Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

Importancia y uso:

5.1 Facet Prosthesis Components—The facet replacement may comprise a variety of shapes and configurations. Its forms may include, but are not limited to, ball-and-socket articulating joints, joints having a free-floating or semi-constrained third body, metallic load-bearing surfaces, and spring and dampening mechanisms. Additionally, it may have a unilateral or bilateral design.

5.2 These test methods are designed to quantify the static and dynamic characteristics of different designs of FPs. The tests are conducted in vitro in order to allow for analysis of individual devices and comparison of the mechanical performance of multiple designs.

5.3 The loads applied to the FP may differ from the complex loading seen in vivo, and therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance in different devices.

5.4 Fatigue testing in a simulated body fluid or saline may cause fretting, corrosion, or lubricate the interconnections and thereby affect the relative performance of tested devices. This test should be conducted in a 0.9 % saline environmental bath at 37 °C at a maximum rate of 10 Hz for metallic devices and 2 Hz for non-metallic devices. Other test environments such as a simulated body fluid, a saline drip or mist, distilled water, other type of lubrication or dry could also be used with adequate justification. Likewise, alternative test frequencies may be used with adequate justification to ensure that they do not impact the device performance.

5.5 It is well known that the failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing these parameters (for example, frequency, material, or environment), care should be taken to allow for appropriate interpretation of the results. In particular, it may be necessary to assess the influence of test frequency on device fracture while holding the test environment, implant materials and processing, and implant geometry constant.

Subcomité:

F04.25

Referida por:

F3292-25

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

dynamic stabilization; dynamic test; facet arthroplasty; posterior instrumentation; spinal implants; static test;