determine complication rates associated with the device; and to compare the obtained data with that previously published in the literature. Four hundred forty-two consecutive patients were enrolled in this 4-year, Food and Drug Administration-monitored investigational device exemption trial to undergo surgery for implantation of the device. Eighteen surgeons at 11 nationwide medical centers performed the operations and subsequent evaluations. The study population was derived from three diagnostic categories: degenerative disc disease, multioperated back, and vertebral fracture. The data source consisted of radiographs, clinical examination, and structured forms and questionnaires. Patients were evaluated preoperatively, intraoperatively, and postoperatively at 3, 6, 12, and 24 months. By the 24-month postoperative interval, attrition had reduced the study population to 342 patients, among whom bony fusion was obtained in 91.5%. Pain scores demonstrated a statistically significant improvement in clinical outcome. Intraoperative complications occurred in 21.9% of patients. Of the 442 study patients, 2.9% experienced device-related complications. Moreover, a total of 2,304 screws and bolts were implanted in this patient population. Of these, 0.39% were reported to have fractured. Among the 342 study patients observed during 24 months, the breakage rate of device components (bolt or screw) was 2.63%. These data compare favorably to existing reports of spinal arthrodesis effected with other types of instrumentation and without device implantation. In a 4-year trial, the experimental transpedicular fixation instrumentation produced successful spinal fusion in the majority of our study population, with acceptable complication rates.
本研究的目的是通过评估融合率以及临床疼痛和功能评分，来确定一种设计用于经椎弓根脊柱固定的实验性器械装置的疗效和安全性；确定与该装置相关的并发症发生率；并将获得的数据与先前发表在文献中的数据进行比较。442例连续患者参与了这项为期4年、由美国食品药品监督管理局监测的研究器械豁免试验，接受该装置植入手术。全国11个医疗中心的18名外科医生进行了手术及后续评估。研究人群来自三个诊断类别：椎间盘退变疾病、多次手术的背部疾病和椎体骨折。数据来源包括X光片、临床检查以及结构化表格和问卷。对患者在术前、术中以及术后3个月、6个月、12个月和24个月进行评估。到术后24个月时，损耗使研究人群减少至342例患者，其中91.5%实现了骨融合。疼痛评分显示临床结果有统计学上的显著改善。21.9%的患者发生术中并发症。在442例研究患者中，2.9%出现与装置相关的并发症。此外，该患者群体共植入2304枚螺钉和螺栓。其中，据报告有0.39%发生骨折。在24个月观察期内的342例研究患者中，装置部件（螺栓或螺钉）的破损率为2.63%。这些数据优于其他类型器械且未植入装置的脊柱融合术的现有报告。在一项为期4年的试验中，实验性经椎弓根固定器械在我们的大多数研究人群中实现了成功的脊柱融合，并发症发生率可接受。
