Standard Test Methods for Sacroiliac Joint Fusion Devices

Importancia y uso:

4.1 The function of the SIJ fusion device assembly is to stabilize the SIJ to facilitate arthrodesis of the motion segment. This test method outlines materials and methods for the characterization and evaluation of the mechanical performance of different SIJ fusion device assemblies so that comparisons can be made between different designs.

4.2 These test methods are designed to quantify the static and dynamic characteristics of different designs of SIJ fusion device assemblies. These tests are conducted in vitro to allow for analysis and comparison of the mechanical performance of SIJ fusion device assemblies to specific force modalities.

4.3 The forces applied to the SIJ fusion device assemblies during the tests described herein 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 of different SIJ fusion device assemblies.

4.4 Since the environment may affect the dynamic performance of SIJ fusion device assemblies, dynamic testing in a saline environment may be considered for implants with wearing surfaces or with movable components or for implants with components that are temperature dependent. Fatigue tests should first be conducted in air (at ambient temperature) for comparison purposes since the environmental effects could be significant. If a simulated in vivo environment is necessary, the investigator should consider testing in a saline environmental bath at 37 °C (for example, 0.9 g NaCl per 100 mL water). A simulated body fluid, a saline drip or mist, distilled water, or other type of lubrication at 37 °C could also be used with adequate justification.

4.5 If the devices are known to be temperature and environment dependent, testing should be conducted in physiologic solution as described in 4.4. Devices that require physiologic solution for testing should be tested in the same type of solution for comparison purposes.

4.6 The location within the simulated joint space and position of the SIJ fusion device assembly with respect to the loading axis will be dependent upon the design, the manufacturer’s recommendation, or the surgeon’s preferred method for implant placement.

4.7 It is well known that failure of materials is dependent upon stress, test frequency, surface treatments, and environmental factors. Therefore, when determining the effect of changing one of these parameters (for example, frequency, material, or environment), all others must be kept constant to facilitate interpretation of results.

Subcomité:

F04.25

Referida por:

F3292-25

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prosthetics and orthotics)

Palabras clave:

dynamic test methods; sacroiliac joint (SIJ) fusion device; SIJ implants; static test methods;