AccScience Publishing / IJB / Online First / DOI: 10.36922/IJB025310312
Submit to IJB
Cite this article
16
Download
337
Views
Journal Browser
Volume | Year
Issue
Search
Forthcoming Issue
Current Issue
View All
News and Announcements
View All
RESEARCH ARTICLE

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*
Show Less
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.
IJB, 025310312 https://doi.org/10.36922/IJB025310312
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/ )
Download PDF
XML
Cite
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.

Graphical abstract
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.
References
  1. Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011;42(Suppl 2):S3-S15. doi: 10.1016/j.injury.2011.06.015
  2. Campana V, Milano G, Pagano E, et al. Bone substitutes in orthopaedic surgery: from basic science to clinical practice. J Mater Sci Mater Med. 2014;25(10):2445-2461. doi: 10.1007/s10856-014-5240-2
  3. Ran ZY, Wang Y, Li JX, et al. 3D-printed biodegradable magnesium alloy scaffolds with zoledronic acid-loaded ceramic composite coating promote osteoporotic bone defect repair. Int J Bioprinting. 2023;9(5):401-417. doi: 10.18063/ijb.769
  4. Wang J, Min L, Lu M, et al. Three-dimensional-printed custom-made hemipelvic endoprosthesis for primary malignancies involving acetabulum: the design solution and surgical techniques. J Orthop Surg Res. 2019;14(1):389. doi: 10.1186/s13018-019-1455-8
  5. Li GY, Wang L, Pan W, et al. In vitro and in vivo study of additive manufactured porous Ti6Al4V scaffolds for repairing bone defects. Sci Rep. 2016;6:34072. doi: 10.1038/srep34072
  6. Wu JX, Xie K, Luo DH, et al. Three-dimensional printing-based personalized limb salvage and reconstruction treatment of pelvic tumors. J Surg Oncol. 2021;124(3):420-430. doi: 10.1002/jso.26516
  7. Xue T, Attarilar S, Liu SF, et al. Surface modification techniques of titanium and its alloys to functionally optimize their biomedical properties: a thematic review. Front Bioeng Biotechnol. 2020;8:603072. doi: 10.3389/fbioe.2020.603072
  8. Souza JCM, Sordi MB, Kanazawa M, et al. Nano-scale modification of titanium implant surfaces to enhance osseointegration. Acta Biomater. 2019;94:112-131. doi: 10.1016/j.actbio.2019.05.045
  9. Wang X, Liu WT, Yu XD, et al. Advances in surface modification of tantalum and porous tantalum for rapid osseointegration: a thematic review. Front Bioeng Biotechnol. 2022;10:983695. doi: 10.3389/fbioe.2022.983695
  10. Schildhauer TA, Robie B, Muhr G, Köller M. Bacterial adherence to tantalum versus commonly used orthopedic metallic implant materials. J Orthop Trauma. 2006;20(7):476-484. doi: 10.1097/00005131-200608000-00005
  11. Wang Q, Qiao YQ, Cheng MQ, et al. Tantalum implanted entangled porous titanium promotes surface osseointegration and bone ingrowth. Sci Rep. 2016;6:26248. doi: 10.1038/srep26248
  12. Guo Y, Xie K, Jiang WB, et al. In vitro and in vivo study of 3D-printed porous tantalum scaffolds for repairing bone defects. ACS Biomater Sci Eng. 2019;5(2):1123-1133. doi: 10.1021/acsbiomaterials.8b01094
  13. Li WY, Li XY, Dong HS. Effect of tensile stress on the formation of S-phase during low-temperature plasma carburizing of 316L foil. Acta Mater. 2011;59(14):5765-5774. doi: 10.1016/j.actamat.2011.05.053
  14. Ueda M, Silva C, Marcondes AR, Reuther H, de Souza GB. Recent experiments on plasma immersion ion implantation (and deposition) using discharges inside metal tubes. Surf Coat Technol. 2018;355:98-110. doi: 10.1016/j.surfcoat.2018.05.009
  15. Zhang LC, Chen LY, Wang LQ. Surface modification of titanium and titanium alloys: technologies, developments, and future interests. Adv Eng Mater. 2020;22(5): 1901258. doi: 10.1002/adem.201901258
  16. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63(8):834-840. doi: 10.1016/j.jclinepi.2010.02.005
  17. Li X, Wang L, Yu XM, et al. Tantalum coating on porous Ti6Al4V scaffold using chemical vapor deposition and preliminary biological evaluation. Mater Sci Eng C Mater Biol Appl. 2013;33(5):2987-2994. doi: 10.1016/j.msec.2013.03.027
  18. Agarwal R, Garcia AJ. Biomaterial strategies for engineering implants for enhanced osseointegration and bone repair. Adv Drug Deliv Rev. 2015;94:53-62. doi: 10.1016/j.addr.2015.03.013
  19. Bohara S, Suthakorn J. Surface coating of orthopedic implant to enhance the osseointegration and reduction of bacterial colonization: a review. Biomater Res. 2022;26(1):26. doi: 10.1186/s40824-022-00269-3
  20. Jansen JA, van de Waerden JP, Wolke JG, de Groot K. Histologic evaluation of the osseous adaptation to titanium and hydroxyapatite-coated titanium implants. J Biomed Mater Res. 1991;25(8):973-989. doi: 10.1002/jbm.820250805
  21. D’Antonio JA, Capello WN, Jaffe WL. Hydroxylapatite-coated hip implants: multicenter three-year clinical and roentgenographic results. Clin Orthop Relat Res. 1992;285:102-115 doi: 10.1097/00003086-199212000-00015
  22. D’Lima DD, Walker RH, Colwell CW Jr. Omnifit-HA stem in total hip arthroplasty: a 2- to 5-year follow-up. Clin Orthop Relat Res. 1999;363:163-169. doi: 10.1097/00003086-199906000-00021
  23. Landor I, Vavrik P, Sosna A, Jahoda D, Hahn H, Daniel M. Hydroxyapatite porous coating and the osteointegration of the total hip replacement. Arch Orthop Trauma Surg. 2007;127(2):81-89. doi: 10.1007/s00402-006-0235-1
  24. Bornstein MM, Hart CN, Halbritter SA, Morton D, Buser D. Early loading of nonsubmerged titanium implants with a chemically modified sand-blasted and acid-etched surface: 6-month results of a prospective case series study in the posterior mandible focusing on peri-implant crestal bone changes and ISQ values. Clin Implant Dent Relat Res. 2009;11(4):338-347. doi: 10.1111/j.1708-8208.2009.00148.x
  25. Schatzle M, Mannchen R, Balbach U, Hammerle CH, Toutenburg H, Jung RE. Stability change of chemically modified sandblasted/acid-etched titanium palatal implants: a randomized-controlled clinical trial. Clin Oral Implants Res. 2009;20(5):489-495. doi: 10.1111/j.1600-0501.2008.01694.x
  26. Markovic A, Colic S, Scepanovic M, Misic T, Ethinic A, Bhusal DS. A 1-year prospective clinical and radiographic study of early-loaded bone level implants in the posterior maxilla. Clin Implant Dent Relat Res. 2015;17(5):1004-1013. doi: 10.1111/cid.12201
  27. Zhang C, Chen H, Fan H, et al. Carpal bone replacement using personalized 3D printed tantalum prosthesis. Front Bioeng Biotechnol. 2023;11:1234052. doi: 10.3389/fbioe.2023.1234052
  28. Girerd D, Parratte S, Lunebourg A, et al. Total knee arthroplasty revision with trabecular tantalum cones: preliminary retrospective study of 51 patients from two centres with a minimal 2-year follow-up. Orthop Traumatol Surg Res. 2016;102(4):429-433. doi: 10.1016/j.otsr.2016.02.010
  29. Shi LY, Wang A, Zang FZ, Wang JX, Pan XW, Chen HJ. Tantalum-coated pedicle screws enhance implant integration. Colloids Surf B Biointerfaces. 2017;160:22-32. doi: 10.1016/j.colsurfb.2017.08.059
  30. Ying J, Cheng L, Li J, et al. Treatment of acetabular bone defect in revision of total hip arthroplasty using 3D printed tantalum acetabular augment. Orthop Surg. 2023;15(5):1264-1271. doi: 10.1111/os.13691
  31. Li Z, Chen G, Xiang Y, et al. Treatment of massive iliac chondrosarcoma with personalized three-dimensional printed tantalum implant: a case report and literature review. J Int Med Res. 2020;48(10):300060520959508. doi: 10.1177/0300060520959508
  32. Wei XW, Zhao DW, Wang BJ, et al. Tantalum coating of porous carbon scaffold supplemented with autologous bone marrow stromal stem cells for bone regeneration in vitro and in vivo. Exp Biol Med (Maywood). 2016;241(6): 592-602. doi: 10.1177/1535370216629578
  33. Levine BR, Sporer S, Poggie RA, Della Valle CJ, Jacobs JJ. Experimental and clinical performance of porous tantalum in orthopedic surgery. Biomaterials. 2006;27(27):4671-4681. doi: 10.1016/j.biomaterials.2006.04.041
  34. Rajgopal A, Panda I, Yadav S, Wakde O. Stacked tantalum cones as a method for treating severe distal femoral bone deficiency in total knee arthroplasty. J Knee Surg. 2019;32(9):833-840. doi: 10.1055/s-0038-1669789
  35. Liu GH, Wang J, Yang SH, Xu WH, Ye SN, Xia TA. Effect of a porous tantalum rod on early and intermediate stages of necrosis of the femoral head. Biomed Mater. 2010;5(6):065003. doi: 10.1088/1748-6041/5/6/065003
  36. Chalkin B, Minter J. Limb salvage and abductor reattachment using a custom prosthesis with porous tantalum components: case report. J Arthroplasty. 2005;20(1):127-130. doi: 10.1016/j.arth.2004.09.029
  37. Zhou Y, Li M, Cheng Y, Zheng YF, Xi TF, Wei SC. Tantalum coated NiTi alloy by PIIID for biomedical application. Surf Coat Technol. 2013;228:S2-S6. doi: 10.1016/j.surfcoat.2012.11.002
  38. Lu T, Wen J, Qian S, et al. Enhanced osteointegration on tantalum-implanted polyetheretherketone surface with bone-like elastic modulus. Biomaterials. 2015;51: 173-183. doi: 10.1016/j.biomaterials.2015.02.018
  39. Bobyn JD, Stackpool GJ, Hacking SA, Tanzer M, Krygier JJ. Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial. J Bone Joint Surg Br. 1999;81-B(5):907-914. doi: 10.1302/0301-620X.81B5.9283
  40. Bobyn JD, Poggie RA, Krygier JJ, et al. Clinical validation of a structural porous tantalum biomaterial for adult reconstruction. J Bone Joint Surg Am. 2004;86-A (Suppl 2):123-129. doi: 10.2106/00004623-200412002-00017
  41. Tian YL, Jiang WB, Deng L, et al. A fractal-like hierarchical bionic scaffold for osseointegration. Adv Funct Mater. 2025;35(8):2415880. doi: 10.1002/adfm.202415880

 

 

 



Share
Back to top
International Journal of Bioprinting, Electronic ISSN: 2424-8002 Print ISSN: 2424-7723, Published by AccScience Publishing
We use cookies on our website to ensure you get the best experience.
Read more about our cookies here
Accept