Jeffrey P Little’s research while affiliated with North Carolina State University and other places

Purpose – The aim of this study is to describe an improved experimental substrate for the mechanical testing of patient-specific implants fabricated using direct metal additive manufacturing processes. This method reduces variability and sample size requirements and addresses the importance of geometry at the bone/implant interface. Design/methodology/approach – Short-fiber glass/resin materials for cortical bone and polyurethane foam materials for cancellous bone were evaluated using standard tensile coupons. A method for fabricating bone analogs with patient-specific geometries using rapid tooling is presented. Bone analogs of a canine radius were fabricated and compared to cadaveric specimens in several biomechanical tests as validation. Findings – The analog materials exhibit a tensile modulus that falls within the range of expected values for cortical and cancellous bone. The tensile properties of the cortical bone analog vary with fiber loading. The canine radius models exhibited similar mechanical properties to the cadaveric specimens with a reduced variability. Research limitations/implications – Additional replications involving different bone geometries, types of bone and/or implants are required for a full validation. Further, the materials used here are only intended to mimic the mechanical properties of bone on a macro scale within a relatively narrow range. These analog models have not been shown to address the complex microscopic or viscoelastic behavior of bone in the present study. Originality/value – Scientific data on the formulation and fabrication of bone analogs are absent from the literature. The literature also lacks an experimental platform that matches patient-specific implant/bone geometries at the bone implant interface.

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.

The performance of orthopedic implants is often evaluated using cadaveric bone specimens. The high inter-specimen variability of cadaveric bone properties requires large sample sizes to obtain statistical significance. With recent focus on custom implants manufactured using direct metal freeform fabrication techniques, the need for a customized bone analog model is recognized. Data for bone geometry and internal structure were obtained from computed-tomography imaging. Traditional rapid prototyping techniques are then used to generate the rapid tooling from which composite bones that mimic the properties of the real bone can be duplicated. This work focused on the manufacturing process of bone analog models.