Vaccaro AR, Garfin SR
Department of Orthopaedic Surgery, Jefferson Medical College of Thomas Jefferson University, Philadelphia.
J Am Acad Orthop Surg. 1995 Oct;3(5):263-274. doi: 10.5435/00124635-199509000-00002.
This article provides a perspective on the development of pedicle-screw fixation in the lumbar spine, the biomechanics of its application, the possible complications, and the scientific evidence that supports specific applications in selected disorders. The overall goal is to objectify the debate currently surrounding the use of these devices. Lumbar-pedicle fixation devices are currently considered class III med-ical devices. According to the Food and Drug Administration, such devices are investigational or experimental, have not been proved safe and effective, and may potentially pose a risk to patients.
本文阐述了腰椎椎弓根螺钉固定技术的发展、应用的生物力学、可能出现的并发症以及支持其在特定疾病中具体应用的科学依据。总体目标是使目前围绕这些器械使用的争论更加客观。腰椎椎弓根固定器械目前被视为III类医疗器械。根据美国食品药品监督管理局的规定，此类器械属于研究性或实验性的，尚未被证明安全有效，并且可能会对患者构成潜在风险。
