Personalized 3D-printed tantalum-coated titanium alloy pelvic reconstruction prosthesis for complex pelvic defects: A prospective randomized controlled trial

Abstract

The functional reconstruction of complex pelvic defects remains a global challenge. To address this, a personalized 3D-printed tantalum-coated titanium alloy pelvic reconstruction prosthesis was independently developed to enhance the osteogenic activity of existing titanium alloy prostheses. This prospective randomized controlled trial evaluated its efficacy, safety, and early clinical outcomes in 21 patients with complex pelvic defects. The patients were randomly assigned to an experimental group (11 cases of tantalum-coated prostheses) or a control group (10 cases of uncoated prostheses). The coated prostheses were designed using preoperative imaging data and coated with an approximately 15-μm tantalum coating through plasma immersion ion implantation. After post-treatment and sterilization, the prostheses were implanted during surgery. Operation time, intraoperative blood loss, and laboratory indices were recorded and compared between groups. Postoperative follow-up assessments included imaging assessments, complication monitoring, bone ingrowth analysis at the prosthesis–bone interface, and functional evaluation with the Harris Hip Score. All 21 surgeries achieved primary wound healing without early complications. Mean follow-up time was 15.1 ± 7.1 months. There was no significant difference in operation time, intraoperative blood loss, and abnormal laboratory indices. The prosthesis shape matched well with the bone defects, ensuring good stability. In the experimental group, one periprosthetic infection and one artificial femoral head dislocation occurred, compared to two periprosthetic infections and one dislocation in the control group. At final follow-up, the experimental group demonstrated significantly higher Harris Hip Scores (p < 0.01) and bone ingrowth rates (90.9% vs. 30.0% in control; p < 0.001). In conclusion, the personalized 3D-printed tantalum-coated titanium alloy pelvic reconstruction prosthesis effectively promotes bone ingrowth, enhances prosthesis stability, and improves lower limb function, representing an effective approach for reconstructing complex pelvic defects.

Keywords

3D printing / Complex pelvic defect / Pelvic reconstruction prosthesis / Tantalum coating / Titanium alloy

Funding

This work was financially supported by the National Key Research & Development Program of China (2024YFB3814700), National Key Research & Development Program of China (2022YFC2406000), National Natural Science Foundation of China (52401056), Shanghai Municipal Commission of Economy and Informatization (2024-GZL-RGZN-01023), Domestic Science and Technology Cooperation Projects of Shanghai Municipal Science and Technology Commission (24010701700), Key Research & Development Programs of Ningxia, China (2020BCH01001), Shanghai Engineering Research Center of Innovative Orthopedic Instruments and Personalized Medicine (19DZ2250200), Biomaterials and Regenerative Medicine Institute Cooperative Research Project, Shanghai Jiao Tong University School of Medicine (2022LHA01), 3-year Action Plan of Shenkang Development Center (SHDC2020CR2019B) and Shanghai Pujiang Program (23PJ1421600).

Conflict of Interest

The authors declare they have no competing interests.

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