Research on the design of hip joint prosthesis coatings has become a hot topic in recent years. Traditional techniques, such as ion spraying, high-temperature sintering, electrophoretic deposition, and micro-arc oxidation sol-gel method, can provide a certain degree of initial stability and long-term bone integration between the cup and the host bone. However, when dealing with cases with poor bone quality such as osteoporosis, bone radiation necrosis, and bone defects, the above techniques may only provide limited initial stability. At the same time, many studies have reported failures due to the sintering of titanium beads and coating shedding[5–7]. Traditional processing techniques usually have strong constraints on the design scheme, while metal additive manufacturing technology can manufacture acetabular cups with high porosity, appropriate and controllable pore size, elastic modulus similar to human bone, and better friction coefficient according to a three-dimensional model. Perticarini[23] et al.'s research reported the clinical results of using 3D printed titanium alloy trabecular acetabular cups in European patients. The study included 133 patients, mainly with HOA, AVN, and DDH. In at least 5 years of follow-up, all patients had significant pain relief and functional recovery. Castagnini[24] et al. conducted a retrospective study of continuous cases, including 24 cases with an average follow-up of 134 months. Their report confirmed the reliable mid-term clinical and radiographic results of 3D printed titanium alloy trabecular acetabular cups. Huang[10] et al. reported the results of using 3D printed titanium alloy bone beam acetabular cups in 32 cases in the first THA. The average follow-up was 93.5 months, the hip HSS score improved significantly, and there were no complications during the perioperative and follow-up periods. At the last follow-up, all acetabular cups showed good bone integration, and 89.0% of patients expressed satisfaction or very satisfaction with the surgery. Our study also showed that during the average follow-up period of 26.2 months, all 236 acetabular cups achieved good initial stability and long-term bone ingrowth. The hip HSS score of the patients improved significantly from 43.7 ± 6.8 points before surgery to 85.6 ± 9.3 points at the last follow-up. The WOMAC score improved significantly from 59.2 ± 5.8 points before surgery to 13.1 ± 3.5 points at the last follow-up. The high survival rate (100.0%) of the cup and patient satisfaction (92.3% satisfied or very satisfied) confirmed the safety and effectiveness of 3D printed titanium alloy trabecular acetabular cups in the first THA.
The good clinical and radiographic results of 3D printed titanium alloy trabecular acetabular cups depend on their good initial stability and long-term bone ingrowth, which may be related to the following factors. Firstly, the cup prepared by EBM electron beam melting technology with a structure optimized design has an average porosity of 80%, a pore size of 600–800µm, and a structure with interconnected pores in three-dimensional structure. The surface structure provides good friction between the cup and the host bone. Castagnini's research [24] reported that the friction coefficient between the cup and cancellous bone is 1.08, which is better than the friction coefficient of porous tantalum (0.98) and sintered titanium beads (0.5). A good friction coefficient provides good initial stability for the cup and also is beneficial to long-term bone ingrowth.
Secondly, the porous structure reduces the elastic modulus of the cup and can change the strength and mechanical properties of the material by adjusting the pore size [25, 26]. The elastic modulus of the cup is on average 0.5–1.3 GPa, which is similar to human cancellous bone. Stress shielding phenomenon is caused by a severe stiffness mismatch between the implanted prosthesis and the bone. Currently, the stiffness of most THA implant materials is much higher than that of bone. After the high elastic modulus prosthesis is implanted into the human body, it will bear most of the stress, which will prevent the stress transmission to the host bone. The redistribution of stress will cause bone reconstruction, and bone resorption will occur in areas with low stress, which will cause micro-movement of the implant-bone interface and eventually lead to implant loosening [27]. Therefore, the elastic modulus of the cup helps to reduce the risk of stress shielding and bone resorption and improve bone ingrowth rate [28].
Furthermore, the characteristics of the cup's porous, solid, and pore-connected three-dimensional structure simulate the structure of natural bone beams. Research by Ponader [29] and Otsuki [30] have confirmed that high porosity is conducive to improving local blood flow and vascular formation, reducing fibrosis of the surrounding tissue of the implant, and stimulating new bone growth into the pores. Similarly, research by Devine [31] has also confirmed that the aforementioned characteristics of the 3D printed titanium alloy trabecular acetabular cup can stimulate the proliferation and differentiation of bone cells, stimulate tissue vascularization, and have bone-inducing and bone-conducting properties. The above characteristics of the cup provide a good foundation and necessary conditions for long-term bone ingrowth. In a 2-year follow-up study of 91 titanium alloy trabecular acetabular cups produced using EBM technology, Massari [28] and other scholars did not observe any radiolucent lines between the cup and the host bone. Similarly, Perticarini [23] reported that in a follow-up study of 134 titanium alloy trabecular acetabular cups, with an average follow-up time of 72.7 months, no radiolucent lines were observed between the cup and the host bone. Our study found that all cups showed good bone integration (meeting at least three or more bone integration criteria) at the last follow-up, and no cases met the cup loosening criteria. At the one-month postoperative review, 18 cases showed radiolucent lines of less than 2mm between the cup and the bone bed, all of which disappeared after six months postoperatively.
Although this study reported good early clinical and imaging results, as well as patient satisfaction in 236 cases of 3D-printed titanium alloy acetabular cups with bone ingrowth, the study still have some limitations. Firstly, although the number of cases is relatively large, the follow-up time is relatively short and there is no control group. Long-term prospective randomized controlled studies are needed to confirm its long-term safety and efficacy. Secondly, there were some lost to follow-up cases, which may have some impact on the results. Thirdly, the surgeries in this study were performed by two senior orthopedic surgeons, but they may also have some confounding effects on the results. Finally, in the current study, evaluations such as CT three-dimensional reconstruction and bone density DXA were not performed, and the serum metal ion concentration of the cases was not detected to evaluate the corrosion safety of the acetabular cup. These issues need to be considered and improved in future studies.