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Purpose: We investigate an application of multisource extremity Cone-Beam CT (CBCT) with capability of weight-bearing tomographic imaging to obtain quantitative measurements of load-induced deformation of metal internal fixation hardware (e.g. tibial plate). Such measurements are desirable to improve the detection of delayed fusion or non-union of fractures, potentially facilitating earlier return to weight-bearing activities. Methods: To measure the deformation, we perform a deformable 3D-2D registration of a prior model of the implant to its CBCT projections under load-bearing. This Known-Component Registration (KC-Reg) framework avoids potential errors that emerge when the deformation is estimated directly from 3D reconstructions with metal artifacts. The 3D-2D registration involves a free-form deformable (FFD) point cloud model of the implant and a 3D cubic B-spline representation of the deformation. Gradient correlation is used as the optimization metric for the registration. The proposed approach was tested in experimental studies on the extremity CBCT system. A custom jig was designed to apply controlled axial loads to a fracture model, emulating weight-bearing imaging scenarios. Performance evaluation involved a Sawbone tibia phantom with an ~4 mm fracture gap. The model was fixed with a locking plate and imaged under five loading conditions. To investigate performance in the presence of confounding background gradients, additional experiments were performed with a pre-deformed femoral plate placed in a water bath with Ca bone mineral density inserts. Errors were measured using eight reference BBs for the tibial plate, and surface point distances for the femoral plate, where a prior model of deformed implant was available for comparison. Results: Both in the loaded tibial plate case and for the femoral plate with confounding background gradients, the proposed KC-Reg framework estimated implant deformations with errors of <0.2 mm for the majority of the investigated deformation magnitudes (error range 0.14 - 0.25 mm). The accuracy was comparable between 3D-2D registrations performed from 12 x-ray views and registrations obtained from as few as 3 views. This was likely enabled by the unique three-source x-ray unit on the extremity CBCT scanner, which implements two off-central-plane focal spots that provided oblique views of the field-of-view to aid implant pose estimation. Conclusion: Accurate measurements of fracture hardware deformations under physiological weight-bearing are feasible using an extremity CBCT scanner and FFD 3D-2D registration. The resulting deformed implant models can be incorporated into tomographic reconstructions to reduce metal artifacts and improve quantification of the mineral content of fracture callus in CBCT volumes.
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