Resonance Frequency Analysis Identifies Implant- and Host-Related Factors Associated With Bone-Anchored Hearing Implant Stability.

HYPOTHESIS: Resonance frequency analysis (RFA) is a reliable, noninvasive method to assess the stability of bone-anchored hearing implants (BAHIs), although surgical-, implant-, and host-related factors can affect its outcome. BACKGROUND: BAHI plays an important role in restoring hearing function. However, implant- and host-related factors contribute to premature implant extrusion. To mitigate this, noninvasive methods to assess implant stability, along with a better understanding of factors contributing to BAHI failure, are needed. METHODS: We evaluated the utility of RFA to quantify implant stability in sawbone (bone mimicking material), 29 human cadaveric samples, and a prospective cohort of 29 pediatric and 27 adult participants, and identified factors associated with implant stability. To validate the use of RFA in BAHI, we compared RFA-derived implant stability quotient (ISQ) estimates to peak loads obtained from mechanical push-out testing. RESULTS: ISQ and peak loads were significantly correlated (Spearman rho = 0.48, p = 0.0088), and ISQ reliably predicted peak load up to 1 kN. We then showed that in cadaveric samples, abutment length, internal table bone volume, and donor age were significantly associated with implant stability. We validated findings in our prospective patient cohort and showed that minimally invasive Ponto surgery (MIPS; versus linear incision), longer implantation durations (>16 wk), older age (>25 yr), and shorter abutment lengths (≤10 mm) were associated with better implant stability. Finally, we characterized the short-term reproducibility of ISQ measurements in sawbone and patient implants. CONCLUSIONS: Together, our findings support the use of ISQ as a measure of implant stability and emphasize important considerations that impact implant stability, including surgical method, implant duration, age, and abutment lengths.

A numerical study of dehydration induced fracture toughness degradation in human cortical bone.

A 2D plane strain extended finite element method (XFEM) model was developed to simulate three-point bending fracture toughness tests for human bone conducted in hydrated and dehydrated conditions. Bone microstructures and crack paths observed by micro-CT imaging were simulated using an XFEM damage model. Critical damage strains for the osteons, matrix, and cement lines were deduced for both hydrated and dehydrated conditions and it was found that dehydration decreases the critical damage strains by about 50%. Subsequent parametric studies using the various microstructural models were performed to understand the impact of individual critical damage strain variations on the fracture behavior. The study revealed the significant impact of the cement line critical damage strains on the crack paths and fracture toughness during the early stages of crack growth. Furthermore, a significant sensitivity of crack growth resistance and crack paths on critical strain values of the cement lines was found to exist for the hydrated environments where a small change in critical strain values of the cement lines can alter the crack path to give a significant reduction in fracture resistance. In contrast, in the dehydrated state where toughness is low, the sensitivity to changes in critical strain values of the cement lines is low. Overall, our XFEM model was able to provide new insights into how dehydration affects the micromechanisms of fracture in bone and this approach could be further extended to study the effects of aging, disease, and medical therapies on bone fracture.

Impact of heavy alcohol consumption on cortical bone mechanical properties in male rhesus macaques.

Chronic heavy alcohol consumption may influence the skeleton by suppressing intracortical bone remodeling which may impact the quality of bone and its mechanical properties. However, this aspect has not been thoroughly assessed in either humans or animal models whose cortical bone microstructure resembles the microstructure of human cortical bone. The current study is the first to investigate the effects of chronic heavy alcohol consumption on various mechanical properties of bone in a non-human primate model with intracortical remodeling. Male rhesus macaques (5.3 years old at the initiation of treatment) were induced to drink alcohol and then given the choice to voluntarily self-administer water or ethanol (4 % w/v) for approximately 14 months, followed by three abstinence phases (lasting 34, 41, and 39-46 days) with approximately 3 months of ethanol access in between. During the initial 14 months of open-access, monkeys in the alcohol group consumed an average of 2.9 ± 0.8 g/kg/d ethanol (mean ± SD) resulting in a blood ethanol concentration of 89 ± 47 mg/dl in longitudinal samples taken at 7 h after the daily sessions began. To understand the impact of alcohol consumption on material properties, various mechanical tests were conducted on the distal tibia diaphysis of 2-5 monkeys per test group, including dynamic mechanical analysis (DMA) testing, nano-indentation, microhardness testing, compression testing, and fracture resistance curve (R-curve) testing. Additionally, compositional analyses were performed using Fourier-transform infrared (FTIR) spectroscopy. Significant differences in microhardness, compressive stress-strain response, and composition were not observed with alcohol consumption, and only minor differences were detected in hardness and elastic modulus of the matrix and osteons from nanoindentation. Furthermore, the R-curves of both groups overlapped, with similar crack initiation toughness, despite a significant decrease in crack growth toughness (p = 0.032) with alcohol consumption. However, storage modulus (p = 0.029) and loss factor (p = 0.015) from DMA testing were significantly increased in the alcohol group compared to the control group, while loss modulus remained unchanged. These results indicate that heavy alcohol consumption may have only a minor influence on the material properties and the composition of cortical bone in young adult male rhesus macaques.

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.

When Cortical Bone Matrix Properties Are Indiscernible between Elderly Men with and without Type 2 Diabetes, Fracture Resistance Follows Suit.

Type 2 diabetes mellitus (T2DM) is a metabolic disease affecting bone tissue and leading to increased fracture risk in men and women, independent of bone mineral density (BMD). Thus, bone material quality (i.e., properties that contribute to bone toughness but are not attributed to bone mass or quantity) is suggested to contribute to higher fracture risk in diabetic patients and has been shown to be altered. Fracture toughness properties are assumed to decline with aging and age-related disease, while toughness of human T2DM bone is mostly determined from compression testing of trabecular bone. In this case-control study, we determined fracture resistance in T2DM cortical bone tissue from male individuals in combination with a multiscale approach to assess bone material quality indices. All cortical bone samples stem from male nonosteoporotic individuals and show no significant differences in microstructure in both groups, control and T2DM. Bone material quality analyses reveal that both control and T2DM groups exhibit no significant differences in bone matrix composition assessed with Raman spectroscopy, in BMD distribution determined with quantitative back-scattered electron imaging, and in nanoscale local biomechanical properties assessed via nanoindentation. Finally, notched three-point bending tests revealed that the fracture resistance (measured from the total, elastic, and plastic J-integral) does not significantly differ in T2DM and control group, when both groups exhibit no significant differences in bone microstructure and material quality. This supports recent studies suggesting that not all T2DM patients are affected by a higher fracture risk but that individual risk profiles contribute to fracture susceptibility, which should spur further research on improving bone material quality assessment in vivo and identifying risk factors that increase bone fragility in T2DM. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.