A new ligament-compatible patient-specific 3D-printed implant and instrumentation for total ankle arthroplasty: from biomechanical studies to clinical cases

BACKGROUND: Computer navigation and patient-specific instrumentation for total ankle arthroplasty have still to demonstrate their theoretical ability to improve implant positioning and functional outcomes. The purpose of this paper is to present a new and complete total ankle arthroplasty customization process for severe posttraumatic ankle joint arthritis, consisting of patient-specific 3D-printed implant and instrumentation, starting from a ligament-compatible design. CASE PRESENTATION: The new customization process was proposed in a 57-year-old male patient and involved image analysis, joint modeling, prosthesis design, patient-specific implant and instrumentation development, relevant prototyping, manufacturing, and implantation. Images obtained from a CT scan were processed for a 3D model of the ankle, and the BOX ankle prosthesis (MatOrtho, UK) geometries were customized to best fit the model. Virtual in silico, i.e., at the computer, implantation was performed to optimize positioning of these components. Corresponding patient-specific cutting guides for bone preparation were designed. The obtained models were printed in ABS by additive manufacturing for a final check. Once the planning procedure was approved, the models were sent to final state-of-the-art additive manufacturing (the metal components using cobalt-chromium-molybdenum powders, and the guides using polyamide). The custom-made prosthesis was then implanted using the cutting guides. The design, manufacturing, and implantation procedures were completed successfully and consistently, and final dimensions and location for the implant corresponded with the preoperative plan. Immediate post-op X-rays showed good implant positioning and alignment. After 4 months, clinical scores and functional abilities were excellent. Gait analysis showed satisfactory joint moment at the ankle complex and muscle activation timing within normality. CONCLUSIONS: The complete customization process for total ankle arthroplasty provided accurate and reliable implant positioning, with satisfactory short-term clinical outcomes. However, further studies are needed to confirm the potential benefits of this complete customization process. LEVEL OF EVIDENCE: 5. Case report.