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Tag Archives: NuVasive

Clinical Retrieval and Simulator Comparison of an Investigational Cervical Disc Replacement: An A Priori Requirement

The evolvement of cervical and lumbar disc replacement designs as alternatives to spinal fusion has resulted in a significant number of ongoing United States Food and Drug Administration (USFDA)-sponsored clinical trials. While these seek to establish “safety and effectiveness”, they are of limited in vivo duration and benefit from long-term benchtop comparison. To assure implant durability, mechanical and biological evaluation of these devices, particularly long-term fatigue behavior, is necessary. Both the ASTM and ISO have provided guidance in the evaluation of the performance of artificial spinal discs. These guides propose 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 the wear characteristics of an articulating cervical disc replacement during approximately 80 years of simulated loading in an electro-mechanical multi-axial spinal disc simulator with comparison to clinical retrievals. These results are useful in demonstrating the safety and effectiveness of this device and also present a pre-clinical evaluation methodology for future disc replacement designs.

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Posted in Spine| Tagged |

The Current State of Cervical and Lumbar Spinal Disc Arthroplasty

The growth of spinal implant and orthobiologic technologies over the last several years is increasing in tempo and fast approaching the US hip and knee markets in annual dollar sales. During this time, a number of start-up and established medical device manufacturers have focused increasing resources on solutions for spinal problems. The role of the orthopaedic and neurosurgeon in these enterprises as inventor, owner, and user has contributed to this march of progress. This handout describes a small (<1%), but increasingly visible, aspect of these advancing technologies, that of artificial disc replacement.

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