The Spine Journal, Volume 2, Issue 6, November-December 2002, Pages 460-463
Scott L. Blumenthal, Donna D. Ohnmeiss, Richard D. Guyer, Stephen Hochschuler, Paul McAfee, Rolando Garcia, Richard Salib, Hansen Yuan, Casey Lee, Rudolph Bertagnoli, Vincent Bryan, Robert Winter
Subject
Lumbar Total Disc Replacement , New Technologies
Introduction
This is a synopsis of a symposium presented to the North American Spine Society Annual Meeting in Seattle, Washington, 2001.
To bring to the reader who may not have attended the symposium a distillation of the material presented on this frontier of spinal surgery.
Methods
Panel presentation.
Results
The proposed indication for artificial disc replacement is a degenerated but contained disc, painful to the point of major lifestyle interruption, refractory to at least one year of non-operative treatment, preferably at a single lumbar level and without infection, listhesis or major facet joint disease or spinal stenosis. Total disc replacements have been developed and used mostly in Europe. Disc nucleus replacements have also been developed. No disc replacement has been approved for general use in North America as yet. The U.S. Food and Drug Administration is conducting investigational device exemption studies at this time.
Conclusions
Artificial disc replacement is not a new concept, the first attempts having been done in the early 1950s. During the past 15 years, considerable advance has been made with large numbers of patients, mostly in Europe, having surgery with either total disc prostheses or disc nucleus replacements. Only with truly scientific studies using patient randomization, pre- and postsurgery outcome analyses by unbiased independent observers and statistical analysis by independent experts will the real value of these devices be realized.
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