Each year in the United States, approximately 200,000 patients receive spinal fusions to combat degenerative disc disease and begin the long, 15-month road to rehabilitation. Largely thanks to European innovation in artificial disc implantation however, the days of spinal fusion as a routine procedure may be numbered. The top two models of artificial disc, the SB Charité Artificial Disc and the ProDisc, are currently undergoing FDA-sponsored clinical trials and may be available to the American public as early as 2004.Orthopaedic surgeons have long sought a better method of replicating the spine’s natural function and flexibility. The development of the SB Charité Artificial Disc and ProDisc models represent the culmination of this process, and have advanced disc repair to the same level as hip or knee replacement technology. The parent models for both the SB Charité Artificial Disc and ProDisc were invented by Europeans in the 1980s, by German and French surgeons, respectively. Both devices are very similar in structure, featuring two endplates, and an inner pliable cushion. The endplates are formed of a cobalt chromium alloy, and grip the vertebrae above and below the missing disc. The inner cushion consists of a flexible, polyethylene core that mimics the mobility of a normal human disc. The devices can vary in endplate size, total height, and even angle to accommodate patient requirements.
As this technology has been available to Europeans since 1987, clinical studies have already documented the success of both the SB Charité Artificial Disc and ProDisc. Studies which have followed Italian, French, and Dutch recipients of SB Charité Artificial Discs report high patient satisfaction and no device failures in the years following surgery. Similarly, results for ProDisc implants found no device-related safety issues, complications, or adverse effects, and a 92.7% satisfaction level among recipients.
In addition to such studies reporting high satisfaction with artificial discs, the actual surgery requires only a relatively short recuperation time. The European experience has consisted of a short hospital stay of only 1-4 days, with rehabilitation beginning almost immediately, and normal activity levels resumed at a relatively fast pace. Such a quick recovery is clearly preferable to the 15 months of recuperation required after spinal fusion. Moreover, preliminary results released by the Texas Back Institute, which has been at the forefront of the US clinical trials, indicate that this high level of improvement is sustained during the 12 months following surgery.
Currently, the FDA considers both the SB Charité Artificial Disc and ProDisc "investigational devices." The US clinical trials for the SB Charité Artificial Disc began in March 2000, and were completed at the end of 2001. Pending the results of a 24-month follow-up with patients and review of the study, the FDA will announce their decision on the device in 2004. Similar trials for ProDisc began in 2001, and thus the FDA judgment on that model will probably come after the SB Charité Artificial Disc decision.
To read more about the SB Charité Artificial Disc, visit www.linkspinegroup.com.
To read more about the ProDisc, visit www.spinesolutionsinc.com.
Images courtesy Link Spine Group, Inc.
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