Osteointegration of hydroxyapatite-coated and uncoated titanium screws in long-term ovariectomized sheep.

This study was designed to evaluate the osteointegration of HA-coated and uncoated titanium screws in the cortical bone of long-term (24 months) ovariectomized sheep (OVX group) compared to sham-aged sheep (Control group). At 12 weeks after implantation, the screws were tested biomechanically (extraction torque) and histomorphometrically (affinity index: AI) in both femoral and tibial diaphyses. Cancellous bone status was assessed by iliac crest biopsy. BMD of the L5 vertebra and a histomorphological study of the femoral and tibial shafts were performed to acquire data on cortical bone. A significant difference was found between the OVX and Control groups for BMD (p<0.0005), and a significant reduction in the cancellous bone area was observed in the OVX group. Femoral and tibial cortical bone parameters showed significant differences between the groups. The type of material selected (femurs: p<0.0005; tibiae: p<0.0005) and ovariectomy (femurs: p<0.005; tibiae: p<0.005) had a significant effect on the extraction torque. AI results were related to the presence or absence of ovariectomy (p<0.05) and strictly depended on the material implanted in the femur and tibia (p<0.0005). In conclusion, at implantation OVX sheep showed a significant loss of trabecular and cortical bone versus sham-aged sheep. The biomechanical and histomorphological results achieved suggest employing HA-coated screws in the presence of osteopenic cortical bone.     

Tibial implants: biomechanical and histomorphometric studies of hydroxyapatite-coated and uncoated stainless steel and titanium screws in long-term ovariectomized sheep.

This study was designed to evaluate osteointegration of HA-coated and uncoated titanium and stainless steel screws in the cortical bone of long-term (24 months) ovariectomized sheep (OVX group), in comparison with Sham-aged sheep (control group). The screws were tested biomechanically (extraction torque) and histomorphometrically (affinity index: Al) 12 weeks after their implantation in tibial diaphyses. Tibial cortical bone parameters showed significant differences between the groups, showing a reduction of the selected parameters in the OVX group. ANOVA showed significant effects for both material and ovariectomy factors on obtained extraction torque (material: F=159.26, p < 0.0005; ovariectomy: F=20.04, p < 0.0005) and Al data (material: F=8.04, p < 0.001; ovariectomy: F=7, 17, p < 0.05). In both groups the extraction torque for coated screws of both materials was significantly higher than for uncoated screws, and uncoated titanium had a better extraction torque than uncoated stainless steel. In the OVX group, the HA-coated stainless steel and titanium Al data were significantly higher than uncoated Al data. In conclusion, the biomechanical and histomorphological results obtained suggest employing HA-coated screws in the presence of osteopenic cortical bone.     

Biomechanical and histomorphometric study on the bone-screw interface of bioactive ceramic-coated titanium screws

The purpose of this study was to compare the osseointegration of 4 different kinds of bioactive ceramic-coated screws with uncoated screws by biomechanical and histomorphometric analysis. Calcium pyrophosphate (CPP), apatite-wollastonite 1:3 glass ceramic (W3G), apatite-wollastonite 1:1 glass ceramic (WAG) and bioactive CaO-SiO2-B2O3 glass ceramic (CSG) coatings were prepared and coated by the dipping method. Coated and uncoated titanium screws were inserted into the tibia of 18 adult mongrel male dogs for 2, 4, and 8 weeks. The insertion torques, radiographs, undecalcified histology, histomorphometric analysis, and extraction torques were evaluated. No difference of insertion torque was found among the five screw types. At 2 and 4 weeks after implantation, the extraction torque of ceramic-coated screws was significantly higher than that of uncoated screws (p < or = 0.0001). At 8 weeks, the extraction torques of CPP-, W3G-, and WAG-coated screws were significantly higher than those of CSG-coated and uncoated screws (p<0.0001). At 2, 4, and 8 weeks, the extraction torques of 4 different ceramic-coated screws were significantly higher than the corresponding insertion torque. Strong fixation was observed even at 2 weeks in the CPP-, W3G- and WAG-coated screws. The bone-screw contacts of the 4 different coated screws at 2 and 4 weeks were statistically higher than that of the uncoated screws, and the bone-screw contacts of the CPP-, W3G- and WAG-coated screws at 8 weeks were also statistically higher than that of the uncoated screws. The fixation strength was increased by the presence of osteoconductive coating materials, such as CPP, W3G, and WAG, which enabled to achieve higher fixation strength even as early as 2-8 weeks after the insertion.     

Axial cyclic behavior of the bone-screw interface

Screw fixation strength is investigated by using a pullout test. Despite many screw pullout studies, the effects of loading rate on the pullout behavior of pedicle screws are not known. The objective of this study was to assess the effects of loading rate on the pullout stiffness and strength of pedicle screws. Sixty pedicle screws were inserted in foam blocks and pulled out at four different rates: 0.1, 1, 5 and 50 mm/min. Twenty of these 60 screws were cycled non-destructively at four different rates sequentially, i.e., 0.1, 1, 5 and 50 mm/min prior to pullout. Ten additional pedicle screws were inserted in five calf lumbar vertebrae, cycled as in foam group, and pulled out at a rate of either 0.1 or 50 mm/min. The results showed that the stiffness was higher at all rates compared to 0.1 mm/min in foam model but in bone model only 1 and 5 mm/min groups were higher compared to 0.1 mm/min. The pullout strength in 50 mm/min group was higher than that in 0.1 mm/min group in both foam and bone model. The results suggested that loading rate influenced the mechanics of the bone-screw interface. Therefore, a fair comparison between the pullout studies can be achieved under same loading rate conditions. Moreover, the cycling of the pedicle screws in axial direction within a pre-yield region showed an unusual hysteresis curve. Further studies are needed for a better understanding of the mechanics of the screw-bone interface.     

Osteointegration of bioactive glass-coated and uncoated zirconia in osteopenic bone: an in vivo experimental study

In elderly and osteoporotic patients an age-related loss of osteoinductivity could be the biological cause of implant failure regardless of the high quality of the implanted device. yttria stabilized tetragonal zirconia (YSTZ), either coated with the bioactive glass named RKKP bioglaze (RKKP) or uncoated, was implanted in the distal femurs of sham-operated and ovariectomized female rats. Animals were sacrificed at 30 and 60 days. Histomorphometry and microhardness tests were performed to assess osteointegration rate as well as bone quality around the implants. Significant decreases (p < 0.0005) in trabecular bone volume, BV/TV (41%), trabecular bone surface BS/TV (33%), trabecular thickness Tb.Th (20%), and trabecular number Tb.N (32%), together with a significant increase in trabecular separation Tb.Sp (184%), were found for the osteopenic rats compared with the sham-operated rats. At both experimental times the RKKP coating ensured a better osteointegration rate with higher AI values than the uncoated YSTZ, even when osteopenic rats were used (48% at 30 days and 12% at 60 days). No differences were observed at the bone-biomaterial interfaces for either material when comparing sham-operated with osteopenic rats. The present results demonstrate that the RKKP bioactive glass used as a coating ensures a high osteointegration rate even in osteoporotic bone, which is already visible from postoperative day 30 and is still apparent on day 60.     

Fourier transform infrared imaging analysis of cancellous bone in alendronate- and raloxifene-treated osteopenic sheep

Fourier transform infrared imaging spectroscopy (FTIRI)-assessed bone composition parameters (mineral content, collagen maturity, crystal size and perfection, and carbonate content) describe bone quality and correlate to bone fracture risk. The challenge with studying bone quality in patients treated with antiresorptive drugs such as bisphosphonates (e.g., alendronate) and selective estrogen receptor modulators (SERMs) (e.g. raloxifene) is being able to test bone mechanical performance and material properties pre- and posttreatment. The purpose of this study was to evaluate the FTIRI changes in a large animal model of osteoporosis (female sheep with dietary induced metabolic acidosis; MA). Previous studies have investigated the relationship between bone material properties and bone strength in humans and smaller animals and have shown that changes in compositional properties influence fracture risk. Here we characterize the MA model at 6 and 12 months, demonstrate the loss of bone and changes in compositional properties, and show that 6 months of treatment with both antiresorptives ameliorate the bone loss as assessed by bone mineral density and FTIRI. This preliminary data suggest that the MA sheep model allows investigation of whether drug treatments preserve bone properties that exist at the time of treatment or if they induce further beneficial changes.     

Isolation and characterization of osteoblast cultures from normal and osteopenic sheep for biomaterials evaluation

Being very useful in the analysis of bone cell differentiation and activity, osteoblast cultures are also used in the in vitro biocompatibility study of new materials. The aim of this work was to evaluate sheep osteoblast cultures derived from normal and ovariectomized animals, and then to assess the in vitro biomaterial behavior on these cultures, taking into account the quality of bone where orthopedic devices are clinically used. For this purpose, we characterized sheep osteoblast cultures, isolated from iliac crest bone of normal (NB osteoblast culture) and osteopenic after ovariectomy (OB osteoblast culture) sheep. Moreover, we studied cell behavior when cultured on different biomaterials (titanium and two biological glasses, RKKP and AP40). Cell characterization at baseline demonstrated that both cultures (NB and OB) showed normal osteoblastic behavior. On the contrary, osteoblasts derived from osteopenic bone and cultivated on AP40 for 6 days revealed a different behavior in terms of both cell morphology and metabolic activity. Statistical analysis (one-way analysis of variance and Scheffé's post hoc multiple-comparison tests) revealed significant differences in Ca level (p<0.0005), MTT test (p<0.0005) and OC production (p<0.05). These in vitro tests demonstrated that sheep osteoblast cultures can be useful when determining biocompatibility and osteointegration of orthopedic materials, and also when evaluating for the presence of osteoporosis.     

Evaluation of systemic metal diffusion after spinal pedicular fixation with titanium alloy and stainless steel system: a 36-month experimental study in sheep

It is known that titanium alloys cause more extensive local metallosis due to fretting corrosion than stainless steel implants. The aim of the present study was to investigate possible systemic metal releases (Ti, Al, V, Cr, Ni) in sheep where L4-L5 were implanted with titanium alloy (Ti6Al4V, ASTM F 136) and stainless steel (AISI 316 L). 16 sheep were used: 8 were implanted with Ti6Al4V and 8 with stainless steel. At 6, 12, 24 and 36 months, the following examinations were performed: histology, atomic absorption spectrophotometry (AAS) and scanning electron microscopy (SEM), on liver, lung, kidney, brain, spleen and lumbo-aortic lymph nodes. Hair, urine and arteria blood samples were also analysed by AAS before implantation and at sacrifices. A histologic and ultrastructural study was performed on peri-implant tissues, too. Particular attention was paid to avoid contamination from dissection instruments or use of containers. In basal and in samples at 6 and 12 months, no metals were found in blood, urine, hair or other target tissues of the animals implanted with either Ti6Al4V or stainless steel. Regarding Al, V, Co and Ni, negative results in all tissues and body fluids were obtained also at 24 and 36 months. On the contrary, Ti traces were found in lumbo-aortic lymph nodes and lungs of one sheep only (10 and 30 ng/g, respectively) at 24 months. At 36 months, a systemic diffusion of Ti was observed in all tissues of both sheep instrumented with Ti6Al4V (2-16.5 ng/g), except for body fluids and hair. Metal research in target tissues by light and SEM micro-probe analysis provided negative results. Current data suggest that the amount of Ti found in organs after stable pedicular fixation is extremely low and not biologically available. This observation would lead us to exclude the hypothesis of any toxic reaction and such a release seems to be due to the passive diffusion through lymphatic fluids. Additional studies are needed to confirm if this long-term release of Ti particles might cause tissue damage.     

Biological performance of uncoated and octacalcium phosphate-coated Ti6Al4V

The in vivo behavior of a porous Ti6Al4V material that was produced by a positive replica technique, with and without an octacalcium phosphate (OCP) coating, has been studied both in the back muscle and femur of goats. Macro- and microporous biphasic calcium phosphate (BCP) ceramic, known to be both osteoconductive and able to induce ectopic bone formation, was used for comparison purpose. The three groups of materials (Ti6Al4V, OCP Ti6Al4V and BCP) were implanted transcortically and intramuscularly for 6 and 12 weeks in 10 adult Dutch milk goats in order to study their osteointegration and osteoinductive potential. In femoral defects, both OCP Ti6Al4V and BCP were performing better than the uncoated Ti6Al4V, at both time points. BCP showed a higher bone amount than OCP Ti6Al4V after 6 weeks of implantation, while after 12 weeks, this difference was no longer significant. Ectopic bone formation was found in both OCP Ti6Al4V and BCP implants after 6 and 12 weeks. The quantity of ectopically formed bone was limited as was the amount of animals in which the bone was observed. Ectopic bone formation was not found in uncoated titanium alloy implants, suggesting that the presence of calcium phosphate (CaP) is important for bone induction. This study showed that CaPs in the form of coating on metal implants or in the form of bulk ceramic have a significantly positive effect on the bone healing process.     

Biological and biochemical characterization of sheep scrapie in Japan

Due to the apparent absence of an agent-specific nucleic acid genome, scrapie strains cannot be classified by genome characterization, which is commonly used for the classification of many viruses. However, scrapie strains can be distinguished to some extent by biological properties such as transmissibility to experimental animals and distribution of neuropathological lesions and by biochemical properties such as the molecular mass and relative protease-resistance of the disease-specific isoform of prion protein (PrP(Sc)). In order to preliminarily characterize the scrapie strains that are prevalent in Japan, we analyzed the transmissibility of sheep scrapie isolates to mice and the relative proteinase K (PK) resistance of the corresponding PrP(Sc). The results indicate that Japanese scrapie strains can be divided into at least three groups based on biological and biochemical properties. The first group includes isolates which cause disease in mice with an incubation period of approximately 400 days and possess PrP(Sc) with relatively high PK resistance. Isolates of the second group contain PrP(Sc) that is highly resistant to PK digestion but transmit poorly to mice. The final group consists of isolates that cause disease in mice with an incubation period of less than 300 days and are associated with PrP(Sc) with reduced PK resistance. Sheep scrapie has occurred sporadically in Japan since1982, with only approximately 60 officially reported cases so far. However, the diversity of scrapie strains in the field suggested by our data raises the concern that a scrapie strain similar to the parental agent of bovine spongiform encephalopathy could exist or emerge in Japan. Thus, continuous surveillance for scrapie will be required to prevent the further spread of scrapie, not only among the sheep population but also to other species, and to eliminate any potential risk of sheep scrapie to public health.     

下颈椎椎弓根放射影像学观察可描述椎弓根个性化特点及置钉相关性

背景：因颈椎椎弓根结构复杂以及形态变异大,术中个性化置钉需要简便、可靠的监测方法。 目的：通过放射影像学观察描述下颈椎椎弓根在X射线片上的影像特点,为在下颈椎椎弓根内安全置钉提供帮助,以减少并发症。 方法：制备10新鲜颈椎骨标本,以细钢丝缠绑在下颈椎椎弓根狭窄部,摄颈椎正、侧、斜位片,观察下颈椎椎弓根形态在不同投照位置中的变化。 结果与结论：X射线片中下颈椎椎弓根的正位片影像是椎体两侧倾斜的管状结构,椎弓根椭圆形截面的长轴向内倾斜。侧位片上椎弓根未被直接显示,仅为重叠在椎体后上壁的高密度影。斜位片清楚的显示了椎弓根狭窄部的4个侧壁及其截面形状。提示颈椎正、斜位片的椎弓根影像可以较好地反映下颈椎椎弓根的形态,对了解椎弓根个性化的特点及置钉有重要意义。     

The interface between bone and tendon at an insertion site: a study of the quadriceps tendon insertion

Traumatic avulsions of ligament or tendon insertions rarely occur at the actual interface with bone, which suggests that this attachment is strong or otherwise protected from injury by the structure of the insertion complex. In this study we describe the terminal extent of quadriceps tendon fibres where they insert into the patellae of adult rabbits, humans, dogs and sheep. Specimens were examined by scanning electron microscopy (SEM) and light microscopy (LM). To facilitate tracing of tendon fibres the specimens were decalcified for SEM, and polarised light microscopy (PLM) was used in the LM segment of the study. By SEM it was possible to identify mature bone by the presence of osteocytes and a lamellar organisation. PLM and SEM showed that, unlike tendon fibres elsewhere, those in the calcified fibrocartilage were not crimped. No specific cement line was identified by SEM. Tendon fibres interdigitated among separate bone lamellar systems, (osteons or marrow spaces), but did not merge with the collagen systems of individual lamellae. The interdigitation was more extensive and the margin between tendon and bone was less distinct in the anterior third of the insertion. The segment of calcified tendon which interdigitated with bone stained less intensely blue and was less cellular than the more proximal calcified fibrocartilage zone adjacent to the tidemark. Lamellar collagen fibres of the bony trabeculae in the anterior patella were unusually parallel and longitudinal in orientation, making distinction of interposed tendon fibres difficult on LM and PLM sections. LM, SEM and transmission electron microscopy of rabbit patellae at birth revealed that anterior quadriceps tendon fibres extended over the patella in a fibrous cellular layer. By 2 wk of age, this layer had acquired chondroid features (i.e. cell lacunae and metachromasia) and contained vessels extending from patellar marrow. At 6 wk of age, part of this fibrocartilaginous layer was replaced by mature bone and osteoid. In the young adult animal, the quadriceps tension interdigitates extensively with the patellar bone. This segment of the insertion is perhaps the remnant of calcified fibrocartilage which has been remodelled by bone formation.     

Effects of bone morphogenetic protein-2 and hyaluronic acid on the osseointegration of hydroxyapatite-coated implants: an experimental study in sheep

Research efforts aim at enhancing early osseointegration of cementless implants to improve early fixation and, thus, reduce the risk of loosening. The aim of the present study was to investigate whether bone morphogenetic protein (BMP) 2 had a positive effect on the osseointegration of hydroxyapatite-coated implants. Hydroxyapatite (HA) implants (perforated hollow cylinders and solid rods) were coated with BMP-2 and hyaluronic acid (HY) as the carrier or with HY alone. Uncoated HA implants served as controls. The osseointegration of the implants was evaluated either by light microscopy or by pullout tests after 1, 2, and 4 weeks of unloaded implantation in the cancellous bone of 24 sheep. The BMP-2 coating significantly increased bone growth into the implant perforations compared with HA-coated implants at 2 and 4 weeks. Bone-implant contact and interface shear strength of BMP-2 implants were lower than HA implants at 2 weeks. At 4 weeks, there was no significant difference in bone-implant contact and shear strength between BMP-2 and HA-coated implants. The BMP-2 coating enhanced gap healing but had no positive or even an inhibitory effect (at 2 weeks) on bone-implant contact and interface shear strength. In the clinical situation, a perfect press-fit implantation cannot be achieved, and BMP-2 may be beneficial for enhancing bone growth into gaps around cementless implants.     

Effect of bone mineral density and amorphous diamond coatings on insertion torque of bone screws

In this study, the potential of high-quality amorphous diamond (AD) coatings in reducing the torque and failures of bone screws was studied. Torque values were recorded for 32 stainless steel screws, 2.7 or 3.5 mm in diameter and 60 mm in length. Half of the screw sets were coated with the AD coating before installing in predrilled holes of human cadaveric femoral bone samples. The bone samples were selected from two groups of four persons with mean ages of 34 years (range 25-41 years) and 75 years (range 73-77 years), respectively. The bone mineral density (BMD) values of the samples were determined exactly at the screw insertion site by peripheral quantitative computed tomography (pQCT). In the mechanical tests, insertion and removal torques were measured. BMD had a significant effect on insertion torque; the maximum torque (adjusted with respect to the screw diameter) was significantly higher for the young bone than for the old bone (p < 0.05). By using a polished AD coating, insertion torque was decreased even up to 50% in comparison with the screws without coating. The results suggest that AD coating provides a stable, smooth surface and reduces the risk of screw failures.     

An automatic and patient-specific algorithm to design the optimal insertion direction of pedicle screws for spine surgery templates

Many diseases of the spine require surgical treatments that are currently performed based on the experience of the surgeon. For pedicle arthrodesis surgery, two critical factors must be addressed: Screws must be applied correctly and exposure to harmful radiation must be avoided. The incorrect positioning of the screws may cause operating failures that lead to subsequent reoperations, an increase in the overall duration of surgery and, therefore, more harmful, real-time X-ray checks. In this paper, the authors solve these problems by developing a method to realize a customized surgical template that acts as a drilling template. The template has two cylindrical guides that follow a correct trajectory previously calculated by means of an automatic algorithm generated on the basis of a vertebra CAD model for a specific patient. The surgeon sets the template (drilling guides) on the patient’s vertebra and safely applies the screws. Three surgical interventions for spinal stabilization have been performed using the template. These have had excellent results with regard to the accuracy of the screw positioning, reduction of the overall duration of the intervention, and reduction of the number of times the patient was exposed to X-rays.     

Biological glass coating on ceramic materials: in vitro evaluation using primary osteoblast cultures from healthy and osteopenic rat bone

ZrO2 and Al2O3 substrates were successfully coated by a double layer of a silica-based glass named RKKP, using a low-cost firing technique. RKKP is a glass well known for its bioactivity; therefore, a RKKP coating on Al2O3 or ZrO2, allows to combine the excellent mechanical properties of these strong ceramic substrates with its bioactivity. ZrO2 samples were easily coated using a double layer of RKKP by a simple enamelling technique. To accommodate the thermal expansion coefficient mismatch between Al2O3 and RK K P, this substrate was coated using a multilayered composite approach. All of the coatings were characterised from a morphological and compositional point of view, and an extensive biological evaluation was performed using fresh rat osteoblasts. Osteoblast primary cultures were derived from the trabecular bone of femoral condyles harvested from intact (NB) and osteopenic (OB) rats. After characterisation of their phenotype, osteoblasts were seeded on material samples of ZrO2 or Al2O3 coated with RKKP, and cultured for 7 days. Cell proliferation (MTT test) and cell differentiation (alkaline phosphatase activity) were evaluated at the end of the experiment, to assess osteoblast behaviour in the presence of biomaterials and determine if the results were related to the host bone quality. Results of both materials showed a good level of biocompatibility. In particular, MTT significant higher values were detected in NB cultures on ZrO2-RKKP samples; ALP activity significantly increased in NB cultures on Al2O3-RKKP and in OB cultures on both coated samples.     

Biological fate of tissue-engineered porcine valvular conduits xenotransplanted in the sheep thoracic aorta

The ideal prosthesis to replace the diseased human aortic valve is not yet available. We have previously shown that porcine acellular aortic-valve conduits, obtained by detergent-enzymatic method, display hemodynamic performances similar to those of their native counterparts. Hence, it seemed worthwhile to ascertain whether these tissue-engineered prostheses can be successfully xenotransplanted. Porcine acellular conduits, which immunocytochemistry demonstrated to lack MHC class I and II antigens, were implanted in the thoracic aorta of 9 sheep. Two animals died just after surgery, and the other 7 sheep were sacrificed 1 or 5 months after transplantation. A rather favorable outcome of the implant was observed in 4 sheep. In these animals, aortic valves remained pliable and coaptive, and the luminal surface of the conduits was endothelized just after one month from surgery. An intense inflammatory response was present at 1 month, and, although attennuated, it persisted for 5 months, located mainly between the tunica intima and media and at the border of the implant. Vimentin-positive and smooth muscle actin-positive myofibroblasts proliferated within tunica media and adventitia, and an obvious thickening of the tunica intima was also observed. Small vessels were seen in the adventitia, and elastic fibers were well-preserved in both the aorta wall and valve leaflets. In the cases of unfavorable outcome (3 of 7 survived sheep), implants were detached from the aorta recipient and surrounded by a connective mass that almost completely obstructed their lumen. These masses were composed of a fibromyxoid background where proliferating cells, resembling those occurring in human reactive myofibroblastic lesions (proliferative fascitis), were embedded. Collectively, these rather disappointing findings indicate that acellular valve conduits, obtained by the detergent-enzymatic method, are presently not suitable for clinical applications because of the persistent inflammatory response, which conceivably triggers overgrowth mechanisms that lead to implant failure.     

The effect of screw insertion angle and thread type on the pullout strength of bone screws in normal and osteoporotic cancellous bone models

Screw fixation can be extremely difficult to achieve in osteoporotic (OP) bone because of its low strength. This study determined how pullout strength is affected by placing different bone screws at varying angles in normal and OP bone models. Pullout tests of screws placed axially, and at angles to the pullout axis (ranging from 10° to 40°), were performed in 0.09 g cm^?3, 0.16 g cm^?3 and 0.32 g cm^?3 polyurethane (PU) foam. Two different titanium alloy bone screws were used to test for any effect of thread type (i.e. cancellous or cortical) on the screw pullout strength. The cancellous screw required a significantly higher pullout force than the cortical screw (p < 0.05). For both screws, pullout strength significantly increased with increasing PU foam density (p < 0.05). For screws placed axially, and sometimes at 10°, the observed mechanism of failure was stripping of the internal screw threads generated within the PU foam by screw insertion. For screws inserted at 10°, 20°, 30° and 40°, the resistance to pullout force was observed to be by compression of the PU foam material above the angled screw; clinically, this suggests that compressed OP bone is stronger than unloaded OP bone.     

The ovariectomised sheep as a model for testing biomaterials and prosthetic devices in osteopenic bone: a preliminary study on iliac crest biopsies

A histomorphometric and ultrastructural evaluation on sheep iliac bone was performed. Six sheep were ovariectomised (OVX Group) and 6 were left intact (Sham-aged, Control Group). An iliac crest biopsy was performed randomly in 6 animals at the beginning of the study, then, in all the animals, after 12 and 24 months. A significant decrease in trabecular bone volume, trabecular thickness (p<0.0005) and cell volume (p<0.005) was observed in OVX animals. A modest decrease in trabecular number and osteoid thickness together with an increase in trabecular separation were observed in OVX animals at 12 and 24 months. The osteoid volume showed a significant difference (p<0.05) between the groups. In OVX animals, at 12 months, Scanning Electron Microscopy revealed an enlargement of the trabecular space and a progressive replacement of bone matrix with adipose tissue. These signs were accentuated at 24 months. In conclusion, OVX sheep showed a loss of trabecular bone starting at 12 months after ovariectomy. The developed osteopenic state may be considered as a useful tool when doing research on biomaterial osteointegration.