New Design Process for Anatomically Enhanced Osteosynthesis Plates.

This study evaluated the implementation and effectiveness of an iterative process aimed to quantify and enhance the anatomical fit of an osteosynthesis plate design for the fifth metacarpal bone regarding a defined shape-based acceptance criterion (SAC) while complying with basic clinical requirements and engineering limitations. The process was based on employing virtual tools (a database of individual three-dimensional bone models, statistical analysis of the bone geometry, and proprietary software tools) to evaluate conformity between plate designs and bone shape. The conformity was quantified by the mean distance between plate and bone (MBP). The enhancement was completed when the median MBP of the population was below the SAC threshold. This was fulfilled by the third plate design (two enhancement iterations). The intentionally abstract enhancement process may serve as a guideline for development of plate designs for other indications.