Test protocols for evaluation of spinal implants.

Abstract

Prior to implantation, medical devices are subjected to rigorous testing to ensure safety and efficacy. A full battery of testing protocols for implantable spinal devices may include many steps. Testing for biocompatibility is a necessary first step. On selection of the material, evaluation protocols should address both the biomechanical and clinical performance of the device. Before and during mechanical testing, finite element modeling can be used to optimize the design, predict performance, and, to some extent, predict durability and efficacy of the device. Following bench-type evaluations, the biomechanical characteristics of the device (e.g., motion, load-sharing, and intradiscal pressure) can be evaluated with use of fresh human cadaveric spines. The information gained from cadaveric testing may be supplemented by the finite element model-based analyses. Upon the successful completion of these tests, studies that make use of an animal model are performed to assess the structure, function, histology, and biomechanics of the device in situ and as a final step before clinical investigations are initiated. The protocols that are presently being used for the testing of spinal devices reflect the basic and applied research experience of the last three decades in the field of orthopaedic biomechanics in general and the spine in particular. The innovation within the spinal implant industry (e.g., fusion devices in the past versus motion-preservation devices at present) suggests that test protocols represent a dynamic process that must keep pace with changing expectations. Apart from randomized clinical trials, no single test can fully evaluate all of the characteristics of a device. Due to the inherent limitations of each test, data must be viewed in a proper context. Finally, a case is made for the medical community to converge toward standardized test protocols that will enable us to compare the vast number of currently available devices, whether on the market or still under development, in a systematic, laboratory-independent manner.