Comparative osteoconductivity of bone void fillers with antibiotics in a critical size bone defect model.

The study aimed to evaluate the comparative osteoconductivity of three commercially available bone void fillers containing gentamicin with respect to new bone, growth, host tissue response and resorption of the implant material. Defects were created in the cancellous bone of the distal femur and proximal tibia of 12-skeletally mature sheep and filled with three commercially available bone void fillers containing gentamicin (Stimulan-G, Cerament-G, Herafill-G). Peripheral blood was taken pre-operatively and at the time of implantation, as well as at intermittent timepoints following surgery to determine systemic gentamicin levels (5-,15- and 30- minutes, 1, 2, 3, 6, 12, 24, 48- and 72-hours, 3-, 6- and 12-weeks). Decalcified, embedded samples were stained with haematoxylin and eosin (H&E) and used to assess the host tissue response and the formation of new bone in the presence of test implant materials. No adverse reactions were noted at harvest at any time points for any cancellous implantation sites with the various implant materials. Comparative microCT analysis of the Stimulan-G, Cerament-G and Herafill-G test materials revealed a similar increase in bone surface area and volume between animals implanted with Stimulan-G or Cerament-G test materials. Animals implanted with Herafill-G test materials demonstrated the lowest increases in bone volume and surface area of the test materials tested, at levels similar to the negative control sites. By 12-weeks, Stimulan-G defects were completely closed with mature bone and bone marrow whilst the Cerament-G material was still present after 12 weeks by histological examination. In conclusion, this study demonstrated differences in the bone regenerative capacity of a range of bone void fillers in an in vivo setting.

Effects of SCCO2, Gamma Irradiation, and Sodium Dodecyl Sulfate Treatments on the Initial Properties of Tendon Allografts.

Sterile and decellularized allograft tendons are viable biomaterials used in reconstructive surgeries for dense connective tissue injuries. Established allograft processing techniques including gamma irradiation and sodium dodecyl sulfate (SDS) can affect tissue integrity. Supercritical carbon dioxide (SCCO2) represents a novel alternative that has the potential to decellularize and sterilize tendons with minimized exposure to denaturants, shortened treatment time, lack of toxic residues, and superior tissue penetration, and thus efficacy. This study attempted to develop a single-step hybrid decellularization and sterilization protocol for tendons that involved SCCO2 treatment with various chemical additives. The processed tendons were evaluated with mechanical testing, histology, scanning electron microscopy (SEM), and Fourier-transform infrared (FTIR) spectroscopy. Uniaxial mechanical testing showed that tendons treated with SCCO2 and additive NovaKillTM Gen2 and 0.1% SDS had significantly higher (p < 0.05) ultimate tensile stress (UTS) and Young's modulus compared to gamma-irradiated and standard-SDS-treated tendons. This was corroborated by the ultrastructural intactness of SCCO2-treated tendons as examined by SEM and FTIR spectroscopy, which was not preserved in gamma-irradiated and standard SDS-treated tendons. However, complete decellularization was not achieved by the experimented SCCO2-SDS protocols used in this study. The present study therefore serves as a concrete starting point for development of an SCCO2-based combined sterilization and decellularization protocol for allograft tendons, where additive choice is to be optimized.

Effects of supercritical fluid CO2 and 25 kGy gamma irradiation on the initial mechanical properties and histological appearance of tendon allograft.

Tendon allografts, when autograft options are limited or when obtaining an autograft is not aligned with the patients' best interest, play an important role in tendon and ligament reconstruction. To minimize the risk of infectious disease transmission tissue banks perform screening tests and the allografts cleaned are sterilized. The current study examines and compares the initial mechanical properties and histological appearance of supercritical CO2 (SCCO2)-treated and gamma-irradiated porcine extensor tendons. Thirty intact porcine forelimb extensor tendons randomized equally into three groups: control group, gamma-irradiation group, and SCCO2-treated group. Once treated, histological assessment and histomorphologic measurements were made on the histological sections obtained from each tendon while stiffness and ultimate failure loads were evaluated from tensile testing. Histological evaluation of gamma-irradiated tendons showed significant disruption to the hierarchical morphology of the fascicle bundles, which was not evident in SCCO2-treated specimens. Histomorphologic measurements showed a significant increase for measured dead space (void) between tendon fibrils of the gamma-irradiated group comparing to both control and SCCO2 treated groups (p < 0.01). There was a significant reduction in the ultimate failure load for tendons treated by gamma-irradiation compared to the control group (p < 0.05). No statistically significant difference was detected between control and SCCO2-treated tendons in the ultimate failure load. Stiffness values were not significantly different between three-study groups. This study suggests that while gamma-irradiation has a deleterious effect on mechanical properties of tendon tissue, SCCO2 does not alter the biomechanical properties and the histological structure of porcine extensor tendons.

A biomechanical comparison of Kirschner-wire fixation on fracture stability in Salter-Harris type I fractures of the proximal humeral physis in a porcine cadaveric model.

BACKGROUND: The physis is the weakest component of immature long bones, and physeal fractures constitute about 30% of fractures in growing dogs. Fractures of the proximal humeral physis typically have a Salter Harris type I or II configuration. These fractures require accurate reduction and adequate stabilization to allow for any potential continued longitudinal bone growth, in conjunction with physeal fracture healing. Conventional internal fixation of these fractures involves insertion of two parallel Kirschner wires, although other methods described include tension band wiring, Rush pinning, and lag screws. However these recommendations are based on anecdotal evidence, and information about the biomechanical stability of physeal fracture repair is sparse. The unique anatomical structure of the epiphyseal-metaphyseal complex makes the gripping of the epiphysis for ex vivo biomechanical testing of physeal fracture repair very challenging. The objective of our study was to biomechanically assess the optimal number (three, two or one) of implanted Kirschner wires in a porcine Salter Harris I proximal humeral physeal fracture model, using motion analysis tracking of peri-fragmental retro-reflective markers while constructs were subjected to a constant axial compression and a sinusoidal torque of +/- 2 Nm at 0.5 Hz for 250 cycles. RESULTS: There were significant differences between the three constructs (three, two or one Kirschner wire repair) for gross angular displacement (p < 0.001). The difference between three pins and two pins on toggle was not significant (p = 0.053), but both three-pin and two-pin fixation significantly reduced rotational toggle compared to one-pin fixation. Construct stiffness was not significantly different between any of the pin groups (p > 0.33). CONCLUSIONS: Motion analysis tracking using peri-fragmental markers in this porcine model of physeal fracture repair found that the stability at the fracture site of one-pin fixation was significantly less than two-pin and three-pin fixation. Whether there was increased stabilization of these fractures with three-pin fixation compared to two-pin fixation was not conclusive in this porcine model.

Meniscal allograft sterilisation: effect on biomechanical and histological properties.

Sterilisation of allografts are a crucial step in ensuring safety and viability. Current sterilisation standards such as 25 kGy gamma irradiation (γ) can have adverse effects on the ultrastructure and biomechanical properties of allograft tissue. Supercritical CO2 (SCCO2) technology, represents an improved sterilisation process that potentially preserves tissue properties. This study aimed to test the effect of SCCO2 sterilisation on the biomechanical and histological properties of the meniscus and compare this to the current standard of γ. Thirty-two 18-month old ovine menisci were randomly assigned into three groups for sterilisation (SCCO2, γ and control). After treatment, biomechanical indentation testing (stiffness and stress relaxation) or histological analysis [percentage of void, cells and extracellular matrix (ECM) per slide] was undertaken. Both SCCO2 and gamma groups displayed an increase in stiffness and stress relaxation as compared to control, however, this difference was lesser in samples treated with SCCO2. No significant histological quantitative differences were detected between SCCO2 and control specimens. Gamma-treated samples demonstrated a significant increase in void and decrease in ECM. Interestingly, both treatment groups demonstrated a decreasing mean void and increasing ECM percentage when analysed from outer to inner zones. No significant differences were detected in all-endpoints when analysed by section. SCCO2 sterilisation represents a potential feasible alternative to existing sterilization techniques such as γ.

Characterization of an advanced bone graft material with a nanocrystalline hydroxycarbanoapatite surface and dual phase composition.

The bone formation response of ceramic bone graft materials can be improved by modifying the material's surface and composition. A unique dual-phase ceramic bone graft material with a nanocrystalline, hydroxycarbanoapatite (HCA) surface and a calcium carbonate core (TrelCor®-Biogennix, Irvine, CA) was characterized through a variety of analytical methods. Scanning electron microscopy (SEM) of the TrelCor surface (magnification 100-100,000X) clearly demonstrated a nanosized crystalline structure covering the entire surface. The surface morphology showed a hierarchical structure that included micron-sized spherulites fully covered by plate-like nanocrystals (<60 nm in thickness). Chemical and physical characterization of the material using X-ray Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), and Scanning Electron Microscopy Energy Dispersive X-ray Spectroscopy (SEM-EDX) showed a surface composed of HCA. Analysis of fractured samples confirmed the dual-phase composition with the presence of a calcium carbonate core and HCA surface. An in vitro bioactivity study was conducted to evaluate whether TrelCor would form a bioactive layer when immersed in simulated body fluid. This response was compared to a known bioactive material (45S5 bioactive glass - Bioglass). Following 14-days of immersion, surface and cross-sectional analysis via SEM-EDX showed that the TrelCor material elicited a bioactive response with the formation of a bioactive layer that was qualitatively thicker than the layer that formed on Bioglass. An in vivo sheep muscle pouch model was also conducted to evaluate the ability of the material to stimulate an ectopic, cellular bone formation response. Results were compared against Bioglass and a first-generation calcium phosphate ceramic that lacked a nanocrystalline surface. Histology and histomorphometric analysis (HMA) confirmed that the TrelCor nanocrystalline HCA surface stimulated a bone formation response in muscle (avg. 11% bone area) that was significantly greater than Bioglass (3%) and the smooth surface calcium phosphate ceramic (0%).

Applying the Techniques of Materials Science towards an Understanding of the Process of Canine Intervertebral Disc Degeneration.

Intervertebral disc degeneration in dogs occurs in an accelerated way and involves calcification, which is associated with disc herniation or extrusion. The degenerative process is complex and involves the transformation of collagen fibres, loss of proteoglycans and notochord cells and a reduction in water content; however, how these processes are linked to future disc extrusion remains unknown. We have employed techniques including Fourier Transform Infra-red Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), Transmission Electron Microscopy (TEM), Uniaxial Compression Loading and Atomic Force Microscopy (AFM) in an attempt to gain a greater understanding of the degenerative process and its consequences on the physical properties of the disc. FTIR verified by TEM demonstrated that calcium phosphate exists in an amorphous state within the disc and that the formation of crystalline particles of hydroxyapatite occurs prior to disc extrusion. AFM identified crystalline agglomerates consistent with hydroxyapatite as well as individual collagen fibres. SEM enabled the identification of regions rich in calcium, phosphorous and oxygen and allowed the visualization of the topographical landscape of the disc. Compression testing generated stress/strain curves which will facilitate investigation into disc stiffness. Ongoing work is aimed at identifying potential areas of intervention in the degenerative process as well as further characterizing the role of calcification in disc extrusion.

Effect of gamma irradiation and supercritical carbon dioxide sterilization with Novakill™ or ethanol on the fracture toughness of cortical bone.

Sterilization of structural bone allografts is a critical process prior to their clinical use in large cortical bone defects. Gamma irradiation protocols are known to affect tissue integrity in a dose dependent manner. Alternative sterilization treatments, such as supercritical carbon dioxide (SCCO2 ), are gaining popularity due to advantages such as minimal exposure to denaturants, the lack of toxic residues, superior tissue penetration, and minor impacts on mechanical properties including strength and stiffness. The impact of SCCO2 on the fracture toughness of bone tissue, however, remains unknown. Here, we evaluate crack initiation and growth toughness after 2, 6, and 24 h SCCO2 -treatment using Novakill™ and ethanol as additives on ~11 samples per group obtained from a pair of femur diaphyses of a canine. All mechanical testing was performed at ambient air after 24 h soaking in Hanks' balanced salt solution (HBSS). Results show no statistically significant difference in the failure characteristics of the Novakill™-treated groups whereas crack growth toughness after 6 and 24 h of treatment with ethanol significantly increases by 37% (p = .010) and 34% (p = .038), respectively, compared to an untreated control group. In contrast, standard 25 kGy gamma irradiation causes significantly reduced crack growth resistance by 40% (p = .007) compared to untreated bone. FTIR vibrational spectroscopy, conducted after testing, reveals a consistent trend of statistically significant differences (p < .001) with fracture toughness. These trends align with variations in the ratios of enzymatic mature to immature crosslinks in the collagen structure, suggesting a potential association with fracture toughness. Additional Raman spectroscopy after testing shows a similar trend with statistically significant differences (p < .005), which further supports that collagen structural changes occur in the SCF-treated groups with ethanol after 6 and 24 h. Our work reveals the benefits of SCCO2 sterilization compared to gamma irradiation.

The effects of low-intensity pulsed ultrasound on tendon-bone healing in a transosseous-equivalent sheep rotator cuff model.

PURPOSE: The purpose of this study was to examine the effects Low-intensity Pulsed Ultrasound has on initial tendon-bone healing in a clinically relevant extra-articular transosseous-equivalent ovine rotator cuff model. METHODS: Eight skeletally mature wethers, randomly allocated to either control group (n = 4) or treatment group (n = 4), underwent rotator cuff surgery following injury to the infraspinatus tendon. All animals were killed 28 days post surgery to allow examination of early effects of Low-intensity Pulsed Ultrasound treatment. RESULTS: General improvement in histological appearance of tendon-bone integration was noted in the treatment group. Newly formed woven bone with increased osteoblast activity along the bone surface was evident. A continuum was observed between the tendon and bone in an interdigitated fashion with Sharpey's fibres noted in the treatment group. Low-intensity Pulsed Ultrasound treatment also increased bone mineral density at the tendon-bone interface (p < 0.01), while immunohistochemistry results revealed an increase in the protein expression patterns of VEGF (p = 0.038), RUNX2 (p = 0.02) and Smad4 (p = 0.05). CONCLUSIONS: The results of this study indicate that Low-intensity Pulsed Ultrasound may aid in the initial phase of tendon-bone healing process in patients who have undergone rotator cuff repair. This treatment may also be beneficial following other types of reconstructive surgeries involving the tendon-bone interface.

Controlling the bone regeneration properties of bioactive glass: Effect of particle shape and size.

The ability of particulate bioactive glass to function as an effective bone graft material is directly related to its in vivo dissolution, ion release, and interparticle spacing (area associated with bone in-growth). A spherical shape represents an optimal geometry to control bioactive glass bone formation properties. Spherical particles were fabricated from 45S5 bioactive glass with unimodal (90-180, 180-355, and 355-500 µm) and bimodal size ranges (180-355/355-500 and 90-180/355-500 µm). Particles were formed into bone graft putties and compared to a commercially available product composed of irregular 45S5 bioactive glass particles (32-710 µm). Scanning electron microscopy characterization of spherical particles showed a relatively uniform sphere shape and smooth surfaces. Irregular particles were characterized by random shapes with flat surfaces and sharp edges. X-ray fluorescence and X-ray diffraction indicated that the spheroidization process maintained the properties of 45S5 bioactive glass. Cross-sectional micro-computed tomography imaging of the putty samples demonstrated that smaller spheres and irregular particles resulted denser packing patterns compared to the larger spheres. Isolated particles were immersed in simulated body fluid for 14 days to measure silicon ion release and bioactivity. Inductively coupled plasma spectroscopy showed faster ion release from smaller particles due to increased surface area. Bioactivity characterization of 14-day simulated body fluid exposed particle surfaces showed the presence of a hydroxycarbanoapatite mineral layer (characteristic of 45S5 bioactive glass) on all bioactive glass particles. Results demonstrated that spherical particles maintained the properties of the starting 45S5 bioactive glass, and that particle shape and size directly affected short-term glass dissolution, ion release, and interparticle spacing.

Standalone titanium/polyetheretherketone interbody cage for anterior lumbar interbody fusion: Clinical and radiological results at 24 months.

Context: Anterior lumbar interbody fusion (ALIF) is a common procedure for patients suffering degenerative, deformity, or posttraumatic pathologies of the lumbar spine. Aims: The aim of this study is to evaluate the clinical and radiological outcomes of a combination Titanium/Polyetheretherketone (Ti/PEEK) 3-screw fixation ALIF cage. Settings and Design: This was a prospective multisurgeon series of 87 patients (105 implants), with a minimum 24-month follow-up. Twelve patients (12/87) were supplemented with posterior percutaneous pedicle screw fixation for additional stability for pars defect spondylolisthesis correction. Radiological follow-up with fine-cut computed tomography (CT) scan occurred at 4-6 months, and again at 18-24 months if no fusion observed on initial CT, was performed to evaluate early and final fusion rates, and integration of the Ti/PEEK cage at the end-plate junction. Clinical follow-up included the subjective measures of pain and functional status and objective wearable device monitoring. Results: The fusion rate was 85% (97/105 implants) 6 months postoperatively, with no implant-related complications, and 95% at 24 months, based on independent radiological assessment. Patients experienced statistically significant improvement in subjective pain and functional outcomes compared to preoperative status. The objective measures revealed a daily step count with a 27% improvement, and gait velocity with a mean increase from 0.97 m/s to 1.18 m/s, at 3 months postoperatively. Conclusions: A Ti/PEEK cage, with allograft and bone morphogenetic protein-2 (BMP-2), achieved rapid interbody progression to fusion and is an effective implant for use in anterior lumbar surgery with high early fusion rates and no peri-endplate lucency. Supercritical CO2 allograft provided an osteoconductive scaffold and combined well with BMP-2 to facilitate fusion.

Integral fixation titanium/polyetheretherketone cages for cervical arthrodesis: Two-year clinical outcomes and fusion rates using ß-tricalcium phosphate or supercritical carbon dioxide treated allograft.

CONTEXT: Despite increasing promising reports regarding composite titanium (Ti)/PolyEtherEtherKetone (PEEK) cages, further longer-term, quality research is required. Synthetic bone graft substitutes are another rapidly developing area of spinal surgical research. AIMS: The purpose of this study is to evaluate the outcomes of an integral fixation composite Ti/PEEK cage for anterior cervical discectomy and fusion (ACDF) and compare a synthetic bone graft substitute (ß-tricalcium phosphate; [ßTCP]) with allograft processed using supercritical fluid technology. METHODS AND DESIGN: Data from 195 consecutive patients were prospectively collected from a single centre. Indications were largely degenerative. Allograft and ßTCP were used in a 3:1 randomization protocol. Patients were followed up for a minimum of 6 months and up to 48 months. Clinical outcomes included visual analogue scale and neck oswestry disability index. Radiographic outcomes included fusion rates, subsidence rates and implant complications. RESULTS: Graft sub-cohorts were largely comparable and included 133 and 52 patients in the allograft and ßTCP sub-cohorts, respectively. Clinical outcomes overall significantly improved (P < 0.001), with no significant inter-cohort differences. There were no implant-related complications. Overall fusion rate was 94.1% (175/186). The allograft cohort produced a significantly greater fusion rate of 97.7% (126/129) compared to 77.6% (38/49) for the ßTCP cohort (P = 0.001). CONCLUSIONS: This study demonstrates the viability of an integral fixation composite Ti/PEEK ACDF device in effectively and safely improving patient outcomes and achieving fusion. Allograft is more effective in achieving fusion compared to ßTCP, though both were similarly efficacious in improving clinical outcomes.

Load Sharing and Endplate Pressure Distribution in Anterior Interbody Fusion Influenced by Graft Choice.

BACKGROUND: Cage subsidence is a known complication of spinal fusion. Various aspects of cage design have been investigated for their influence on cage subsidence, whereas the potential contribution of graft material to load sharing is often overlooked. We aimed to determine whether graft in the aperture affects endplate pressure distribution. METHODS: The pressure distributions of a polyetheretherketone interbody cage with 3 different aperture graft conditions were evaluated: empty, demineralized bone matrix, and supercritical CO2-treated allograft bone crunch (SCCO2). RESULTS: Graft materials contributed as much as half the load transmission for SCCO2, whereas demineralized bone matrix contributed one third. Endplate areas in contact with the cage demonstrated decreased areas within the highest-pressure spectrum with SCCO2 graft materials compared with empty cages. CONCLUSIONS: Graft choice plays a role in reducing peak endplate pressures. This finding is relevant to implant subsidence, as well as graft loading and remodeling.

Moment arm function dictates patella sagittal height anatomy: Rabbit epiphysiodesis model alters limb length ratios and subsequent patellofemoral anatomical development.

Patellofemoral anatomical dysplasia is associated with patellofemoral instability and pain. The closure of the knee physis occurs at the same age as the peak incidence of patellofemoral dislocation. This study determined the effect on the patellofemoral anatomical development in a rabbit epiphysiodesis model. Twenty-four skeletally immature New Zealand White rabbits were divided into three groups (a) distal femur epiphysiodesis (FE) (b) proximal tibia epiphysiodesis (TE) (c) control; no epiphysiodesis (C) performed at 6 weeks of age. The primary endpoint was shape analysis using three-dimensional reconstructions of micro-computed tomographys (CTs) performed at 30 weeks of age. The limb length ratios (femur:tibia) were significantly different for both FE (mean 0.72, SD 0.0381, P < .001) and TE (mean 0.91, SD 0.0383, P < .001) treatment groups compared to control (mean 0.81, SD 0.0073). Patella height, as measured from the most distal point of the patella to the tibial joint surface (modified Caton-Deschamps measurement), was lower (baja) in the FE and higher (alta) for the TE, compared with the control group. Our findings suggest femoral and tibial shortening can influence the development of the patellofemoral joint, which may be dictated by moment arm function and is potentially responsible for the etiology of patella alta. Future studies are warranted to explore this association further with the view for the development of treatment options for patella alta in human patients.

Bone ongrowth and mechanical fixation of implants in cortical and cancellous bone.

BACKGROUND: What is the right surface for an implant to achieve biological fixation? Surface technologies can play important roles in encouraging interactions between the implant surface and the host bone to achieve osseointegration. Preclinical animal models provide important insight into in vivo performance related to bone ongrowth and implant fixation. METHODS: A large animal model was used to compare the in vivo response of HA and plasma-sprayed titanium coatings in a well-reported adult ovine model to evaluate bone ongrowth in terms of mechanical properties in cortical sites, and histology and histomorphometry in cortical and cancellous sites at 4 and 12 weeks. RESULTS: Titanium plasma-sprayed surfaces outperformed the HA-coated samples in push-out testing in cortical sites while both surfaces supported new bone ongrowth and remodeling in cortical and cancellous sites. CONCLUSIONS: While both HA and Ti plasma provided an osteoconductive surface for bone ongrowth, the Ti plasma provided a more robust bone-implant interface that ideally would be required for load transfer and implant stability in the longer term.

In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model.

Introduction: Demineralized bone matrix (DBM) is a widely used bone graft in spinal fusion. Most commercial DBMs are composed of demineralized bone particles (~125-800 microns) suspended in a carrier that provides improved handling but dilutes the osteoinductive component. DBM fibers (DBF) provide improved osteoconductivity and do not require a carrier. It has been suggested that 100% DBF may offer improved performance over particulate-based DBMs with carrier. Study Design: Seven commercially available DBM products were tested in an athymic rat posterolateral fusion model. There were four 100% DBFs, two DBFs containing a carrier, and one particulate-based DBM containing carrier. Objective: The study objectives were to evaluate the in vivo performance: (1) compare fusion rate and fusion maturity of six commercially available DBFs and one particulate-based DBM, and (2) assess the effect of carrier on fusion outcomes for DBFs in a posterolateral fusion model. Methods: The DBF/DBM products evaluated were: StrandTM Family, Propel® DBM Fibers, Vesuvius® Demineralized Fibers, Optium® DBM Putty, Grafton® DBF, Grafton Flex, and DBX® Putty. Single-level posterolateral fusion was performed in 69 athymic rats. Fusion was assessed bilaterally after 4 weeks by manual palpation, radiograph and CT for bridging bone. Fusion mass maturity was assessed with a CT maturity grading scale and by histology. Statistical analysis was performed using Fishers Exact Test for categorical data and Kruskal-Wallis Test for non-parametric data. Results: Strand Family achieved 100% fusion (18/18) by manual palpation, radiographic and CT evaluation, significantly higher than Propel Fibers, Vesuvius Fibers, Optium Putty, and DBX Putty, and not statistically higher than Grafton DBF and Grafton Flex. Strand Family provided the highest fusion maturity, with CT maturity grade of 2.3/3.0 and 89% mature fusion rate. Fusion results suggest a detrimental effect of carrier on fusion performance. Conclusions: There were large variations in fusion performance for seven commercially available DBM products in an established preclinical fusion model. There were even significant differences between different 100% DBF products, suggesting that composition alone does not guarantee in vivo performance. In the absence of definitive clinical evidence, surgeons should carefully consider available data in valid animal models when selecting demineralized allograft options.

Corrosion of 3D-Printed Orthopaedic Implant Materials.

3D-printing technologies such as electron beam melting (EBM) have allowed for patient-specific orthopaedic implants, however differences generated from the fabrication process may alter the corrosion properties of Ti6Al4V implants. This study evaluated the corrosion characteristics of EBM-fabricated Ti6Al4V, alongside any linked microstructural and surface changes. EBM-fabricated Ti6Al4V and wrought Ti6Al4V specimens (n = 10 per group) underwent microstructural and surface characterisation before and after corrosion testing. Cyclic potentiodynamic polarisation of specimens was conducted in accordance with ASTM Standard F2129-17. The degree of corrosion damage was subsequently assessed via qualitative and quantitative measures. EBM-fabricated Ti6Al4V demonstrated a higher proportion of ß phases and greater surface roughness, compared to wrought Ti6Al4V. Significant differences were observed for all corrosion parameters between the two groups. The lower breakdown potentials (Eb) for EBM-fabricated Ti6Al4V (2.035 V), compared to wrought Ti6Al4V (3.667 V), indicate a lower resistance to pitting corrosion. A greater resultant spread, and severity of corrosion damage was noted on wrought Ti6Al4V. An inferior in vitro corrosion resistance was observed for EBM-fabricated Ti6Al4V. Without post-processing, the rougher surface and differences in microstructure are likely to contribute to this. This suggests potential clinical implications upon in vivo implantation, although corrosion measures remain above recommended minimums.

The use of demineralised bone fibres (DBF) in conjunction with supercritical carbon dioxide (SCCO2) treated allograft in anterior lumbar interbody fusion (ALIF).

Spinal fusion is a common procedure for the treatment of various spinal pathologies. Since the early days, spinal fusion has been carried out with the use of bone grafts as interbody spacers. With the development of synthetic interbody implants, bone grafts were used to facilitate fusion. Although autograft provides the best outcomes for fusion, allografts have been sought after due to donor site morbidity and other shortcomings. Currently, a vast variety of demineralised bone matrix (DBM) products are available with their methods of processing and preparation impacting their properties and clinical outcomes. Demineralised bone fibres (DBF), a form a DBM can be easily packed into implants when mixed with other substances such as allograft bone and patient's blood providing a scaffold for the mixture. We report two cases of anterior lumbar interbody fusion (ALIF) utilising a titanium-polyetheretherketone (PEEK) interbody cage filled with DBF, allograft and patient's blood with a maximum of 12 months follow-up outcome.

Does implantation site influence bone ingrowth into 3D-printed porous implants?

BACKGROUND CONTEXT: The potential for osseointegration to provide biological fixation for implants may be related to anatomical site and loading conditions. PURPOSE: To evaluate the influence of anatomical site on osseointegration of 3D-printed implants. STUDY DESIGN: A comparative preclinical study was performed evaluating bone ingrowth in cortical and cancellous sites in long bones as well as lumbar interbody fusion with posterior pedicle screw stabilization using the same 3D-printed titanium alloy design. METHODS: 3D-printed dowels were implanted in cortical bone and cancellous bone in adult sheep and evaluated at 4 and 12 weeks for bone ingrowth using radiography, mechanical testing, and histology/histomorphometry. In addition, a single-level lumbar interbody fusion using cages based on the same 3D-printed design was performed. The aperture was filled with autograft or ovine allograft processed with supercritical carbon dioxide. Interbody fusions were assessed at 12 weeks via radiography, mechanical testing, and histology/histomorphometry. RESULTS: Bone ingrowth in long bone cortical and cancellous sites did not translate directly to interbody fusion cages. While bone ingrowth was robust and improved with time in cortical sites with a line-to-line implantation condition, the same response was not found in cancellous sites even when the implants were placed in a press fit manner. Osseointegration into the porous walls with 3D porous interbody cages was similar to the cancellous implantation sites rather than the cortical sites. The porous domains of the 3D-printed device, in general, were filled with fibrovascular tissue while some bone integration into the porous cages was found at 12 weeks when fusion within the aperture was present. CONCLUSION: Anatomical site, surgical preparation, biomechanical loading, and graft material play an important role in in vivo response. Bone ingrowth in long bone cortical and cancellous sites does not translate directly to interbody fusions.