Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices

Importancia y uso:

5.1 IBFDs can be single-piece or multicomponent designs and can be 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 Intra-operative IBFD assembly failures can result in significant clinical consequences.4 This test method outlines materials and methods for the comparative characterization and evaluation of the intra-operative impact performance of IBFD assemblies.

5.3 The impact forces applied during a surgical procedure may be highly variable and, therefore, the results from these tests may not directly predict in vivo performance. The results, however, can be used to compare mechanical performance of different IBFD assemblies. The tests may also identify the weakest, most likely to fail points in particular IBFD-inserter combinations, thus enabling design improvements.

5.4 Intra-operative clinical failures may be due to several factors, some of which may not be simulated in the current method. For example, off-axis impact loads applied to the IBFD assembly are not simulated in the current method yet may contribute to intra-operative clinical failures in some designs. The user of this standard should consider incorporating such factors into their evaluations.

Subcomité:

F04.25

Volúmen:

13.02

Palabras clave:

IBFD; impact; insertion; spinal cage fracture; spinal implants;