Development of a prosthetic intervertebral disc.

This article is a preliminary report of a 10-year investigation of the development of an intervertebral disc prosthesis. Spinal fusion is a method for the treatment of chronic, disabling low-back pain that does not respond to nonoperative treatments. Spinal fusion, however, has various adverse effects, and the results of spinal fusion are often unpredictable. The goal of this research project was to develop disc prostheses that have mechanical properties very similar to those of natural, normal discs. Two types of disc prosthesis, one with fiber-reinforced polyurethane and the other with multicomponent, non-fiber-reinforced polymers (C-Flex), have been designed and manufactured. The fiber-reinforced disc was made of polyurethane end-plates with A100 hardness, a homogenous nucleus with A40, and 12 layers of multidirectional (0, +45 degrees), fiber-reinforced anulus with A40 polyurethane. The design and modeling of the multicomponent polymers (non-fiber-reinforced) was made of C-Flex endplates with A90 hardness, a nucleus with A35 occupying 35% of the volume, and an anulus with 70A. Mechanical testing of these disc prostheses demonstrated similar mechanical properties to those of natural, normal discs.