Why off-the-shelf clavicle plates rarely fit: anatomic analysis of the clavicle through statistical shape modeling

Background: The clavicle presents a large variability in its characterizing sigmoid shape. Prominent and nonproperly fitting fixation plates (FP) cause soft tissue irritation and lead to hardware removal. It is therefore key in FP design to account for shape variations. Statistical shape models (SSMs) have been built to analyze a cluster of complex shapes. The goal of this study was to describe the anatomic variation of the clavicle using SSMs. Methods: Two different SSMs of the clavicle were created, and their modes of variation were described. One model contained 120 left male and female clavicles. The other model consisted of 76 left and corresponding right clavicles, 41 originating from men and 35 from women. Results: The model of 120 left clavicles showed that 10 modes of variation are necessary to explain 95% of the variation. The most important modes of variation are the clavicle length, inferior-superior bow, and medial and lateral curvature. Statistically significant differences between male and female clavicles were seen in length, sigmoid shape, and medial curvature. Comparison in men between left and right revealed significant differences in length and medial curvature. For women, a statistically significant difference between left and right was only seen in the length. Conclusions: Although the operative treatment of displaced midshaft clavicular fractures has clear benefits, the variable anatomy of the clavicle often makes it challenging for the surgeon to make the plate fit adequately. Based on the identified variability in the clavicle's anatomy, it seems unlikely that a clavicle plating system can fit the entire population. (C) 2018 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved.