Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation

Importancia y uso:

4.1 Due to the variety of small bone fractures, plates used for the fixation of these fractures come in a variety of shapes and configurations. Table 1 categorizes the plate types for each anatomical area. Flat plates are the simplest; see Fig. 2 for an example of a basic flat plate. Many other plates have features to accommodate specific anatomies, such as condylar, complex (such as cuneiform), pre-contoured (such as metatarsophalangeal joint (MPJ)), step, orbital, orthognathic step, and wedge plates. Other plates, such as mesh-based and burr hole plates, are generally flat but are designed to be used in specific anatomical regions, so their designs are not the same as conventional straight plates. If test data is used from one type of plate for justification of the mechanical properties of another type of plate, this justification shall be described in the final report.

4.2 Most of the testing described herein is focused on a “functional unit,” which can be described as a single-line fracture being spanned by a plate with one screw hole on each side of the fracture. This configuration allows for the simplest determination of worst-case size if the strut geometry is the determining factor for the worst case. If a worst-case size cannot be isolated to a functional unit/strut geometry, perhaps due to irregular screw hole patterns or the shape of the plate, it is understandable that some tests would need to be modified, or possibly removed from test consideration, to accommodate the shape of the plate or the screw hole. Any test modifications or omissions shall be described in the final report with a rationale related to the plate’s anatomical use, indications, and functional requirements.

Subcomité:

F04.21

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prosthetics and orthotics)

Palabras clave:

bone plate; cranium; digits; extremities; fingers; jaw; lower face; mandible; midface; small bone fracture fixation; static testing; toes; upper face;