AccScience Publishing / IJB / Online First / DOI: 10.36922/IJB025310312
RESEARCH ARTICLE
Early Access

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

Zhaoyang Ran1,2,3† Boran Pang1,2,3† Yulin Tian4 Dinghao Luo1,2,3 Junxiang Wu1,2,3 Lei Wang1,2,3 Kai Xie1,2,3 Jingke Fu1,2,3 Liang Deng1,2,3* Wei Li4* Yongqiang Hao1,2,3*
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1 Shanghai Key Laboratory of Orthopaedic Implants, Department of Orthopaedic Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
2 Clinical and Translational Research Center for 3D Printing Technology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
3 Shanghai Engineering Research Center of Innovative Orthopaedic Instruments and Personalized Medicine, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
4 School of Materials Science and Engineering, Shanghai Jiao Tong University, Shanghai, China
†These authors contributed equally to this work.
Received: 7 July 2025 | Accepted: 21 August 2025 | Published online: 25 August 2025
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
Abstract

The functional reconstruction of complex pelvic defects has remained a globally recognized challenge. To address this challenge, a personalized 3D-printed tantalum-coated titanium alloy pelvic reconstruction prosthesis was independently developed, aiming to enhance the osteogenic activity of existing titanium alloy prostheses. This study was designed to determine the efficacy, safety, and early clinical outcomes of this novel prosthesis. A prospective randomized controlled trial enrolled 21 patients with complex pelvic defects who met the inclusion and exclusion criteria. The patients were randomly divided into an experimental group (11 cases of personalized 3D-printed tantalum-coated titanium alloy pelvic reconstruction prostheses) and a control group (10 cases of uncoated prostheses). Personalized 3D-printed titanium alloy pelvic reconstruction prostheses were designed and fabricated using preoperative patient imaging data. Prostheses in the experimental group underwent plasma immersion ion implantation (PIII) to deposit an approximately 15μm tantalum coating. After post-treatment and sterilization, the prepared prosthesis was installed accurately according to the plan during the operation. After operation, the prosthesis was examined by imaging, and the surgical time, intraoperative blood loss and abnormal laboratory indexes were compared between the two groups. Regular postoperative follow-up assessments were conducted, with all postoperative complications systematically documented during the follow-up period. Postoperative imaging evaluation was performed to comparatively analyze bone ingrowth at the prosthesis-bone interface between the two groups. Harris Hip Score was used to evaluate the lower limb function of the two groups at the last follow-up. All 21 procedures were successfully completed with primary wound healing and no early complications. All patients were followed up, with an average follow-up time of 15.1±7.1 months. There was no statistically significant difference in the comparison of operation time, intraoperative blood loss, and abnormal laboratory indexes between the two groups of patients (P>0.05). The shape of the pelvic reconstruction prosthesis was highly matched with the bone defect in all patients, and the stability was good. One patient in the experimental group experienced periprosthetic infection and one patient experienced dislocation of the artificial femoral head; Two cases of periprosthetic infection and one case of artificial femoral head dislocation occurred in the control group of patients. At final follow-up, the Harris Hip Score was significantly higher in the experimental group compared to the control group, and the difference was statistically significant (P<0.01); The excellent/good rate of bone ingrowth at the prosthesis-bone interface was significantly higher in the experimental group (90.9%) than in the control group (30.0%, P<0.001).The independently developed personalized 3D-printed tantalum-coated titanium alloy pelvic reconstruction prosthesis, fabricated using PIII technology, which can promote bone ingrowth, enhance the stability of the prosthesis, improve lower limb function of patients, represents an effective approach for reconstructing complex pelvic defects.

Keywords
3D-printing
Titanium alloy
Tantalum coating
Pelvic reconstruction prosthesis
Complex pelvic defect
Funding
This work was financially supported by National Key Research & Development Program of China (2022YFC2406000), National Natural Science Foundation of China (82273489 and 52401056), 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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International Journal of Bioprinting, Electronic ISSN: 2424-8002 Print ISSN: 2424-7723, Published by AccScience Publishing