ORL Brochure

Evaluation of Total Disc Replacements with a Novel Multi-Axis Spine Simulator: An A Priori Requirement

Mar 8, 2007 | Spine

The evolvement of cervical and lumbar disc replacement designs as alternatives to spinal fusion has resulted in a significant number of ongoing FDA-sponsored clinical trials. While these seek to establish “safety and effectiveness”, they are of limited in vivo duration. To assure implant durability, mechanical and biological evaluation/testing of these devices, particularly long-term fatigue characteristics, is necessary. The ASTM has expressed an interest in the performance of artificial spinal discs in Standard Guide for the Functional, Kinematic, and Wear Assessment of Total Disc Prostheses (F 2423-05). This guidance proposed the biochemical environment, motions, and loading appropriate to simulate long-term use of prostheses employed in total disc arthroplasty. The parameters evaluated include wear measured by gravimetric weight loss, as well as changes in the articular surface shape and roughness to the extent that these may influence function. This handout describes a novel, electro-mechanical, multi-axial spinal disc simulator whose operation supplements the above and establishes a long-term fatigue and particulate characteristics for both articulating and non-articulating (elastomeric) spinal implant devices. It enables performance comparison between devices, and fulfills the pre-clinical evaluations of every FDA-sponsored clinical device trial.

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