Contact Mechanics and Failure Modes of Compliant Polymeric Bearing Materials for Knee Cartilage Replacemen

Osteoarthritis (OA) is the most common cause of disability affecting millions of people worldwide. Total knee replacement is the current state-of-the-art treatment to alleviate pain and improve mobility among patients in the late stage of knee OA. The current gold standard materials for total knee arthroplasty are cobalt-chromium and ultra-high molecular weight polyethylene (UHMWPE). However, wear debris and implant loosening-related revision persists; consequently, total knee replacements are not universally recommended for all patient subgroups with OA. This work explores the potential of using compliant polymeric materials in knee cartilage replacement devices, which are closer in lubrication and mechanical properties of articular cartilage, to prevent excessive removal of underlying bone and prolong the need for a total knee replacement. Two materials investigated in this thesis are polycarbonate urethane, Bionate 80A, and a novel hydrogel, Cyborgel, both of which have shown promising wear and lubrication properties under physiological loads. Polycarbonate urethane has been previously tested for the effects of gamma sterilization and has shown no significant changes in its mechanical strength or chemical bonds. Since an important aspect of medical device development is the sterilization process, this thesis first evaluated the effect of 30-35 kGy electron beam and gamma radiation on the polymer swell ratio, and the mechanical, chemical and tribological behavior of the novel hydrogel. Three different formulations were mechanically tested, and biphasic material properties were identified using finite element analysis. Fourier transform infrared spectroscopy was used to investigate chemical changes, while the wear properties were tested for 2 million cycles in bovine serum. The results showed no significant difference (p > 0.05) in the swell ratio, mechanical and tribological properties of the electron beam and gamma sterilized hydrogel sample as compared to the control samples. However, chemical spectra of electron beam sterilized samples revealed minor changes, which were absent in unsterilized and gamma sterilized samples. Upon successful sterilization evaluation, both polycarbonate urethane and the novel hydrogel were investigated for the contact mechanics of compliant-on-compliant artificial knee bearings using a finite element analysis approach. A simplified, axisymmetric, finite element model of a medial knee compartment was developed and validated, and a design of simulation experiments was carried out to evaluate the effect of implant conformity, implant thickness and material properties on the contact mechanics of compliant knee bearings under normal walking and stair climbing loads. All input parameters, namely, implant conformity, implant thickness and material properties, significantly (p<0.001) affected the maximum principal stress, Von Mises stress, maximum shear stress, maximum principal strain, maximum contact pressure and contact area. The knee implant contact mechanics demonstrated sensitivity to all the three design factors, and a correlation between resulting stresses and implant conformity as well as thickness was observed. However, the conformity had the highest effect-size on the contact mechanics. The maximum principal stress value halves and the contact area doubles when ? 95% implant conformity (i.e. the ratio of femoral to tibial surface's radii of curvature) and ? 3mm thickness was used, hence, these parameters were recommended for the design of compliant knee bearings. Finally, a battery of mechanical tests was carried out to evaluate the failure criteria of the proposed compliant polymers under physiological loads and strain rates. Uniaxial tests, including tension and unconfined compression, and biaxial tests, such as plane strain compression, were carried out to characterize the mechanical behavior of different material formulations at physiologically relevant testing rates. The materials failed under tension between 250 -- 750% true strain, while those under uniaxial and biaxial compression test sustained compression of 50 - 70% engineering strain (39 - 53% true strain) without any signs of cracking or fracture. The tension was determined to be the primary failure mode for the proposed materials, and the tensile test was used to define the failure criteria of the materials. The unconfined compression tests were used to define the yield stresses and strains under compression, which is the main mode of loading for the knee joint. The results of the plane strain compression were modeled using a finite element model and the maximum principal stress, von Mises stress, maximum shear stress, and maximum principal strain failure criteria were predicted at the corresponding yield strain of each material formulation. Upon comparing the knee model contact stress and strain prediction under normal walking and stair climbing loads with those of the empirical failure criteria at yield, the polycarbonate urethane showed better overall potential for use in compliant knee implants, while the hydrogels exhibited higher potential for delamination or fracture, especially if appropriate implant conformity and thickness are not employed. The outcome of this study and the previous parametric model results helped to determine a niche design space within which designing a knee implant with compliant bearing materials may be feasible. In summary, the potential of compliant bearing materials was thoroughly examined in this thesis, and the results provided a foundation for future testing and development of a compliant cartilage replacement implant. Such an implant would be a promising improvement and alternative to conventional total knee replacements.