Stand-Alone Anterior Cervical Discectomy and Fusion Using an Additive Manufactured Individualized Bioactive Porous Titanium Implant without Bone Graft: Results of a Prospective Clinical Trial.

The purpose of this study was to introduce our patient-specific bioactive porous titanium implant manufactured using selective laser melting (SLM) and to establish the efficacy and safety of the implant for stand-alone anterior cervical discectomy and fusion (ACDF) based on a prospective clinical trial. We designed a customized ACDF implant using patient-specific data and manufactured the implant using SLM. We produced a bioactive surface through a specific chemical and thermal treatment. Using this implant, we surgically treated four patients with cervical degenerative disc disease and evaluated the clinical and radiological results. We achieved successful bony union in all but one patient without autologous bone grafting within 1 year. We observed no implant subsidence during the follow-up period, and all clinical parameters improved significantly after surgery, with no reported implant-related adverse effects. Our customized bioactive porous titanium implant is a safe and promising implant for stand-alone ACDF.

Bioactive treatment promotes osteoblast differentiation on titanium materials fabricated by selective laser melting technology.

Selective laser melting (SLM) technology is useful for the fabrication of porous titanium implants with complex shapes and structures. The materials fabricated by SLM characteristically have a very rough surface (average surface roughness, Ra=24.58 µm). In this study, we evaluated morphologically and biochemically the specific effects of this very rough surface and the additional effects of a bioactive treatment on osteoblast proliferation and differentiation. Flat-rolled titanium materials (Ra=1.02 µm) were used as the controls. On the treated materials fabricated by SLM, we observed enhanced osteoblast differentiation compared with the flat-rolled materials and the untreated materials fabricated by SLM. No significant differences were observed between the flat-rolled materials and the untreated materials fabricated by SLM in their effects on osteoblast differentiation. We concluded that the very rough surface fabricated by SLM had to undergo a bioactive treatment to obtain a positive effect on osteoblast differentiation.

Effect of pore size on bone ingrowth into porous titanium implants fabricated by additive manufacturing: An in vivo experiment.

Selective laser melting (SLM) is an additive manufacturing technique with the ability to produce metallic scaffolds with accurately controlled pore size, porosity, and interconnectivity for orthopedic applications. However, the optimal pore structure of porous titanium manufactured by SLM remains unclear. In this study, we evaluated the effect of pore size with constant porosity on in vivo bone ingrowth in rabbits into porous titanium implants manufactured by SLM. Three porous titanium implants (with an intended porosity of 65% and pore sizes of 300, 600, and 900µm, designated the P300, P600, and P900 implants, respectively) were manufactured by SLM. A diamond lattice was adapted as the basic structure. Their porous structures were evaluated and verified using microfocus X-ray computed tomography. Their bone-implant fixation ability was evaluated by their implantation as porous-surfaced titanium plates into the cortical bone of the rabbit tibia. Bone ingrowth was evaluated by their implantation as cylindrical porous titanium implants into the cancellous bone of the rabbit femur for 2, 4, and 8weeks. The average pore sizes of the P300, P600, and P900 implants were 309, 632, and 956µm, respectively. The P600 implant demonstrated a significantly higher fixation ability at 2weeks than the other implants. After 4weeks, all models had sufficiently high fixation ability in a detaching test. Bone ingrowth into the P300 implant was lower than into the other implants at 4weeks. Because of its appropriate mechanical strength, high fixation ability, and rapid bone ingrowth, our results indicate that the pore structure of the P600 implant is a suitable porous structure for orthopedic implants manufactured by SLM.

Additive-manufactured patient-specific titanium templates for thoracic pedicle screw placement: novel design with reduced contact area.

PURPOSE: Image-based navigational patient-specific templates (PSTs) for pedicle screw (PS) placement have been described. With recent advances in three-dimensional computer-aided designs and additive manufacturing technology, various PST designs have been reported, although the template designs were not optimized. We have developed a novel PST design that reduces the contact area without sacrificing stability. It avoids susceptibility to intervening soft tissue, template geometric inaccuracy, and difficulty during template fitting. METHODS: Fourteen candidate locations on the posterior aspect of the vertebra were evaluated. Among them, locations that had high reproducibility on computed tomography (CT) images and facilitated accurate PS placement were selected for the final PST design. An additive manufacturing machine (EOSINT M270) fabricated the PSTs using commercially pure titanium powder. For the clinical study, 36 scoliosis patients and 4 patients with ossification of the posterior longitudinal ligament (OPLL) were treated with thoracic PSs using our newly developed PSTs. We intraoperatively and postoperatively evaluated the accuracy of the PS hole created by the PST. RESULTS: Based on the segmentation reproducibility and stability analyses, we selected seven small, round contact points for our PST: bilateral superior and inferior points on the transverse process base, bilateral inferior points on the laminar, and a superior point on the spinous process. Clinically, the success rates of PS placement using this PST design were 98.6 % (414/420) for scoliosis patients and 100 % (46/46) for OPLL patients. CONCLUSION: This study provides a useful design concept for the development and introduction of patient-specific navigational templates for placing PSs.

Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh.

OBJECTIVE: Development of new custom-made devices to reconstruct alveolar bone for implantation, and comparison with conventional methods were the goals of this study. MATERIALS AND METHODS: Using a computer-aided design technique, three-dimensional images were constructed. From these data, custom-made devices were produced by a selective laser melting method with pure titanium. Clinical trials also have been conducted with 26 participants who needed bone reconstruction before implantation; they were divided into 2 groups with 13 patients each. The first group uses custom-made devices; the other uses commercial titanium meshes that need to bend during operation. Some clinical aspects are evaluated after the trial. RESULTS: The custom-made devices can be produced closely by following the data precisely. Devices are fit for bone defect site. Moreover, the operation time of the custom-made group (75.4 ± 11.6 min) was significantly shorter than that of the conventional group (111.9 ± 17.8 min) (p < 0.01). Mucosal rupture occurs, without significant difference (p = 0.27), in a patient in the custom-made without severe infection (7.7%), and 3 in conventional (23.1%), respectively. The retaining screw is significantly fewer in the custom-made group than commercial mesh group (p < 0.01). CONCLUSION: These results indicate that our novel protocol could be simple and safe for providing powerful support for guided bone regeneration.

Custom-made titanium devices as membranes for bone augmentation in implant treatment: Modeling accuracy of titanium products constructed with selective laser melting.

OBJECTIVE: The purpose of this study was to verify the modeling accuracy of various products, and to produce custom-made devices for bone augmentation in individual patients requiring implantation. MATERIALS AND METHODS: Two-(2D) and three-dimensional (3D) specimens and custom-made devices that were designed as membranes for guided bone regeneration (GBR) were produced using a computer-aided design (CAD) and rapid prototyping (RP) method. The CAD design was produced using a 3D printing machine and selective laser melting (SLM) with pure titanium (Ti) powder. The modeling accuracy was evaluated with regard to: the dimensional accuracy of the 2D and 3D specimens; the accuracy of pore structure of the 2D specimens; the accuracy of porosity of the 3D specimens; and the error between CAD design and the scanned real product by overlapped images. RESULTS: The accuracy of the 2D and 3D specimens indicated precise results in various parameters, which were tolerant in ISO 2768-1. The error of overlapped images between the CAD and scanned data indicated that accuracy was sufficient for GBR. In integrating area of all devices, the maximum and average error were 292 and 139 µm, respectively. CONCLUSIONS: High modeling accuracy can be achieved in various products using the CAD/RP-SLM method. These results suggest the possibility of clinical applications.