The Potential Biomechanical Etiology for Lumbar Disc Replacement Failures: Review of 24 Patients and the Rationale for Revision

Rosen, Charles; Kiester, Douglas; Lee, Thay Q.
July 2007
Internet Journal of Minimally Invasive Spinal Technology;2007, Vol. 1 Issue 2, p2
Academic Journal
The Charite III artificial disc replacement was approved for use in the United States in October of 2004 by the FDA when Depuy Spine, the manufacturer, received their letter of conditional approval. Like all current models of lumbar disc replacements, the Charite may have been based on a faulty design that concluded the center of rotation of lumbar segmental motion was anterior to the spinal canal. As a result, numerous failures began quickly appearing and accumulating as time passed. The authors began seeing increasing numbers of patients who had both the Charite III, as well as the Prodisc II, implanted with poor results and complications. These included not only various fractures and dislocations, but, most disturbingly, patients in severe pain without any seemingly obvious radiographic abnormalities. These events had been either written off as surgeon error, "learning curve," or an unexplained event not related to device failure. This lack of a logical solution may have been re-enforced with a financial disincentive to find one, given that the design had been accepted, applied, and marketed at great expense to both industry and investors. This manuscript addresses the failures of lumbar disc replacements presenting to the UCI Spine Center in terms of their cause and treatment. The authors discuss the possible reasons and its lack of correction before FDA approval of disc replacements in the U.S. Specifically, the complications presenting to the University of California (UCI) Spine Center were compiled and analyzed. Attempts to determine the probable sources of pain from some of the disc replacements were made by diagnostic testing as well as direct surgical intervention. Ultimately, the concept of lumbar segmental motion was revisited so that the complications were explained. All previous biomechanical models that lead to the current concepts of spinal motion used mathematical assumptions that were well known to be unreliable and erroneous for the small degrees of angular measurement of segmental spinal motion. Additionally, some of the previous findings that are contrary to current assumptions were not considered. As a result, current disc replacements may be inherently flawed in their intended function.


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