Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Importancia y uso:

5.1 Intervertebral body fusion devices are generally simple geometric-shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.

5.2 This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.

5.3 The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.

5.4 The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.

Subcomité:

F04.25

Referida por:

F3631-24, F3292-19, F2789-10R20

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

intervertebral body fusion device; spinal implants; subsidence and static axial compression;