• prodisc L has a very long clinical history (25+ years) and has been widely used throughout the world. The prodisc line of total disc replacements (TDRs) are the most widely studied TDRs, with over 400 peer-reviewed published studies, reporting on over 13,000 patients. The first implantation of a prodisc L took place in 1990, and the second generation design received US PMA approval in 2006.

• This page outlines some of the clinical studies, biomechanical, and cost-effectiveness evaluations that have been published on prodisc L.

• No other disc replacement system has been studied more: nearly 40% of all TDR papers report on prodisc. More published lives than for any other system with over 13,000 patients reported on in over 400 articles.

• The prodisc design has been validated with over 125,000 device implantations and a reported reoperation rate of less than 1%.

Maintaining Spinal Balance & Motion

Degenerative disc disease can be a segmental destabilizing process. In addition, conducting the surgical procedure to perform a discectomy is inherently destabilizing, since it involves the removal of the ALL, the disc, and often the PLL. In the absence of these restricting structures, it is important that a disc replacement have constraints, in order to protect the facet joints.

In order to provide constraint, the prodisc mechanism of action enables movement with a fixed center of motion, enabling A/P translation only with flexion / extension.

Decelerate Adjacent Level Reoperations

The ‘gold standard’ for treating degenerative disc disease is to conduct a fusion and fuse the joint. However, immobilizing a segment of the spine has been shown to increase the rate of adjacent level degeneration. By enabling motion, prodisc is intended to decelerate adjacent level degeneration. A paper published on the results with the US IDE PMA clinical study showed that, at five years follow-up, patients had 3.5 times more development of adjacent level disease with fusion than with prodisc L.