BACKGROUND: The inclusion of a connecting path in a porous implant can promote nutrient diffusion to cells and enhance bone ingrowth. Consequently, this study aimed to evaluate the biomechanical, radiographic, and histopathological performance of a novel 3D-printed porous suture anchor in a rabbit femur model.
METHODS: Three test groups were formed based on the type of suture anchor (SA): Commercial SA (CSA, Group A, n = 20), custom solid SA (CSSA, Group B, n = 20), and custom porous SA (CPSA, Group C, n = 20). The SAs were implanted in the lateral femoral condyle of the right leg in each rabbit. The rabbits (New Zealand white rabbits, male, mean body weight of 2.8 ± 0.5 kg, age 8 months) underwent identical treatment and were randomized into experimental and control groups via computer-generated randomization. Five rabbits (10 femoral condyles) were euthanized at 0, 4, 8, and 12 weeks post-implantation for micro-CT, histological analysis, and biomechanical testing.
RESULTS: At 12 weeks, the CPSA showed a higher BV/TV (median 0.7301, IQR 0.7276-0.7315) than the CSSA and CSA. The histological analysis showed mineralized osteocytes near the SA. At 4 weeks, new bone was observed around the CPSA and had penetrated its porous structure. By 12 weeks, there was no significant difference in ultimate failure load between the CSA and CPSA.
CONCLUSIONS: We demonstrated that the innovative 3D-printed porous suture anchor exhibited comparable pullout strength to conventional threaded suture anchors at the 12-week postoperative time-point period. Furthermore, our porous anchor design enhanced new bone formation and facilitated bone growth into the implant structure, resulting in improved biomechanical stability.

The long-term performance of porous coated tibial implants for total ankle replacement (TAR) primarily depends on the extent of bone ingrowth at the bone-implant interface. Although attempts were made for primary fixation for immediate post-operative stability, no investigation was conducted on secondary fixation. The aim of this study is to assess bone ingrowth around the porous beaded coated tibial implant for TAR using a mechanoregulatory algorithm. A realistic macroscale finite element (FE) model of the implanted tibia was developed based on computer tomography (CT) data to assess implant-bone micromotions and coupled with microscale FE models of the implant-bone interface to predict bone ingrowth around tibial implant for TAR. The macroscale FE model was subjected to three near physiological loading conditions to evaluate the site-specific implant-bone micromotion, which were then incorporated into the corresponding microscale model to mimic the near physiological loading conditions. Results of the study demonstrated that the implant experienced tangential micromotion ranged from 0 to 71 μm with a mean of 3.871 μm. Tissue differentiation results revealed that bone ingrowth across the implant ranged from 44 to 96 %, with a mean of around 70 %. The average Young\'s modulus of the inter-bead tissue layer varied from 1444 to 4180 MPa around the different regions of the implant. The analysis postulates that when peak micromotion touches 30 μm around different regions of the implant, it leads to pronounced fibrous tissues on the implant surface. The highest amount of bone ingrowth was observed in the central regions, and poor bone ingrowth was seen in the anterior parts of the implant, which indicate improper osseointegration around this region. This macro-micro mechanical FE framework can be extended to improve the implant design to enhance the bone ingrowth and in future to develop porous lattice-structured implants to predict and enhance osseointegration around the implant.

Porous structures are frequently used in surgical implants to strengthen the interlocking power produced by bone ingrowth. Therefore, we aimed to elucidate the mechanism underlying bone ingrowth into a porous structure accompanied by vascularization. A nonbioactive polyetheretherketone implant with a 3D-printed porous structure was prepared and implanted in a bone hole created in the tibias of rabbits. We observed bone ingrowth in the same individual specimens immediately and at 2, 4, 8, and 12 weeks post-implantation using in-vivo computed tomography (CT). Furthermore, a detailed evaluation with blood vessels of each specimen at 2, 4, and 12 weeks was performed with ex-vivo CT and histological specimen. Additional histological evaluation was performed using thin sections of an implant made with thermoplastic polyurethane having the same structure. As a result, the bone invasion began after four weeks, when the construction of fibrous tissue and the spread of new blood vessels within the voids matured. As the bone matured in the load-bearing area, new blood vessels outside the bone matrix regressed. This longitudinal evaluation study suggests that preceding fibrogenesis and vascularization may be key in developing bone ingrowth. STATEMENT OF SIGNIFICANCE: A porous structure is an essential structure for dental and orthopedic implants because it provides strong fixation through bone invasion. Although it was known that vascularization was involved in this, the details were not known. This in vivo study revealed that in order for bone ingrowth to begin, a preparatory period of approximately 4 weeks was required to establish blood flow inside and outside the implant. Furthermore, it was confirmed that by spreading the fibrous structure in advance, it has an advantageous effect on the migration of cells involved in the formation of bones and blood vessels. We pointed out that it is necessary to consider fibrogenesis and vascularization when creating future implants.

The additive manufacturing of titanium into porous geometries offers a means to generate low-stiffness endosseous implants with a greater surface area available for osseointegration. In this work, selective laser melting was used to produce gyroid-based scaffolds with a uniform pore size of 300 μm or functionally graded pore size from 600 μm to 300 μm. Initial in vitro assessment with Saos-2 cells showed favourable cell proliferation at pore sizes of 300 and 600 μm. Following implantation into rabbit tibiae, early histological observations at four weeks indicated some residual inflammation alongside neovessel infiltration into the scaffold interior and some early apposition of mineralized bone tissue. At twelve weeks, both scaffolds were filled with a mixture of adipocyte-rich marrow, micro-capillaries, and mineralized bone tissue. X-ray microcomputed tomography showed a higher bone volume fraction (BV/TV) and percentage of bone-implant contact (BIC) in the implants with 300 μm pores than in the functionally graded specimens. In functionally graded specimens, localized BV/TV measurement was observed to be higher in the innermost region containing smaller pores (estimated at 300-400 μm) than in larger pores at the implant exterior. The unit cell topology of the porous implant was also observed to guide the direction of bone ingrowth by conducting along the implant struts. These results suggest that in vivo experimentation is necessary alongside parametric optimization of functionally graded porous implants to predict short-term and long-term bone apposition.

In this study, metal 3D printing technology was used to create lattice-shaped test specimens of orthopedic implants to determine the effect of different lattice shapes on bone ingrowth. Six different lattice shapes were used: gyroid, cube, cylinder, tetrahedron, double pyramid, and Voronoi. The lattice-structured implants were produced from Ti6Al4V alloy using direct metal laser sintering 3D printing technology with an EOS M290 printer. The implants were implanted into the femoral condyles of sheep, and the animals were euthanized 8 and 12 weeks after surgery. To determine the degree of bone ingrowth for different lattice-shaped implants, mechanical, histological, and image processing tests on ground samples and optical microscopic images were performed. In the mechanical test, the force required to compress the different lattice-shaped implants and the force required for a solid implant were compared, and significant differences were found in several instances. Statistically evaluating the results of our image processing algorithm, it was found that the digitally segmented areas clearly consisted of ingrown bone tissue; this finding is also supported by the results of classical histological processing. Our main goal was realized, so the bone ingrowth efficiencies of the six lattice shapes were ranked. It was found that the gyroid, double pyramid, and cube-shaped lattice implants had the highest degree of bone tissue growth per unit time. This ranking of the three lattice shapes remained the same at both 8 and 12 weeks after euthanasia. In accordance with the study, as a side project, a new image processing algorithm was developed that proved suitable for determining the degree of bone ingrowth in lattice implants from optical microscopic images. Along with the cube lattice shape, whose high bone ingrowth values have been previously reported in many studies, it was found that the gyroid and double pyramid lattice shapes produced similarly good results.

Three-dimensional (3D) printed titanium (Ti-6Al-4V alloy) cages are widely used for spinal fusion applications. However, the structural design and shape of the cages are a major determinant of the optimal clinical outcome. In this study, we constructed a newly designed 3D-printed helical-shaped titanium cage (HTC) with a flexible body, and compared its healing and fusion efficacy in cervical vertebral defects after corpectomy in rabbits to that of a 3D-printed traditional titanium cage (TTC). We performed radiological examinations 1 and 16 weeks after TTC and HTC implantation. We assessed bone ingrowth in TTC and HTC using micro-computed tomography (micro-CT) and histological staining of tissue sections at 16 weeks. The radiographic data showed that the HTC-implanted group had better restoration of vertebral height than the TTC group, indicating a lower risk of cage subsidence. The micro-CT and histological observations showed that HTC promoted bone regeneration and osseointegration more effectively than TTC. Histomorphometry further revealed significant new bone formation in the HTC group compared to the TTC group. These findings demonstrate that HTC has better healing and bone fusion effects than TTC in cervical vertebral defects in rabbits, indicating its potential clinical value.

Electron beam melting (EBM) has been used to fabricate three-dimensional (3D) porous Ti-6Al-4V surfaces for acetabular cups in total hip arthroplasty. However, there are radiographic concerns regarding poor implant fixation and bone ingrowth around electron beam melted (EBMed) 3D porous cups. We hypothesize that nano-hydroxyapatite (nHA) coating can promote bone ingrowth and thus decrease the occurrence of radiolucent lines around EBMed 3D porous cups. This study aimed to investigate the effect of a novel nHA coating on the biological performance of EBMed 3D porous implants in a beagle transcortical model. Low-porosity (control) and high-porosity 3D porous Ti-6Al-4V implants were manufactured using EBM. Half of the high-porosity implants were coated with nHA without clogging the 3D pores. Implants were inserted into the femoral diaphysis of the beagles. The beagles were euthanized at 4, 8, and 12 weeks postoperatively, and push-out testing was performed. Bone ingrowth was evaluated by histological analysis. Although the increase in porosity alone had no effect on biological behavior, the addition of nHA to high-porosity 3D implants significantly improved early bone fixation and bone ingrowth into the deep region of porous structures compared to low-porosity implants. This is the first report of a novel nHA coating that improved bone ingrowth into the deeper regions of 3D porous implants, which can prevent the occurrence of radiolucent lines around EBMed 3D porous cups.

A novel biomimetic artificial intervertebral disc (bioAID) for the cervical spine was developed, containing a hydrogel core representing the nucleus pulposus, an UHMWPE fiber jacket as annulus fibrosis, and titanium endplates with pins for mechanical fixation. Osseointegration of the UHMWPE fibers to adjacent bone structures is required to achieve proper biomimetic behavior and to provide long-term stability. Therefore, the aim of this study was to assess the osteoconductivity of several surface modifications of UHMWPE fabrics, 2D weft-knitted, using non-treated UHMWPE fibers (N), plasma treated UHMWPE fibers (PT), 10% hydroxy apatite (HA) loaded UHMWPE fibers (10%HA), plasma treated 10%HA UHMWPE fibers (PT-10%HA), 15%HA loaded UHMWPE fibers (15%HA) and plasma treated 15%HA UHMWPE fibers (PT-15%HA). Scanning electron microscopy (SEM) was used for surface characterization. Biological effects were assessed by evaluating initial cell attachment (SEM, DNA content), metabolic activity (PrestoBlue assay), proliferation, differentiation (alkaline phosphatase activity) and mineralization (energy dispersive x-ray, EDX analysis) using human bone marrow stromal cells. Plasma treated samples showed increased initial cell attachment, indicating the importance of hydrophilicity for cell attachment. However, incorporation only of HA or plasma treatment alone was not sufficient to result in upregulated alkaline phosphatase activity (ALP) activity. Combining HA loaded fibers with plasma treatment showed a combined effect, leading to increased cell attachment and upregulated ALP activity. Based on these results, combination of HA loaded UHMWPE fibers and plasma treatment provided the most promising fabric surface for facilitating bone ingrowth.

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A large number of materials with different compositions and shapes have been proposed and studied for the purpose of bone tissue regeneration. Collagen-based materials have shown promising results for this application, with improved physicochemical properties. The aim of the present in vivo animal study was to evaluate and compare two commercially available collagen-based biomaterials for bone regeneration, with these being implanted in circumferential bone defects created in the calvarium of rabbits. Twenty rabbits received bilateral parietal osteotomies, performed with the aid of a 6.5 mm diameter trephine. Two groups were created: the BC group, where the defect was filled with a scaffold composed of 90% bovine bone particles and 10% porcine collagen, and the EG group, where the defect was filled with a scaffold composed of 75% hydroxyapatite particles of bovine origin and 25% bovine collagen. Ten animals were sacrificed at 30 days and another 10 at 45 days after implantation, and the samples were processed and histologically analyzed. In the evaluations of the samples at 30 days, no important differences were found in the results. However, in the samples at 45 days after surgery, the EG group showed better results than the BC group samples, mainly in terms of the amount of bone matrix formation (P < 0.0001) and the volume in area measured in each sample, where the EG group had a value 65% higher than that in the BC group samples. Based on the results obtained, we conclude that the amount of collagen and the particle characteristics present in the composition of the scaffolds can directly influence the amount of neoformation and/or bone regeneration.