The American journal of orthopedics
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The Food and Drug Administration (FDA) does more than regulate food and drug products. Through its medical device evaluation process, FDA affects every orthopedic surgeon's practice and every orthopedic patient every day. FDA regulations affect the development of each orthopedic device in some way, from the product's inception to its senescence, but the regulatory process and what the FDA's stamp of approval means are not part of the curriculum in medical school or residency. ⋯ How different types of devices get to the patient are reviewed, and the basics of the regulatory process are explained in this paper. Common myths are set straight, and FDA's concerns with "off-label" use are discussed. The role of the orthopedic surgeon in the regulatory process is also introduced.
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This comprehensive review article encompasses a broad variety of topics within the spinal literature and includes an update on the latest technology and techniques for the spine.
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Treatment of high-grade isthmic and dysplastic spondylolisthesis in children and adolescents remains a challenge. Surgical treatment of spondylolisthesis has been recommended in adolescents with pain refractory to nonoperative modalities, slippage progression, or > 50% slippage on presentation. Controversy exists as to the optimal surgical approach for high-grade spondylolisthesis. ⋯ Each patient received treatment consisting of decompression, reduction, and circumferential fusion with transpedicular and segmental fixation from a posterior approach. Two patients had transient L5 nerve root deficit, which resolved within 3 months. Reduction benefits include a decrease in shear stresses (and resulting decreased rates of postoperative pseudarthrosis and slip progression), restoration of sagittal alignment and lumbosacral spine balance, and improvement in clinical deformity.