Article

Development and validation of a canine radius replica for mechanical testing of orthopedic implants

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Abstract

To design and fabricate fiberglass-reinforced composite (FRC) replicas of a canine radius and compare their mechanical properties with those of radii from dog cadavers. Replicas based on 3 FRC formulations with 33%, 50%, or 60% short-length discontinuous fiberglass by weight (7 replicas/group) and 5 radii from large (> 30-kg) dog cadavers. Bones and FRC replicas underwent nondestructive mechanical testing including 4-point bending, axial loading, and torsion and destructive testing to failure during 4-point bending. Axial, internal and external torsional, and bending stiffnesses were calculated. Axial pullout loads for bone screws placed in the replicas and cadaveric radii were also assessed. Axial, internal and external torsional, and 4-point bending stiffnesses of FRC replicas increased significantly with increasing fiberglass content. The 4-point bending stiffness of 33% and 50% FRC replicas and axial and internal torsional stiffnesses of 33% FRC replicas were equivalent to the cadaveric bone stiffnesses. Ultimate 4-point bending loads did not differ significantly between FRC replicas and bones. Ultimate screw pullout loads did not differ significantly between 33% or 50% FRC replicas and bones. Mechanical property variability (coefficient of variation) of cadaveric radii was approximately 2 to 19 times that of FRC replicas, depending on loading protocols. Within the range of properties tested, FRC replicas had mechanical properties equivalent to and mechanical property variability less than those of radii from dog cadavers. Results indicated that FRC replicas may be a useful alternative to cadaveric bones for biomechanical testing of canine bone constructs.

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Objectives— To compare the pullout properties of 3.5‐mm AO/ASIF self‐tapping screws (STS) to corresponding standard cortex screws (CS) in a uniform synthetic test material and in canine femoral bone. The influence of screw‐insertion technique, test material, and test‐material thickness were also assessed. Study Design— In vitro experimental study. Sample Population— Two independent studies: a uniform synthetic test material and paired femurs from mature dogs. Methods— Mechanical testing was performed in accordance with standards established by the American Society for Testing and Materials for determination of axial pullout strength of medical bone screws. Completely inserted STS, completely inserted CS, and incompletely inserted STS were tested in 3 groups of 10 test specimens each in 4.96‐mm and 6.8‐mm thick sheets of synthetic material. In the bone study, group 1 consisted of 24 completely inserted STS compared with 24 completely inserted CS, and group 2 consisted of 24 incompletely inserted STS versus 24 completely inserted CS. Comparisons were made between paired femurs at corresponding insertion sites. Pullout data were normalized, thereby eliminating the effect of test‐material thickness on pullout properties. Mean values were compared using 2‐way ANOVA. Statistical significance was set at P < .05 . Results— In both the 4.96‐mm and 6.8‐mm synthetic material, pullout testing of the completely inserted STS demonstrated significantly greater yield strength and ultimate strength than completely inserted CS. There was no significant difference between incompletely inserted STS and completely inserted STS. The 6.8‐mm test material significantly increased yield strength and ultimate strength for all test groups compared with the 4.96‐mm test material. In canine bone, there was no significant difference in yield strength of completely inserted STS and completely inserted CS. Yield strength of completely inserted STS and completely inserted CS were significantly greater than incompletely inserted STS. Conclusions— Pullout properties of completely inserted STS were significantly greater than corresponding CS in a uniform test material. In canine bone, the pullout strength of STS and CS were not different. Incomplete STS insertion resulted in an 18% reduction in holding power as compared with completely inserted CS and STS in canine bone. Clinical Relevance— The length of STS used in canine bone should be such that the cutting flutes extend beyond the trans cortex to maximize pullout strength.
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The purpose of this study was to compare the structural properties of a new vs. established design of composite replicate femurs and tibias. The new design has a cortical bone analog consisting of short-glass-fiber-reinforced (SGFR) epoxy, rather than the fiberglass-fabric-reinforced (FFR) epoxy in the currently available design. The hypothesis was that this new cortical bone analog would improve the uniformity of structural properties between specimens, while having mean stiffness values in the range of natural human bones. The composite replicate bones were tested under bending, axial, and torsional loads. In general, the new SGFR bones were significantly less stiff than the FFR bones, although both bone designs reasonably approximated the structural stiffnesses of natural human bones. With the exceptions of the FFR bone axial tests, the highest variability between specimens was 6.1%. The new SGFR bones had similar variability in structural properties when compared to the FFR bones under bending and torsional loading, but had significantly less variability under axial loading. Differences in epiphyseal geometry between the FFR and SGFR bones, and subsequent seating in the testing fixtures, may account for some of the differences in structural properties; axial stiffness was especially dependent on bone alignment. Stiffness variabilities for the composite replicate bones were much smaller than those seen with natural human bones. Axial strain distribution along the proximal-medial SGFR femur had a similar shape to what was observed on natural human femurs by other investigators, but was considerably less stiff in the more proximal locations.
Article
To evaluate the fatigue life of stacked and single, veterinary cuttable plates (VCP) and small, limited contact, dynamic compression plates (LC-DCP). In vitro biomechanical study. Fracture models (constructs; n = 8) were assembled for each of 6 groups all with 8-hole plates: 2.0 mm LC-DCP; 2.4 mm LC-DCP; single 1.5/2.0 mm VCP; stacked 1.5/2.0 mm VCP; single 2.0/2.7 mm VCP; and stacked 2.0/2.7 mm VCP. Plate(s) were secured to 2 polyvinylchloride pipe lengths, mounted in a testing system with a custom jig, and subjected to axial loading (10-100 N) for 1,000,000 cycles at 10 Hz or until failure. Differences in number of cycles to failure among groups were compared. Failure mode was determined. All LC-DCP and single VCP constructs failed before 1,000,000 cycles. Stacked 2.0/2.7 mm VCP constructs withstood 1,000,000 cycles without failure. ANOVA and Fisher's least significant difference tests demonstrated significantly more cycles to failure for the stacked 1.5/2.0 mm VCP and stacked 2.0/2.7 mm VCP compared with the single 1.5/2.0 mm VCP, single 2.0/2.7 mm VCP, 2.0 mm LC-DCP, or 2.4 mm LC-DCP. Constructs that failed did so through a screw hole adjacent to the gap. Stacked VCP constructs have greater fatigue lives than comparably sized LC-DCP or single VCP constructs. Plates with 2.4 mm screws were not significantly different from the comparable construct with 2.0 mm screws. Although these data reveal that stacked VCP create a superior construct with respect to cyclic fatigue, surgeons must decide whether this is a clinical advantage on a case-by-case basis.
Article
The relevance of Finite-Element models for hip fracture prediction should be increased by the recent subject-specific methods based on computed tomography (CT-scan), regarding the geometry as well as the material properties. The present study focused on the prediction of subject-specific mechanical parameters of cortical bone (Young's modulus and ultimate strength) from the bone density measured by CT. A total of 46 compression and 46 tension samples from 13 donors (mean age+/-S.D.: 81.8+/-12.7 years) were harvested in the femoral mid-diaphysis and tested until failure. The Young's modulus and ultimate strength were linearly correlated with the bone density measured by CT, for tension as well as compression (0.43<r(2)<0.72, p<0.001). To take into account the remaining uncertainties on the mechanical properties prediction, the standard error of the estimate (S.E.E.) was evaluated in each case (2694-2788MPa for Young's modulus, 13-16MPa for ultimate strength). The significant correlations obtained in the present study and the quantification of the errors will be helpful for the assessment of the cortical mechanical properties from the CT-scan data in order to create subject-specific FE-models.
Article
Third-generation mechanical analogue bone models and synthetic analogue cortical bone materials manufactured by Pacific Research Laboratories, Inc. (PRL) are popular tools for use in mechanical testing of various orthopedic implants and biomaterials. A major issue with these models is that the current third-generation epoxy-short fiberglass based composite used as the cortical bone substitute is prone to crack formation and failure in fatigue or repeated quasistatic loading of the model. The purpose of the present study was to compare the tensile and fracture mechanics properties of the current baseline (established PRL "third-generation" E-glass-fiber-epoxy) composite analogue for cortical bone to a new composite material formulation proposed for use as an enhanced fourth-generation cortical bone analogue material. Standard tensile, plane strain fracture toughness, and fatigue crack propagation rate tests were performed on both the third- and fourth-generation composite material formulations using standard ASTM test techniques. Injection molding techniques were used to create random fiber orientation in all test specimens. Standard dog-bone style tensile specimens were tested to obtain ultimate tensile strength and stiffness. Compact tension fracture toughness specimens were utilized to determine plane strain fracture toughness values. Reduced thickness compact tension specimens were also used to determine fatigue crack propagation rate behavior for the two material groups. Literature values for the same parameters for human cortical bone were compared to results from the third- and fourth-generation cortical analogue bone materials. Tensile properties of the fourth-generation material were closer to that of average human cortical bone than the third-generation material. Fracture toughness was significantly increased by 48% in the fourth-generation composite as compared to the third-generation analogue bone. The threshold stress intensity to propagate the crack was much higher for the fourth-generation material than for the third-generation composite. Even at the higher stress intensity threshold, the fatigue crack propagation rate was significantly decreased in the fourth-generation composite compared to the third-generation composite. These results indicate that the bone analogue models made from the fourth-generation analogue cortical bone material may exhibit better performance in fracture and longer fatigue lives than similar models made of third-generation analogue cortical bone material. Further fatigue testing of the new composite material in clinically relevant use of bone models is still required for verification of these results. Biomechanical test models using the superior fourth-generation cortical analogue material are currently in development.
Article
The objective was to determine signalment-related differences in bone mineral content (BMC) and bone mineral density (BMD) in dogs. Unilateral appendicular bones were harvested from 62 canine cadavers. Mid-diaphyseal regions of interest (ROIs) were scanned using a Hologic DXA device Braincon, Vienna, Austria). BMC and BMD were calculated within this region. Middle-aged dogs (3-10 years) revealed the highest BMC and BMD levels. Mean BMC and BMD were higher in males compared to females. Furthermore, body-weight of the male dogs was significantly higher compared to the females (P < 0.0001). Body weight and bone length were significantly associated with BMC and BMD (P < or = 0.023) in all bones but the radius. These data suggest that BMC and BMD appear to be highest in male large-breed dogs with a body weight greater than 30 kg. These results may help determine risk factors in fracture development and healing.
Article
To design and manufacture custom titanium bone plates and a custom cutting and drill guide by use of free-form fabrication methods and to compare variables and mechanical properties of 2 canine tibial plateau leveling methods with each other and with historical control values. 10 canine tibial replicas created by rapid prototyping methods. Application time, accuracy of correction of the tibial plateau slope (TPS), presence and magnitude of rotational and angular deformation, and replica axial stiffness for 2 chevron wedge osteotomy (CWO) methods were assessed. One involved use of freehand CWO (FHCWO) and screw hole drilling, whereas the other used jig-guided CWO (JGCWO) and screw hole drilling. Replicas used for FHCWO and JGCWO methods had similar stiffness. Although JGCWO and FHCWO did not weaken the replicas, mean axial stiffness of replicas after JGCWO was higher than after FHCWO. The JGCWO method was faster than the FHCWO method. Mean +/- SD TPS after osteotomy was lower for FHCWO (4.4 +/- 1.1 degrees ) than for JGCWO (9.5 +/- 0.4 degrees ), and JGCWO was more accurate (target TPS, 8.9 degrees ). Slight varus was evident after FHCWO but not after JGCWO. Mean postoperative rotation after JGCWO and FHCWO did not differ from the target value or between methods. The JGCWO method was more accurate and more rapid and resulted in more stability than the FHCWO method. Use of custom drill guides could enhance the speed, accuracy, and stability of corrective osteotomies in dogs.
Basic facilities and instruments for mechanical testing of bone
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