Ion release in ceramic bearings for total hip replacement: Results from an in vitro and an in vivo study.

INTRODUCTION: Literature on the potential release of trace elements following implantation of Zirconia-platelet toughened alumina (ZPTA) ceramic components is scant. The present study therefore analysed the in vitro and in vivo potential release of ions from ZPTA bearings. MATERIAL AND METHODS: An in vitro and in vivo study was conducted. The in vitro study compared leaching in bovine serum from two groups: ZPTA ceramic heads and Co-28Cr-6Mo alloy heads, both 28-mm diameter. A third group without implant served as reference group. An in vivo clinical study compared trace elements in the whole blood of patients with 36-mm diameter ZPTA ceramic-on-ceramic articulation after three and 12 months. A cohort of subjects without any prosthesis was used as control group. The release of ions was determined by high resolution-inductively coupled plasma-mass spectrometry. RESULTS: In the in vitro experiment, significant differences (p ≤ 0.01) in trace element release for chromium, cobalt and molybdenum were found, with increased levels of ion release in the Co-28Cr-6Mo metal group. The very low detection limit for yttrium allowed detection of a small yttrium release from the ZPTA heads, which was not confirmed by the in vivo study. No significant difference between the groups was found for strontium, aluminium, and zirconium. In the in vivo study, no relevant differences in ion levels between the reference group without any implant and the study group were found at the three and 12-month follow-up. CONCLUSION: This study supports that ZPTA ceramic articulation components are safe in terms of ion release, and may be an excellent alternative to bearings based on Co-28Cr-6Mo alloys.

Development and validation of patient-specific finite element models of the hemipelvis generated from a sparse CT data set.

To produce a patient-specific finite element (FE) model of a bone such as the pelvis, a complete computer tomographic (CT) or magnetic resonance imaging (MRI) geometric data set is desirable. However, most patient data are limited to a specific region of interest such as the acetabulum. We have overcome this problem by providing a hybrid method that is capable of generating accurate FE models from sparse patient data sets. In this paper, we have validated our technique with mechanical experiments. Three cadaveric embalmed pelves were strain gauged and used in mechanical experiments. FE models were generated from the CT scans of the pelves. Material properties for cancellous bone were obtained from the CT scans and assigned to the FE mesh using a spatially varying field embedded inside the mesh while other materials used in the model were obtained from the literature. Although our FE meshes have large elements, the spatially varying field allowed them to have location dependent inhomogeneous material properties. For each pelvis, five different FE meshes with a varying number of patient CT slices (8-12) were generated to determine how many patient CT slices are needed for good accuracy. All five mesh types showed good agreement between the model and experimental strains. Meshes generated with incomplete data sets showed very similar stress distributions to those obtained from the FE mesh generated with complete data sets. Our modeling approach provides an important step in advancing the application of FE models from the research environment to the clinical setting.

Nanosurfaces and nanostructures for artificial orthopedic implants.

Nanomaterials and structures, such as nanoparticles, nanofibers, nanosurfaces, nanocoatings, nanoscaffolds and nanocomposites, are considered for various applications in orthopedics and traumatology. This review looks at proposed nanotechnology inspired applications for implants from the perspective of the orthopedic industry. Investigations support consistently the theory that most nanomaterials in various physical forms are able to enhance the cell response selectively for biological tissue integration or increase the strength and wear resistance of current orthopedic materials. At this stage, most of the studies are at the laboratory scale or in early in vivo testing. Significant basic and applied research and development is needed to realize their full clinical potential and biological, manufacturing, economic and regulatory issues have to be addressed. Nevertheless, a crucial factor for success is well-coordinated multimethod and multidiscipline teamwork with profound industrial and medical expertise.

The use of sparse CT datasets for auto-generating accurate FE models of the femur and pelvis.

The finite element (FE) method when coupled with computed tomography (CT) is a powerful tool in orthopaedic biomechanics. However, substantial data is required for patient-specific modelling. Here we present a new method for generating a FE model with a minimum amount of patient data. Our method uses high order cubic Hermite basis functions for mesh generation and least-square fits the mesh to the dataset. We have tested our method on seven patient data sets obtained from CT assisted osteodensitometry of the proximal femur. Using only 12 CT slices we generated smooth and accurate meshes of the proximal femur with a geometric root mean square (RMS) error of less than 1 mm and peak errors less than 8 mm. To model the complex geometry of the pelvis we developed a hybrid method which supplements sparse patient data with data from the visible human data set. We tested this method on three patient data sets, generating FE meshes of the pelvis using only 10 CT slices with an overall RMS error less than 3 mm. Although we have peak errors about 12 mm in these meshes, they occur relatively far from the region of interest (the acetabulum) and will have minimal effects on the performance of the model. Considering that linear meshes usually require about 70-100 pelvic CT slices (in axial mode) to generate FE models, our method has brought a significant data reduction to the automatic mesh generation step. The method, that is fully automated except for a semi-automatic bone/tissue boundary extraction part, will bring the benefits of FE methods to the clinical environment with much reduced radiation risks and data requirement.

Severe wear and fracture of zirconia heads against alumina inserts in hip simulator studies with microseparation.

The wear of zirconia femoral heads against alumina acetabular inserts with swing-phase microseparation was investigated in a hip joint simulator. Under mild microseparation conditions, the wear was very low, with an average wear rate of 0.05 mm(3)/million cycles reported over 5 million cycles of testing. However, under severe microseparation conditions representative of greater joint laxity, the wear rate of zirconia against alumina increased by 2 orders of magnitude, producing severe wear and, in one case, femoral head fracture. The adverse results of this study indicate that the combination of a zirconia femoral head articulating against an alumina acetabular insert is not recommended for clinical use. The results further raise concerns over the suitability of conventional simulators in evaluating the wear of ceramic hip prostheses.

Long-term wear of ceramic matrix composite materials for hip prostheses under severe swing phase microseparation.

The purpose of this study was to evaluate the long-term wear performance of alumina matrix composite (AMC) heads against alumina matrix composite inserts and alumina matrix composite heads against alumina (Al) inserts with the use of a hip-joint simulator incorporating severe swing phase joint microseparation. The wear of AMC on Al produced an average wear rate of 0.61 mm3/million cycles over the 5-million-cycle test duration. The wear of AMC on AMC produced an average wear rate of 0.16 mm3/million cycles over the 5-million-cycle test duration. Both the AMC on alumina and AMC on AMC produced significantly lower wear than previously tested HIPed alumina, where an average wear rate of 1.84 mm3/million cycles was reported over 5 million cycles. The wear mechanisms and wear debris of AMC on AMC and AMC on Al were similar to those observed in previous alumina retrieval studies with stripe wear caused by intragranular fracture and wear debris consisting of predominantly uniform 10-20-nm-sized particles and a few irregular particles up to 3 microm in size.