Current fixation plates used to operatively stabilize clavicular fractures are suboptimal, leading to reoperation rates up to 53%. Plate irritation, which can be caused by a poor geometric fit and plate thickness, has been found to be an important factor for reoperation. Moreover, muscle attachment sites (MAS) have to be detached occasionally. To improve current surgical clavicle fracture treatment with plate osteosynthesis, a change in plate design is required. The goal of this study was to design a patient-specific clavicle fracture fixation plate that includes geometrical optimization and stiffness determination. Its biomechanical performance has been compared with a commercial plate by examining the geometric fit, anatomical outline, stresses and interfragmentary motion using a finite element analysis with physiological loading and boundary conditions. Evaluation showed a better geometrical fit of the patient-specific plate as well as an improved fracture reduction. Displacements between fracture fragments were lower in case of the patient-specific plate, both when a fracture gap and no fracture gap were present. Results indicate a superior mechanical performance in terms of all investigated outcomes of the patient-specific plate compared to the commercial plate, while better aligning with the patient-specific geometry and without the need for MAS release. Due to the patient-specific geometry and reduced thickness, these fixation plates are expected to decrease the operation time, as intraoperative contouring will become irrelevant, and to decrease reoperation rates as implant irritation will be minimized.

Mechanical performance of clavicle fracture fixation plates is often evaluated using finite element (FE) analysis. Typically, these studies use simplified loading conditions and assume a transversal fracture orientation. However, the loading conditions and fracture orientation influence how the fracture site and thus fixation plate is loaded. In this study, a musculoskeletal model that included the clavicle muscles and scapulohumeral rhythm was defined based on previously published models. The standard OpenSim workflow (inverse kinematics, inverse dynamics, static optimization, and joint reaction analysis) was used to calculate muscle and joint contact forces based on 3D marker data collected in three subjects during seven activities of daily living (ADL). These loading conditions were then applied to a 3D clavicle model with three different fracture orientations and the mean resulting moments on both fragments were calculated to assess fracture stability. Magnitude of glenohumeral contact forces showed good agreement with instrumented shoulder prosthesis data, whereas simulated muscle activations were comparable to experimental EMG data. An oblique fracture orienting from superomedial to inferolateral was the least self-stabilizing. The loading to which the clavicle is exposed during ADL tasks is more complex than the simplified loading conditions typically used as boundary conditions in FE analyses of clavicle fracture fixation plates. Additionally, transversal fractures did not represent the least self-stabilizing fracture orientation, and thus calculated stresses in the plate could be underestimated. Therefore, more complex loading conditions and evaluation of a midshaft fracture running from superomedial to inferolateral is more relevant in FE analyses of midshaft clavicle fracture fixation plates.