Development and Biomechanical Evaluation of an Anatomical 3D Printing Modularized Proximal Inter-Phalangeal Joint Implant Based on the Computed Tomography Image Reconstructions.

In this study, we developed a modularized proximal interphalangeal (PIP) joint implant that closely resembles the anatomical bone articular surface and cavity contour based on computed tomography (CT) image reconstruction. Clouds of points of 48 groups reconstructed phalanx articular surfaces of CT images, including the index, middle, ring, and little fingers, were obtained and fitted to obtain the articular surface using iterative closest points algorithm. Elliptical-cone stems, including the length, the major and minor axis at the stem metaphyseal/diaphyseal side for the proximal and middle phalanxes, were designed. The resurfacing PIP joint implant components included the bi-condylar surface for the proximal phalanx with elliptical-cone stem, ultra-high molecular weight polyethylene bi-concave articular surface for middle phalanx with hook mechanism, and the middle phalanx with elliptical-cone stem. Nine sets of modularized designs were made to meet the needs of clinical requirements and the weakness structure from the nine sets, that is, the worst structure case combination was defined and manufactured using titanium alloy three-dimensional (3D) printing. Biomechanical tests including anti-loosening pull-out strength for the proximal phalanx, elliptical-cone stem, and articular surface connection strength for the middle phalanx, and static/dynamic (25000 cycles) dislocation tests under three daily activity loads for the PIP joint implant were performed to evaluate the stability and anti-dislocation capability. Our experimental results showed that the pull-out force for the proximal phalanx implant was 727.8N. The connection force for the hook mechanism to cone stem of the middle phalanx was 49.9N and the hook mechanism was broken instead of stem pull out from the middle phalanx. The static dislocation forces/dynamic fatigue limits (pass 25000 cyclic load) of daily activities for piano-playing, pen-writing, and can-opening were 525.3N/262.5N, 316.0N/158N, and 115.0N/92N, respectively, and were higher than general corresponding acceptable forces of 19N, 17N, and 45N from the literatures. In conclusion, our developed modularized PIP joint implant with anatomical articular surface and elliptical-cone stem manufactured by titanium alloy 3D printing could provide enough joint stability and the ability to prevent dislocation.