Prediction of bone ingrowth into a porous novel hip-stem: A finite element analysis integrated with mechanoregulatory algorithm.

Bone ingrowth into a porous implant is necessary for its long-term fixation. Although attempts have been made to quantify the peri-implant bone growth using finite element (FE) analysis integrated with mechanoregulatory algorithms, bone ingrowth into a porous cellular hip stem has scarcely been investigated. Using a three-dimensional (3D) FE model and mechanobiology-based numerical framework, the objective of this study was to predict the spatial distribution of evolutionary bone ingrowth into an uncemented novel porous hip stem proposed earlier by the authors. A CT-based FE macromodel of the implant-bone structure was developed. The bone material properties were assigned based on CT grey value. Peak musculoskeletal loading conditions, corresponding to level walking and stair climbing, were applied. The geometry of the implant-bone macromodel was divided into multiple submodels. A suitable mapping framework was used to transfer maximum nodal displacements from the FE macromodel to the cut boundaries of the FE submodels. CT grey value-based bone materials properties were assigned to the submodels. Thereafter, the submodels were solved and simulations of bone ingrowth were carried out using mechanoregulatory principle. A gradual increase in the average Young's modulus, from 1200 to 1500 MPa, of the bone tissue layer was observed considering all the submodels. The distal submodel exhibited 82% of bone ingrowth, whereas the proximal submodel experienced 65% bone ingrowth. Equilibrium in the bone ingrowth process was achieved in 7 weeks postoperatively, with a notable amount of bone ingrowth that should lead to biological fixation of the novel hip stem.

Bone ingrowth induced by gelatin/chitosan internal matrix of 3DP Ti6Al4V scaffold.

Regarding its structural and mechanical adaptability to bone defects, 3D printed (3DP) Ti6Al4V scaffolds are widely used in orthopedics now, purposed to restore the function and mechanical stability of impaired bone. In scaffold fabrication, surface modification is acknowledged as a reliable strategy to enhance the interface interaction between 3DP Ti6Al4V scaffold and bone. Despite its advantage in bone-Ti6Al4V bonding improvement, surface modification lacks the ability to induce bone in-growth efficiently as expected. As an attempt to overcome this challenge, in the current work the inner voids of 3DP Ti6Al4V scaffold were occupied by a gelatin/chitosan porous matrix, purposed to act as a platform for guiding bone ingrowth. Firstly, the gelatin/chitosan matrix was prepared via freeze-drying using genipin as a crosslinker, resulting in a trabecular bone-like interconnected porous network characterized with a gelatin/chitosan ratio dependent swelling capability, degradation and model anti-bacterial drug release behavior. Besides of that, gelatin in the matrix was witnessed to accelerate biomineralization in simulated body fluid. Secondly, a formulated gelatin/chitosan matrix was embedded into 3DP Ti6Al4V scaffold to generate a composite scaffold capable of inducing bone in-growth. The followed studies showed gelatin/chitosan matrix can endow the scaffold with good biological and sustained drug release properties, along with minimal change to the compressive strength of the scaffold. The in vivo experiment results revealed that after 4 weeks of implantation, more new bone formation was witnessed in the inner structure of the composite scaffold than the 3DP Ti6Al4V scaffold, with the average bone volume fraction (BV/TV) value increased from 24.09 % to 46.08 %, the average trabecular bone thickness (Tb. Th) value increased from 0.118 mm to 0.278 mm. Therefore, it was confirmed an inner matrix in 3DP Ti6Al4V scaffold played an essential role in guiding bone in-growth.

3D-printed porous titanium suture anchor: a rabbit lateral femoral condyle model.

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.

Assessment of bone ingrowth around beaded coated tibial implant for total ankle replacement using mechanoregulatory algorithm.

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.

Bone ingrowth into a porous structure is achieved by preceding fibrogenesis and vascularization.

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.

Osseointegration of functionally graded Ti6Al4V porous implants: Histology of the pore network.

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.

Comparative Analysis of Bone Ingrowth in 3D-Printed Titanium Lattice Structures with Different Patterns.

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.

Efficacy of a newly designed helical-shaped 3D-printed titanium cage for cervical vertebral defect healing in rabbits.

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.

Novel nano-hydroxyapatite coating of additively manufactured three-dimensional porous implants improves bone ingrowth and initial fixation.

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.

Surface modifications to promote the osteoconductivity of ultra-high-molecular-weight-polyethylene fabrics for a novel biomimetic artificial disc prosthesis: An in vitro study.

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.

Comparative evaluation of two collagen-based biomaterials with different compositions used for bone graft: An experimental animal study.

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.

A fully ingrowing implant for cranial reconstruction: Results in critical size defects in sheep using 3D-printed titanium scaffold.

Current alloplastic materials such as PMMA, titanium or PEEK don't show relevant bone ingrowth into the implant when used for cranioplasty, ceramic implants have the drawback being brittle. New materials and implant designs are urgently needed being biocompatible, stable enough for cranioplasty and stimulating bone formation. In an in vivo critical size sheep model circular cranial defects (>2.4 cm) were covered with three different types of a 3D-printed porous titanium scaffolds with multidirectional, stochastically distributed architecture (uncoated scaffold, hydroxyapatite-coated scaffold, uncoated scaffold filled with a calcium phosphate bone cement paste containing ß-TCP granules). An empty titanium mesh served as control. Among the different investigated setups the hydroxyapatite-coated scaffolds showed a surprisingly favourable performance. Push-out tests revealed a 2.9 fold higher force needed in the hydroxyapatite-coated scaffolds compared to the mesh group. Mean CT density at five different points inside the scaffold was 2385HU in the hydroxyapatite-coated group compared to 1978HU in the uncoated scaffold at nine months. Average lateral bone ingrowth after four months in the hydroxyapatite-coated scaffold group was up to the implant center, 12.1 mm on average, compared to 2.8 mm in the control group covered with mesh only. These properties make the investigated scaffold with multidirectional, stochastically distributed structure superior to all products currently on the market. The study gives a good idea of what future materials for cranioplasty might look like.

Biomechanical analysis of three popular tibial designs for TAR with different implant-bone interfacial conditions and bone qualities: A finite element study.

BACKGROUND: The long-term success of total ankle replacement (TAR) depends on both bone ingrowth and remodelling. The extreme values of implant-bone micromotion hinder bone ingrowth. Whereas, bone resorption due to bone remodelling is triggered by stress shielding. This study aims to investigate the biomechanical performance of three popular tibial designs (STAR, Salto and Mobility) for TAR with different implant-bone interfacial conditions and bone qualities. METHODS: In this study, CT data were used for the geometric modelling of bone. The cancellous bone was considered to be heterogeneous with location-based properties. Total 48 Finite Element (FE) models were prepared i.e., 45 implanted and 3 intact. For the three designs, three bone qualities were considered. For each bone quality, five implant-bone interface coefficients of friction were considered (0.1 to 0.5). The proximal part of the tibia was fully constrained and dorsiflexion loading condition was applied. RESULTS: There was a reduction in micromotion as the coefficient of friction increased and increase in micromotion as the bone quality reduced. The effect of implant-bone coefficient of friction was trivial on tibial stress (von Mises stress) however, bone quality and implant design was considerable. Stress shielding was seen in all the models and it increased when the bone quality degraded. CONCLUSIONS: This study establishes the effect of the implant-bone interfacial condition, bone quality and implant design on implant-bone micromotion and bone stress. For long-term fixation of the tibial component, due attention should be given while selecting the tibial component design for TAR, especially for STAR and Mobility design.

Effect of different structures fabricated by additive manufacturing on bone ingrowth.

OBJECTIVE: To study the effects of different structures (solid/hollow) and pore diameters (300/600 µm) on bone ingrowth. METHODS: Porous titanium alloy scaffolds (3.2 * 10.5 mm) were printed using electron beam melting. The implants were divided into either Hollow or Solid Group. The upper half of each implant was printed with a pore diameter of 600 µm while the bottom half was printed with a pore diameter of 300 µm. Visualization of the structural morphology was done using Scanning Electron Microscope (SEM). Cell proliferation was evaluated with the cell counting kit-8 assay and live/dead staining assay. The different lateral femoral condyles of 15 New Zealand rabbits were implanted with different groups of scaffolds. The rabbits were randomly sacrificed at the 4th, 8th, and 12th week postoperatively. Bone mineral density (BMD) and bone volume fraction (BV/TV) evaluation was completed by quantitative Micro-Computed Tomography (Micro-CT). Tissue histology were stained with toluidine blue to observe bone ingrowth under an optical microscope, and the percentage of new bone area were calculated using Image Pro-Plus 6.0. RESULTS: SEM images showed a significant decrease in residual powder in the hollow implant and cell studies showed no obvious cytotoxicity for the Ti6Al4V scaffolds. Micro-CT reconstruction revealed high levels of new bone formation around the scaffolds. The trabeculae around the implants showed a gradual increase with each week, and new bone filled the scaffold pores gradually. BMD, BV/TV, and tissue histology revealed the 300 µm pore diameter is more conducive to bone ingrowth than the 600 µm (p < .05). CONCLUSION: Our study revealed that Ti6Al4V implants with hollow structure could reduce the residual metal powder and implants with 300 µm pore diameter were more effective on bone formation than a 600 µm.

Irregular porous titanium enhances implant stability and bone ingrowth in an intra-articular ovine model.

Two commercially available porous coatings, Gription and Porocoat, were compared for the first time in a challenging intra-articular, weight-bearing, ovine model. Gription has evolved from Porocoat and has higher porosity, coefficient of friction, and microtextured topography, which are expected to enhance bone ingrowth. Cylindrical implants were press-fit into the weight-bearing regions of ovine femoral condyles and bone ingrowth and fixation strength evaluated 4, 8, and 16 weeks postoperatively. Biomechanical push-out tests were performed on lateral femoral condyles (LFCs) to evaluate the strength of the bone-implant interface. Bone ingrowth was assessed in medial femoral condyles (MFCs) as well as implants retrieved from LFCs following biomechanical testing using backscattered electron microscopy and histology. By 16 weeks, Gription-coated implants exhibited higher force (2455 ± 1362 vs. 1002 ± 1466 N; p = 0.046) and stress (12.60 ± 6.99 vs. 5.14 ± 7.53 MPa; p = 0.046) at failure, and trended towards higher stiffness (11,510 ± 7645 vs. 5010 ± 8374 N/mm; p = 0.061) and modulus of elasticity (591 ± 392 vs. 256 ± 431 MPa; p = 0.061). A strong, positive correlation was detected between bone ingrowth in LFC implants and failure force (r = 0.93, p < 10-13 ). By 16 weeks, bone ingrowth in Gription-coated implants in MFCs was 10.50 ± 6.31% compared to 5.88 ± 2.77% in Porocoat (p = 0.095). Observations of the bone-implant interface, made following push-out testing, showed more bony material consistently adhered to Gription compared to Porocoat at all three time points. Gription provided superior fixation strength and bone ingrowth by 16 weeks.

On-Growth and In-Growth Osseointegration Enhancement in PM Porous Ti-Scaffolds by Two Different Bioactivation Strategies: Alkali Thermochemical Treatment and RGD Peptide Coating.

A lack of primary stability and osteointegration in metallic implants may result in implant loosening and failure. Adding porosity to metallic implants reduces the stress shielding effect and improves implant performance, allowing the surrounding bone tissue to grow into the scaffold. However, a bioactive surface is needed to stimulate implant osteointegration and improve mechanical stability. In this study, porous titanium implants were produced via powder sintering to create different porous diameters and open interconnectivity. Two strategies were used to generate a bioactive surface on the metallic foams: (1) an inorganic alkali thermochemical treatment, (2) grafting a cell adhesive tripeptide (RGD). RGD peptides exhibit an affinity for integrins expressed by osteoblasts, and have been reported to improve osteoblast adhesion, whereas the thermochemical treatment is known to improve titanium implant osseointegration upon implantation. Bioactivated scaffolds and control samples were implanted into the tibiae of rabbits to analyze the effect of these two strategies in vivo regarding bone tissue regeneration through interconnected porosity. Histomorphometric evaluation was performed at 4 and 12 weeks after implantation. Bone-to-implant contact (BIC) and bone in-growth and on-growth were evaluated in different regions of interest (ROIs) inside and outside the implant. The results of this study show that after a long-term postoperative period, the RGD-coated samples presented higher quantification values of quantified newly formed bone tissue in the implant's outer area. However, the total analyzed bone in-growth was observed to be slightly greater in the scaffolds treated with alkali thermochemical treatment. These results suggest that both strategies contribute to enhancing porous metallic implant stability and osteointegration, and a combination of both strategies might be worth pursuing.

Effect of pore size on tissue ingrowth and osteoconductivity in biodegradable Mg alloy scaffolds.

Magnesium has mechanical properties similar to those of bone and is being considered as a potential bone substitute. In the present study, two different pore sized scaffolds of the Mg alloy LAE442, coated with magnesium fluoride, were compared. The scaffolds had interconnecting pores of either 400 (p400) or 500 µm (p500). ß-TCP served as control. Ten scaffolds per time group (6, 12, 24, 36 weeks) were implanted in the trochanter major of rabbits. Histological analyses, µCT scans, and SEM/EDX were performed. The scaffolds showed slow volume decreases (week 36 p400: 9.9%; p500: 7.5%), which were accompanied by uncritical gas releases. In contrast, ß-TCP showed accelerated resorption (78.5%) and significantly more new bone inside (18.19 ± 1.47 mm3). Bone fragments grew into p400 (0.17 ± 0.19 mm3) and p500 (0.36 ± 0.26 mm3), reaching the centrally located pores within p500 more frequently. In particular, p400 displayed a more uneven and progressively larger surface area (week 36 p400: 253.22 ± 19.44; p500: 219.19 ± 4.76 mm2). A better osseointegration of p500 was indicated by significantly more trabecular contacts and a 200 µm wide bone matrix being in the process of mineralization and in permanent contact with the scaffold. The number of macrophages and foreign body giant cells were at an acceptable level concerning resorbable biomaterials. In terms of ingrown bone and integrative properties, LAE442 scaffolds could not achieve the results of ß-TCP. In this long-term study, p500 appears to be a biocompatible and more osteoconductive pore size for the Mg alloy LAE442.

Early bone ingrowth and segmental stability of a trussed titanium cage versus a polyether ether ketone cage in an ovine lumbar interbody fusion model.

BACKGROUND CONTEXT: Lumbar interbody fusion is an effective treatment for unstable spinal segments. However, the time needed to establish a solid bony interbody fusion between the two vertebrae may be longer than twelve months after surgery. During this time window, the instrumented spinal segment is assumed to be at increased risk for instability related complications such as cage migration or subsidence. It is hypothesized that the design of new interbody cages that enable direct osseointegration of the cage at the vertebral endplates, without requiring full bony fusion between the two vertebral endplates, might shorten the time window that the instrumented spinal segment is susceptible to failure. PURPOSE: To quantify the bone ingrowth and resulting segmental stability during consolidation of lumbar interbody fusion using two different cage types. STUDY DESIGN: Preclinical ovine model. METHODS: Seven skeletally mature sheep underwent bi-segmental lumbar interbody fusion surgery with one conventional polyether ether ketone (PEEK) cage, and one newly developed trussed titanium (TT) cage. After a postoperative time period of 13 weeks, non-destructive range of motion testing, and histologic analysis was performed. Additionally, sample specific finite element (FE) analysis was performed to predict the stability of the interbody fusion region alone. RESULTS: Physiological movement of complete spinal motion segments did not reveal significant differences between the segments operated with PEEK and TT cages. The onset of creeping substitution within the cage seemed to be sooner for PEEK cages, which led to significantly higher bone volume over total volume (BV/TV) compared with the TT cages. TT cages showed significantly more direct bone to implant contact (BIC). Although the mean stability of the interbody fusion region alone was not statistically different between the PEEK and TT cages, the variation within the cage types illustrated an all-or-nothing response for the PEEK cages while a more gradual increase in stability was found for the TT cages. CONCLUSIONS: Spinal segments operated with conventional PEEK cages were not different from those operated with newly developed TT cages in terms of segmental stability but did show a different mechanism of bone ingrowth and attachment. Based on the differences in development of bony fusion, we hypothesize that TT cages might facilitate increased early segmental stability by direct osseointegration of the cage at the vertebral endplates without requiring complete bony bridging through the cage. CLINICAL SIGNIFICANCE: Interbody cage type affects the consolidation process of spinal interbody fusion. Whether different consolidation processes of spinal interbody fusion result in clinically significant differences requires further investigation.

Bone Ingrowth Around an Uncemented Femoral Implant Using Mechanoregulatory Algorithm: A Multiscale Finite Element Analysis.

The primary fixation and long-term stability of a cementless femoral implant depend on bone ingrowth within the porous coating. Although attempts were made to quantify the peri-implant bone ingrowth using the finite element (FE) analysis and mechanoregulatory principles, the tissue differentiation patterns on a porous-coated hip stem have scarcely been investigated. The objective of this study is to predict the spatial distribution of evolutionary bone ingrowth around an uncemented hip stem, using a three-dimensional (3D) multiscale mechanobiology-based numerical framework. Multiple load cases representing a variety of daily living activities, including walking, stair climbing, sitting down, and standing up from a chair, were used as applied loading conditions. The study accounted for the local variations in host bone material properties and implant-bone relative displacements of the macroscale implanted FE model, in order to predict bone ingrowth in microscale representative volume elements (RVEs) of 12 interfacial regions. In majority RVEs, 20-70% bone tissue (immature and mature) was predicted after 2 months, contributing toward a progressive increase in average Young's modulus (1200-3000 MPa) of the interbead tissue layer. Higher bone ingrowth (mostly greater than 60%) was predicted in the anterolateral regions of the implant, as compared to the posteromedial side (20-50%). New bone tissue was formed deeper inside the interbead spacing, adhering to the implant surface. The study helps to gain an insight into the degree of osseointegration of a porous-coated femoral implant.