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J Am Acad Orthop Surg, Vol 16, No 10, October 2008, 566-573.
© 2008 the American Academy of Orthopaedic Surgeons
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Randomized Controlled Trials of the Treatment of Lumbar Disk Herniation: 1983-2007

Paul A. Anderson, MD, Paul C. McCormick, MD, MPH and Peter D. Angevine, MD, MPH

Dr. Anderson is Professor, Department of Orthopedic Surgery and Rehabilitation, University of Wisconsin, Madison, WI. Dr. McCormick is Professor of Clinical Neurosurgery, Columbia University College of Physicians and Surgeons, New York, NY. Dr. Angevine is Assistant Professor of Neurological Surgery, Columbia University College of Physicians and Surgeons.

Dr. Anderson or a member of his immediate family has received royalties from Surgical Monitoring Associates and Pioneer Surgical; serves as a consultant to or is an employee of Medtronic Sofamar Danek, Pioneer Surgical, and Expanding Orthopedics; has received research or institutional support from Medtronic Sofamar Danek; and has stock or stock options in Titan Surgical, Pioneer Surgical, Expanding Orthopedics, and Crosstrees. Dr. Angevine or a member of his immediate family has received compensation for participation in a speakers bureau or presenting for Medtronic Sofamor Danek and Stryker. Neither Dr. McCormick nor a member of his immediate family has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article.

Reprint requests: Dr. Anderson, Department of Orthopedic Surgery and Rehabilitation, University of Wisconsin, 600 Highland Avenue K4/736, Madison, WI 53792.

Randomized controlled trials are considered to provide the strongest data regarding the relative benefits of treatment alternatives for medical conditions. Uncertainty persists regarding the optimal treatment of patients with symptomatic lumbar disk herniation. Five randomized controlled trials were published between 1983 and 2007 that compared lumbar diskectomy with nonsurgical treatment. The studies enrolled more than 1,000 patients. Inclusion and exclusion criteria were generally similar, but there was substantial variation in the outcomes measurements used. In all studies, more than one third of patients assigned to nonsurgical care crossed over to have surgery. Crossover in the opposite direction ranged from 0% to almost 40%. As a result of the large number of crossovers, the estimated treatment effect size of diskectomy likely is underestimated. Valid inferences about the safety and effectiveness of continued nonsurgical care cannot be made. The use of frequentist statistical techniques threatens the validity of post hoc subgroup analysis. Large cohort studies and alternative statistical techniques may yield more accurate estimates of the effectiveness of lumbar diskectomy and aid in identifying patients who may benefit from early surgical intervention.






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Copyright © 2008 by the American Academy of Orthopaedic Surgeons.